Today the Federal Circuit (Judges Moore, Dyk, and Reyna) ruled in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc. that tribal sovereign immunity does not apply in IPR proceedings. The appeal represented the first opportunity for the Federal Circuit to address the issue of sovereign immunity in IPR proceedings. Continue Reading Federal Circuit Affirms that Tribal Sovereign Immunity Does Not Apply in IPRs

During the week of July 9, the Board issued four decisions in Technology Center 1600, three decisions denying institution of inter partes review and one Final Decision finding the challenged claims patentable. In addition to these four decisions the Board, in ABS Global, Inc. v. XY, LLC, No. IPR2017-02184, also granted Patent Owner’s request for an adverse judgement. The four decisions are as follows:

Continue Reading PTAB Tech Center 1600 Round-up: Week of July 9-13, 2018

Drug product labels (also known as prescribing information) are often asserted as prior art by patent challengers, both in front of the PTAB and in district court ANDA litigation.  Before the PTAB, using such prior art requires showing that it qualifies as a “printed publication” under 35 U.S.C. §§ 102 and 311(b).  Recently, the PTAB appears to be applying greater scrutiny to the use of such prior art when cited in invalidity grounds.  The Board’s analysis in such situations “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.”  Sandoz Inc. v. AbbVie Biotechnology Ltd., IPR2018-00156, Paper 11 at *9 (June 5, 2018) (citing In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004)).  A pair of recent rulings identify some of the evidentiary issues catching the eyes of PTAB panels as they consider invalidity arguments that rely on product-label prior art.

Continue Reading Recent PTAB Rulings Reflect Greater Scrutiny Of Product-Label Prior Art

The Board issued two decisions in TC 1600 during the week of June 25, both of which relate to Petitions filed by Trans Ova Genetics, LC (“Trans Ova”) against XY, LLC (“XY”).  Summaries of the decisions are below:

Continue Reading PTAB Tech Center 1600 Round-Up: Week of June 25-29, 2018

The “on-sale bar” deems that certain sales of an invention that occur more than one year before a patent application is filed are a bar to patentability.  See 35 U.S.C. § 102(b) (pre-America Invents Act (“AIA”)); 35 U.S.C. § 102(a)(1) (AIA).  On Monday, June 25, 2018, the Supreme Court granted Helsinn’s petition for certiorari in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., to interpret the on-sale bar provision of 35 U.S.C. § 102 in the AIA.  Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., — S. Ct. —, 2018 WL 1142984 (2018) [SCOTUSblog case file].  The question presented to the Supreme Court is: “Whether, under the Leahy-Smith America Invents Act, an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.”  Petition for Certiorari, Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., No. 17-1229, 2018 WL 1168243 (Feb. 28, 2018).

Continue Reading Did the AIA Change the On-Sale Bar Standard? The Supreme Court Will Decide.

During the week of June 18-22, 2018, the Patent Trial and Appeal Board issued two decisions in Tech Center 1600 denying institution of IPR petitions.  The petitions were filed by Samsung Bioepis Co. Ltd. (“Bioepis”) against Genentech, Inc. (“Genentech”), and Initiative for Medicines, Access & Knowledge (I-MAK), Inc. (“I-MAK”) against Gilead Pharmasset LLC (“Gilead”), respectively.  The decisions follow.

Continue Reading PTAB Tech Center 1600 Round-Up: Week of June 18-22, 2018

In view of the Federal Circuit’s April 13, 2018 decision in Vanda Pharms. Inc. v. West-Ward Pharms., 877 F.3d 1117(Fed. Cir. 2018), regarding subject matter patent eligibility, the USPTO issued a memorandum on June 7, 2018, to “address[] the limited question of how to evaluate the patent eligibility of ‘method of treatment’ claims” and announce modifications to life sciences example 29 of the PTO’s current patent-eligibility guidance. Memo at 3.

Continue Reading USPTO’s Subject Matter Eligibility Guidance Evolves After Vanda Pharms. Inc. v. West-Ward Pharms.

The Patent Trial and Appeal Board issued seven decisions in TC 1600 during the week of June 11-15, 2018, including four decisions denying institution of inter partes review and three final written decisions.  Summaries of the decisions follow:

Continue Reading PTAB Tech Center 1600 Round-Up: Week of June 11-15, 2018

SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018), established a clear rule requiring institution on all challenged claims in future IPR proceedings. But the Supreme Court’s April 24 decision created immediate uncertainty regarding the hundreds of IPRs in which the PTAB had already instituted review or issued a final written decision on fewer than all claims and all grounds presented in the petition. The Federal Circuit’s immediately apparent interest in SAS transitional issues has led to swift action—the court’s precedential decision in PGS Geophysical AS v. Iancu explains that (1) SAS requires institution on all claims and all grounds presented in a petition for IPR, (2) the Federal Circuit can exercise appellate jurisdiction in pre-SAS cases where the Board granted only partial institution, and (3) parties can waive requests for SAS-based relief on appeal. Continue Reading Federal Circuit Rules that Pre-SAS Appeals from Partially Instituted IPRs Can Proceed

Other than quickly granting Petitioner’s unopposed motion to dismiss with prejudice in Pfizer, Inc. v. Biogen, Inc., No. IPR2018-00231 (Decision Entered June 6, 2018), during the week of June 4, the Patent Trial and Appeal Board issued three decisions in TC 1600, two denying institution of IPR petitions filed by Sandoz, Inc. and Sanofi Pasteur, Inc., respectively, and one final decision finding all challenged claims unpatentable in an IPR filed by Acrux DDS Pty Ltd., joined to an IPR filed by Argentum Pharmaceuticals LLC.  The decisions are as follows: Continue Reading PTAB Tech Center 1600 Round-up: Week of June 4-8, 2018