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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 (1)
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Articles 1 - 2 of 2
Full-Text Articles in Law
Pharmaceutical Drug Pricing: The Internet As A Solution For This Health Issue Turned Financial Issue, Thomas P. Kelly
Pharmaceutical Drug Pricing: The Internet As A Solution For This Health Issue Turned Financial Issue, Thomas P. Kelly
Brooklyn Journal of Corporate, Financial & Commercial Law
Over the course of five decades, American annual expenditure on pharmaceutical drugs has increased by more than $350 billion. This drastic increase has led many patients to struggle to afford their necessary, and potentially life-saving, medications. Today’s high pharmaceutical prices are largely due to the fact that name-brand drug manufacturers have few restrictions on how much they can charge for their products. Additionally, name-brand manufacturers are able to monopolize the manufacture of their drugs because patent laws prevent other manufacturers from using the formula of these drugs for two decades. To combat these high prices, this Note proposes a partnership …
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 …