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On April 28, the U.S. District Court for the District of New Jersey denied Janssen Biotech, Inc. (“Janssen”) and Johnson & Johnson’s motion for a preliminary injunction seeking to enjoin Samsung Bioepis Co. Ltd. (“Samsung”)...more
On April 15, 2025, Biocon announced it reached a settlement agreement with Regeneron, dismissing CAFC Appeal No. 24-2002 and Case No. 1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) and allowing the...more
Just under two weeks ago, we reported the Court of Appeal had awarded AstraZeneca (AZ) a preliminary injunction in the UK against Glenmark’s generic dapagliflozin (dapa) product for type II diabetes, until the hearing...more
Patent holders must start Unified Patent Court (UPC) proceedings on the merits within a certain period if they do not want to risk the revocation of provisional measures. The UPC has now clarified that filing the statement of...more
In a reversal of fortune, yesterday (9 April) the UK Court of Appeal awarded AstraZeneca (AZ) an interim injunction keeping Glenmark’s dapagliflozin (dapa) off the UK market until the form of order hearing in the parallel...more
On March 28, 2025, Michael Tappin KC, sitting as a deputy judge of the High Court, refused to grant AstraZeneca (“AZ”) an interim injunction to restrain Glenmark from launching in the U.K. a generic version of its type 2...more
Governed by 19 U.S.C. § 337, the U.S. International Trade Commission (“ITC”) is empowered to investigate unfair acts in the importation of articles into the United States. The ITC can be a powerful forum for owners of U.S....more
The US Court of Appeals for the First Circuit vacated a preliminary injunction, explaining that the district court should have immediately issued a statutory stay of the proceeding under 28 U.S.C. § 1659(a) because a...more
On March 5, 2025, the Federal Circuit affirmed the grant of a preliminary injunction against the launch of Celltrion’s proposed EYLEA® (aflibercept) biosimilar CT-P42 in CAFC Case Nos. 24-2058 and 24-2147 (appealing from...more
On March 14, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s denial of a preliminary injunction against Amgen Inc. (“Amgen”) in the ongoing...more
The United Kingdom's Court of Appeal has issued an important decision on the principles governing the grant of interim licenses in standard essential patent ("SEP") disputes....more
Completing a recent jurisprudential "hat trick,"* the Federal Circuit affirmed a District Court grant of a preliminary injunction against a biosimilar applicant for Regeneron's EYLEA biologic drug in Regeneron...more
On March 5, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entry of a preliminary injunction preventing Celltrion, Inc. (“Celltrion”) from...more
In this edition of The Precedent, we outline the decision in Regeneron Pharms., Inc. v. Mylan Pharms. Inc. In Regeneron Pharms., Inc. v. Mylan Pharms. Inc., the Federal Circuit affirmed the district court’s grant of a...more
On 25 February, the Court of Justice of the European Union (CJEU) issued its much-anticipated decision in BSH Hausgeräte v. Electrolux (C-339/22) on cross-border competence in patent litigation. At the heart of the dispute is...more
The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated Biologics License Applications (aBLAs) are subject to jurisdiction in the United States....more
Note: This post addresses two Federal Circuit decisions issued on January 29, 2025. Both appeals involved Plaintiff-Appellee Regeneron Pharmaceuticals, Inc., with the first appeal involving Defendant-Appellant Formycon AG...more
On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction by the Northern District of West Virginia in favor of Regeneron Pharmaceuticals, Inc. against Samsung...more
Addressing a preliminary injunction in patent litigation related to the Biologics Price Competition and Innovation Act (BPCIA), the US Court of Appeals for the Federal Circuit upheld the district court’s grant of a...more
On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entries of preliminary injunction preventing Samsung Bioepis Co., Ltd....more
Apple Inc., et al. v. Gesture Technology Partners, LLC, Nos. 2023-1501, -1554 (Fed. Cir. (PTAB) Jan. 27, 2025). Opinion by Dyk, joined by Lourie and Hughes....more
On January 29, 2025, the CAFC issued opinions affirming the preliminary injunctions issued against biosimilars of Regeneron’s EYLEA® (aflibercept): Samsung Bioepis’s Opuviz™ (aflibercept-yszy) (CAFC Case Nos. 24-1965,...more
Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Appeal Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025) Our Case of the Week is a 31-page decision that touches on a variety of issues, including...more
Nearly two years in, the Unified Patent Court (UPC) continues to reshape the patent litigation landscape in Europe by providing swift, cross-border resolutions and an innovative approach to patent enforcement and revocation....more
Entresto® (valsartan/sacubitril) - Case Name: Novartis Pharms. Corp. v. MSN Pharms., Inc., Nos. 2024-2211, 2024-2212, 2024 WL 4969281 (Fed. Cir. Dec. 4, 2024) (Circuit Judges Lourie, Prost, and Reyna presiding; Opinion by...more