Patent Law Weblog
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- USPTO Revokes Guidance on AI-Assisted Inventorship, But Rules Remain Basically the Same
- Why the Alice Test is Stupid, Part III: Eligible Independent Claims Can Have Ineligible Dependent Claims
- Chewing the Cud: Are Tariffs Sucking IP Blud?
- USPTO Issues Notice Regarding Improper Small and Micro Entity Status
- Aortic Innovations LLC v. Edwards Lifesciences Corp. (Fed. Cir. 2025)
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Category: Hatch-Waxman
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By Kevin E. Noonan — The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals, wherein the District Court entered an injunction ordering Teva to delist five Orange Book-listed patents, in Teva Pharms. Inc. v. Amneal Pharms. LLC. This post concerns Amneal's…
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By Kevin E. Noonan — The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals wherein the District Court entered an injunction ordering Teva to delist five Orange Book-listed patents, in Teva Pharms. Inc. v. Amneal Pharms. LLC. This post concerns Teva's…
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By Kevin E. Noonan — The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals wherein the District Court entered an injunction ordering Teva to delist five Orange Book-listed patents, in Teva Pharms. Inc. v. Amneal Pharms. LLC. To recap, the issues…
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By Kevin E. Noonan – In a decision characterized (somewhat remarkably) by the Circuit Court as being one of first impression, the Second Circuit affirmed dismissal with prejudice of an antitrust allegation by a class of plaintiffs* against Forest Laboratories and several generic drug companies** for settlement agreements in ANDA litigation, in CVS Pharmacy Inc. v. Forest…
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By Kevin E. Noonan – The Federal Circuit handed down an opinion earlier this month that invalidated several asserted claims and found infringement under 35 U.S.C. § 271(e)(2) of the claims, while refusing to modify its judgment on infringement after Defendant Norwich submitted a revised ANDA containing a Section viii "carveout" in Salix Pharmaceuticals, Ltd. v. Norwich…
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By Kevin E. Noonan – A fractured affirmance of a district court decision to dismiss an infringement action under 35 U.S.C. § 271(e)(1) was the occasion for the Federal Circuit to illustrate the continued debate over the scope of the safe harbor enacted as part of the Hatch-Waxman Act in Edwards Lifesciences Corp. v. Meril Life Sciences…
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By Kevin E. Noonan — A decade ago the Federal Trade Commission engaged in a crusade against reverse settlement payment agreements in ANDA litigation (which they termed, Madison Avenue-like, "pay for delay" settlements), arguing that such agreements were per se antitrust violations, despite almost universal rejection of their position by most Courts of Appeal prior…
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By Kevin E. Noonan – Over the past several years Congress has tried to address high drug prices, with variable success (see "FTC to the Rescue Regarding High Drug Prices and Patents"; "Even More Ill-Conceived Remedies from Congress Regarding Prescription Drug Costs"; "More Ill-conceived Remedies from Congress Regarding Prescription Drug Costs"; and "A Solution in Search…
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By Donald Zuhn –- After reflecting upon the events of the past twelve months, Patent Docs presents its 16th annual list of top patent stories. For 2022, we identified ten stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and…
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Federal Circuit Denies En Banc Review in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA By Kevin E. Noonan — The 2020 decision by a divided Federal Circuit panel in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA regarding the extent to which an ANDA applicant who obtained regulatory approval under the Section viii carve-out provisions of the statute…
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