Celgene Revlimid Patent Infringement

Dec 20, 2022 | Indian Patents Act 1970, IPR & Business

Celgene corporation is a subsidiary of Bristol Myers (BMS), an American multinational pharmaceutical company, headquartered in New York City. BMS is one of the world’s largest pharmaceutical companies. One of the main drugs manufactured by Celgene is an immunology drug against cancer, namely Lenalidomide sold under the trade name Revlimid, used to treat (MM) Multiple Myeloma and (MDS) Myelodysplastic Syndromes.

In December 2005, Celgene received approval from the FDA to market Revlimid.. It is part of a class of drugs called immunomodulatory drugs (IMiDs), which work against cancer cells partly by supporting the function of the immune system. Since then, many generics have filed  ANDA (Abbreviated New Drug Application) for Revlimid drug including renowned pharmaceutical companies such as Dr Reddy Laboratories, Cipla Pharmaceutical Company, Natco Pharma and Lotus Pharmaceutical.

Celgene faced its first generic contender in 2010 when Natco Pharma, Arrow Pharmaceuticals and Watson Pharmaceutical Private Limited  (collectively as NACTO ) filed an ANDA with FDA seeking approval to make a generic version of Celgene Corporations Lenalidomide Drug under the market name Revlimid, whereas Celgene Corporation proposed that Natco infringes its patents, which on the other hand initiated a Hatch-Waxman Lawsuit (known as Drug Price Competition and Patent Term Restoration Act).

Natco Pharma is an Indian multinational pharmaceutical company based in Hyderabad, which makes finished dosage formulations and active pharmaceutical ingredients (API). It is the market leader in branded oncology medicines in India, and among the country’s top three producers of hepatitis C drugs. A settlement agreement was agreed upon  between Celgene Corporation and Natco Pharma which allowed Natco to initiate generic launch of the drug in March 2022. The agreement allowed Natco Pharma to begin manufacturing “mid-single-percentage” of Revlimid’s total volume, with this specified figure gradually increasing over time to one-third of Revlimid’s numbers.

Followed by Natco Pharma’s license to sell volume-limited amounts of generic lenalidomide in the U.S. beginning on a confidential date after March 2022, Dr  Reddy Laboratories was also granted the license to sell volume-limited amounts of Revlimid in U.S after March 2022.

In 2017,   Celgene Corporation filed a patent infringement suit against Dr Reddy Laboratories. . The settlement agreement between Celgene and Dr Reddy Laboratory remains confidential. But in a settlement of all outstanding claims in this litigation, Celgene has agreed to provide Dr. Reddy’s Laboratories with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S. beginning on a confidential date after March 2022 subject to regulatory approval.   Dr. Reddy’s was also granted a license to sell generic lenalidomide capsules in the U.S. without volume limitation beginning on January 31, 2026. The earliest licensed entry of any generic lenalidomide in the U.S. continues to be March 2022, based on the settlement executed.

In an agreement between Celgene corporation and Alvogen in 2019, Celgene Corporation was able to settle disputes and reach a settlement with Alvogen over the sale and manufacturing of the anti-cancer drug. Alvogen  is an American pharmaceutical company which has about 350 different medical and non-medical products, and it markets the products under the brand name pharmaceutical companies. Both Celgene and Alvogen reached a settlement and licensed Alvogen to sell generics up to single-digit percentages of Revlimid volumes sometime after March 2022. Alvogen had already launched a Revlimid generic earlier in some European countries. Global pharmaceutical company Alvogen reached the settlement of their litigation relating to patents for Revlimid (lenalidomide) with Celgene Corporation along with Oral oncology and specialty pharmaceutical Lotus Pharmaceutical Co. Ltd.

Celgene Corporation settled its patent dispute with Natco Pharma, Dr Reddy Laboratories and Alvogen respectively and all three companies can now roll out unlimited generics in the U.S. after January 31, 2026.

In March 2021 Cadila Healthcare settled its patent suit with Celgene Corporation over the anti-cancer drug Revlimid. Cadila Health (also known as Zydus Cadila) is an Indian multinational pharmaceutical company headquartered in Ahmedabad, Gujarat, India primarily engaged in the manufacturing of generic drugs. In 2021 both Celgene and Cadila Healthcare will file a consent judgement which is a judgement specifying the settling disputes between the parties. This suit will be filed before the US Court which prohibits Zydas from marketing the generic drug before its patent expiration.

