BMS sues MSN over Pomalyst generic
Bristol Myers Squibb has sued MSN Laboratories over its planned generic of Pomalyst (Pomalidomide), which it claims infringes six patents owned by BMS’ subsidiary Celgene.
In a lawsuit filed at the US District Court for the District of New Jersey Wednesday, April 6, Celgene said that MSN’s submission of an Abbreviated New Drug Application (ANDA) seeking approval to sell a generic of Pomalyst infringes its patents.
MSN wants to market 2mg, 3mg and 4mg doses of pomalidomide capsules, all of which are allegedly protected by Celgene’s IP.
The patents-in-suit are US patent numbers: 8,198,262, 8,673,939, 8,735,428, 8,828,427, 9,993,467, and 10,555,939, the last of which is set to expire in 2030.
Celgene seeks a judgment that MSN’s ANDA infringes the six patents and asks the court for a preliminary and permanent injunction enjoining MSN from making, using or selling the generic before the expiration of the patents.
According to the complaint, MSN sent a notice letter “no earlier than February 18, 2022” alleging that the claims of the six patents were invalid, unenforceable, or would not be infringed by MSN’s ANDA.
It also notified Celgene that it sought approval to market its generic before the expiration of the patents.
Pomalyst is one of Bristol Myers’ flagship products, netting $854 million in revenue from sales in Q4 2021 according to its financial statements, making it the fourth-biggest seller for the quarter.
Last month, MSN Laboratories was also targeted in a lawsuit from Japanese drugmaker Otsuka Pharmaceuticals, which looked to block the company’s planned generic of the Samsca heart medication.
Otsuka has asked the court to rule that MSN has infringed at least one claim of the two patents in suit and issue an order barring the sale or manufacturing of the generic prior to the expiration of the patents.
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