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Your search for “patent exclusivity” returned the following results.
…applicant’s patent certification obligation is clear on the face of the statute: such applicant need only certify to the product patents or the method-of-use patents that are associated with the…
…which Judge Hilton ordered the Patent and Trademark Office (“PTO”) to consider timely filed The Medicines Company’s (“MDCO’s”) PTE application for U.S. Patent No. 5,196,404 covering ANGIOMAX (bivalirudin) under a…
…to dismiss patent infringement litigation on U.S. Patent No. 6,503,894 (“the ‘894 patent”) in exchange for a profit-sharing arrangement and provided the generic competitors would not launch their generic versions…
…or the “Medco fix”), which would legislatively resolve The Medicines Company’s (“MDCO’s”) decade-long battle to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 covering ANGIOMAX (bivalirudin). As…
…was in order on where things stand with MDCO’s efforts to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX. Section 37 of…
…salmeterol xinafoate), and SEREVENT (salmeterol xinafoate), begs the question why? Many of the new patent listings concern patents issued years ago and are therefore late-listed patents. (Generic applicants with pending…
…to exercise discretion to accept untimely filed Patent Term Extension (“PTE”) applications. As we previously reported, a similar provision was added to the Patent Reform Act of 2007 (S.1145) by…
…FDA and the U.S. Patent and Trademark Office (“PTO”) requesting declaratory and injunctive relief with respect to Wyeth’s request for a Patent Term Extension (“PTE”) for U.S. Patent #4,916,154 (“the…
…that the brand manufacturer has identified [in its patent use code listed in the Orange Book] as covering its patented uses, can the generic manufacturer be held liable on a…
…Presumably the next exclusivity battle over PEPs will concern whether each PEP is a new chemical entity eligible for 5-year exclusivity or whether 3-year “new use” exclusivity applies. An FDA…
By Kurt R. Karst – Efforts to include a 12-year period of exclusivity for biological products in the Trans-Pacific Partnership (“TPP”) agreement chapter on intellectual property rights are alive and…
By Kurt R. Karst – In yet another letter to FDA Commissioner Hamburg concerning the 12-year period of reference product exclusivity (which can be extended to 12.5 years with pediatric…
…page A-7 of the publication. There, in the “PATENT AND EXCLUSIVITY DRUG PRODUCT LIST,” FDA showed the additon of several patents and two periods of exclusivity for Teva Pharmaceuticals, Inc.’s…
…which final approval is blocked by Ranbaxy’s alleged eligibility for 180-day exclusivity (see our previous post here). The petition drew comments from both Ranbaxy (here) and Teva Pharmaceuticals USA, Inc. (here)….
…of its NDA, as well as any unexpired marketing exclusivity, as the result of a proprietary name review issue FDA identified in a footnote to an April 30, 2014 denial…