Recently, a number of bills that would significantly impact the biotech and pharma industry have been introduced in Congress.
These bills include the Preserve Access to Affordable Generics Act (S. 369), which would prohibit brand name drug companies from compensating generic drug companies for delaying the entry of generic drugs into the market; the Promoting Innovation and Access to Life-Saving Medicine Act (H.R. 1427), which would create a follow-on biologics regulatory pathway in the U.S.; and the Patent Reform Act of 2009 (S. 515 and H.R. 1260), which would make a number of important changes to Title 35.
Lost in the introduction of these bills was the introduction of the Fair Prescription Drug Competition Act (S. 501 and H.R. 573), which would prohibit the marketing of authorized generic drugs.
In particular, the new legislation would amend § 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355) to add a new subsection prohibiting the holder of a New Drug Application (NDA) from manufacturing, marketing, selling, or distributing an authorized generic drug, either directly or indirectly, or authorizing any other person to manufacture, market, sell, or distribute an authorized generic drug.
The House bill, which was introduced on January 15, was sponsored by Representative Jo Ann Emerson (R-MO) and co-sponsored by Representatives Marion Berry (D-AR), Dennis Moore (D-KS), and Zach Wamp (R-TN).
The Senate bill, which was introduced on February 26, was sponsored by Senator John D. Rockefeller, IV (D-WV) and co-sponsored by Senators Sherrod Brown (D-OH), Daniel Inouye (D-HI), Herb Kohl (D-WI), Patrick Leahy (D-VT), Charles Schumer (D-NY) Jeanne Shaheen (D-NH), and Debbie Stabenow (D-MI).
Donald L. Zuhn, Jr. has more than a decade of experience in all aspects of patent prosecution, litigation, counseling, and licensing. He represents a variety of clients, including biotechnology and pharmaceutical companies both large and small, and universities. See more information at http://www.patentdocs.org
