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Your search for “patent exclusivity” returned the following results.
…incentive? That is, because patent challenges often result in patent settlements that allow for generic competition (i.e., launch) prior to patent expiration, a CGT-like exclusivity regime that triggers the exclusivity…
…26, 2014 (12 mg/3 mg). Presumably those patent certifications were to U.S. Patent Nos. 8,017,150 (“the ‘150 patent”), 8,475,832 (“the ‘832 patent”), and 8,603,514 (“the ‘514 patent”), which were listed…
…two patents: (1) U.S. Patent No. 5,616,599 (“the ‘599 patent”), which is identified as a drug product, drug substance, and method-of-use patent and the pediatric exclusivity for which expires on…
By Kurt R. Karst – A recent decision from the Patent and Trademark Office (“PTO”) in which the Office granted an interim Patent Term Extension (“PTE”) for U.S. Patent No….
…patents submitted after the original ANDA was submitted (even where those patents were submitted before the submission of the new strength supplement). Because it is not directly implicated by this…
…the delisting of a patent on the existence of patent litigation and deprive an ANDA applicant eligible for 180-day exclusivity of such exclusivity does not apply to the version of…
…180-day exclusivity forfeiture, and another concerning 3-year exclusivity. The two 180-day exclusivity forfeiture decisions are interesting reads, but not overly noteworthy. One FDA Memorandum provides FDA’s rationale for determining that…
…the requirements related to submission of information for certain patent types, FDA’s proposed rule tackles reissued patents and describes the Agency’s approach to treating original and reissued patents as a…
…with respect to one Orange Book-listed patent on which Nostrum qualified for 180-day exclusivity (U.S. Patent No. 5,912,013 (“the ‘013 Patent”)), and FDA’s interpretation that 180-day exclusivity terminates with the July…
…for the District of Delaware after Intelliject notified Meridian of Paragraph IV certifications to the ‘432 patent and U.S. Patent No. 7,449,012 (“the ‘012 patent”) included in Intelliject’s 505(b)(2) application…
…NCE exclusivity despite the previous approval of products containing isosorbide dinitrate. The exclusivity entry in the Orange Book for the VERAMYST NDA remained blank as FDA mulled over the exclusivity…
…for the potential of a hollow exclusivity incentive? That is, because patent challenges often result in patent settlements that allow for generic competition (i.e., launch) prior to patent expiration, a…
…case. The ‘703 patent, which Daiichi statutorily disclaimed, is a 180-day exclusivity-bearing patent, and therefore, remains listed in the Orange Book, but with a “Patent Delist Request Flag.” This flag…
…FDA may not condition the delisting of a patent on the existence of patent litigation and deprive an ANDA applicant eligible for 180-day exclusivity of such exclusivity does not apply…
…list implements FDA’s new method-of-use patent/patent use code patent challenge regulations and fulfills FDA’s new requirement to “promptly post information on its Web site regarding whether a patent listing dispute…