IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
AZURITY PHARMACEUTICALS, INC. v. ALKEM LABORATORIES LTD. Before Murphy, Moore, and Chen. Appeal from the United States District Court for the District of Delaware. Arguments and amendments made during prosecution of a parent...more
The US Court of Appeals for the Federal Circuit affirmed a district court’s noninfringement determination, finding that the presence of a disclaimed compound in the accused product precluded infringement. Azurity Pharm., Inc....more
Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., Appeal No. 2023-1977 (Fed. Cir. Apr. 8, 2025) In our Case of the Week, the Federal Circuit affirmed that defendant Alkem’s proposed generic antibiotic did not...more
Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original...more
Actavis Labs. FL, Inc. v. United States, Appeal No. 2023-1320 (Fed. Cir. Mar. 21, 2025) Our Case of the Week, in the words of its author, Circuit Judge Stark, “is not actually a patent case. It is, instead, a tax case.” In...more
On March 13, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed a five-year patent term extension (“PTE”) for Merck’s sugammadex patent, holding that the district court had correctly calculated PTE based on the...more
Precedential and Key Federal Circuit Opinions - STEUBEN FOODS, INC. v. SHIBUYA HOPPMANN CORPORATION [OPINION] (2023-1790, 1/24/2025) (Moore, Hughes, Cunningham) - Moore, Chief J. The Court reversed the district...more
The Federal Circuit recently reversed a District of Delaware decision that invalidated claims of Novartis’s Orange Book listed patent, U.S. Patent No. 8,101,659 (the “’659 patent”), for its blockbuster drug Entresto®, a...more
CloudofChange, LLC v. NCR Corp., Appeal No. 2023-1111 (Fed. Cir. Dec. 18, 2024) In our Case of the Week, the Federal Circuit addressed the question of divided infringement in the context of system claims. In its...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
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
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
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
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
This case is an appellate review of the district court’s findings regarding patent obviousness and priority date. Background Amgen produces and markets apremilast, a medication for the treatment of certain types of psoriasis...more
We are excited to share Sheppard Mullin’s inaugural quarterly report on key Federal Circuit decisions. The Spring 2023 Quarterly Report provides summaries of most key patent law-related decisions from January 1, 2023 to March...more
The US Court of Appeals for the Federal Circuit ordered that the only Orange Book patent asserted in a lawsuit must be delisted since its claims were directed to the computer-implemented distribution system and not a method...more
On February 24, 2023, the U.S. Court of Appeals for the Federal Circuit, in Jazz Pharmaceuticals, Inc., v. Avadel CNS Pharmaceuticals, LLC, Case No. 23-1186, affirmed a decision from the District Court of Delaware directing...more
The US Court of Appeals for the Federal Circuit affirmed a district court’s finding of noninfringement in a Hatch-Waxman case under 35 U.S.C. § 271(e)(2) and § 271(a)-(b). The Court found that the alleged infringer’s...more
On June 21, in Novartis Pharmaceuticals Corporation v. Accord Healthcare, Inc., a reshuffled Federal Circuit panel reversed course on rehearing to find that a negative claim limitation was not supported by silence in the...more
The US Court of Appeals for the Federal Circuit upheld a finding that patents covering Narcan, a naloxone-based intranasal opioid overdose treatment, were obvious despite evidence of long-felt need. Adapt Pharma Operations...more
On January 3, 2021, The Federal Circuit held in a 2-1 decision in Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022) that the claims of Novartis’ U.S. Pat. No. 9,187,405 (“the ’405 patent”) met the...more
Vacating a stipulated infringement judgment based on an incorrect claim construction, the US Court of Appeals for the Federal Circuit explained that it is improper to isolate claim language from the intrinsic evidence when...more