IPR decision finding mesalamine method claims obvious affirmed, Salix’s appeal of DC non-infringment holding dismissed

Dr. Falk Pharma GmbH v. Generico, LLC et al., Salix Pharm. v. Mylan Pharm.

Docket 2017-2312 (IPR2016-00297, -01386, -01409); 2017-2636, 2018-1320
June 12, 2019

Brief summary: Board’s IPR obviousness determination affirmed and Salix’s appeal of DC holding of non-infringement dismissed as moot.

Summary: Dr. Falk and exclusive licensee Salix appealed Board IPR obviousness decision and DC holding of non-infringement of US 8,865,688 directed to “[a] method for maintaining the remission of ulcerative colitis” using a “granulated mesalamine formulation”, administered without food or antacids, where “remission is defined as a” Sutherland Disease Activity Index1 (DAI) “score of 0 or 1”, and “85% to 90% of the mesalamine reaches the terminal ileum and colon.” The FC panel opinion points out that Salix (Valeant) holds NDA No. 22-301 (for the mesalamine product Apriso for which the ‘688 patent is solely listed on the OB). Mylan submitted ANDA 20-7271 including a Paragraph IV notice letter alleging invalidity and/or no infringement, and Salix/Dr. Falk sued. Mylan et al. then filed the IPR challenges. The Board and DC decisions were consolidated into this appeal. The obviousness challenged was based on a combination of five references including two Salix press releases regarding clinical trials, journal articles regarding controlled release delivery systems and the gastrointestinal tract and the use of pellets as a vehicle for treating ulcerative colitis (including “independent of food”). The Board construed the DAI score “consistent with the specification’s express definition” thereof as “the sum of four subscores”, found “all claim limitations…were satisfied by the prior art and that there was a motivation to combine the asserted references with a reasonable expectation of success” (e.g., Salix press release “announces a successful outcome of a Phase III trial to evaluate the safety and efficacy of the same or similar granulated mesalamine formulation for the same disease” with “no indication” that it “had to be administered with food”, “comparative studies are not necessary…especially when the claims at issue do not recite an efficacy requirement related to the effect of food”). In a Markman hearing, the DC construed “the 85% to 90% limitation” as having “its plain and ordinary meaning”, which the DC concluded Salix had not been demonstrated “by a preponderance of the evidence” would be infringed by Mylan’s proposed product. The FC panel first explained its agreement with the Board’s claim construction under both the broadest reasonable interpretation (BRI) and the Phillips standard (FC 2005, for IPRs filed on or after Nov. 13, 2018 (FN6); In re Schwemberger, FC 2010 (patentee as lexicographer); “[W]hile Dr. Falk is correct that the specification at times references a special definition of remission, the claim language does not claim that special definition.”) The FC panel also found that “the Board did not change theories…to show obviousness of the without food limitation” (SAS, FC 2016; e.g., it correctly focused on asking “whether a skilled artisan would have ‘ha[d] a motivation to combine accompanied by a reasonable expectation of success of achieving what is claimed in the patent-at-issue’” and “correctly found Dr. Falk’s evidence as falling outside the scope of the claims” (Int. Bio-Sys., FC 2016)). The FC panel therefore affirmed the Board’s obviousness determination as dismissed Salix’s appeal as moot.

This entry was posted in Claim Construction, Generics / ANDA, Inter Parties Review (IPR), IPR, Obviousness. Bookmark the permalink.

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