Under 35 U.S.C. § 315(e), inter partes review (IPR) estoppel applies to “any ground that the petitioner raised or reasonably could have raised during that inter partes review.” In 2018, the Federal Circuit held in Shaw Industries Group, Inc. v. Automated Creel Systems, Inc., 817 F.3d 1293 (Fed. Cir. 2016), that IPR estoppel does not apply to grounds where review was denied by the Patent Trial and Appeal Board (PTAB). Later that same year, the Supreme Court held in SAS that if the PTAB institutes review, it must review all challenged claims and asserted grounds, i.e., there cannot be partial institution. SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348 (2018). In the latest line of these cases, the Federal Circuit held in California Institute of Technology v. Broadcom Ltd., Nos. 2020-2222, 2021-1527, 2022 WL 333669 (Fed. Cir. Feb. 4, 2022) (original opinion) (errata), that IPR estoppel applies to all grounds that reasonably could have been asserted against the challenged claims, including grounds that were not stated in the petition.
Continue Reading Federal Circuit Confirms the Broad Reach of IPR Estoppel

Section 325(d) gives the Patent Trial and Appeal Board (“PTAB”) discretion to deny a post-grant petition when “the same or substantially the same prior art or arguments previously were presented to the Office.”  35 U.S.C. § 325(d).  Both the PTAB and the Federal Circuit have opined on the discretionary denial provisions in 35 U.S.C. § 325(d) in the context of serial inter partes review (“IPR”) petitions.  The Federal Circuit has now held that § 325(d) applies to requests for ex parte reexamination.  This decision did not involve biotechnological subject matter, but the holdings are nevertheless applicable.
Continue Reading Federal Circuit Applies § 325(d) to Reexamination Requests

The Federal Circuit’s August 5, 2021 ruling in GlaxoSmithKline LLC v. Teva Pharm. USA, Inc. (link to issued opinion), is an important development in the law of “skinny” generic pharmaceutical labels and induced infringement claims. See GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021) (“GSK II”) (Google Scholar link).  Read on for important aspects of the majority’s opinion and Judge Prost’s dissent.
Continue Reading Federal Circuit Issues Second GSK v. Teva Opinion On “Skinny” Label-Based Inducement

On August 3, 2020, the Federal Circuit (Judges Lourie, Moore, and Reyna (dissenting)) (“the Court”) granted a petition for panel rehearing and issued a modified opinion (“Mod. Op.”) that maintained its prior patent-eligibility determination in Illumina, Inc. v. Ariosa Diagnostics, Inc., Case No. 19-1419.  Specifically, the modified majority opinion again held that the challenged claims of U.S. Patent Nos. 9,580,751 (the “’751 patent”) and 9,738,931 (the “’931 patent”), generally directed to methods of preparing cell-free fetal DNA from maternal blood for genetic analysis, are not invalid under 35 U.S.C. § 101 as directed to a natural phenomenon under the Alice/Mayo test, and are differentiated from other cases where the Court held claims ineligible.
Continue Reading Method Claims Relying On A Naturally-Occurring Phenomenon Are Patent-Eligible Where They Recite “Human-Engineered Parameters”

In a previous post, we reported that the PTAB’s Precedential Opinion Panel (POP) tackled issue joinder in Proppant Express Investments v. Oren TechsIPR2018-00914, Paper 24 at 2.

As background, in Proppant, the POP addressed the following issues:

  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 § 315(b), or any other relevant facts, have any impact on the first two questions?

The POP determined that § 315(c) “provides discretion to allow a petitioner to be joined to a proceeding in which it is already a party and provides discretion to allow joinder of new issues into an existing proceeding.”  IPR2018-00914, Paper 38, at 4.

In Facebook, Inc., v. Windy City Innovations, LLC, the Federal Circuit reversed the POP opinion.  953 F.3d 1313 (Fed. Cir. 2020) (the “Decision”).  Specifically, the court held that “[t]he clear and unambiguous text of § 315(c) does not authorize same-party joinder, and does not authorize the joinder of new issues.”  Decision at 1322. 
Continue Reading Federal Circuit Reverses PTAB’s Precedential Opinion Panel on Aspects of Joinder

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.

On August 27, 2018, the Federal Circuit in Ericsson Inc. v. Intellectual Ventures I LLC, vacated the Patent Trial and Appeal Board’s (“PTAB”) final written decision in an inter partes review (IPR) and remanded for the PTAB to properly consider all portions of the petitioner’s reply.  No. 17-1521, slip op. at 13 (Aug. 27, 2018).
Continue Reading Arguments in Reply that Expand on Previously Argued Rationale Should Be Considered by the PTAB

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.