IP and Innovation Law
Brand-name drug manufacturers in the United States charge high prices during market-exclusivity periods, enabled by patents that block direct competition from generics and biosimilars. When bringing a generic or biosimilar drug to the market, potential competitors must avoid infringing on each patent protecting the brand-name drug by waiting for relevant patents to expire, making product-design choices to avoid overlap with patented inventions, or challenging patents and having them invalidated by a court. Successful drugs are frequently protected by a large number of often-overlapping patents, known as a patent thicket. These patent portfolios make it difficult for generics or biosimilars to enter the market and can extend market-exclusivity periods.
View full article here: https://www.nejm.org/doi/full/10.1056/NEJMp2412999.
Authors: Bernard Chao (University of Denver), Ryan Whalen, Aaron S. Kesselheim (Brigham and Women’s Hospital, Boston), and S. Sean Tu (West Virginia University)
Published in the The New England Journal of Medicine, Massachusetts Medical Society, Vol. 391 n. 23, 2024.