Johnson & Johnson and Momenta Pharmaceuticals have filed a lawsuit against NATCO and its marketing partner Mylan Pharmaceuticals & others alleging infringement of two old Patents associated with 20mg per ml and 40mg per ml Glatiramer Acetate Injection.
The J&J drug in question is Momenta’s Glatopa, or glatiramer acetate injection, a generic formulation of Teva Pharmaceutical’s multiple sclerosis medicine Copaxone. Under a partnership with Sandoz, the Momenta won an approval as the first generic to Teva’s blockbuster multiple sclerosis medicine back in April 2015.
This lawsuit has been filed in the Pennsylvania Federal Court. NATCO and its marketing partner, Mylan believe this is a meritless suit for a product that has been in the market for more than 5 years. Mylan and NATCO will strongly defend against this suit.
Mylan officially launched 20 and 40 mg generics in the U.S. in October 2017 after approval. In the new lawsuit, J&J and Momenta allege Mylan and its Indian manufacturing partners Natco Pharma and Gland Pharma violated two patents related to Glatopa’s production. Momenta is the exclusive holder of both patents in question, dubbed ‘489 and ‘374 in the complaint. It's not immediately clear why Momenta is bringing the lawsuit years after Mylan's approval.
