News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Patent Trial and Appeal Board

MoFo Life Sciences

Federal Court Invalidates Dosing Patent Based On Clinical Trials Disclosure

MoFo Life Sciences on

As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more

Dechert LLP

Initiatives to Increase Communication Between the USPTO and the FDA Concerning Pharmaceutical Patent Applications

Dechert LLP on

President Biden, in July 2021, issued an Executive Order (“E.O.”) observing that “too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and...more

ArentFox Schiff

Legislative Changes to FDA’s Orange Book and Purple Book Listing Requirements

ArentFox Schiff on

Recent legislative developments include amendments to expand upon Orange Book and Purple Book listing requirements. Amidst the breathtaking sweep of activities in the Trump Administration’s waning days in office, the...more

McNees Wallace & Nurick LLC

Intellectual Property 2014 Year in Review

The year 2014 saw some important developments in the area of intellectual property law. A number of intellectual property-related issues even made national headlines. Who can forget the public debate over the rightful...more

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