Challenges with NDA’s In the Digital Age

Celebrating Mother’s Day: Honouring the Ingenious Contributions of Mother Inventors

May 12, 2024 | General

Mother’s Day is celebrated to express love, appreciation, and gratitude towards Mothers and Mother figures for their unconditional love, support, and sacrifices. It is not only a time to express gratitude for the nurturing mothers in our lives but also an opportunity to celebrate their remarkable achievements and contributions to the world. While we often acknowledge mothers for their caregiving roles, it’s equally important to recognize their ingenuity and innovative spirit. Throughout history, countless Mothers have made significant contributions to the world of invention, leaving a lasting impact on society. This Mother’s Day, let us delve into the fascinating realm of mother inventors and explore a few of their groundbreaking creations.

The Pioneering Legacy of Mother Inventors

In the vast landscape of invention, certain individuals stand out not only for their groundbreaking creations but also for the barriers they shattered and the paths they forged. Among these pioneers are Mothers whose ingenuity and determination have left an indelible mark on history. From revolutionizing industries to empowering communities, these remarkable women have paved way for innovators and are inspiring generations to come.

From household conveniences to groundbreaking technologies, Mother inventors have played a pivotal role in shaping our daily lives. Despite facing numerous challenges and juggling multiple responsibilities, these remarkable women have demonstrated exceptional creativity and resilience. Their inventions have not only simplified tasks but have also revolutionized industries and sparked new avenues of innovation.

Let us explore a few innovative contributions by Mother Inventors.

1. The Disposable Diaper, invented by Marion Donovan

 Marion Donovan, a mother of two, revolutionized infant care with her invention of the disposable diaper. In the late 1940s and early 1950s, Donovan, a mother frustrated with the inconvenience of cloth diapers, set out to create a more practical and convenient alternative. Donovan’s first breakthrough came when she developed a waterproof covering for cloth diapers using shower curtains. This innovation helped to prevent leaks and made diaper changes easier. Building on this idea, she then created the first disposable diaper prototype using layers of absorbent material, a waterproof outer layer, and a fastening system to keep the diaper in place. In 1951, Marion Donovan patented her disposable diaper design, known as the “Boater.” The disposable diaper revolutionized childcare practices by providing a more hygienic, convenient, and time-saving option for parents. Since Donovan’s initial invention, disposable diapers have undergone numerous improvements and innovations, including the introduction of elastic leg cuffs, resealable fasteners, and advanced absorbent materials. Today, disposable diapers are a staple product for parents around the world, offering convenience and comfort for both babies and caregivers.

2. Glass Bead Liquid Culture Technology, invented by Dr. Seema Prakash.

Dr. Seema Prakash, a mother of two from Uttar Pradesh, invented Glass Bead Liquid Culture Technology (GBLCT). With Glass Bead Liquid Culture Technology (GBLCT), sterilized glass beads and liquid nutrients are used to replace the agar as the culture medium, where by using the glass beads, the cost of the media is brought down by 94% on a per plant basis. Glass Bead Liquid Culture Technology is different from traditional tissue culture, as traditional tissue culture uses agar as a gel, whereas in Glass Bead Liquid Culture Technology, the media is a liquid that surrounds the glass beads. This allows for aeration when the culture vessels are shaken and the glass beads offer a greater surface area between the piece of plant tissue that is used to initiate the tissue culture and the liquid medium. Using glass beads with liquid beneath them provides good root aeration for the plantlets and when combined with the high humidity in the culture vessels, results in plants that need less hardening because they develop a stronger root system. This invention will help in cost-effective plant cloning, which in turn will benefit Indian Farmers.

3. Dishwasher, invented by Josephine Cochrane

 Josephine Cochrane, a mother, invented the first commercially successful dishwasher in the late 19th century. She was frustrated with the chipping and breakage of her fine Chinaware during handwashing, which resulted in designing of a mechanical dishwasher that used high-pressure jets of water to clean dishes. Her invention not only saved time and labour but also preserved delicate tableware, catering to the needs of households and commercial kitchens alike. In 1886, she patented the first practical dishwasher, which used high-pressure jets of water to clean dishes in a wire basket. The invention was showcased at the 1893 World’s Columbian Exposition in Chicago and was initially marketed towards hotels and restaurants. Over time, improvements and innovations have been made to dishwashers, including advancements in efficiency, water and energy consumption, noise reduction, and additional features such as adjustable racks and specialized wash cycles. Now, dishwashers are common household appliances, simplifying the chore of dishwashing for millions of people worldwide.

4. Windshield Wipers, invented by Mary Anderson

Mary Anderson, a widowed mother and entrepreneur, invented the windshield wiper in 1903. While traveling in New York City, Anderson noticed that streetcar drivers struggled to see through their windows during rainy weather. In search of a solution for this problem, she developed a manually operated windshield wiper system that cleared away rain and snow, improving visibility and safety for drivers. Mary Anderson patented the first operational windshield wiper in 1903, where the invention consisted of a swinging arm mechanism with a rubber blade that could be operated manually from inside the vehicle to clear rain or snow from the windshield. The windshield wiper remains an essential component of vehicle safety, helping drivers maintain clear visibility on the road in adverse weather conditions.

5. Kevlar, invented by Stephanie Kwolek

Stephanie Kwolek, a chemist and mother, made a groundbreaking discovery while working at DuPont in the 1960s. In her pursuit of developing a lightweight fibre for tires, Kwolek accidentally created Kevlar, a high-strength synthetic material. Kevlar is a synthetic fiber known for its high tensile strength-to-weight ratio, making it incredibly strong yet lightweight. Kwolek was conducting research on high-performance fibers when she discovered a liquid crystalline solution that could be spun into exceptionally strong fibers. This discovery led to the development of Kevlar, which has since found widespread applications in various industries. Kevlar’s remarkable durability and resistance to impact made it an ideal material for bulletproof vests, revolutionizing personal protective equipment for law enforcement and military personnel worldwide. Kevlar is also used in helmets, gloves, and other protective gear. Additionally, Kevlar is utilized in aerospace applications, such as reinforcing composite materials in aircraft and spacecraft. Its high strength, durability, and heat resistance make it valuable in numerous industrial and consumer products, including tires, ropes, cables, and sporting equipment. Stephanie Kwolek’s invention has had a significant impact on various fields, enhancing safety, performance, and efficiency in numerous applications.

6. Home Security System, invented by Marie Van Brittan Brown

Marie Van Brittan Brown, a nurse and mother, developed the first home security system in 1966. Brown worked long hours as a nurse and often came home late at night. Her husband also worked irregular hours and Brown worried about who might knock on her door if she were home alone at night. Concerned about the safety of her family in their New York City apartment, Brown designed a system comprising peepholes, cameras, and two-way microphones connected to a monitoring device. In 1966, Brown first had the idea, and she soon applied for a patent alongside her husband Albert Brown. The system includes a motorized camera to project images on a monitor with four peepholes. In addition, the invention includes a remote control to unlock doors for easy access to first responders, in emergencies. Brown was later granted an award from the National Scientists Committee for her innovation. The innovative security apparatus laid the groundwork for modern home surveillance systems, empowering homeowners to protect their properties and loved ones.

Honouring Mother Inventors

As we celebrate Mother’s Day, let’s pay tribute to the remarkable achievements of Mother inventors around the world. Their ingenuity, perseverance, and groundbreaking contributions continue to inspire generations of innovators. From everyday conveniences to life-saving technologies, the legacy of Mother inventors serves as a testament to the power of creativity and determination. So, let us cherish and celebrate the indomitable spirit of motherhood and innovation this Mother’s Day, recognizing the invaluable contributions of mother inventors to our shared human experience.

We wish you all a Happy Mother’s Day!!

Author: Megha Nadiger, Senior Patent Associate, Origiin IP Solutions

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Story of Natural Ice cream

Apr 29, 2024 | General

“You are an original when you stay true to what you know.” Following this philosophy for 40 years since 1984, Natural Ice Cream has become a well-known brand for using fruits in creating ice creams. With around 125 flavors to offer 147 outlets across the country and the recently launched factory in Mumbai, Natural Ice Cream is poised to continue expanding its reach in spreading the joy of fruits and natural ingredients in the form of delicious and mouth-melting ice creams.

Where today, most ice creams in the market consist of fruit flavors, stabilizers, and additives; what makes Natural Ice cream so different from others is being true to their tradition and traditional methods, which include the non-usage of any preservatives, stabilizers and artificial colors or chemicals and relying on three ingredients only, i.e., milk, fruit, and sugar, most of them sourced from India, making Natural Ice cream delicious and wholesome.

Furthermore, Natural Ice Cream is recognized as one of the pioneering brands responsible for introducing flavors such as Tender Coconut Ice Cream, Jackfruit Ice Cream, Watermelon Ice Cream, and Chickoo Ice Cream, among others, which are consistently available throughout the year. They also pioneered the idea of seasonal specials like Naturals Sitaphal Ice Cream, Naturals Mango Ice Cream, Pink Guava, Lychee, and more. Additionally, several new flavor concepts, including festive flavors, Friday Funday flavors, and berry festival flavors, were introduced a few years later, all offered at highly affordable prices.

Consistent focus on evolving while preserving its authentic flavors drives Natural Ice Cream’s sustained growth. Unsurprisingly, the brand has been recognized among the top 10 Home-grown brands in India by the KPMG Consumer survey and honored as Icons of India by the Economic Times.

History

The journey began with a fruit venture in a small village in Mangalore, where Mr. Raghunandan Kamath, the founder, aided his father, a mango seller. Enchanted by the realm of fruits, he mastered the skills of selecting, plucking, sorting, and preserving ripe produce. This profound knowledge became an asset for the company in crafting fruit ice creams.

From Mangalore to Bombay, armed with a second-class ticket and a brilliant idea, Mr. Raghunandan Kamath embarked on his entrepreneurial journey. Initially serving Pav Bhaji as the main dish, he cleverly added ice cream as an enticing addition to attract customers. This modest eatery quickly garnered attention, evolving into a bustling ice cream parlor known as “NATURALs,” inaugurated as the First Outlet in Juhu Scheme, Mumbai, on February 14, 1984. The overwhelming demand for their ice cream led to traffic congestion in Juhu’s narrow lanes. To meet the increasing demand, Mr. R S. Kamath had to innovate and develop new machines capable of producing more ice cream using existing methods.

By 1994, the company expanded its presence by inaugurating five additional outlets in Malad, Borivali, Bandra, Lokhandwala Complex, and Vile Parle. In 2000, Pune became the company’s first branch outside of Mumbai, further expanding into Ahmedabad, Goa, Hyderabad, Bangalore, Jaipur, Delhi, and Kolkata. In response to its increasing popularity, the company also introduced distinctive thermocol packaging, quickly becoming ubiquitous nationwide.

Trademark

One of the obstacles that Natural Ice Cream faced was its trademark. When Mr. Raghunandan Kamath began his business of a full-fledged ice cream parlor in Mumbai on February 14, 1984, under the mark ‘NATURAL’, it became the company’s identity. Over time, the mark obtained trademark registrations across multiple classes, including 29, 30, 35, 42, and 43. Under this trademark, the company has expanded its network to 140 franchisees across 42 cities in India. Moreover, it has extensively advertised on social media platforms like Facebook and Twitter. Despite having such a reputation, there were instances where the company had to deal with consumer confusion due to the similarity of trademarks with those of other companies.

One such instance can be found in the recent case of Siddhant Icecreams LLP & Ors. Vs. Ameet Pahilani & Ors, where the plaintiff filed a suit against Partners of NIC Natural Ice Creams seeking a decree of permanent injunction from trademark infringement along with an application for ad-interim injunction before the Hon’ble Delhi High Court[1]. It occurred when NIC NATURAL ICE CREAMS, another ice cream firm, started enticing customers with its varied range of ice cream flavors, which were not only accessible in physical stores throughout India but also featured on online food delivery platforms, much like Natural Ice Cream. However, since both firms utilized the same mark, ‘NATURAL,’ in an equal shade of green and dealt primarily with comparable products and services, as well as similar packaging, concerns of infringement, misrepresentation, and customer confusion were likely to arise. The primary allegation was that Ameet Pahilani, a partner at NIC Natural Ice Creams, was formerly associated with one of the franchisees of Natural Ice Cream. Following the termination of their agreement, he allegedly registered a mark bearing the name ‘NIC Natural Ice Creams’ in a dishonest manner.

In conclusion, on October 19, 2022, Justice Jyoti Singh issued an “ex parte ad interim injunction” in favor of the plaintiffs Siddhant Ice Creams LLP & others. The court found that all the evidence and facts favor the plaintiff, and thus, not granting an injunction order could result in “irreparable loss” to the plaintiffs. The court’s ruling forbade the defendants, NIC Natural Ice Creams, from using the plaintiffs’ marks in any way, including marks that were similar to them, and from utilizing the same trade dress, colors, and packaging. Additionally, they were barred from using domain names containing the mark ‘NATURAL’ and the plaintiffs’ marks as meta-tags or keywords for advertisement. The court even ordered food delivery aggregators to verify that infringing trademarks were not used in conjunction with the defendants’ business[2]. An appeal by the defendants followed this injunction order. However, both parties reached an interim arrangement on November 25, 2022, allowing them to conduct business without prejudice.

Before this incident, Natural Ice Cream faced a similar situation in the case Siddhant Icecreams LLP and Ors v. Natural Ice Cream And Anr., [3]in which Raghunandan Kamath promoted firms Siddhant Icecreams LLP, and Kamaths Ourtimes Ice Creams Pvt Ltd filed a lawsuit against the Manjalpur (Vadodara)-based ‘Natural Ice Cream.’ In addition to requesting damages for trademark infringement of Rs. 150 crore, the lawsuit aimed to stop the defendant brand in Vadodara from using the same trade name for its goods. The court ruled that the proprietor of the defendant company had no independent right to use the ‘NATURAL’ mark, even if the signage indicated usage ‘since 1992’. The plaintiffs, registered proprietors with usage dating back to 1984, sufficiently demonstrated a prima facie case. This led to the injunction order restraining the defendants from using or infringing the ‘Natural’ Family registered marks for their products or business names until September 9. Due to such brand recognition, Natural Ice Cream has been able to preserve and protect its brand identity and maintain consumer trust.

Conclusion:

In conclusion, Natural Ice Cream has garnered numerous accolades over the years, including the Corporation Bank’s National SME’s Excellence Award in the Food and Agro-Industry in 2006, Best in Customer Service – Regional Retailer Of the Year in 2013, a gold medal for the most innovative ice cream flavor (cucumber) in the Great Indian Ice Cream Contest in 2014, and recognition in 2016 for its homegrown concept in food service by Coca-Cola Golden Spoon Awards. These achievements underscore the brand’s reputation, which extends beyond mere advertising to the genuine appreciation of its customers. With a keen understanding of fruit-based ice cream’s potential, the company and its founder have consistently delivered a delicious end product celebrated nationwide. Natural Ice Cream remains a symbol of excellence in the ice cream industry, firmly establishing itself as one of India’s premier homegrown brands.

Author: Gautam Bhatia, CHRIST University

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Odisha’s ‘Kai Chutney’ Receives GI Tag: Exploring the Culinary and Health Benefits of Red Ant Chutney

Apr 7, 2024 | General

Recognising Odisha’s culinary heritage, the beloved delicacy known as “Kai Chutney” has been bestowed with the prestigious geographical indication (GI) tag under the Geographical Indications of Goods (Registration and Protection) Act, 1999^[1]. Hailing from the Mayurbhanj district, this savoury condiment from red weaver ants stands out for its unique cultural significance and remarkable health benefits.

Weaver ants, scientifically known as Oecophylla smaragdina, play a central role in the creation of Kai Chutney. These industrious insects are commonly found in Mayurbhanj throughout the year, crafting nests from the leaves of host trees. Their nests, ranging from small single-leaf structures to large elliptical formations, demonstrate impressive resilience against wind and water.

The culinary journey of Kai Chutney begins with the careful collection and cleaning of red weaver ants from their forest habitats. Tribal communities, deeply rooted in this age-old tradition, sustain their livelihoods by harvesting these insects and crafting the renowned chutney. The preparation process involves grinding a blend of salt, ginger, garlic, and chillies with the collected ants and their eggs, resulting in a flavorful and aromatic paste.

But Kai Chutney is more than just a culinary delight; it’s also celebrated for its numerous health benefits. Packed with essential nutrients such as protein, calcium, zinc, and vitamins, this unique condiment offers a natural boost to one’s well-being. It is believed to alleviate ailments like flu, common cold, and whooping cough while enhancing appetite and vision.

Beyond its nutritional value, Kai Chutney holds cultural significance among the tribal communities of Odisha. It serves as a symbol of tradition and heritage, embodying centuries-old practices passed down through generations. Additionally, integrating red weaver ants into the diet showcases a sustainable approach to food production, offering an eco-friendly alternative to conventional livestock farming.

With its recent recognition through the GI tag, Kai Chutney stands as a testament to the rich culinary diversity of Odisha and the innovative utilisation of local resources. As this beloved condiment continues to captivate taste buds and promote well-being, it reinforces the importance of preserving and celebrating indigenous food traditions^[2].

Author: Gayatri Singh, UPES, Dehradun

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Understanding Diabetic Peripheral Neuropathy

Mar 14, 2024 | General

Diabetes is rapidly becoming a major global health crisis in the 21st century. There are currently 537 million persons between the ages of 20 and 79 who are living with diabetes, which is equal to 10% of the world’s population [1]. It is predicted that the number of individuals with diabetes will increase to 643 million by 2030, and further to 783 million by 2045 [2]. Diabetes is responsible for the majority of neuronal damage, visual impairment, and kidney failure in the non-elderly population. Approximately half of diabetic peripheral neuropathies (DPNs) may not exhibit symptoms, underscoring the importance of comprehensive screening, as neglecting foot care measures heightens the likelihood of harm.

