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Your search for “patent exclusivity” returned the following results.
…Teva II decisions, the Agency was compelled to apply an estoppel-based standard, under which the Agency evaluated whether a patentee was estopped from suing for patent infringement for 180-day exclusivity…
…that the Patent Term Extension (“PTE”) granted by the U.S. Patent and Trademark Office (“PTO”) with respect to U.S. Patent No. 5,053,407 (“the ‘407 patent”) covering Ortho McNeil’s (“Ortho’s”) LEVAQUIN…
…‘321 patent”), 6,245,911 (“the ‘911 patent”), and 6,372,760 (“the ‘760 patent”) – and one expired patent – U.S. Patent No. 4,895,841. The ‘760 patent is listed with a “delist requested”…
…venue statute in 28 U.S.C. § 1400(b). Both parties agreed that the venue provisions for patent cases states that an action for patent infringement may be brought “where the defendant…
…of which are the subject of PTE applications submitted to the PTO: U.S. Patent No. 7,473,678 (“the ‘678 patent”) (FDA Docket No. FDA-2016-E-2396); U.S. Patent No. 7,799,754 (“the ‘754 patent”)…
…§ 156, the term of a patent claiming a drug is extended from the original expiration date of the patent if: (1) the term of the patent has not expired;…
…patent brings a patent infringement action against the applicant, the applicant may assert a counterclaim seeking an order requiring the holder to correct or delete the patent information submitted by…
…While the FTC Brief takes no position on Jazz’s specific patent, it argues that a patent only covering drug distribution should be delisted: As a general matter, however, patents that…
…day after the May 21, 2018 expiration of a period of pediatric exclusivity associated with U.S. Patent No. 5,859,006 listed in the Orange Book for CIALIS.) As to 180-day exclusivity,…
…of whether a drug product change eligible for 3-year exclusivity is limited to labeling additions, or whether labeling deletions can also qualify for exclusivity, has not been clearly stated by…
…180-day exclusivity eligibility under FDC Act § 505(j)(5)(D)(i)); (2) “Ineligible first applicants” (i.e., those first applicants who have forfeited 180-day exclusivity eligibility under FDC Act § 505(j)(5)(D)(i)(IV), but nevertheless remain…
By Kurt R. Karst – Speculating about the prospects that FDA will grant a period of marketing exclusivity – 5-year New Chemical Entity (“NCE”) exclusivity, 3-year new clinical investigation exclusivity,…
…Judge Contreras, while deferring to FDA’s interpretation of the FDC Act’s NCE exclusivity provisions that led the Agency to deny Ferring NCE Exclusivity in 2012, directed FDA and Ferring to…
…exclusivity once a patent expires and the applicability of pediatric exclusivity. FDA is being asked to address these issues in three recent citizen petitions submitted to the Agency concerning amlodipine…
…May 17, 2012 expiration of a period of pediatric exclusivity associated with Orange Book-listed U.S. Patent No. 4,847,265 (“the ‘265 patent”) was preceded by a sideshow that brings to light…