Takeaway: To establish inherent disclosure of a limitation in a prior art reference, a petitioner must show that the limitation is necessarily present in the prior art.

In its Final Written Decision, the Board found that Petitioner had not established by a preponderance of the evidence that any challenged claim of the ’216 patent is unpatentable, and therefore dismissed the contingent Motion to Amend. The Board also denied the parties’ Motions to Exclude Evidence, granted Patent Owner’s Motion for Entry of Protective Order, granted-in-art Patent Owner’s First Motion to Seal, and granted Patent Owner’s Second Motion to Seal.

The ’216 patent relates to “oral controlled release pharmaceutical formulations comprising oxymorphone, and methods of using the same for sustained pain relief.” The Board had instituted two grounds of unpatentability: obviousness of claims 1, 2, 6, and 12 over Maloney and obviousness of claims 1, 2, 6, 12-14, 17, 21-43, 45-51, and 54-71 over Oshlack and the Handbook of Dissolution Testing.

The Board first addressed claim construction, giving the claims terms their broadest reasonable construction in light of the specification. Petitioner argued that the term “controlled release” is defined by the specification as “encompassing formulations that ‘release no more than about 80% of their active pharmaceutical ingredients within 60 minutes’ under the claimed dissolution conditions.” Petitioner also argued that the term “about” encompasses “‘at least the standard statistical error’ for dissolution testing values.” The Board agreed that Petitioner’s proposed constructions were the broadest reasonable interpretations.

The Board next analyzed the asserted prior art. With respect to the Maloney reference, Petitioner asserted that the reference inherently discloses the recited “multiple peak plasma levels of oxymorphone.” Patent Owner, citing to a New Drug Application submitted to the U.S. Food and Drug Administration, argued that the multiple peaks are not inherent to all oxymorphone compositions. The Board found that Petitioner did not establish that the multiple peaks limitation was inherently disclosed, pointing to Patent Owner’s “evidence indicating that certain oxymorphone formulations … do not present more than one peak of oxymorphone plasma concentration.” Even Petitioner’s expert acknowledged at deposition, with respect to published studies concerning multiple peaks, that “[s]ometimes they’re there, and sometimes they weren’t there.” Thus, the Board found that Petitioner did not establish unpatentability of claims 1, 2, 6, and 12 over Maloney under the first asserted ground.

With respect to the alleged ground based on Oshlack in view of the Handbook, the parties again disputed the multiple peaks limitation. As discussed above, the Board found that Petitioner did not establish that the multiple peaks was inherent to all oxymorphone compositions. Patent Owner argued that the combination of Oshlack and the Handbook does not disclose the recited dissolution profile, “i.e., recited percentage by weight ranges of oxymorphone released over time in an ‘in vitro dissolution test comprising USP Paddle Method at 50 rpm in 500 ml media having a pH of 1.2 to 6.8 at 37°C.’” The Board found that Petitioner’s position “relies, at least in part, on an inherency position to make its case,” and that Petitioner did not provide adequate evidence in support of its position. The Board found that Petitioner did not establish unpatentability of claims 1, 13, 21, 31, 38, 49, 55, and 66 over Oshlack and the Handbook under the second asserted ground.

The Board, therefore, dismissed Patent Owner’s contingent Motion to Amend because Petitioner did not establish that the challenged claims are unpatentable.

With respect to the parties’ Motions to Exclude Evidence, the Board did not rely upon the evidence subject to the Motions to Exclude, and therefore, dismissed them as moot.

Turning to Patent Owner’s Motions to Seal and Motion for Entry of Protective Order, the Board first granted the unopposed Motion for Entry of Protective Order. Patent Owner sought to seal its Patent Owner Response, two expert declarations, and several exhibits. The Board noted the “strong public policy in favor of making information filed in an inter partes review open to the public, especially because the proceeding determines the patentability of claims in an issued patent and, therefore, affects the rights of the public.” The standard for granting a motion to seal is “for good cause,” and the party requesting to seal “must explain why the information sought to be sealed constitutes confidential information.” The Board was persuaded that good cause exists for sealing some of the documents, but denied the Motions as to portions that the Board relied upon in its Decision.

Amneal Pharmaceuticals, LLC v. Endo Pharmaceuticals Inc., IPR2014-00360

Paper 103: Final Written Decision

Dated: July 22, 2015

Patent: 8,329,216 B2

Before: Toni R. Scheiner, Francisco C. Prats, and Jacqueline Wright Bonilla

Written by: Bonilla

Related Proceedings: Endo Pharms. Inc. v. Amneal Pharms.LLC, C.A. No. 12-CIV-8115 (S.D.N.Y.); In re Kao, 639 F.3d 1057 (Fed. Cir. 2011); IPR2014-00361; IPR2014-00160; IPR2014-01365