Diabetic neuropathy, a condition characterized by high prevalence and disability, poses significant challenges in terms of management. These challenges include various complications, which not only burden individuals but also incur substantial financial costs. Diabetic foot is a significant factor in the global burden of disability and decreased quality of life. 14 -24% of diabetic foot patients require major or minor lower limb amputations [3]. There are 70 million diabetics in India out of which 50% have diabetic peripheral neuropathy and nearly 25-34% of them develop diabetic foot ulcer (DFU) and 1.2 million need special care for DFU [4]. The 5-year survival rate of diabetic foot patients with major amputations is 30%. There are 100000 registered amputations per year due to diabetes in India [5].

Additionally, individuals with a prediabetic status are more likely to develop DN at an earlier stage. The main complication associated with peripheral sensory neuropathy is the development of DFUs and subsequent minor or major amputations. Research has indicated that having underlying peripheral neuropathy raises the risk of any amputation by 1.7 times [6]. The risk increases by a factor of 12 if there is a deformity (caused by motor neuropathy) and increases significantly to 36 times if there is a previous history of ulcers.

Classifications of DPN

The primary categories of neurologic disorders in DM encompass:

• Subclinical neuropathy is determined by abnormalities in electrodiagnostic and quantitative sensory testing
• Diffuse clinical neuropathy with distal symmetric sensorimotor and autonomic syndromes.
  • Sensory or sensorimotor polyneuropathy
  • Selective small-fibre polyneuropathy
  • Autonomic neuropathy
• Focal syndromes:
  • Truncal mononeuropathy
  • Mononeuritis multiplex
  • Asymmetric lower limb motor neuropathy (amyotrophy)
  • Cranial neuropathy
• Mixed forms

Subclinical neuropathy is identified when there are no clinical indications of neuropathy, but abnormal electrodiagnostic tests show reduced nerve conduction velocity (NCV) or amplitude; quantitative sensory tests (QSTS) reveal altered perception of vibration, touch, and temperature; and autonomic function tests (AFTs) indicate dysfunction in sympathetic and parasympathetic nerves.

Risk factors for peripheral neuropathy

The risk factors for the development of diabetes-related peripheral neuropathy are as follows:

The risk factors with a major impact are:

1. Poor control of blood sugar levels
2. Long-standing diabetes
3. Damage to blood vessels
4. Alcohol consumption
5. Metformin use

The risk factors with a minor impact are:

1. Autoimmune factors
2. Genetic susceptibility
3. Smoking
4. Low levels of high-density lipoprotein (HDL)
5. Cardiovascular disease

A study found that the duration of diabetes mellitus (DM) is a major risk factor for neuropathy. Patients with DM for more than 15 years have an odds ratio of 8.03 (95% confidence interval 5.96-10.8, p<0.001) for developing neuropathy compared to those with a duration of less than 5 years [7]. The study also found that increasing age, the presence of dyslipidemia, and the presence of other microvascular complications are significantly associated with peripheral neuropathy (Fig.1).

Pathogenesis of peripheral neuropathy

The pathophysiology of diabetic peripheral neuropathy is multifactorial and is thought to result from vascular disease occluding the vasa nervorum; endothelial and myelin synthesis dysfunction and diminishing sodium-potassium adenine triphosphatase (ATPase) activity; chronic hyperosmolarity, causing oedema of nerve trunks; and effects of increased sorbitol and fructose. 

Nonenzymatic glycation predisposes ligaments to stiffness. Neuropathy causes loss of protective sensation and loss of coordination of muscle groups in the foot and leg, both of which increase mechanical stresses during ambulation.

Motor dysfunction of peripheral nerves in diabetic neuropathy leads to muscular imbalances in the diabetic foot. Muscle wasting of the intrinsic pedal muscles leads to overpowering of the spared extrinsic muscles, which results in significant forefoot deformities such as claw toes or hammer toes.  Autonomic dysfunction of the peripheral nervous system may lead to sudomotor dysfunction. This will result in dry, cracked skin, and intrinsic minus foot, which is more prone to injury and breakdown. 

The result of loss of sensation in the foot is repetitive stress; unnoticed injuries and fractures; structural foot deformity, such as hammertoes, bunions, metatarsal deformities, or Charcot foot; further stress; and eventual tissue breakdown.

Unnoticed excessive heat or cold, pressure from a poorly fitting shoe, or damage from a blunt or sharp object inadvertently left in the shoe may cause blistering and ulceration. These factors, combined with poor arterial inflow, confer a high risk of limb loss on the patient with diabetes.

Metabolic Hypothesis

Chronic hyperglycemia cause damage to peripheral nerves through various pathways, one of which involves an increase in the entry of polyol that is regulated by aldose reductase, also known as the polyol pathway. Another theory suggests that injury to the endoneurium of peripheral nerves is caused by an excessive build-up of advanced glycation end-products (AGES). Additionally, hyperglycemia contributes to peripheral neuropathy by generating oxidative stress-induced free radicals during the glycolytic process ( Fig.2 and 3).

Immune Hypothesis

In patients with DN, the presence of antiphospholipid antibodies and autoantibodies to gangliosides indicates a potential role of these factors in the development of DN.

Microvascular Hypothesis

Nerve ischemia is caused by microvascular insufficiency resulting from inadequate blood supply to the vasa vasorum. This insufficiency is contributed by an increase in the thickness of the vessel walls, hyalinization of the basal lamina, and impaired vasoconstriction and vasodilation.

Neurotrophic Hypothesis

Patients with DN exhibit a deficiency in neurotrophic factors such as nerve growth factor (NGF), neurotrophin-3/4/5, and insulin-like growth factor (IGF)-1

Clinical evaluation

The neuropathic symptoms are divided into focal and diffuse forms, of which the latter is far more common .

Diffuse Neuropathies

One should look for specific motor and sensory symptoms in patients as it helps in understanding the underlying nerves at fault. This can be understood from the following:

Acute Painful Neuropathy

Some patients with diabetes mellitus (DM) present with acute symptoms that persist for less than six months and are accompanied by moderate-to-severe pain. The pain caused by sensory neuropathy worsens at night and is often more pronounced in the feet than in the hands. As a result of the nocturnal pain, patients frequently complain of sleep disturbances and insomnia. The nature of the pain can be described as burning, stabbing, tingling, pins and needles, paresthesia, or a prick sensation.

In this scenario, the following possibilities should be considered:

– Insulin neuritis – Rapid correction of blood glucose levels – Chronic alcohol consumption – Associated amyloidosis and multiple myeloma – Human immunodeficiency virus (HIV) infection – Heavy metal poisoning (e.g., arsenic) – Fabry’s disease

Chronic Painful Neuropathy

Chronic painful neuropathy is a separate condition that typically develops later in individuals who have been diagnosed with DM for several years. In this case, the debilitating pain persists for more than six months.

Over time, many patients may experience a lack of pain, which is not necessarily indicative of symptom improvement, but rather due to neuronal loss. Hyperalgesia, on the other hand, refers to an increased perception of pain even in response to normal stimuli. Allodynia is the sensation of pain caused by a stimulus that is not typically painful.

The sensation of burning and pricking is attributed to C and Ao fibers, while Aẞ fibers are responsible for dysesthesias, paresthesias, and allodynia.

Large-fiber neuropathies

Large-fiber neuropathies affect the sensory or motor nerves. These neuropathies display more signs than symptoms. Fiber neuropathies cause changes in vibration perception, position sense, and cold thermal perception. These myelinated, rapidly conducting fibers primarily affect the toes rather than the fingers, as they are length-dependent fibres that are more noticeable in electromyography (EMG). The alteration of these fibres leads to a sensation of walking on cotton in the feet and, in severe cases, difficulty in distinguishing shapes and turning pages in books.

The clinical presentation of large-fiber neuropathies includes:

• Impaired vibration perception (often the first objective evidence) and position sense
• Decreased tendon reflexes.
• A deep-seated gnawing pain similar to a toothache in the bones of the feet, or even a crushing or cramp-like pain
• Wasting of the small muscles in the feet, resulting in hammer toes.
• Shortening of the Achilles tendon, leading to pes equinus.
• Increased blood flow, causing warm foot

Proximal motor neuropathies

Proximal motor neuropathies, also known as femoral neuropathy, diabetic amyotrophy, and diabetic neuropathic cachexia, have distinct symptoms and signs. This condition primarily affects the elderly, typically occurring after the age of fifty. The onset of symptoms can be gradual or abrupt, beginning in one leg and progressing to the other. The initial symptom is often pain in the thighs, hips, or buttocks, followed by proximal myopathy. Interestingly, heel or toe standing is usually unaffected despite weakness in the proximal muscles. Patients may experience spontaneous or provoked fasciculations, and electromyography (EMG) often reveals features of lumbosacral plexopathy. While proximal motor neuropathy is commonly associated with diabetes mellitus, it is important to consider other potential causes such as chronic inflammatory demyelinating polyneuropathy (CIDP), monoclonal gammopathy of unknown significance (MGUS), circulating GMI antibodies, and antibodies to neuronal cells and inflammatory vasculitis. If demyelination is the predominant finding on EMG, further investigation into causes other than diabetes mellitus is warranted, as the treatment options may differ in cases of femoral neuropathy.

Asymmetric neuropathies

Mononeuropathy

• Generally acute with pain.
• Usually in older population.
• It can involve truncal and cranial nerves (III and VI).
• Self-limiting and resolving in 6-8 weeks.
• Usually due to vessel occlusion.
• Treatment: Symptomatic for pain and physiotherapy.

Entrapment neuropathy

• Starts slowly and progresses slowly.
• Commonly involves the median (carpal tunnel), ulnar, radial, femoral, and lateral cutaneous nerve of the thigh.
• Treated with splints, nonsteroidal anti-inflammatory drugs (NSAIDs), and local injection.
• In some cases, surgery to decompress.

Mononeuropathies must be distinguished from entrapment syndromes, which start slowly, progress, and persist without intervention.

Nerve conduction studies

Electromyography-nerve conduction velocity (EMG-NCV) has become a crucial technique for tracking the early development and progression of peripheral neuropathy. These measures are objective, quantitative, noninvasive, and highly sensitive. The primary purpose of EMG is to distinguish between diabetic neuropathy and neuropathy of non-diabetic origin. Studies have rep that patients with an average HbA1c level >10% over an 8-year period exhibited a significant decrease in NCV.

Newer techniques

Newer techniques for evaluating small-fibre function include the use of:

• Corneal confocal microscopy, which allows the identification of unmyelinated axons in the cornea.
• Sudomotor function devices.

Treatment

Small fiber neuropathy

In order to manage the condition, it is important to engage in certain practices. For example, daily inspection of the feet is necessary, and using a handheld mirror to examine the soles of the feet can be helpful. It is also crucial to wear well-fitting Microcellular rubber (MCR) shoes to ensure comfort and prevent further complications. Additionally, it is advised to avoid exposing the feet to extreme temperatures. To combat skin drying and cracking, the use of moisturizing creams is recommended. After bathing, it is essential to thoroughly dry the feet. When it comes to nail care, cutting them transversely is the recommended approach.

Large Fiber Neuropathy

 In patients with DM and large fiber neuropathy, it is important to focus on gait and strength training. This is because individuals with this condition have an increased risk of falls due to sensory ataxia, weakness, incoordination, muscle wasting, and the possibility of fractures following falls. This is particularly true for post-menopausal women. Therefore, enhancing muscle strength is crucial in order to prevent complications related to DM and small fiber neuropathy. Microcellular rubber (MCR) footwear is the most commonly used material for patients with DM and peripheral neuropathy. It is recommended to use footwear with a shore value between 8 and 15 for those with DM. MCR footwear has proven to be effective in preventing the development and recurrence of ulcers.

Pharmacological treatment

Many prescription medications are available for diabetes-related nerve pain. Pain-relieving prescription treatments may include:

Anti-seizure drugs. Some medications used to treat seizure disorders (epilepsy) are also used to ease nerve pain. The ADA recommends starting with pregabalin (Lyrica). Gabapentin (Gralise, Neurontin) also is an option. Side effects may include drowsiness, dizziness, and swelling in the hands and feet [8].

Antidepressants. Some antidepressants ease nerve pain [8]. Tricyclic antidepressants may help with mild to moderate nerve pain. Drugs in this class include amitriptyline, nortriptyline (Pamelor) and desipramine (Norpramin). Side effects can be bothersome and include dry mouth, constipation, drowsiness and difficulty concentrating. These medications may also cause dizziness when changing position, such as from lying down to standing (orthostatic hypotension). Serotonin and norepinephrine reuptake inhibitors (SNRIs) are another type of antidepressant that may help with nerve pain and have fewer side effects. The ADA recommends duloxetine (Cymbalta, Drizalma Sprinkle) as a first treatment. Another drug that may be used is venlafaxine (Effexor XR). Possible side effects include nausea, sleepiness, dizziness, decreased appetite and constipation. Sometimes, an antidepressant may be combined with an anti-seizure drug. These drugs can also be used with pain-relieving medication, such as medication available without a prescription. For example, one may find relief from acetaminophen (Tylenol, others) or ibuprofen (Advil, Motrin IB, others) or a skin patch with lidocaine (a numbing substance).

Conclusion

Diabetic peripheral neuropathy is a multifaceted complication of diabetes that involves intricate pathological processes and interactions between various cellular and molecular factors. An in-depth understanding of the underlying pathophysiology is crucial for physicians, enabling them to adopt a targeted approach in diagnosing, treating, and managing DPN effectively. By addressing the pathogenic mechanisms discussed above, healthcare professionals can work towards developing novel therapeutic interventions and significantly improve patient outcomes in DPN management.

Author: Dr. Sanjay Sharma, MS, Diabetic Foot Surgeon

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Prosthetics: The IP Landscape

Dec 23, 2023 | General

Executive Summary

Over 1 billion users currently need assistive technology. This figure is expected to reach 2 billion by 2050 as the population ages and consumer electronics and assistive products converge. The market is shaped not only by demographics and the demand for consumer electronics, and the investment this attracts, but by legislation and policies. The Convention on the Rights of Persons with Disabilities (CRPD) recognizes access to assistive technology as a human right, bringing with it state obligations and expected market influence. Data shows that emerging products are usually not replacing conventional assistive products, but complementing them[1]. And as these assistive technologies improve, so do people’s lives.

What are prosthetic devices? 

A prosthetic device an “artificial device to replace or augment a missing or impaired part of the body”.[2] Although modern medicine and advancements in assistive technology may paint prosthesis as a product of later scientific developments, the use of artificial limbs to better human function dates back as early as 1,600 B.C. The use of an artificial toe around the foot of a Mummy dating back between 950 B.C. to 710 B.C.[3] confirms the fact that prosthesis has been around for ages. History is replete with examples of prosthetic devices even before the advent of modern medicine such as Barbarossa’s silver arm, Gotz of the Iron Hand and many more.

Prosthesis thereby play a vital role in helping people live a life of normalcy. Not only do prostheses help in functionality, but they also hold sociological importance. They help overcome the social stigma around this subject by giving users a new chance at life through artificial means. It is for this reason that they are also known as rehabilitation devices.

Today, technology has infiltrated every aspect of our lives, especially the medical industry. Prosthesis is one such industry that has profited tremendously due to the onslaught of cutting-edge technology and artificial intelligence. Earlier what were made with harnesses and knee lock controls, prostheses now are specialised based on every patients requirements and are equipped with assistive controls that follow realistic commands such as moving one’s fingers, making fists, pinching, etc.

It’s a heady time to be involved in prosthetic technology and development – one marked by quantum leaps in research and understanding how human bodies, and brains, work. From artificial limbs to exoskeletons, the field of prosthetics is exploding with new technologies designed to improve the quality of life for patients. The technology used for prosthetic limbs now includes 3D printing, device implants, digital design tools, and more. As scientists learn more about how the human body functions, prosthetic limbs will start to feel and behave like the real thing[4].

Presently, research in prosthetic technology primarily focuses on:

1. 3D-Printed Prosthetics,
2. Thought-Controlled Prosthetics to restore the sensation of touch,
3. Neuroprosthetics,
4. Brain activity mapping,
5. Ambionics Tests

Applications and types of prosthetic devices

Since prosthetic devices are essentially substitutes for actual body parts, their most important application is to replace, correct or support a body part. There exist a variety of prostheses in the market today. Based on the positioning of the device, i.e., upper extremity or lower extremity, there exist different types of devices. There are also active and passive prostheses: active prostheses perform actual movement and bodily function while passive prostheses serve artificial purposes.

There are broadly three types of upper extremity prostheses:[5]

1. Transradial prostheses: Transradial prostheses attaches below the elbow. These can be either active (powered by myoelectric signals or cables connected to the body) or passive.
2. Transhumeral prostheses: Transhumeral prostheses is connected above the elbow but below the shoulder. Since they replace a majority of the arm, they are more complicated to make as they compensate for a missing elbow as well. They too come in active or passive forms.
3. Silicon hands, fingers, and arms.

For the lower extremity prostheses, there broadly exist two types:[6]

1. Transtibial prostheses: These attach below the knee and their primary function is to distribute the weight as the mobility of the leg remains due to the presence of the knee. Most patients require rehabilitation with this kind of prostheses as the foot usually doesn’t move.
2. Transfemoral prostheses: Transfemoral prostheses are the most complicated of the aforementioned prostheses as they replace a majority of the leg by attaching above the knee but below the hips. In this case, there is a special socket mechanism designed to replicate the structure of the knee thereby giving mobility to the user. Patients in this case too require rehabilitation before they can fully use their prosthetic leg. The prosthetic socket is the main connection between the prosthetic limb and the residual limb which distributes the forces through the residual limb.

