Court Opinion

ID: 811790
Source: CourtListenerOpinion
Date Created: 2012-11-13 16:24:55+00
Date Added: 2024-06-11T08:05:24.865853
License: Public Domain

United States Court of Appeals
      for the Federal Circuit
              __________________________

         EDWARDS LIFESCIENCES AG AND
          EDWARDS LIFESCIENCES LLC,
             Plaintiffs-Cross Appellants,

                           v.
             COREVALVE, INC. AND
          MEDTRONIC COREVALVE, LLC,
              Defendants-Appellants.
              __________________________

                   2011-1215,-1257
              __________________________

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

              Decided: November 13, 2012
              ___________________________

    JOHN E. NATHAN, Paul, Weiss, Rifkind, Wharton & Gar-
rison, LLP, of New York, New York, 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, Delaware.
EDWARDS LIFESCIENCES   v. COREVALVE                         2

    JEFFREY W. SARLES, Mayer Brown LLP, of Chicago, Illi-
nois, argued for defendants-appellants. With him on the
brief were JAMES R. FERGUSON, MELISSA A. ANYETEI and
BRENT A. BATZER. Of counsel on the brief were DONALD M.
FALK and RITA K. LOMIO, of Palo Alto, California.
               __________________________

 Before RADER, Chief Judge, NEWMAN and PROST, Circuit
                        Judges.
  Opinion for the court filed by Circuit Judge NEWMAN.

    Concurring opinion filed by Circuit Judge PROST.

NEWMAN, 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
3                       EDWARDS LIFESCIENCES    v. COREVALVE

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 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:

    1  Edwards Lifesciences AG v. Medtronic, Inc., No. 09-
873-GMS, 2011 U.S. Dist. LEXIS 12022 (D. Del. Feb. 7,
2011).
EDWARDS LIFESCIENCES   v. COREVALVE                        4

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
5                        EDWARDS LIFESCIENCES    v. COREVALVE

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:
EDWARDS LIFESCIENCES    v. COREVALVE                           6

         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 in-
    vention 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.
7                       EDWARDS LIFESCIENCES    v. COREVALVE

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.”).
EDWARDS LIFESCIENCES     v. COREVALVE                           8

     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 verdict that invalidity on the ground of
non-enablement had not been proved by clear and convinc-
ing evidence. The judgment of validity is affirmed.

                                II

                        INFRINGEMENT

    There was evidence at trial on the origin and develop-
ment of the patented device by the Danish inventors and
their licensees. Witnesses described the initial professional
skepticism including refusal of medical journals to publish
the inventors’ results; the persistence of the inventors; and
the eventual recognition of their work as “most exciting” and
9                        EDWARDS LIFESCIENCES   v. COREVALVE

“pioneering.” The record includes praise for the inventors
from the CoreValve founder and the CoreValve CEO.

    The litigation began with “claim construction,” including
two Markman hearings and opinions. Claim 1 of the ’552
patent is as follows, with emphasis added to the terms that
were the focus of the dispute as to infringement:
    1. A valve prosthesis for implantation in a body
       channel, the valve prosthesis comprising a col-
       lapsible elastical valve which is mounted on an
       elastical stent, the elastical valve having a plu-
       rality of commissural points, wherein the stent
       comprises:
               cylindrical support means which is ra-
       dially collapsible for introduction within the
       body channel and which has a plurality of
       circumferentially-expandable sections such that
       the cylindrical support means is radially ex-
       pandable for being secured within the body
       channel; and
               a plurality of commissural supports pro-
       jecting from one side of the cylindrical support
       means in a direction generally parallel to the
       longitudinal axis thereof for supporting the
       commissural points of the collapsible valve, at
       least one circumferentially expandable section of
       the cylindrical support means lying between
       each of the commissural supports,
               such that the collapsible valve may be
       collapsed and expanded together with the cylin-
       drical support means for implantation in the
       body channel by means of a technique of cathe-
       terization.
’522 patent col.7 1.57-col.8 1.19.
EDWARDS LIFESCIENCES   v. COREVALVE                          10

