Other than quickly granting Petitioner’s unopposed motion to dismiss with prejudice in Pfizer, Inc. v. Biogen, Inc., No. IPR2018-00231 (Decision Entered June 6, 2018), during the week of June 4, the Patent Trial and Appeal Board issued three decisions in TC 1600, two denying institution of IPR petitions filed by Sandoz, Inc. and Sanofi Pasteur, Inc., respectively, and one final decision finding all challenged claims unpatentable in an IPR filed by Acrux DDS Pty Ltd., joined to an IPR filed by Argentum Pharmaceuticals LLC. The decisions are as follows:
Sandoz Inc. v. AbbVie Biotechnology Ltd., No. IPR2018-00156 (Decision Entered June 5, 2018). In its petition, Sandoz challenged claims 1–30 of U.S. Patent No. 9,187,559 (“the ’559 patent”) as obvious over the combination of a 2003 Humira Package Insert and WO 02/100330 A2 (“WO ’330”) in view of Goodman & Gilman, a 2002 Remicade Package Insert, and Hanauer. AbbVie filed a preliminary response. As a threshold matter, the parties disputed whether the 2003 Humira Package Insert qualified as a “printed publication” under 35 U.S.C. § 102(b). The Board agreed with Sandoz that the Insert qualified as a prior art printed publication because it was publicly accessible on the effective filing date, based on: (i) a Wayback Machine screenshot and supporting affidavit indicating the packaging was on the FDA website as of March 31, 2003, and (ii) testimony of one skilled in the art regarding how one skilled in the art could have located the package insert with reasonable diligence on the FDA website, speaking from his personal experience. The Board acknowledged AbbVie’s argument that evidence of indexing is probative of public accessibility, but concluded that such evidence is not required in all cases when testimony such as that provided by Sandoz’s expert supports availability. On the merits, the claims at issue relate to methods for treating tumor necrosis factor α (TNFα) related disorders, comprising steps of administering a TNFα inhibitor during an “induction or loading phase,” followed by administering the inhibitor during a “maintenance or treatment phase” at a lower dose. The Board denied institution of inter partes review, finding that one skilled in the art, without the benefit of hindsight, would not have had a reason to use a 160 mg induction dose, or to select an intermediate dose as a “baseline” to calculate the induction dose, because the prior art suggested an induction dose 50% lower.
Sanofi Pasteur Inc. v. Pfizer Inc., No. IPR2018-00188 (Decision Entered June 5, 2018). In the petition, Sanofi Pasteur, Inc. and SK Chemicals Co., Ltd. (collectively “Petitioner”) challenged claims 1–45 of U.S. Patent No. 9,492,559 (“the ’559 patent”) on anticipation and obviousness grounds, alleging that Pfizer-099 and Pfizer-302 (two international patent application publications) were prior art to the ’559 patent under 35 U.S.C. § 102(a)(1) or 35 U.S.C. § 102(a)(2). Pfizer Inc. filed a preliminary response. First, Petitioner alleged that the ’559 patent was not entitled to the priority date of its provisional application, U.S. Provisional Patent App. No. 61/929,547 (“the ’547 provisional”) because the ’547 provisional (i) did not describe a polysaccharide to carrier protein ratio range “between 0.4 and 2,” as recited in the sole independent claim of the ’559 patent; (ii) failed to describe sufficient species in the molecular weight range of 1,000–12,500 kDa; and (iii) only exemplified one carrier protein that, according to Petitioner, “cannot represent the entire genus of any carrier proteins.” The Board disagreed, finding that the ’547 provisional provided support for carrier proteins in the claimed ratio range and disclosed species between 1,000 and 12,500 kDa. With respect to carrier proteins, the Board found that the ’547 provisional provided support for the genus because it taught many different carrier proteins. Second, the Board rejected Petitioner’s 35 U.S.C. § 102(a)(2) argument because Pfizer-302 and Pfizer-099 were assigned to Patent Owner prior to the ’559 patent’s filing date and therefore fell within the exception contained in AIA 35 U.S.C. § 102(b)(2)(C) (disqualifying commonly-owned prior art from an invalidity analysis). Accordingly, the Board denied the petition.
Acrux DDS Pty Ltd. v. Kaken Pharmaceutical Co., Ltd., No. IPR2017-00190 (Decision Entered June 6, 2018). In its petition, Acrux DDS Pty Ltd. and Acrux Limited (collectively “Petitioner”) challenged claims 1 and 2 of U.S. Patent No. 7,214,506 (“the ’506 patent”) on six sets of obviousness grounds. Patent Owner filed a preliminary response and the Board instituted inter partes review. After institution, Argentum filed a follow-on petition (IPR2017-01429), and the Board joined the proceedings. The claims at issue relate to a method of treatment wherein a therapeutically effective amount of an antifungal compound of a defined formula (depicted in claims 1 and 2 as “formula I” and “formula II,” respectively) is administered to the nail of a subject having onychomycosis. Formula II (claim 2) is also known as KP-103 or efinaconazole, the active ingredient in Patent Owner’s Jublia® product. As a threshold matter, the Board concluded that Patent Owner demonstrated prior reduction to practice of the invention thereby invalidating one of Petitioner’s references (Ogura) as prior art. Without Ogura as prior art, the Board found that Petitioner’s first three obviousness challenges failed. The remaining three obviousness grounds related to combinations of the “Kaken Abstracts” (three abstracts involving KP-103 or efinaconazole), JP ’639, the ’367 patent, and Hay. The Board agreed with Petitioner that three of the references (JP ’639, the ’367 patent, and Hay) taught the limitation of “a method for treating a subject having onychomycosis wherein the method comprises topically administering to a nail of said subject having onychomycosis a therapeutically effective amount of an antifungal compound” considering the breadth of the definitions of “nail” and “onychomycosis” used in the claims, and that the Kaken Abstracts showed that KP-103 was effective at treating fungal infections. Patent Owner offered evidence of secondary considerations of nonobviousness including unexpected results, commercial success, industry praise, and long-felt, but unmet need for its Jublia® product to support a finding of nonobviousness. The Board concluded that Patent Owner failed to persuasively demonstrate unexpected results, commercial success, industry praise, and long-felt need for Jublia®, but observed that even if it had, the evidence would not outweigh the Petitioner’s strong showing of obviousness in this case. Accordingly, the Board found claims 1 and 2 of the ’506 patent unpatentable.