Month: May 2006
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In an opinion released last Friday, Judge Kent A. Jordan of the U.S. District Court for the District of Delaware denied Abbott’s motion to dismiss numerous antitrust claims in Abbott Labs et al. v. Teva Pharms. et al., No. 02-1512. The antitrust claims were originally brought by Teva and Impax as counterclaims in patent infringement…
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Vermont Senator Patrick Leahy, co-chairman of the Intellectual Property Subcommittee of the Senate Judiciary Committee, introduced a bill last week entitled "Life-Saving Medicines Export Act of 2006." If enacted, the bill would provide for compulsory licensing of patented medicines (including vaccines and diagnostic tests) in the United States. According to a statement from Sen. Leahy's…
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The FDA has appealed the decision in Ranbaxy v. Leavitt to the D.C. Circuit Court of Appeals. On May 1st, the district court in the case found that by denying Ranbaxy’s and Teva’s citizen petitions, the FDA improperly stripped the companies of their 180-day marketing exclusivity rights for generic Zocor. The citizen petitions had asked the FDA to relist…
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The Solicitor General's recent recommendation to deny certiorari in FTC v. Schering seems to raise the likelihood that the Supreme Court will decline to hear the case. If the Supreme Court denies cert, perhaps Congress should consider the policy issues at play. In FTC v. Schering, the FTC is appealing an Eleventh Circuit decision…
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Teva announced Monday that the FDA has granted final approval of generic Lexapro to Teva’s IVAX unit. Lexapro, manufactured by Forest Laboratories, is a selective serotonin reuptake inhibitor (SSRI) antidepressant, with annual sales of over $2 billion in the United States. Lexapro sales account for 60% of Forest’s revenue. Forest Labs’ patent infringement case against…
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Responding to the Supreme Court’s invitation, the Solicitor General has filed an amicus brief in SmithKline Beecham v. Apotex. The Solicitor General recommends that the Supreme Court deny SKB’s petition for certiorari. Previously, SKB lost its patent infringement suit against Apotex both in the district court and at the Federal Circuit. In the suit, SKB…
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In this antitrust case, In re Wellbutrin SR Antitrust Litigation, Nos. 04-5525, 04-5898, 05-396 (E.D. Pa.), three classes of plaintiffs, representing direct and indirect purchasers of Wellbutrin SR, as well as Medical Mutual of Ohio, a "third-party payor for Wellbutrin SR," sued GlaxoSmithKline (GSK) for violating various state and federal antitrust laws. The plaintiffs allege…
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As Patently-O reported early this morning, the Solicitor General has filed an amicus brief in FTC v. Schering. The Supreme Court, while considering whether to grant certiorari in the case, had asked for the views of the Solicitor General last fall. The Solicitor General’s brief advises the Court not to grant the FTC’s cert petition.…
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In a recent decision, Ranbaxy v. Leavitt, the federal district court for the District of Columbia held that the FDA improperly denied Ivax’s (a division of Teva) and Ranbaxy’s citizen petitions to relist two Merck patents on Zocor. According to the court, by denying the citizen petitions, the FDA effectively nullified Ivax’s and Ranbaxy’s rights…
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Generic drug companies may finally hear from the Supreme Court on whether merely listing a patent in the Orange Book creates a sufficient basis for a declaratory judgment action. Last October, the Supreme Court denied cert in Teva v. Pfizer, in which the Federal Circuit held that listing a patent in the Orange Book does…
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