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

IPR petitioners Proppant Express Investments, LLC and Proppant Express Solutions, LLC (collectively, “PropX”) have a pending instituted inter partes review (IPR) on certain claims of U.S. Patent No. 9,511,929 (“the ’929 patent”).  Unfortunately for PropX, it mistakenly grouped its arguments against one of the dependent claims—claim 4—into the wrong ground, which led the Patent Trial and Appeal Board (the “Board”) to deny institution of IPR of that claim, due to inadequate support.  IPR2017-02103, Paper 19 at 32, 34.  After institution, PropX sought to amend the petition to move claim 4 into the proper ground.  The Board denied PropX’s request because PropX was not diligent: despite Patent Owner’s (“Oren”) Preliminary Response pointing out PropX’s mistake, PropX failed to notice the mistake until after institution.  IPR2017-02103, Paper 22.

Continue Reading PTAB Holds that 35 U.S.C. § 315(c) Prevents Same-Party Joinder of Issues to An Instituted IPR

As we have reported in several recent posts, the PTAB often rigorously evaluates public accessibility when considering non-patent prior art.  Disputes over accessibility are often pivotal because insufficient evidence of accessibility can disqualify a reference as a “printed publication” under § 102.  The Federal Circuit recently expanded on the applicable standard for online publications in a case rooted in computer technology, but the decision provides relevant insights for life science practitioners as well. Continue Reading Federal Circuit Upholds PTAB Decision Finding Library Website’s Indexing and Search Capabilities Insufficient to Establish Public Accessibility

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 8, 2018, the Patent Trial and Appeal Board (“the Board”) issued five decisions in Tech Center 1600.  One decision denied institution of post-grant review (“PGR”), and the other four—which were related inter partes review (“IPR”) petitions—instituted the IPR petitions and granted the requests for joinder.  The decisions are summarized below. Continue Reading PTAB Tech Center 1600 Round-Up: Week of October 8-12, 2018

This morning, the US Patent and Trademark Office issued its final rule implementing district court-style claim construction at the PTAB, replacing the “broadest reasonable interpretation” standard.  The official text of the rule will publish in the Federal Register on October 11, 2018, in final form.  The new rule is not retroactive and will apply to petitions filed on or after the effective date of the final rule, which is Nov. 13, 2018 (i.e., the first federal business day after 30 days from publication). [Note: 30 days from an October 11, 2018 publication falls on Saturday, November 10, 2018, but the PTO’s press release [PDF] reports the effective date as November 13, 2018.]

Continue Reading USPTO Issues Claim Construction Final Rule for Patent Office Trials – In with Phillips, Out with BRI