Recently in June 2021, Sun Pharmaceutical Industries Ltd, Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra, settled a patent litigation with Celgene Corp, a subsidiary of Bristol Myers Squibb. This litigation was regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Revlimid (lenalidomide capsules) in the US by Sun Pharma.
Revlimid (lenalidomide) in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma and is a single agent which is also indicated as a maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant. It is approved in the U.S. for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Lenalidomide is on the World Health Organization’s List of Essential Medicines.
Abbreviated New Drug Application (ANDA) is an application that is filed at FDA to get approval for generic drug where the innovator drug is already approved. Typically, generic drug is equivalent to an innovator drug product in terms of dosage, form, strength, route of administration, quality, performance, characteristics and intended use. All approved products, both innovator and generic are listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
ANDA application passes through 4 levels of certifications where paragraph IV certification is very critical. It requires applicant to establish that the generic drug for which ANDA is filed does not infringe any existing patent rights of the third parties. To understand patent infringement, it is important to know rights of a patent holder. In a given jurisdiction where patent is granted, a patent holder has right to prevent third parties from making, using, selling, offering for sale and even importing the patented product. Violation of any of the rights of the patent holder or patentee is called as infringement.
In this case, Celgene had a patent on Revlimid and upon ANDA filing by Sun Pharma, Celgene filed a lawsuit for patent infringement against Sun Pharma. Licensing is one of the popular ways, the companies adopt to settle the patent litigation in exchange of royalty payment. The word “license” means “permission”, which may be granted by the patent holder on certain terms and condition for a specific period of time by executing an exclusive or non-exclusive license agreement. In this case, Celgene agreed to grant license to Sun Pharma, for a specific amount of money to be paid by Sun Pharma as royalty, to manufacture and sell the drug, subject to the U.S. Food and Drug Administration approval. By providing license, Celgene would allow Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the U.S. from Jan. 31, 2026.
Before this case between Celgene and Sun Pharma, other Indian companies, Cipla Ltd., Natco Pharma Ltd., Cadila Healthcare Limited and Dr. Reddy’s Laboratories Ltd. and the U.S.-based Alvogen had settled patent litigations for Revlimid with Celgene. Celgene granted patent license to all these companies, required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning after January 31, 2026. However, these company’s ability to market lenalidomide in the U.S. will be contingent on its obtaining approval of an Abbreviated New Drug Application.
By Bindu Sharma and Deepa ES
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