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Your search for “patent exclusivity” returned the following results.
…The issue is whether 35 U.S.C. § 156 permits a patent owner who owns more than one patent to obtain more than one patent term extension for the same FDA…
…12-year exclusivity period provided by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) as a period of “market exclusivity” instead of “data exclusivity.” The Senators also take the…
…active moiety as the drug with exclusivity, and, in fact, the Court finds that the FDA’s interpretation of the FDCA’s exclusivity provisions is entirely reasonable. Furthermore, to the extent that…
…final rule largely deals with the non-180-day exclusivity provisions of the MMA, though it does include some discussion about 180-day exclusivity (e.g., commercial marketing to trigger exclusivity). Finally, and with…
…mg, and 200 mg, a generic version of GlaxoSmithKline LLC’s LAMICTAL ODT (NDA 022251). The Orange Book Cumulative Supplement showed the addition of periods of “PC” exclusivity (i.e., 180-day patent…
…of the Medicare Modernization Act (“MMA”) when 180-day exclusivity was patent-by-patent. In October 2012, Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia ruled against…
In September, we reported that FDA established a public docket (#2007N-0417) soliciting comment on certain 180-day exclusivity forfeiture and Orange Book patent “delisting” issues concerning the diabetes drug acarbose (marketed…
…not a particularly robust patent portfolio remaining. However, for newer biological products with a robust patent portfolio, biosimilar applicants may, in fact, choose to engage in the patent dance in…
…ANGIOMAX patent battle that has been brewing in the U.S. District Court for the District of Delaware over the two other Orange Book-listed patents for the drug – U.S. Patent…
…the Combination Drug Development Incentive Act of 2013. That bill, which is reportedly backed by POZEN Inc., would amend the FDC Act’s exclusivity provisions to allow for 5-year exclusivity for…
…Entity (“NCE”) exclusivity and 3-year new clinical investigation exclusivity. By way of background, the CDER Exclusivity Board was established to “oversee certain exclusivity determinations, including whether and what type of…
…patent challenge in the district court or is not sued for patent infringement by the brand company. Maximizing the incentive for all generic challengers to fight to bring products to…
…another. According to Professor Carrier, patent settlement agreements and product hopping create a “lethal combination” that “erects a significant roadblock to pharmaceutical competition.” Specifically: For a settlement that prevents patent…
…is listed in the Orange Book with two unexpired patents – U.S. Patent No. 5,859,021 (“the ‘021 Patent”), which expires on May 15, 2012, and U.S. Patent No. 5,905,082 (“the…
…(“the ‘217 patent”), 5,382,600 (“the ’600 patent”), 6,630,162 (“the ‘162 patent”), and 6,770,295 (“the ‘295 patent”), which expire on Aug 26, 2019, March 25, 2012, November 11, 2019, and August…