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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 October 13, 2020, the Supreme Court granted petitions for certiorari filed by the United States (in No. 19-1434), Smith & Nephew, Inc. (in No. 19-1452), and Arthrex, Inc. (in No. 19-1458) regarding the appointments of the administrative patent judges of the Patent Trial and Appeal Board.  No date has been set to argue the cases, but the Court consolidated them and allotted one hour for argument time.  Because the Court consolidated the cases for briefing and oral argument, it noted that “future filings and activity in the cases will now be reflected on the docket of No. 19-1434.”  On December 31, 2020, the Court set oral argument for March 1, 2021.

The various petitions were granted only to the extent of “Questions 1 and 2 as set forth in the July 22, 2020 Memorandum for the United States.”  See Orders List at 2.

Question 1 asks “[w]hether, for purposes of the Appointments Clause, U.S. Const. Art. II, § 2, Cl. 2, administrative patent judges of the U.S. Patent and Trademark Office are principal officers who must be appointed by the President with the Senate’s advice and consent, or ‘inferior Officers’ whose appointment Congress has permissibly vested in a department head.”

Question 2 asks “[w]hether, if administrative patent judges are principal officers, the court of appeals properly cured any Appointments Clause defect in the current statutory scheme prospectively by severing the application of 5 U.S.C. § 7513(a) to those judges.”

Links to the briefs, and details of the briefing schedule, are below. [Updated 1/8/2021, to reflect most current filings, and argument date]…
Continue Reading Supreme Court grants certiorari in PTAB Appointments Clause cases

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 Uniloc 2017 LLC v. Hulu, LLC, No. 2019-1686 (Fed. Cir. July 22, 2020), the Federal Circuit considered whether the AIA permits the PTAB to reject substitute claims proposed during an IPR for patent ineligibility under § 101. …
Continue Reading Federal Circuit confirms that the PTAB can consider the patent eligibility of substitute claims proposed during an IPR

Last week, we wrote about Arthrex, Inc. v. Smith & Nephew, Inc. and described recent developments that suggested the Federal Circuit was leaning toward holding that all current PTAB judges had been unconstitutionally appointed in violation of the Appointments Clause of Article II. The Federal Circuit has now done just that …
Continue Reading Federal Circuit Holds that PTAB Judges Were Unconstitutionally Appointed

An order from the Federal Circuit on October 15 suggests the court may be close to holding that the PTAB has been operating in violation of the Appointments Clause, which could significantly disrupt PTO operations.  The case presents important questions: whether the PTAB’s judges have been lawfully appointed, and if not, what happens to decisions that have been issued by panels of those judges?
Continue Reading Constitutional Challenge under the Appointments Clause May Upend PTAB Proceedings

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.
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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.