    The district court construed “cylindrical support means”
as “a portion of the stent supporting the valve that has a
shape of or relating to a cylinder.” The court ruled that the
portion supporting the valve had to be cylindrical, but that
the entire stent did not have to be of uniform cylindrical
shape. The court instructed the jury as follows:

    “cylindrical support means” means “a portion of the
    stent supporting the valve that has a shape of or re-
    lating to a cylinder.” The term “cylindrical” does not
    mean that the object described must be a cylinder
    with a diameter that is constant along its length or
    longitudinal axis. To put it another way, the term
    “cylindrical” as used in the patent in this case does
    not require the presence of a perfect geometric cyl-
    inder.

Final Jury Instructions at 16-17 (April 1, 2010).

    The district court instructed the jury as to the “project-
ing” term of the claim, as follows: “projecting from one side
of the cylindrical support means in a direction generally
parallel to the longitudinal axis thereof” means “projecting
from one side of the cylindrical support means in a direction
generally parallel to the longitudinal axis of the cylindrical
support means.”

    The accused Medtronic/CoreValve Generation 3 is
shown in the trial exhibit marked by Dr. Buller in conjunc-
tion with his testimony on whether this device met the
claim limitations:
11                       EDWARDS LIFESCIENCES    v. COREVALVE

The jury found infringement. The parties agreed that
“projecting” and “generally parallel” should be given their
plain and ordinary meaning. On this appeal, CoreValve
states that the district court’s claim construction and thus
the jury instructions were incorrect, and that on the correct
construction, no reasonable jury could find infringement of
the claim terms “cylindrical support means” and “commis-
sural supports projecting . . . in a direction generally paral-
lel.”

    Jury instructions are reviewed for correctness as a mat-
ter of law. Claim terms are construed in accordance with
their usage in the patent specification, and as elaborated in
EDWARDS LIFESCIENCES   v. COREVALVE                       12

the prosecution history. Phillips v. AWH Corp., 415 F.3d
1303, 1314 (Fed. Cir. 2005) (en banc).

                             A

     CoreValve argues that the district court improperly in-
structed the jury, by construing “cylindrical support means”
sufficiently broadly that it could include the stent of the
Generation 3. CoreValve states that “cylindrical support
means” should be defined as a “stent structure where the
mesh has a diameter that is constant along a longitudinal
axis.” CoreValve argues that the court’s construction erro-
neously enlarged the ordinary meaning of “cylindrical”
beyond its established meaning as a geometric term, and
that the drawings in the ’552 patent show that the inventors
contemplated only the simple cylindrical shape that is
illustrated in Figure 1. CoreValve states that the correct
definitions exclude the Generation 3 device.

     The district court explained in its Markman opinions
that CoreValve’s proposed construction “imports limitations
that are not supported by the patent specification or the
prosecution history . . . . Specifically, the term ‘mesh’ and
the limitation that the diameter be ‘constant along the
longitudinal axis’ are not found in the specification.” We
agree that the court’s construction comports with the speci-
fication. Applying this construction, Dr. Buller testified
that the portion of the Generation 3 that supports the valve
is cylindrical, and that the Generation 3 device is a “cylin-
drical support means which is radially collapsible for intro-
duction within the body channel.” CoreValve argued to the
jury that the general shape of the Generation 3 is not “cy-
lindrical.” Edwards pointed out that the specification
describes a device designed for “implantation in a body
channel,” and that anatomical channels are rarely perfect
cylinders. Witnesses for both sides agreed that the Genera-
13                       EDWARDS LIFESCIENCES    v. COREVALVE

tion 3 shape is designed to fit at the conjunction of the aorta
and the left ventricle in order to inhibit migration of the
stent after implantation, and Dr. Buller testified that the
lower portion of the Generation 3 is the “cylindrical support
means” for the commissural supports for the valve.

