Jul 3, 2014 | Exclusive Interview, General
This section is an initiative by Origiin to introduce latest innovations and valuable expert opinions on protection, exploitation of Intellectual property by Intellectual Property experts to provide inspiration to the readers and also make our readers aware about the emerging technologies, products and innovations. This section also aims at bringing out the importance of patent protection and the way such innovations make difference in evolution of scientific progress in the country.
In this issue, we are extremely happy to publish interview of Dr M S Swaminathan, the Father of India’s Green Revolution.
Dr. Swaminathan who holds the UNESCO Chair in Ecotechnology at the M.S. Swaminathan Research Foundation in Chennai, was the former director general of the Indian Council of Agricultural Research as well as of International Rice Research Institute. He also became president of the International Union for the Conservation of Nature and Natural Resources in 1988. He has also served as Independent Chairman of the FAO Council, along with as the Chairman of the UN Science Advisory Committee set up in 1980 to take follow-up action on the Vienna Plan of Action. Dr Swaminathan, a plant geneticist by training with a Ph.D. from Cambridge University has established the National Bureau of Plant, Animal and Fish Genetic Resources of India and the International Plant Genetic Resources Institute, besides serving as the Principal Secretary in the Ministry of Agriculture, Government of India.
Dr MS Swaminathan has got many prestigious awards and fellowships. He was awarded the First World Food Prize in October 1987 and has been described by the United Nations Environment Programme as “the Father of Economic Ecology”, besides being one of three Indians to be included in TIME Magazine’s 1999 list of the “20 most influential Asian people of the 20th century”, along with Mahatma Gandhi and Rabindranath Tagore. Life Time Achievement Award of All Indian Management Association, Ramon Magsaysay Award for community Leadership and many more he has been awarded. He has many books to his credit. An Evergreen Revolution, I Predict: A Century of Hope Towards an Era of Harmony with Nature and Freedom from Hunger, Gender Dimensions in Biodiversity Management, Agro biodiversity and Farmers’ Rights, Sustainable Agriculture: Towards Food Security are some of his notable books.
Below are expert opinions of the “Living Legend” himself for various issues in food security, agricultural policies and biodiversity.
Origiin: Hello Dr Swaminathan. It is a great pleasure and honor for us to have opportunity to interact with you and publish your thoughts in the form of this interview.
Dr Swaminathan : Thank you and my best wishes are with Origiin.
Origiin: The world look upon to you as the “the Father of Economic Ecology” and refers you more popularly as the “Leader of Green Revolution”. You have been extensively associated with sustainable agriculture and food security. Please let us know how has your journey been so far in projecting food crisis to the world?
Dr Swaminathan: There is much greater understanding of the basic fact that where hunger rules, peace cannot prevail. Also my message that the future belongs to nations with grains and not guns is now making an impact worldwide. We are today much better prepared to face famines and food crisis than we were at the time of the great Bengal famine of 1942-43.
I give below an extract from my speech at the Indian Science Congress held at Varanasi on January 3, 1968.
“Exploitative agriculture offers great dangers if carried out with only an immediate profit or production motive. The emerging exploitative farming community in India should become aware of this. Intensive cultivation of land without conservation of soil fertility and soil structure would lead, ultimately, to the springing up of deserts. Irrigation without arrangements for drainage would result in soils getting alkaline or saline. Indiscriminate use of pesticides, fungicides and herbicides could cause adverse changes in biological balance as well as lead to an increase in the incidence of cancer and other diseases, through the toxic residues present in the grains or other edible parts. Unscientific tapping of underground water will lead to the rapid exhaustion of this wonderful capital resource left to us through ages of natural farming. The rapid replacement of numerous locally adapted varieties with one or two high-yielding strains in large contiguous areas would result in the spread of serious diseases capable of wiping out entire crops, as happened prior to the Irish potato famine of 1854 and the Bengal rice famine in 1942. Therefore the initiation of exploitative agriculture without a proper understanding of the various consequences of every one of the changes introduced into traditional agriculture, and without first building up a proper scientific and training base to sustain it, may only lead us, in the long run, into an era of agricultural disaster rather than one of agricultural prosperity.”
The above is the basis of the concept of the ever-green revolution viz increases in productivity in perpetuity without ecological harm.
Origiin: Can you please throw us some light on the role of CGIAR (Consultative Group on International Agricultural Research) towards development of Indian Agriculture and its policies on patent issues, plant variety protection, in situ and ex situ conservation, and the dissemination of information on CGIAR genetic resources research.
Dr Swaminathan: CGIAR has been playing a major role in genetic resources conservation and plant variety protection through Biodiversity International. I played an important role in setting up the International Board of Plant Genetic Resources in 1972-74, an organization now known as Biodiversity International. As Chairman of the CGIAR Genetic Resources Policy Committee for over 10 years, I helped to develop procedures for defensive patenting of important scientific material, so that they are always available for public good and not for private profit.
Origiin: Where does India stand in terms of Plant Variety Protection and Farmer’s right compared to her other counter parts? Are Indian farmers and breeders much aware of this privilege and Biodiversity Act?
