Pigs Fly: Court Declares Heart Valve Patent Enabled for Human Use Despite Testing Only on Pigs

35 U.S.C §112 ¶1 requires that a claimed invention be reduced to practice; that is, described in the patent specification such that one of skill in the relevant art area would be able to read the patent and implement the invention. Without this requirement, useless specifications could confer patents on vague ideas rather than practical inventions. Doing away with this requirement would make a mockery of patent law. The Court of Appeals for the Federal Circuit disagrees.

In a recent patent law decision, Edwards Lifesciences AG v. CoreValve, Inc., 2012 U.S. App. LEXIS 23385 (Fed. Cir. Nov. 13, 2012), the asserted patent (5,411,552) went to a stent for a prosthetic heart valve. Prior to filing the patent, it had been tested only on pigs, not humans, which the invention ostensibly claimed. The various experimental implants in pigs were not always successful and design changes were made after the patent application was filed.

Edwards (the company asserting the patent) agrees that more developmental work was required at the time of filing. Co-inventor Knudsen wrote, in a contemporaneous report, that "questions such as size reduction, material and design optimization, and stent valve sterilization, remain unsolved," and that "much more work had to be done before anybody ever even contemplated using this for a human." Edwards' expert witness Dr. Buller 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."

Despite the law, the patent was found enabled, and hence valid under §112 ¶1. The claim construction ruling by the district court, affirmed by the court of appeals, demonstrated bias towards the patent holder, as did an excessive damages award. The law seems to have been bent to fit the case.

In this case the court of appeals also went directly against the Supreme Court's eBay decision regarding injunctive relief. In eBay, the Supreme Court ruled that normally, financial compensation was sufficient; that injunctions were to be granted only after considerations of equity, which were not applied in this case. Instead, the court of appeals stated: “The innovation incentive of the patent is grounded on the market exclusivity whereby the inventor profits from his invention. Absent adverse equitable considerations, the winner of a judgment of validity and infringement may normally expect to regain the exclusivity that was lost with the infringement.”

Judge Prost’s dissent in the case, regarding the court’s treatment of the injunction standard, says it best:

“Some complain of areas of patent law in which our guidance is mixed or muddled. This is not - or should not be - one of those areas after the Supreme Court's clear pronouncement in eBay. eBay made clear that there is no general rule that a successful plaintiff is entitled to an injunction; rather, the plaintiff bears the burden of establishing the four equitable factors that weigh in its favor in order to obtain a permanent injunction. We should take care to avoid possible misinterpretation of an otherwise clear Supreme Court standard. [T]he majority's statements appear to me to deviate from the standard articulated by the Supreme Court and our court.”