In Amerigen Pharmaceuticals v. UCB Pharmaceuticals, the Federal Circuit held that a generic Abbreviated New Drug Application (“ANDA”) filer with a Paragraph III certification to an Orange Book-listed patent has standing to appeal decisions from the Patent Trial and Appeal Board (“the Board”). Case No. 17-2529, Doc. 54, January 11, 2019 (the “Decision”). In this case, Amerigen was a Petitioner in inter partes review proceedings involving U.S. Patent No. 6,858,650 (“the ’650 patent”). The Board found the challenged claims not unpatentable, and Amerigen appealed. On appeal, UCB argued that Amerigen lacked standing to appeal because Amerigen had filed a Paragraph III certification with its ANDA. The Federal Circuit disagreed.

Continue Reading ANDA Filers with Paragraph III certifications = standing to appeal Inter Partes Review decisions according to Federal Circuit

During the week of December 17, 2018, the Patent Trial and Appeal Board (“the Board”) issued five decisions in TC 1600.  Those decisions instituted inter partes review (“IPR”) of five petitions, four of which involved related patents.  As detailed below, the Patent Owners did not substantively challenge the petitions at the Preliminary Response stage, but instead opposed institution on procedural grounds—namely, failure to name a real party in interest or duplicative issues under 35 U.S.C. § 325(d).

Merck Sharp & Dohme Corp. v. GlaxoSmithKline Biologicals SA, Nos. IPR2018-01229; IPR2018-01234; IPR2018-01236; and IPR2018-01237 (Decisions Granting Institution Entered December 18, 2018).  Merck Sharp & Dohme Corp. (“Merck”) filed four IPR petitions, Continue Reading PTAB Tech Center 1600 Round-Up: Week of December 17-21, 2018

During the week of December 10, 2018, the Board issued several Final Written Decisions and institution decisions in Technology Center 1600.  The decisions are summarized below: Continue Reading PTAB Tech Center 1600 Round-Up: Week of December 10-14, 2018

Today, the U.S. Patent and Trademark Office announced “revised guidance for subject matter eligibility under 35 U.S.C. § 101,” and “guidance on the application of 35 U.S.C. § 112 to computer-implemented inventions.”  The guidance documents are available in the Federal Register and will take effect on Monday, January 7, 2019. Continue Reading USPTO Announces Revised Guidance for Sections 101 and 112

During the week of December 3, 2018, the Board issued one decision in Technology Center 1600 denying institution of inter partes review:

  • Mylan Pharm. Inc. v. Bayer Intellectual Prop. GmbH, IPR2018-01143 (Decision Denying Institution of Inter Partes Review, December 3, 2018).  Petitioner Mylan challenged the patentability of claims 1-4 of U.S. Patent No. 9,539,218 (the ’218 patent) as obvious over Straub, Kubitza Abstracts, and Forsman.  Patent owner Bayer filed a preliminary response to the petition.  The Board exercised its discretion to deny the petition under 35 U.S.C. § 325(d) and 314(a).  The ’218 patent relates to a method of treating a thromboembolic disorder by a once-daily administration of a “rapid-release tablet” of a direct factor Xa inhibitor, e.g., rivaroxaban.  The Board denied the petition under 35 U.S.C. § 325(d) after finding that substantially the same prior art and arguments were previously presented to the Office and the Board in an ex parte appeal.  IP2018-01143, Paper 13 at 12.  The Board exercised its discretion to deny the petition under 35 U.S.C. § 314(a) after finding that a trial would be an inefficient use of Board resources due to the parallel district court case set for trial on April 1, 2019.  Id. at 13.  The Board emphasized three reasons for taking this step:  1) the district court proceeding was at an advanced stage; 2) the Board adopted the same claim construction as the district court; and 3) the prior art and expert testimony asserted in the petition overlapped extensively with those presented in the district court.  Id.

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