A recent PTAB order refused joinder of IPR petitions challenging the same formulation patent at issue in a previously instituted IPR proceeding despite almost complete overlap between the challenged claims and reliance on the exact same prior art. Famy Care Ltd. v. Allergan, Inc., IPR2017-00566, Paper 12, (PTAB July 12, 2017). The patent at issue – U.S. Patent No. 8,648,048 – is listed in the Orange Book for Allergan’s Restasis® (cyclosporine) product.
Petitioner filed a motion for joinder seeking to join its petition with one filed by Mylan Pharmaceuticals (“Mylan”) against the same patent. Petitioner challenged claims 1-23 of the patent based on two pieces of prior art. Mylan challenged all but three of those claims based on the same art. Petitioner, however, relied on two different experts than the one expert Mylan used, and presented “extensive additional arguments and evidence regarding secondary considerations.”
The Patent Owner opposed joinder, arguing that there are significant differences in the petitions. The Patent Owner, however, stated it would agree to joinder under a number of conditions that effectively would have limited Petitioner to Mylan’s arguments and expert. Id. Petitioner refused, stating that its experts include a clinician who would add value and would provide a valuable perspective for the Board on the secondary considerations that Allergan “heavily relies on.” Id.
The Board refused joinder. The Board noted that Petitioner “does not concede to simply taking a ‘silent understudy’ role with respect to Mylan, and instead seeks the opportunity to present additional arguments, briefing and evidence, including two additional expert declarations….” The Board also noted that, to the extent the denial of joinder would result in duplicative proceedings for Allergan, that basis for denial was muted by Allergan’s opposition of the joinder motion.
Based on this order, ANDA petitioners should be aware that attempts to introduce new expert declarants or argument may result in an inability to join a previously instituted IPR proceeding, even when the petitions are directed to the same patent and rely on the same prior art.