Janssen Pharmaceutica et al. v. Mylan Pharms., No. 07-1021 (Fed. Cir. 2007)
Last Thursday, the Federal Circuit heard oral arguments in Mylan's appeal of a district court decision upholding the validity of Janssen Pharmaceutica's patent on Risperdal (risperidone), an antipsychotic medication with over $2 billion in annual U.S. sales. On Friday, the Federal Circuit affirmed the decision under Rule 36 without issuing an opinion. The case is noteworthy because the central issue on appeal was obviousness and the judges asked numerous questions about the effect KSR on the case.
Much of the oral argument focused on whether the district court erred by rigidly applying a "lead compound standard," requiring Mylan to prove at trial that one of skill in the art would have chosen a single particular starting compound from which to develop the claimed compound. The district court had called this standard, set forth in the Federal Circuit's Yamanouchi v. Merck decision, a "factually-specific application of the 'motivation-suggestion-teaching' test."
The Federal Circuit judges specifically asked whether KSR called the lead compound standard into question. Counsel for Janssen replied, "no," arguing that whether you call it "lead compound analysis," "motivation," "reason," or "common sense," the district court's analysis was correct. Janssen's attorney further expressed his belief that the Supreme Court in KSR essentially endorsed the TSM test, so long as it is not rigidly applied.
Judges Gajarsa, Prost, and Otero (by designation from the Central District of California) presided over the oral argument. If you would like to listen to the argument, search for case no. 07-1021 on the oral arguments web-page of the Federal Circuit website.