Category: Paragraph IV Cases
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In a 31-page opinion by Judge Prost, joined by Judge Gajarsa, a Federal Circuit panel held yesterday that Teva had raised a substantial question as to the validity of Abbott’s patents covering its extended release clarithromycin product, Biaxin XL, and therefore vacated a preliminary injunction that had been entered against Teva by the U.S. District…
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Following the Solicitor General’s advice, the Supreme Court today denied SmithKline Beecham’s petition for certiorari in SKB v. Apotex, No. 05-489. The issue presented was whether inherent anticipation occurs only when one of skill in the art recognizes the prior creation of the invention. The Federal Circuit had held that inherent anticipation may occur regardless…
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The Court of Appeals for the D.C. Circuit today upheld an FDA rule stating that a district court order dismissing a patent suit for lack of subject matter jurisdiction is not a "court decision" under the Hatch-Waxman Act, and is therefore insufficient to trigger the first ANDA filer’s 180-day exclusivity period. The case is Apotex…
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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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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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Merck has asked the federal district court in Delaware to vacate a judgment that Merck’s patent on its Fosamax Once Weekly drug product is invalid, alleging that Teva committed fraud in the previous litigation. In its 2003 decision, the district court upheld Merck’s patent. However, in a 2005 decision, the Federal Circuit reversed the district…
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Barr Labs announced that yesterday, Eli Lilly filed a patent infringement lawsuit against Barr relating to Lilly’s Prozac Weekly drug product. Lilly filed suit in the Southern District of Indiana, alleging infringement of U.S. reissue patent RE39,030. According to Barr’s press release, Barr filed its ANDA seeking approval of a generic version of Prozac Weekly…
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