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Novartis AG v. Torrent Pharmaceuticals Ltd.

No Nexus to Objective Indicia Where No Persuasive Link Between Product’s Success and Innovative Patent Features

Novartis AG v. Torrent Pharmaceuticals Ltd., 2017 U.S. App. LEXIS 6245 (Fed. Cir. Apr. 12, 2017) (Taranto, CHEN, Stoll) (PTAB) (3 of 5 stars)

Fed Cir affirms IPR determination of unpatentability for both original claims and proposed substitutes. Novartis’s patent related to a solid pharmaceutical composition used in treating multiple sclerosis. There was no due process/APA error in the Board’s partial reliance on a reference (“Sakai”) as supporting motivation to combine. Though the Board’s Institution Decision had declined to institute on anticipation/obviousness over Sakai, both the petition and the conduct of the proceeding indicated that Sakai was still in play, at least to support motivation to combine other references. The opinion notes that Novartis elected not to move to specifically exclude Sakai, citing Genzyme Therapeutic Products, 825 F.3d 1360 (Fed. Cir. 2016). Slip op. at 15 n.2. The Board also did not err in finding Novartis’s claims obvious. The opinion rejects Novartis’s argument that the Board failed to take into account the potential negatives surrounding the proposed combination. Medichem, 437 F.3d 1157 (Fed. Cir. 2006), instructs tribunals to take into account that there might be “conflicting” teachings as to potential combinations; the opinion holds that the Board properly analyzed the record. Medichem does not impose a requirement to “expressly discuss each and every negative and positive piece of evidence lurking in the record.” Slip op. at 20.

The opinion also discusses Novartis’s tender on objective indicia of nonobviousness. As to unexpected results, the Board did not err in finding that Novartis had failed to substantiate this argument, and declines to take up arguments Novartis was raising for the first time on appeal. As to nexus, the Board did not err in rejecting Novartis’s argument that the commercial success, industry praise, and long-felt need evidence relating to its Gilenya product demonstrated nonobviousness. While Gilenya was the first FDA-approved, commercially available solid multiple sclerosis composition, such compositions were already known in the field prior to Gilenya’s release, so the mere fact that Gilenya was first to market did not demonstrate nonobviousness. Per Asyst Technologies, 544 F.3d 1310 (Fed. Cir. 2008), it is appropriate to find no nexus where the evidence indicates that the commercial success was not “attributable” to the claimed advantages of the patent.

KEYWORDS: ADMINISTRATIVE PROCEDURE ACT; DUE PROCESS; OBJECTIVE INDICIA; NEXUS; OBVIOUSNESS (YES)