Organisation: US Food and Drug Administration

A deep dive into patent law and exclusivity in the United States

Featured in The Guide to Life Sciences: Key issues for senior life sciences executives 2024

Life science legislation is nuanced and must be carefully navigated to when creating an effective patent portfolio. Having a keen understanding of regulatory provisions is key to navigating the many minefields inherent in the commercialisation of a successful product.

24 June 2024

FTC opposes 300 more Orange Book patents

The US Federal Trade Commission is ramping up pressure on pharma patentees

02 May 2024

Five stories that made 2023 a momentous year for life sciences IP

The dawn of a new era for CRISPR patent strategy, multiplying mRNA patent wars, and 10x Genomics and NanoString’s cross-border spat were among the developments that defined the last 12 months

02 January 2024

First US CRISPR Cas9 approval marks start of new era of patent wars

Friday’s green light from the FDA is watershed for IP strategy in the field

11 December 2023

Historic CRISPR drug approval heralds new era in Cas9 IP wars

Green light for first ever Cas9 therapy ushers in next phase of licensing and litigation efforts.

17 November 2023

Biosimilars and biologics litigation in the United States

Featured in The Guide to Life Sciences: Key issues for senior life sciences executives 2023

Whether the new Inflation Reduction Act will protect and foster the growing biosimilar market remains to be seen, but litigation in the biosimilars space has already transformed the landscape, making it increasingly difficult to navigate for biopharma companies and IP professionals.

25 August 2023

Humira interchangeable launches will send important signals for patent strategy

Wave of adalimumab market entrants to provide crucial information about nascent biosimilars market and impact IP tactics

14 July 2023

Federal Circuit fails to clear up REMS patent uncertainties in latest Orange Book ruling

Questions over FDA patent listing remain following Jazz v Avadel dispute

09 March 2023

Why the United States urgently needs patent subject-matter eligibility reform

The law is in a state of disarray that has led to inconsistent case decisions, deep uncertainty in the innovative, investment and legal communities, and unpredictable outcomes in prosecution and litigation. David Kappos, Paul Michel, Corey Salsberg and Matthew Dowd argue that the United States' legislators must act to ensure the country maintains its long-standing competitive edge in the global innovation race

07 September 2022

The sword, the shield, the olive branch – NuCurrent’s path to IP value creation

In an exclusive interview, the company’s CEO Jacob Babcock details its journey to becoming a technology licensing business

16 August 2022