    The record shows that there was substantial evidence to
support a jury finding that the cylindrical support means of
the claim is embodied in the Generation 3 device.

                              B

     CoreValve also argued to the jury that the commissural
supports in the Generation 3 are not “generally parallel” to
the longitudinal axis of the stent, as required by claim 1.
CoreValve argues on this appeal that “parallel” should have
been strictly construed as a geometric term with no flexibil-
ity of meaning or application, citing International Rectifier
Corp. v. IXYS Corp., 361 F.3d 1363, 1371 (Fed. Cir. 2004),
where the court construed “polygonal” as requiring straight
edges for only a straight-edged polygon was exemplified in
the specification.

    The district court construed “commissural points” to
mean “points or locations where the leaflets of the valve are
joined,” and “commissural supports” to mean “portions of
the stent that support the commissural points of the valve.”
The parties presented testimony and argument on the
embodiment of these elements in the accused prosthesis.

    Dr. Buller in his testimony acknowledged that the draw-
ings of the ’552 patent show the commissural supports as
taller than in the Generation 3 device.2 He testified that the

     2  It was undisputed that the two small loops at the
top of the Generation 3 device are not the commissural
supports; they serve to attach the stent to the catheter.
EDWARDS LIFESCIENCES    v. COREVALVE                        14

Generation 3 device meets the “projecting” limitation be-
cause the “whole structure, one can say, is projecting gener-
ally upwards,” drawing the upward axis on the exhibit as
shown supra. CoreValve witnesses testified that the Gen-
eration 3 commissural supports are an “integrated wire
mesh” of “rounded, interconnecting diamonds” that do not
protrude or jut out from the stent and that are at a 30
degree angle from the longitudinal axis, and are not “gener-
ally parallel.” CoreValve stressed the advantages of its
structure that anchors the device in the aorta, as compared
with the shape in the ’552 patent. Edwards’ witnesses
disputed CoreValve’s argument that the Generation 3
commissural supports do not project from the stent struc-
ture. Edwards argued that “projecting” is not limited to
“sticking out” or “protruding,” and its witnesses testified
that the CoreValve commissural supports project in a direc-
tion generally parallel to the longitudinal axis of the sup-
porting stent.

    The district court noted that “Dr. Buller testified that
the ‘top’ portion of CoreValve’s device as shown in PTX
2136-37 contained the commissural supports (Tr. 768:21-
771-2; PTX 2137) while the ‘bottom’ portion contained the
cylindrical support means.” Edwards, at *7 n.4. The court
remarked that the jury could have believed Edwards’ ex-
perts and not CoreValve’s experts, as to the way the devices
were structured and operated.

    The testimony at trial was in direct conflict. “In deter-
mining whether the evidence at trial was sufficient to
sustain the verdict, the court may not weigh the evidence,
determine the credibility of witnesses, or substitute its
version of the facts for the jury’s version.” Lightning Tube,
Inc. v. Witco Corp., 4 F.3d 1153, 1166 (3d Cir. 1993) (citation
omitted). See Perkin-Elmer Corp. v. Computervision Corp.,
732 F.2d 888, 893 (Fed. Cir. 1984) (the court may not “sub-
15                      EDWARDS LIFESCIENCES    v. COREVALVE

stitute its choice for that of the jury between conflicting
elements of the evidence”).

   On the entirety of the proceedings at trial, there was
substantial evidence to support the jury verdict that the
Generation 3 device infringes claim 1 of the ’552 patent.
The judgment of infringement is affirmed.

                             III

                         REMEDIES

                              A

    The record states that in 2004 CoreValve moved its
manufacturing from France to California and hired former
Edwards engineers, and that CoreValve’s first implantation
in humans was in 2006. The jury awarded Edwards its lost
profits for the infringement, finding that Edwards could
have met the demand, starting with the initiation of the
Generation 3 design in January 2006. The jury also found
that the infringement was willful.