Prosthodontics is a branch of dentistry that deals with prosthetic devices designed for the purpose of replacing missing or damaged teeth. Prosthodontics is becoming highly relevant with the advent of Artificial Intelligence (AI) which is being deployed to enhance the industry. There are four branches of prosthodontics. These are:

1. Fixed prostheses: These are permanent prosthodontics and include devices such as crowns, bridges, onlays, inlays and veneers.
2. Removable prostheses: These are designed to last for long periods of time subject to replacement or removal for cleaning. They are not fixed but fitted. Examples include dentures and gingival veneers.
3. Implant prostheses: These implants such as small titanium cylinders are designed to hold the prosthetic device in place to secure their position inside the mouth.
4. Maxillofacial prostheses: These focus on correcting malformed or missing tissues that may be congenital (acquired from birth) or may be a result of an injury, illness or disease. These can be intra-oral (inside the body) such as palate covers, palate lifts, jaw replacements, etc. or extra-oral (outside the body) such as eye (ocular, orbital), ear (auricular), radiation shields, etc.[7]

The Working and Science behind prosthetics

The documentation of limb amputations and availability of prostheses is scarcely documented.

However, statistics from the USA show that 41,000 persons live there with substantial upper-limb absences. In addition, 5-6,000 major limb amputations are performed in England each year with around a fifth of these involving the upper limb[8].

With more research and development in the field of prostheses, multiple ways of making artificial limbs have been devised. More recently, the integration of sophisticated technology is one of them. This includes AI (Artificial Intelligence) aided prosthetic limbs. The prosthesis is first used on the functioning arm. The AI integrated in this learns and remembers the actions of this arm which is then attached to the phantom arm. AI has made possible incredibly accuracy of limb movements such as pinching and naturalised the whole process for the user.

Another popular prosthesis mechanism is the mind-control prosthesis or the brain-computer interface integrated neuroprosthesis which can recognize real-time data as well as learn virtual functions.

Prosthetic limbs are made from materials lighter than the conventional ones such as wood and plastic. Prosthetic companies now use urethanes, silicone, and mineral-based liners to improve the product flexibility and comfort. This contributes to the prostheses’ flexibility which has fuelled the global artificial limbs and body parts industry.

The major types of Prosthetics include:

• Upper Extremity
• Lower Extremity
• Liners
• Sockets

While the primary Modular Components are:

• Orthotics Upper Limb
• Lower Limb
• Spinal

The Market Players

Newly released Prosthetics and Orthotics Market analysis report by Future Market Insights shows that global Prosthetics & Orthotics Market sales in 2022 were held at US$ 6.5 Billion. With a CAGR of 6% from 2023 to 2033, the market is projected to cross US$ 12 Billion by 2033. The market through Orthotics is expected to generate significant revenue and is projected to grow at a CAGR of around 6% from 2023 to 2033.[9]

As per the Prosthetics & Orthotics Market research by Future Market Insights – a market research and competitive intelligence provider, historically, from 2018 to 2022, the market value of the Prosthetics & Orthotics Market increased at around 5.3% CAGR[10].

Some factors that influence the Prosthetics & Orthotics industry include the increased frequency of neurological disorders and cardiovascular diseases that damage the patients’ neural and spinal systems. As discussed in section 2.3 of this report, the technical advancements in the prosthetics industry are to play a huge role in influencing the industry. Furthermore, the rise in number of trauma cases is expected to boost the orthopaedics industry. The influence of phantom limb pain and residual limb pain due to the prolonged usage of prosthetics devices has increased in users thereby giving way for newer, better technologies to replace them.

The key providers of prosthetics and orthotics include Ossur, Blatchford, Inc., Fillauer LLC, Otto bock Healthcare GmbH, The Ohio Willow Wood Company, Ultraflex Systems, and Steeper Group.[11]

Endolite announcing its fully integrated, microprocessor-controlled lower limb system Linx that has been awarded the German Design Award in the Universal Design Category in October 2022 is a notable development amongst the Prosthetics and Orthotics providers.[12]

The Market Dynamics

The global prosthetics and orthotics market is categorized into orthotics and prosthetics on the basis of their types. The orthotics market holds the largest revenue share of around 75% in 2021, due to the increase in the prevalence of osteoarthritis, sports injuries and the penetration of orthopaedic technologies.[13] The dominance of the orthotics sector can be attributed to the fact that they are recommended for fixing or accommodating foot deformities, aligning and supporting the ankle or foot. Further, the increase in recorded number of spine injuries and the cumulative occurrences of osteoarthritis are additional factors contributing to the increasing sales of orthotics. These solutions also offer tremendous potential in minimizing pain and addressing physical and postural problems.

Prosthetics type is sub-divided into modular components, liners, lower extremity, and upper extremity. The prosthetics market is anticipated to witness substantial growth in the years to come due to the upsurge in disability rates globally. Some prominent manufacturing companies in this industry include Zimmer Biomet Holdings Inc., Ossur HF and Blatchford Inc. According to the report published by the Rehabilitation Research and Training Centre on Disability Statistics and Demographics, in 2018, the percentage of people with disabilities in the United States increased from around 11.9% in 2010 to 12.9% in 2017, thereby leading to increasing demand for prosthetics in the country[14]

Drivers: Rise in demand for orthotic devices – The demand for orthotics devices can be attributed to multiple factors. The ageing population, for instance, is more prone to suffer from ailments such as osteoarthritis, osteoporosis and more bone-injury related ailments. There is also an increase in sport-related injuries. Orthotic devices are great alternatives to surgical deformity repair and pain management. Furthermore, the technological advancements in the prosthetics and orthotics market are making the orthotic products more affordable and accessible. Thus, this rising demand is boosting the overall growth of the prosthetics and orthotics market during the forecast period.

Restraints: Lack of consumer awareness – Although there have many technological advancements in the prosthetics and orthotics sector, the lack of consumer awareness in developing and under-developed countries acts as a setback for the progress of this industry. Since these devices are used to reduce pain, people with orthopaedic disorders can utilise these devices. However, the lack of awareness poses as an obstacle to this.

Opportunities: Rising geriatric population – According to the United Nations, the global population of people aged 60 and more is predicted to grow to 2.1 billion to 2050. People over 60 are more prone to illnesses like osteoporosis and osteopenia, which increases the demand for orthopaedic solutions.[15] Thus, the growing senior population globally is one of the main causes of the increasing demand for prosthetics and orthotics in the world.

Challenges: Higher cost of orthotic devices – With technological advancements in this sector, the cost as well as demand for customized orthotic devices has increased. Due to their low cost and accessibility, pre-fabricated devices are still being extensively used despite the fact that customized orthotic devices offer more functionality. Nowadays, pre-fabricated orthotic devise are highly advanced and come in various types and ranges depending on the diseases and ailments they cater to. As a result, customized orthotics are finding it difficult to compete and this is one of the biggest challenges for the growth of the prosthetics and orthotics market.

The Industry Analysis: The IP Scenario

Patent Trends

Leading Assignees

Edward Lifesciences dominates the prosthetic patent landscape with its aggressive filing of patent applications in tis domain and is closely followed by Medtronic Inc. Zimmer Biomet Holding, Johnson & Johnson, Stryker Corp, Abbott Lab, Cook Group Inc, Beijing Akec Medical Co Ltd, Boston Scientific Corp, Otto Bock Healthcare GMBH, Ossur HF and Beijing Chunlizhengda Medical also figures among the leading assignees.

Figure 3 showcases the graphical representation of patenting activity of the leading companies in this domain. Edward Lifesciences filed 557 patent applications in this domain in the last ten years and continued to be a major applicant over the years.

Bock Otto Healthcare Prod GMBH dominates the prosthetic design registration landscape  in this domain and is closely followed by Austin Cole. Medtronic Inc., Zimmer Biomet Holding, Johnson & Johnson, , Stryker Corp, and Abbott Labs also figures among the leading assignees.

Edwards Life Sciences specializes in artificial heart valves and hemodynamic  monitoring. Over the span of the last ten years, they have dominated the patent market by owning 4% of the total patents filed in this period. Medtronic Incorporation is an American company that develops and manufactures healthcare technologies. It comes at a close second by holding 3.9% of the patents in this industry. Other companies such as Zimmer Biomet currently hold 2.4% of the patents, Johnson & Johnson hold 2.3%, Stryker Corp 2.1%. These are the top 5 patent holders in this industry in the last ten years.

Patent Filing Trends

The number of patent applications filed in the prosthetics industry from 2014-2023 have seen an increase in the last few years peaking in 2021 at 1,105 applications. The trend saw a steep decrease in 2022, the lowest record in the last two years. The trends in grants published have been fluctuating with the highest number of grants published in 2014 at 809, and declining steadily since. 2022 saw a slight increase therefore becoming an anomaly in the trend with 485 grants published, the highest since 2017.

Geographical Patent Filing Trends

United States of America emerges as the leading country with 5,864 patents filed in the last ten years in the prosthesis industry.

Leading companies such as Edwards Life Sciences, Medtronic, Zimmer Biomet Holdings Inc., Stryker Corp, Abbott Laboratories, Cook Medical Group, Boston Scientific, etc. are based in the United States of America hence making it the world leader in this domain. China is US’s biggest competitor with 2863 patent filings in the last ten years. World players such as Beijing Akec Medical Co Ltd and Beijing Chunlizhengda Medical combined hold about 10% of the country’s prosthesis patents. Following China is Germany at 875 patents. Otto Bock Healthcare GMBH which places 10^th on the list of market leaders hails from Germany and holds about 16% of the Germany’s prosthesis patents. France places 4^th on the list with 606 patents, followed by South Korea at 454, United Kingdom with 379, Switzerland, Italy, Russia and Ireland. Israel, Australia, Iceland, Japan and Canada are emerging leaders in this domain. 

Trends in various types of prosthetic devices

The highest number of patents are 13,262 and are filed in the CPC group filters implantable into blood vessels, prostheses, i.e., artificial substitutes or replacements for parts of the body, appliances for connecting them with the body, devices providing patency to, or preventing collapsing of, tubular structures, e.g. stents. This category broadly includes all kinds of prostheses patents filed in the last ten years. There are 8252 patents for implantable devices, 2682 for special features of prostheses that fall under other CPC groups. The total number of patents for prostheses filed in this period are 13,775.

Design Registration Trends

Leading Assignees

Otto Bock Healthcare GMBH is the global leader in design patent filings in the last ten years. The number of designs filed in the last ten years are significantly lower than the number of patents filed in the same period. This could be because design patents only cater to the appearance or configuration of the product and without any actual functionality or utility. Otto Bock Healthcare GMBH holds 8% of all design patents filed in the last decade. Following Otto Bock Healthcare is Austin Cole with 10 design filings. Other notable players are Cormatrix Cardiovascular Inc. based in the United States of America with 9 design filings, Sutures India Pvt. Ltd. based in India and Coloplast which is a Danish company specialising in developing ostomy, continence, interventional urology, wound and skin care products and services.

Some of the notable patent holders such as Edwards Life Sciences, Stryker Corp, Ossur HF and Otto Bock Healthcare come in the top 20 design holders as well, although their share is significantly lesser in this domain. Edwards Life Sciences merely holds 1.5% of the total design filings, Stryker Corp holds 2.6%  same as Ossur HF.

Design Filing Trends

The design filing trends from 2014-2023 show fluctuation throughout the period. The number of applications filed in this time period hit their second highest peak in 2017 (13) which was a steep increase from 2014. They then saw a significant drop in the years 2018 and 2019 with only 1 design application filed in both these years respectively. 2020 saw an increase in number to 8 applications which then decreased to 5 in 2021. The highest number of design applications were filed in 2022 at 15.

The trends in grants published show a similar fluctuation but more exaggerated. They highest number of grants were published in 2015 which were 34. From the years 2015 to 2018 they saw a steady decline to 9 grants published in 2018. There was a momentary increase from the years 2018 to 2020. 2021 saw the sharpest decline to 8, the lowest number of grants published in the last ten years in the prosthetics industry. However, the number of grants published showed a 200% increase in 2022.

Geographical Design Filing Trends

It is evident from the map above that designs have been filed in very few countries. Some countries such Russia and the African continent have registered zero designs from 2014-2023. The country with the highest number of design filings is the United States of America with 70 design filings which is around 27% of the total design filings in the last ten years. Second on this list is India with 34 design filings accounting to 13% of the total design filings in this period. Amongst the top market assignees, Sutures India Pvt and Chetan Meditech Pvt. Ltd. together make up 35% of the country’s design filings. Third on the list is Germany with 18 design filings. Otto Bock Healthcare that hails from Germany is the owner of maximum number of design filings in the last ten years. Following Germany is Austria with 16 designs (6%), Canada with 11 designs (4%), Iceland with 10 from Ossur HF holding 70% of the country’s design filings. Italy, United Kingdom, Japan and Australia make the top 10 countries in the world in the design filings in the prosthetics industry.

Current IP Scenario

The global orthopaedic prosthetics market will see a 4.5% increase by 2030, with upper extremity prostheses accounting for nearly two-thirds of the market share.[16] In 2022, 828 patent applications were filed and 485 were granted. The MedTech industry was already growing before the global pandemic, but after the COVID-19 pandemic of 2020, the highest number of patent applications were recorded in 2021. With the European Patent Office (EPO) introducing the Unified Patent System in June 2023 which will simplify the patent processes across EU[17], the current IP scenario appears to be going in a positive direction. This could be prosperous not only for the prostheses industry, but the entire global patent landscape.

Economic Analysis:

Impact of Patents and Design Filings on the Revenues of the Market Leaders

A significant share of the global Prosthetics & Orthotics market is held by North America as of 2022. Multiple factors such as increased awareness amongst the older populations about cardiovascular and neurological disorders as well as awareness about sports injuries contribute to this success. Additionally, support from the Government and the ease of accessibility to high-quality medical facilities and attractive reimbursement policies play a vital role in its success.[18]

In 2018, North America led the myoelectric prosthetics market, owing to a convergence of trends such as greater acceptance of new technologies, an increase in the number and instances of Critical Limb Ischemia, and higher investment in the area[19].

The global prosthetics and orthotics market is categorized into four key regions, comprising North America, Europe, Asia-Pacific, and the Rest of the World (RoW). North America accounted market share of around 38% in 2021.[20] Due to the presence of established prosthetic makers in the United States, the demand and growth of the prosthetics and orthotics market has been growing at an unprecedented rate. Due to the better proficiency and skill of medical experts, many choose to get their treatment from U.S. However, it is expected that the prosthetics and orthotics market in Europe and APAC will pick up pace during years to come[21].

How patents and design filings contribute to a company’s revenue and profits

Patents are valuable intangible assets of a company. They protect a company’s innovation for a limited period of time (20 years) granting them exclusive rights and access to that invention. It is therefore clear why a company would need to protect their intellectual property or innovations and inventions. It gives them a competitive edge in the market can help make the business more efficient. There are multiple ways through which patents and design filings and protections benefit a company’s revenue.

• Licensing and royalties: In an industry which thrives on innovation such as the medical technology and prosthetics industry, out-licensing patents is a very good way for companies to generate revenue. The income from out-licensing patented technologies may be in the form of royalties.
• Exclusivity: By patenting the technologies and inventions, companies can prevent third parties from making, using, selling, offering for sale or importing the patented inventions in the country(ies) where the patent is granted. This gives a competitive edge to the companies and they are able to prevent their competitors from making the same or similar products. This is used as a defensive strategy by big companies to avoid litigation for the same.

One of the most impending legal risks that companies face is their inability to safeguard their intellectual property. E.g., Edwards Life Sciences in their 2022 form 10-K list[22] “a, Inability to protect our intellectual property, b, Inability to defend against intellectual property claims property claims from third parties” as their biggest threats under Legal, Compliance and Regulatory Risks.[23]

Many companies such as Edwards Life Sciences, Zimmer Biomet, Johnson and Johnson etc. have stated in their financial statements that, “Our inability to protect our intellectual property or failure to maintain the confidentiality and integrity of data or other sensitive company information, by cyber- attack or other event, could have a material adverse effect on our business.”[24] Patents therefore play a vital role in ensuring the success and competitiveness of a company.

• Attracting investments and collaborations: When an invention is brought to the market to attract investors, it’s imperative that the invention is protected or else there is a risk of someone else copying it. In that case, an investor would not be interested in funding a project that can be done by other companies as well. Hence, patented and protected inventions serve as a measure of security which in turns boosts investments and collaborations.
• Company valuation: Patents not only serve as an apparent protection for companies but also carry monetary value for companies in the form of intangible assets. For example, as of December 31, 2022, the total value of Intellectual Property Rights of Zimmer Biomet was $137.7 million.[25] In the year 2022, the gross value of intangible assets such as patents and trademarks  for Johnson & Johnson was $21,746 million.[26] For Medtronic Inc., in the year 2022 the gross carrying amount of purchased technologies and patents was $10,802 million and $473 million for trademarks and tradenames.[27]

The aforementioned statistics of some of the largest patent holders in the prosthetics industry shows how important it is for a company to safeguard their intellectual properties and technologies which can in turn yield huge revenues.

