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Lipocine Announces US Court of Appeals for the Federal Circuit Affirms Decision of USPTO
SALT LAKE CITY, April 9, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine
About this update from Lipocine Inc.
[{"type":"text","content":"SALT LAKE CITY, April 9, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, announced today that the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the Patent Trial and Appeal Board (\"PTAB\") of the United States Patent and Trademark Office (\"USPTO\") under Rule 36. Previously the PTAB granted Lipocine's Priority Motion in the interference case, Patent Interference No. 106,045, between Clarus Therapeutics, Inc. (\"Clarus\") U.S. Patent No. 8,828,428 (the \"Clarus '428 Patent\") and Lipocine Inc. (\"Lipocine\"), U.S. Patent Application No. 14/713,692 (the \"Lipocine '692 Application\"), and entered adverse judgment against Clarus. \n\n \n \n \n \n \n \n\n \n\"We are extremely pleased with the Federal Circuits's affirmation of the judgement of the PTAB canceling all the claims of the Clarus '428 Patent. This decision further validates the strength of Lipocine's patent portfolio,\" said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine.\nAbout LipocineLipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and has a PDUFA date of August 28, 2020. LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of pre-cirrhotic NASH. TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of NASH cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate, with end of phase 2 meeting completed, indicated for the prevention of re...