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Your search for “patent exclusivity” returned the following results.
…had to await patent expiration. To balance these concerns, Congress delegated to FTC the authority to review and sign off on all generic drug and biosimilar patent settlement agreements based…
…this week, FDA ruled that ANDA sponsors could omit (i.e., carve out) from their generic drug labeling information protected by U.S. Patent No. 6,716,867 (“the ‘867 patent”). The ‘867 patent…
…in a challenge mounted by the Genetics & IVF Institute (“GIVF”) to the PTO’s August 2010 denial of a Patent Term Extension (“PTE”) for U.S. Patent No. 5,135,759 (“the ‘759…
In June, the U.S. Patent and Trademark Office (“PTO”) determined that AstraZeneca’s U.S. Patent No. 5,674,860 (“the ‘860 patent”), which covers the drug product SYMBICORT (budesonide; formoterol fumarate dihydrate) Inhalation…
By Kurt R. Karst – Hatch-Waxman Patent Term Extension (“PTE”) disputes never get old for this blogger. There’s often some new twist for FDA or the U.S. Patent and Trademark…
By Kurt R. Karst – A recent letter decision from FDA to the Patent and Trademark Office (“PTO”) concerning the availability of a Patent Term Extension (“PTE”) for U.S. Patent…
…the U.S. Court of Appeals for the Eleventh Circuit held that, “absent sham [patent] litigation or fraud in obtaining the patent, a reverse payment settlement is immune from antitrust attack…
…to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX (bivalirudin). FDA approved ANGIOMAX at 5:18 PM on Friday, December 15, 2000 under…
…the patent number, or the words “patent,” “patentee,” or the like, with the intent of counterfeiting or imitating the mark of the patentee, or of deceiving the public and inducing…
…§ 271(e)(2) for patent infringement – see Orange Book Blog and Patent Docs posts), and as we all patiently await a decision from the U.S. Supreme Court in the patent use…
…Inc., Case No. 2014-1693 (Fed. Cir. 2014). The case involves two patents Roche licensed to Amgen – U.S. Patent Nos. 8,063,182 (“the ‘182 patent”) and 8,163,522 (“the ‘522 patent”) –…
By Kurt R. Karst – The Federal Trade Commission’s (“FTC”) drumbeat of opposition to patent settlement agreements (or what opponents call “pay-for-delay” or “reverse payment” agreements) grew louder last week…
…Division) added another twist (or turn) and ordered the U.S. Patent and Trademark Office (“PTO”) to issue a second interim Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404…
By Kurt R. Karst – The continuing court battle 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 (bivalirudin)…
…exclusivity for the newly approved use. To the extent the Court’s decision can be read to deprive Teva marketing exclusivity under the circumstances here – that is, to the extent…