In June 2021,  Celgene settled a patent infringement suit with Sun Pharmaceutical Industries Ltd, an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. This litigation was regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Revlimid (lenalidomide capsules) in US by Sun Pharma. Celgene  agreed to grant a license to Sun Pharma, for a specific volume in exchange of royalty to manufacture and sell the drug, subject to the U.S. Food and Drug Administration approval. Celgene granted Sun Pharma a license to sell a certain limited quantity of generic lenalidomide capsules in the U.S. subject to USFDA approval, beginning on a confidential date, sometime after March 2022.

Therefore to conclude,  Celgene corporation has settled its patent infringement suit against  Sun Pharma in June 2021 and subsequently with companies like Natco Pharma, Dr Reddy Laboratories, Alvogen, Cadila Healthcare, Lotus Pharmaceuticals respectively. These Indian companies are leading pharma Medicare producers in India and are ranked amongst the fastest growing pharmaceutical companies in India.

By: ANUSHKA SEEMENDRA, ICFAI UNIVERSITY, DEHRADUN

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Expedited Examination of Patent Applications for start-ups

Sep 19, 2022 | Indian Patents Act 1970, IPR & Business

The Patent Act, 1970 comprehends several proceedings from filing of the application till the grant of the patent. Examination of the patent application is one such process. In general, once the patent application is filed, a request for examination is filed in Form 18 u/r 24-B within 48 months from the date of priority. The filing of request for examination is followed by examination of the patent application by the controller.

Conventionally, the timeline for the grant of a patent was tedious and overlong. A provision to file for an expedited examination of application has been provided u/r 24-C of the Patent Rules, 2003 with amendments in 2016 and 2019. An expedited examination of application is filed in Form 18-A. A request for expedited examination of patent applications has to be filed along with a request for publication unless already published. In addition, a request for examination filed can also be converted to an expedited examination by filing Form 18-A under applicable grounds.

The grounds to apply for expedited examination include:

• India has been included as competent ISA or has been elected as IPEA
• Small entity
• Start-ups
• Natural person
• Department of Government
• Institution established by government
• Government company
• Institution financed by the government

A significant reduction in the span of grant of the patent is seen with expedited examination of patent applications. Under expedited examination of patent application, the examiner examines the application and makes a report within 1 month but not exceeding 2 months. Further, the controller issues a first statement of objections within 1 month from the date of receipt and the controller shall dispose the application within 3 months from the date of receipt of last reply to the first statement of objections,

The expedited examination of patent applications was introduced for start-ups initiatives under the 2016 amendment of Patent Rules, 2003. Later, the grounds were expanded under the 2019 amendment of Patent Rules, 2003. On filing a request for expedited examination, the applicant receives the first statement of objections within 2 months from the date of receipt and the applicant may receive a grant within 1.5 years from the date of filing/priority.

To promote start-ups, the IPO & DIPP has been taking many initiatives to speed up the patent grant process. A request for expedited examination has to be filed along with Form 28 and evidence for start-up which include a certificate of recognition by DIPP has to be filed.

The grant of a patent under expedited examination for start-ups assists in generating revenue for the research and development. Additionally, the grant of a patent assures authenticity of the invention for the investors. The grant of patent further provides complete protection against infringement which is a crucial aspect for start-ups. The market-value and market-presence are increased for the invention of a granted patent. With an early grant of patent, a complete public disclosure of the invention becomes feasible. Essentially, misuse and duplication of an invention can be prevented at a faster rate. Also, fast-tracking of examination and grant of patent application keeps the competitive inventions at check. For start-ups having patent rights, the company value is increased potentially in the market.

The expedited examination of patent applications has brought in an accelerated timeline for patenting procedures. The global IP standards are being coped with expedited examination of patent applications. In case of start-ups, filing an expedited examination of patent application followed by an early grant attracts funding and prevents counterfeiting of their invention. In addition to providing protection to the invention, the competition with the existing market is withstood upon grant. 

By Anagha MS

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Parle Gluco to Parle-G: A One-of-a-Kind Success Story

Aug 20, 2022 | Indian Patents Act 1970, IPR & Business

Parle Products introduced Parle-G way back in 1938. The biscuits themselves have had a long journey attaining global recognition, with the brand undergoing reimaging in 1982. One may wonder why an exceedingly popular and successful brand had to undergo reimaging after so many years of being introduced to the market and becoming a hit among consumers. The answer lies in an understanding of trademarks.