Revenue from Prosthetics and market leaders

In the previous section of this report, we had discussed the leading patent owners in the prosthetics industry. They are as follows:

• Edwards Life Sciences: Edwards Life Sciences ranks #1 as the holder of maximum number of patents in this industry. Headquartered in Irvine, California, Edwards Life Sciences was founded in 1958 and specializes in artificial heart valves and hemodynamic monitoring.[28] It’s net revenue in 2022 was $5,382.4 million (Form 10-K).
• Medtronic Inc.: Ranking #2 in the list of global leaders in the prosthetics industry, Medtronic Inc. currently is the owner of 538 patents of prosthesis. Headquartered in Minneapolis, Minnesota, Medtronic is a global leader in developing and manufacturing healthcare technologies.[29] It’s net revenue in 2022 was $31,686 million (Form 10-K).
• Zimmer Biomet: Zimmer Biomet was founded in 1927 and is headquartered in Indiana, United States of America.[30] It’s revenue in the year 2022 was $6,960 million (Form 10-K).
• Johnson & Johnson: Johnson & Johnson is a multi-national corporation in the consumer health, pharmaceutical and MedTech industry. It was founded in 1886 and is headquartered in New Jersey, United States of America.[31] In 2022, it’s net sales were $94,943. (Form- 10K)
• Stryker Corp: Stryker is one of the world’s leading medical technology companies and specialises in medical and surgical equipment, orthopaedics, neurotechnology and training and education.[32] It made a revenue of $18,449 million in 2022. (Form 10-K)
• Abbott Laboratories: Headquartered in Illinois, United States, Abbott Laboratories is a multinational company founded in 1888. It primarily specializes in medical devices and healthcare. It’s revenue in 2022[33] was $43,653.00 million. (Form 10-K)
• Cook Medical Group: Cook Medical is based in Bloomington, Indiana, United States and is primarily involved with the manufacturing of medical devices.[34]
• Beijing Akec Medical Co Ltd.: Beijing AKEC Medical Company Limited develops, manufactures and sells orthopedic medical device products. The Company’s main product is artificial arthroplasty, which includes artificial knee joints, and artificial hip joints products. It’s net sales in 2022[35] were $73.31 million.[36]
• Boston Scientific Corporation: Boston Scientific is an American Company that specialises in endoscopy, interventional cardiology, neuromodulation, peripheral interventions, rhythm management, urology and pelvic health.[37] It’s annual revenue in 2022 was $12,682.00 million. (Form 10-K)
• Otto Bock Healthcare GMBH: Otto Bock GMBH is world leader in the prosthetics industry and is based in Duderstadt, Germany. It specialises in orthopaedics, wheelchairs, exoskeletons and prosthetics. It’s annual revenue in 2022 was 1.3 billion euros.[38]

Revenue distribution in the prosthetics industry

Many of these companies specialize primarily on developing and manufacturing prosthetic devices such as Zimmer Biomet Holding, Beijing Akec Medical Co. Ltd. And Otto Bock Healthcare GMBH. Other companies such as Johnson & Johnson, Medtronic Inc, etc. specialize in many other fields of medical sciences.

It is observed that Abbott Laboratories that rank #6 globally in the prosthesis patent market yielded the maximum revenue of $14,687 million in the year 2022. The prostheses products constitute nearly 1/3^rd of the company’s total revenue. Second in the list is Johnson & Johnson, making $8,587 million from medical devices and prostheses alone. This sector only makes up 9% of the total revenue of the company. Stryker Corp places third with 42% of their revenue coming from prostheses valued at $7,838 million. Boston Scientific Corp is a close fourth after Stryker Corp, closing in at $7,705 million which is nearly 61% of their total revenue. Medtronic Inc, despite being the second largest prostheses patent holder places 5^th on the list of revenue from prostheses which constitutes 18% of their total sales. Interestingly, Edwards Life Sciences which owns the largest number of patents in this industry places 6^th on the list of prostheses revenues despite prostheses constituting 67.5% of their total revenue. Otto Bock Healthcare GMBH, the world leader in prostheses design filings places 8^th on the revenue list. Beijing Akec Medical Co. and Zimmer Biomet are close competitors as well.

Contribution of Patents and Designs for the Market Leaders

As stated in section 4.1 of this report, patents and designs play a huge role in ensuring the success of a company. Patents, designs, trademarks are usually listed as intangible assets in a company’s financials, but they are assets, nonetheless. Patents and designs also indirectly increase the monetary value of companies. They do this by increasing the goodwill and trust of consumers in the respective companies, they can be used in out-licensing of patented technologies and enabling organizations and companies to enforce their rights.

• Edwards Life Sciences:

In Edwards Life Sciences form 10-K for the year 2022, it is observed that the company invested $205.5 million in patents, which are finite-lived intangible assets. This is an increment from 2021 by about $20 million. The net carrying value of the patents at the end of 2022 is $20.5 million, about thirteen times more than 2021. This indicates that Edwards Life Sciences understands the importance of investing in patents and safeguarding their intellectual property which will yield great revenues in the future.

• Medtronic Inc.

For Medtronic Inc., in the year 2022 the gross carrying amount of purchased technologies and patents was $10,802 million and $473 million for trademarks and tradenames. The high investment in purchasing technology and patents is highly beneficial for the company as it can help them expand their existing product/innovation line and contribute in research and development.

• Zimmer Biomet Holdings

Zimmer Biomet’s intangible assets such as Intellectual Property Rights are valued at $137.7 million and trademarks and tradenames at $711 million. This is a decrease from 2021 owing to the increase in amortization of the intangible assets. Trademarks and tradenames constitute 14% of the total value of intangible assets of 2022.

• Johnson & Johnson

There is a positive trend in the patents investments from 2021 resulting in greater values for patents and trademarks. Johnson & Johnson is a multinational corporation with maximum focus on consumer health products, therefore It realizes the importance of protecting its innovations in this incredibly competitive industry.

For the global leaders, protecting their technologies is extremely vital. Stryker Co. in 2022 had intangible assets (patents + trademarks) worth $251 million. Not only do patents ensure security but the mere investment in patenting technologies is an important factor to consider while ascertaining the company’s commitment to its successful future

Linking the Revenue to Patents and Designs

The trends are very inconsistent and there is no linearity observed between the patents filed and the revenue generated. Edwards Life Sciences, the largest patent holder generated minimal revenue from prosthesis. This could mean that the company has filed multiple patents to avoid other companies to use the same technology, or to increase their brand value and marketing without any actual utility of those patents. Further, these patents could be utilised in the future to generate larger revenues.

The annual revenue of Edwards Life Sciences is also in the lower half of the top 10 companies which could signify that the company is not investing the right amount of resources or facilities to yield the complete potential of their prostheses patents. This could be a risk to the business as 2/3^rd of the revenue is generated by prostheses thereby making it an integral part of their business.

Abbott Labs have made the most revenue from their prosthetic devices with nearly 34% of their business coming from this sector. This is a sharp contrast from Edwards’ financials which hold almost double the number of patents and yields almost one-fifth the revenue of Abbott Labs from prostheses.

Johnson & Johnson has the highest annual revenue amongst all companies and second highest revenue from prostheses. Prostheses contribute only 9% of the company’s revenue and yet places second. Johnson & Johnson does not specialise in prostheses as compared to its other competitors such as Otto Bock Healthcare and yet performed exceptionally well.

There is also a disparity in Medtronic Inc.’s prostheses patents and revenue generated. 18% of Medtronic’s revenue comes from prostheses.

Litigation in the Prosthetic Devices Industry

After the COVID-19 global pandemic, the MedTech industry has becoming increasingly relevant. Recent patent filings have been primarily focused on information and communications technology (ICT) specially adapted for medical diagnosis such as point-of-care devices, wearables, and remote monitoring systems such as telemedicine, medical simulation, or medical data mining followed by surgical robots.[39] With Artificial Intelligence (AI) becoming extremely prevalent in almost all sectors and industries, its introduction in the MedTech and especially prosthetics industry is notable. Recent technologies with the help of AI are aiming to revolutionise the current models of prosthetic devices. In built AI systems in the devices will learn the movements of the functioning body part which they will then remember and replicate. This will then be installed in the phantom body part as a prosthetic device. This does away with the previously used myoelectric and body connected prosthetic devices.

With an increase in innovation and patent filings in this industry, there have been litigations and oppositions as well.

Disputes in the Industry

In the last ten years, there have been multiple oppositions and litigations in the prosthetics industry. Some of these involve the biggest players in the industry such as Edwards Life Sciences, Zimmer Biomet, Cook Medical, etc. Listed below are the legal proceedings and disputes in the industry amongst the biggest players. Some notable disputes are as follows:

• Edwards Life Sciences v. Abbott Laboratories

In 2019, Abbott Laboratories alleged Edwards’ transcatheter valve repair system Pascal infringes on its MitraClip patents in lawsuits filed in the U.S. and several European markets.[40]  In 2020, Edwards Life Sciences agreed to pay Abbott $368 million upfront to settle disputes over patents for transcatheter mitral and tricuspid valve repair products, plus roughly $100 million in royalties through mid-2024.[41] This led to Edwards Life Sciences spending approximately $405 million on intellectual property related litigation settlements in 2020.[42]

At present, Edwards Life Sciences is in a legal proceeding led by Aortic Innovations LLC in 2021 alleging that Edwards’ SAPIEN 3 Ultra product infringes certain of its patents.[43]

• Stryker Corp v. Conformis

Stryker Corp acquired Wright Medical in November 2021. Conformis alleged that many patient-specific devices made by Wright Medical infringed upon their patents. In this dispute, Stryker Corp had to pay $15 million to Conformis.[44]

• NuVasiv v. Medtronic

The lawsuit was initially filed in 2008 regarding spinal products, and in 2016 both companies agreed mutually to settle the lawsuit for $40 million paid by NuVasiv to Medtronic Inc.

Opposed Patents

There have been multiple oppositions to patent applications and grants in the last ten years. Most of the oppositions have been recorded from the European Patent Office, followed by United States, South Korea and Germany.

• EP898943B1: Dental Prosthetic Part[45]

Applicants: WIELAND DENTAL & TECHNIK GMBH [DE]

On 2004-08-12, opposition was filed by DENTALES SERVICE ZENTRUM GMBH & CO.KG post-grant.

• EP3400908B1: Artificial Valve Prostheses[46]

Applicants: COOK MEDICAL TECHNOLOGIES LLC [US]

On 2021-04-28, opposition was filed by NEOVASC TIARA INC. in Germany after the patent was granted.

• EP2982337A1: Paravalvular Leak Detection, Sealing, and Prevention[47]

Applicants: EDWARDS LIFESCIENCES PVT INC [US]

On 2021-05-25, opposition was filed in Germany. On 2021-06-29, opposition was filed in Finland by ABBOTT CARDIOVASCULAR SYSTEMS, INC. and NEOVASC TIARA INC.

On 2021-06-30, both companies filed oppositions.

On 2023-06-30, date of receipt of notice of appeal recorded. This was the latest legal development in this case.

• EP2962726A1: System for excitation of phantom sensations[48]

Applicants: MEIER-KOLL ALFRED [DE]

On 2021-08-03, opposition against patent was filed in Germany by SAPHENUS MEDICAL TECHNOLOGY GMBH.

On 2023-06-03, opposition was rejected.

• EP2720648B8: Femoral Component for a knee prosthesis with improved articular characteristics[49]

Applicants: ZIMMER INC [US]

On 2016-06-08, opposition was filed by SLINGSBY PARTNERS LLP. The appeal procedure was closed on 2021-11-17. On 2022-09-13, the patent was revoked following opposition.

• US9907561B2: Ankle replacement and method[50]

Original Assignee: WRIGHT MEDICAL TECH INC (US)

Current owners: STRYKER CORP (upon acquiring WRIGHT MEDICAL), WRIGHT MEDICAL GROUP NV.

• KR20180122237A: Apparatus for exercising prostatic hyperplasia by neural stimulation[51]

Applicants: PARK JEONG HOON (KR)

On 2019-01-31, the decision to refuse the application was passed.

Legal status: Inactive-rejected/ refused/ suspended

Corporations and companies expend certain sums of money per annum for settlements to counter oppositions and litigation claims. Many of these patents cease to exist  due to fierce oppositions.  The patents listed above are a few of many oppositions filed in the last ten years and is not exhaustive.

Litigations

While there have been many patent oppositions, the litigations in this industry are also many in number. There have been a total of 20 litigations in the last ten years, some of which have costed big corporations huge sums of money owing to patent infringements. Some of these have been listed in section 5.1. 14 out of these 20 litigations have been from US patents and the rest are from China and Japan.

• US8623077B2: Apparatus for replacing cardiac valve.

This patent was published on 07-Jan-2014 by Medtronic Inc. A petition was filed by Edwards Life Sciences in 2014 in the United States Patent and Trademark office before the Patent Trial and Appeal Board. The petitioner, Edwards Life Sciences requested for a review of certain sections of the publication filed by Medtronic Inc. due to non-distinctness of their existing products. The final decision has not been decided yet.[52]

There have been multiple litigations between these two companies in the past regarding transcatheter aortic valve replacement systems. In 2010, a $73 million  judgement in favour of Edwards was regarding similar products. Another case’s recent ruling in January 2014 for nearly $394 million in favour of Edwards in a case against Medtronic.[53]

• US9393110B2: Prosthetic Heart Valve.

This patent was published on 19-July-2016 by Edwards Life Sciences who is the current owner. Edwards was the plaintiff that alleged that the defendant Meril Inc was attempting to capitalize on Edwards’ success by infringing  multiple Edwards’ patents, designs, innovations and trademarks. Although both corporations had settled their dispute by paying settlement money, a court ruling dated May 18^th,  2022 held in favour of the plaintiffs and against Edwards. [54]

• US9492280B2: Multiple-cam, posterior-stabilized knee prosthesis.

This patent was published on 15-Nov-2016 by MEDIDEA LLC. In the same year, the plaintiffs MedIdea brought a case against the defendants DePuy Orthopaedics Inc. for patent infringement. The United States District Court of Massachusetts  ruled in favour of the defendants DePuy orthopaedics and against MEDIDEA LLC. The patent is currently terminated.[55]

JP2018519868A is a litigated patent for palm unit for artificial hands by ハイファイブプロ エーエス,  a Japanese   company. Some Chinese patents are as follows: CN104207863B (Introduce the total joint replacement prostheses of torque), CN102098984B (Anchoring of tendon f biceps of prosthetic device under arthroscope), etc.

Mergers and Acquisitions

There have been many significant acquisitions in for the top players in the industry.

• Edwards Life Sciences

Edwards Life Sciences did not acquire any companies in 2022. Its latest acquisitions include Corvia Medical in 2019 for $35 million and CAS Medical Systems in the same year for $100 million. The largest acquisition done by Edwards was in the year 2015 when it acquired CardiAQ Valve Technologies, Inc. for $400 million. Sector-wise, 77% of their total acquisitions come from the medical products sector, followed by life sciences (8%). Totally, they have acquired 13 companies (add-on acquisitions and divestitures). [56]

• Medtronic Inc.

Medtronic Inc. has acquired a total of 62 companies. It’s latest acquisition is of EOFlow (2023) which is a South-Korean medical device company for $738 million.[57] In 2022, it acquired Massachusetts-based Affera, a medical technology company specialising in innovations related to cardiac arrhythmia for $925 million. Medtronic’s biggest acquisition till date is of Covidien PLC for $42.9 billion in 2014.

Sector-wise, 58 companies acquired are from the medical products sector (88%). 7% is from healthcare services and 2% is from life sciences.[58]

• Zimmer Biomet Holdings:

Zimmer Biomet Holdings has acquired 24 companies. It’s largest acquisition was of Biomet Inc. for $13.3 billion in 2014. It’s latest acquisitions include A&E Medical Corp in 2020 for $250 million.[59] In 2022, it had reached a definitive agreement to acquire Embody Inc. for $155 million and up to an additional $120 million subject to achieving future regulatory and commercial milestones over a three year period.[60]

• Johnson & Johnson:

Johnson & Johnson has acquired a total of 41 companies. It acquired Abiomed in 2022 for $16.6 billion. It’s largest acquisition was of Actelion Ltd., a biopharmaceutical company for $30 billion in the year 2017. In 2011, it acquired Synthes Inc. for $19.3 billion. 39% of the companies acquired by Johnson & Johnson are from the medical products industry. A close second is the life sciences industry (37%) followed by consumer products (12%) and digital media (5%). [61]

• Stryker Corp:

Stryker Corp has acquired a total of 44 companies. It’s most recent acquisitions include Vocera in 2022 for $3 billion and Gauss Surgical in 2021. It is to acquire Cerus Endovascular in 2023. It’s largest acquisition was in 2019 when it acquired Wright Medical Group N.V. for $5.4 billion. It’s highest acquisitions have been in the medical products sector (75%), followed by healthcare services (14%) and manufacturing (7%).[62]

• Abbott Laboratories:

Abbott Laboratories acquired Cardiovascular Systems Inc. in February 2023 for $890 million. Their total number of acquisitions are 34. Their biggest add-on acquisition was of St. Jude Medical Inc. in 2016 for $25 billion. 56% of these acquisitions are from the medical products industry, followed by Life Science (32%) and information technology (3%).[63]

• Boston Scientific:

Boston Scientific Corp has acquired a total of 62 companies with its most recent acquisition being Acotec in 2022. Its biggest acquisition was of Guidant Corp. in 2006 for $24.6 billion. 77% of their acquisitions are in the medical products industry, followed by health care services (13%) and life sciences (8%). [64]   

The Future

The future of the orthotics and prosthetics industry looks promising. This report has substantiated this point through analysing various patent trends and industry analysis. It is expected that the orthotics market will grow significantly in terms of revenue in the next ten years. Orthotics is forecasted to grow at the highest CAGR of over 5.9% from 2023 to 2033.[65]

As discussed earlier, cardiovascular, neural and bone-related ailments have increased in the projected period therefore increasing the demand for orthotics and prosthetics. Additionally, diabetes-related amputations are also becoming common globally, further increasing market growth. Orthotics can be used in conjunction with physiotherapy procedures such as muscular training and stretching, gait and balance retraining, and reach and grip tactics to help patients achieve their goals[66].

The USA is expected to account for a significant market of US$ 3.7 Billion by the end of 2033.[67] This can be attributed to the fact that most of the major players in this industry such as Edwards Life Sciences, Zimmer Biomet Holdings, Medtronic, Johnson & Johnson hail from the U.S. The proficiency and skill of the region’s medical specialists and doctors have motivated people from other locations to travel there for prosthetic and orthotics treatments. According to the National Limb Loss Information Centre, approximately 1.7 million people in the USA have lost a limb for whatever reason.[68] According to some estimates, one out of every 200 people in the USA has had a limb amputated.[69]

The market in the UK is expected to reach a valuation of US$ 522 Million by 2033, growing at a CAGR of over 5% from 2023 to 2033. During the forecast period, the market is projected to witness an absolute dollar opportunity of US$ 218 Million.[70]

In Japan, the market is projected to gross an absolute dollar opportunity of US$ 320 Million from2023 to 2033, growing at a CAGR of 8.3%. By 2033, the market is projected to reach US$ 583Million.[71]

The Indian scenario is different. Due to the economic disparities amongst the people of India, the affordability of prosthetics is the biggest challenge in this industry. High-end prosthetic devices cost lakhs and the cheaper alternatives offer limited functionality. According to reports, India has more than half a million amputees, with tens of thousands added to the amputee population every year.[72] However, this is expected to change with Indian prostheses start-ups such as Robo-Bionics, Chetan Meditech, etc. making great strides in this field.

