The United States-Mexico-Canada Agreement (USMCA) provisions on the term of protection of test data for new pharmaceutical products has received considerable attention, and in some cases, some inaccurate reports on the agreement have conflated the term for test data protection… Continue Reading
Walgreen and Kroger, two major U.S. pharmacies, have filed suit against Johnson & Johnson in the U.S. District Court Eastern District of Pennsylvania, alleging antitrust violations stemming from exclusionary contracts and rebates designed to prevent biosimilars of J&J’s Remicade (INN:… Continue Reading
In a 6 December 2013 letter, Representative Henry Waxman wrote to USTR Ambassador Michael Froman opposing USTR’s proposal of a term of 12 years of exclusivity for biologics in the Trans Pacific Partnership (TPP). The letter notes,
[w]hile I have worked closely with Senator Hatch on important health issues, including the generic drug law that we co-authored in 1984, I strongly disagreed that the United States should be proposing twelve years of exclusivity.