In a previous post, we reported that in Proppant Express Investments v. Oren Techs., a panel of the PTAB held that 35 U.S.C. § 315(c) allows only joinder of other parties to an IPR, and not same-party joinder of new patentability issues.  See IPR2018-00914, Paper 21 at 4-6.

In a recent order, the PTAB’s new Precedential Opinion Panel decided to review the Proppant holding on issue joinder, which appeared to differ from earlier rulings in similar cases.  The Panel expressly noted that “Board decisions conflict on the proper interpretation of 35 U.S.C. § 315(c)”:

Compare, e.g., Target Corp. v. Destination Maternity Corp., Case IPR2014-00508 (Paper 28) (Feb. 12, 2015) (concluding that 35 U.S.C. § 315(c) permits a petitioner to be joined to a proceeding in which it is already a party), with SkyHawke Techs., LLC v. L&H Concepts, LLC, Case IPR2014-01485 (Paper 13) (Mar. 20, 2015) (reaching opposite conclusion).
IPR2018-00914, Paper 24 at 2.  The Panel will include Andrei Iancu, Director of the US Patent and Trademark Office, Drew Hirshfeld, Commissioner of Patents, and Scott Boalick, Acting Chief Judge of the PTAB.
The Panel will address three questions related to issue joinder:
  1. Under 35 U.S.C. § 315(c) may a petitioner be joined to a proceeding in which it is already a party?
  2. Does 35 U.S.C. § 315(c) permit joinder of new issues into an existing proceeding?
  3. Does the existence of a time bar under 35 U.S.C. § 315(b), or any other relevant facts, have any impact on the first two questions?

IPR2018-00914, Paper 24 at 2.  The parties and any amicus curiae may submit briefs, of no more than 15 pages, no later than December 28, 2018.  Id. at 3.  The parties may then file response briefs, of no more than 10 pages, no later than January 14, 2019.  Id.

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