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Your search for “patent exclusivity” returned the following results.
…3-year exclusivity provisions (FDC Act § 505(c)(3)E)(iii) and (iv)), the Agency’s regulation governing 3-year exclusivity (21 C.F.R. § 314.108), and the Administrative Procedure Act (“APA”) in approving ARISTADA. According to Otsuka: The…
By Kurt R. Karst – If you wait around long enough, almost any scenario feasible under the FDC Act with respect to Hatch-Waxman exclusivity is bound to happen. Nearly six…
…for Orange Book listing a patent), or on the generic side of the equation (e.g., qualifying for and forfeiting 180-day exclusivity). A recent split decision by FDA on 180-day generic…
…still subject to priority review: Submissions with inadequate generic competition and no blocking patents or expired exclusivities listed in the Orange Book; Submissions with paragraph IV certifications and exclusivity considerations;…
…chemical entity exclusivity, 3-year new clinical investigation exclusivity, 6-month pediatric exclusivity, 7-year orphan drug exclusivity, and any 5-year add-on exclusivity as a result of the 2012 Generating Antibiotic Incentives Now…
…non-patent market exclusivity system for drugs that has been in place since the enactment of the Hatch-Waxman Act in 1984 with a new “prize system” (for both drugs and biologics)…
…Act to address patent settlement agreements and an amendment to legislatively extend a patent covering The Medicines Company’s ANGIOMAX (bivalirudin), it was a fait accompli that Sen. Bill Nelson (D-FL)…
…into patent settlement agreements. Last December, the FTC issued its most recent report on the topic (see our previous post here), saying that Fical Year 2013 saw 145 final patent…
…of certain patents and non-patent marketing exclusivities. The FTC may also promulgate regulations to further implement the exceptions included in H.R. 3995. As in previous versions of legislation addressing patent…
…. . . of potentially securing the 180-day exclusivity period available upon a victory in a subsequent infringement lawsuit.’ . The panel majority’s claim that the statutory exclusivity period cedes…
…behalf of certain plaintiffs-appellants in In Re Ciprofloxacin Hydrochloride Antitrust Litig,, an antitrust challenge to certain patent settlement agreements (what opponents call “pay-for-delay” agreements) involving manufacturers of Ciprofloxacin HCl (CIPRO). …
…the options for rationally ending patent disputes. A brand-name company might settle to protect a high-risk investment even if it is convinced that its patent is strong, because anything can…
…Sandoz’s refusal to participate in the patent dance after filing of an aBLA relying on Amgen’s Neupogen is heading to the Supreme Court this term (see our previous coverage here,…
…exclusionary potential of a patent does not immunize a drug patent settlement agreement from antitrust attack. (That case in now progressing as reported yesterday by Law360.) The silence from Capitol…
…by the BPCIA based on any patent it reasonably believes has been infringed, and it may seek additional information regarding that patent claim through discovery. Given the government’s strong recommendation…