On January 19, 2023 Exelixis, Inc. (Nasdaq: EXEL) reported that in the lawsuit Exelixis, Inc. (Exelixis) v. MSN Laboratories Private Limited et al. (MSN), Action No. 19-2017 (Consolidated), the U.S. District Court for the District of Delaware ruled in Exelixis’ favor, rejecting MSN’s challenge to the cabozantinib compound patent (U.S. 7,579,473) (Press release, Exelixis, JAN 19, 2023, View Source [SID1234626382]). The District Court’s decision follows an earlier Stipulation and Order of October 1, 2021, that MSN’s proposed generic cabozantinib product (Abbreviated New Drug Application [ANDA] No. 213878) infringes the ’473 patent.
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Additionally, the District Court ruled that MSN’s proposed ANDA product does not infringe Exelixis’ N-2 polymorph patent (U.S. 8,877,776), 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.
"We are pleased the court upheld the validity of Exelixis’ cabozantinib compound patent," said Jeffrey Hessekiel, J.D., Executive Vice President, General Counsel and Secretary, Exelixis. "While we are disappointed with the court’s decision concerning infringement of the ’776 patent, we remain confident in the strength of the cabozantinib patent estate. We will continue to vigorously defend our intellectual property, safeguarding the scientific innovation that drives Exelixis’ ability to continue to discover, develop and ultimately bring new medicines to patients with difficult-to-treat cancers."
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, which is the expiration date of Exelixis’ ‘473 patent.
This ruling does not impact Exelixis’ separate and ongoing suit against MSN, Exelixis, Inc. vs. MSN Laboratories Private Limited et al., Civil Action No. 22-00228 (Consolidated) (MSN II), concerning four different Orange Book-listed patents related to cabozantinib, including U.S. Patents No. 11,091,439 (crystalline salt forms); 11,091,440 (pharmaceutical compositions); 11,098,015 (methods of treatment); and 11,298,349 (pharmaceutical composition). MSN has already stipulated to infringement of the ’439, ’440, and ’015 patents, which expire on January 15, 2030. The remaining ’349 patent expires on February 10, 2032. Trial in MSN II is scheduled to begin in October 2023 in the U.S. District Court for the District of Delaware.