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?
Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to...more
As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more
In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more
Sen. Orrin Hatch has introduced a bill that would augment the Hatch-Waxman Act, limiting challengers ability to proceed with patent challenges both in court and at the PTAB. Following is the introduction of the “Hatch-Waxman...more
On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes...more
Senator Orrin Hatch (R-Utah), the namesake and coauthor of the Hatch-Waxman Act, proposed (but has not yet introduced) an amendment titled the “Hatch-Waxman Integrity Act of 2018” during the Senate Judiciary Committee held on...more
As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance many say has been skewed by Inter Partes Review...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
Textile Copyright Cases Ripe for ADR - While normally focused on music and media matters, copyright lawyers in California have grown busy with something else: fabrics. Hundreds of textile copyright suits involving fabric...more
The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more
On August 19th, the USPTO released a new set of proposed rules related to post-grant proceedings before the Patent Trial and Appeal Board (PTAB). Among the many offered rules was the addition of a “Rule 11-type certification”...more
The recently established inter partes review (IPR) and post-grant review (PGR) of the America Invents Act have been in the spotlight lately, especially now that the life sciences industry has begun to utilize these...more