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Your search for “patent exclusivity” returned the following results.
…regulations preclude the listing of process patents in the Orange Book, which means that process patents are not included in the Hatch-Waxman patent dance. Indeed, the Federal Circuit has even…
…the strength of the patent rather than sharing of monopoly profits. Reverse payments are not necessary to settle patent cases, and the payments “serve no obvious redeeming social purpose.” State…
…will extract significant [earnings per share] and [net present value] upside from utilization of PUC (Patent Use Code) narrative strategies. In the absence of listed Orange Book patents, it is…
By Kurt R. Karst – Earlier this year, the U.S. Patent and Trademark Office (“PTO”) denied an application for a Patent Term Extension (“PTE”) for U.S. Patent No. 6,869,939 (“the…
By Kurt R. Karst – We previously reported on the Patent and Trademark Office’s (“PTO’s”) determination that U.S. Patent #5,817,338 (“the ‘338 patent”), which covers AstraZeneca’s PRILOSEC OTC (omeprazole magnesium)…
…above-quoted language, a PTE application was recently submitted to the PTO for U.S. Patent No. RE 41,571 (“the ‘571 patent”), a method-of-use patent listed in the Orange Book covering BUTRANS…
…apply in drug patent settlement cases (also known as “pay-for-delay” or “reverse payment” cases) (see our previous post on the Actavis decision). According to the FTC Staff Report, FY 2015…
…Rehearing and Rehearing En Banc concerning an an antitrust challenge to certain patent settlement agreements involving Ciprofloxacin HCl (CIPRO). Patent settlement opponents had thought the full Court might take up…
By Kurt R. Karst – With all of the hubbub over Patent Use Codes (“PUCs”) since the U.S. Court of Appeals for the Federal Circuit issued its April 2010 decision…
…on intellectual property. As we previously reported, the chapter on intellectual property is where the latest battle over biologics exclusivity is happening, and which was the subject of several letters…
…exclusivity for pioneer biologics, according to various press reports (here, here, and here). The HELP Committee reportedly did not vote on other competing FOB proposals that would have provided exclusivity…
…first-to-file generic applicants’ 180-day exclusivity to spur access and competition. Prevents first-to-file generic drug applicants from blocking, beyond a 180-day exclusivity period, the entrance of subsequent generic drugs to the…
…been conducted if BPCA exclusivity was not an option, but the Agency appears ready to test the theory that PREA is all it needs, when applicable. BPCA exclusivity, consequently, appears…
…Section 351(a) BLA approval, or “the date of issuance of the interim final rule controlling the drug.” A similar change is made to the Patent Term Extension (“PTE”) statute at…
…Each drug product listing links to the same patent and exclusivity information appearing in the paper and electronic versions of the Orange Book, and includes links defining patent use codes and…