Proof Of Efficacy Not Required For Reference To Be Enabled For Purposes Of Anticipation

Case: Rasmusson v. Smithkline Beecham Corp., 04-1191, -1192 (Fed. Cir. 6/27/05)

The One Sentence Summary: The Federal Circuit concluded that even though prior applications lacking experimental proof of the efficacy of a method of treating prostate cancer were not sufficiently enabled to establish priority of a claimed invention, they could still be used to establish anticipation of another's invention.

Federal Circuit Holdings:

• An issue was how much, if any, data were required to demonstrate the therapeutic use of a specific compound (finasteride) for treatment of prostate cancer, in order for prior applications to be found sufficiently enabled to either support a later method claim for use of the compound, or to allow the application to serve as prior art that anticipated another's invention.
  
• The court looked to prior decisions holding that without evidence that one skilled in the art would accept, without question, statements as to the effect of the claimed drug product, and without evidence to demonstrate that the product has the claimed effect, utility is not demonstrated and an applicant cannot establish enablement sufficient to establish priority for a later claim.
  
• The court then reasoned that there was sufficient evidence for the Board of Interference's finding that a person of ordinary skill in the art would not have believed finasteride was effective in treating prostate cancer, because scientific articles and expert testimony showed that at the time of appellant Rasmusson's earlier applications, multiple explanations existed for the observed anti-tumor effects. As a result, the Board correctly found that those applications, which contained no experimental proof of the invention's effectiveness in treating cancer, were not enabled.
  
• The court rejected Rasmusson's argument that it was enough to show that it was plausible that the invention would be effective, because patent law is not meant to reward inventors who have made no more than respectable guesses as to the likelihood of their success.
  
• The court then considered whether a prior European application by Rasmusson anticipated and rendered obvious the claims of Smithkline Beecham. It noted that the test for enablement in the context of anticipation as prior art is different than that used under section 112 for allowance of a claim. Anticipation can be established even if the prior art does not teach how to use a fully disclosed compound for a specific use. In short, the court held that, consistent with Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368 (Fed. Cir. 2001), proof of efficacy is not required for a reference to be enabled for purposes of anticipation.
  
• Since the Board had not expressly considered whether every limitation in Smithkline's claims was anticipated by Rasmusson's prior European application, the Court remanded the case to the Board. It also left it for the Board to decide whether the prior European application, which was published more than a year before a subsequent U.S. application by Rasmusson, invalidated that application under section 102(b).