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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

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 June 10, 2019, the Supreme Court held that a federal agency is not a “person” who can file a petition for review of a patent under one of the three new proceedings created by the America Invents Act (“AIA”).  Return Mail, Inc. v. United States Postal Service, 587 U.S. ____, 2019 WL 2412904, at *3 (U.S. June 10, 2019) (“Return Mail“).  Specifically, the Court held that federal agencies cannot file a petition for inter partes, post-grant, or covered business method review with the Patent Trial and Appeal Board (“PTAB”) (collectively, “PTAB proceedings”).  Id.
Continue Reading Supreme Court Prevents the Government from Challenging Patents in PTAB Proceedings

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.

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

On April 13, 2018, the Federal Circuit issued a new decision in its recent line of cases analyzing whether generic drug labels may be evidence of induced infringement of method of treatment claims in Hatch-Waxman cases. In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., the Court, in upholding the District Court’s finding of induced infringement, held that proposed instructions to physicians can satisfy the specific-intent element of induced infringement. 887 F.3d 1117 (Fed. Cir. 2018) (Judges Lourie and Hughes, Chief Judge Prost dissenting on other issues). This decision follows and builds upon the Federal Circuit’s 2017 decisions in Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017) and Sanofi v. Watson Laboratories Inc., 875 F.3d 636 (Fed. Cir. 2017).
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Continue Reading Generic Drug Labels May Establish Specific Intent to Induce Infringement of Method of Use Claims