Celgene has filed a lawsuit against Indian drugs manufacturer Dr Reddy’s Laboratories (DRL) to halt its plan to produce and market generic versions of Pomalyst (pomalidomide)—Celgene’s multiple myeloma treatment.
The US pharmaceutical company filed a complaint with the United States District Court of New Jersey on 8 February, challenging DRL’s abbreviated new drug application (ANDA) with the FDA to manufacture Pomalyst generics.
The Indian company plans to create 1mg, 2mg, 3mg and 4mg generics for import to the US. Celgene claims that the company plans to market its drugs in the US prior to the expiration of key Pomalyst patents, specifically US numbers 10,093,647, 10,093,648, and 10,093,649.
All three patents were issued on October 9, 2018, by the United States Patent and Trademark Office (USPTO) and are set to expire in 2037.
‘Invalid or unenforceable’ notice
In DRL’s ANDA to the FDA, it claimed that several other Pomalyst-related patents (US numbers 8,198,262, 8,673,939, 8,735,428, 8,828,427, 9,993,467, and 10,555,939) were either invalid, unenforceable, or will not be infringed by its plan to manufacture generics.
DRL restated these claims towards all but one of the patents in a letter sent to Celgene’s headquarters “no earlier than May 31, 2019” , according to the filing.
A second notice was sent making the same claims for the remaining patent (‘939), “no earlier than May 4, 2020.
Celgene’s case states that DRL’s ANDA letter had been pending with the FDA since at least May 31, 2019, the date that DRL sent the first letter of notice to Celgene and that there is justiciable controversy between whether DRL infringes on the ‘647, ‘648 and ‘649 patent.
Celegne, which merged with fellow US pharma giant Bristol-Myers Squibb in 2019, specialises in developing treatments for severe and life-threatening conditions.
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Dr. Reddy’s Laboratories, ANDA, FDA, Celgene