In the chemical and biological arts, it is common for patent challengers to allege obviousness based upon prior art disclosures of ranges combined with “routine optimization” by one skilled in the art.  In E.I. du Pont de Nemours & Co. v. Synvina C.V., No. 17-1977 (Fed. Cir. Sept. 17, 2018), the Federal Circuit reversed the PTAB’s (“Board”) final written decision upholding Synvina’s U.S. Patent No. 8,865,921 (“’921 patent”) as non-obvious, in response to du Pont’s inter partes review (“IPR”) challenge on such grounds.  In particular, in E.I. du Pont, the Court found that the patentee failed to demonstrate that 1) the claimed range produced a new and unexpected result, different in kind and not merely in degree from the prior art, 2) the optimized parameter was not recognized as a result-effective variable, 3) the disclosure of broad ranges did not invite more than routine optimization, or 4) that the prior art taught away from the range.

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During the week of October 15-19, the Board issued one decision in Technology Center 1600, instituting inter partes review. The decision is as follows:

Mylan Pharmaceuticals Inc. v. Bristol-Meyers Squibb Co., No. IPR2018-00892 (Decision Entered October 15, 2018). In ground 1 of the Petition, Mylan Pharmaceuticals Inc. (“Petitioner”) challenged claims 1–38 of U.S. Patent No. 9,326,945 (“the ’945 patent”) as obvious over the references of Carreiro, Wei, and the FDA Dissolution Guidance. IPR2018-00892, Paper 24 at 5. In ground 2, Petitioner challenged claims 1–38 as obvious over the references of Carreiro, Wei, Rudnic, and the FDA Dissolution Guidance. Id. In ground 3, Petitioner challenged claims 1–38 as obvious over the references of Pinto, Wei, and the FDA Dissolution Guidance. Id. at 6. In ground 4, Petitioner challenged claims 1–38 as obvious over the references of Pinto, Wei, Rudnic, and the FDA Dissolution Guidance. Id. Bristol-Meyers Squibb Company and Pfizer, Inc. (“Patent Owner”) filed a Preliminary Response. Id. at 2.
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During the week of September 17-21, 2018, the Board issued two decisions in Technology Center 1600, one instituting inter partes review and one final written decision finding the challenged claims had not been proven unpatentable.  The decisions are as follows:
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During the week of August 6, the Board issued nine decisions in Technology Center 1600, two denying institution of IPR, two Final Written Decisions finding the challenged claims not unpatentable, two Final Written Decisions finding the challenged claims unpatentable, and two terminating inter partes review (“IPR”) proceedings, in whole or in part.  The decisions follow.

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We wrote previously regarding Incyte Corp. v. Concert Pharms., Inc., IPR2017-01256, in which the Board reached different conclusions regarding the availability of two pieces of prior art, over a dissent by Judge Fitzpatrick.  Regarding art referred to as the Concert Backgrounder, the Board’s earlier ruling found public accessibility where the Backgrounder was 1) identified on a cached WebCite page, 2) cited in an International Search Report for a patent application, and 3) used in a law review article that cited the WebCite page.  In a new decision in the same case, the Board ruled on Petitioner’s motion for additional discovery regarding public availability of the Concert Backgrounder, granting the discovery in part.  Interestingly, the Board declined to allow discovery that it viewed as changing the Petitioner’s theory of public availability of the art.
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