In re Lantus Direct Purchaser Antitrust Litigation, No. 18-2086 (1st Cir. 2020)Annotate this Case
The First Circuit held that Sanofi-Aventis U.S., LLC improperly submitted a patent for listing in "the Orange Book" and that Sanofi was potentially liable under the antitrust laws to drug purchasers who were allegedly harmed by the effective extension of Sanofi's monopoly.
At the center of this appeal was a publication maintained by the FDA called Approved Drug Products with Therapeutic Equivalence Evaluations, known as "the Orange Book," which lists patents said by their owners to claim FDA-approved drugs. When a patent is listed in the Orange Book the patent-owning drug manufacturer has the ability to trigger an automatic, thirty-month suspension of the FDA's approval of a competing product. Plaintiffs alleged that Sanofi artificially restricted competition in the market for insulin glargine by improperly listing a certain patent in the Orange Book, thereby delaying competition in the insulin glargine market and resulting in inflated prices. The district court dismissed Plaintiffs' Sherman Act claims. The First Circuit vacated the dismissal as to Sanofi's alleged improper Orange Book listing of the patent, holding that Sanofi improperly submitted the patent for listing in the Orange Book and that Sanofi potentially liable under the antitrust laws to drug purchasers who were allegedly harmed by the effective extension of Sanofi's monopoly.