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

Last week, Magistrate Judge Jennifer Hall of the U.S. District Court for the District of Delaware recommended denial of two motions to dismiss and denied a motion to sever in a case involving a novel induced infringement claim against a health insurance provider. See Amarin Pharma, Inc. v. Hikma Pharm. USA Inc., No. 20-1630-RGA-JLH, 2021 WL 3396199 (D. Del. Aug. 3, 2021) (“Amarin R. & R.”) (docket version); Amarin Pharma, Inc. v. Hikma Pharm. USA Inc., No. 20-1630-RGA-JLH, 2021 WL 3363496 (D. Del. Aug. 3, 2021) (“Amarin Mem. Order”) (docket version). The dispute relates to Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC’s (collectively, “Hikma”) generic version of the plaintiffs’ VASCEPA® product (icosapent ethyl).  Hikma’s generic product has been on the market since November 2020. See Amarin R. & R., 2021 WL 3396199, at *3. The plaintiffs asserted three patents against Hikma and a health insurance company, Health Net, LLC (“Health Net”). Hikma and Health Net both moved to dismiss for failure to state a claim, and Health Net also moved to sever the claims against it from those against Hikma. Magistrate Judge Hall recommended that the motions to dismiss be denied, and she denied the motion to sever. Id. at *1; Amarin Mem. Order, 2021 WL 3363496, at *1.
Continue Reading Delaware Magistrate Judge: Novel Induced-Infringement Claim Against Health Insurance Provider Survives Dismissal

On January 5, 2021, the Orange Book Transparency Act of 2020, H.R. 1503, was signed into law. H.R. 1503 amends provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) related to patent information that new drug applicants must submit to the Food and Drug Administration (“FDA”) and FDA must publish in the “Orange Book.”[1] See H.R. 1503, 116th Cong. § 2(a)–(d) (2021). The amendments require “manufacturers to share complete and timely patent information with the . . . (FDA), ensure that periods of exclusivity listed in the Orange Book are promptly updated, and clarify that patents found to be invalid through a court decision or a decision by the Patent Trial and Appeal Board would be required to be removed from the Orange Book promptly, but not before time for appeal has expired.” H.R. Rep. No. 116-47, at 3–4 (2019). The amendments also require FDA and the Comptroller General to submit reports to Congress about the types of patents that should and should not be listed in the Orange Book. See H.R. 1503 § 2(e)–(f).
Continue Reading Orange Book Transparency Act of 2020 Signed Into Law

On December 4, 2020, the Board designated three cases from October as precedential. Together, the rulings help understand the Board’s approach to both serial challenges to issued patents and application of 35 U.S.C. § 315’s limitations on proceedings. Two of the newly precedential decisions address the real party in interest (“RPI”) requirement and the third concerns follow-on petitions and joinder motions. See RPX Corp. v. Applications in Internet Time, LLC, IPR2015-01750, Paper 128 (P.T.A.B. Oct. 2, 2020) (“RPX”); Apple Inc. v. Uniloc 2017 LLC, IPR2020-00854, Paper 9 (P.T.A.B. Oct. 28, 2020) (“Apple v. Uniloc”); SharkNinja Operating LLC v. iRobot Corp., IPR2020-00734, Paper 11 (P.T.A.B. Oct. 6, 2020) (“SharkNinja”).Read more about these decisions below.
Continue Reading PTAB designates three precedential cases on Section 315’s time-bar and estoppel provisions

The Patent Trial and Appeal Board (“the Board”) recently provided guidance to practitioners on its discretion to deny institution under 35 U.S.C. § 325(d) and § 314(a) by designating three decisions as informative or precedential.[1]  Under 35 U.S.C. § 325(d), the Board may deny institution of inter partes review (“IPR”) because “the same or substantially the same prior art or arguments previously were presented to the Office.” Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) (precedential), Oticon Med. AB v. Cochlear Ltd., IPR2019-00975, Paper 15 (PTAB Oct. 16, 2019) (precedential), and PUMA N. Am., Inc. v. NIKE, Inc., IPR2019-01042, Paper 10 (PTAB Oct. 31, 2019) (informative) all provide guidance related to § 325(d).  Under 35 U.S.C. § 314(a), the Board may deny institution as an exercise of its discretion in certain circumstances, such as when parallel proceedings are underway.  In Oticon, the Board also addressed the parallel proceedings issue under § 314(a).

In Advanced Bionics, the Board denied institution under § 325(d), set forth a two-part framework for applying § 325(d), and explained how the factors from Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (Dec. 15, 2017) (precedential as to § III.C.5, first paragraph) (“Becton, Dickinson”) fit into the two-part framework.

In Oticon, however, the Board refused to exercise its discretion under § 325(d) and instituted the proceeding over similar arguments by a patent owner. While it did not characterize the § 325(d) inquiry as a two-part analysis, and it grouped the Becton, Dickinson factors into three categories, the Board focused on the same two issues: (1) whether the same or substantially similar prior art and arguments were previously considered, and (2) whether the Patent Office erred in its prior assessment of the art. The Board also rejected a request to deny institution under § 314(a) and distinguished an earlier precedential ruling, NHK Spring Co. v. Intri-Plex Techs., Inc., IPR2018-00752, slip op. at 19–20 (PTAB Sept. 12, 2018) (Paper 8) (precedential) (“NHK”), in which institution was denied because of a parallel district court proceeding.

In PUMA, the Board denied institution under § 325(d) after analyzing the Becton, Dickinson factors and finding the same prior art was previously considered and the petitioner did not persuasively demonstrate the examiner materially erred in evaluating the prior art during prosecution.

This is a longer read, but worthwhile, given the importance of the issues.  As detailed in the following summaries, the rulings collectively show the fact-specific nature of the § 325(d) and § 314(a) inquiries. The Board will assess the prior-art teachings considered in prosecution and earlier Board proceedings, will compare those to the teachings asserted in the petition, will carefully compare the disclosures of supposedly duplicative prior art, and will assess the issues and progress of parallel district court cases. Litigants should be prepared for this level of scrutiny and establish the needed records on the prior art teachings and parallel district court cases.
Continue Reading Recent Precedential and Informative Decisions Clarify Standard for Discretionary Denials of Institution

In an April 11, 2019 order, Judge Andrews of the District of Delaware ruled that a Hatch-Waxman defendant’s obviousness defenses were precluded under 35 U.S.C. § 315(e)(2) even though the barring PTAB decision issued over a year after the court had held an obviousness trial.  Novartis Pharm. Corp. v. Par Pharm., Inc., No. 14-cv-01289 (D. Del. Apr. 11, 2019), Docket No. 198.  Read on for the details.
Continue Reading Court Applies Post-Trial IPR Estoppel Where Final Judgment Didn’t Address All Obviousness Defenses