    CoreValve argues that the criteria for award of lost prof-
its were not met, stating that it “could have manufactured
its device overseas by March 2007,” CoreValve Br. 3, and
thus would have avoided all liability for infringement, by
avoiding infringement. CoreValve argues that this elimi-
nates liability for damages based on its manufacture in the
United States, or that at most it should be liable for only a
modest royalty. Neither the jury nor the district court was
persuaded by this argument. Nor are we. Whether or not
CoreValve could have avoided infringement, it did not do so,
although it was notified as early as 2005 of Edwards’ posi-
tion, and the record showed CoreValve’s familiarity with the
patents and the inventors.
EDWARDS LIFESCIENCES    v. COREVALVE                        16

    We affirm the district court’s ruling sustaining the jury’s
damages award. See Brooktree Corp. v. Advance Micro
Devices, 977 F.2d 1555, 1580 (Fed. Cir. 1992) (“the jury’s
finding must be upheld unless the damages award is
‘grossly excessive or monstrous,’ clearly not supported by
the evidence, or based only on speculation or guesswork”).
With respect to the verdict of willful infringement, although
this finding was sustained by the district court, the court
declined to enhance damages or award attorney fees, stating
that the issues were “sufficiently close” and the defenses not
frivolous. See Bard Peripheral Vascular, Inc. v. W.L. Gore &
Assocs., Inc., 682 F.3d 1003, 1005 (Fed. Cir. 2012) (en-
hancement of damages is not automatic). We do not discern
abuse of discretion in the court’s decision not to enhance
damages.

                              B

    Edwards requested entry of an injunction against future
infringement, and cited several equitable considerations,
including the importance of establishing customer relation-
ships now that FDA approval has been obtained, and the
fact that Medtronic, as a large medical device manufacture,
could overwhelm the much smaller Edwards.

    A patentee’s right to exclude is a fundamental tenet of
patent law. Richardson v. Suzuki Motor Co., Ltd., 868 F.2d
1226, 1247 (Fed. Cir. 1989) (“The right to exclude recognized
in a patent is but the essence of the concept of property.”)
(quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542,
1548 (Fed. Cir. 1983)). The innovation incentive of the
patent is grounded on the market exclusivity whereby the
inventor profits from his invention. Absent adverse equita-
ble considerations, the winner of a judgment of validity and
infringement may normally expect to regain the exclusivity
that was lost with the infringement. Edwards argues that
17                        EDWARDS LIFESCIENCES    v. COREVALVE

the Court’s ruling in eBay Inc. v. MercExchange, L.L.C., 547
U.S. 388 (2006) supports its position, for the willfulness of
the infringement and other equitable aspects weigh in favor
of restoration of the exclusive patent right.

     The Court in eBay did not hold that there is a presump-
tion against exclusivity on successful infringement litiga-
tion. The Court did not cancel 35 U.S.C. §154, which states
that “Every patent shall contain . . . a grant . . . of the right
to exclude others from making, using, offering for sale, or
selling the invention,” nor did the Court overrule Article I
section 8 of the Constitution, which grants Congress the
power to “secur[e] for limited Times to Authors and Inven-
tors the exclusive Right to their respective Writings and
Discoveries.” The Court held that equitable aspects should
always be considered, stating: “We hold only that the deci-
sion whether to grant or deny injunctive relief rests within
the equitable discretion of the district courts, and that such
discretion must be exercised consistent with traditional
principles of equity, in patent disputes no less than in other
cases governed by such standards.” eBay, 547 U.S. at 394.
Statutory and historical as well as commercial considera-
tions impinge on every equitable determination.

