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Full-Text Articles in Law
Pay-For-Delay Settlements In The Wake Of Actavis, Michael L. Fialkoff
Pay-For-Delay Settlements In The Wake Of Actavis, Michael L. Fialkoff
Michigan Telecommunications & Technology Law Review
“Pay-for-delay” settlements, also known as reverse payments, arise when a generic manufacturer pursues FDA approval of a generic version of a brand-name drug. If a patent protects the brand-name drug, the generic manufacturer has the option of contesting the validity of the patent or arguing that its product does not infringe the patent covering the brand-name drug. If the generic manufacturer prevails on either of these claims, the FDA will approve its generic version for sale. Approval of a generic version of a brand-name drug reduces the profitability of the brand-name drug by forcing the brand-name manufacturer to price its …
Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook
Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook
Michigan Telecommunications & Technology Law Review
Should a branded pharmaceutical company be allowed to pay a generic competitor to stay out of the market for a drug? Antitrust policy implies that such a deal should be prohibited, but the answer becomes less clear when the transaction is packaged as a patent-litigation settlement. Since Congress passed the Hatch-Waxman Act, which encourages generic manufacturers to challenge pharmaceutical patent validity, settlements of this kind have been on the rise. Congress, the Department of Justice, and the Federal Trade Commission have condemned these agreements as anticompetitive and costly to American consumers, but none of these bodies has been able to …
Antitrust Enfocement And High-Technology Markets, William J. Baer, David A. Balto
Antitrust Enfocement And High-Technology Markets, William J. Baer, David A. Balto
Michigan Telecommunications & Technology Law Review
Although the antitrust laws apply to all industries, the application must be tempered in each case by the myriad ways in which competition can be modified by structural, behavioral, technological, regulatory, and other characteristics. The Commission applies the antitrust laws with sensitivity to the special characteristics of high-tech industries and of intellectual property, but also with the recognition that--as in other industries--competition plays an important role in spurring innovation and in spreading the benefits of that innovation to consumers. This focus is not new. This balanced approach has roots that go back at least to the 1977 Antitrust Guide to …