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Your search for “patent exclusivity” returned the following results.
…musical terms serve as a nice metaphor for The Medicines Company’s (“MDCO’s”) decade-long battle (multi-movement symphony) to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404…
…Green Book-listed patent for the reference product. As under Hatch-Waxman, a timely filed patent infringement lawsuit stemming from a Paragraph IV certification triggers an automatic 30-month stay on ANADA approval. …
…on: Publicly available FDA resources that should be included when training USPTO patent examiners to assess the patentability of claimed inventions; Mechanisms to assist patent examiners in determining whether patent…
…an OCA to provide the NDA holder/patent owner confidential access to certain information from an ANDA “for the sole and limited purpose of evaluating possible infringement of the patent that…
…require a split certification (Paragraph IV certification and “section viii” statement) with respect to U.S. Patent No. 5,246,937 (“the ‘937 patent”), one of five patents listed in the Orange Book…
…Patent No. 6,087,380 (“the ‘380 patent) covering Boehringer’s PRADAXA (dabigatran etexilate) Capsules (NDA 022512). The Complaint was prompted by a December 2014 PTE regulatory review period decision in which FDA…
…to the enforceability and validity of the patent on the active ingredient in Plavix. Long story short: The patent is valid and Apotex is enjoined from further infringing the patent….
…the patent. The Federal Circuit Court found that because patents are presumed valid and provide the patentee with the right to exclude others (infringers) from the market, the challenged anticompetitive…
…standards that courts should apply in drug patent settlement cases (also known as “pay-for-delay” or “reverse payment” cases) (see our previous post on the Actavis decision). Actavis has rippled through…
…FTC v. Actavis, Inc., 133 S. Ct. 2233 (2013), which addressed the standards that courts should apply in drug patent settlement cases (also known as “pay-for-delay” or “reverse payment” cases). …
…veterinary biological products. As we previously reported, Momenta Pharmaceuticals, Inc. (“Momenta”) sued Amphastar for patent infringement alleging that Amphastar infringed U.S. Patent No. 7,575,866 (“the ‘866 patent”) assigned to Momenta…
…post here), U.S. Patent No. 7,575,866 (“the ‘866 patent”) assigned to Momenta that generally relates “to methods for analyzing heterogeneous populations of sulfated polysaccharides” such as enoxaparin, and 35 U.S.C….
In the second lawsuit in as many months, the Patent and Trademark Office (“PTO”) has been sued over a decision to deny a Patent Term Extension (“PTE”). As we previously…
…District of New Jersey that U.S. Patent No.5,338,874 (“the ‘874 patent”) covering ELOXATIN was not infringed by certain generic applicants. Just a few days later, Sanofi filed a Motion for…
…Eastern District of Virginia (Alexandria Division) challenging the Patent and Trademark Office’s (“PTO”) March 19, 2010 decision denying a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404…