Biotechnology mammoth Biocon recently announced that they had struck a deal with Celgene Corporation over patents for Revlimid, a bone marrow cancer treatment. In a regulatory filing, the Bengaluru-based firm stated that it and its subsidiaries had reached a secret settlement agreement with Celgene Corporation, a wholly-owned subsidiary of Bristol Myers Squibb, over patents for Revlimid (lenalidomide). It is interesting to note that the agreement’s specifics were not publicly disclosed.
Celgene Corporation has already filed a lawsuit against Biocon in the District of New Jersey, alleging patent infringement by a possible Biocon generic medicine. Meanwhile, Biocon had applied to the Food and Drug Administration for approval (FDA).
Biocon Limited and its subsidiaries have entered into a confidential settlement agreement with Celgene Corporation (Celgene), a wholly-owned subsidiary of Bristol Myers Squibb (NYSE: BMY), relating to patents for REVLIMID (lenalidomide), according to the filing.
The settlement’s other elements are kept under wraps.
Celgene’s Stand: Celgene will offer Sun Pharma a licence to its patents, allowing it to manufacture and sell a limited quantity of generic lenalidomide capsules in the United States, subject to USFDA approval, starting on an undisclosed date after March 2022. Celgene claimed that Biocon’s Abbreviated New Drug Application (ANDA) for the generic version of Revlimid (lenalidomide capsules) in the US would be approved before the patents Celgene holds expire, resulting in infringement.
The position of Sun Pharma: Sun Pharma will also be able to manufacture and sell an unlimited number of generic lenalidomide capsules in the United States starting January 31, 2026, under the licence terms. Sun Pharma recently announced that they had achieved a deal with Celgene to resolve patent litigation over the submission of an abbreviated new drug application (ANDA) for a generic version of Revlimid in the United States, along with one of its wholly-owned subsidiaries. As a result, any Hatch-Waxman litigation involving the Revlimid patents between Sun Pharma and Celgene would be dismissed. Sun Pharma stated that the arrangement is subject to customary regulatory approvals.
Other Such disputes: Natco Pharma and Dr Reddy’s Laboratories are two firms that have settled patent disputes over the medicine used to treat multiple myeloma in the past.
Case: Bayer Corporation is an American subsidiary of Bayer AG, a German multinational chemical and pharmaceutical corporation. Bayer Corporation developed a medication named Sorafenib Tosylate, which was used to treat advanced stage (stage 4) cancer patients (kidney and liver cancer).
Nexavar (a cancer medicine used to treat HCC or Hepatic Cell Carcinoma of the liver, and RCC, or Rental Cell Carcinoma of the kidney) was the brand name in India. Bayer first sought a patent in the United States, then expanded into the international market by applying for patents in countries such as India and the European Union. On March 3, 2008, Bayer’s medicine Nexavar was granted a patent in India under the rules of the India Patent Act by the Indian Patent Office. The corporation was permitted to import and sell the medicine in India.
Natco Pharma Ltd. is a generic pharmaceutical firm based in India. Bayer Corporation rejected Natco Pharma’s request for a voluntary licence of the medicine, and Natco Pharma then sought a forced licence from the Controller of the patents court. Natco Pharma, the applicant, requested a compulsory licence under section 84 (1) of the Patent (Amendment) Act, 2005. It asserted that the patentee, Bayer Corporation, had not complied with the provisions of section 84 (1).
Compulsory licencing was invoked by the Indian Controller of Patents through the Indian Patents Act, allowing a generic pharma business (Natco Pharma) to produce and sell a generic version of a patent-protected medicine to another company (Bayer Corporation). Nexavar, also known as Sorafenib Tosylate, was an anti-cancer medication developed by Natco Pharma.
This decision sparked debate over whether granting a compulsory licence to Natco Pharma would weaken Intellectual Property Rights protection in India. At the same time, consumers and society argue that granting a compulsory licence to Natco Pharma would benefit the people by allowing pharmaceutical companies to price drugs based on a user’s affordability and preventing the abuse of monopolies granted through patents. Ultimately all pharma and biotech companies want to build a strong portfolio.
Some other strategies for budding biotechnology firms for achieving greater heights include:
- Identify and hang on to your company’s genuine skill or worth.
- Today’s biotech company, more than ever, must be laser-focused on its business model and execute flawlessly.
- Establish a foundation of cooperation and support.
- Share your skills and learn from others to find new ways to overcome typical start-up obstacles. Always plan for the worst-case scenario while striving for the most acceptable potential outcome in your business strategy.
- Put together a solid team.
- In the long run, finding and securing the proper competence for each stage of development will pay dividends. For attaining goals on a short budget, forming a team atmosphere with external contract research and production groups is critical. A great team-focused approach includes clearly defined plans, regular communication, and an open and flexible culture that encourages innovative ideas.
- Take into account the possibility of repayment.
- To be eligible for reimbursement, small biotech companies must constantly collect data to demonstrate that they have positive outcomes to offer.
- Decide on an exit strategy.
Today’s small biotech CEO must always think ahead and plan the actions required to execute the exit strategy. Clinical trial data must be of high quality to be shared with potential partners.
Disclaimer: The present article intends to provide general guidance on the subject, and you can also consult us in your specific case.