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…three circumstances is dispositive in establishing an actual declaratory judgment controversy as to all the paragraph IV certified patents, whether the patentee has sued on all or only some of…
…of section 402(g) would be entitled to substantial deference. The case is Alliance for Natural Health US et al. v. Sebelius et al., No. 1:09-cv-01523-CKK (D.D.C. filed August 12, 2009)…
…Court greater assurance that the question presented is of recurring significance and the legal issues have fully percolated in lower courts,” says Acting Solicitor General Neal Katyal in the government’s…
…alleged violative conduct and initiation of the FTC’s suit, and no allegations of future circumstances in which Shire could be expected to repeat the alleged misconduct – suggest that the…
…the Orange Book as a method-of-use patent with a U-812 patent use code defined as “RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS.” In February 2010, Sandoz allegedly…
…its assessment of whether the Plaintiffs have plausibly alleged exclusionary conduct sufficient to state a claim under Section 2 of the Sherman Act. In doing so, the FTC also addresses…
…In a December 2011 Complaint, several direct purchasers allege that Wyeth, acting alone and/or in concert with first generic applicant Teva Pharmaceuticals USA, Inc. (“Teva”) violated Section 2 of the…
…among other federal laws. These listings materially impact the economic rights of competing drug sponsors. Thus, TE listings have automatic and significant binding legal consequences under state and federal law….
…heart of Takeda’s early October 2014 lawsuit against FDA. Briefly, Takeda alleges that FDA’s approval of MITIGARE violates the FDC Act and the Administrative Procedure Act in several respects:…
…our blog post here), it also included a host of directives to FDA to issue guidances, certain procedural rules, and by November 26, 2019, a final rule on nonprescription sunscreens…
…USA, Inc. (jointly, “Teva”) by direct purchasers of certain anti-epileptic drug products containing the active ingredient lamotrigine and marketed by GSK as LAMICTAL. The direct purchaser plaintiffs allege that GSK…
…as implemented, on innovation, as well as on the availability, inter alia supply shortages and deferred or missed market launches, and accessibility of medicinal products, including high priced essential medicinal…
By Susan J. Matthees– The United States District Court for New Jersey recently denied a motion by the Federal Trade Commission (“FTC”) to hold Lane Labs-USA, Inc. (“Lane Labs”), Andrew Lane,…
…final approval if tentative approval is not warranted) is 40 months during the period of July 9, 2012 and September 30, 2015, and not 30 months. FDA’s application of the…
…approval. In 2002, FDA was first faced with the question of whether a generic applicant must certify to Orange Book-listed patents covering the original NDA on which the approval of…