India has developed Intellectual Property Laws and awareness in the recent past and is still making constant developments in these laws, resulting in IP protection being a new yet essential field in the Indian Legal System. However, Parle Products, having been started during the Swadeshi Movement, has been around for a longer time. Like any successful business, Parle Products gauged the changing legal environment surrounding brand protection in India and adapted to these changes by reimaging ‘Parle Gluco’ and renaming it as ‘Parle-G’.

In order to understand the relevance of this particular change, it is important to understand two important limitations to trademark registration which in turn protects brands and other related intellectual property. First, if a trademark consists of a descriptive element, describing the specifics of the kind of product, such a trademark cannot be registered. Second, certain words, by virtue of them being used commonly to refer to a thing, belong to the public at large for use and cannot be owned by a private entity. These trademarks are called “Publici Juris Trademarks”.

In the case of ‘Parle Gluco’, because of the grounds mentioned above, Gluco could not be registered as a trademark. Gluco for Glucose biscuits is descriptive of the specifics of the kind of biscuits those were and cannot be used exclusively by one company. For example, in the case of M/s Hindustan Development Corporation Ltd. v. The Deputy Registrar of Trade Marks, the word ‘RASOI’, which is primarily associated with cooking, could not be registered as a trademark for cooking oil. [1]

Further, the term Gluco describing Glucose, a natural substance, is “publici juris”, that is, it belongs to the public at large, for anyone to use, and cannot be owned exclusively by a private entity. Thus, in Parle Gluco, ‘Gluco’ is considered to be the non-distinctive part of the brand name and therefore cannot be registered as a trademark. Similarly, in SBL Ltd v. Himalayan Drug Company, using “Liv” for “Liver” was considered as the non-distinctive part of the mark as it is common practice to use “Liv” for “Liver”, making it “publici juris.” [2]

With the rising popularity and demand for glucose biscuits, many other biscuit companies started selling ‘gluco’ biscuits. There existed unfair competition for Parle as it had created a consumer base for its Gluco biscuits which was now being divided among the many different alternatives, with no distinguishing brand name unique to the glucose biscuits started by Parle. In order to restore its consumer base and ensure brand loyalty, ‘Parle Gluco’, a brand name which could not be registered, was changed to ‘Parle-G’, a registered trademark and a unique product of Parle Products, in a reimaging done by Everest Brand Solutions.

The reimaging helped create a unique identity for the glucose biscuits started by Parle Products and helped restore its popularity amongst its loyal consumers.

By: Ria Mishra

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[1] M/s Hindustan Development Corporation Ltd. v. The Deputy Registrar of Trade Marks, AIR 1955 Cal. 519

[2] SBL Ltd v. Himalayan Drug Company, 1997 (17) PCT 540

Career in IPR for advocates

Jul 20, 2022 | Indian Patents Act 1970, IPR & Business

Intellectual property (IP) refers to creations of the mind, such as inventions, designs, name of products and services, literary and artistic pieces of work, etc. To protect these creations of the mind, law comprises provisions in the form of patents, trademarks, copyrights, and so on. These rights are collectively called Intellectual Property Rights (IPR), where IPR is a kind of legal right provided by the Government for the protection of creations, provided the creations fulfil certain conditions. IP can be protected and registered under different legal frameworks depending on the type of IP.

IPR law is amongst the rare breed of law practices where professionals with varied backgrounds in domains such as engineering, biotechnology, chemical engineering, pharmaceuticals, and so on are fairly successful despite their seemingly unrelated backgrounds. Patent law is a domain of IPR law that requires practicing professionals to have a sound technical and theoretical understanding of science because patents primarily relate to core technologies, inventions and related work. Due to the ability of STEM graduates to understand technical aspects of technologies or technical inventions, most companies prefer them over advocates to handle the tasks of patent searches, drafting/filing/prosecution of patent applications and more.

It is interesting to note that in order to file patent application on behalf of the client in India, it is important for a person to be a registered Indian patent agent. A registered patent agent is a person who is firstly at least a graduate in science, has secondly cleared the Indian patent agent examination and lastly has registered themselves as a registered patent agent. Due to this, a patent agent who may not be an advocate becomes authorised to draft, file, prosecute patent applications on behalf of the clients. A person who is registered as an advocate with the Bar council but not as a patent agent is not authorised by the patent office to act on behalf of any client and draft/file/prosecute their patent application in India. The list of registered patent agents is published on the official website of Indian Patent Office (IPO).

