Month: September 2007
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These features aren’t actually that new. They’ve been on Orange Book Blog for months–and you may have noticed or even used them. But I never really drew attention to them, and I think they’re useful so I wanted to do that now. "Search 32 Pharma/Patent News Sites": Until today, this was called "Pharma Patent News…
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In re Gabapentin Patent Litigation, No. 2006-1572 (Fed. Cir. 2007) Last Friday, the Court of Appeals for the Federal Circuit reversed a 2005 district court ruling granting summary judgment of noninfringement to several companies who sought to market generic versions of Pfizer’s epilepsy drug Neurontin (gabapentin). The district court had ruled on summary judgment that…
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FDA Law Blog has a great post about a very interesting district court decision concerning Apotex’s attempt to market generic Prilosec before AstraZeneca’s pediatric exclusivity expires. Congress passed FDA reform legislation this week, albeit without provisions for biosimilars. (AP article; FDA Law Blog; PhRMA release). In the Pipeline is a great blog by a medicinal…
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Roche Palo Alto LLC v. Apotex, Inc., No. C05-02116-MJJ (N.D. Cal. 2007) Apotex suffered a loss last week in its effort to relitigate the validity of U.S. Patent No. 5,110,493, which covers Roche's ketorolac tromethamine (KT) ophthalmic solution (i.e., Acular®). The U.S. District Court for the Northern District of California granted Roche's motion for summary…
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Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO), spent some quality time this afternoon answering questions from bloggers about follow-on biologics, patent reform, and FDARA/PDUFA legislation. Mr. Greenwood said that follow-on biologics are a "critical, critical issue" for BIO. From BIO's perspective, the ideal bill would reflect and parallel the Hatch-Waxman Act. It would…
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The Federal Circuit reissued its July 11 opinion in Daiichi Sankyo v. Apotex as a precedential opinion, one day after denying Daiichi's petition for rehearing. According to Hal Wegner, a major reason for making the decision precedential was Prof. Joseph Scott Miller's Rule 47.6(c) filing. Biosimilars legislation is "off the table" for now. The FDA…
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Novartis Pharms. v. Teva Pharms. USA, No. 05-1887 (D.N.J. 2007) Novartis and Teva have been in litigation over Teva’s ANDA for generic Famvir (famciclovir), Novartis’s antiviral treatment for herpes, since 2005. Teva was prepared to launch its generic famciclovir product on August 24, 2007–the day the 30-month stay expired. To prevent such an at-risk launch,…
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Federal Circuit Invalidates Aventis’s Altace Patent on Obviousness Grounds, Handing Victory to Lupin
Aventis Pharma and King Pharms. v. Lupin, No. 2006-1530 (Fed. Cir. 2007) The Court of Appeals for the Federal Circuit today reversed a district court trial verdict that held the asserted claims of Aventis's patent on Altace not invalid, finding instead that the claimed invention would have been obvious. The patent in suit was U.S.…
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Altana Pharma AG and Wyeth v. Teva Pharms. USA, No. 04-2355 (D.N.J. 2007) Last Thursday, a federal district court denied Wyeth’s motion for a preliminary injunction that would have prevented generic drug manufacturer Teva from launching its generic version of Protonix. The opinion denying Wyeth's motion was filed under seal; only the order is publicly…
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The Institute for International Research will be holding its 8th annual “Generic Drugs Summit” at the Fairmont Hotel in Washington, D.C., September 17-19. According to IIR, this is “the leading independent forum for addressing business and legal concerns impacting the Generics marketplace.” The conference features three pre-event symposia and workshops on September 17: Full day:…
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