The FDA maintains a publication called Approved Drug Products with Therapeutic Equivalence Evaluations, known in the industry as "the Orange Book." The Orange Book lists patents said by their owners to claim FDA approved drugs. The listing of a patent in the Orange Book arms the patent-owning drug manufacturer with the ability to trigger an automatic, thirty-month suspension of the FDA's approval of a competitive product. The principal questions posed on this appeal are whether Sanofi improperly submitted a patent for listing in the Orange Book and, if so, whether Sanofi is potentially liable under the antitrust laws to drug purchasers who were allegedly harmed by the effective extension of Sanofi's monopoly. We answer "yes" to both questions and vacate the dismissal of the plaintiffs' complaint to the extent that the district court held otherwise.
Registering your trademarks is one of the best long-term investments you can make in your business. Contact us today for more information.
Visit Gehrke & Associates, SC.