Edwards Life Sciences AG et al. v. CoreValve, Inc. et al.

Docket No. 2011-1215, -1257
RADER, NEWMAN, PROST(C)
November 13, 2012

Brief summary: Applicant must only show one “mode of making an using the invention” and “in the testing and development of drugs and medical devices, the enablement requirement may be met by animal tests or in vitro data”.

Summary: CoreValve appealed jury verdict that Edwards’ patent directed to a transcatheter heart valve was valid and willfully infringed. CoreValve challenged the patent for “lack of enablement based on the undisputed fact that at the time the ’552 patent application was filed the stent/valve prosthesis had been implanted only in pigs”, the various experimental implants in pigs were not always successful, and that design changes were made after the patent application was filed.” During the trial, Edwards’ expert witness testified that at the time the patent application was filed, it was “a device to perform testing on” and “not a device to move in and treat patients” (it was tested in pigs). The FC panel agreed with the determination that the claims were enabled because the specification described a “mode of making an using the invention” (Johns Hopkins, FC 1998; Transocean, FC 2010 (not required to enable “the most efficient commercial embodiment”); In re Wands, FC 1998) and pigs are a standard experimental animal for heart valve research (“…it has long been recognized that when experimentation on human subjects is inappropriate, as in the testing and development of drugs and medical devices, the enablement requirement may be met by animal tests or in vitro data” (MPEP §2164.02; In re Brana, FC 1995 (“one who has taught the public that a compound exhibits some desirable pharmaceutical property in a standard experimental animal has made a significant and useful contribution to the art, even though it may eventually appear that the compound is without value in the treatment in humans”); Scott v. Finney, FC 1994 (“Title 35 does not demand that such human testing occur within the confines of Patent and Trademark Office proceedings.”)). The panel also agreed with the conclusion of infringement, finding the court’s claim construction determinations were consistent with the specification. On damages, CoreValve argued that it was not liable for more than a “modest royalty” because it could have manufactured the valve overseas but neither the DC nor the FC panel was convinced. The decision not to enhance damages was affirmed as well (“issues were ‘sufficiently close’ and the defenses not frivolous”). The panel remanded the DC decision not to grant an injunction (eBay, US 2006) because “the circumstances have not been fully explored in the record before us”. It also noted that the DC could consider the protective “patent prosecution bar” on remand.