Dr Swaminathan: India is the only country in the world which has an integrated legislation on breeders’ and farmers’ rights. The Act is known as Plant Variety Protection and Farmers’ Rights Act. I prepared the first draft of this integrated Act. In my view, farmers and breeders are allies in the struggle for food security. Therefore their rights should be mutually reinforcing and not antagonistic. Also we should rename UPOV as the International Union for the Protection of Breeders’ and Farmers’ Rights.
Origiin: Indian Cultural heritage and indigenous knowledge is counted as one of the world’s top ten hot spots of biodiversity. But there has been a substantial amount of IP infringement and attack on national biodiversity due to various external and internal instances. How strong is Indian Biodiversity Act to protect local flora and fauna?
Dr Swaminathan: India has a rich heritage in biodiversity based on culture, culinary habits and medicinal applications. The Indian Biodiversity Act in whose formulation also I played a major role is very strong in the areas of conservation, sustainable use and equitable sharing of benefits.
Origiin: Agricultural lands are being snatched away by large scale industries, real estate and infrastructure development leaving a little space for cultivation. How do we cope up with this problem?
Dr Swaminathan: At the moment, land is becoming a very expensive commodity. Therefore there is tendency for land grab. We have dealt with this in detail in the report of the High Level Panel of Experts to the Committee on Food Security (of which I was Chairman until recently). We have shown that converting prime farm land for fuel production may lead to food shortages, particularly in an era of climate change.
Origiin: Is there acute shortage of investment in agriculture compared to other sectors in the country?
Dr. Swaminathan : Investment in agriculture is rather low. We need more investments particularly in the areas of rural communications, grain storage, soil health care and enhancement and water conservation and sustainable use.
Origiin: Sir, you had supported the government’s decision to allow 51 per cent FDI in multi-brand retail. What steps should state government take in order to safeguard the interest of farmers?
Dr. Swaminathan: I did not support FDI in Retail except where it is going to help improve rural infrastructure in post harvest technology. FDI should be a win-win both for rural families and for the commercial firm. It should be based on a participatory process with emphasis on the livelihood security of the poor and on ethical behavior.
Origiin: What is your take on Genetically Modified Food? Recently America introduced the bill “Safe and Accurate Food Labeling Act” in order to prevent maximum level of accidental GMO presence.
Dr. Swaminathan : Genetic modification is a very important tool in all the sectors like medicine, industry and environment. Bio-remediation is important to control pollution. However in the case of food biotechnology, there is need for caution. We need an effective regulatory mechanism in the areas of biotechnology and bio safety which can help to measure risks and benefits objectively and in a transparent manner.
Origiin: Do we see a second green revolution in India in near future?
Dr. Swaminathan: I do not believe in a second green revolution. What I would like to see is an ever-green revolution which leads to improvement in productivity in perpetuity without ecological harm. We must mainstream ecology in technology development and dissemination.
Origiin: Thank you so much Sir, for your valuable inputs.
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Jun 4, 2014 | Patent
The word corona represents crown. The term coronavirus was coined in 1968 for the virus which resembled a solar corona, the bright crown-like ring of gasses surrounding the sun that is visible during a solar eclipse.
Corona Virus are a group of RNA virus which affects the mammals and birds. In mammals, the attack and effect the respiratory tract causing infections, that can be mild to severe to lethal. Mild illnesses in humans include some cases of the common cold (which is also caused by other viruses, predominantly rhinoviruses), while more lethal varieties can cause SARS, MERS, and COVID-19. In cows and pigs, they cause diarrhea, while in mice they cause hepatitis and encephalomyelitis. Corona viruses constitute the family of Coronaviridae, order Nidovirales and realm riboviria. Corona Virus have been said to have existed for around 8000 BCE. The Human Corona Virus have their origin in Bats. Coronavirus can have cold with major symptoms, such as fever, cough and sore throat.
In total six species of corona viruses are known till date, in which one strain is divided into two different strains making it a number of seven. Three human coronaviruses produce potentially severe symptoms:
- Severe acute respiratory syndrome coronavirus (SARS-CoV), β-CoV (identified in 2003)
- Middle East respiratory syndrome-related coronavirus (MERS-CoV), β-CoV (identified in 2012)
- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), β-CoV (identified in 2019)
These cause the diseases commonly called SARS, MERS, and COVID-19 respectively.
Leading Manufacturers of Corona Virus or Covid-19 vaccines
Vaccine and vaccination are derived from Variolae vaccinae (smallpox of the cow), the term devised by Edward Jenner (who both developed the concept of vaccines and created the first vaccine) to denote cowpox.
There are around 10 companies in various stages of clinical trials and over a hundred of companies in it preclinical stage. The top ten companies that are leading the race of COVID-19 Vaccine are CanSino Biological, Moderna, SinoVac, University of Oxford, BioNTech, Novavax, Wuhan Institute of Biological Products, Inovio Pharmaceuticals, Beijing Institute of Biological Products/Sinophar, and Chinese Academy of Medical Sciences. [1]
The list of leading companies are below:
Covid-19 Vaccine manufacturers and their patents
- Name of the Vaccine: COVISHIELD/VAXZEVRIA
Developer/Manufacturer: University of Oxford/Astrazeneca
Kind of vaccine: Weakened Viral Vector.
