Edwards Lifesciences AG v. CoreValve, Inc., No. 2011-1215 (Nov. 13, 2012).
Edwards Lifesciences brought suit on its patent on a prosthetic device, called a “transcatheter heart valve,” mounted on a stent and implanted in the heart by catheter, thus avoiding the risks of open heart surgery. The Federal Circuit affirmed the verdict for the patentee, but reversed the trial court’s denial of injunctive relief and remanded, using some evocative language about when injunctions are appropriate.
The court affirmed the finding of enablement, rejecting the defendant-appellant’s argument the claims were not enabled because the only testing had been done on pigs and not always successfully. The court noted the long-time recognition that, when experimentation on human subjects is inappropriate, as in the testing and development of medical devices, the enablement requirement may be met by animal tests or in vitro data. The court noted that the prosthetic device had been successfully implanted in pigs, in accordance with procedures described in the specification, and that pigs are a standard experimental animal, and cited evidence about the established use of porcine valves in humans.
The court also affirmed the infringement finding and affirmed, without any detailed discussion, the damages award of almost $74 million.
Most notably, the Federal Circuit vacated the trial court’s denial of an injunction, holding that: "[a]bsent 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." (Emphasis supplied.) The court noted the parties were direct competitors and that the trial court had erred in (a) finding that the patentee had already lost market share in the U.S., because the evidence showed the FDA had not yet authorized sales in the U.S.; and (b) finding that the patentee had given up its exclusivity by licensing the technology to another competitor because, as the defendant conceded, there was no such license. Also, the trial court had relied on the defendant’s statements that it was immediately moving production to Mexico. The patentee argued on appeal and the defendant did not deny that it actually continued its production of infringing product in California. The court remanded the case for the trial court to reconsider the request for an injunction in light of subsequent events.
Judge Prost concurred with the decision to vacate the denial of the injunction but disagreed with the majority's statement quoted above, concluding that it deviates from the Supreme Court's four-factor test for an injunction in eBay:
“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 … . We should take care to avoid possible misinterpretation of an otherwise clear Supreme Court standard.”
Despite Judge Prost’s admonition, it will be interesting to see if this case signals a shift by the Federal Circuit in favor of granting injunctive relief, where the parties are competitors.