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Hatch-Waxman; Hatch-Waxman Act; ANDA; FDA; 355(b)(1); 21 U.S.C.; Patent Information; False Patent Information; In re Actos; 848 F.3d 89; Disputed Patents; Mislabeled; Section viii; Sherman Act; Section 2; Monopoly; Antritrust; Orange Book; NDA; Patent Infringement
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Full-Text Articles in Law
A Brand-Name Drug Company May Violate Section Two Of The Sherman Act By Mislabeling A Submitted Patent In The Orange Book: An Implication From In Re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017), Ping-Hsun Chen
Brooklyn Journal of Corporate, Financial & Commercial Law
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 …