Patent law in Europe: What pharmaceutical companies need to know
Precedential and Key Federal Circuit Opinions - LABORATORY CORPORATION OF AMERICA HOLDINGS v. QIAGEN SCIENCES, LLC [OPINION] (2023-2350, 08/13/2025) (Lourie, Dyk, Cunningham) - Lourie, J. The Court reversed the...more
The Federal Circuit recently issued a significant decision in the ongoing patent litigation between Laboratory Corporation of America Holdings (Labcorp) and Qiagen Sciences, LLC, reversing a Delaware district court’s judgment...more
PowerBlock Holdings, Inc. v. iFit, Inc., No. 2024-1177 (Fed. Cir. (D. Utah) Aug. 11, 2025). Opinion by Stoll, joined by Taranto and Scarsi (sitting by designation). PowerBlock sued iFit for infringement of a patent directed...more
The US Court of Appeals for the Federal Circuit reversed a district court’s denial of a motion for judgment as a matter of law (JMOL) of noninfringement, finding that the jury’s infringement findings were unsupported by...more
The Federal Circuit recently reversed a $4.7M verdict in a patent lawsuit involving two patents concerning next-generation sequencing methods—U.S. Patent Nos. 10,017,810 and 10,450,597. Both patents concern DNA preparation...more
Laboratory Corporation of America Holdings v. Qiagen Sciences, LLC, Appeal No. 2023-2350 (Fed. Cir. Aug. 13, 2025) - In our Case of the Week, the Federal Circuit reversed a jury finding of infringement from the District...more
The US Court of Appeals for the Federal Circuit recently held that cancellation of a claim during prosecution may give rise to prosecution history estoppel, precluding the patentee from recapturing the surrendered subject...more
JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC. - Before Prost, Reyna, and Taranto. Appeal from the United States District Court for the District of New Jersey. The Federal Circuit found that claims reciting a...more
In Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Appeal No. 25-1228, The Federal Circuit found that claims reciting a dosing regimen with unequal loading doses were not obvious and that a presumption of...more
Prosecution history estoppel may narrow the scope of a claim that was unamended during prosecution, if another closely related claim is amended or cancelled during prosecution....more
On July 18, 2025, the U.S. Court of Appeals for the Federal Circuit reversed a $106 million jury verdict in Colibri Heart Valve LLC v. Medtronic CoreValve, LLC, No. 2023-2153, finding that Colibri’s infringement claim under...more
COLIBRI HEART VALVE LLC v. MEDTRONIC COREVALVE, LLC - Before Taranto, Hughes, and Stoll. Appeal from the United States District Court for the Central District of California. The Federal Circuit reversed a $106 million...more
On July 18, 2025, the US Court of Appeals for the Federal Circuit reversed a lower court ruling in Colibri Heart Valve LLC v. Medtronic CoreValve, LLC, holding that prosecution history estoppel barred the patentees’ doctrine...more
Prosecution history estoppel typically arises when a claim is rejected during prosecution and is then amended (narrowed) to overcome the rejection. However, in Colibri Heart Valve LLC v. Medtronic CoreValve, LLC, No....more
In a July 18 precedential decision in Colibri Heart Valve LLC v. Medtronic CoreValve LLC, the U.S. Court of Appeals for the Federal Circuit overturned a $106 million jury verdict against Medtronic for infringement of a patent...more
The doctrine of equivalents (DOE), a creation of the Supreme Court in Graver Tank & Mfg. v. Linde Air Products (1950), is balanced by the concept of prosecution history estoppel (PHE), the contours of which were delineated...more
In the last week, Amgen, Inc and Amgen Manufacturing Ltd, LLC (“Amgen”) filed three more BPCIA complaints against companies seeking approval for a denosumab biosimilar. ...more
In Steuben Foods Inc. v. Shibuya Hoppmann Corporation, the Federal Circuit addressed the boundaries a district court may impose on experts by deeming their testimony wrong as a matter of law. Background - Steuben Foods...more
Simbrinza® (brinzolamide / brimonidine) - Case Name: Alcon Inc. v. Padagis Israel Pharms. Ltd., Civ. No. 22-1422-WCB, 2025 WL 457119 (D. Del. Feb. 5, 2025) (Bryson, C.J.) Drug Product and Patent(s)-in-Suit: Simbrinza®...more
In this edition of The Precedent, we outline the decision in Steuben Foods Inc. v. Shibuya Hoppmann Corp. This case addresses whether the reverse doctrine of equivalents (RDOE) is a viable defense to patent infringement....more
Conflicting expert testimony constituted substantial evidence supporting the jury’s rejection of a reverse doctrine of equivalents argument....more
On January 24, in Steuben Foods, Inc v. Shibuya Hoppman Corporation, the Federal Circuit found that Steuben had made a compelling argument that the common law Reverse Doctrine of Equivalents (RDOE) did not survive the 1952...more
The US Court of Appeals for the Federal Circuit ruled that the “substantially the same way” comparison in connection with a doctrine of equivalents (DOE) analysis involving a means-plus-function claim limitation should focus...more
Steuben Foods, Inc. v. Shibuya Hoppman Corp., Appeal No. 2023-1790 (Fed. Cir. Jan. 24, 2025) In its only precedential patent decision this week, the Federal Circuit addressed an “anachronistic exception, long mentioned but...more
Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed release portions infringed on a...more