Institution of Inter Partes Review IPR2015-01117


Takeaway: The crux of a determination that a party is a real party-in-interest is whether that party has control over the proceeding.

In its Decision, the Board found a reasonable likelihood that Petitioner would prevail on its challenges to claims 1-12 of the ’012 Patent, and instituted inter partes review. The ’012 Patent is directed to “treatment of patients with nitrogen retention states, in particular urea cycle disorders (UCDs) . . . [by] administer[ing] compounds that assist in elimination of waste nitrogen from the body.”

The Board began by discussing real parties-in-interest. Petitioner identified Par Pharmaceutical, Inc. (“Par Inc.”) as a real party-in-interest, but did not identify its parent company, Par Pharmaceutical Companies, Inc. (“Par Co.”) as a real party-in-interest. Patent Owner argued that Par Co. should have been identified as such, and that because of this deficiency, the Petition should not receive its filing date and should be barred by the one year limitation based upon a prior civil suit allegation of infringement. Patent Owner argued that Par Co. is a real party-in-interest because it is involved in developing, manufacturing, and distributing generic pharmaceutical products; in a different proceeding, Par Co. pleaded guilty and agreed to perform certain actions on behalf of Petitioner; and that statements were made to the SEC stating that “we” (indicating Petitioner and Par Co.) filed petitions for inter partes review. However, the Board was not persuaded by these arguments because none of them established that Par Co. has control over the proceeding.

The Board then turned to claim construction, stating that the terms are interpreted according to their broadest reasonable interpretation in light of the specification. Petitioner only argued that the term “mean conversion . . . of about 60%” be construed, but the Board determined it was not necessary to construe the term at this time.

Next, the Board discussed the merits of Petitioner’s claims. The Board noted that Patent Owner did not present any countervailing arguments regarding the merits, and the Board found that Petitioner had presented contentions that were adequately supported by evidence. However, the Board declined to institute trial as to the challenges that claims 1-12 are obvious over Brusilow ’91 alone, or in combination with one or more of Simell, Fernandes, the ’647 patent, and Kasumov, under 37 C.F.R. § 42.108(a), on the basis that it would be inefficient to institute trial on these grounds that are somewhat duplicative of the grounds upon which trial was instituted.

Par Pharmaceutical, Inc. v. Horizon Therapeutics, Inc., IPR2015-01117 Paper 13: Decision on Institution of Inter Partes Review Dated: November 4, 2015 Patent 8,642,012 B2 Before: Toni R. Scheiner, Deborah Katz, and Grace Karaffa Obermann Written by: Scheiner Related Proceeding: Hyperion Therapeutics, Inc. v. Par Pharmaceutical, Inc., No. 2:14-cv-384-JRG-RSP (E.D. Tex.); IPR2015-01127