Exelixis Inc.
08/31/2026 | Press release | Distributed by Public on 08/31/2026 14:18
Material Event (Form 8-K)
Item 8.01. Other Events.
On August 31, 2026, Exelixis, inc. (Exelixis) announced that the U.S. Court of Appeals for the Federal Circuit (Court of Appeals) issued a decision in Exelixis, Inc. v. MSN Laboratories Private Limited et al., Appeal No. 25-1236, affirming the judgment of the U.S. District Court for the District of Delaware that U.S. Patent Nos. 11,091,439, 11,091,440 and 11,098,015 are not invalid.
The Court of Appeals also dismissed as moot MSN's appeal relating to the validity of U.S. Patent No. 11,298,349, which expires on February 10, 2032, and vacated the portion of the district court's decision addressing that issue.
Based on the Court of Appeals' opinion, the effective date of any final approval by the U.S. Food and Drug Administration of MSN's ANDA shall not be a date earlier than January 15, 2030, the expiration date of each of U.S. Patents No. 11,091,439, 11,091,440 and 11,098,015, subject to any further appellate proceedings, applicable regulatory exclusivity, and the outcome of separate litigation involving U.S. Patent No. 12,128,039, which expires in February 2032 and for which trial is currently scheduled to begin in November 2026.
This Current Report on Form 8-K contains forward-looking statements, including, without limitation, statements related to the timing of any commercial launch by MSN of its proposed generic product in the U.S., the outcome of pending litigation, and applicable regulatory exclusivity. 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, including the factors described under the caption "Risk Factors" in Exelixis' most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis' other filings with the Securities and Exchange Commission. Exelixis undertakes no obligation to update these forward-looking statements except as required by law.
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