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US patent board cancels patent at core of Lipocine, Clarus Therapeutics' dispute

Lipocine Inc. said the U.S. Patent and Trademark Office canceled a patent at the core of the company's dispute with Clarus Therapeutics Inc.

Both companies have been in a dispute since at least 2016 when Clarus said Lipocine's male testosterone replacement therapy Tlando, or LPCN 1021, infringed on its patent number 8,828,428. However, the U.S. Patent Trial and Appeal Board made a ruling that effectively cancels Clarus' patent.

Lipocine had sought approval of its product in the U.S., but its application was rejected by the U.S. Food and Drug Administration for lack of certain information, including the reliability of certain data related to the medicine's ability to convert testosterone undecanoate — the active ingredient in Tlando — into testosterone.