During the week of March 18, 2019, the Patent Trial and Appeal Board (“the Board”) issued the following decision in TC 1600 instituting a post-grant review:

Hybrigenics SA v. Forma Therapeutics, Inc., No. PGR2018-00098 (Decision Granting Institution of Post-Grant Review Entered March 20, 2019). The Board instituted a post-grant review (“PGR”) sought by Hybrigenics

During the week of March 4, 2019, the Patent Trial and Appeal Board (“the Board”) issued two decisions in TC 1600.  One decision denied institution of a petition, and one decision was a final decision finding all claims unpatentable.

Luitpold Pharm., Inc. v. Apicore US LLC, IPR2018-01640 (Decision Denying Institution Entered March 6, 2019): In Luitpold,
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During the week of March 11–15, 2019, the Patent Trial and Appeal Board (“Board”) issued 1 IPR non-institution decision, 1 IPR institution decision, and 4 IPR final written decisions (on the same patent) in TC 1600.

Alvogen Pine Brook LLC v. Celgene Corp., IPR2018-01714

The Board denied institution of Alvogen Pine Brook LLC’s (“Alvogen”) petition
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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.

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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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