Edwards Lifesciences Ag. v. Corevalve, Inc.
105 U.S.P.Q. 2d (BNA) 1039, 2012 U.S. App. LEXIS 23385, 699 F.3d 1305 (2012)
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Rule of Law:
A patent for a medical device satisfies the enablement requirement if its disclosure allows a person skilled in the art to practice the invention without undue experimentation, which may be established through successful animal testing when human testing is inappropriate. A jury's finding of patent infringement will be upheld if supported by substantial evidence based on the court's proper construction of the patent's claims.
Facts:
- Dr. Henning R. Andersen and his colleagues invented a prosthetic heart valve mounted on a collapsible stent, designed for implantation via a catheter to avoid open-heart surgery.
- They filed a patent application for this invention, which later issued as the '552 patent.
- At the time the patent application was filed, the device had been implanted only in pigs, which were considered a standard experimental animal for heart valve research.
- The inventors acknowledged contemporaneously that the device was not yet ready for human use and that further development, such as material and design optimization, was required.
- CoreValve, Inc. began developing and manufacturing its own transcatheter heart valve, the 'Generation 3 Re-Valving System.'
- In 2004, CoreValve moved its manufacturing operations from France to California and hired engineers who had previously worked for Edwards.
Procedural Posture:
- Edwards Lifesciences sued CoreValve in the U.S. District Court for the District of Delaware for patent infringement.
- The district court held two Markman hearings to construe the meaning of the patent's claims.
- Following a trial, a jury found that the '552 patent was valid, that CoreValve's device infringed the patent, and that the infringement was willful.
- The jury awarded Edwards over $73 million in damages for lost profits and reasonable royalties.
- The district court entered judgment on the verdict but denied Edwards' motion for enhanced damages for the willful infringement and also denied its request for a permanent injunction to stop CoreValve's future infringement.
- Both parties appealed to the U.S. Court of Appeals for the Federal Circuit; CoreValve appealed the judgment of validity and infringement, while Edwards appealed the denial of the permanent injunction.
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Issue:
Does a patent for a medical device fail the enablement requirement of 35 U.S.C. § 112 simply because, at the time of filing, the device had only been successfully tested in animals and not yet in humans?
Opinions:
Majority - Newman, J.
No. A patent for a medical device is not invalid for lack of enablement merely because it has only been tested in animals at the time of filing, provided the disclosure enables one skilled in the art to practice the invention without undue experimentation. The court reasoned that for medical devices where human testing is inappropriate at early stages, animal testing is a recognized and acceptable way to demonstrate the invention's utility and enable its practice. Applying the multi-factor test from In re Wands, the court found substantial evidence, including the successful implantation in pigs, to support the jury's conclusion that the patent was not invalid for lack of enablement. The court also affirmed the jury's infringement verdict, finding it was supported by substantial evidence and based on the district court's correct claim construction. Lastly, the court vacated the denial of a permanent injunction and remanded for reconsideration, because the district court had relied heavily on CoreValve's representation that it would move its manufacturing to Mexico, a circumstance that appeared to have changed.
Concurring - Prost, J.
This opinion agrees with the majority's judgment but clarifies the legal standard for permanent injunctions. The concurrence argues that the majority's statement that a prevailing patentee 'may normally expect to regain... exclusivity' could be misread as creating a presumption in favor of an injunction. It emphasizes that the Supreme Court's decision in eBay Inc. v. MercExchange, L.L.C. eliminated any such presumption and established a four-factor equitable test where the plaintiff bears the full burden of demonstrating that an injunction is warranted.
Analysis:
This case reinforces the principle that an invention, particularly in the medical field, does not need to be in a commercially perfected or human-ready state to satisfy the enablement requirement for patentability. By affirming that successful animal testing can suffice, the decision protects inventors who file for patents early in the development process, which is often crucial for securing investment and continuing research. The opinion also underscores the high degree of deference appellate courts give to a jury's factual findings on infringement, provided there is substantial evidence in the record. The remand on the injunction highlights that courts must base equitable remedies on current facts and that a party's representations about future conduct are critical to the analysis.
