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Your search for “patent exclusivity” returned the following results.
…ANDA Regulations; Patent and Exclusivity Provisions (Hatch-Waxman Title I): 1911 days (from and including Tuesday, July 11, 1989, to and including Monday, October 3, 1994) Proposed Patent Term Restoration Regulations…
…certain generic companies violated various federal antitrust laws when they agreed to dismiss patent infringement litigation on U.S. Patent No. 6,503,894 (“the ‘894 patent”) in exchange for a profit-sharing arrangement…
…and Non-infringement concerning two patents Roche licensed to Amgen – U.S. Patent Nos. 8,063,182 (“the ‘182 patent”) and 8,163,522 (“the ‘522 patent”) – that purportedly cover Amgen’s biological product ENBREL…
Earlier this week, we posted Part 1 of our three-part series on U.S. Patent and Trademark Office (“PTO”) Patent Term Extension (“PTE”) decisions under 35 U.S.C. § 156, as added…
Because a drug is designated an “Orphan” if it is intended to treat a “rare condition,” the condition itself always has been integral to Orphan Drug Exclusivity. Indeed, the condition…
…previously reported, FDA’s rationale for denying NCE exclusivity for VASCEPA – and instead granting a period of 3-year new clinical investigation exclusivity – was that eicosapentaenoic acid (“EPA”), “the single…
…protected by periods of orphan drug exclusivity applicable to HUMIRA. Comments submitted to FDA on the draft guidance by Daiichi are specific to the off-label use/exclusivity controversy: Data exclusivity thus…
…patent (that expires more than 30 months after ANDA submission), and a paragraph IV certification for a later patent, and a subsequent applicant has paragraph IV’s for both patents, the…
…patent on the existence of patent litigation and deprive an ANDA applicant eligible for 180-day exclusivity of such exclusivity.) Earlier this month, FDA filed a Motion to Dismiss the case on…
…rules apply, earning exclusivity, forfeiture of exclusivity, commencing the exclusivity term, and enjoyment (use) of the exclusivity term. It devotes considerable attention to developments since 2009 (our last article): new…
…the later of the expiration of any applicable 7-year orphan drug exclusivity or the 12-year market exclusivity period (or 7.5 years and 12.5 years with pediatric exclusivity). Sen. Sanders states…
…180-day exclusivity eligibility because the only exclusivity-qualifying patent – U.S. Patent No. 5,608,075 – “expired” last year after Merck ceased paying certain patent maintenance fees. FDA’s approved Teva’s ANDAs on…
…marketing exclusivity from a “patent-by-patent” approach (under which shared exclusivity can exist for cross-Paragraph IV filers to different patents) to a “first applicant to any patent” approach. Yet, the lawsuits…
…patent on the existence of patent litigation and deprive an ANDA applicant eligible for 180-day exclusivity of such exclusivity.) FDA filed a Motion to Dismiss the case on several grounds…
…HCl Extended-Release Tablets share two common Orange Book patent listings; however, there are several other Orange Book-listed patents covering EFFEXOR XR that are not listed for Osmotica’s drug product. At…