On May 26, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported that the United States District Court for the District of Delaware ("Court") has granted Clarus Therapeutics, Inc.’s ("Clarus") motion for Summary Judgment, finding the asserted claims of Lipocine’s U.S. patents 9,034,858; 9,205,057; 9,480,690; and 9,757,390 invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112. Clarus still has remaining claims before the Court (Press release, Lipocine, MAY 26, 2021, View Source [SID1234580617]).

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"We are extremely disappointed in the court’s decision and believe the ruling is contrary to the established law of Section 112. We continue to believe in the strength and validity of our intellectual property," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine. "We are in the process of evaluating the court’s decision and determining next steps."