Exelixis ‘pleased with the court’s ruling’ in trial with MSN Laboratories

Exelixis announced that in the lawsuit Exelixis, Inc. vs. MSN Laboratories Private Limited et al., Civil Action No. 22-00228, the U.S. District Court for the District of Delaware ruled in Exelixis’ favor, rejecting MSN’s challenge to three Orange Book-listed patents related to cabozantinib, including U.S. Patents No. 11,091,439; 11,091,440; and 11,098,015. The District Court’s decision in Exelixis’ favor on the validity of these patents follows an earlier Stipulation entered on June 21, 2022, that MSN’s proposed generic cabozantinib product infringes the ‘439, ‘440, and ‘015 patents, which expire on January 15, 2030. Additionally, the court ruled that Exelixis’ pharmaceutical composition patent, U.S. 11,298,349, is not invalid and not infringed by MSN’s proposed ANDA product. “We are pleased with the court’s ruling, which upheld the validity of Exelixis’ ‘439, ‘440, ‘015 and ‘349 patents. We remain confident in the strength of the current and emerging cabozantinib patent estate. We will continue to pursue every available legal action to defend our intellectual property rights, which are crucial to safeguarding the scientific innovation that drives our mission to help cancer patients recover stronger and live longer,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. “MSN is seeking approval for a product containing a different polymorphic form of cabozantinib (l)-malate than the form contained in Exelixis’ breakthrough CABOMETYX product. To Exelixis’ knowledge, the U.S. Food and Drug Administration has not yet granted tentative approval of that potential product. If the FDA ultimately approves MSN’s ANDA, given today’s decision, the earliest that MSN may be permitted to commercially launch its proposed generic product in the U.S. is January 15, 2030, subject to any appeals or additional regulatory exclusivity,” the company added.