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?
It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more
Clients often ask if a law firm can represent both brand and generic drug manufacturers. It’s a reasonable question, particularly when the popular perception is that potential conflicts pigeonhole law firms, forcing them to...more
In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more
On 25 March 2021 the European Court of Justice (ECJ) dismissed all the appeals brought by Danish pharmaceutical company H. Lundbeck A/S (Lundbeck) and five generic manufacturers against the judgments of the General Court of...more
The Federal Circuit’s October 2020 split decision in GSK v. Teva made waves throughout the pharmaceutical industry and among Hatch-Waxman litigators. In the broadest reading, some see the majority opinion as rendering any...more
When Big Pharma insists its sky-high prices are justified, patients may want to keep in mind key findings just revealed about prescription drugs and their makers...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
The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469). The Waiver has been introduced with the stated aim of putting EU generic and...more
Addressing the validity of patents involved in a Hatch-Waxman litigation, the US Court of Appeals for the Federal Circuit held that claims were invalid for lack of an adequate written description because the specification...more
Manufacturers who want to introduce generic drugs face a special delay and enjoy a corresponding special right to challenge patents on branded drugs based on the great compromise in the Hatch-Waxman Act. ...more
Five years after the U.S. Supreme Court found in FTC v. Actavis, 570 U.S. 136 (2013), that large and unjustified payments from a brand pharmaceutical manufacturer to prevent generic entry can provide a basis for an antitrust...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
On July 11, in The Medicines Company v. Hospira, Inc., the Federal Circuit held that a contract manufacturer's sale of manufacturing services to an inventor did not constitute a commercial sale of the patented invention for...more
Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented...more
The court’s decision provides insight into which activities trigger the on-sale bar provision. On July 11, in The Medicines Co. v. Hospira, Inc., No. 14-1469 (Fed. Cir. July 11, 2016), the U.S. Court of Appeals for the...more
Those working in the pharmaceutical space are used to hearing complaints about the high costs of drugs, and patents often are blamed for allowing pharmaceutical companies to charge “too much” for their products. But are drug...more
In The Medicines Company v. Hospira, Inc., the Federal Circuit held that a transaction with a contract manufacturer gave rise to an on sale bar that invalidated The Medicines Company’s Angiomax® patents. Are the facts of this...more
The Generic Pharmaceutical Association (GPhA) issued a statement today regarding ongoing talks between major Pacific Rim countries (including the U.S.) related to the proposed Trans-Pacific Partnership Agreement. This trade...more