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
As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more
Recently, the Federal Circuit addressed a significant issue of first impression with respect to obviousness-type double patenting (ODP), holding that ODP applies to patent claims that claim priority to the same application...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
Addressing for the first time how patent term adjustments (PTAs) interact with obviousness-type double patenting (ODP), the US Court of Appeals for the Federal Circuit concluded that when members of a patent family have...more
Precedential and Key Federal Circuit Opinions - VOLVO PENTA v. BRUNSWICK CORP. [OPINION] (2022-1765, 8/24/2023) (Moore, Lourie, and Cunningham) - Moore, Chief J. The Court vacated and remanded the Patent Trial and...more
In re Cellect, LLC, Appeal Nos. 2022-1293, -1294, -1295, -1296 (Fed. Cir. Aug. 28, 2023) In a significant appeal from ex parte reexamination proceedings before the Patent Trial and Appeal Board, the Federal Circuit...more
Last week, the Federal Circuit held that obviousness-type double patenting trumps patent term adjustment, opening the door for invalidity attacks that to date had been questionable. In re Cellect was an appeal from a...more
A patent gives the patent holder the right to exclude others from making, using, selling, offering to sell, or importing an invention covered by the patent. However, the right only lasts for a limited period of time and will...more
Barry v. Medtronic, Inc. (No. 2017-2463, 1/24/19) (Prost, Moore, Taranto) - Taranto, J. Affirming judgement of no invalidating public use of patents related to methods for correcting spinal column anomalies. Also...more
A Post-URAA Patent that Issues After but Expires Before a Related Pre-URAA Patent Is Not a Double-Patenting Reference Against the Pre-URAA Patent - In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc.,...more
Federal Circuit Summary - Before Moore, Chen, and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: Obviousness-type double patenting does not invalidate an otherwise validly...more
The drug company Actelion Pharmaceuticals, Ltd., recently lost a bid to increase the term of its U.S. Patent No. 8,658,675 by five days, ultimately because its patent attorney failed to check a box on the application form. ...more
Please see list of Countries and their rules regarding offering Patent Term Extensions and Supplementary Protection Certificates. ...more