Innovators rejoice while generic sponsors mourn: In the wake of the latest in GSK v. Teva decision, the skinny label may be dead. The “skinny label,” also known as a “carve-out” or a “section viii statement,” is a widely-used statutory provision adopted in the Hatch Waxman …
Meet the newest category of drug applications: the PANDA. A PANDA, or the Pre-Hatch-Waxman Abbreviated New Drug Application, refers to abbreviated drug applications submitted and approved under sections 505(b) and 505(c) of the Federal Food, Drug, and Cosmetic Act (FDCA) prior to the enactment of …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 37th iteration – is scheduled to take place from September 29-30, 2021 (Eastern Standard Time). The conference is billed as the premier event to provide folks with a roadmap to navigate the …
Every year, the Food and Drug Law Institute (FDLI) publishes a compendium of the Top Food and Drug Cases from the previous year, as well as Cases to Watch, in conjunction with its popular Annual Conference. This year was no different. Recently, FDLI published on …
Over the past few days there’s been an avalanche of FDA-related legislation introduced in both the U.S. House of Representatives and the U.S. Senate. Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “Addressing Anticompetitive Conduct and Consolidation in …
So-called “Pay-for-Delay” settlements, also called Reverse Payment, settlements—in which an innovator sponsor pays a generic sponsor to settle ongoing patent infringement litigation in exchange for a delay in generic market entry—have been fodder for antitrust concerns for decades (see, for example, our coverage from 2013). …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Sara W. Koblitz will be discussing the fundamentals of FDA law as it relates to Intellectual Property law in a remote program hosted by the DC Bar. The program, titled “FDA Law for IP Lawyers: Tips …
There’s no question that drug pricing is one of the most important issues in health care right now, and while such pricing considerations are outside FDA’s statutory mandate, it has not stopped FDA from trying to address pricing issues through enhancing drug competition (see, for …
Perhaps when you’re carving out a patented method of use? Well, at least that’s what GSK is arguing. As the now-infamous GSK v. Teva case makes its way through the Federal Circuit once again to address what many have called the death-knell to skinny-labeling (also …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 36th iteration – is scheduled to take place from March 24-25, 2021 (Eastern Time). The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult …
Those of you keeping up with the Orange Book know that FDA has been considering changes to patent listing requirements, many of which industry has been requesting for decades. Now, Congress is trying to facilitate effective administration of the Orange Book. On January 5, 2021, …
The FDA Law Blog may appear to have become a little patent-heavy over the last few months, but you can thank the Federal Circuit for that. It just can’t stop changing the landscape for Hatch-Waxman litigation. In October, the Federal Circuit, for all intents and …
To close out 2020, Hyman, Phelps & McNamara, P.C. is pleased to present the latest issue of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to receive contemporaneous posts on regulatory and enforcement …
Identification of and comparison to a Reference Listed Drug (“RLD”) and Reference Standards (“RS”) are the lynchpin of generic drug development and approval. It’s therefore no surprise that, upon significantly updating the Orange Book in January 2017, FDA dedicated an entire guidance to fundamental definitions …
2020 was supposed to be a year remembered for the 40th anniversary of the publication of the Orange Book—a celebration of one aspect of the Hatch-Waxman Amendments—but it could turn out that 2020 is remembered as the year in which the Hatch-Waxman Amendments took a …
