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Your search for “patent exclusivity” returned the following results.
…patent covering a medical device, though such actions on a Patent Term Extension (“PTE”) request do come up from time to time (see our previous posts here and here). The…
…FTC in the Amicus Brief). Though Teva listed the asserted patents as “drug product” patents, FTC explains that “none of the [patents in suit] mention any drug in their claims,…
By Kurt R. Karst – The U.S. Patent and Trademark Office (“PTO”) recently indicated in a letter to FDA that U.S. Patent No. RE 41,571 (“the ‘571 patent”), a method-of-use…
Under the Hatch-Waxman Act, certain patents related to products regulated by FDA are eligible for extension if patent life was lost during a period when the product was undergoing regulatory…
…the FDC Act’s patent listing provisions that the key factor in determining whether a drug product patent must be submitted for Orange Book listing is “whether the patent being submitted…
…the Patent and Trademark Office’s (“PTO’s”) denial of a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin), and remanded…
…U.S. Patent and Trademark Office (“PTO”) to allow a Patent Term Extension for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX (bivalirudin), an anticoagulant drug product FDA first approved…
An interesting issue is percolating at the U.S. Patent and Trademark Office (“PTO”) concerning Patent Term Extensions (“PTEs”). We hinted at this issue in our recent post concerning the PTO’s…
Legislation that would permit the U.S. Patent and Trademark Office (“PTO”) to exercise discretion to accept untimely filed Patent Term Extension (“PTE”) applications has reportedly been added to the “Patent…
…of “exclusivity stacking” started in 1997 with the creation of 6-month pediatric exclusivity by extending a period of 3-year new clinical investigation exclusivity by two years if the NDA sponsor…
…5 years of market exclusivity, and a modification of a previously approved product would be entitled to 3 years of market exclusivity. This exclusivity scheme is similar to the current…
…in the base business).” The “180-day exclusivity cliff” tracks the “patent cliff” brand-name companies are expected to face as many blockbuster drugs come off patent between 2011 and 2014. …
…its process patents. As we explained several weeks ago, the biosimilar patent dance includes process patents in the exchange of patent information, permitting the enforcement of process patents prior to…
…all 6 Orange Book-listed patents. Sepracor sued Dey for patent infringement on 5 of the 6 patents, and Dey brought a declaratory judgment action seeking a declaration of non-infringement on…
…by the Medicare Modernization Act, with respect to 180-day exclusivity under FDC Act § 505(j), as well as to the patent laws at 35 U.S.C. § 271(e), and is aimed…