Conclusions

Amputations are done on an estimated 158,000 people in the USA each year, with the absolute number of amputations growing. For upper-limb amputation, reported rates of prosthesis use range from 27% to 56%, while lower-limb amputation rates range from 49% to 95%. The industry is expanding due to the rising desire for custom-made foot orthotics[73].

This report sheds light on the current IP scenario of the prostheses industry. The patenting trends are on an increase especially after the COVID-19 global pandemic, indicating a positive trend. However, we have also observed that the number of patents filed by a company is not necessarily proportional to the revenue generated. Amongst the largest patent holders, there is a need to maximise the potential from these patents to maximise revenues.

There has also been an uptick in the number of design filings, with several Indian companies becoming relevant in this context. Geographically, the United States dominates both patent and design filings from the trends observed in the last ten years.

Technological advancements have been accelerated in the last decade. This has led to the development of Artificial Intelligence-based prostheses amongst others. This has the potential to completely revolutionarise the industry. Some other key developments include the advent of neuromuscular signal processing.

3D printing is another important driver in the development and manufacturing of prosthetic devices. It plays an incredibly vital role in simplifying the process of creating customised prosthetic limbs and devices.  The traditional orthotic solutions are generic therefore the boosters of this industry are the customisable prosthetics that provide patients more comfort. 3D printing aids this.

Authors:  Prof (Dr) Anindya Sircar (DPIIT Chair Professor; NALSAR University of Law, Hyderabad, India) and Ms Bhavya Sharma (BBA LLB Student, Jindal Global Law School, Sonipet, India)

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Technology Transfer Agreement and it’s important clauses

Jun 14, 2023 | General

In today’s rapidly evolving technological landscape, the transfer of intellectual property rights, know-how, and technology plays a crucial role in driving innovation and economic growth. Technology transfer agreements serve as legally binding contracts that govern the transfer of these valuable assets from one party to another. Such agreements provide a framework for the licensor (the party transferring the technology) and the licensee (the party receiving the technology) to establish their rights and obligations, ensuring a smooth and mutually beneficial transfer process.

A technology transfer agreement is a legal contract that governs the transfer of intellectual property rights, know-how, or technology from one party to another party. This agreement ensures that both parties understand their rights and obligations regarding the use, ownership, and protection of the transferred technology.

Advantages of Technology Transfer Agreements:

1. 1. Facilitates Knowledge Exchange and Collaboration

Technology transfer agreements enable the exchange of specialized knowledge, expertise, and technical information between the licensor and the licensee. This collaboration allows the licensee to gain insights into new technologies, methodologies, or processes, which can enhance their own research and development efforts. It promotes innovation by leveraging the strengths and capabilities of both parties.

2. Accelerates Commercialization of Technology

By entering into a technology transfer agreement, the licensor can commercialize their technology more effectively. The licensee gains the rights to use, manufacture, or sell the technology, leveraging their existing infrastructure, market access, and distribution channels. This accelerates the process of bringing innovative products or services to the market, benefiting both the licensor and the licensee.

3. Expands Market Reach

Technology transfer agreements often involve the transfer of technology across geographical boundaries. For the licensor, this opens up new markets and opportunities that they may not have been able to access independently. The licensee, on the other hand, gains access to cutting-edge technologies or intellectual property rights that can enhance their competitiveness in existing or new markets. It facilitates market expansion and growth for both parties involved.

4. Risk Mitigation and Shared Expertise

 Technology transfer agreements allow for the sharing of risks and responsibilities between the licensor and the licensee. The licensor can mitigate their risks by transferring technology to a party that has the necessary resources, capabilities, and market presence. At the same time, the licensee benefits from the licensor’s expertise, research, and development efforts, reducing their own risks associated with developing new technologies from scratch.

5. Access to Intellectual Property and Exclusive Rights

 For the licensee, a technology transfer agreement provides access to valuable intellectual property rights, patents, trademarks, or copyrights associated with the technology being transferred. This grants them exclusive rights within a specified territory or market, ensuring a competitive advantage over rivals. The licensee can leverage these intellectual property rights to protect their investments and prevent unauthorized use by others.

6. Cost Savings and Efficiency

Technology transfer agreements can lead to cost savings for both parties. The licensee avoids the expenses associated with extensive research and development, as they can leverage the existing technology or know-how. The licensor benefits from the monetization of their technology, generating revenue streams through licensing fees, royalties, or other financial arrangements outlined in the agreement. This efficient utilization of resources benefits both parties.

7. Legal Protection and Clarity

By entering into a technology transfer agreement, both the licensor and the licensee obtain legal protection and clarity regarding their rights and obligations. The agreement clearly outlines the scope of the license, the permitted uses of the technology, and any restrictions or limitations. It also includes provisions for confidentiality, intellectual property rights, representations and warranties, and dispute resolution mechanisms. This clarity minimizes the potential for misunderstandings, disputes, or infringement issues.

While the specific clauses included in a technology transfer agreement can vary depending on the nature of the technology and the parties involved, here are some important clauses commonly found in such agreements.

1. Introduction and Background

The agreement typically begins with an introduction section that identifies the parties involved and provides a brief background on the purpose and context of the technology transfer. It may include a description of the technology being transferred and the objectives of the agreement.

2. Definitions

This clause is included to ensure clarity and common understanding of key terms used throughout the agreement. It provides precise definitions of important terms, such as the technology being transferred, intellectual property rights, know-how, confidential information, and any other specific technical or legal terms unique to the technology or the agreement.

3. Grant of License

 This clause outlines the scope and terms of the license being granted by the licensor to the licensee. It specifies whether the license is exclusive or non-exclusive, meaning whether the licensor grants the licensee the sole rights to use the technology or if other licensees may also be allowed. The clause may also define the geographical territory or market in which the license applies.

4. Payment Terms:

This clause details the financial aspects of the agreement, including any upfront fees, royalties, or milestone payments that the licensee is required to pay to the licensor. It may specify the payment schedule, currency, and any additional financial considerations. This clause also commonly addresses audit rights to ensure accurate reporting and verification of sales or usage data.

5. Confidentiality and Non-Disclosure

 Given the sensitive nature of technology transfer, this clause establishes the obligations of both parties to maintain the confidentiality of the transferred technology and related information. It includes provisions for marking information as confidential, restrictions on disclosure to third parties, and the duration of the confidentiality obligations. This clause ensures that proprietary information remains protected.

6. Intellectual Property Rights

 This clause addresses the ownership and protection of intellectual property rights associated with the technology being transferred. It clarifies whether the licensor retains ownership or if it is transferred to the licensee. It may also include provisions for the registration, maintenance, and enforcement of these rights, as well as any limitations or restrictions on their use.

7. Representations and Warranties

 In this clause, the licensor makes certain statements and assurances regarding the technology being transferred. These representations and warranties may include affirmations about the licensor’s ownership of the technology, its validity, or its non-infringement of third-party rights. This clause provides a level of assurance to the licensee regarding the quality and legality of the technology.

8. Indemnification

This clause outlines the parties’ obligations to indemnify and hold each other harmless from any claims, damages, or liabilities arising from the transfer or use of the technology. It provides protection in case of intellectual property infringement or other legal disputes. The clause may specify the indemnification process, including notice requirements and the extent of the indemnifying party’s liability.

9. Term and Termination

This clause defines the duration of the agreement and the conditions under which either party can terminate it. It may include provisions for termination due to breach of contract, insolvency, or mutual agreement, as well as any post-termination obligations, such as returning or destroying confidential information or discontinuing the use of the technology.

10. Governing Law and Jurisdiction

This clause determines the jurisdiction and laws that will govern the interpretation and enforcement of the agreement. It helps resolve any potential disputes by specifying the courts or arbitration procedures that will have jurisdiction over the agreement. This clause ensures that the agreement complies with the legal requirements of a specific jurisdiction or that it aligns with the parties’ preferences for resolving disputes.

In conclusion, technology transfer agreements play a vital role in facilitating the transfer of intellectual property rights and technology between parties. They promote collaboration, accelerate commercialization, expand market reach, mitigate risks, provide legal protection, and offer various other advantages to both licensors and licensees. These agreements are essential tools for fostering innovation, driving economic growth, and maximizing the value of technology.

Reference

Akhzami, & Al, S. (2018). Technology Transfer and Commercialisation. Daya Publishing House. Retrieved from https://www.perlego.com/book/3067576/technology-transfer-and-commercialisation-pdf (Original work published 2018)

Author: Anas, Christ Academy Institute of Law, Bengaluru

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Importance of PoSH Policy in a company

Jun 7, 2023 | General

In the year 1977, despite the absence of established safeguards for women, the Supreme Court acknowledged their importance in the case of Vishaka & Ors. vs. State of Rajasthan. As a result, several laws were subsequently established in India to prevent the sexual harassment of women.

One significant legislation is the Sexual Harassment of Women at Workplace (Prevention, Prohibition, and Redressal) Act, 2013, commonly referred to as the ‘PoSH Act.’ This Indian law was enacted to foster a safer work environment by preventing, prohibiting, and addressing instances of sexual harassment. The Ministry of Women and Child Development enforced this law nationwide in December 2013. Under this Act, sexual harassment is recognized as a violation of a woman’s fundamental rights, including equality, dignity, and the freedom to pursue any profession or occupation. By acknowledging the importance of safeguarding women’s well-being at work, the PoSH Act plays a vital role in promoting gender equality and protecting the rights of women.

PoSH Compliance

The scope of the POSH Act extends to cover companies, workplaces, facilities, or organizations with a workforce of ten or more individuals, regardless of their employment type (full-time, part-time, interns, or contract workers), industry, or location.

According to definition of workplace given under section 2, the PoSH Act applies to workplaces of all types, including government and private sector offices, factories, shops, and more. It is intended to protect women in the workplace from sexual harassment, regardless of their age, marital status, or position within the company. The policy also covers women who are indirectly associated with the company, such as contractors or service providers under its control and supervision. Its purpose is to provide comprehensive protection and support to all women in the workplace, regardless of their employment status or contractual arrangements.

This legislation outlines several essential measures that companies must implement to establish a conducive workplace environment for their female employees. These measures include:

1. Formulating a policy aimed at preventing sexual harassment within the company.
2. Establishing an Internal Complaints Committee (ICC) responsible for handling and resolving sexual harassment complaints.
3. Conducting regular awareness programs to educate employees about their rights and responsibilities in creating a safe workplace.
4. Preparing and submitting an annual POSH Compliance Report to ensure ongoing adherence to the Act’s requirements and guidelines.

By adhering to these prescribed measures, companies can proactively cultivate an environment that prioritizes the well-being and security of their female workforce, thereby fostering an inclusive and supportive workplace culture.

PoSH Policy

The PoSH policy encompasses the guidelines and procedures that Indian companies must follow to comply with the law. The PoSH Act mandates every company to establish an Internal Complaints Committee (ICC) responsible for investigating sexual harassment allegations. The policy outlines the composition, duties, and responsibilities of the ICC, as well as the procedures for handling and resolving complaints. It also sets specific timelines for conducting investigations and resolving cases related to sexual harassment.

Furthermore, the policy provides protection to women who report sexual harassment complaints, safeguarding them from any form of victimization or retaliation. In accordance with the PoSH Act of 2013, companies are also obligated to conduct regular awareness and training programs on sexual harassment prevention and ensure a safe and supportive workplace for all employees.

Non-compliance with the PoSH Act can result in legal and financial consequences for employers. Hence, it is crucial for companies to establish and enforce the PoSH policy, prioritizing employee protection and fostering a positive work environment.

Important clauses in a PoSH Policy

1. Scope and Objective– The policy should start with a section that introduces its purpose, scope, and application. It should provide a comprehensive overview of the policy’s extent, including the types of employees (full-time, part-time, contract-based, interns) and workplace environments (offices, branches, remote locations) to which it pertains.
2. Definitions- This clause of the policy should provide proper definitions of important terms like employer, workplace, employee, aggrieved woman, sexual harassment, etc. which is also in line with the definitions provided in the PoSH Act.
3. Prohibition of Sexual Harassment– The policy should clearly state that the workplace has a zero-tolerance policy towards sexual harassment and that all forms of harassment will be met with appropriate disciplinary measures.
4. Responsibility of the Employer– The policy should highlight the role of the employer in ensuring the prevention of sexual harassment at workplace and o diligently implement the PoSH policy in the company.
5. Internal Complaints Committee– The policy should include information about the ICC’s composition, functions, and duties, as well as their training and the method for reporting complaints.
6. Complaint Procedure– The policy should provide the process to submit a complaint to the ICC including the time limits. It should also mention the procedure for ICC to receive, investigate and decide upon the complaint accordingly.
7. Confidentiality- The policy should emphasis on maintaining the confidentiality and privacy of those involved in the complaint procedure.
8. Training and Awareness Program- The policy should encompass provisions regarding the implementation of routine awareness and training initiatives focused on preventing sexual harassment, guaranteeing that all employees are well-informed about their rights and obligations in this regard.
9. Disciplinary Action- The policy should clearly mention what kinds of disciplinary action will be taken against employees for non-compliance with the PoSH policy.

To conclude, the implementation of a PoSH Policy in every company is the right step to take to ensure a safe and inclusive workplace for all employees, especially women. It is the fundamental right of every woman to be able to work in a dignified manner, without being exposed to harassment. Thus, having a PoSH policy can empower employees, promote equality, and ultimately lead to the overall success and well-being of a company.

Author: Indra Priyadarshini,  Origiin IP Solutions LLP

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The Data Protection Bill in India: Cause for concern over the Digital Privacy

Nov 9, 2022 | General

The Digital Personal Data Protection Act, 2023 (also known as DPDP Act or DPDPA-2023) is an act of the Parliament of India to provide for the processing of digital personal data in a manner that recognises both the right of individuals to protect their personal data and the need to process such personal data for lawful purposes and for matters connected therewith or incidental thereto.

With the entrance of the digital age, and where personal data to become the most wanted currency in the e-universe, India is giving ample consideration to digital privacy rights of the citizens. Visible in the centre of this movement is the so-called Data Protection Bill or DPDP Act shortly (Data Protection and Privacy Bill). Viewed as a complete set of rules which, with the aim of supervising the collection, processing and storage of personal data, the DPDP Act indeed is to bring the new digital era of data protection in India.

Understanding the Need

The soaring of digital technology has overhauled information-processing processes by changing the way people gather, send and use data. The fast expansion of digital world brought us in few words unimaginable ease of use and connection; though, the same evolution is engaging people in an active process of personal data usage discussion since the process is interconnected with safety issues. As an example, data breaches, unauthorized surveillance, and improper use of personal information have caught the data protection attention. People’s data have always been at stake, which made it imperative to implement strong measures regarding data protection legislation.

Awareness of the existing challenges, the Indian government began its journey of mapping a legal structure that not only caters the contemporary scenario’s but also conforms with the globally adopted strategies. When we consider India having the DPDP Act, we realize that this country is resolved to protect the digital privacy rights of its citizens against deterioration in an ever more interconnected global village.

The adoption of the DPDP Bill in the Parliament comes 6 years after Justice K.S. Puttaswamy v Union of India, a landmark case in which the Supreme Court of India recognized a fundamental right to privacy in India, including informational privacy, within the “right to life” provision of India’s Constitution. In this judgment, a nine-judge bench of the Supreme Court urged the Indian Government to put in place “a carefully structured regime” for the protection of personal data. As part of India’s ongoing efforts to create this regime, there have been several rounds of expert consultations and reports, and two previous versions of the bill were introduced in the Parliament in 2019 and 2022.[1]

Key Provisions

For the sake of enacting Personal Data Protection Act (DPDP Act) a set of legal instruments and rules has been put into people’s hands to bring in more responsibility and transparency into the field of personal data management, as well as introduce in the companies and institutions very tight rules and terms of data protection. Here are some key highlights of the bill: Below is some of the monthly bill highlights:

1. Consent Mechanism: The act clearly outlines individual’s right to privacy through a consent contract and the introduction of the clear notification system of non-disclosure of sensitive personal information. This consent-based mechanism constitutes the critical principle that the individual should own their data and they should have the will power to decide how the data is used, shared and stopped in case they so desire.

2. Data Localization: In the wake of the need to guard the data sovereignty and boost the security of sensitive personal information, the newly proposed Data Protection and Privacy Act (DPDP) compels to locate storage of some sensitive personal data inside the territory of India. This regulation indeed implying the prevention of the unauthorized traffic of confidential information in and putting bearing guidance in communications among nations which is a subject matter of data exchange.

3. Data Protection Authority: The Act shall be passed to set up a Data Protection Authority which is the main supervisory body under the authority of DPDP Act and charged with the responsibility of observation of the implementation of the provisions of the legislation. The obvious task of the DPA is to verify the conformity to data protection principles, launch investigations into personal data breaches, and fine persons/organisations if the requirements are not complied with.

4. Data Processing Principles: The DPDP Act provides for the codification of some of the fundamental principles that define the collection and processing of data and these comprise data minimization, purpose limitation, transparency, and accountability respectively. The fundamental aspects are a compass, containing the true order of the data which is processed by each of the stakeholders of the data.

5. Rights of Individuals: Firstly, the law differentiates in non-transferable nature of the private data of every individual as thus, exceeding individual’s rights are accordingly, the subject of: access to one’s data, rectification, to be forgotten and data portability. Rights to individuals’ personal data and information a user can fully exercise these rights so as to take hold of how data controllers are utilizing them.

Challenges and Opportunities

Alongside the Data Protection Regulation Act of India that unquestionably heralds a great epoch in the Indian information security realm, some difficulties and complexities also prevail. One of the greatest concerns revolves around the question of how to it appears well between encouraging continuous developing and protecting privacy rights. The piece of legislature must successfully pass the challenges associated with regulating an economy centred around data without dissuading innovation or impeding progress with innovations.

