Attempting to reconcile two apparently conflicting lines of precedent, the U.S. Court of Appeals for the Federal Circuit has held that "what constitutes proper enablement of a prior art reference for purposes of anticipation under section 102…differs from the enablement standard under section 112." Rasmusson v. Smithkline Beecham Corp., Case Nos. 04-1192, -1192 (Fed. Cir. June 27, 2005) (Bryson, J.).
In a patent interference, the Board of Patent Appeals and Interferences found Rasmusson’s application was not entitled to the benefit of an earlier filing date and, therefore, did not establish priority over Smithkline’s patents. The Board also found Smithkline’s patents were not anticipated by a published European patent application. The Federal Circuit affirmed the Board’s finding on Rasmusson’s effective filing date but reversed and remanded on anticipation.
The count in the interference was a method of treating prostrate cancer. Rasmusson sought the benefit of earlier-filed applications disclosing a chemical compound (finasteride) known to inhibit an enzyme that converts testosterone into an androgen (DHT) now known to be associated with prostrate cancer. The Federal Circuit agreed with the Board that Rasmusson’s earlier-filed applications failed to show the efficacy of the chemical compound finasteride as a way to treat prostrate cancer (in part because Rasmusson failed to provide experimental data). According to contemporaneous literature in the art, it was not clear that DHT caused prostrate cancer, and finasteride’s anti-tumor effects may have been due to inhibition of testosterone receptor binding instead of DHT enzyme inhibition. The Federal Circuit held that the enablement requirement under §112 requires more than "an unproved hypothesis," namely, disclosure of a practical utility of the invention.
At the same time, the Federal Circuit declined to apply this standard to whether a prior art reference was sufficiently enabling to anticipate. Unlike §112, §102 does not require the prior art permit "use" of the invention: "[A] prior art reference need not demonstrate utility in order to serve as an anticipating reference under section 102." Although the prior art reference failed to demonstrate the efficacy of finasteride in treating prostrate cancer, the Federal Circuit—holding the reference could still be enabling and anticipatory—remanded for further findings by the Board.
Practice Note
This decision is of particular importance in the chemical and biological arts. Applicants tempted to file their applications quickly, before testing their inventions, should be mindful they may actually be called upon to prove the practical utility and efficacy of their inventions.
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