In Edwards Lifesciences AB v. Corevalve, Inc. (now a part of Medtronic), Appeal No. 2011-1215-1257 (Fed. Cir. Nov. 13, 2012), Corevalve challenged the validity of US Pat. No. 5,411,552 directed to a “transcather heart valve” on the basis that the valve had only been implanted in pigs as of the effective filing date of the patent, and that not all of the experimental implants were successful. The Fed. Cir. disagreed, and Edwards provides a succinct review of the standards for enablement based on animal testing.
The panel began by reminding the parties that “[t]he enablement requirement is met if the description [in the specification] enables any mode of making and using the invention.” Johns Hopkins Univ. v. CellPro, Inc. 152 F.3d 1342, 1361 (Fed. Cir. 1998). In other contexts, this statement permits claims based on “benchtop” syntheses, even if the claimed compound or process is being produced or practiced on a pilot plant scale. “The most efficient commercial embodiment need not be disclosed. Durel Corp. v. Osram Sylvania, Inc., 256 F.3d 1298 (Fed. Cir. 2001).”