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Your search for “patent exclusivity” returned the following results.
…that patent settlement agreements are pro-competitive and increases opportunities for consumer savings. The FTC’s analysis of such agreements (see our previous post here) estimates that patent settlement agreements “cost American…
By Kurt R. Karst – The Patent and Trademark Office’s (“PTO’s”) recent denial of a Patent Term Extension (“PTE”) for U.S. Patent No. 5,270,305, which was reissued as U.S. Patent No….
By Kurt R. Karst – Earlier this week, we reported on the latest in the ongoing saga over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the…
…in the Orphan Drug Designation provisions rather than the indication ultimately approved, as FDA had been interpreting the scope of Orphan Drug Exclusivity. This means that Orphan Drug Exclusivity for…
…a generic’s exclusivity.” Thus, a mere patent delisting request is not enough to trigger a forfeiture event under the failure-to-market forfeiture provision at FDC Act § 505(j)(5)(D)(i)(I). In July 2010,…
…approval,” and “[i]njunctive relief effectuating UTC’s orphan drug exclusivity by enjoining Defendants from approving any other drug covered by UTC’s exclusivity for the treatment of PAH until December 20, 2020.”…
…exclusivity expires, and then later for the pediatric population indication once that second period of orphan drug exclusivity expires. But not all cases are as easy as the one above….
By Kurt R. Karst – We recently came across what we think is a pretty interesting FDA Exclusivity Letter Decision on 180-day exclusivity for generic versions of EDLUAR (zolpidem tartrate)…
…exclusivity: [D]uring the initial four years of the 12-year period, effectively a reference brand product has both data exclusivity for its application and market exclusivity in relation to biosimilar applicants…
…(“NCE”) exclusivity for the drug product. Although FDA approved CREON in early May 2009, the most recent Orange Book Cumulative Supplement does not yet show any period of exclusivity applicable…
…provided the statutory criteria are met. Whether several companies may jointly sponsor the required clinical studies to qualify a single applicant for 3-year exclusivity (who may then waive that exclusivity…
…of Generic Drugs (“OGD”). 180-Day Exclusivity Forfeiture. Section 2 of H.R. 4332 deals with FDC Act § 505(j)(5)(D)(i)(IV), which is one of the six 180-day exclusivity forfeiture provisions added to…
…the final patent settlements reviewed by the FTC contained provisions relating to AGs. Between FY2004-FY2008, 76 final patent settlement agreements were with first-filer generics. About one-quarter (20 out of 76)…
Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). As has been explained,…
…the reference product is licensed) may occur when a condition of use is protected by exclusivity, such as Orphan drug Exclusivity, or by patent. In such a case, FDA can…