Gary Rasmusson v. SmithKline Beecham (Fed. Cir. 2005).
Finasteride, a 5aR inhibitor, is thought to be a useful drug in the fight against prostate cancer — as well as hair loss. In 2001, the PTO declared an interference between an application by Rasmusson and one filed on behalf of SmithKline. The dispute revolved around whether Rasmusson’ should be allowed to claim the beneficial filing date of its earlier applications — i.e., whether the early applications enabled the later drafted claims.
Relying on articles demonstrating that various multi-active 5aR inhibitors were effective in treating prostate cancer, Rasmusson argues that a person of ordinary skill in the art at the time of his applications would have believed that administering a therapeutically effective amount of finasteride could be used for treating human prostate cancer. For that reason, Rasmusson asserts that he did not need to provide any data to demonstrate the efficacy of finasteride.
Based on published articles and expert testimony, the CAFC agreed with the BPAI that the later drafted claims were not enabled: although it was known that 5aR inhibitors blocked DHT production, at that the time of filing, “it was not clear wither DHT or testosterone caused prostate cancer.”
Rasmusson also argued that SmithKline’s patent claims were anticipated by a reference that disclosed the claimed method of administering finasteride. SmithKline, contended that the reference could not be anticipatory because is not enabling (since the reference purports to show data that finasteride could not be used to treat prostate cancer). Agreeing with Rasmusson, the CAFC found that “proof of efficacy is not required in order for a reference to be enabled for purposes of anticipation.”
In conclusion: Rasmusson loses interference to SmithKline, but SmithKline’s patent is anticipated. Perhaps the parties should have settled. . . .