Webinar: Orange Book listing sheets under the microscope
Key Considerations for Reshoring U.S. Drug Manufacturing
Drug Pricing Initiatives During the Trump Presidency
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Patent law in Europe: What pharmaceutical companies need to know
EU excessive pricing laws
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
Vascular Solutions LLC, et al. v. Medtronic, Inc., et al., No. 2024-1398 (Fed. Cir. (D. Minn.) Sept. 16, 2024). Opinion by Mazzant (sitting by designation), joined by Moore and Prost....more
The use of the word “about” in a patent claim as part of a numeric range might permit the patent holder to preclude competitor formulations falling outside the approximate range, as illustrated in a fairly recent decision Par...more
It has long been understood that claim construction can, and frequently is, dispositive in patent litigation. This truism was the basis for the Federal Circuit affirming the District Court's decision against a generic drug...more
Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., Appeal No. 2019-2402 (Fed. Cir. Nov. 5, 2020) - In our Case of the Week, the Federal Circuit addressed a lingering question about venue following the...more
Precedential Federal Circuit Opinions - ANTENNASYS, INC. v. AQYR TECHNOLOGIES, INC. [OPINION] (O’Malley, Bryson, Reyna) - O’Malley, J. Remanding to district court to address threshold issues of whether case should be...more
IBSA INSTITUT BIOCHIMIQUE, S.A. V. TEVA PHARMACEUTICALS USA, INC. Before Prost, Reyna, and Hughes. Appeal from the District Court of Delaware - Summary: A term may be indefinite when the proposed construction is not...more
The US Court of Appeals for the Federal Circuit affirmed a district court’s invalidity and infringement judgments for patents directed to a topical nonsteroidal anti-inflammatory drug, finding that a patent claim reciting a...more
The US Court of Appeals for the Federal Circuit affirmed a district court’s finding, based largely on the prosecution history, that disputed “wherein” clauses were limiting and therefore the grant of a preliminary injunction...more
Addressing an appeal from four related actions concerning Orange Book patents covering Suboxone® sublingual film, the US Court of Appeals for the Federal Circuit affirmed the district court’s judgments that certain generic...more
In Allergan Sales, LLC v. Sandoz, Inc., (Fed. Cir. 2018-2207, Aug. 29, 2019), the Federal Circuit held that “wherein” clauses in a patent claim were limitations because the “wherein” elements were material to patentability....more
Priority Claims Cannot Be Incorporated by Reference - In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited, Appeal Nos. 2016-2707 and 2016-2708, the Federal Circuit held that when a patent for a...more
Before Moore, Mayer, and Stoll. Appeal from the United States District Court for the District of New Jersey. Summary: Plain claim language will not be narrowed based on a patent’s specification unless the patentee clearly...more
Distribution Agreements Can Constitute Offers for Sale Under Section 102(b) - In The Medicines Company v. Hospira, Inc., Appeal Nos. 2014-1469, 2014-1504, the Federal Circuit held that a distribution agreement qualified as...more
As post-Actavis antitrust litigation over so-called “reverse payment” patent settlements proceeds, courts continue to provide further illumination about what evidence a private plaintiff would need to offer to survive summary...more
We pointed out in a recent article that, based on recent decisions by the Courts of Appeals for the First and Third Circuits, private antitrust plaintiffs seeking damages from so-called “reverse-payment” settlement agreements...more
Amidst a spate of high-profile IPR filings in the life sciences space by hedge fund financiers, the biotechnology industry has mobilized behind two chief legislative strategies designed to limit or eliminate its exposure to...more
When inter partes review (IPR) proceedings became effective in September 2012, few people would have predicted the transformative effect it would have on patents and the litigation landscape. Three years in, IPR has become...more
Case Name: Shire Development, LLC v. Watson Pharms., Inc., 787 F.3d 1359 (Fed. Cir. June 3, 2015) (Circuit Judges Prost, Chen, and Hughes presiding; Opinion by Hughes, J.) (Appeal from S.D. Fla., Middlebrooks, J.) - Drug...more
In a divided opinion issued in Braintree Labs., Inc. v. Novel Labs., Inc., the Federal Circuit reversed the district court on one of two challenged claim construction issues and vacated the district court’s finding of...more
Claim construction in patent cases, and the propensity for the Federal Circuit to disagree with a district court's conclusions regarding the scope and meaning of claim terms, remains one of the most vexing aspects of patent...more