    Precedent illustrates the variety of equitable considera-
tions, and responsive equitable remedy in patent cases; for
example, the grant of a royalty-bearing license instead of
imposing an injunction in situations where the patentee
would experience no competitive injury, as in ActiveVideo
Networks, Inc. v. Verizon Communications, Inc., U.S. App.
LEXIS 18032, at *67-68 (Fed. Cir. Aug. 24, 2012); or where
there is an overriding public interest in continued provision
of the infringing product, as in Bard Peripheral Vascular,
Inc. v. W.L. Gore & Assocs., Inc., No. 03-CV-0597 (D. Ariz.
July 21, 2010), where the Gore vascular graft materials
were not available from the successful patentee Bard.
EDWARDS LIFESCIENCES   v. COREVALVE                        18

Another form of equitable response is illustrated in Broad-
com Corp. v. Qualcomm Inc., 543 F.3d 683, 704 (Fed. Cir.
2008), where the court postponed the effective date of an
injunction for twenty months, to relieve hardship on the
infringer.

    In Advanced Cardiovascular Sys. v. Medtronic Vascular,
Inc., 579 F. Supp. 2d 554 (D. Del. 2008), the court observed
that: “Courts awarding permanent injunctions typically do
so under circumstances where plaintiff practices its inven-
tion and is a direct market competitor.” Id. at 558. Ed-
wards argues that these conditions here prevail. However,
the district court declined to impose the requested injunc-
tion. First, the district court responded to Edwards’ argu-
ment that without exclusivity it would lose first-mover
advantage and market share and reputation, by stating that
these had already been lost – although Edwards states that
this is incorrect, for sales in the United States had not yet
been authorized by the FDA, as to either the Edwards or the
CoreValve/Medtronic product. The district court also stated
that Edwards had given up exclusivity by licensing the ’552
patent to another competitor. CoreValve does not dispute
that the district court erred in its view of that transaction,
and that no such license exists.

    The district court’s explanation of why it was withhold-
ing an injunction placed significant weight on CoreValve’s
statements that it was immediately moving this manufac-
turing operation to Mexico, and thus that infringement
would terminate. Edwards at *29 (“The remaining two
eBay factors do not alter the court’s analysis, since the only
practical effect of a permanent injunction would be that
CoreValve would be forced to move its United States manu-
facturing operations for the accused product to Mexico.”).
The district court stated that if CoreValve should renew its
infringing manufacture in the United States, then “[a]s it
19                       EDWARDS LIFESCIENCES    v. COREVALVE

did in this case, Edwards can bring suit against CoreValve
and seek damages if CoreValve continues its infringing
manufacturing operations in spite of the judgment of in-
fringement.” Id. at *28. Edwards states on this appeal, and
CoreValve does not deny, that CoreValve never stopped its
infringing manufacture in California. Whether or not that
representation was known to be false when made, the
situation before us reflects, at least, changed circumstances.

    In TiVo Inc. v. Echostar Corp., 646 F.3d 869, 890 n.9
(Fed. Cir. 2011) this court en banc noted that “district courts
are in the best position to fashion an injunction tailored to
prevent or remedy infringement.” Recognizing that the
circumstances have not been fully explored in the record
before us, we vacate the denial of the injunction, and re-
mand to the district court for consideration in light of ensu-
ing events and any other relevant factors.

                              IV

                     PROTECTIVE ORDER

    The parties had stipulated to a protective order with a
“patent prosecution bar,” which precludes all persons who
had access to the opponent’s confidential information pro-
duced for this trial, from “working on patent prosecution” on
this subject matter. Edwards asked the district court to
confirm that this restraint did not apply to patent reexami-
nation, pointing out that Medtronic had filed several reex-
amination requests against Edwards’ patents. Edwards
states that confidential information is not likely to be in-
volved, but that this restriction would deprive Edwards of
the services of its patent attorneys and technical expert who
know most about Edwards’ patents and this technology.
EDWARDS LIFESCIENCES   v. COREVALVE                       20

