Patent Law Weblog
recent posts
- Why the Alice Test is Stupid, Part IV: The Usefulness Paradox
- Teva Capitulates to Federal Trade Commission Coercion
- USPTO Issues Memoranda on Subject Matter Eligibility
- 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
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Category: Food and Drug Administration
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By Kevin E. Noonan — "Plus ça change, plus c'est la même chose," Jean-Baptiste Alphonse Karr (1849) In the last years of the Biden Administration, the Federal Trade Commission issued a policy statement and sent letters to ten companies having Orange Book-listed patents claiming devices for administering drugs challenging the propriety of those listings and…
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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 – The Federal Circuit once again had an opportunity to opine on the extent of behavior by a generic drugmaker who opts to accept a "section viii carve-out" in its FDA approval (resulting in a so-called "skinny label) on liability for inducing infringement in Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. The…
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By Kevin E. Noonan – After taking most of a decade to approve its first interchangeable biosimilar (Semglee (insulin glargine-yfgn), the U.S. Food and Drug Administration has approved three interchangeable biosimilars since the beginning of this year. The first of these is simlandi (adalimumab-ryvk), approved on February 24th, made by Alvotech and Teva Pharmaceuticals, and interchangeable with…
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By Kevin E. Noonan – On October 3, 2023, the U.S. Food and Drug Administration (FDA) announced approval of Biogen's Byooviz (ranibizumab-nuna) as an interchangeable biosimilar to Genentech's Lucentis (ranibizumab injection). The drug was approved for intravitreal injection for the following indications: • Neovascular (Wet) Age-Related Macular Degeneration (AMD),• Macular Edema Following Retinal Vein Occlusion (RVO), and•…
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By Kevin E. Noonan – Earlier this year, the U.S. Food and Drug Administration announced approval of Amgen's Wezlana (ustekinumab-auub) as an interchangeable biosimilar to Janssen Biotech's Stelara (ustekinumab). The drug was approved for multiple inflammatory disorders: Adult patients with: • moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;• active psoriatic arthritis;•…
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By Kevin E. Noonan – Ever since Watson and Crick ended their seminal Nature paper in 1953 by saying that: "It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the genetic material," James Watson & Francis Crick, "Molecular Structure of Nucleic Acids; A Structure for Deoxyribose…
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By Kevin E. Noonan – It was not so long ago that many, including members of Congress, were bemoaning the slow approval and introduction into the marketplace of biosimilar alternatives to (generally expensive) biologic drugs. See "Trump Administration Considering Reduction in Biologics Exclusivity Period"; "A Solution in Search of a Problem"; "FDA Issues Plan for Further…
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