Along with this, the efficient implementation of the DPDP Act will be developed based on competent enforcement mechanisms, capacity building classes and public awareness programs. Generating an environment of data privacy awareness needs conjoint efforts from all the actors along the whole field beginning from government agencies to the non-governmental ones, private companies, civil society organizations, and every individual citizen.

Besides these challenges exist incessant possibilities for India to emerge as world class in set data protection norms and regulatory laws. A Country like India which promote a data-driven ecosystem by practicing ethical data management will increase its economic digital attraction for foreign investors and upgrade its economy through innovation. Adding the element of high data protection standards to the norm can certainly serve to increase our standing in the international arena and promote contracting parties the ability to mutual adequacy agreements with others jurisdictions.

Conclusion

Enforcing the Data Protection and Privacy Act kick-starts a new web governance system in India wherein citizens will be provided with protection of their information and data. With the DPDB Act the dream of Indian digital-empowered society and knowledge economy is achieving a new life because for a certain duration data subjects have their data rights to control and the trust and accountability in digital innovation are maintained.

[1] https://fpf.org/blog/the-digital-personal-data-protection-act-of-india-explained/

Author: Rohan Patil, ISBR College

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Personality Rights and IP Law

Dec 15, 2021 | General

Recently, an app’s advertisement read “Speak English as fluently as Shashi Tharoor,” regarding which, the Kerala MP was forced to clarify that he is not endorsing the app and that legal action would be taken against the makers of the app for misusing his name and picture for promotion[i]. We come across many such instances in the contemporary world due to the advent of various social media platforms, and in such cases, the personality rights of a person are violated.

G.W.F. Hegel, a German philosopher, viewed property as an extension of personality[ii]. Based on this, many modern theorists argue that property rights are linked to human rights such as liberty, privacy, identity, etc. Personality is a means through which a person is identified in the society and therefore, the protection of personality in the form of a right essentially protects private property which are of the form of intellectual property. Each person has a right to control the commercial use of their name, image, or any matter that forms a part of their identity. These rights are called personality rights. In India, there are no codified laws enacted to protect personality rights, but it is protected under fundamental rights, Copyright Act, Trademark Act, and through various judicial pronouncements. An overview of the protection guaranteed under the law is presented in this article.

Common Law and Constitutional Protection of Personality Rights

One of the earliest case laws that we can find on the violation of personality rights is that of Tolley v. JS Fry & Sons Ltd[iii], although the case was about defamation under tort. The defendant’s advertised their product, ‘Fry’s Chocolate Creams’, using a caricature representing the claimant, who was a well-known amateur golfer, without his consent. The court held that the defendants are guilty of libel because they had exploited a person’s image without his consent, thereby amounting to an ‘appropriation of personality’. The offence of passing off under tort, which prevents a trader from misappropriating another trader’s goods or services, is also an example of protection guaranteed to personality rights under tort.

Personality rights as such do not find a place in the Indian Constitution but in the case of Justice K.S.Puttaswamy(Retd) vs. Union Of India[iv], privacy was recognized as a fundamental right under Article 21 of the Constitution. Privacy, as an extension of liberty, is a ‘right to be let alone’[v], and any person misappropriating the identity of a person without their consent is said to have violated the fundamental right to privacy and thereby, the personality right.

Personality Rights and The Indian Copyright Act, 1957

Section 13 (1) of the Act defines the scope of the Act and states that it is applicable to:

1. original literary, dramatic, musical and artistic works;
2. cinematographic films;
3. sound recordings.

Further, Section 14 of the Act provides exclusive right to do or authorize reproduction of their artistic work. Copyrights are not provided to identity as such, and the copyrights of the image of a person is vested with the photographer and not the said person. Therefore, the misuse of any such image violates the copyrights of the photographer and fails to protect the personality right. However, Section 38 of the Act provides right over performances to the performer and the performer has exclusive rights over the recording and reproducing of the performance. Even after the performer has consented to the incorporation of the performance in other forms, the moral rights of the performer are protected from distortion or mutilation of the performance which could harm his reputation. Right to paternity and right to integrity is protected under Section 57 of the Act, thereby protecting the personality rights of the artists. In the case of Amar Nath Sehgal vs. Union of India[vi], Amar Nath Sehgal created a bronze mural for International Convention Hall in Delhi as per the request of the government of India in 1959, which was placed on a wall in Vigyan Bhavan. Later it was pulled down and consigned to the storeroom of the Union of India in the year 1979 without his permission. The Delhi High Court upheld the moral right of the artist, holding that the act of the government amounted to distortion of the artist’s work which is detrimental to his reputation.

Personality Rights and The Indian Trade Marks Act, 1999

Section 2(1) of the Indian Trade Marks Act, 1999, allows registration of any “sign capable of distinguishing goods and services of one person from another” and Section 2(1)(m), which provides the definition of ‘mark’ to include name as well. Section 14 of the Act states that when an application is made for registration of a mark which dishonestly suggests an association with a living person or a person whose death took place within 20 years of the date of application, the Registrar may seek consent from the living person or the legal representatives of the deceased person before granting the registration. Through Section 2 and Section 14, the Indian Trade Marks Act, 1999, protects the identity of an individual from being misused.

Judicial Recognition

One of the most important cases where personality rights were recognized, was in the case of ICC Development (International) Ltd. vs. Arvee Enterprises[vii], in which the Delhi High Court held that: “The right of publicity has evolved from the right of privacy and can inhere only in an individual or in any indicia of an individual’s personality like his name, personality trait, signature, voice. etc. An individual may acquire the right of publicity by virtue of his association with an event, sport, movie, etc”

In the case of TITAN Industries vs. M/s Ramkumar Jewelers[viii], the Delhi High Court granted a permanent injunction against the hoarding of the defendant’s advertisement which was similar to the plaintiff’s and featured Mr. Amitabh Bachchan and Mrs. Jaya Bachchan. The court stated that: “When the identity of a famous personality is used in advertising without their permission, the complaint is not that no one should not commercialize their identity but that the right to control when, where and how their identity is used should vest with the famous personality. The right to control the commercial use of human identity is the right to publicity”.

Conclusion

Shakespeare in his celebrated play, Romeo and Juliet, writes:

“What’s in a name? that which we call a rose

By any other name would smell as sweet”

Although the lines suit the context of the play, they can hardly be generalized. The identity of a person is of vital importance as there is an increase in the commercialization of the personality. Any person imitating a celebrity, even if the person’s imitation is accurate, is still not the same as a celebrity. The ‘name’ or the ‘image’ of the personality is what drives the commercialization rather than their art, which has taken the form of an intangible property over the years. The Copyright Act and Trade Marks Act protect personality rights to a certain extent, but there is a need for enacting a law that protects personality rights more effectively.

Author: Rachel Thomas

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Covid-19 – A clarion call for a robust public-private disaster management program

Jul 13, 2020 | General

Bill Gates had predicted in 2015 that the global catastrophe killing millions of people would most likely be a highly infectious virus, not nuclear missiles as everyone thought. If you have missed this popular one, you can watch the video here: https://www.youtube.com/watch?v=6Af6b_wyiwI.

Now, digest this. Four years on, in their annual report on global preparedness for health emergencies, the Global Preparedness Monitoring Board in September 2019^[1] specifically warned that there is a very real threat in the near future of a rapidly moving, highly lethal pandemic of a respiratory pathogen killing anywhere between 50 to 80 million people and wiping out nearly 5% of the world’s economy.

In a connected, digitally-enabled world that has increasingly spent billions on technological progress, nuclear deterrents, consumer products, AI enabled predictive models and sciences and even diagnostic healthcare spends, it is appalling that leaders across the world and global watchdogs alike including the WHO have ignored all warning signs of the impending catastrophe.

The GPMB states that large scale viral outbreaks have been on the rise for the past several decades and this trend will likely continue. Even as the world scrambles to battle the COVID-19 pandemic with no long-term planning, my fear is that the next wave of this epidemic, or the next muted virus will be more severe, with consequences much worse. The COVID-19 crisis is a clarion call for a globally synchronized Disaster Management Program that needs to be implemented at regional levels, in every single country, to ensure this nightmare doesn’t repeat.

Here are my thoughts on WHY and HOW governments and international healthcare regulatory bodies must act today to set up effective Disaster Management Programs to save us from existential crisis.

1. More active role by global entities like the WHO: The modern, uber-connected world is symptomatic of a lifestyle unimaginable two decades ago. The globe has shrunk with transnational supply chains and frequent international travel – both magnifying the extent of infection spread and subsequent economic and social impact as we are experiencing with COVID-19. [2] As I mentioned in my paper on The New Socio-Economic Normal After the Coronavirus Pandemic, COVID-19 has driven home the fact that no single institution or country, however developed, can step up adequately to address the impact all by itself. This reiterates the need for extensive international co-ordination, communication and collaboration in the prevention of infectious diseases. It calls for arduous and obsessive governance by stakeholders like the WHO and Global Technical Council on Infectious Disease Threats. These organizations need to rise beyond mere policy making and arbitration to ensure effective planning, governance, regulation, implementation of necessary measures and contingency efforts while providing necessary leadership and support to countries globally.
2. Disaster Management planning is not equal to healthcare spends: Globally, statistics reveal that spends in healthcare on research in non-communicable diseases, advancements in procedures and precision medicine have increased substantially in the last decade. For instance, the US spent nearly 16.9% of their GDP on health, and Italy and Spain – 9% of their GDP. And yet, these are some of the countries most unprepared and impacted by COVID-19. Mc Kinsey and Company’s report suggests it could take the US and Eurozone economies up to 3 years to recover from the impact of COVID-19.[3] The next epidemic will likely take global powerhouses even longer to recover from if we do not act now to focus on proactive disaster management.
3. Increased investment in research: Research spends globally on infectious diseases has been flagging in recent years. Across the world, nations have followed a cycle of panic and neglect when it comes to pandemics: we step up efforts too late in the cycle – when in the eye of the storm, and then quickly forget about them when the threat subsides. The key to controlling the impact of pandemics lies in proactive research and preparedness to minimize the social, health and economic impact of the outbreaks at a global level. According to the NCBI, a commitment of an incremental $4.5 billion USD per year would make the world much safer. There must be continuous study, transparent knowledge-sharing, research collaboration, and a sustained exchange program of talent, skill and technology to ensure equitable access to the latest in preventive research. This is the ONLY way the world will survive another disaster such as this.
4. Proactive and dedicated Disaster Management Program: It is well past time to act and budget specifically for a Disaster Management Program. Governments needs to specifically pump up preventive research funding in biological sciences, homegrown pharmaceutical companies and biotechnology. This must also include provisioning for healthcare infrastructure, material, emergency supplies and medical equipment, PPE, home-grown technology and know-how. Equally important, healthcare professionals and workers across the country must mandatorily attend Disaster Management Program certifications. Collaboration between government healthcare institutions and private sector hospitals will help train caregivers, doctors and nursing staff on the basics and essentials of caregiving during pandemic times. The Disaster Management Program must be a comprehensive, proactive, preventive program that is carried out as a centralized, national policy, a defined part of the union budget/plan. It cannot be a reactive measure as is the case today.

According to the United Nations Office for Disaster Risk Reduction (UNDRR), even the most conservative models suggest that pandemic risks are on par with other high-profile economic threats, including climate change or natural disasters. Even as we struggle to cope with COVID-19, it would bode well for us to start preparing for the next inevitable viral wave. It is time to focus on turning off the tap with an effective Disaster Management Program in place, instead of spending all our efforts on mopping the floor, costing us millions of precious lives and the economy, years of recovery.

Author: Dr. Srivats Bharadwaj, MDS, Chairman & CEO, Vatsalya Dental

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An urgent call for CPR to resuscitate dentistry in the country

May 6, 2020 | General

As a practicing dentist for 23 years now, I have seen my fair share of success during what has been a promising time for dentistry in the last decade. The overall market size of the Indian dental industry was estimated to be approximately USD 2 billion in 2019. Investors have been pumping money into dental chains and specialist dental centers over the last few years. Every fifth ad on TV is for an oral healthcare product. Dental tourism accounted for about 10% of the total medical tourism and was projected to grow at 30% per annum. The India dental service market was expected to grow at a CAGR of 7.34% through 2025.

However, this scenario has changed dramatically today with the coronavirus pandemic. According to the New York Times, dental surgeons are at the highest risk of contracting and transmitting the Coronavirus, alongside paramedics, nurses, and other healthcare workers. Agreeably, dental clinics across the country have been shut for over a month and a half since lockdown measures were announced, and for longer in Karnataka. Most of us who understand the ramifications of this pandemic are preparing to hold off reopening our clinics for at least a few more months – which translates into zero earnings, and consequently a very uncertain future for us and the staff at our clinics.

Here is a quick peek into the stark future of dental practice post CoVID-19. According to the DCI’s advisory released on 16th April 2020, dentists must now strictly follow all protocols to decontaminate, disinfect and sterilize at the clinics as prescribed, enabling us to treat a maximum of only 3 or 4 patients a day. Dentists and our assistants will now need to mandatorily use PPE suits, goggles, face shields, N95 FFP3 masks, surgical gloves and shoe covers, single use chair covers etc., and more for all procedures. With this, already exorbitant treatment costs will at least double, if not more. Informal checks suggest that nearly 80% of dental clinics at present don’t follow the most basic sterilization protocols. If some of these practitioners choose to compromise on the quality of PPE used or sanitation maintained in their clinics, the resulting impact to societal health will be catastrophic. Apart from the huge monetary investments required to continue safe dental practice, there is also the equally important issue of proper training and process management in following these protocols to ensure minimal risk to patients and dentists alike. The advisory also recommends only emergency dental services in the near future, further impacting the financial plight of dentists. When the lockdown measures do ease up finally, given the overall uncertainty in the economy, people will tend to put off any elective dental procedures as they are not covered under health insurance schemes, despite repeated appeals by dentists in the last decade.

Now for some math. India has over 2.7 lakh dentists registered with the Dental Council of India (DCI) according to the NHP 2018, and we have an average of 27,000 new dentists graduating every year. Unemployment of dentists in urban areas is a huge issue already with projections revealing a surplus of about one lakh dentists in the country today. Now, multiply this with the unemployment aftermath of CoVID-19. While there are no official statistics released in India on the impact of CoVID-19 on dentistry yet, a poll conducted by the American Dental Association says 46 percent of dentists indicated they would likely need to sell their practice or file for bankruptcy if the current situation continued beyond August 2020. I suspect the scenario would be the same in our country, if not worse.

CoVID-19 is threatening to reverse the growth trajectory and ring in the death knell on dentistry as a profession in India. There is a serious and immediate need for government intervention to help support and stabilize the dental industry. Call it an urgent requirement of CPR for dentistry if you will.

Here are 5 ways the government can address the malady affecting the dental industry today.

1. Inject fiscal support for the fledging industry over the next two years: This could be on subsidized provision of quality PPE, sanitization equipment and material, and reduction on import duty levied on expensive dental equipment to ensure dentists maintain adequate hygiene standards and aseptic protocols necessary for safe practicing. What would also help is perhaps an easing of taxes for the industry for the next two years, interest-free loans and top-ups. Equally importantly, there is a need for a government led business insurance plan for dentists and their practicing staff protecting them for losses and health concerns arising as a result of exposure to the viral strain or other pandemics. In parallel, we must bring dental treatment under insurance coverage for the general public. Combined with this, the government must also actively look into setting up ancillary industries that can cater to the requirements of the healthcare industry, boosting employment locally and reducing our dependence on medical imports.  
2. Move away from a compartmentalized approach to oral health: Dentistry has long been the forgotten, poor cousin amongst healthcare practitioners and consequently, in public perception as well. However oral health is the window to general health – with more than 120 medical conditions that can be diagnosed through an examination of the oral cavity. Regular preventive oral checkups can reduce both the risk of diseases and the cost of oral treatment which can otherwise be very expensive. The government should ensure every government hospital and primary healthcare center across the country has a dedicated oral healthcare department – this will also provide employment to the thousands of dental graduates in the country who can train to pick up expertise and practical knowledge on the field that is currently lacking.
3. Restructure dental education and bring it under general medicine: I will say this one like it is. Dentistry has mostly been an afterthought profession for aspirants of general medicine who did not quite make the cut with their entrance scores. As a result, there is general apathy towards dentists both within the medical community and in the larger healthcare segment. Combined with this, the standards of dental education are abysmally low in the country. Concepts taught in dental schools haven’t changed in the last 3 or 4 decades while what is practiced on the field is vastly different, aided by technological and scientific advancements. Dental graduates are unable to diagnose basic general health conditions or read ECG / CT scan reports. Pharmacology likewise has become very advanced while dental grads fresh off the campus struggle with basic prescription details. The science of dentistry is fast disappearing and what colleges are churning out are mere technicians practicing age old procedures that are no longer relevant.

The standards of dental education must improve for long term gains. Dentistry should be brought under general medicine where students earn a primary MBBS degree and then specialize in dental sciences at the post-graduate level. The government should also relook at existing teaching licenses for colleges in the country and weed out those who do not meet the requisite standards in theory and practical exposure. This will help address 3 issues plaguing the industry currently – Dentistry will no longer be a poor substitute option for MBBS reject candidates, and quality of service will no longer be impacted. Dental graduates will be better equipped to study the field as a holistic science, understand the co-dependence of dental health and overall health, and will be better prepared in dealing with any medical emergencies in their practice, resulting in better patient care.  Third, in the event of national health emergencies such as the CoVID-19 pandemic, the country will have a larger, better equipped pool of medical professionals who can provide basic health care services at scale.