    The risk of inadvertent disclosure or improper use of
confidential information is balanced against the potential
harm of restricting a party’s right to continued representa-
tion by its counsel. In In re Deutsche Bank Trust Co. Ameri-
cas, 605 F.3d 1373, 1381 (Fed. Cir. 2010), the court held
that “a party seeking imposition of a patent prosecution bar
must show that the information designated to trigger the
bar, the scope of activities prohibited by the bar, the dura-
tion of the bar, and the subject matter covered by the bar
reasonably reflect the risk presented by the disclosure of
proprietary competitive information.” The district court,
denying Edwards’ request for relief, stated that it “would
create a high risk that confidential CoreValve/Medtronic
information would be used or disclosed.” Meanwhile, Ed-
wards advises that the reexamination of the ’552 patent has
now terminated (in Edwards’ favor) by Order of May 20,
2011. Edwards argues that the balance of equities weighs
on the side of permitting Edwards to have the services of its
experienced patent attorneys and technical expert, in con-
nection with the ongoing reexaminations of other patents.

    Since the ’552 patent is no longer undergoing reexami-
nation, if the question is not moot as to other patents, on
remand the district court may reconsider its protective
order.

                            SUMMARY

    The judgment of the district court is affirmed, with the
exception that we remand for reconsideration by the district
court, in view of changed circumstances, of the court’s
rulings on the permanent injunction and the protective
order.

    AFFIRMED IN PART, REMANDED IN PART
  United States Court of Appeals
      for the Federal Circuit
               __________________________

         EDWARDS LIFESCIENCES AG AND
          EDWARDS LIFESCIENCES LLC,
             Plaintiffs-Cross Appellants,

                            v.
             COREVALVE, INC. AND
          MEDTRONIC COREVALVE, LLC,
              Defendants-Appellants.
               __________________________

                    2011-1215, -1257
               __________________________

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

PROST, Circuit Judge, concurring.

     I join this opinion in all respects except one—the ma-
jority’s discussion of the permanent injunction standard.
The majority opines that “[a]bsent adverse equitable
considerations, the winner of a judgment of validity and
infringement may normally expect to regain the exclusiv-
ity that was lost with the infringement.” Majority Op. 16.
To the extent that one reads this statement as creating
the presumption of an injunction once the plaintiff pre-
vails, which must be rebutted by the defendant, that is
not the law.
EDWARDS LIFESCIENCES   v. COREVALVE                        2

     Nor do the selected portions of eBay cited by the ma-
jority provide support for its position. First, while I agree
with the majority that in eBay the Supreme Court did not
cancel 35 U.S.C. § 154, the majority overlooks the Court’s
explanation that “the creation of a right is distinct from
the provision of remedies for violations of that right,” such
that “injunctive relief ‘may’ issue only ‘in accordance with
the principles of equity.’” eBay Inc. v. MercExchange,
L.L.C., 547 U.S. 388, 392 (2006) (quoting 35 U.S.C. § 283).
Second, the majority excludes from its analysis the four-
factor equitable standard, the preamble of which states
that “the plaintiff must demonstrate” these factors.
Indeed, the majority’s analysis might be read to suggest
that the defendant, not the plaintiff, bears the burden of
establishing the equitable factors.

    Some complain of areas of patent law in which our
guidance is mixed or muddled. This is not—or should not
be—one of those areas after the Supreme Court’s clear
pronouncement in eBay. eBay made clear that there is no
general rule that a successful plaintiff is entitled to an
injunction; rather, the plaintiff bears the burden of estab-
lishing the four equitable factors that weigh in its favor in
order to obtain a permanent injunction. We should take
care to avoid possible misinterpretation of an otherwise
clear Supreme Court standard. Because the majority’s
statements appear to me to deviate from the standard
articulated by the Supreme Court and our court, I re-
spectfully concur. See Robert Bosch LLC v. Pylon Mfg.
Corp., 659 F.3d 1142, 1149 (Fed. Cir. 2011) (recognizing
that “eBay abolishes our general rule that an injunction
normally will issue when a patent is found to have been
valid and infringed”).