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Your search for “patent exclusivity” returned the following results.
…created by the BPCIA (see our previous posts here and here). In particular, Amgen alleged that Sandoz unlawfully opted out of the information and patent exchange procedures (i.e., the “patent…
…patent test” and applying the “quick look” rule, under the “quick look” rule “the finder of fact must treat any payment from a patent holder to a generic patent challenger…
…other patents related to ZILVER PTX: U.S. Patent No. 6,299,604 (Docket No. FDA-2013-E-0677); U.S. Patent Nos. 6,515,009 (Docket No. FDA-2013-E-0681); and U.S. Patent No. 7,820,193 (Docket No. FDA-2013-E-0676).) Element number…
…NDA sponsor does submit to FDA for listing in the Orange Book a patent for NDA No. 2. While the remainder of the period of NCE exclusivity granted for the…
…week the Orange Book Blog reported that FDA requested comment on ramipril (ALTACE) 180-day exclusivity issues. These requests follow others from earlier this year on a variety of exclusivity issues…
…2011, and, like Product 002, is currently marketed. Product 002 is listed in the Orange Book with two patents: (1) U.S. Patent No. 4,939,130 (“the ‘130 patent”), which expired on…
…basis on which to list the patent, . . . the patent would no longer be eligible for listing in the Orange Book. In such a case, the patent must…
…of whether we are talking about Orange Book patent listings and non-patent marketing exclusivity under Title I, or Patent Term Extensions (“PTEs”) under Title II of Hatch-Waxman (notwithstanding one exception). …
…the Third Circuit in In Re: K-DUR Antitrust Litigation. In that case, the Court rejected the so-called “scope of the patent test” when considering whether patent settlement agreements violate the…
…of exclusivity remaining on the original application, unless the change occurs after or toward the end of the initial 5 years of exclusivity and independently qualifies for exclusivity under another…
…exclusivity on brand name biologics. Beginning in 2014, this proposal would award brand biologic manufacturers seven years of exclusivity, rather than 12 years under current law, and prohibit additional periods…
…with two patents – the ‘288 patent and U.S. Patent No. 5,948,437 (“the ‘437 patent”). The ‘437 patent expires on May 28, 2017, but is subject to a period of…
…the availability and applicability of both 180-day generic drug exclusivity and pediatric exclusivity with respect to U.S. patent No. 4,879,303 (“the ‘303 patent”) covering NORVASC. On Monday, the U.S. District…
…of 180-day exclusivity for a generic version of Janssen Phaemaceutica’s schizophrenia drug RISPERDAL (risperidone) Tablets based on Teva’s Paragraph IV certification to U.S. Patent #5,158,952 (“the ‘952 patent”). As we…
…manipulative and deceptive practices before the U.S. Patent & Trademark Office to improperly extend the length of its patent monopoly for Remicade®, and to obtain patents the Patent Office never…