Two terms used most frequently in the industry are “patent attorney” and “patent agent”, and it is therefore of prime importance to understand the difference between the two clearly. A patent agent is someone who possesses at the minimum an undergraduate degree, has cleared the Indian patent agent examination and has registered himself as a registered patent agent with the IPO. The Indian patent agent examination is generally conducted by the IPO once a year. A patent attorney on the other hand is an advocate who practices IP law and may or may not be a patent agent. Further, a patent attorney must be registered with Bar council of India as an advocate. An advocate is not eligible to write the Indian patent agent exam if he is not a graduate of a scientific domain. These limitations for advocates often results in a loss of direction for them regarding what potential opportunities await them if they want to practice IPR and in particular patent law. In this article, we will try to explore the areas of IPR for advocates to practice in.

Patent law

Before a patent application is filed, typically a patent search is performed to assess novelty of the invention. A patent application is published after an expiry of 18 months from the date the patent application is filed, where this date is called the priority date or date of filing. After the application is published, there may be an opposition to the grant of patent and this opposition is called as pre-grant opposition. However, if the opposition is filed within 12 months from grant of a patent, the opposition is called post-grant opposition. Further, if opposition is raised after the elapsing of 12 months from the date of grant of the patent, it is called revocation. An advocate who is not a patent agent can handle such oppositions or revocations before the Controller of Patents or IPAB (Intellectual Property Appellate Boards).

Advocates can also conduct their practice in the following areas:

1. Patent or IP audits at the time of acquisition & merging of companies where there may be a need to check legal status of patents, and docketing of the same for upcoming deadlines, renewal fee calculation, etc.
2. Valuation and commercialisation of patent. Negotiations and drafting of technology transfer-related contracts may also be required to be done by an advocate at the time of such transfer.
3. Docketing of patent cases and coordination with foreign attorneys regarding foreign patents is required by most law firms and this can also be undertaken by advocates.
4. Searches such as freedom-to-operate searches can also be carried out by advocates. Specialized searches such as these are usually performed by patent agents but advocates have a vital role to play in claim interpretation and referring right statues along with case-laws. In fact, several companies require such FTO reports to be signed by advocates.
5. Patent-related disputes like patent infringement or litigation.
6. Portfolio management of innovative companies to look after legal-commercial strategies, planning regarding portfolio creation and management, licensing of technologies, etc.

 Trademark law

The number of trademark applications filed in trademark registry are far more as compared to patents. In fact, the number of disputes, infringement cases and related litigation matters are also very high compared to patents. Due to this, trademark is a very potential area for advocates to specialise in and must be an advocate in State Bar Council but for non-advocates, it is important to be a trademark agent to file and prosecute trademark application and must have to clear and qualify the examination of Trademark Agents Examination However, there is no need for an advocate to be a trademark agent. The scope of work includes:

1. Advising clients on selection of trademark for new products and services
2. Trademark searches to give opinion on strength of the mark
3. Preparing, filing, prosecuting trademark application
4. Handling oppositions, disputes, litigations

The trademark agent/attorney helps in choosing an apt trademark after ensuring compliance with the legal norms and thus reducing the chances of rejection of trademark application. The filing of the application has very specific requirements that can be dealt with by ease by a trademark attorney in India. In case there are any objections to the trademark registration, it is upon the attorney to reply to the objection and provide with an alternative. Trademark attorney also provide important advice about the nuances of trademark infringement.

Copyright Law

Copyright laws are very necessary to protect your original works and determine the ownership of creative output such as written works, music and motion pictures. In problems related to copyright issues and cases, the copyright attorney helps in getting the authority and ownership of original works. The Copyright Attorneys in India help creators of unique work in filing an application that needs to be submitted for copyright registration. They also help in prosecuting and registration of patents, designs meant for industrial sector, trade mark, etc. They not only help in the filing of the application but also its licensing, renewal and carrying out its enforcement.

In case, after filing an application for copyright registration, there are any defects, these defects are communicated to the applicant. Copyright attorney can go through this application and help the applicant to identify the defects and remove them.

Other forms of IPR

Further, for an advocate, all areas for filing, prosecution of applications for registration as well as enforcement are open in case of , design, Geographical Indication (GI), etc.

Conclusion

IPR is a potential area to for advocates to continue their practice. However, it is to be understood clearly that an advocate is not authorised by the Indian Patent office to draft/file/prosecute patent application in India or PCT. Despite this, there are numerous opportunities for advocates in other areas of patents, trademarks, copyrights, GI etc.

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