BioPharma Law Group PLLC

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

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