Federal Trade Commission, United States Federal Trade's Generic Drug Entry Prior To Patent Expiration: An FTC Study PDF

By Federal Trade Commission, United States Federal Trade Commission

This research tested even if the behavior that the FTC challenged, which was once sure antitrust activities opposed to brand-name and customary drug businesses, represented remoted situations or is extra regular, and even if the 180-day exclusivity and the 30-month remain provisions of the Hatch- Waxman Amendments are liable to suggestions to hold up or deter customer entry to widespread possible choices to model- identify drug items. The research focuses exclusively at the strategies used to facilitate regularly occurring drug industry access sooner than expiration of the patent(s) that defend model- identify drug product.

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This research tested even if the behavior that the FTC challenged, which was once yes antitrust activities opposed to brand-name and usual drug businesses, represented remoted situations or is extra normal, and even if the 180-day exclusivity and the 30-month remain provisions of the Hatch- Waxman Amendments are liable to ideas to hold up or deter patron entry to well-known possible choices to model- identify drug items.

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Both courts have found the agreements to be per se restraints of trade under Section 1 of the Sherman Antitrust Act. D. Mich. D. Mich. D. Fl. 2000). Both of these district court decisions are currently on appeal. 5 Two different generic applicants were the first to file on different strengths of the same drug product. The brand-name company settled the litigation with both applicants (one settlement was a license agreement and the other was a supply agreement). Because the different strengths are covered by only one NDA, the drug product is counted only once as a “supply agreement” to ensure consistency in counting drug products with agreements.

Supreme Court; or (2) entry of another generic Hytrin product. Geneva also agreed not to transfer, assign, or relinquish its 180-day exclusivity right. These provisions ensured that no other company's generic version of Hytrin could obtain FDA approval and enter the market during the term of the agreement, because Geneva's agreement not to launch its product meant the 180-day exclusivity period would not begin to run. Under the Commission's consent order, Abbott and Geneva are barred from entering into agreements pursuant to which a first-filing generic company agrees with a manufacturer of a branded drug that the generic company will not (1) give up or transfer its exclusivity or (2) bring a non-infringing drug to market.

365 (2000). 15 Id. at 391. See, also, John R. Allison & Mark A. Q. 185 (1998). Allison and Lemley study the outcomes of patent validity cases from 1989 to 1996. They focus on those cases in which there exist final written decisions at either the district court or the Federal Circuit levels. In their study, a district court decision is “final” if a later decision by the Federal Circuit does not supersede it. In their data set of 299 patents in 239 different cases, they find that 46 percent of the final decisions hold the relevant patent invalid.

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Generic Drug Entry Prior To Patent Expiration: An FTC Study by Federal Trade Commission, United States Federal Trade Commission


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