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…for discounts (United States ex rel. Banigan v. Organon USA, Inc., et al. (Case 1:07-cv-12153-RWZ)). Just one day after issuing her opinion in the Omnicare case, Judge Zobel used similar…
…to liability under the AKS. In the second case before Judge Zobel, United States ex rel. Banigan v. Organon USA, Inc., et al. (Case 1:07-cv-12153-RWZ), defendant Omnicare filed a reply…
…Yoplait USA argued that according to FDA yogurt may contain MPC. Defendants filed a motion to dismiss arguing, among other things, that primary jurisdiction barred Taradejna’s claims. As explained by…
…Complaint, GSK and Teva allegedly “delayed generic competition in the markets for Lamictal Tablets and Lamictal Chewables . . . and improperly manipulated the Hatch-Waxman Act to impede, rather than…
…Teva Pharmaceuticals USA, Inc. (“Teva”) filed a Complaint and a Motion for Preliminary Injunctive Relief against FDA concerning 180-day exclusivity forfeiture for generic versions of Merck & Co., Inc.’s (“Merck’s”)…
…A/S v. Caraco Pharmaceutical Laboratories, Ltd., 601 F.3d 1359 (Fed. Cir. 2010), which addressed whether the patent delisting counterclaim provisions at FDC Act §505(j)(5)(C)(ii)(I), as added by the Medicare Modernization…
…hired a compliance officer to insure that the company remained in compliance with the consent decree. Lane Labs also offered two experts who testified that the company had competent and…
…Pharms., USA, 620 F. Supp. 2d 899 (N.D. Ill. 2009), Kellogg v. Wyeth, 612 F. Supp. 2d 421 (D. Vt. 2008), Schrock v. Wyeth, Inc., 601 F. Supp. 2d 1262…
…‘underlying NDA’ only if the subsequent 505(b)(2) applicant specifically relied for approval on the drug product approved in the underlying NDA. . . .” (italics in original; bold italics added)….
…patent infringement suit, through which generic companies can force brand companies to delist an improperly asserted patent. See 21 U.S.C. § 355(j)(5)(C)(ii)(I). This counterclaim provision is the only portion of…
…Circuit’s recent decision in Teva Pharms USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010), in which the court ruled that Teva did no forfeit 180-day exclusivity eligibility under…
…595 F.3d 1303 (D.C. Cir. 2010), and Roxane Laboratories, Inc. has appealed to the D.C. Circuit the D.C. District Court’s April 2, 2010 ruling denying Roxane’s preliminary injunction motion – FDA…
…Teva Pharms USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010), in which the D.C. Circuit was convinced by Teva’s structural argument that the patent delisting counterclaim provision at…
…the D.C. Circuit has ended one battle in the fight over generic COZAAR/HYZAAR 180-day exclusivity. But another battle wages on . . . . Roxane Laboratories, Inc. and Apotex, Inc….
…the U.S. District Court for the District of New Jersey in Medeva Pharma Suisse A.G. v. Par Pharmaceuticals, Inc., Case No. 3:10-cv-04008 (D.N.J., Mar 29, 2011), is one of them. …