Posts Tagged: "generic drugs"

How Public Opinion Polls Expand the Conversation on GSK v. Teva and Skinny Labeling

The Federal Circuit’s recent majority opinion and Chief Judge Prost’s dissenting opinion in the GlaxoSmithKline LLC v. Teva Pharmaceuticals “skinny labeling” case has raised eyebrows and piqued interest beyond the usual circles. The decision’s result is a lower bar for finding induced infringement—a win for brand-name companies. While the jury found infringement against Teva’s skinny labeled carvedilol, a congestive heart failure drug, we could not help but wonder if the American public sees the issue more like the majority Federal Circuit opinion or more like the dissenting opinion of Chief Judge Prost? How do Americans view “skinny labeling,” and how might those opinions intersect with future findings of the evolving law? Will jurors see the stronger position of brand companies as something to uphold or does the consumer benefit of generics foster a different preference? We discuss the legal perspectives and national surveys on skinny labeling and patent protections to expand the conversation.

China’s New Patent Linkage System: A Guide for Foreign Chinese Patent Holders

In compliance with the Phase One Trade Agreement, China has implemented a patent linkage system in their amended patent law, which became effective June 1, 2021 (Article 76 of the Patent Law of the People’s Republic of China (2020)). The Chinese patent linkage system prevents marketing approval of generic drugs until after the expiration of patents covering the drugs or uses. Specifically, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has set up a registration system to register patents covering: chemical drugs and uses; traditional Chinese medicines (TCM) and uses; and biologics: Active Pharmaceutical Ingredients (API) sequence structure and medical use. The registration system started public testing in May and is now live.

Hatch-Waxman and BPCIA Cases and Trends to Watch in 2021

As we turn the page to 2021, we expect at least two major cases to be resolved that could have long-lasting effects on where and how Hatch-Waxman and Biologics Price Competition and Innovation Act (BPCIA) cases are litigated. Specifically, the future of skinny labels is in doubt, and available venues for Plaintiffs could be significantly narrowed. The number of new drugs eligible for generic competition will also rebound in 2021, but only time will tell if the global pandemic affects the overall number of generic filings. While there are many more Hatch-Waxman and BPCIA developments to watch this year, these are a few that we will be following closely.

China’s NMPA and CNIPA Propose Draft Measures on Patent Linkage for Public Comment: Implications for the Future of Innovative and Generic Drugs

The National Medical Products Administration (NMPA), in conjunction with the China National Intellectual Property Administration (CNIPA), recently solicited public comments on the draft of “Measures For the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)” (“Draft Measures”). The purpose of the Draft Measures is to establish an early resolution mechanism for drug patent disputes. The deadline for submission of comments is October 25, 2020.

Federal Circuit Says Teva Induced Infringement of GSK Patent on Congestive Heart Failure Drug

In GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the United States Court of Appeals for the Federal Circuit (CAFC) on Friday reversed a district court’s motion for judgment as a matter of law (JMOL) for Teva, finding that Teva was liable for induced infringement of GlaxoSmithKline’s (GSK’s) patent directed to a method of treating Congestive Heart Failure (CHF) using carvedilol….. Chief Judge Prost authored a dissenting opinion, wherein she expressed the majority’s opinion undermined a critical balance between patent protection and public access once a patent expires “by allowing a drug marketed for unpatented uses to give rise to liability for inducement and by permitting an award of patent damages where causation has not been shown.”