4. Encourage public – private partnerships: Dentistry and the medical field in general are lacking innovation and a healthy competitive spirit at the graduate level. There is a pressing need for privatization and globalization of dentistry and medicine, which will bring in a healthy dose of aggressiveness, agility and exposure to cutting-edge technology and the latest research – opening up opportunities and access to knowledge – all ultimately benefiting the practitioners, the industry and patient care. The government must encourage private partnerships within the country and with reputed universities abroad. They can well counter any perceived reduction in quality of education by formulating appropriate guidelines to be strictly enforced by regulatory bodies that govern these alliances.
5. Periodic assessment and mandatory skills upgradation: The dental industry must have an active regulatory authority that periodically assesses all dental clinics across various parameters including expertise and exposure to the latest in dental practices and hygienic practicing conditions. This could be implemented through a mandatory skills upgradation program that is linked to license renewal for dentists every two years, after a thorough assessment.

The road to recovery will be painful and prolonged. But this health emergency won’t be the last one. And we must be better prepared for what is likely to come next and equip the dental fraternity and industry to overcome the next hurdle. The above measures will not only help us produce dentists and medical professionals who are competent and confident in tackling health issues in the new decade, they will also bring in much needed investment and revenue injection into healthcare. This in turn will increase employment in allied fields including dental technicians, assistants, lab specialists, etc. It will also provide an impetus to ancillary manufacturing industries that will further generate employment and revenue in the country, nudging us back onto the growth trajectory of being a leading dental and healthcare destination globally.

Author: Dr. Srivats Bharadwaj, MDS, Chairman & CEO, Vatsalya Dental

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In Vitro Diagnostics (IVD) and Regulatory Approvals

Nov 16, 2019 | General

In Vitro Diagnostics (IVDs) are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act. According to section 351 of Public Health Services act, IVDs are biological products. Similar to any other medical devices, IVDs are also subjected to premarket or postmarket controls. IVDs are generally also subject to categorization under the Clinical Laboratory Improvement Amendments (CLIA ’88) of 1988.

Some examples of IVDs are:[1]

• Hepatitis or HIV tests
• Clinical chemistry
• Coagulation test systems
• Urine test strips
• Pregnancy tests
• Blood sugar monitoring systems for diabetics
• Receptacles manufactured specifically for medical specimens

Classification Of IVDs By FDA

FDA has classified the IVDs into three classes, Class I, Class II, Class III. The classification has been based on the level of regulatory control that is necessary to reasonably assure the safety and effectiveness of the devices.

The Code of Federal Regulations lists the classification of existing IVDs in 21 CFR 862, 21 CFR 864, and 21 CFR 866.

IVDs & Covid-19

In terms of immediacy and global demand, SARS-CoV-2 presents a totally different opportunity and challenge compared to all other IVDs tests. The number of SARS-CoV-2 tests already being carried out worldwide most likely outstrips all other infectious disease testing.[2]

But, there are some IVDs that seriously exist and help in further diagnosis of corona virus infection.

The IVDs and SARS CoV-2 & COVID-19 have several enlisted:

1. DIAGNOSTIC TESTS: Tests that detect the designated corona virus and the infection with SARS Cov-2 virus. These include molecular tests and molecular tests and antigens tests.
2. SEOLOGY/ ANTIBODY AND OTHER ADAPTIVE IMMUNE RESPONSE TEST

These are the tests that detect anti bodies in the body of a person. These anti bodies are IgM, IgG. But the limitation of these tests are that these cannot be used when the person is currently infected.

3. TEST FOR MANAGEMENT OF COVID-19 PATIENTS

There are some tests that are authorized for the use in the management of the patients with COVID-19 infection. These are basically bio markers to test the inflammation in the body.

IVDs though are useful, but they do possess risks when used without knowledge. They are:

• There is a risk of false positive and false negative results with all in-vitro diagnostic tests.
• Failure to follow the IFU may affect test performance and impact the validity of the test result.
• Positive results need to be considered alongside other clinical information such as past medical history, results from diagnostic testing and history of exposure.
• A false negative result may occur due to inadequate sample collection, storage, and/or handling, therefore, a negative test result does not eliminate the possibility of SARS-CoV-2 infection.
• When self-swabbing is required, it can be difficult to ensure that a sufficient sample has been obtained. It is important to follow the instructions for use carefully.
• Some tests may not have been evaluated for use in asymptomatic individuals (i.e. individuals without signs and symptoms of respiratory infection). The test performance may differ in these individuals.
• The IFU may specify that the test must be used within a number of days post onset of symptoms.
• The predictive value of the test (probability of a given result being a true result) depends on the prevalence of the disease.

Approval needed in case of IVDs

Step 1

Medical devices and IVDs are regulated by the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO), part of the Ministry of Health and Family Welfare. The regulatory framework for medical devices is based on the Medical Device Rules, 2017. In India, only few Medical Devices and IVDs need approval and go through a lengthy approval system. A full list can be found in the CDSCO’s Notice on the classification of medical devices and IVDs. This is not an exhaustive list. CDSCO does not maintain a single list of regulated devices, but rather subjects devices to regulation through the Drugs and Cosmetics Rules, the Medical Device Rules 2017, and subsequent Gazette Notifications, which should be reviewed prior to making a final determination of a device’s regulatory status.

Step 2

The person manufacturing the IVD or medical device has to appoint an Authorized agent to interact with CDSCO on his behalf. The agent should comply with all the requirements.

Step 3

Class B, C, and D IVDs require in-country performance testing through the National Institute of Biologicals (NIB) or an accredited lab. Class D IVDs require performance testing through the National Institute of Biologicals (NIB). Class B and C IVDs require performance testing through an accredited Indian lab, though CDSCO may instead accept existing reports for such products with approval in a major regulatory market.

Step 4

The next step includes, compiling the applications, including manufacturing facility information, device technical information, ISO 13485 certificate, IFU, testing results (if applicable), clinical data (if applicable), proof of approval in the US, EU, Australia, Canada, or Japan, plus proof of approval in home country (satisfied by CFS/CFG).

Step 5

Then, we can file an application for registration/Import license with CDSCO and pay the required fees. The documents should be English.

Step 6

The CDSCO reviews applications and may require a Technical Presentation. Approximately 25% of applications require a formal Technical Presentation. The Technical Presentation is an in-person meeting with the CDSCO to discuss the product in more detail. A representative from the manufacturer (such as an engineer) is expected to attend this meeting along with the India Authorized Agent.

Novel devices will also undergo a Subject Expert Committee (SEC) review. Devices novel to the Indian market (new technology, material, intended use) may face additional regulatory hurdles. CDSCO may require clinical studies conducted in India prior to regulatory approval, or the agency may issue a restricted approval. A restricted approval could include a requirement to actively collect and submit post-market data. The SEC meeting will include local clinicians and other experts who will weigh in on the acceptability of the existing clinical data.

Step 7

The CDSCO issues an Import License in Form MD-15. Following the implementation of the Medical Device Rules, 2017, the processes for obtaining device registration and import licensing were combined in India. Accordingly, the CDSCO does not issue Registration Certificates under the Medical Device Rules, instead issuing market authorization for foreign devices through the Import License (Form MD-15).

The License does not expire; however, license retention fees are due every five years.

Step 8

Once approved, only the Indian Authorized Agent may import products. However, one can obtain multiple registrations for the same device through different Authorized Agents.

This is an improved outline of the process for approval. The CDSCO may choose to audit the submission and request more documents, which will add time to the IVDs approval.

Author: Apoorva, ICFAI Law School, ICFAI University, Dehradun

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[1] https://www.tuvsud.com/en-in/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/invitro-diagnostic-medical-devices-directive

[2] “In Vitro diagnostics and the corona virus pandemic”- Liz Thorn

https://www.europeanpharmaceuticalreview.com/article/127199/in-vitro-diagnostics-and-the-coronavirus-pandemic/

Talwar Bindi: From Beauty to Health

Sep 14, 2018 | General

India is one of the countries where Iodine deficiency is a major cause of concern. According to a survey conducted by the Indian Journal of Medical Research it was found that 263 districts out of 325 that were examined for the survey showed high risk of Iodine Deficiency Disorder which shows the lack of iodine consumption by the people (Pandav et al., 2013, 418-433).

Such deficiency of Iodine in the body can lead to various diseases such as goitre, Hypothyroidism and additional complications like decreased fertility and increased death rate among infants. The lack of iodine consumption by the people shows the lack of awareness among people in rural areas regarding the importance of iodine. In order to combat the problem in India, the Government and various NGOs have started different initiatives at the local and national levels. However, no one comes close to the creativity and effectiveness of the mission launched by the NGO called Grey Singapore which is called ‘The Life Saving Dot’ (Basu, 2015). This article will talk about the idea behind the initiative and its impact on the lives of women in different parts of the country.

CORE INNOVATION

The objective behind launching such an initiative was to help the women in rural parts of India, fight the problem of Iodine deficiency without impacting their daily lifestyle or habits so that they don’t have to invest in any other fancy equipment. These conditions were fulfilled by an ornament. Bindi is widely worn by women in India and the idea of using it as a tool to fight against Iodine deficiency, firstly came to Ali Shabaz who is the Chief Creative Officer of Grey Singapore (Basu, 2015). This was the first initiative of its kind, as never before a traditional ornament was used to fight disease. Grey Singapore saw the potential in the idea and teamed up with “Talwar”, one of the major bindi manufacturers and distributors in India, and also with “Neelvasant Medical Foundation” another NGO, which is widely active in the region of South India, in distribute the bindis to the tribal women, with having the vision of overcoming the Iodine deficiency disease among women. (Basu, 2015).

Manufacturing of such bindis does not require any special machinery and the process of usage is also as simple as placing it on the forehead. Such bindis have a certain amount of iodine in its adhesive roughly around 150-200 micrograms. When a woman wears the bindi some of the iodine which is present in the adhesive, gets absorbed by the skin through the process of dispersion, which takes place through the skin of the person while wearing the bindi (WPP, n.d.). The amount of dispersion of iodine that takes place is around 12% which is around 24 micrograms of iodine a day which will have a significant impact on the health of women.

CONCLUSION

The iodine bindi can be seen as a very effective tool against Iodine deficiency disease. On top of providing various benefits to the user, it has no side effects on the body of women who use them regularly. When it comes to pregnant women, Iodine bindi is safe to use and has no effects on the health of the infants; rather they tend to lower the chances of headache which is common among iodine deficient women during pregnancy.

Iodine bindi has been helping women in rural areas, tremendously in combating iodine deficiency disease, uniquely and creatively. It is one of the very cheap fixes to the iodine deficient diet of rural Indian women. With the advancement of technology its effectiveness and awareness will go up significantly, which can be very helpful to India for eradicating the problem of Iodine deficiency.

Author: Prajal Joshi (2nd Year, BBA-LLB), Symbiosis Law School Hyderabad

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Particle Board Made of Rice Husks: A Success Story

Oct 7, 2017 | General

Forest resources alone will not be able to meet the growing demand for wood and wood-based panel materials. Rice Husk Particle Board, made from readily available rice husk, can effectively replace the demand for panel materials. Additionally, these boards allow for the reuse of waste materials and can be made at a minimal cost. The Indian Plywood Industries Research & Training Institute (IPIR&TI), Bangalore, India, has developed a unique method for manufacturing boards from rice husk using suitable binding agents. This method is unique in terms of value addition and completes utilization of the husk without strict chemical composition requirements. In 1985, IPIRTI’s RHPB technology was transferred to the National Research Corporation (NRDC) of New Delhi, India, a Government of India enterprise, for further development and commercialization. In 1987, NRDC licensed the technology to M/S Padmavathy Panel Boards Pvt. Ltd (PPBL), Bangalore, Karnataka, and cooperated with PPBL to solve the difficulty of moving technology from the lab to the factory.

Rice Husk Board is the first product of its kind to be produced in India as a viable alternative to wood-based panel boards. NRDC has been assigned IPIR’s patented technology for commercial exploitation. In 1988, the technology was licensed to a Bangalore entrepreneur who planned to build a commercial plant. The NRDC has provided the firm with an interest-free developmental loan through its ‘Technology Development Programme’ to fulfill the project’s costs. The NRDC has also provided engineering assistance to the project. The Corporation and the entrepreneur worked together to supervise the project. In a world record time of 18 months, the unit was put into production. The company is currently in regular production and has produced several goods to fulfill a variety of needs. As a substitute for wood-based panel boards, the product is well-received on the market.

GENERAL CHARACTERISTICS: When compared to wood particle boards and other similar panel materials, the upgraded rice husk particle boards have the following distinguishing advantages:

• Resistance to Termites
• Resistance to Decay
• Resistance to fire
• Resistance to Rodents

Rice husk boards are available in a variety of densities, thicknesses, kinds, and grades to meet a variety of needs. The manufacturing method, which is based on cutting-edge technology, provides total quality. Wall Paneling, Doors, Windows, Furniture, Table Tops, False Ceilings, Roofing Panels, Insulation, Partitions, Stage Setting, Industrial and Domestic Floorings, and so on are only a few examples of product applications.

IPIR & TI, Bengaluru, has refined and improved the technology for producing rice husk particle board using modified resin binding technology to achieve multilayers. The RHBP panels are strong enough to meet the requirements of the applicable specifications and standards. RHPB has improved over the years, as shown in the table below:

RHPB Technology was founded in 1985.

(RHPB Technology Post 2010)

1. Rice husk particle board with many layers
2. Face and core particles are separated, resulting in a clean surface finish.
3. The physical and mechanical qualities meet the requirements of IS3087-1985: Medium Density Particle Board Type Specification. 2 three-layered flat pressed boards
4. The board is resistant to termites, rot, and fire.

Rice-growing countries around the world have enormous challenges in disposing of rice husk trash, which poses a major environmental concern if burned. Rice Husk Particle Board manufacturing method developed at the Indian Plywood Industries Research Institute in Bangalore has emerged as one of the finest answers to this problem because it helps to maintain eco-balance and conserve the eco-system. In India, as well as many other rice-growing countries, patents have been submitted.

This board has shown to be a viable alternative to wood in a variety of applications. Furthermore, these boards can be created to be decorative. Several Indian companies have been granted licenses, and a turnkey facility has been established in Malaysia. The company has also created floor tiles (made of rice husk), fire-resistant doors, and other products with a granite-like finish. Furthermore, during the Gujarat earthquake, the technology’s licensee assisted in the construction of a huge number of low-cost houses.

Rice husk is the most readily available of all agricultural wastes. It is a by-product of the country’s most major agro-based sector, paddy milling. Rice husk is produced in the country in quantities of 2 million tonnes per year. For the past two decades, researchers have been trying to figure out how to use rice husk to make useful products. However, due to its high silica concentration, the traditional particle board manufacturing method failed.

For the past three decades, researchers have been trying to figure out how to use rice husk to make useful products. However, few successful approaches have been developed because of their peculiar chemical composition.

Using modified phenol cardanol formaldehyde resins, IPIRTI has perfected a process for producing multilayered particleboard. The panels’ strength qualities meet the applicable specifications’ requirements. The boards have a strong termite resistance and are fire-resistant.

The proposed method has a large environmental impact because it uses rice husk to avoid deforestation in one way.

IPIR&TI, Bengaluru, will supply all technical know-how, as well as training and process demonstrations on a pilot plant size. Please contact NRDC if your company is interested in commercializing the product in India or other countries.

Conclusion

Rice Husk Particle Board’s research and development is an example of radical product development innovation. In everyday applications, it takes the place of well-known and widely used wood and wood-based particle board. It took a long time to do the research

To avoid depletion of forest resources and environmental deterioration, the Ministry of Science and Technology recognized the necessity to find alternative materials (identification of new products). It was determined that a specialized research institute capable of conducting research projects could be found. The necessary” funds were made available to conduct research. NRDC, which had extensive experience in the subject, was given the duty of technology transfer. The transfer of technology has been smooth and the project has been a success thanks to the provision of necessary funds and the promoter’s commitment.

Author: Pratik Maitra, Symbiosis Law School, Hyderabad

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Paper Boat: Nurturing Childhood Memories

Nov 7, 2014 | General

It is a great honour for Origiin to bring out the story of Paper Boat as a company “Ahead of the Curve”.  Reviving traditional Indian beverages and foods produced and marketed by Hector Beverages, which is headquartered in Bengaluru, India, Paper Boat is one of the most popular and trendy brands today in beverages.

Name of company

HECTOR BEVERAGES PRIVATE LIMITED

Date of incorporation

13^th October, 2009

Founding members

Source: www.startuptalky.com

1. Neeraj Kakkar

https://www.linkedin.com/in/neeraj-kakkar-2410839/

2. James Nuttall

https://www.linkedin.com/in/jpnuttall/

3. Suhas Mishra

https://www.linkedin.com/in/neerajbiyani/

4. Neeraj Biyani

https://www.linkedin.com/in/suhas-misra-6143245/

Seed capital – Not Available

Place of business

Registered Address – Plot No. 132, Sector 3, IMT Manesar Manesar Gurgaon Gurgaon HR 122050 IN

Core products

Paper boat currently manufactures over 12 varieties of Indian ethnic drinks such as: Thandai, Serbet-e-khaas, Rose tamarind, Chilli guava, Jaljeera, Anaar, Kokum, Aam panna, Ginger-lemon tea, Jamun, Aamras, Neer more and Panakam. Panakam and Sherbet are seasonal drinks as they are made available during Navami and Eid, respectively.

Paper boat also makes Indian snacks and delicacies like Chikki bar, peanut bar, Aam pappad, sesame peanut bar, coconut water, Pani puri pellets etc.

Journey

Although Hector Beverages was found in the year 2009, the Company was into producing an energy drink called Tzinga and another protein-based drink at this time. Paper boat was born only towards the end of 2012. Paper boat became a comprehensive effort towards bringing authentic Indian tastes into the market, in an organized fashion. Paper boat, along with its name has a tagline that says drinks and memories. This itself is the driving force behind the initiative. The Company tries to restore old memories by re-introducing authentic Indian tastes to our tastebuds. That too in a fresh new way. An old taste in a modern is quite the oxymoron, but that is what gives the Company its own space. Paper boat currently has more than 300 employees and has a revenue of over 100 crores.

