Origiin IP sees that patent infringements are inevitable in pharmaceutical sector. There have been a slew of such infringements, of which the notable ones include Teva versus Natco and Glenmark versus Symed Labs.
Patent is an exclusive right granted to the inventors by the government for novel, inventive and industrially useful inventions. Having a patent gives the right to the patent owner to prevent third parties from manufacture, sale and importing the patented product in the area where patent is granted. Violation of any of these rights of patent owner is a patent infringement, stated Bindu Sharma, Patent Attorney and chief executive officer, Origiin IP Solutions.
Referring to the latest infringement in India she said, “Last month, Sun Pharma settled patent litigation with Celgene Corp, a subsidiary of Bristol Myers Squibb. This litigation was regarding the submission of an Abbreviated New Drug Application (ANDA) for a generic version of Revlimid or 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 maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant. It is approved in the US to treat patients with mantle cell lymphoma (MCL) whose disease who have relapsed or progressed after two prior therapies, one of which included bortezomib. Lenalidomide is on the WHO’s List of Essential Medicines.
All approved products, both innovator and generic are listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations or the Orange Book. ANDA goes through 4 levels of audit where paragraph IV certification is critical. The applicant needs to establish that the generic drug for which ANDA is filed does not infringe any existing patent rights of the third parties, she said.
To understand patent infringement, it is important to know the rights of a patent holder. In a given jurisdiction where the patent is granted, a patent holder has the right to prevent third parties from making, using, selling, and even importing the patented product. Violation of any of the rights of the patent holder or patentee is an infringement, she added.
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 for royalty payment, noted Sharma.
In this case, Celgene agreed to grant a license to Sun Pharma, for a specific sum to be paid by the latter as royalty, to manufacture and sell the drug, subject to the US FDA approval. By providing a license, Celgene would allow Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US from January 31, 2026, said Deepa ES, Senior patent analyst, Origiin IP.
Before this case between Celgene and Sun Pharma, other Indian companies like Cipla, Natco, Cadila Healthcare, Dr Reddy’s and the US-based Alvogen had settled patent litigations for Revlimid with Celgene.
In fact, Celgene granted a patent license to all these companies, required to manufacture and sell an unlimited quantity of generic lenalidomide in the US beginning after January 31, 2026. However, this would depend on the company’s ability to market lenalidomide in the US after obtaining approval of an ANDA, said Deepa.