Patent number: WO2012-172277
Abstract of patent: The present invention provides recombinant adenoviral vectors, immunogenic compositions thereof and their use in medicine, and methods for generating recombinant adenoviral vectors. In particular, the present invention provides an adenovirus vector comprising a capsid derived from chimpanzee adenovirus AdY25, wherein said capsid encapsidates a nucleic acid molecule comprising an exogeneous nucleotide sequence of interest.
Contact Information: University of Oxford, University Offices, Wellington Square, Oxford, OX1 2JD, United Kingdom, Telephone: +44 1865 270000, Fax: +44 1865 270708
- Name of the vaccine: SPUTNIK-V
Developer/Manufacturer: GAMALEYA RESEARCH INSTITUTE OF EPIDEMIOLOGY- RUSSIA
Kind of vaccine: A VIRAL VECTOR VACCINE, adenovirus vectors rAd26 and rAd5, which promote the delivery of antigens to the human body, to promote the immune response.
Patent Number: The Russian patent RU2720614C1 has already been internationalized through application WO2021002776A1 and in the future patent protection in other countries should be requested.
Abstract of the patent: FIELD: Biotechnology, immunology, virology. SUBSTANCE: The invention relates to the field of biotechnology, immunology and virology, in particular to an immunobiological agent for the prevention of diseases caused by the severe respiratory syndrome virus SARS-CoV-2. Also, a method is disclosed for inducing specific immunity to the SARS-CoV-2 virus, comprising administering one or more immunobiological agents to the mammalian body for the prevention of diseases caused by the severe respiratory syndrome virus SARS-CoV-2. The invention allows to effectively induce an immune response against SARS-CoV-2 virus. EFFECT: the invention allows to effectively induce an immune response against SARS-CoV-2 virus.
Contact Information: The Russian Direct Investment Fund (RDIF) Capital City, South Tower, 7th 8th floor 8 bid. 1 Prsenenskaya nab, Moscow, Russian 123112, T- +7 495 644 3414, F- +7 495 644 3413
Email: sputnikvaccine@rdif.ru
- Name of the vaccine: MODERNA
Developer/Manufacturer: American company Moderna, the U.S. National Institute of Allergy and Infectious Diseases, the U.S. Biomedical Advanced Research and Development Authority, and the Coalition for Epidemic Preparedness Innovations.
Kind of vaccine: mRNA VACCINE
Patent number: 10702600
Abstract of the patent: The disclosure relates to respiratory virus ribonucleic acid (RNA) vaccines and combination vaccines, as well as methods of using the vaccines and compositions comprising the vaccines.
Contact Information: Global Headquarters 200 Technology Square Cambridge, MA 02139, T- 617- 714-6500
- Name of the vaccine: Janssen COVID-19 Vaccine, JNJ-78436735
Developer/Manufacturer: Janssen Pharmaceuticals Companies of Johnson & Johnson
Kind of vaccine: Viral Vector
Patent Number: US7888102
Patent’s abstract: The invention relates to the production of coronaviruses. In particular, the invention relates to methods for producing SARS-CoV by using cells expressing a functional SARS-CoV receptor.
Address: https://www.janssen.com/us/contact-us
- Name of the vaccine: SPUTNIK LIGHT
Developer/Manufacturer: Russian Gamaleya Research Institute of Epidemiology
and Microbiology.
Kind of vaccine: Viral Vector
Patent Number: The Sputnik Light vaccine is the first component (recombinant human adenovirus 26 serotype (rAd26) of the Sputnik V vaccine. Therefore, has the same characteristics as of Sputnik V.
Contact Information: The Russian Direct Investment Fund (RDIF) Capital City, South Tower, 7th 8th floor 8 bid. 1 Prsenenskaya nab, Moscow, Russian 123112, T- +7 495 644 3414, F- +7 495 644 3413
- Name of the vaccine: CONVIDECIA
Developer/Manufacturer: Chinese company CanSino Biologics and the Beijing Institute of Biotechnology of the Academy of Military Medical Sciences
Kind of vaccine: Viral Vector
Patent Number: CN111218459
Patent’s abstract: The invention provides a novel coronavirus vaccine taking human type 5 replication-defective adenovirus as a vector. The vaccine takes replication-defective human type 5 adenovirus with combined deletion of E1 and E3 as a vector, HEK293 cells integrating adenovirus E1 genes as a packaging cell line and carried protective antigen genes are 2019 novel coronavirus (SARS-CoV-2) S protein genes (Ad5-nCoV) which are subjected to optimization design. After the S protein gene is optimized, the expression level in the transfected cells is obviously increased. The vaccine has good immunogenicity on mouse and guinea pig models and can induce organisms to generate strong cellular and humoral immune responses in a short time. The protection effect research on the hACE2 transgenic mouse shows that the virus load in lung tissues can be obviously reduced after a single immunization of Ad5-nCoV14 days, and the vaccine has a good immune protection effect on 2019 novel coronavirus. In addition, the vaccine is fast and simple to prepare, and can be produced in a large scale in a short time to cope with sudden epidemic situations.
