Federal Circuit Reaffirms Sufficiency of Animal Testing for Medical Device Patents, Makes eBay Test Less Rigid

Patent Food and Drug Administration Jurisdiction
Edwards Lifesciences v. CoreValve By David LeRay – Edited by Dorothy Du Edwards Lifesciences v. CoreValve, No. 2011-1215, -1257 (Fed. Cir. Nov. 13, 2012) Slip opinion The Federal Circuit affirmed in part and remanded in part the United States District Court for the District of Delaware, which had found that CoreValve infringed upon Edwards Lifesciences’ heart valve patent and awarded lost profits damages, but did not issue an injunction. The Federal Circuit affirmed the lower court’s claim construction and the findings of validity and infringement. The patent at issue was Patent No. 5,411,552, entitled “Valve Prosthesis for Implantation in the Body and a Catheter for Implanting Such Valve Prosthesis.” The patent relates to prosthetic heart valves that can be implanted without open heart surgery, known as transcatheter aortic valve implantation (TAVI). Businessweek and Reuters both provide an overview of the case. Patent Hawk argues the decision was overly favorable to the patent holder plaintiff because of the low enablement threshold and the forgiving analysis of the eBay injunction factors. The filing date of the patent at issue was in 1994, and the first human demonstration of TAVI technology was accomplished in 2002. Both companies in the lawsuit sell TAVI products in overseas markets, but CoreValve manufactures its devices in the United States. The FDA approved Edwards’ device, known as Sapien, for sale in the United States in November 2011. Defendant CoreValve argued that the patent was not enabled because at the time of filing, the device had only been implanted in pigs. Edwards at 7. However, the Federal Circuit held that the enablement requirement may be met by animal tests, because “[c]ontinuing development is often contemplated and necessary, while early filing is often essential.” Id. Thus, the court found the jury’s verdict of the patent’s validity to be supported by substantial evidence. Plaintiff Edwards sought lost profits damages and a permanent injunction. Regarding the lost profits, the lower court found that Edwards could have met demand for the infringed product and captured the infringing sales. Id. at 15. The record also stated that the defendant was on notice about the patents as early as 2005 and that the defendant was familiar with the patents and inventors. Id. Regarding the permanent injunction, the lower court denied the injunction because an injunction would not prevent irreparable harm to Edwards as required by eBay Inc. v. MercExchange, L.L.C, 547 U.S. 388, 391 (2006). The defendant CoreValve had insisted that it would simply move operations to Mexico in order to avoid infringement, since its infringing activity was the manufacture, not the sale, of the infringing product in the United States. Id. at 18. The Federal Circuit dismissed this justification because CoreValve has not ceased operations in the United States during the pendency of the appeal. In addition, the court took the position that district courts should not view the eBay test as dispositive, noting that permanent injunctions are most typically issued when the plaintiff and defendant are direct competitors, as in this case. Id. at 18. Circuit Judge Prost concurred in the judgment, but took issue with the majority’s legal analysis on the permanent injunction issue. Specifically, she criticized the majority for failing to apply the four-factor test mandated by eBay. Judge Prost thought eBay set forth a “clear pronouncement” that the four-factor test be used and that the court should apply the test rather than risk muddling the case law. Id. (Prost, J., concurring) at 2. The case is significant because (1) it re-affirms that animal testing may be sufficient for enablement of a patent and (2) it is decidedly pro-plaintiff regarding permanent injunctions as a remedy. Biotechnology companies will often not pursue the expensive regulatory process unless they are able to obtain a patent, and human testing is often unavailable until late in the development of a drug or medical device. If animal testing were insufficient for enablement, there would likely be less commercialization of biotech innovations. David LeRay is a 3L at Harvard Law School.