Zyprexa Patent Verdict Coming April 14
This article was originally published in The Pink Sheet Daily
Executive Summary
Timing of the Indianapolis court's verdict suggests the outcome could be favorable for Lilly. The announcement comes a week after a federal appeals court rescinded a ruling on a Paxil patent that could have aided generic companies' challenges to the olanzapine patent.
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Indianapolis federal Judge Richard Young will announce his long-awaited ruling on the validity of Lilly's Zyprexa (olanzapine) patent after the financial markets close April 14. The timing of the court's verdict suggests the ruling could be favorable for Lilly. The announcement comes a week after a federal appeals court rescinded an opinion in a separate case that could have aided generic companies' challenges to the validity of the Zyprexa patent. On April 8, the Federal Circuit Court of Appeals rescinded an opinion in a Paxil patent case that limited when clinical trials constitute an "experimental use" of an invention that can nullify the "public use" bar (1 (Also see "Paxil Patent Ruling Revised: Will GSK’s Loss Be A Gain For Lilly’s Zyprexa?" - Pink Sheet, 8 Apr, 2005.)). A patent is invalid if the invention was in public use more than one year before the patent application was filed. However, there is an exception to the public use bar for experimental use of an invention. In post-trial briefs filed with the Indianapolis court, generic companies cited the initial Paxil appellate ruling (issued in April 2004) in arguing that Lilly's patent no. 5,229,382 is invalid because clinical trials of olanzapine in the mid-1980s constituted public uses and not experimental uses. The '382 patent is the only Zyprexa patent listed in the "Orange Book"; it expires in 2011. In rescinding its earlier ruling in the Paxil case, the Federal Circuit nevertheless invalidated GlaxoSmithKline's paroxetine patent on the basis that it was inherently anticipated. However, the revised opinion did not address the subject of the public use bar or the experimental use exception. The Indianapolis court held a bench trial in the Zyprexa patent case in early 2004. In light of the delayed verdict, there had been speculation that the court was waiting for the Federal Circuit to rule on petitions for rehearing in the Paxil case before announcing its findings on the Zyprexa patent. Generic companies have raised various other challenges to the validity of Lilly's patent. Ivax and Dr. Reddy's are active defendants in the patent case. Ivax believes it holds first-to-file rights on all dosage strengths of olanzapine except the 20 mg tablet, for which Dr. Reddy's is believed to hold the generic exclusivity rights. Teva is not actively participating in the case but has agreed to be bound by the court's decision. Teva and Mylan hold tentative ANDA approvals for olanzapine. - Sue Sutter |