- Name of the vaccine: RBD-DIMER
Developer/Manufacturer: Chinese company Anhui Zhifei Longcom Biopharmaceutical
Kind of vaccine: Subunit vaccine
Patent number: CN106928326
Patent’s abstract: The invention discloses a kind of coronavirus vaccine of the receptor binding domain subunit based on dimerization, belong to pharmaceutical technology field.The present invention expresses RBD (E367 Y606) regions of MERS CoV albumen and the RBD (R294 F515) of ARS CoV by baculoviral body in insect cell, so that RBD by the cysteine residues of S protein itself 603 can form dimer or form dimer by the cysteine residues of S protein itself 512, Balb/c mouse are immunized using the RBD albumen dimer and monomer of purifying respectively. The RBD of dimerization of the invention overcomes the not enough shortcoming of RBD monomeric immunogenics, and the neutralizing antibody for substantially increasing mouse for MERS CoV is produced.
- Name of the vaccine: MINHAI
Developer/Manufacturer: Minhai Biotechnology Co. and Kangtai Biological
Products Co. Ltd. in China.
Kind of vaccine: Inactivated Virus
Patent number: US20160166675
Abstract of the patent: NO INFORMATION IN PUBLIC DOMAIN
Contact Information: No. 35, Simiao Road, Daxing Biomedical Industrial Base, Zhongguancun Science Park, Daxing District, Beijing, T- 010-59613600
- Name of the vaccine: PFIZER-BIONTECH
Developer/Manufacturer: GERMANY COMPANYBIONTECH AMERICAN COMPANY- PFIZER
Kind of vaccine: mRNA VACCINE
Patent number: NO DATA AVAILABLE IN THE PUBLIC DOMAIN.
Url of the company: https://www.pfizer.com/
Contact Information: 235 East 42nd Street NY, NY 10017, T- (212) 733-2323
- Name of the vaccine: COVIVAC
Developer/Manufacturer: Chumakov Centre at the Russian Academy of
Sciences
Kind of vaccine: Inactivated Virus
Patent number: NO DATA AVAILABLE IN THE PUBLIC DOMAIN
Contact Information:108819, Russian Federation, city of Moscow, settlement Moskovsky, settlement of the Institute of Poliomyelitis, household 8, building 1, T- +7(495) 841-90-02, +7(495) 531-01-70
Email Address: sue_polio@chumakovs.su
- Name of the vaccine: QazCovid-in/QazVac
Developer/Manufacturer: Research Institute for Biological Safety Problems in Kazakhstan
Kind of vaccine: Inactivated Virus Vaccine
Patent number: NO DATA AVAILABLE IN THE PUBLIC DOMAIN.
Contact Information: 15 Momyshuly str., Guardeyskiy uts of Korday district of Zhambyl region, postcode: 080409, T- (726-36) 7-22-28
- Name of the vaccine: EPIVAC CORONA
Developer/Manufacturer: Russian State Research Center of Virology and Biotechnology VECTOR.
Kind of vaccine: Peptide Vaccine
Patent number: NO DATA AVAILABLE IN THE PUBLIC DOMAIN.
Contact Information: Koltsovo, Novosibirsk reg., 630559, Russia, T- 7+3833+366010
Email Id: vector@vector.nsk.su
- Name of the vaccine: COVIran Barakat
Developer/Manufacturer: Shifa Pharmed Industrial Co in Iran.
Kind of vaccine: Inactivated Virus
Patent number: NO DATA AVAILABLE IN THE PUBLIC DOMAIN.
Contact Information: 1701 K Street NW, Suite 805, Washington, DC 20006 USA, T- 202-223-8299
- Name of the vaccine: Sinopharm-BBIBP
Developer/Manufacturer: China National Pharmaceutical Group.
KIND OF VACCINE: Inactivated Virus Vaccine
Patent number: NO DATA AVAILABLE IN THE PUBLIC DOMAIN.
Contact Information: No. 20 Zhichun Road, Haidian District, Beijing, China, Postal Code: 100191, T- 86-10-82287727
- Name of the vaccine: COVAXIN
Developer/Manufacturer: Indian Company- Bharat Biotech & ICMR
Kind of vaccine: Inactivated Virus.
Patent number: NO DATA AVAILABLE IN PUBLIC DOMAIN
Contact Information: Genome Valley Shameerpet, Hyderabad – 500 078 Telangana INDIA, T- +91 40 2778 4084, Ph: +91 40 2348 0567, Mob: +91 99480 80567, Fax: +91 40 2348 0560
- Name of the vaccine: Sinopharm-BBIBP
Developer/Manufacturer: China National Pharmaceutical Group
Kind of vaccine: Inactivated Virus Vaccine
Patent number: NO DATA AVAILABLE IN THE PUBLIC DOMAIN.
