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Your search for “patent exclusivity” returned the following results.
…of market exclusivity. Innovator companies would get a period of 12-year exclusivity after initial licensure that may be increased to 14 years if during the 8-year period following licensure of…
…a pediatric exclusivity period; a new chemical entity (“NCE”) or new-indication exclusivity period; an orphan-drug exclusivity (“ODE”) period; a 180-day exclusivity period; or by approving disputed labeling change. That is…
…an unexpired period of 7-year orphan drug exclusivity for another product that is otherwise the same orphan drug, and/or the subsequent product can earn a period of orphan drug exclusivity. …
…the initiation of patent infringement litigation – it’s the entire fabric of the BPCIA that is is in jeopardy, including biosimilar exclusivity: Non-compliance with subsection (l)(2)(A) vitiates the entire scheme…
…involve our researchers in patent litigation, diverting institutional resources away from scientific research,” and that “[t]he longer the data exclusivity period, the more likely it is that a university’s patent…
…of Maryland, and Gerald C. Kell from the Department of Justice (December 21, 2006) in Biovail Corporation. v. FDA. Q4: What is the date on which patent information was first listed…
…FDA in March 2005 with paragraph IV certifications to two Orange Book-listed patents covering DEPAKOTE: U.S. Patent #4,988,731 (“the ‘731 patent”) and #5,212,326 (“the ‘326 patent”). These patents are scheduled…
…start of the testing phase, the better. As background, under the PTE statute at 35 U.S.C. § 156(g), certain patents covering animal drugs are eligible for a PTE if patent…
…seek a preliminary injunction against the applicant marketing the newly licensed aBLA within those 180 days based on alleged patent infringement of certain patents held by the reference product sponsor. …
…consider whether drug patent settlement agreements (aka “reverse payment agreements” or “pay-for-delay agreements”) are generally per se lawful, or presumptively anticompetitive and unlawful under federal competition laws, and ending with…
…“improper” patents. The FTC has put out policy statements, challenged patent listings, tapped Congress, appeared on talk shows, and filed amicus briefs all in the span of the last 8…
…not fully carve out the patented use from their labels.” GSK explains that Teva did not thoroughly carve out all of GSK’s patented use, and it’s the label’s claims that…
…all without any new taxes or cuts in government programs.” How? Yes, you guessed it – by curbing patent settlement agreements (or what opponents refer to as “pay-for-delay” or “reverse…
…for Summary Judgment and ordered the U.S. Patent and Trademark Office (“PTO”) to consider timely filed MDCO’s Patent Term Extension (“PTE”) application for U.S. Patent No. 5,196,404 (“the ‘404 patent”)…
…– the saga over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) has been a legal thriller for…