Is proof of efficacy required for a prior art reference to be enabling for anticipation?
This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.
No, proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation. The MPEP 2122 cites a Federal Circuit decision that clarifies this point:
“[P]roof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation.” – Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006)
This means that a prior art reference can be considered enabling and anticipatory even if it doesn’t provide evidence that the disclosed invention actually works as intended. The disclosure itself is sufficient for anticipation purposes.