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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
Allergan USA, Inc. v. MSN Laboratories Private Ltd., Appeal No. 2024-1061 (Fed. Cir. August 13, 2024) In this week’s Case of the Week, the Federal Circuit clarifies rules relating to when an applicant’s patent can be...more
On August 13, 2024, a three-judge panel of the Court of Appeals for the Federal Circuit issued a decision, authored by Judge Lourie, in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061, which limits the...more
Late last week in Natera, Inc. v. NeoGenomics Laboratories, Inc. (24-1324), the Federal Circuit affirmed a preliminary injunction ruling from the lower court that mostly prohibits NeoGenomics from selling its oncology test...more
The US Court of Appeals for the Federal Circuit held that a branded pharmaceutical manufacturer properly pled a theory of inducement by alleging that the generic competitor promoted its product as “generic” to the branded...more
On June 10, 2024, Judge Stanley R. Chesler of the United States District Court for the District of New Jersey granted the Amneal defendants’ motion for partial judgment on their counterclaims in a Hatch-Waxman dispute, and...more
In Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals, Inc. 2023-1952 (Fed. Cir. April 11, 2024), this case involves appellate review of a district court’s findings regarding patent obviousness and infringement in...more
The US Court of Appeals for the Second Circuit affirmed the dismissal of a lawsuit against pharmaceutical companies accused of violating antitrust laws by using reverse payments to delay entry of a generic version of a...more
On May 17, 2024, an Appeals Review Panel (ARP) of the United States Patent and Trademark Office (“USPTO”) released its decision in Ex parte Chamberlain (referred to in Federal Circuit proceedings as In re Xencor;...more
Copan Italia SPA v. Puritan Med. Prods. Co. LLC, Appeal No. 2022-1943 (Fed. Cir. May 14, 2024) The Federal Circuit’s only precedential opinion concerning a patent case this week had nothing to do with patent law....more
In DexCom, Inc., v. Abbott Diabetes Care, Inc., 89 F.4th 1370 (Fed. Cir. 2024), the U.S. Court of Appeals for the Federal Circuit affirmed a district court’s denial of a preliminary injunction, finding that a patentee could...more
As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, “the Biocon Defendants”) regarding the Biocon Defendants’...more
Janssen Pharms., Inc. et al. v. Teva Pharm. USA, Inc. et al., Appeal Nos. 2022-1258, -1307 (Fed. Cir. April 1, 2024) In this week’s Case of the Week, the Federal Circuit vacated-in-part a district court’s bench trial...more
Addressing an issue of first impression, the US Court of Appeals for the Second Circuit concluded that two medications that contain the same ingredients but are packaged in different forms constitute separate markets for...more
In a 2022 decision involving Janssen and Pharmascience, the Federal Court found that the claims of Canadian Patent No. 2,655,335 (335 patent, relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA)) were not invalid...more
As previously reported, the Federal Court released a pair of decisions relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA), finding in a summary trial that each of Pharmascience and Apotex would induce infringement...more
In H. Lundbeck A-S v. Lupin Ltd., Case No. 2022-1194 (Fed. Circ. December 7, 2023), Plaintiffs, H. Lundbeck A/S (“Lundbeck”) and Takeda Pharmaceutical Company Ltd., Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals...more
In a patent infringement action brought by Allergan and AbbVie under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations), in relation to 0.01% w/v bimatoprost solution for ophthalmic...more
In light of the 2023 Supreme Court of the United States decision in Amgen Inc. v. Sanofi, the US Patent & Trademark Office (PTO) published guidelines for PTO employees to use, regardless of technology, to ascertain compliance...more
The US Court of Appeals for the Federal Circuit made explicit what has long been considered implicit based on Warner-Lambert and its progeny, namely, that plaintiffs asserting an induced infringement theory to bar the entry...more
VLSI Technology LLC v. Intel Corporation, Appeal No. 2022-1906 (Fed. Cir. December 4, 2023) In this week’s Case of the Week, the Federal Circuit vacated an approximately $2.2 billion damages award against appellant Intel...more
Proper construction of claim limitations reciting the chemical property of pH (which denotes the concentration of hydrogen ions in a solution as an indication of acidity) has arisen several times in district court and Federal...more
In a matter of first impression, the US Court of Appeals for the Federal Circuit concluded that the Patent Trial & Appeal Board has the authority to issue a final written decision (FWD) in a post-grant review (PGR) proceeding...more
As previously reported, the Federal Court (FC) dismissed Janssen’s application for judicial review of the decision of the Office of Submissions and Intellectual Property (OSIP) refusing to list Canadian Patent No. 3,113,837...more
The US Court of Appeals for the Federal Circuit determined that the limitation “a pH of 13 or higher” could not be construed using the asserted patents’ intrinsic evidence and therefore remanded to the district court with...more