Contact Information: No. 20 Zhichun Road, Haidian District, Beijing, China, Postal Code: 100191, T- 86-10-82287727
- Name of the vaccine: Coronavac/Sinovac
Developer/manufacturer: Chinese company Sinovac, Life Sciences (Beijing, China)
Kind of vaccine: Inactivated Virus.
Patent number: NO DATA AVAILABLE IN PUBLIC DOMAIN
Author: Apoorva, ICFAI Law School, ICFAI University, Dehradun
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[1] https://intellizence.com/insights/top-10-companies-leading-the-race-of-covid-19-vaccine/
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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Apr 16, 2014 | Patent
The concept of Drug Exclusivity can be perceived as a period or duration of time when a drug of a particular brand is protected from other generic drugs competition in the market. The conceptualization of Exclusivity was majorly evolved to induce and bring about a balance between new drug production and competition of generic drugs.
Initially, the concept of “exclusivity” was attributed to the protection of undisclosed data, and information that have highly commercialised value that needs to be protected in accordance with the TRIPS Agreement. Under the common law, these types of date have been protected as Trade Secrets.
Therefore, Data Exclusivity can be perceived as a transformational notion of protecting data by not disclosing the data to the general public which essentially is the protection of data in the form of trade secrets and the basis of principles such as equity and good faith. In addition, the invention whose information is kept protected must confine itself to the essentialities of a patent that is- the invention must be new, should be an inventive step and must be capable of being industrially applied.
Therefore, in specific pertinence to drugs, there arises a need to gauge and assess the existing conditions in the developing countries wherein a generic drug manufacturer might develop drugs at prices that are cheaper by manufacturing a biologically equivalent drug that is similar to the innovator company.
The concept of exclusivity acts as a conflict between the inventing company that has already availed protection under the existing patent laws and that of the public interest.
Extension of Data Exclusivity to Drugs
In India, the Indian Pharmaceutical Alliance was brought notice about a rule change that was proposed by the Central Government to provide a longer duration of protection to drugs that are newly manufactured which would bring about an impact of generic and low cost medicines for the public in India.
This change was suggested in lieu of the United States Trade Representative (USTR), which falls under the United States government that is responsible for the enforcement of intellectual property from the US around the world. The proposed change by the central government was to increase the exclusivity period from the existing four years to that of ten years.
Data Exclusivity in essence includes the exclusion of registration data, and can be established as the period of not disclosing the chemical compositions, pharmaceutical compositions and any other form of agrochemical registration or test data. This is an individual intellectual property right and cannot be included under the protection that is provided by the other rights like the patents.
For Drugs, there are many clinical trials and tests that are conducted, the results of which cannot be disclosed as it is a resultant scientific discovery and the innovating company has invested expenses as well as time. A simple molecular discovery and development generally takes about a decade and is seen to be expending millions of dollars. Within this, the generation of test results takes 50% of the cost. Therefore, the data when publically disclosed might be taken advantage of by third parties.
Data and Drug exclusivity provide the innovating company with the right to secrecy and prevents third parties from utilising the data to obtain any marketing authorization for duration of time. But this right does not prevent any third parties from producing their own data.
Subsequent manufacturers could apply for their formulations and discoveries, but they have to get it sanctioned by the innovating company and prove the equivalence of the product with that of international standards. Otherwise, by simply making reference to the originator’s submitted information, they get an unnecessary benefit, as they have not played out any of the costly and tedious tests or presented any information to show the security and viability of their item. Therefore this process helps in securing and making sure that-
- The innovating company obtains exclusivity of the drugs for a specified period which would enable the company to recover the costs that would be incurred while obtaining approvals.
- The regulatory authority is not supposed to check the innovating company’s data, without the consent, while reviewing applications put forth by the subsequent manufacturers.
The subsequent generic manufacturers could apply for marketing sanctions if they are in a position to generate their own test results.
Without a drug data exclusivity period, subsequent registrants can bring identical items into the market solely based on bioequivalence tests without leading tedious and costly preliminary tests that are needed to show the effectiveness of the discovery. This would bring about extreme detriment to the innovating company, having made significant speculation and investments to their discoveries.
An Anatomization of Drug Data Exclusivity: A Global Frame of Reference
Data protection of drugs came into effect and gathered international limelight when the issue of unfair competition was undertaken in the Paris Convention and importance was attributed to undisclosed information. The Agreement on Trade-Related Aspects of Intellectual Property Rights, 1994 also advocates the exclusivity of information under Article 39(3).
Accordingly, the concept of drug exclusivity provides that there exists a predefined period where no subsequent manufacturer could demonstrate bioequivalence and stay away from a tests for adequacy, safety and different properties. A trade off is struck where the innovating company is permitted a specific timeframe to recover the costs engaged with the testing in; and the public premium objective of benefiting protected and proficient items in the commercial center, while empowering subsequent participant items to enter the market yet after a characterized period. The subsequent participant may not be permitted during this period to be absolutely or to some extent excluded from recording unique testing information by demonstrating bio-equality. This is a commitment of non-dependence, both by the authorities and that of the third parties.
A Reference to Indian Legal Framework
There has been immense tension on India from the nations like the US and the EU, as international embargoes on the issue of drug data exclusivity, obviously on the grounds that the vast majority of the drug monsters have a place with these nations.
