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Your search for “patent exclusivity” returned the following results.
…“relate back” decision is important here, because pediatric exclusivity extends all other types of Orange Book-listed patent and non-patent marketing exclusivity an application holder may have under the FDC Act,…
…Mt. Sinai Health System, seconded Mr. Boutin’s call for additional statutory exclusivity. He proposed as an alternative that Congress create categories of exclusivity for specific areas with unmet medical need. …
…exclusivity associated with VASCEPA; and the period of “New Product” 3-year exclusivity that previously appeared in the Orange Book expired on July 26, 2015. So what’s the hang-up? As folks…
…expiration of [U.S. Patent No. 4,895,841 (‘the ’841 patent’), upon which shared 180-day exclusivity is based], there will be ‘no opportunity for a triggering event and subsequent generic entry to…
…petitions, SEROQUEL and SEROQUEL XR are listed in FDA’s Orange Book with various periods of patent and non-patent exclusivities. U.S. Patent No. 4,879,288 (“the ‘288 patent”), the pediatric exclusivity for…
…were then approved under FDC Act § 507, from the Act’s patent and non-patent market exclusivity provisions (except for the availability of a patent term extension). FDAMA repealed FDC Act…
…will forfeit the marketing and/or data exclusivity grants that the FDA is empowered to make – but not your patents from the US Patent Office – and encourage competitors to…
…biogeneric drugs, the likely competitive effects of reference product regulatory exclusivity, biotechnology patent issues, the likely competitive effects of follow-on biologic regulatory incentives, and the patent resolution process.” The panel…
…each step of a multi-step patent-exchange process regarding the sponsor’s possible patent claims. Congress carefully spelled out both the action the applicant or sponsor “shall” take as a condition precedent…
…grounds that the ANDA contains a paragraph IV certification to a later-listed patent and the NDA holder or patent owner has sued the ANDA applicant for patent infringement as a…
…case stems from a May 2008 Paragraph IV patent certification Sandoz, Inc. made with respect to the ‘558 patent, and a timely filed patent infringement lawsuit triggering a 30-month stay…
…excluded antibiotic drugs, which were then approved under FDC Act § 507, from the Act’s patent and non-patent market exclusivity provisions (except for the availability of a patent term extension);…
…to consider how the new law applies and might affect Eisai’s request for a Patent Term Extension (“PTE”) for U.S. Patent No. 6,949,571 (“the ‘571 patent”) covering Eisai’s FYCOMPA (perampanel)…
By Kurt R. Karst – Massachusetts-based The Medicines Company (“TMC”) has lost its latest battle with the U.S. Patent and Trademark Office (“PTO”) for a Patent Term Extension for…
…in their briefs (here, here, and here) that the so-called “scope of the patent test” used by Eleventh Circuit correctly reflects patent and antitrust precedent. That test is different from…