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Case Name: Astellas Pharma, Inc. v. Sandoz Inc., Nos. 2023-2032, 2023-2063, 2023-2089, 2024 WL 4219374 (Fed. Cir. Sept. 18, 2024) (Circuit Judges Lourie, Prost, and Reyna presiding; Opinion by Lourie, J.) (Appeal from D....more
On October 22, 2024, the Federal Circuit (CAFC Case No. 24-2351) denied Regeneron’s request for an injunction pending appeal for Amgen’s EYLEA® (aflibercept) biosimilar Pavblu™ (aflibercept-ayyh), concluding that “Regeneron...more
Last week, GlaxoSmithKline and Northwestern University filed separate lawsuits against Moderna, accusing its mRNA-based vaccines of patent infringement....more
The US Court of Appeals for the Federal Circuit issued its opinion in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061 (Fed. Cir. 2024), holding that “a first-filed, first-issued, later-expiring claim cannot...more
On October 4, 2024, District Judge Philip M. Halpern (S.D.N.Y.) denied Defendant Regeneron Pharmaceuticals Inc. (“Regeneron”)’s Motion for Summary Judgment that (1) Allele was not entitled to any pre-suit infringement damages...more
On October 4, 2024, Amgen filed a BPCIA complaint in the District Court for the Northern District of Illinois Eastern Division against Fresenius Kabi related to Fresenius Kabi’s proposed biosimilar of Amgen’s PROLIA and...more
On August 14, 2024, the US District Court for the District of Delaware entered final judgment in Wyeth—a patent infringement case relating to pharmaceuticals for treating non-small cell lung cancer (“NSCLC”)—vacating a jury...more
On October 4, 2024, Amgen filed Case No. 1:24-cv-09555 (N.D. Ill.) against Fresenius Kabi, alleging FKS518 (denosumab), its proposed Prolia® / Xgeva® (denosumab) biosimilar, would infringe 33 of Amgen’s patents....more
Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more
Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Rituximab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
In the last few weeks, the PTAB has granted institution of eight IPRs filed by Merck on Johns Hopkins patents directed to methods of treatment using pembrolizumab. The eight patents are generally directed to methods...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
September 21, 2024, marked the seventh anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the seventh year...more
Precedential and Key Federal Circuit Opinions - 1. ASTELLAS PHARMA v. SANDOZ INC. [OPINION] (2023-2032, 2023-2063, 2023-2089, 9/18/24) (Lourie, Prost, Reyna) - Lourie, J. The Court vacated and remanded the district...more
Vascular Solutions LLC, et al. v. Medtronic, Inc., et al., No. 2024-1398 (Fed. Cir. (D. Minn.) Sept. 16, 2024). Opinion by Mazzant (sitting by designation), joined by Moore and Prost....more
In a sealed order that issued on September 24, 2024, the District Court for the Northern District of West Virginia denied a preliminary injunction against Amgen in the aflibercept BPCIA litigation. ...more
On September 23, 2024, Regeneron’s motion for a preliminary injunction against the commercial launch of Amgen’s EYLEA® (aflibercept) biosimilar Pavblu™ (aflibercept-ayyh) was denied in Case No. 1:24-cv-00039 (N.D.W. Va.) /...more
On August 22, 2024, Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals, PLC (collectively Hikma), filed a petition for rehearing en banc, asking the US Court of Appeals for the Federal Circuit to reconsider its recent...more
On June 28, 2024, the United States Patent and Trademark Office (“USPTO”) requested the public’s views on the current state of the common law experimental use exception to patent infringement and whether legislative action...more
This Federal Circuit opinion addresses a district court’s decision granting plaintiff’s motion for a preliminary injunction. Background - Plaintiff Natera, Inc. (“Natera”) and defendant NeoGenomics Laboratories, Inc....more
On August 30, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) and Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) settled their BPCIA dispute related to...more