Edwards Lifesciences Ag. v. Corevalve, Inc.
699 F.3d 1305
Fed. Cir.2012Background
- Edwards sued CoreValve and Medtronic CoreValve for infringement of the '552 patent on a transcatheter heart valve.
- The jury found the '552 patent valid, infringement by CoreValve’s Generation 3 device, and willful infringement.
- The jury awarded lost profits and a royalty; the district court denied enhanced damages and an injunction.
- The court declined Edwards’ requests to modify a protective order and allow patent counsel/experts to participate in ongoing reexamination proceedings.
- The court later remanded for reconsideration of injunction and protective-order rulings in light of changed circumstances.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Enablement of the '552 patent at filing | Edwards argues enablement existed via animal testing and ongoing development. | CoreValve contends testing in pigs cannot enable human use. | Enablement supported despite animal testing. |
| Infringement of claim 1 by Generation 3 device | Edwards asserts Generation 3 meets ‘cylindrical support means’ and ‘projecting commissural supports’. | CoreValve contends Generation 3 does not meet those claim terms. | Substantial evidence supports infringement. |
| Remedies: injunction and willful infringement damages | Edwards seeks injunction and enhanced damages to protect exclusivity. | CoreValve argues no injunction necessary; damages not excessive. | Remand on injunction; no abuse in no enhancement; damages upheld. |
| Protective order reexamination and counsel participation | Edwards seeks to allow participation in reexams; argues risk of competitive harm minimal. | CoreValve argues bar should limit dissemination of confidential information. | Remand may reconsider protective order; not moot for other patents. |
Key Cases Cited
- Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342 (Fed.Cir. 1998) (enablement may be satisfied by any mode of making and using the invention)
- Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc., 617 F.3d 1296 (Fed.Cir. 2010) (district court error if requiring the most efficient embodiment for enablement)
- Durel Corp. v. Osram Sylvania Inc., 256 F.3d 1298 (Fed.Cir. 2001) (explicit enablement guidance not required for every detail)
- In re Brana, 51 F.3d 1560 (Fed.Cir. 1995) (animal model data can satisfy enablement when correlates to disclosed method)
- Scott v. Finney, 34 F.3d 1058 (Fed.Cir. 1994) (safety/efficacy testing of devices often left to FDA; not required in PTO)
- eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (S. Ct. 2006) (four-factor equitable test governs injunctions in patent cases)
- Bard Peripheral Vascular, Inc. v. Gore & Assocs., Inc., 682 F.3d 1003 (Fed.Cir. 2012) (examples of non-injunctive equitable relief and nuanced remedies)
- ActiveVideo Networks, Inc. v. Verizon Communications, Inc., 694 F.3d 1312 (Fed.Cir. 2012) (royalty licenses as alternatives to injunctions in certain cases)
- Broadcom Corp. v. Qualcomm Inc., 543 F.3d 683 (Fed.Cir. 2008) (equitable relief considerations can delay or adjust injunctions)
- TiVo Inc. v. EchoStar Corp., 646 F.3d 869 (Fed.Cir. 2011) (district courts fashion tailored injunctions based on circumstances)