## Facts

- Edwards owned U.S. Patent No. 5,411,552, covering a catheter-delivered transcatheter heart valve mounted on a stent.
- CoreValve marketed the Generation 3 ReValving System, which Edwards accused of infringing claim 1 of the patent.
- After a jury trial, the district court entered judgment that the patent was valid, CoreValve infringed, and the infringement was willful.
- The jury awarded Edwards $72,645,555 in lost profits and $1,284,861 as a reasonable royalty.
- The district court declined to enhance damages, denied a permanent injunction, and denied Edwards’s request to modify a protective order to permit participation by Edwards’s prosecution counsel and technical expert in PTO reexaminations.
- On appeal, CoreValve challenged validity, infringement, and damages; Edwards cross-appealed the denial of enhanced damages, the injunction denial, and the protective-order ruling.

## Issues

1. Whether substantial evidence supported the jury’s finding that the patent was enabled under 35 U.S.C. § 112 despite the invention having been tested primarily in animals and requiring further refinement for human use.
2. Whether substantial evidence supported the jury’s findings of infringement, willfulness, and the lost-profits and reasonable-royalty awards.
3. Whether the district court erred under *eBay* by denying a permanent injunction based on its view of irreparable harm and CoreValve’s asserted plan to relocate manufacturing outside the United States.
4. Whether the district court abused its discretion by refusing to modify the protective order to allow participation in PTO reexaminations, including as to patents not in suit.

## Decision

- Affirmed the judgment that the patent was not invalid for lack of enablement.
- Affirmed the findings of infringement and willfulness and affirmed the damages award.
- Affirmed the district court’s refusal to enhance damages despite willfulness.
- Vacated and remanded the denial of a permanent injunction for reconsideration in light of alleged changed circumstances concerning ongoing domestic manufacture and competitive effects.
- Affirmed the refusal to modify the protective order as to the patent in suit, but remanded for reconsideration of the order as applied to patents not in suit, to the extent the issue remained live.

## Legal Principles

- Enablement is satisfied if the specification enables any mode of making and using the invention without undue experimentation; ongoing optimization and development do not, by themselves, defeat enablement.
- In medical-device contexts where human testing is inappropriate at filing, animal testing or in vitro data may support enablement, assessed under the *In re Wands* undue-experimentation factors.
- Jury findings on infringement and damages are upheld when supported by substantial evidence in the trial record.
- Enhanced damages for willful infringement are discretionary; a willfulness finding does not require enhancement.
- Permanent injunctions in patent cases require a fact-specific equitable analysis under *eBay*; when material facts change (including continued domestic infringing activity), denial of injunctive relief may require reconsideration.

## Conclusion

The Federal Circuit upheld the verdict on enablement, infringement, willfulness, and damages, and it upheld the trial court’s refusal to enhance damages, but it required renewed consideration of prospective equitable relief and part of the protective-order restrictions due to potentially incorrect or outdated factual premises.


Edwards Lifesciences AG v. CoreValve, Inc., 699 F.3d 1305 (Fed. Cir. 2012)