Mumbai: Cipla Limited and Celgene Corporation Settlement

Cipla Limited has recently announced the settlement of its litigation with Celgene Corporation, a wholly-owned subsidiary of Bristol Myers Squibb, relating to patents for REVLIMID (lenalidomide).

As part of the settlement, the Parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin Cipla from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement, as described below.

In settlement of all outstanding claims in the litigation, Celgene has agreed to provide Cipla with a license to Celgene's patents required to manufacture and sell certain volume-limited amounts of generic lenalidomide in the United States beginning on a confidential date that is some time after March 2022. For each consecutive twelve-month period (or part thereof) following the volume-limited entry date until January 31, 2026, the volume of generic lenalidomide sold by Cipla cannot exceed certain agreed-upon percentages. The specific volume-limited license date and percentages agreed-upon with Cipla are confidential.

In addition, Celgene has agreed to provide Cipla with a license to Celgene's patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning no earlier than January 31, 2026. Cipla's ability to market lenalidomide in the U.S. will be contingent on its obtaining approval of an Abbreviated New Drug Application.

Mr. Arunesh Verma, CEO, Cipla North America, said, "This is an important step forward for us and is in line with our pursuit of improving access to high-quality life-saving treatments."

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In the U.S., REVLIMID (lenalidomide) in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. REVLIMID as a single agent is also indicated as maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant. REVLIMID is indicated for patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID 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.

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