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…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…
…to the December 2003 enactment of the Medicare Modernization Act (“MMA”) is alive and kicking. . . . and will likely be around for years to come. Sometimes FDA’s decisions…
…was most famously the topic of the U.S. Supreme Court’s decision in Caraco Pharm. Labs, Ltd. v. Novo Nordisk A/S, __ U.S. __; 132 S. Ct. 1670 (2012) (see our…
…FDA forfeiture decision. But that’s the topic of today’s post . . . a recent and interesting case concerning generic ACTONEL (risedronate sodium) Tablets approved under NDA No. 020835. And…
…product for reasons other than sale within the control of the manufacturer or application holder.” Hmmmm . . . . . This is not the first time Connecticut has put…
…that “the alleged action taken (giving rise to the injury-in-fact) [is] [the] listing [of] particular patents in the Orange Book.” Teva Pharms., USA, Inc. v. Eisai Co. Ltd., 620 F.3d…
…Capsules, 20 mg and 40 mg. But it wasn’t Ranbaxy Laboratories, Ltd./Ranbaxy, Inc. (“Ranbaxy”) that scored the approval for its long-pending application (ANDA 077830); it was Teva Pharmaceuticals USA subsidiary…
…other applicant has received tentative approval).” Based on the D.C. Circuit’s March 2, 2010 decision in Teva Pharms USA, Inc. v. Sebelius, a mere patent delisting request is not enough…
By Douglas B. Farquhar, Jennifer M. Thomas & Kurt Karst – We can’t help celebrating a recent court victory in which Hyman, Phelps & McNamara, P.C. represented Mylan Pharmaceuticals, Inc….
…off is Otsuka Pharmaceutical Co., Ltd.’s (“Otsuka”) two-count Complaint and Motion for Summary Judgment filed against FDA in the U.S. District Court for the District of Maryland concerning ABILIFY (aripiprazole). …
…Inc., U.S. Smokeless Tobacco Company LLC, R.J. Reynolds Tobacco Company, American Snuff Company, LLC, Santa Fe Natural Tobacco Company, Inc., and Lorillard Tobacco Company argue that the Final Guidance was…
…activities undertaken by the ‘applicant’ — the patent owner or its agent, as required by the statute. . . .” (see also Hoechst-Roussel Pharms., Inc. v. Lehman, No. 95-650-A (E.D….
…(W.D.N.Y. July 29, 2010) (No. 10-cv-587); Consent Decree, United States v. Jason Pharms, Inc., (D.C. Cir. 2012) (No. 12-1476), ECF No. 3. Thus, in response to the Bayer decision (following…
…global pharma companies to the threat of simultaneous enforcement actions in multiple jurisdictions. Pharma companies as a consequence are redoubling their efforts to preach and practice ethical compliance worldwide. But…
…denied Omnicare, Inc.’s motion for summary judgment in the ongoing qui tam case, United States ex rel. Banigan v. Organon USA, Inc., et al. (Case 1:07-cv-12153-RWZ). In their complaint, filed…