As per The Official Secrets Act, 1923- has been enacted that binds the public servants and government official from using any information that is deemed to be confidential in an unauthorised manner which would ultimately affect the security, integrity and sovereignty of the country. An oppressed party might sue the Government in a Civil Court. Nonetheless, the extent of this enactment is exceptionally restricted as it doesn’t guarantee data protection, however is restricted to security against divulgence of the information which is just one of the components of information protection. There is no arrangement to address against unfair competition brought about by outsider to unlawfully depend on the innovative company’s exclusive information. Albeit, this resolution accurately concedes an oppressed party the option to guarantee harms in a common suit and get damages, it doesn’t proactively guarantee insurance against out of line business utilization of the information. Consequently, the Official Secrets Act, 1923 doesn’t guarantee information security according to TRIPS Article 39.3 principles.
Trade secret protection is a solution to forestall the revelation of information, yet it is a private cure that is untested against administrative experts in India. Moreover, regardless of whether such an apparatus might be utilized to limit the abuse of test information, it again doesn’t keep the regulatory authorities from depending on it themselves to allow endorsements to subsequent manufacturers.
The Indian Patents Act, 1970 is another significant enactment. In any case, the Patent Act is appropriate just to patentable developments and doesn’t secure new utilization of a known substance or definitions by blends. Further, patent security stretches out just to the creation yet not to the information produced by the originator.
Conclusion
The methodology suggested for drugs and pharmaceuticals includes a momentary period for which initial steps will be taken to carry out the process of minimum data protection for example to work on the protection information the board in the Drug Regulatory Authorities and to forestall unapproved revelation of information. This period will can be trailed by a post transition period which will involve a duration of 5 years in which the Drug Regulatory Authority would not depend on the information put together by the innovating company while giving second and ensuing marketing approvals.
Author: Haritha Dhinakaran, Symbiosis Law School, Pune
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Mar 19, 2014 | Exclusive Interview
Dr. Gautam has got many prestigious awards and fellowships. Presently, he is the Vice President of National Academy of Agricultural Sciences and Member of Executive Board of Global Crop Diversity Trust and Vice Chairman of Trust for Advancement of Agricultural Sciences
Below are his expert opinions on the issues of Plant Variety Protection, Farmer’s right and Government’s measures to National Biodiversity.
Origiin: Hello Dr Gautam. It is pleasure to have opportunity to interact with you.
Dr Gautam: Hello Sabina. At the outset, my New Year greetings to you and the Origiin.
It is nice to interact with you and through you the readers of Origiin.
Origiin: As you know that India has not been very aggressive regarding protection and enforcement of Intellectual Property Rights so far resulting in patents on our traditional knowledge by foreign companies. What has been sole reason for it?
Dr Gautam: In 1992, Convention on Biological Diversity acknowledged the sovereign rights of the nation on their biological resources and prior to this Convention, the bio-resources and associated traditional knowledge were regarded as common heritage of humankind. The Article 8(j) of the Convention further recognized the contribution of communities and indigenous local people in the conservation and preservation of biological resources and fair and equitable share in the benefits arising out of utilization of such knowledge. The Agreement on Trade related of Intellectual Property Rights (TRIPS) an international agreement administration by the World Trade Organization (WTO) laid down standards for many forms of intellectual property (IP) regulations. The TRIPS mandated the member countries to enforce minimum standards of IP protection for a wide range of intellectual properties. It’s Article 27.3 provided that member countries may exclude from patentability plants and animals other than micro-organism and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, members shall provide for the protection of plants varieties by patents or by an effective sui generis system and by combination thereof. Therefore, countries were free to choose their own effective sui generis regime for the protection of plant varieties. India being one of the members of the CBD, ITPGRFA and WTO, enacted Protection of Plant Varieties and Farmers Rights Act 2001 and Biological Diversity Act 2002. In addition, India amended Indian Patents Act 1970(amendments in 1999, 2002 and 2005) and enacted Geographical Indications of Goods (Registration & Protection,) Act 1999 and Trademarks Act 1999, and its amendment 2010.
The People’s Biodiversity Registers (PBRs) are being documented by the BMCs under the Biological Diversity Act, 2002 of India. So far, 1915 PBRs have been documented by different states. These registers include comprehensive codified and oral information about traditional knowledge associated with bio-resources and may help provide protection from patenting and their illegal exploitation. The Indian Council of Agricultural Research has initiated massive programmes for the registration of bio-resources of plants, animals, fish, microbes, insects etc.
Under the PPV & FR Act, 2001, the farmer’s varieties are being registered. So far, farmers and breeders varieties of 54 crop species have been registered. The PPV & FR authority is also developing compendia for documentation, indexing and cataloguing of all varieties including farmers’ varieties. It has identified 22 agrobiodiversity hotspots for focused attention on conservation and sustainable use of agrobiodiversity. It is also maintaining databases of NORV (Notified and Released Varieties of India) and IINDUS ( Indian Information System as per DUS guidelines-a database for released ,example and reference varieties of all notified crops).
