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Your search for “patent exclusivity” returned the following results.
…35 U.S.C. § 156. Rather, the bill allows the owner of record of an applicable patent to submit to the Director of the Patent and Trademark Office (“PTO”) an application…
…provisions – an administrative patent challenge proceeding at the U.S. Patent and Trademark Office (“PTO”) before the Patent Trial and Appeal Board (“PTAB”) that serves as a parallel or alternative…
Under Title II of the Hatch-Waxman Act, certain patents related to products regulated by FDA are eligible for extension by the U.S. Patent and Trademark Office (“PTO”) if patent life…
…approved after the last expiring Orange Book-listed patent, we assume that FDA did not grant any first applicant 180-day exclusivity – 180-day exclusivity dies with patent expiration. In other cases,…
…2014. According to FDA, “[t]he legal and regulatory framework on exclusivity and drug approvals contemplate only a single date of approval for determining when exclusivity begins for an NDA. For…
…the “base period” of exclusivity, and a single 1-year second period of “bonus exclusivity” under certain circumstances. However, such exclusivity would only be available for products approved after enactment of…
…which an ANDA was submitted to FDA containing a Paragraph IV certification – in this case to U.S. Patent No. 6,100,274 (“the ‘274 patent”), the only patent listed in the…
…be identified by a “Patent Challenge” (PC) code in the Exclusivity Data section of the Orange Book.) Further, the addition of patent expiration dates may be helpful in knowing whether…
…180-day exclusivity will be removed after the exclusivity has been extinguished or relinquished. Patents may also be removed from the Orange Book as a result of a patent listing dispute….
…is claimed by the patent or a use of which is claimed by the patent brings a patent infringement action against the applicant, the applicant may assert a counterclaim seeking…
…(pegfilgrastim) infringes two Amgen patents, one about to expire composition of matter patent and one process patent expiring in 2031. This is the first lawsuit in which the parties at…
…patent dance information exchanges, declare that this failure means that there can be no “immediate patent infringement action” under 42 U.S.C. § 262(l)(6), and declare that Amgen may get injunctive…
…2010-1534, perhaps starting (or ending) another chapter in 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…
…the Hatch-Waxman Act and the [BPCIA], generic and biosimilar companies generally must address patent issues before launching a product through costly and protracted patent litigation. Eliminating invalid patents under §…
…an aspect of the reference listed drug (RLD) labeling by removing that patent-protected use from the generic labeling. Typically, generic sponsors carve out a patent-protected indication or patient population, but…