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Your search for “patent exclusivity” returned the following results.
…approved drug as a constituent product must include patent information and one of four patent certifications such as, That the patent information has not been filed (Paragraph I), That the…
…Bioepis infringed five patents covering Enbrel and asks for a declaratory judgment that Samsung Bioepis has infringed and/or would infringe one or more claims of each of the patents at…
…hammered into the coffin of any attempts to deny The Medicines Company (“MDCO”) a win in the company’s decade-long battle to obtain a Patent Term Extension (“PTE”) for U.S. Patent…
By Kurt R. Karst – The drama in the decade-old fight over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”)…
…P.C.’s Kurt R. Karst will be on a panel discussion of Non-Patent Marketing Exclusivity with Brian McCormick (Hogan & Hartson), Stephen Albainy-Jenei (Frost Brown Todd LLC; Patent Baristas Blog), and…
…ZARXIO (filgrastim-sndz), a biosimilar version of Amgen’s NEUPOGEN (filgrastim). Amgen sought injunctions to enforce the BPCIA patent dance requirements and for patent infringement while Sandoz counterclaimed for declaratory judgments that…
…patents listed in the Orange Book because a 505(b)(2) applicant is required to certify to any patents that claim the same use as the test product, including use patents for…
…FDA and the PTO (see our previous posts here and here). The case of U.S. Patent No. 6,087,380 (“the ‘380 patent) covering Boehringer Ingelheim Pharmaceuticals, Inc.’s (“BIPI’s”) PRADAXA (dabigatran etexilate)…
…patent or the use of which is claimed in a patent.” This patent provision, wrote Judge Gilstrap protects the property rights of name brand drug manufactures, and stands as a…
…into the United States” of its generic version of PLAVIX (clopidogrel bisulfate) Tablets until the expiration of a particular patent (and any associated pediatric exclusivity). As Apotex was gearing up…
…and applicability of any non-patent exclusivity listed in the Orange Book for the listed drug. And don’t forget issues surrounding intervening NDA approvals and change in listed drug (see here…
…the Green Book (the animal drug equivalent of the Orange Book) with U.S. Patent No. 5,756,506 (“the ‘506 patent”), which expires on June 27, 2015. The ‘506 patent covers methods…
…to Wyeth’s request for a Patent Term Extension (“PTE”) for U.S. Patent No. 4,916,154 (“the ‘154 patent”) covering Wyeth’s new animal drug CYDECTIN (moxidectin) Pour-On. As we previously reported (here…
The American Conference Institute will be holding its 12th annual “Maximizing Pharmaceutical Patent Life Cycles” conference in New York City from October 3-5, 2011. A copy of the conference program…
…the product also would be treated as an NCE for marketing exclusivity purposes, and, accordingly, granted 5-year exclusivity. [(emphasis added)] In the case of PEPs, FDA had previously stated that…