Traditional knowledge has always been an easily accessible treasure and thus has been susceptible to misappropriation and bio-prospecting. It is often misappropriated, because it is conveniently assumed that being in public domain, communities have given up all claims over it. Traditional Knowledge includes both the codified (documented) as well as non-codified information. Bio-piracy of codified Indian traditional knowledge continues, since, this information exists in regional languages. The reliability of the traditional medicine systems coupled with the absence of such information with patent offices, provides an easy opportunity for business houses for getting patents on formulations derived from traditional medicine systems. The grant of such patents has been matter of great concern to the developing world. Patent literature, is usually wholly contained in several distinctive databases and can be more easily searched and retrieved whereas it is not so with non-patent literature prior art. Thanks to the efforts of CSIR and AYUSH, TKDL targeted Indian Systems of Medicine, viz., Ayurveda, Unani, Siddha and Yoga available in public domain. This has been documented collating the information on traditional knowledge from Sanskrit, Urdu, Arabic, Persian and Tamil in digitized format, which is available in five international languages – English, German, Spanish, French and Japanese. TKDL acts as a bridge between formulations existing in local languages and a Patent Examiner at a global level, since the database provides information on modern as well as local names in a language and format understandable to Patent Examiners. Today, India through TKDL is capable of protecting about 2.5 lakh medicinal formulations. TKDL access has been given to eight International Patent Offices viz. Indian, European, German, United Kingdom, United States , Canadian, Australian and Japanese Patent Offices under Access (non-disclosure) Agreement. Based on the evidences of prior art submitted by the TKDL team on the basis of the information present in the TKDL database, so far 88 patent applications of the pharma companies of United States, Great Britain, Spain, Italy, China, etc. have been either set aside or withdrawn/cancelled or declared as dead patent applications at no cost and within few weeks of submission of prior art evidences, whereas cancellations of patents have been known to take 4-13 years of complex and expansive legal battle. Considering the novelty, utility and its effectiveness in preventing the grant of wrong patents several countries and organizations have expressed their keenness in replicating the TKDL model for their own countries.
Although, India started these initiatives after the above mentioned global developments, good progress has been made thanks to the aggressive steps in protecting IPRs including the traditional knowledge.
Origiin: India is one of the few countries in the world to have exclusive legislation for Protection of Plant Varieties and Farmers’ Rights, which is extremely encouraging. How does it actually benefit the farmers?
Dr Gautam: Yes, India is one of the pioneers in enacting the legislation providing rights to breeders, researchers, communities and farmers under the PPV& FR Act .The Act recognizes farmer as cultivator, conserver and breeder. The Act provides the following rights to the farmers:
- Right on seed to save, use, sow, re-sow, exchange, share or sell their farm produce including seed of protected varieties(except branded seed of protected variety under the Act) as were entitled before coming into force of the Act (Sec. 39(1)(iv)).
- Right to register existing farmer varieties fulfilling the laid out requirements (Sec.39 (1) (iii)).
- Right for award, reward and recognition from National Gene Fund (Sec. 39(i)(iii)& Sec.45(2)(C)).
- Right for compensation in case of non performance of the variety as claimed by the breeder of protected/ registered variety (Sec. 39(2)).
- Right for protection against innocent infringements (Sec. 42)
- Exemption from registration fee for registration of framer’s variety and any fee for legal proceedings related to infringement or other causes in courts, tribunal etc. (Sec.44)
- Right for access to quality seeds of protected varieties at reasonable price(Sec. 47)
- Right for benefit sharing, if genetic material conserved by tribal or rural families is used by a breeder in the development of a protected variety (Sec.26)
- Prior authorization in respect of use of farmer’s variety by the breeder for commercialization of essentially derived variety (Sec.34(c))
Origiin: In terms of biodiversity, India is one of the richest countries in the world. Unfortunately this has also led to exploitation of the same resulting in extinction of many plant varieties. In this scenario, how does implication of PPV&FR Act helps?
Dr Gautam: India is one of the mega diverse countries. There is global interdependence on plant genetic resources and hence access to such resources has to be facilitated, on mutually agreed terms and prior informed consent, by the countries as per commitments of CBD and ITPGRFA. Due to the extensive monoculture of crops, climate change, land and habitat destruction,and alien species, there had been erosion of traditional crop varieties. However, India has long history of systematic programmes for exploration, collection,characterization and conservation of germplasm. Resultantly, nearly 4 lakh germplasm of 1586 crops has been conserved under the umbrella of NBPGR/ ICAR.
The PPV & FR Act provides for protection of farmer and breeder varieties and their seeds are maintained in the gene bank of the Authority. This seed may be used for initial multiplication of a variety, in the event of invoking compulsory licensing by the government. In normal course, the seed is to be transferred to National Gene Bank of NBPGR after the period of protection of a particular variety is over. Hence, the legislation is becoming an effective instrument for protection and conservation of the farmers varieties.
Origiin: Under Protection of Plant Varieties and Farmers’ Rights Act, there are various Awards, Rewards & Recognitions for the farmers. Please tell us briefly about it.
