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Edwards Lifesciences Ag and Edwards Lifesciences LLC v. Corevalve

November 13, 2012

EDWARDS LIFESCIENCES AG AND EDWARDS LIFESCIENCES LLC, PLAINTIFFS-CROSS APPELLANTS,
v.
COREVALVE, INC. AND MEDTRONIC COREVALVE, LLC, DEFENDANTS-APPELLANTS.



Appeal from the United States District Court for the District of Delaware in No. 08-CV-0091, Chief Judge Gregory M. Sleet.

The opinion of the court was delivered by: Prost. Newman, Circuit Judge.

Before RADER, Chief Judge, NEWMAN and PROST, Circuit Judges.

Opinion for the court filed by Circuit Judge NEWMAN.

Concurring opinion filed by Circuit Judge

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 inven- tors are Dr. Henning R. Andersen, an interventional cardi- ologist 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 "transcathe- ter 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 infringe- ment 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 Genera- tion 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.*fn1

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 opera- tions 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 in- junction 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.

I 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 cathe- ter. 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 un- disputed 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 ex- perimental 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 re- quired 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 suf- ficiently detailed to enable those skilled in the art to practice the invention. The purpose of this re- quirement 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 in- tent 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 experimenta- tion, the patent is invalid. However, some routine amount of experimentation to make and use the in- vention 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 es- tablishes 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 recog- nized 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 specifi- cation, in effect, constitutes a 'working example' if that example 'correlates' with a disclosed or claimed method invention."). This general rule has been elaborated in various situations, e.g., In re Brana, 51 F.3d 1560, 1566 (Fed. Cir. 1995) ("one who has taught the public that a compound exhibits some desirable pharmaceutical property in a standard experimental animal has made a significant and useful contribution to the art, even though it may eventually appear that the compound is without value in the treatment in humans"); Scott v. Finney, 34 F.3d 1058, 1063 (Fed. Cir. 1994) ("Testing for the full safety and effective- ness of a prosthetic device is more properly left to the Food and Drug Administration. Title 35 does not demand that such human testing occur within the confines of Patent and Trademark Office proceedings.").

Useful criteria for determination of enablement for pur- poses of section 112 are summarized in In re Wands, 858 F.2d 731 (Fed. Cir. 1988). Factors to be considered in de- termining whether the subject matter requires undue experimentation include "(1) the quantity of experimenta- tion necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims." Id. at 737.

There was evidence that the stent/valve prosthetic de- vice was successfully implanted in pigs, in accordance with the procedure described in the '552 specification. It was explained that pigs were a standard experimental animal for heart valve research. Witnesses for both sides discussed the vascular anatomies of pigs and the established use of porcine valves in humans. Witnesses discussed the nature of the ongoing experimentation, in light of the district court's instruction on the enablement requirement. We agree with the district court that substantial evidence supported the jury ...


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