Success mantra

Paper boat’s success comes from many factors. Firstly, the Company makes it imperative that they use no preservatives in their products. The Company not only makes tasty drinks but also prioritises our health. Secondly, the brand offers a good variety. Paper boat began with only 2 flavours and currently, they have more than 10 varieties of Indian drinks. Thirdly, the funding and investments of the Company is carried out dynamically. Paper boat was able to raise capital from various investors like Sequoia Capital, Trifecta Capital Advisors, Catamaran Ventures, A91 partners etc. The Company has grown vehemently with a steady increase in sales over the years. Their efficient marketing strategy is also commendable. Keeping in touch with customers through networking, innovative advertising techniques, information and feedback collection etc. truly make them winners. Lastly and most importantly, Paper boat has successfully evoked nostalgia in a lot of people and reinstated their bond with the lost tastes from their childhood.

Intellectual Properties

Hector Beverages owns several trademarks. The first mark PAPERBOAT (DEVICE) was applied for on 5th July 2012 and the same was granted on 11th July 2016. This was under Class 32. Similarly, an application for wordmark PAPER BOAT was made in 2013 and was granted in 2018. Similarly, marks like TOP SECRET (valid since 2016), Paper Boat Swing Label (valid since 2019) and PAPER BOAT DRINKS AND MEMORIES (valid since 2018) are registered under Class 32. Paper Boat also owns the mark PAPER BOAT FOOD AND MEMORIES under Class 29. This was granted in October 2018. PAPER BOAT SUPER NATIVE is another mark Hector Beverages owns under Class 29. PAPER BOAT DRINKS AND MEMORIES, PAPER BOATS FOODS AND MEMORIES are also granted protection under Class 30. On March 1st 2021, an application for Trademark registration of PAPER BOAT SUPER NATIVE was made under Class 30 and the same is marked for exam.

Other than these trademarks, Hector Beverages also owns a registered Design for the cap used on their products. The Design registration application was made on 24th November 2015 and was granted on 24th February 2017. The article name is provided as ‘Cap for Pouch’ and is registered under Class 09-07-closing means and attachments.

Innovation in business

To ensure hygiene and safety, Paper boat ensures optimum conditions of temperature and pressure in their production units. The packaging used for their drinks is unique and helps the products remain fresh without the help of preservatives. This unique packaging is also known to be more eco-friendly than other methods of packaging currently available in the market. Along with television Ads, Paper boat also has a collection of animated short films on themes like friendship, hope and nostalgia. These films are available on YouTube.

Paper boat has also ventured into the E-commerce business. Their products are now available on Amazon. The online sale has increased after the pandemic hit. Paper boat uses technology to improve their marketing. Customer feedbacks are collected on a large scale through surveys and is incorporated into the production process.

Problems of consumer they focused on

• Lack of availability of authentic Indian flavours
• increase in the intake of carbonated drinks
• lack of better alternatives for aerated soft-drinks
• ascending use of preservatives

Meaning of Trade Mark

The Company’s trademark contains the name ‘Paper boat’ along with a tagline drinks and memories. This represents the basic motive behind the company, that is, to bring back memories of your childhood through these authentic Indian flavoured drinks.

Source: www.paperboatdrinks.com

Awards

• Paper Boat designed by Elephant Design was presented The India Story Design Award 2016 to applaud the emotional power and timeless nature of its design.

Contact Information

1860-425-4425

paperboat@hectorbeverages.com

neeraj@hectorbeverages.com

REFERRENCES

1. http://www.paperboatdrinks.com/
2. https://www.amazon.in/s?rh=n%3A2454178031%2Cp_4%3APaper+Boat&ref=bl_dp_s_web_2454178031
3. http://www.mca.gov.in/mcafoportal/companyLLPMasterData.do#
4. https://ipindiaonline.gov.in/tmrpublicsearch/tmsearch.aspx?tn=197889735&st=Wordmark

Author: Bhavana, School of Law, CHRIST, Bangalore

BALLB (Hons.)

Email: bhavanababu44@gmail.com

Phone: +91 9400840460

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Voting Ink: A valuable Trade-secret

Jun 1, 2014 | General

Mysore Paints and Varnish Limited (MVPL) was founded in 1937 as Mysore Lac & Paints Limited, by Nalvadi Krishnaraja Wodeyar, the Maharaja of Mysore, for manufacturing paints and related products. It is the company that inks every voter’s fingertip in India, and it was converted to a public sector company in 1947. It is listed on the Bangalore Stock Exchange and the Karnataka Government holds 91.39% stake in the company.

MVPL is an integral part of the Indian Democracy and it was primarily established to provide employment opportunities for the people of Mysore with the effective utilization of national resources, like Lac, which was used for manufacturing sealing waxes. The company also manufactured and supplied paint to government departments and the defense departments.

MVPL is the only company authorized to produce indelible ink, which is used in the elections in India, and after its transition to a public sector company in 1947, it is owned and operated by the Government of Karnataka under the chairmanship of the Ex-Mayor of MCC –Mr. Anantha. In 1962, the Election Commission, along with the Law Ministry, National Physical Laboratory and National Research Development Corporation came to an agreement to select and authorize MVPL to manufacture inedible ink.

The inedible ink was used for the first time in the Third General Lok Sabha Elections in India, and since then it has been used in every Parliamentary election, every assembly election and local election. Until 1988, the company only manufactured ink and paint but in 1989 it expanded further and started manufacturing varnish and was renamed as the Mysore Paints & Varnish LTD. MVPL also manufactures and supplies primers, enamels, chemical resistant and decorative paints, industrial coating, distempers, sealing wax, postage stamp cancellation, polishes & thinners.

The Election Commission of India is the major customer of the inedible ink manufactured by MVPL, but the ink is also exported to Malaysia, Thailand, Nigeria, South Africa, Singapore and 25 other countries. MVPL’s inedible ink marker pens have also been used in the elections held in Afghanistan and in the elections held in Cambodia in 2008 & 2012. The sealing wax manufactured by MVPL is used by the Indian Post and by the Election commission to seal ballot boxes.

The inedible ink is produced to meet the needs of the Elections and it is supplied in vials with volumes of 5ml, 7.5, ml, 20ml, 50ml & 80ml. A 5ml vial can be used for about 300 voters and it is estimated that over a period of 45 years more than 300 million people have had this ink applied on their fingers. Initially the ink was provided in glass bottles, but it resulted in heavy losses due to breakage and leaks so, in 1979, the company switched to plastic bottles thereby reducing breakage and leaks from 15% to 1%.

The ink leaves an inedible mark on the fingernail of the voters which remains for nearly 20 days and is not easy to erase, thereby averting electoral fraud by preventing the voter from voting again.  Silver Nitrate is one of the known ingredients of the inedible ink and it stains the nail on exposure to ultraviolet light. It cannot be washed off with detergent, soap or even chemicals and the ink last for a few weeks until the nail grows. The ink is photosensitive, so it is stored in amber colored bottles and is guarded against exposure to direct sunlight.

The inedible ink produced for elections is dispatched under strict security measures with the bottles scrutinized thoroughly and sealed in crates. The ink is not available for sale to the public, and it is only sold to those having legal and genuine need for it. Apart from being used in elections, the ink is also used in Pulse Polio campaigns and in hospitals to mark cancer affected areas of the body.

Since 1962, MVPL has been making the inedible ink based on a secret chemical formula devised by the National Physical Laboratory Of India (NPL), and so far the manufacturing process of the ‘Inedible Ink’ has been kept a closely guarded secret. Only two chemists of MVPL know the chemical formula of the ink, and they are required to pass it on to their successors when they retire.

The Inedible Ink is the time-tested gift of NPL, the measurement standard laboratory of India, to the spirit of democracy so the patent of the inedible ink rests with them

It is the duty of MVPL to safeguard and protect the chemical formula and the company has taken strict measures to ensure the safety by installing CCTV cameras, frisking staff and members, password protecting entries to certain areas and banning lunch boxes inside the factory. Additionally, guards seal the factory locks with the sealing wax produced by the factory every evening.

Author: Divesh Kumar, SDM Law College, Mangalore

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Top 10 Products Developed to Combat the COVID-19 Pandemic

Jul 18, 2011 | General

The start-up ecosystem in India has emerged as a significant force in recent years, owing largely to the efforts of stakeholders and government policies to encourage the establishment of start-ups. Investments in start-ups have risen considerably from $550 million in 2010 to $14.5 billion in 2019[1]

Sequoia Capital sent a memo titled Coronavirus: The Black Swan of 2020, addressing its portfolio firm founders and CEOs, emphasizing the necessity to be “adaptable” in order to survive the down-curve. The message emphasized the importance of challenging every assumption about one’s firm, including cash-flows, fund-raising, marketing, sales forecasting, capital spending, and so on.[2]

The lockdown has had an adverse effect on not only small diurnal business operations, but it has also pushed several start-ups to prepare survival plans to reduce personnel and employee compensation. Recently founders of a number of start-ups have also made substantial curtailment with respect to worker’s (or employee’s) pay in order to minimize their losses.

To keep up with the adversities, essential service entrepreneurs built flexible business structures and demonstrated considerable ingenuity and self-sufficiency. Though the pandemic put India’s startup environment to the test, it also presented an opportunity with great promise in several sectors.

Here are the top 10 start-ups that are specifically designed and distributed to cater Covid needs:

1. Ethereal Machines

In India, the need for ventilators is paramount with the profusion of daily rise in the COVID-19 cases.

While myriad startups and tech businesses have begun manufacturing ventilators or similar alternatives to satisfy the demand, Bengaluru-based Ethereal Machines has a unique answer. Ethereal Machines, a 3D printing ventilator splitter company founded by Kaushik Mudda and Navin Jain in 2014, is designed exclusively for treating two patients with differing ventilatory needs by differential pressure splitting.

When two patients require two different oxygen supply from the ventilator, these splitters are employed. The team was able to come up with a device that also helps to avoid cross-contamination between paired patients courtesy to the doctors’ expertise in Bengaluru

This is the Two Way Ventilator Splitter taken from https://www.etherealmachines.com/covid.

2. bio

To accommodate rising demand during the COVID-19 pandemic, Mumbai-based healthtech firm sense.bio has opened an e-com selling COVID-19 basics and personal protective gear. The IOT-based health and fitness app has announced the launch of a platform designed to decrease the potential risk of virus transmission. Customers can shop for sense.bio items while staying indoors while protecting them and boosting their immunity. They ensured high-quality products that are manufactured in India.

3. Sicora Technologies

The significance of cleaning, sanitation, and being healthy has also been highlighted by COVID-19. It has increased the demand for disinfection services to keep surfaces clean and free of microbes. Sicora Technologies, based in Mumbai, is fulfilling this demand.

Sicora, founded in 2020 by Yash Jain and Geeta Tolia, makes an antimicrobial surface coating called Dr Nanoxa that sanitizes surfaces and protects them from germs and viruses, including Sars-CoV-2. The coating will be effective for 30 days before needing to be reapplied.

Dr Nanoxa has been found to be effective against germs and viruses, according to the report, the product has been found to be effective against bacteria and viruses, including E.Coli, Salmonella, and Sars-CoV 2, among others.

The product should be sprayed from a distance of 1 foot after taking all necessary procedures and wearing PPE gear. After applying the product, clean the surfaces with a microfiber towel. After that, leave the surface alone for at least 10 to 15 minutes.

Dr Nanoxa taken from https://drnanoxa.com/product/dr-nanoxa/

4. Helyxon

While doctors and healthcare workers battle to save the lives of thousands of people, they are also putting their own lives in danger by constantly monitoring coronavirus patients in hospitals. Many startups, on the other hand, have developed unique technologies that allow for remote monitoring of these patients. Helyxon, located in Chennai, has created OXY 2, a real-time body temperature, heart rate, and oxygen saturation monitoring gadget that notifies doctors or attendants if any of the parameters change abnormally.

The device appears to be a complicated wiring equipment, but it is reported to be simple to operate. One side of the device is attached to a finger and is rolled up like a band on the hand. The device sends data to a mobile application via Bluetooth, which is then forwarded to the company’s servers over internet connectivity.

OXY2 with BLE but no connector and 98.6 Fever Watch – Continuous Fever monitoring system taken from https://helyxon.com/product/

5. E-TEX Kawach Antiviral T-Shirt and Kawach Mask

The experts from IIT Delhi’s Chemical and Textile department have endorsed the products.

According to officials, the antiviral E-TEX’s fabric was created utilizing modern technology that minimizes the likelihood and speed of contaminations and transmissions by eliminating microorganisms on touch. According to officials, two firms incubated at the Indian Institute of Technology (IIT) here have released antiviral T-shirts and a COVID-19 protective lotion at inexpensive pricing. V Ramgopal Rao, the institute’s director, revealed the goods, which are part of an antiviral package.

 Kawach antiviral polo t-shirt and Kawach N95 protective face mask taken from https://etex.in/product-category/new-launch/

6. Clensta

For up to 24 hours, the COVID-19 Protection Lotion, developed by the start-up “Clensta,” provides 99.9% virus protection with antiviral and antiseptic qualities.

The product is an advancement in engineering chemistry with sui generis PAP Technology (Prolonged Antiviral Technology) to prevent bacterial, viral, and fungal infections without harming the environment or human health, and advanced hand sanitizer is formulated with increased alcohol retention time to be effective prevention against multiple viruses.

The product can be applied to any exposed body part, including the face and hands. The application of the solution protects users from infections for nearly 24 hours, reducing the requirement of alcohol-based sanitizers and washing hands several times each day.

7. Staqu

Gurugram-based Staqu, a company that makes facial recognition systems, has invented a thermal camera that uses artificial intelligence to detect possible Covid-19 positive cases. Normally, the corporation sells its smart cameras to law enforcement agencies for surveillance purposes.

If it detects a human with an elevated body temperature, the camera named JARVIS sends out a real-time alarm. The camera can monitor numerous persons at once and has a range of up to 100 meters.

Law enforcement agencies can identify people with Covid-19 symptoms using these cameras in public settings, ultimately halting the pandemic. The fact that they are also equipped with facial recognition capabilities makes it easier for law authorities to apprehend these individuals.

Staqu, which was founded in 2015 by Atul Rai, Chetan Rexwal, Anurag Saini, and Pankaj Sharma, says that its technology is practical and successful in scanning crowded venues such as airports, train stations, and malls.

The startup is utilizing and merging current technology into facial recognition cameras rather than creating the hardware for thermal cameras. JARVIS, he added, works in situations where conventional thermal cameras fail due to ambient light. Staqu was employing these cameras at its workplace before the lockout and was in talks with a few airport officials.

8. Adverto 

Following the coronavirus outbreak, cities such as Mumbai and Delhi, as well as the state of Uttar Pradesh, have made wearing masks in public areas mandatory. Many people in these places, however, continue to go about without wearing a face mask. Adverto, based in Jabalpur, has created a face mask recognition technology that uses a camera stream to determine whether or not someone is wearing a mask.

If a person is spotted without a mask, the system raises an alarm and alerts law authorities to apprehend the perpetrator. The camera also takes a picture of the person so that they may be easily identified.

The business, which was founded by Anurag Soni, is also trying to add a thermal detection feature to these cameras. The camera will therefore be able to tell if a person has a temperature, which is a common indication of Covid-19. The startup is currently working on a proof of concept at the Jabalpur Incubation Centre.

According to Soni, the startup will install one of these cameras at the district collector’s office. Some hospitals have also inquired about Adverto’s technology.

9. CoviDx mPlex 3R and 4R

E V Ramana Reddy, Additional Chief Secretary to the Government of IT, said the department has aided in the development of the 22 products and will assist them in engaging with appropriate commercial partners through the Karnataka Startup Cell and the BBC. According to officials, a MoU was signed between IIT-SINE in Mumbai and the BBC to establish a co-incubation model in which financing and technical expertise would be combined with networking support. CoviDx mPlex 3R and 4R, an in-vitro RT-PCR qualitative test for the detection of COVID-19 using three and four genes identification, was one of the products.

Emvlio, a portable medical-grade refrigeration device, is also used to transport biologicals such as vaccinations, blood, and serums in a safe manner. AskDoc, a Doctor VideoBot that answers questions on COVID-19 disease transmission and control, now has multilingual voice and text capabilities.

CoviDx mPlex 3R and 4R taken from https://www.dssimage.com/covidxtm-mplex-4r.html

10. MedIoTek Health

Patients with Covid-19, especially the elderly and children, require continuous temperature, heart rate, and oxygen saturation monitoring. Monitoring is a challenging task if patients are under home quarantine or in a vast Covid-19 unit with few healthcare professionals.

To help relieve the massive strain on the healthcare system, the Chennai-based MedIoTek Health System has introduced Vincense, a wearable device that continuously detects pulse rate, oxygen levels, skin temperature, and respiration rate.  The data from the gadget is sent from the wearables to a secure cloud server that a healthcare provider can access at any time by smartphone. VinCense promptly warns doctors and nurses if any of the crucial metrics ever exceed the default or user-defined limitations.

It also sends an ambulance to the patient’s home in critical situations after receiving confirmation from family or residents. In the event of an emergency, the patient can also use the device’s help button to raise an alert.

In addition, MedIoTek Health has applied for a patent license for Vincense, which costs INR 27,000. Vincense has also been selected for the Centre for Cellular and Molecular Platforms’ (C-CAMP) accelerator program as one of 13 businesses.

VinCense Risk Detection Protocol taken from https://www.vincense.com/covid-19-risk-detection-protocol.html

These startup businesses are integral and facilitate overcoming challenges and helping the Indian economy grow even during incongruous times such as COVID-19 pandemic.

Author: Vinita R. Gaud, Pravin Gandhi College of Law

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[1] Peerzada Abrar, “Indian start-ups raised a record $14.5 bn in 1185 funding rounds this year”, Business Standard,  https://www.business-standard.com/article/companies/indian-start-ups-raised-a-record-14-5-bn-in-1185-funding-rounds-this-year-119122700061_1.html

[2] “Coronavirus: The Black Swan of 2020”,  https://www.sequoiacap.com/article/coronavirus-the-black-swan-of-2020/,