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By Kurt R. Karst – There’s a first time for everything! And on August 8th, 2012, FDA decided, for the first time since the enactment of the Orphan Drug Act,…
…i.e., until May 27, 2014.” But for the agreements, say Plaintiffs, a generic version of NEXIUM would have been available early as April 14, 2008, when the 30-month stay of…
…September 21, 2012, when pediatric exclusivity applicable to the ‘578 patent expired. September 21, 2012 came and went, however, without an FDA approval decision on the Ranbaxy ANDA. Meanwhile, Mylan,…
…(briefs available here, here, here, here, here, and here) and holding Oral Argument in September 2014, the Fourth Circuit issued its decsion on December 16, 2014. Analyzing this issues…
…drug company’s commitment, as part of a settlement agreement, not to launch an Authorized Generic (“AG”) to compete with a generic version of the product approved under an ANDA –…
…July 11, 2006, all claims of the ‘703 patent were disclaimed, and, according to Apotex, the patent expired on April 12, 2009 for failure to pay maintenance fees. In the…
…Milk Protein Concentrate (“MPC”) is a “proper, permitted ingredient in yogurt.” Earlier this year, on March 30, 2012, plaintiff Martin Taradejna filed a complaint alleging that the marketing of Yoplait…
…federal False Claims Act (“FCA”) violations where one drug manufacture has sued its competitor. In Amphastar Pharm., Inc. v. Aventis Pharma SA, No. 09-0023 (C.D. Cal., Apr. 19,2013), Amphastar, on…
…responsible for ensuring that the required reports are, in fact, submitted to FDA. If Firm A is designated to submit the MDR reports, but failed to do so, [FDA] would…
…albeit ones that are undefined – and refused to dismiss Plaintiff’s claim as preempted. In Trazo et al. v. Nestle USA, Inc., Plaintiffs allege that Defendant makes false and misleading…
…under that pre-MMA regime are contentious, as recent lawsuits against FDA (here, here, and here) concerning generic CELEBREX (celecoxib) Capsules and stemming from an FDA Letter Decision show. Other times,…
…courts had ruled that there was no private right of action to delist an allegedly improperly listed patent (see, e.g., Mylan Pharmaceuticals, Inc. v. Thompson, 268 F.3d 1323, 60 USPQ2d…
…only show that acceptability of one aspect of its ANDA (e.g., chemistry, labeling, or bioequivalence) was delayed due, at least in part, to a change in or review of the…
…1341, 1346-47 (citing Caraco, 527 F.3d at 1292; and Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353, 1359-60 (Fed. Cir. 2008). The same logic applies here. That is, “‘but-for’…
…in 1982 Federal Register notices. According to FDA, since 1969, when FDA first implemented an adverse event reporting system, and as of 2005, the Agency “has received more than 400…