During the week of November 26, 2018, the Patent Trial and Appeal Board (“the Board”) issued seven decisions in TC 1600, one denying institution of inter partes review (“IPR”), one termination decision, and five final written decisions.  Summaries of the decisions follow: Continue Reading PTAB Tech Center 1600 Round-Up: Week of November 26 – 30, 2018

During the week of November 5, 2018, the Board issued one decision granting institution of inter partes review.

Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited, IPR2018-00943 (Decision Granting Institution of IPR November 7, 2018). Petitioner Amneal challenged the patentability of claims 1-13 of United States Patent No. 7,919,499 (“the ᾽499 patent”) on two grounds of anticipation and four grounds of obviousness. IPR2018-00953 at 4. The ᾽499 patent is directed to methods for treating alcohol-dependent patients with a long-acting formulation of naltrexone. Id. at 3. Claim 1 includes a step of administering “a long acting formulation comprising about 310 mg to about 480 mg of naltrexone and a biocompatible polymer” in which “the serum AUC of naltrexone is about three times greater than that achieved by 50 mg/day oral administration.” Id. at 4-5.

Continue Reading PTAB Tech Center 1600 Round-Up: Week of Nov. 5-9

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.

Continue Reading Obviousness of Overlapping Ranges – The Burden-Shifting Framework Applies to Inter Partes Review: E.I. du Pont de Nemours & Co. v. Synvina C.V.

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. Continue Reading PTAB Tech Center 1600 Round-Up: Week of October 15–19

During the week of October 1, 2018, the Board issued seven Final Written Decisions and two institution decisions in Technology Center 1600.  The decisions are summarized as follows: Continue Reading PTAB Tech Center 1600 Round-Up: Week of October 1-5, 2018

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: Continue Reading PTAB Tech Center 1600 Round-Up: Week of September 17-21, 2018

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.

Continue Reading PTAB Tech Center 1600 Round-up: Week of August 6-10, 2018