Patent Law Weblog
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- REGENEXBIO Inc. v. Sarepta Therapeutics, Inc. (Fed. Cir. 2026)
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Category: Federal Circuit
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By Andrew Williams — Saying "But I won't do it" is not sufficient to avoid infringement in a Hatch-Waxman litigation, according to the Federal Circuit in the recently decided Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. The ANDA applicant in that case was applying to market a generic version of Lunesta®, a chiral drug…
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By Kevin E. Noonan — Last week, the Federal Circuit in a non-precedential opinion, invalidated claims to Orange Book-listed patents on omega-three fatty acid formulations in Pronova Biopharma Norge v. Teva Pharmaceuticals USA. The grounds for reversing the District Court's finding that the defendant had not established invalidity under the public use statutory bar under…
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By Kevin E. Noonan — The Federal Circuit revisited the extent of the safe harbor from the judicially created doctrine of obviousness-type double patenting carved out by 35 U.S.C. § 121 in St. Jude Medical, Inc. v. Access Closure Inc. Unlike earlier decisions regarding whether continuation or continuation-in-part applications could benefit from the safe harbor,…
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By Kevin E. Noonan — In a case that raises important issues of perhaps Constitutional dimensions (at least in Circuit Court Judge Newman's view), the Biotechnology Industry Organization (BIO) urged the Federal Circuit to rehear the panel decision en banc in Fresenius v. Baxter Int'l. According to the Federal Circuit, the question the panel addressed…
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By Michael Borella — Recipe for a contentious Federal Circuit decision: empanel two judges who have different understandings of the patent-eligibility of computer-related inventions, sprinkle in a claim or two that could be viewed as a pure business method, let simmer. Judge Lourie and Chief Judge Rader are at it again, carrying out their ongoing…
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By Kevin E. Noonan — From the opening sentence of the Federal Circuit's opinion, it is clear that the Court believed that Bayer had claimed more broadly than it was entitled to and claimed species it had not described, thus failing to satisfy the written description requirement. Regents of Univ. of Cal. v. Eli Lilly…
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By Donald Zuhn — On August 23, in SkinMedica, Inc. v. Histogen Inc., the Federal Circuit determined that the District Court for the Southern District of California did not err in construing the phrase "culturing . . . cells in three-dimensions" in the claims of U.S. Patent Nos. 6,372,494 and 7,118,746, and therefore affirmed the…
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By Kevin E. Noonan — The Federal Circuit, in a split decision, affirmed denial of motions to dismiss on jurisdictional grounds and Federal Court joinder rules in University of Utah v. Max-Planck-Gesellschaft zur Forderung der Wiessenschaften e.V et al., a decision likely to be reviewed by the Supreme Court (if only because the case implicates…
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By Kevin E. Noonan — The Federal Circuit vacated and remanded a District Court decision denying a preliminary injunction to patentee Sequenom over the claims of U.S. Patent No. 6,258,540. While the Court rendered its decision based on traditional principles of claim construction and the lower court's balancing of the equitable factors considered for granting…
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By Kevin E. Noonan — The Federal Circuit's jurisprudence regarding obviousness as determined by the U.S. Patent and Trademark Office continues its post-KSR development in Leo Pharmaceutical Products, Ltd. v. Rea, which involves an obviousness determination by the Office in an inter partes reexamination. The Court reversed the Office's obviousness rejection as a matter of…
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