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 — On March 19, 2015, U.S. District Judge Seeborg of the Northern District of California denied a motion for a preliminary injunction filed by Amgen to prevent the imminent launch by Sandoz of a biosimilar version of NEUPOGEN® (filgrastrim). In so doing, the Court ruled that the disclosure and notice provisions of…
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By Kevin E. Noonan — Earlier this month, the Federal Circuit rendered a decision on damages in what may be the last of a long-running series of ANDA cases involving AstraZeneca's Prilosec® (omeprazole) franchise. As set forth in the opinion, AstraZeneca's lawsuit against Apotex was part of the "second wave" of ANDA litigation, wherein the…
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By Kevin E. Noonan — The Federal Circuit showed once again the importance of a district court's factual findings (and the deference the appellate court gives those findings, particularly when supported by expert testimony), in InSite Vision Inc. v. Sandoz, Inc. In last week's decision in this case the Court affirmed a finding of non-obviousness…
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By Kevin E. Noonan — Late last month, the Federal Circuit handed Exela Pharma Sciences its latest defeat in litigation relating to its ANDA filing on Cadence Pharmaceuticals' injectable acetaminophen-based drug Ofirmev®, in Exela Pharma Sciences LLC v. Lee. This litigation was collateral to Exela's ANDA case against Cadence, and involved an attack on one…
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By Andrew Williams — Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v. Daiichi Sankyo, Inc. case, at least if you are in the wild world of the Hatch-Waxman statute. …
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By Kevin E. Noonan — Earlier this month, the Federal Circuit affirmed a District Court judgment of obviousness in ANDA litigation under the Hatch Waxman Act having a long provenance of earlier litigation, in Senju Pharmaceutical Co., Ltd. v. Lupin Ltd. The case involved patentee Senju Pharmaceutical's (joined by Kyorin Pharmaceutical Co. and Allergan, Inc.)…
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By Kevin E. Noonan — The Federal Circuit has availed itself of another opportunity to demonstrate that the Supreme Court's recent decision in Teva v. Sandoz may be relevant in cases that are the exception rather than the rule. The Federal Circuit's decision in Cadence Pharmaceuticals Inc. v. Exela Pharmsci Inc. affirmed the District Court's…
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By Andrew Williams — When can a district court's factual findings related to the extrinsic evidence in a claim construction determination not be given deference by the Federal Circuit? At least one situation is when the findings do not "override" "the totality of the specification," especially when the specification "clearly indicates . . . the…
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Filing of IDS after Response to Restriction Requirement Constitutes Failure to Engage in Reasonable Efforts to Conclude Prosecution By Donald Zuhn — Last week, in Gilead Sciences, Inc. v. Lee, the Federal Circuit affirmed the decision by the District Court for the Eastern District of Virginia granting summary judgment to the Director of the U.S.…
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Federal Circuit Sides with Patent Office in First IPR Final Written Decision Review By Andrew Williams — Earlier today, the Federal Circuit decided the first appeal from the Patent Trial and Appeal Board ("PTAB" or "Board") related to an inter partes review ("IPR") Final Written Decision. As we have previously reported, the In re Cuozzo…
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