In a temporary reprieve from a district court's order that allowed Teva to launch a generic version of Novartis’s Famvir®, Judge Alvin A. Schall of the U.S. Court of Appeals for the Federal Circuit on Friday, September 7, 2007, granted Novartis’ request to stop the generic drug sales in consideration of the Swiss drug maker’s motion for an injunction pending appeal Novartis Pharmaceuticals Corp., et al. v. Teva Pharmaceuticals USA, Inc., Case No. 07-1542 (Fed. Cir., Sept. 7, 2007) (Schall, J.).
Novartis and Teva have been in litigation over Teva’s Abbreviated New Drug Application (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 on the entry of a generic drug during pending patent-infringement litigation expired. To prevent such an at-risk launch, Novartis filed a motion for a preliminary injunction.
On Wednesday, September 5, following a lengthy oral argument, the district court denied Novartis’ motion. The following day, the court released its opinion, in which it concluded that Novartis was unlikely to succeed on the merits of its case and that Novartis would not suffer irreparable harm from denial of the injunction. The court noted that Novartis had failed to establish the required reasonable probability of success on the merits "because of the obviousness of the U.S. Patent Number 5,246,937." Citing the Supreme Court’s recent decision in KSR International Co. v. Teleflex Inc., the district court ruled that "prior art as a whole" would have motivated scientists to pursue acyclic guanine nucleosides such as penciclovir (the active compound in famciclovir) as an anti-viral drug because they had been proven to be very effective anti-viral agents. Novartis had argued that other prior art taught away from using penciclovir by reporting toxicity of penciclovir in humans. The district court rejected this argument in light of references teaching that penciclovir would act as a powerful antiviral agent. The court noted that the "prior art as a whole" did not teach away from using penciclovir as a lead compound from which to design famciclovir because it was one of only five known acyclic nucleosides to have strong activity and low toxicity. The court further ruled that it would have been obvious to modify penciclovir into an effective orally-absorbed prodrug (famciclovir). Novartis’ patent was also deemed unenforceable by the district court due to inequitable conduct because Novartis’ did not disclose prior art that showed that penciclovir would have strong anti-viral activity while stating in its patent application that the prior art dissuaded the use of penciclovir.
The next day, September 6, Novartis filed an Emergency Motion for an Injunction Pending Appeal with the Federal Circuit. On September 7, Teva announced that it had "commenced shipment of Famciclovir Tablets" and that it is the 180-day exclusivity holder.
Later that day, Judge Schall ordered that "Teva is temporarily enjoined from selling its generic famciclovir product, pending the court’s receipt of Teva’s response and the court’s consideration of the papers submitted."
Practice Note: As the September edition of IP Update is going to print, the Federal Circuit is still considering the parties’ submissions.
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