Patent Law Weblog
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- BioNTech Sues Moderna over mRNA Vaccine Technology
- CNIPA Issues Letter on Identity of Foreign Inventors
- REGENEXBIO Inc. v. Sarepta Therapeutics, Inc. (Fed. Cir. 2026)
- Apple v. Squires: USPTO Director Has Unlimited Discretion on IPR Institution
- The Ghost in the Machine: Why GenAI Can Be Both a Brilliant Researcher and a Terrible Advocate
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Category: Federal Circuit
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By Kevin E. Noonan — The question of the extent to which the "safe harbor" against infringement as part of the Hatch-Waxman Act (set forth in 35 U.S.C § 271(e)(1)) extends to activities post-generic drug approval is unresolved, as evidenced by the different conclusions in Classen Immunotherapies, Inc. v. Biogen IDEC and Momenta Pharmaceuticals, Inc.…
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Will The "No Supplier Exception" to the On-Sale Bar Fall? By Andrew Williams — On November 13, 2015, the Federal Circuit granted a petition for rehearing en banc filed in The Medicines Company v. Hospira, Inc. As we previously reported, the Federal Circuit held in that case that an order placed with a pharmaceutical contract…
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By Andrew Williams — Do you want the good news or the bad news first? Well, the good news is that the Federal Circuit has begun reversing PTAB decisions on the merits for IPR proceedings. To be fair, in the Microsoft case, the Federal Circuit remanded because the claim construction was not reasonable — and…
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By Michael Borella — Many patent attorneys have a visceral, disapproving reaction to negative claim limitations — elements that specify what a claim does not cover. While a line of Federal Circuit cases has established that negative limitations are acceptable in some situations, there still is a wide gap between claiming "a binary value that…
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By Kevin E. Noonan — The Federal Circuit affirmed a judgment of invalidity based on obviousness in a decision rendered in Prometheus v Roxane. In doing so, the Court might also have given an indication of the types of claims for "personalized medicine" (in the form of methods for determining treatment of subsets of individuals…
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By Andrew Williams — Last week, we analyzed the Federal Circuit's Dynamic Drinkware, LLC v. National Graphics, Inc. case from early September. In that case, the Federal Circuit held that an IPR petitioner did not adequately demonstrate that an invalidating reference under 35 U.S.C. § 102(e)(2) was entitled to its provisional filing date because it…
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By Andrew Williams — It is well accepted that in order to establish that a patent is entitled to claim priority to a previously filed provisional application, it must be shown that the claims of the patent have written description support in the provisional. Indeed, this is what 35 U.S.C. § 119(e)(1) requires: An application…
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By Donald Zuhn –- Last week, Appellee Natera, Inc. filed its response to the petition for rehearing en banc filed by Appellants Sequenom, Inc. and Sequenom Center for Molecular Medicine, LLC in August (see "Sequenom Requests Rehearing En Banc") (a summary of the response filed by Appellee Ariosa Diagnostics, Inc. can be found here). In…
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By Donald Zuhn — On Monday, Appellee Ariosa Diagnostics, Inc. filed its response to the petition for rehearing en banc filed by Appellants Sequenom, Inc. and Sequenom Center for Molecular Medicine, LLC in August (see "Sequenom Requests Rehearing En Banc"). In its response, Ariosa argues that in affirming a decision by the District Court for…
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By Kevin E. Noonan — The Federal Circuit today denied the petitions for rehearing by the panel and rehearing by the en banc Court filed by both parties in Amgen v. Sandoz. Amgen had petitioned for rehearing on the panel's decision that the District Court correctly determined that the provisions of the BPCIA requiring disclosure…
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