Dr Gautam: The Act provides for establishment of National Gene Fund. Its Section 70(2) specifies that the gene fund shall be applied to support and reward farmers, community of farmers, particularly the tribal and rural communities engaged in conservation, improvement of genetic resources in areas identified as agro- bio diversity hot spots. It is also used for capacity building on ex-situ conservation at the level of local body, and supporting in-situ conservation, particularly in identified agro- bio diversity hot spots. The PPV & FR authority has instituted the following awards from National Gene Fund to encourage and recognize the self less services of the rural folks in ensuring the continuous availability of biodiversity for plant breeding purposes:
- Plant genome savior community awards (5 per year) of Rs. 10 lac each
- Plant genome savior farmer rewards (10 per year)of Rs. 1 lac each
- Plant genome savior farmer recognitions (20 per year) to the farmers engaged in the conservation of the genetic resources of land acres and wild relatives of economics plants and their improvement through selection and preservation.
Origiin: What is difference between Seed Act 1966 and Plant Varieties and Farmers’ Rights Act 2001?
Dr Gautam: Until 1966 there was no central legislation on seeds. With the advent of high yielding varieties in food crops in 1960s, India realized the need for a seed law so as to create a climate for making available good quality seeds to the farmers. This lead to enactment of the Seeds Act, 1966 which was implemented in its entirety in October 1969.This Act and its rules were amended in 1972, 1973, 1974 and 1981. The enforcement of the provisions of Seeds Act in 1969 marked the beginning of systematic arrangements for large scale seed certification. Seeds Act, 1966 and its rules 1968 provide certification and minimum quality standards of notified kinds/ varieties. Hence, it provides for regulating the quality of certain seeds ( of notified and truthfully labeled varieties) for sale to the farmers . Hence, Seeds Act, 1966, Seeds Rules 1968 with Seeds (Control Order) 1983 are the legal instruments for regulating the production, distribution and the quality of certain seeds for sale and for matters connected therewith. The PPV&FR Act, 2001 grants the proprietary ownership of the variety to the concerned plant breeder or farmer. Intellectual Property Rights are the private rights which confer to the legitimate owners exclusive rights to produce sell, market, distribute, import or export the variety registered under the PPV & FR Act. The PPV &FR Act provides for the establishment of an effective sui-generis system for protection of plant varieties, the rights of farmers and plant breeders and to encourage the development of new varieties of plants. India being member of WTO and signatory to the TRIPS enacted this Act. The Act is unique in the world as it has granted right to both breeders and farmers simultaneously under one Act. It has taken the farmers rights concept forward and genuinely addressed the concern of the farmers as breeders, innovators, cultivators, conservers etc. It has incorporated the features of UPOV, CBD, TRIPS and ITPGRFA along with certain distinctive features of its own as per requirements of the farmers. Its main objectives are:
- To provide an effective system for protection(in terms of IPRs) of plant varieties and rights of farmers and plant breeders
- To recognize and protect rights of farmers in respect of contribution made at any time in conserving, improving and make available PGRs for development of new varieties.
- To accelerate agricultural development in country, protect PBRs and stimulate investment in R&D in public/ private sectors for varietal development.
- To facilitate growth of seed industry to ensure availability of high quality seeds and planting materials to the farmers.
Origiin: What is National Gene Fund and how can farmers make use of it?
Dr Gautam: Section 45 of the PPV& FR Act provides for establishment of National Gene Fund by the central government. The fund has been constituted by the Central Government to promote, recognize and reward those farmers who are engaged in the conservation of genetic resources of land races and wild relatives of economic plants and their improvement through selection and preservation in the agro-biodiversity hot-spots and also to a farmer who is engaged in conservation of genetic resources of landraces and wild relatives of economic plants and their improvement through selection and preservation provided material so selected and preserved has been used as donor of genes in varieties registered under the Act. This fund would be augmented through benefit sharing received from varieties registered under the Act, annual fee payable to the Authority as royalty by the breeders of registered varieties, compensation deposited in gene fund under section 41(4), contribution from any national and international organizations and other sources. The Fund shall be applied for the following purposes:
- Paying benefit sharing under section 26 (5)
- Compensation payable under section 41(3)
- Expenditure for supporting conservation and sustainable use of genetic resources including in-situ and ex-situ collections and for strengthening capability of the panchayat in carrying out such conservation and sustainable use and the expenditure of the scheme relating to benefit sharing under section 46 of the Act. In this respect, there could be linkages between the provisions of this Act and the Biodiversity Management Committees established at the Panchayat/Local Body level under the Biodiversity Act.
- The central government may frame one or more schemes on the items indicated therein, to fulfill the purpose of section 41 and 45 of the Act
- Supporting, recognizing and rewarding the farmers, community of farmers, particularly the tribal and rural communities engaged in conservation, improvement and preservation of genetic resources of economic plants and their wild relatives particularly in identified agro bio-diversity hot spots.
Origiin: Thank you so much Dr Gautam for your valuable inputs.
Dr Gautam: Thank you Saikia. I trust and believe the information will be useful to the readers and the stakeholders.
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