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Your search for “patent exclusivity” returned the following results.
…action for those patents appropriate for early litigation and a secondary action for all remaining patents and patents later acquired or licensed by the sponsor. According to Amgen, the marketing…
…warns that “NDA classification codes are not determinative of classification for purposes of exclusivity,” and that they “are not indicative of the extent of innovation or therapeutic value that a…
…for the District of Columbia Circuit’s decision involving Teva’s 180-day exclusivity for generic versions of Merck’s COZAAR and HYZAAR (i.e., losartan). Teva’s 180-day exclusivity for losartan expired on October 3,…
…the same disease or condition” as its orphan drug-designated product, FIRDAPSE (amifampridine) Tablets (NDA 208078), during its seven-year orphan drug exclusivity period. FDA approved FIRDAPSE in November 2018, with a…
…Chemical Entity (“NCE”) exclusivity, 3-year new clinical investigation exclusivity, and Patent Term Extensions (“PTEs”) has remained largely untouched since 1984. A new article out this week in Health Affairs might…
…In addition, the bill would provide a 12-year period of innovator marketing exclusivity, limited “generic” exclusivity under certain circumstances, and patent resolution provisions. Over the past several days, a provision…
…of exclusivity, though we understand that it will soon.) But it seems to have been quite a slog to get the exclusivity. The story begins in September 2006 when the…
…innovators for years about the fairness of carve-outs. Interestingly, FDA raises questions about the potential application of “umbrella exclusivity” under the exclusivity provisions for reference products section 351(k)(7) of the…
…be published in the Missouri Law Review, is based on a dataset of 570 regulatory review periods culled from patent term extension applications received by the Patent and Trademark Office…
…under the FDA Amendments Act of 2007 and is located at FDC Act § 505A(o), to require the prompt approval of ANDAs when pediatric information protected by patent or exclusivity…
…Hatch-Waxman: New Challenges; Unabated Controversy.” The conference will cover myriad Hatch-Waxman issues, including 180-Day Exclusivity, New Drug Application Exclusivities and Patent Term Extensions, Patent Certification/Litigation, and Regulatory Strategies and Conundrums,…
…the U.S. Patent and Trademark Office (“PTO”) shorted by about two months a Patent Term Extension (“PTE”) for a patent – U.S. Patent No. 6,087,380 (“the ‘380 patent) – covering…
…included the “Preserve Access to Affordable Generics Act,” which is intended to curb patent settlement agreements (what opponents call “pay-for-delay” agreements). The amendment appears to be identical to an amendment…
…protection, a company that successfully develops a new antibiotic is granted a patent extension for another drug that is approaching patent expiration in its portfolio. Suggested lengths of the patent…
…Book to drug substance (ingredient) patents, drug product (formulation or composition) patents, and method-of-use patents. Process patents, packaging and container patents, and patents claiming intermediates or metabolites are not eligible…