{"id":53126,"date":"2023-01-20T01:02:09","date_gmt":"2023-01-20T00:02:09","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/exelixis-announces-update-on-patent-litigation-with-msn-laboratories\/"},"modified":"2023-01-20T01:02:09","modified_gmt":"2023-01-20T00:02:09","slug":"exelixis-announces-update-on-patent-litigation-with-msn-laboratories","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/exelixis-announces-update-on-patent-litigation-with-msn-laboratories\/","title":{"rendered":"Exelixis Announces Update on Patent Litigation with MSN Laboratories"},"content":{"rendered":"
\n

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc.<\/a> (Nasdaq: EXEL) today announced that in the lawsuit Exelixis, Inc. (Exelixis) v. MSN Laboratories Private Limited et al.<\/i> (MSN<\/i>), Action No. 19-2017 (Consolidated), the U.S. District Court for the District of Delaware ruled in Exelixis\u2019 favor, rejecting MSN\u2019s challenge to the cabozantinib compound patent (U.S. 7,579,473). The District Court\u2019s decision follows an earlier Stipulation and Order of October 1, 2021, that MSN\u2019s proposed generic cabozantinib product (Abbreviated New Drug Application [ANDA] No. 213878) infringes the \u2019473 patent.\n<\/p>\n

<\/a><\/p>\n

\nAdditionally, the District Court ruled that MSN\u2019s proposed ANDA product does not infringe Exelixis\u2019 N-2 polymorph patent (U.S. 8,877,776), which expires on October 8, 2030. The District Court\u2019s decision does not address the validity of the \u2019776 patent, which was not contested by MSN.\n<\/p>\n

\n\u201cWe are pleased the court upheld the validity of Exelixis\u2019 cabozantinib compound patent,\u201d said Jeffrey Hessekiel, J.D., Executive Vice President, General Counsel and Secretary, Exelixis. \u201cWhile we are disappointed with the court\u2019s decision concerning infringement of the \u2019776 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\u2019 ability to continue to discover, develop and ultimately bring new medicines to patients with difficult-to-treat cancers.\u201d\n<\/p>\n

\nAs 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\u2019s generic product, subject to any appeals or challenges, would be no earlier than August 14, 2026, which is the expiration date of Exelixis\u2019 \u2018473 patent.\n<\/p>\n

\nThis ruling does not impact Exelixis\u2019 separate and ongoing suit against MSN, Exelixis, Inc. vs. MSN Laboratories Private Limited et al.<\/i>, 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 \u2019439, \u2019440, and \u2019015 patents, which expire on January 15, 2030. The remaining \u2019349 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.\n<\/p>\n

\nAbout<\/b> Exelixis<\/b>\n<\/p>\n

\nExelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by bi-coastal centers of discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody drug conjugates and other biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX\u00ae (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com<\/a>, follow @ExelixisInc<\/a> on Twitter, like Exelixis, Inc.<\/a> on Facebook and follow Exelixis<\/a> on LinkedIn.\n<\/p>\n

\nForward-Looking Statements<\/b>\n<\/p>\n

\nThis press release contains forward-looking statements, including, without limitation, statements related to: Exelixis\u2019 confidence in the strength of the cabozantinib patent estate and plans to pursue every available legal action to defend its intellectual property; Exelixis\u2019 ability to continue to discover, develop and ultimately bring new medicines to patients with difficult-to-treat cancers; the anticipated schedule for the trial in MSN II; Exelixis\u2019 plans to request a specific effective date from the District Court for any potential U.S. regulatory approval of MSN\u2019s generic product; and Exelixis\u2019 plans to reinvest in its business to maximize the potential of the company\u2019s pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis\u2019 current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Exelixis\u2019 ability to protect its intellectual property rights; the degree of market acceptance of CABOMETYX in the indications for which it is approved and in the territories where it is approved, and Exelixis\u2019 and its partners\u2019 ability to obtain or maintain coverage and reimbursement for this product; the effectiveness of CABOMETYX in comparison to competing products; market competition, including the potential for competitors to obtain approval for generic versions of CABOMETYX; Exelixis\u2019 and its partners\u2019 ability to maintain and scale adequate sales, marketing, market access and product distribution capabilities for its products or to enter into and maintain agreements with third parties to do so; Exelixis\u2019 and its partners\u2019 continuing compliance with applicable legal and regulatory requirements; Exelixis\u2019 dependence on third-party vendors for the development, manufacture and supply of its products and product candidates; changes in economic and business conditions, including as a result of the COVID-19 pandemic and other global events; and other factors discussed under the caption \u201cRisk Factors\u201d in Exelixis\u2019 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 1, 2022, and in Exelixis\u2019 future filings with the SEC. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.\n<\/p>\n

\nExelixis, the Exelixis logo and CABOMETYX are registered U.S. trademarks of Exelixis.<\/i>\n<\/p>\n

Contacts<\/b> <\/p>\n

\nInvestors:<\/b>
Susan Hubbard<\/i>
EVP, Public Affairs and
\n
Investor Relations<\/i>
Exelixis, Inc.<\/i>
(650) 837-8194<\/i>
shubbard@exelixis.com<\/a><\/i><\/span>\n<\/p>\n

\nMedia:<\/b>
Claire McConnaughey<\/i>
Director, Public Affairs
\n
Exelixis, Inc.<\/i>
(650) 837-7052<\/i>
cmcconn@exelixis.com<\/a><\/i><\/span>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced 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\u2019 favor, rejecting MSN\u2019s challenge to the cabozantinib compound patent (U.S. 7,579,473). The District Court\u2019s decision follows … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-53126","6":"format-standard","7":"category-industry"},"yoast_head":"\nExelixis Announces Update on Patent Litigation with MSN Laboratories - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/exelixis-announces-update-on-patent-litigation-with-msn-laboratories\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Exelixis Announces Update on Patent Litigation with MSN Laboratories - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. 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