Patent Law Weblog
recent posts
- Moderna Settles Patent Litigation with Arbutus et al.
- USPTO and DOJ Statement of Interest in Collision Communications: Another Thumb on the Scale in Favor of NPE Patent Plaintiffs
- Oasis Tooling, Inc. v. Siemens Industry Software Inc. (Fed. Cir. 2026)
- Why AI Will Not Take Over the World
- BioNTech Sues Moderna over mRNA Vaccine Technology
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Category: Hatch-Waxman
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By Kevin E. Noonan — Presumptions (rebuttable or otherwise) are, intentionally, distortions in the law that have the effect of increasing the difficulty of proving a proposition. Their purpose is typically policy-motivated, to indicate a favored outcome that will not prevail only if the basis of the presumption (and the policy behind it) is not…
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By Kevin E. Noonan — The In re K-Dur Antitrust Litigation case (formally, Louisiana Wholesale Drug Co. et al. v. Merck & Co. and Upsher-Smith Laboratories, Inc.) is significant because, for the first time in almost a decade, the Federal Trade Commission succeeded in convincing a U.S. Circuit Court of Appeals (here, the Third Circuit)…
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By Kevin E. Noonan — Last month, the Federal Trade Commission accomplished a decade-long goal: getting a Federal Circuit Court of Appeal (the 3rd Circuit) to support its position that so-called "reverse payments" (also known as "pay-for-delay" arrangements) between innovator pharmaceutical companies and generic drugmakers in ANDA litigation brought under 35 U.S.C. § 271(e)(2) are…
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By Kevin E. Noonan — Judge Rader wrote a vigorous dissent to the panel majority's opinion in Momenta v. Amphastar, disagreeing with the panel majority's interpretation that the "safe harbor" embodied in 35 U.S.C. § 271(e)(1) extended to post-approval activities. Before considering the substance of his dissenting opinion, the following facts should be remembered: •…
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By Kevin E. Noonan — It is a truism that each case that comes before an appellate court is decided on its own facts and on the court's application of the law to those facts. The Federal Circuit has the additional burden of establishing consistency to how the law (patent law) is applied to the…
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By Andrew Williams — On Monday, the Federal Circuit issued an Order in the Novo Nordisk A/S v. Caraco Pharm. Labs. Ltd. case, modifying an injunction against Novo issued by the lower court from one dictating express language to amend its Orange Book use code to one that required Novo to amend the use code. …
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By Kevin E. Noonan — The Federal Trade Commission (FTC) has been on a mission over the past decade, to eradicate a practice it believes is anticompetitive. That practice relates to so-called "reverse payments" (also known as "pay-for-delay" arrangements, ala those who term non-practice entities "trolls") between innovator pharmaceutical companies and generic drugmakers in ANDA…
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Valeant International (Barbados) SRL v. Watson Pharmaceuticals, Inc. By Andrew Williams — On Monday, the Southern District of Florida denied Valeant International (Barbados) SRL's motion for a permanent injunction to prevent Watson Pharmaceuticals, Inc. from commercially manufacturing or selling its generic version of Aplenzin® (see Order Denying Motion for Injunctive Relief). Valeant had been successful…
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By Andrew Williams — On Monday, in Sciele Pharma Inc. v. Lupin Ltd., the Federal Circuit vacated a preliminary injunction against ANDA-filer Lupin that blocked its sale of generic Fortamet, and remanded the case to the District Court for the District of Delaware for further processing. In so doing, the Federal Circuit reiterated the holding…
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By Kevin E. Noonan — Less than a week after the Senate passed its version of a bill amending the user fee provisions of the Food, Drug and Cosmetic Act (FDCA) for funding FDA review of innovator and generic drugs, medical device and biosimilars (S. 3187; Food and Drug Administration Safety and Innovation Act), the…
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