Exelixis receives favorable ruling in patent litigation with MSN Laboratories

Exelixis announced that in the lawsuit Exelixis v. MSN Laboratories, the U.S. District Court for the District of Delaware ruled in Exelixis’ favor, rejecting MSN’s challenge to the cabozantinib compound patent. The District Court’s decision follows an earlier Stipulation and Order of October 1, 2021, that MSN’s proposed generic cabozantinib product infringes the ‘473 patent. Additionally, the District Court ruled that MSN’s proposed ANDA product does not infringe Exelixis’ N-2 polymorph patent, which expires on October 8, 2030. The District Court’s decision does not address the validity of the ‘776 patent, which was not contested by MSN. As a result of the ruling, Exelixis intends to request that the District Court order that the effective date of any potential U.S. regulatory approval of MSN’s generic product, subject to any appeals or challenges, would be no earlier than August 14, 2026, the expiration date of Exelixis’ ‘473 patent. This ruling does not impact Exelixis’ separate and ongoing suit against MSN, concerning four different Orange Book-listed patents related to cabozantinib. Trial in MSN II is scheduled to begin in October.