Brooklyn Journal of Corporate, Financial & Commercial Law


Ping-Hsun Chen

First Page



The Hatch-Waxman Act encourages generic drug companies to submit an abbreviated new drug application (“ANDA”) for a generic version of a drug approved by the U.S. Food and Drug Administration (“FDA”). Nevertheless, a mechanism exists for a brand-name drug company to adjudicate a patent infringement dispute before the FDA approves an ANDA. The mechanism includes the regulatory scheme of patent information submission implemented by the FDA. 21 U.S.C. § 355(b)(1) requires that patent information be correct. False patent information destroys the objectives of the Hatch-Waxman Act. In re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017), may demonstrate a new form of false patent information, because the defendant there mislabeled the disputed patents as drug product patents rather than method-of-use patents. The mislabeling caused one generic drug company not to use a Section viii statement to speed up approval of its ANDA. As a result of the mislabeling, the marketing of generic drugs was delayed, and patients were forced to pay monopoly prices for their drugs. This Article argues that such mislabeling violates Section 2 of the Sherman Act, which criminalizes monopolization achieved through anticompetitive conduct.