699 F.3d 1305 (Fed. Cir. 2012), 2011-1215, Edwards Lifesciences AG v. CoreValve, Inc.
|Docket Nº:||2011-1215, 2011-1257.|
|Citation:||699 F.3d 1305, 105 U.S.P.Q.2d 1039|
|Opinion Judge:||NEWMAN, Circuit Judge.|
|Party Name:||EDWARDS LIFESCIENCES AG and Edwards Lifesciences LLC, Plaintiffs-Cross Appellants, v. COREVALVE, INC. and Medtronic CoreValve, LLC, Defendants-Appellants.|
|Attorney:||John E. Nathan, Paul, Weiss, Rifkind, Wharton & Garrison, LLP, of New York, NY, argued for plaintiffs-cross appellants. With him on the brief were Catherine Nyarady, Kripa Raman, Brian P. Egan and Robert A. Weinstock. Of counsel on the brief was Jack B. Blumenfeld, of Wilmington, DE. Jeffrey W. S...|
|Judge Panel:||Before RADER, Chief Judge, NEWMAN and PROST, Circuit Judges. Concurring opinion filed by Circuit Judge PROST. PROST, Circuit Judge, concurring.|
|Case Date:||November 13, 2012|
|Court:||United States Courts of Appeals, Court of Appeals for the Federal Circuit|
[Copyrighted Material Omitted]
Edwards Lifesciences AG and Edwards Lifesciences LLC (collectively " Edwards" ) sued defendants CoreValve, Inc. and its successor in interest Medtronic CoreValve, LLC (collectively " CoreValve" ) for infringement of United States Patent No. 5,411,552 (" the '552 patent" ) issued May 2, 1995, entitled " Valve Prosthesis for Implantation in the Body and a Catheter for Implanting Such Valve Prosthesis." Two other patents, initially in suit, are not at issue. The inventors are Dr. Henning R. Andersen, an interventional cardiologist at Aarhus Medical School in Denmark, his surgical colleague Dr. John M. Hasenkam, and then medical student Lars L. Knudsen.
The invention is a prosthetic device called a " transcatheter heart valve." The valve is mounted on a stent and implanted in the heart by catheter, thereby avoiding open heart surgery and its associated risks. Suit for infringement was brought in the United States District Court for the District of Delaware, trial was to a jury, and the verdict was that the '552 patent is valid, that CoreValve's Generation 3 ReValving System infringed patent claim 1, and that the infringement was willful. The jury awarded damages of $72,645,555 in lost profits and $1,284,861 as a reasonable royalty.1
The district court entered judgment on the verdict, but declined to enhance damages for the willful infringement. The court also declined to issue an injunction
against future infringement, apparently on CoreValve's representation that, if enjoined, it would move its manufacturing operations to Mexico. The court also denied Edwards' request to modify the litigation-agreed protective order and to permit Edwards' patent counsel and technical expert to participate in the ongoing reexamination proceedings of the patent in suit and related patents. Each party appeals the rulings adverse to it.
We affirm the district court's rulings, except that we remand for reconsideration of the court's denial of an injunction in view of the representation of changed circumstances, and for reconsideration of the court's ruling on the protective order as applied to patents not in suit, to the extent that this issue has not become moot.
VALIDITY OF THE '552 PATENT
The '552 patent is directed to a collapsible stent that carries a valve for insertion into the heart by balloon catheter. Figure 1 of the '552 patent shows the collapsible stent with projecting apices at 4. Figure 2 includes the elastically collapsible valve 6 held to the apices at commissural points 5:
To implant the valve, the stent and valve are compressed into a balloon catheter, and moved through a blood vessel for release at the implantation site, where the balloon expands the stent and wedges it into the desired location for the valve. The patent illustrates various placements of the valve in the heart. Figure 8 describes " a position between the coronary arteries 20 and the left ventricle of the heart 21:"
The only ground on which CoreValve challenged validity of the patent was for lack of enablement based on the undisputed fact that at the time the '552 patent
application was filed the stent/valve prosthesis had been implanted only in pigs. CoreValve also pointed out that the various experimental implants in pigs were not always successful, and that design changes were made after the patent application was filed.
Edwards agrees that more developmental work was required at the time of filing. Co-inventor Knudsen wrote, in a contemporaneous report, that " questions such as size reduction, material and design optimization, and stent valve sterilization, remain unsolved," and that " much more work had to be done before anybody ever even contemplated using this for a human." Edwards' expert witness Dr. Buller testified that at the time the patent application was filed, it was " a device to perform testing on" and " not a device to move in and treat patients." The jury was instructed on the issue of enablement as follows:
The Patent Laws require that the patent be sufficiently detailed to enable those skilled in the art to practice the invention. The purpose of this requirement is to ensure that the public, in exchange for the patent rights given to the inventor, obtains from the inventor a full disclosure of how to make and use the invention.
If the inventors failed to provide an enabling disclosure, the patent is invalid. However, because descriptions in patents are addressed to those skilled in the art to which the invention pertains, an applicant for a patent need not expressly set forth in his specification subject matter which is commonly understood by persons skilled in the art.
The enablement defense does not require an intent to withhold; all that is required is a failure to teach how to practice the full scope of the claimed invention. In other words, if a person of ordinary skill in the art could not make and use the invention disclosed in the patent without undue experimentation, the patent is invalid. However, some routine amount of experimentation to make and use the invention is allowable.
The patent need not contain a working example if the invention is otherwise disclosed in such a manner that one skilled in the art to which the invention pertains will be able to practice it without an undue amount of experimentation. Final Jury Instructions at 25 (April 1, 2010).
This instruction correctly states the law. Precedent establishes that " [t]he enablement requirement is met if the description enables any mode of making and using the invention." Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1361 (Fed.Cir.1998) (quoting Engel Indus., Inc. v. Lockformer Co., 946 F.2d 1528, 1533 (Fed.Cir.1991)). See also Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc., 617 F.3d 1296, 1307 (Fed.Cir.2010) (" the district court erroneously required Transocean to enable the most efficient commercial embodiment, rather than the claims" ); Durel Corp. v. Osram Sylvania Inc., 256 F.3d 1298, 1307 (Fed.Cir.2001) (" If the disclosure enables a person of ordinary skill in the art to make a particular metal oxide coating from at least one of the suggested precursors, the enablement requirement for that oxide coating is satisfied" ). Continuing development is often contemplated and necessary, while early filing is often essential.
CoreValve argues that in no event does testing in pigs enable use in humans. However, it has long been recognized that when experimentation on human subjects is inappropriate, as in the testing and development of drugs and medical devices, the enablement requirement may be met by animal tests or in vitro data. See
MPEP § 2164.02 (" An in vitro or in vivo animal model example in the specification, in effect, constitutes a ‘...
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