Edwards Lifesciences v. Corevalve: Federal Circuit Sides Strongly with Prevailing Plaintiffs Seeking Injunctions

The Federal Circuit has created some ambiguity regarding its propensity to issue permanent injunctions to prevailing plaintiffs. In Edwards Lifesciences AG v. Corevalve, Inc., 2011-1215 and 2011-1257, (Fed. Cir. Nov. 13, 2012), the Court stated that such plaintiffs may “normally expect” the issuance of a permanent injunction, absent adverse equitable factors.

Background

Edwards Lifesciences (“Edwards”) held the ‘552 patent, which described a transcatheter heart valve, a device used in some types of heart surgery.  Edwards’ competitor, Corevalve, released a competing product, the Generation 3 ReValving System.

Edwards sued Corevalve for patent infringement in the District Court of Delaware.  After a jury trial, the verdict held that the ‘552 patent was valid, that Corevalve’s competing product infringed on one of the ‘552 patent claims, and that infringement was willful.  The jury awarded damages of over $72 million in lost profits and nearly $1.3 million as a reasonable royalty. 

The court declined to issue an injunction against future infringement, apparently relying on Corevalve’s statement that if enjoined, it would move its production out of the United States.

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On appeal to the Federal Circuit, the Court upheld the judgment against Corevalve.  The Court, however, took issue with the district court’s refusal to issue an injunction against Corevalve.

First, the Court felt that case law strongly supported the issuance of an injunction to a prevailing plaintiff.  “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,” the Court declared.  Moreover, Edwards argued that the equitable factor test set by the Supreme Court in eBay v. MercExchange, 547 U.S. 388 (2006) landed in its favor due to the finding of willful infringement and other factors.

The Court did note occasions where it declined to issue an injunction, but distinguished them from the instant case.  For example, the Court did not issue injunctions when the Court found no competitive injury (Active Video Networks v. Verizon, 694 F.3d 1312 (Fed. Cir. 2012)) or overriding public interest in the continued provision of the infringing product (Bard v. W.L. Gore, No. 03-CV-0597 (D. Ariz. 2010)). 

Instead, the Court analogized the instant case to Advanced Cardiovascular Sys. v. Medtronic Vascular, where that court said that permanent injunctions are typically awarded when a “plaintiff practices its invention and is a direct market competitor.”  579 F.Supp.2d 554 (D. Del. 2008).  Thus, the Court’s analysis of case law seemingly pointed to the issuance of an injunction.

Second, the Court found that material facts underlying the district court’s refusal had changed since trial.  At the district court, Corevalve contended that if an injunction was issued, it would move its production to Mexico.  Thus, the district court declined to issue an injunction and advised Edwards to sue again if infringement continued.  Edwards noted on appeal, however, that Corevalve’s manufacturing never left the United States, and thus the main rationale underlying the district court’s decision not to enjoin Corevalve was no longer supported.

Thus, the Court vacated the denial of the injunction and remanded to the district court.

Judge Prost wrote a concurring opinion, expressing her concern that the majority’s dicta (quoted above) should not be read as creating a presumption of an injunction in favor of the prevailing plaintiff.  In fact, she stated, the four-factor equitable standard to win a permanent injunction demands that the plaintiff meet the burden of proof in showing the factors weigh in its favor.

Conclusion

The language of Edwards may signal to district courts that injunctions should be issued more routinely in similar cases, but Judge Prost’s concurrence serves to highlight the ambiguity that the Court seems to be creating on this issue.  Parties involved in patent infringement should contact experienced patent counsel to see how Edwards may affect your case.

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Tom Zuber

Jeff Zuber

Also See:

Gunn, et al., v. Minton: Supreme Court Denies Federal Jurisdiction for Patent-Related Malpractice Suit

Hall v. Bed Bath & Beyond: Federal Circuit Rejects District Court’s Pleading Standards for Design Patent Infringement

Arkema v. Honeywell Intl.: Federal Circuit Explains MedImmune Standard for Declaratory Judgment Jurisdiction Involving Indirect Patent Infringement

America Invents Act: First-to-File Priority for Patent Applications Begins March 16

Fox Group, Inc. v. CREE, Inc.: Federal Circuit Allows Prior Inventor to Invalidate Patent with Single Iteration of Practice and Minimal Disclosure