BioPharma Law Group PLLC
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
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
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