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LPCN: Advisory Committee Required and USPTO Issues Motion for Tlando

By John Vandermosten, CFA


On September 20, Lipocine, Inc. (NASDAQ: LPCN) announced that an Advisory Committee (AdCom) will be convened to review Tlando following the August submission of data in the Dosing Validation and the Dosing Flexibility studies which evaluated the efficacy and tolerability of Tlando. The Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) will review the submission.  While the date of the AdCom has not yet been scheduled, it will conform to the PDUFA goal date of February 8, 2018.  

While there is additional cost and effort required to present before an AdCom, we believe that this is a positive as the FDA would not go through the effort and expense required to schedule one unless there was a degree of confidence Tlando has met the requirements for approval.  

Shortly following Lipocine’s announcement of an AdCom, the Patent Trial and Appeal Board (PTAB) issued a motions decision in the interference case between Lipocine and Clarus.  The PTAB denied both parties’ initial priority dates which had the result of switching senior party status from Lipocine to Clarus.  Following the decision, Lipocine has an accorded priority date of May 15, 2015 and Clarus has a date of April 26, 2014.  Despite the apparent shift in balance to Clarus, the important factor for Lipocine was that the original 2006 priority date for Clarus was thrown out.  

Prior to the PTAB motions decision, Clarus was using a patent filed in 2006 and Lipocine was using evidence from 2002 and 2003 to support their claim.  The PTAB responded that there was no embodiment of all the elements asserted in the earlier dates that both Lipocine and Clarus were citing.  As a result, the PTAB did not allow either of their earlier asserted priority dates.

Lipocine has patents issued in 2009 (8,865,695 and 8,778,922) which contain the specific formulation that is in dispute.  Lipocine believes that the strength of these 2009 filed patents are sufficient to support their claim of priority and easily invalidate Clarus’ 8,828,428 (‘428) patent.  Through either ex parte reexamination or inter partes review, which are the two primary administrative procedures available to challenge a patent, Lipocine expects to obtain a ruling in their favor based on the strength in their 2009 filings.

Patent Litigation Timeline

➢ May 15, 2015 Lipocine filed a request for interference using their owned patent application against Clarus’ patent
➢ November 2, 2015, Clarus filed a complaint against Lipocine alleging that Tlando NDA filing will infringe upon the Clarus’ patent
➢ December 4, 2015, PTAB declared interference between Clarus’ patent and Lipocine's application
➢ January 5, 2016 Lipocine filed a motion to dismiss the complaint with the court
➢ October 6, 2016 the court dismissed the complaint as there was no actionable infringement since Tlando had not received FDA approval
➢ September 20, 2017 PTAB issued motions decision
➢ October 4, 2017 conference call with PTAB, Clarus and Lipocine to discuss the next steps and priority schedule

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