BioPharma Law Group PLLC
Section 1498 in Pharmaceutical Patent Litigation: The Overlooked But Stronger Sister to March-In Rights
Few statutory provisions have generated as much controversy in the pharmaceutical space as the federal government’s retained authority to override patent rights in the public interest. While patent exclusivity is...Read more
Joanna Brougher
Owner & Principal, BioPharma Law Group PLLC, USA
March-In Rights at a Crossroad: What Biopharma Needs To Know Under Trump Administration
Few pieces of legislation have shaped the modern innovation landscape as profoundly as the Bayh-Dole Act of 1980. By allowing universities, small businesses, and non-profit organizations to retain ownership...Read more
Joanna Brougher
Owner & Principal, BioPharma Law Group PLLC, USA
Orange Book Listings Under Scrutiny: What’s In, What’s Out, and Why It Matters
The Food and Drug Administration’s (FDA) Orange Book, officially titled Approved Drug Products with Therapeutic Equivalence Evaluations, plays a key role in the U.S. pharmaceutical patent and exclusivity system. The...Read more
Joanna Brougher
Owner & Principal, BioPharma Law Group PLLC, USA
REMS Patents: Listability and Other Issues
Abstract: Are Risk Evaluation and Mitigation Strategy (REMS) patents Orange Book listable (or even should be)? A straightforward question with a lot of disagreement. This paper discusses recent litigation on...Read more
Joanna Brougher
Owner & Principal, BioPharma Law Group PLLC, USA