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- Drug Price Competition and Patent Term Restoration Act of 1984; Hatch-Waxman Act; Prescription Drug Prices; Generic Drug Manufacturers; Generic Drug Application Process; Consumer Protection; Reverse Payments; Citizen Petitions; Product Hopping; Misclassiication of Drugs; Mylan Pharmaceuticals; EpiPen; Price Gouging; Food and Drug Administration; Generic Drug User Fee Amendments of 2012 (GDUFA); Sherman Antitrust Act; Monopilization of the Pharmaceutical Industry; New Drug Application (NDA); Brand-Name Drug Application Process; Abbreviated New Drug Application (ANDA); Exclusive Right to Market; Federal Trade commission Act (FTCA); Unfair Methods of Competition; "Unfair or Deceptive Acts or Practices"; "Pay-for-Delay"; Patent Infringement; FTC v. Actavis; Administrative Procedure Act (APA); "Eleventh Hour" Petitions; Medicaid and Medicare; "Innovator" and "Non-Innovator" Drugs; Schemes to Coerce Patients; "Soft Switch"; Pharmacy Benefit Managers (PBMs); Oversight Committees; Proposed Amendments; Reverse Payment Penalty; (1)
- 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)
Articles 1 - 2 of 2
Full-Text Articles in Intellectual Property 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 …
Abuse Of The Hatch-Waxman Act: Mylan's Ability To Monopolize Reflects Weaknesses, Kieran Meagher
Abuse Of The Hatch-Waxman Act: Mylan's Ability To Monopolize Reflects Weaknesses, Kieran Meagher
Brooklyn Journal of Corporate, Financial & Commercial Law
The Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act, is intended to lower the average price paid by consumers for prescription drugs. The Hatch-Waxman Act attempts to do so by simplifying the application process for generic drug manufacturers, allowing generic drug applications to circumvent the lengthy FDA testing and approval process that brand-name manufacturers must undergo. Though the Hatch-Waxman Act has successfully created a clear path to the market for generic drugs, it contains loopholes that allow brand name and generic companies to engage in practices aimed at maximizing monopoly profits, effectively …