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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)
- Patent law; copyright law; intellectual property law; fair use; public health; pandemic; epidemic; disease; defenses; infringement (1)
- Trans-Pacific Partnership; international law; biosimilars; biosimilars industry; Taiwan; patents; patent law; intellectual property; United States; Republic of South Korea; patent linkage; pharmaceuticals; pharmaceutical industry; drug regulation; comparative law (1)
Articles 1 - 3 of 3
Full-Text Articles in Intellectual Property Law
Copying Copyright: Adopting A Fair Use Defense In Patent Law In Times Of Public Health Crisis, Kellie C. Van Beck
Copying Copyright: Adopting A Fair Use Defense In Patent Law In Times Of Public Health Crisis, Kellie C. Van Beck
Brooklyn Law Review
Epidemics have devastated humankind for centuries. Given the simultaneous rise of advanced disease prevention and treatment and the great potential for mass public uptake, it is unsurprising that the U.S. pharmaceutical industry has grown to $775 billion in annual sales revenue. It is clear that the commercialization of important public health measures is not without controversy. Of particular debate is that vaccine and other drug manufacturers monopolize their products and control them through patent laws. Yet there is a strong dichotomy between the importance of patents and the need for public access to innovations. This is not to say that …
An Analysis Of The Patent Linkage System And Development Of The Biosimilar Industry In Taiwan, Jerry I-H Hsiao
An Analysis Of The Patent Linkage System And Development Of The Biosimilar Industry In Taiwan, Jerry I-H Hsiao
Brooklyn Journal of International Law
In 2019, as an effort to join the Trans-Pacific Partnership (TPP) Agreement (now Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)), Taiwan has implemented the patent linkage system which covers both small molecule generic drugs and large molecule biosimilar into the Pharmaceutical Affair Act. The system modeled after the U.S.’s patent linkage system designed for small molecule drugs under the Hatch Waxman Act (HWA). Based on the experience of the patent linkage system under the HWA, biosimilar industry representatives in Taiwan contended that the adoption of the patent linkage system will be detrimental to the development of local industry. By …
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 …