Tag: pharmaceuticals
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Exelixis v. MSN Labs: Federal Circuit Upholds Crystalline Salt Genus Under § 112 Written Description
The Federal Circuit’s precedential decision in Exelixis, Inc. v. MSN Laboratories Private Ltd., Case No. 25-1236 (Fed. Cir. Aug. 31, 2026), affirmed a bench-trial finding that patents claiming crystalline cabozantinib (L)-malate satisfied the written-description requirement even though the specification expressly characterized only two crystalline polymorphs. The court concluded that the chemical name and formula of…
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Wyeth v. AstraZeneca: Federal Circuit Invalidates Cancer-Treatment Claims for Failure to Enable Patient Dosing
The Federal Circuit’s decision in Wyeth LLC v. AstraZeneca Pharmaceuticals LP, Case No. 2024-2325 (Fed. Cir. July 9, 2026), affirms that a patent claiming daily administration of a therapeutically effective drug dosage to a patient must teach more than laboratory activity and broad projected dosage ranges. The specification must provide sufficient guidance for a skilled…
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Otsuka v. Hetero Labs: Federal Circuit Upholds Patent Injunction but Requires Rule 65(c) Bond
The Federal Circuit’s decision in Otsuka America Pharmaceutical, Inc. v. Hetero Labs Limited, Case No. 2025-2016 (Fed. Cir. July 1, 2026), upheld a preliminary injunction delaying the launch of a generic version of Nuedexta but vacated the district court’s decision allowing the patent owner to obtain that injunction without posting security under Federal Rule of…
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Enanta v. Pfizer: Federal Circuit Rejects Provisional Priority Based on an Alleged Typographical Error
The Federal Circuit’s decision in Enanta Pharmaceuticals, Inc. v. Pfizer Inc., Case No. 2025-1427 (Fed. Cir. June 23, 2026), holds that a later patent cannot claim the filing date of a provisional application when the provisional expressly discloses a different chemical range, even if the applicant contends that the difference resulted from a typographical error.…
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Hikma v. Amarin: Supreme Court Narrows Induced Infringement Claims Against Skinny-Label Generics
A Significant Win for Generic Drug Manufacturers The Supreme Court’s unanimous decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., Case No. 24-889 (Jun. 4, 2026), is one of the most important patent law decisions of the 2025-2026 Term. While the case arises from the pharmaceutical industry’s unique Hatch-Waxman framework, its significance extends well…
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Actelion v. Mylan: Federal Circuit Limits Equivalents Theory After Ambiguous pH Claim Construction
The Federal Circuit’s decision in Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., Case No. 24-1641 (Fed. Cir. May 13, 2026), provides an important reminder that scientific terminology in patent claims is not interpreted in a vacuum. Even seemingly straightforward numerical limitations can become highly contextual when industry standards, measurement conventions, and prosecution history intersect. In…
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Teva v. Lilly: Federal Circuit Limits Amgen by Distinguishing Method-of-Use Claims from Composition Claims
The Federal Circuit’s decision in Teva Pharmaceuticals International GmbH v. Eli Lilly and Company, Case No. 24-1094 (Fed. Cir. Apr. 16, 2026), marks one of the most important post-Amgen v. Sanofi patent decisions involving antibody claims and Section 112. In a unanimous opinion authored by Chief Judge Prost, the court reversed a district court judgment…
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Duke v. Sandoz: Federal Circuit Invalidates Genus Claim for Lack of Written Description
On November 18, 2025, the Federal Circuit issued a significant written description decision in Duke University v. Sandoz Inc., reversing a jury verdict and holding claim 30 of U.S. Patent No. 9,579,270 invalid for lack of adequate written description. The opinion is a textbook application of the court’s “blaze marks” jurisprudence and a reminder that…
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Bayer Pharma v. Mylan Pharmaceuticals: When “Clinically Proven Effective” Cannot Rescue an Anticipated Treatment Method
The Federal Circuit’s September 23, 2025 decision in Bayer Pharma Aktiengesellschaft v. Mylan Pharmaceuticals Inc., No. 23-2434, delivers a sharp reminder that post-hoc validation, even in the form of successful clinical trial results, does not automatically translate into patentability. The opinion clarifies the limits of method-of-treatment claims that attempt to rely on clinical proof language…
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Acorda v. Alkermes: When Alternative Theories Shut the Federal Circuit Door
The Federal Circuit’s July 2025 decision in Acorda Therapeutics, Inc. v. Alkermes PLC, No. 2023-2374 (Fed. Cir. July 25, 2025), is the latest reminder that most “non-patent patent cases” will not make it past the courthouse steps on Madison Place. The court held that it lacked jurisdiction to review Acorda’s challenge to an international arbitration…