United States Court of Appeals for the Federal Circuit *Revised September 14, 2009
2008-1306, -1331
FRESENIUS USA, INC. and FRESENIUS MEDICAL CARE HOLDINGS, INC.,
Plaintiffs-Appellants,
v.
BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION,
Defendants-Cross Appellants.
Juanita R. Brooks, Fish & Richardson P.C., of San Diego, California, argued for plaintiffs-appellants. With her on the brief were Michael E. Florey, Mathias W. Samuel and Deanna J. Reichel, of Minneapolis, Minnesota, and Robert E. Hillman, of Boston, Massachusetts.
William F. Lee, Wilmer Cutler Pickering Hale and Door LLP, of Boston, Massachusetts, argued for defendants-cross appellants. With him on the brief were Bharat R. Ramamurti; William G. McElwain and Jonathan G. Cedarbaum, of Washington, DC. Of counsel on the brief were Michael J. Abernathy and Sanjay K. Murthy, K & L Gates LLP, of Chicago, Illinois.
Appealed from: United States District Court for the Northern District of California
Judge Saundra Brown Armstrong
* Correction of law firm name. United States Court of Appeals for the Federal Circuit
FRESENIUS USA, INC. and FRESENIUS MEDICAL CARE HOLDINGS, INC.,
BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION,
Appeals from the United States District Court for the Northern District of California in case no. 03-CV-1431, Judge Saundra Brown Armstrong.
_________________________
DECIDED: September 10, 2009 _________________________
Before NEWMAN, GAJARSA, and DYK, Circuit Judges.
Opinion for the court filed by Circuit Judge GAJARSA. Concurring opinions filed by Circuit Judge NEWMAN and Circuit Judge DYK.
GAJARSA, Circuit Judge.
In this patent infringement case, Plaintiffs Fresenius USA, Inc. and Fresenius
Medical Care Holdings, Inc. (collectively “Fresenius”) appeal and Defendants Baxter
International, Inc. and Baxter Healthcare Corporation (collectively “Baxter”) cross appeal
from the final judgment of the United States District Court for the District of California,
which was based on findings that Fresenius infringed claims of three patents asserted by Baxter—U.S. Patent Nos. 5,247,434 (“the ’434 patent”), 5,744,027 (“the
’027 patent”), and 6,284,131 (“the ’131 patent”)—all of which disclose and claim a
hemodialysis machine integrated with a touch screen user interface. Fresenius Med.
Care Holdings, Inc. v. Baxter Int’l, Inc., No. 03-CV-1431 (N.D. Cal. Feb. 12, 2007)
(“JMOL Opinion”). We affirm in part, reverse in part, vacate in part, and remand for
further proceedings consistent with this opinion.
BACKGROUND
I. The Technology and Patents
When a person’s kidneys fail to function properly, a hemodialysis machine can
function in place of the kidneys to cleanse the blood of toxins. During hemodialysis, the
person’s blood is pumped through a hemodialysis machine, which contains a
dialysate—a solution formulated to draw toxins out of the blood. Inside the machine,
the blood is separated from the dialysate by a semi-permeable membrane that allows
toxins to pass from the blood into the dialysate. Because it is important to ensure that
toxins are removed without inadvertently filtering essential nutrients out of the blood, the
hemodialysis machine must facilitate the monitoring and control of numerous
parameters.
All of the patents at issue derived from a parent patent application filed in 1991,
and all of the relevant claims are directed to a hemodialysis machine integrated with a
touch screen user interface. At the time the parent application was filed, touch screens
were known and had been used on other medical devices, such as a heart-lung
machine, but a touch screen had not been integrated with a hemodialysis machine. The
System 1000, which embodies the patents at issue, was introduced in 1991 and was a
2008-1306, -1331 2 commercial success. 1 In 1998, Fresenius introduced the alleged infringing device, a
hemodialysis machine with a touch screen interface called the 2008K machine.
A. The ’027 Patent
The only ’027 patent claim at issue in this appeal is claim 11, which is dependent
on claim 10, which is in turn dependent on claim 7. Claim 7 reads:
A kidney dialysis machine, comprising:
(a) a dialysate pump for circulating dialysate at a dialysate conductivity through a dialysate circuit including a dialysate compartment for a dialyzer; and
(b) a controller operable to receive non-conductivity data concerning a particular selection of dialysate to be circulated and to calculate from the data an expected conductivity reading of the dialysate.
’027 Patent col.36 ll.14–21. Dependent claim 11 additionally requires only a “data input
device” that “comprises a touch screen.” Id. at col.36 l.32–33. The additional limitation
of claim 10 is not at issue in this appeal.
B. The ’131 Patent
Regarding the ’131 patent, independent claim 1 and claims 2, 3, and 13–16,
which are dependent on claim 1, are at issue in this appeal. Claim 1 reads:
A hemodialysis apparatus, comprising:
(a) a dialysate-delivery system for supplying dialysate to a hemodialyzer, the dialysate-delivery system comprising at least one unit selected from the group consisting of (i) a dialysate-preparation unit, (ii) a dialysate-circulation unit, (iii) an ultrafiltrate-removal unit, and (iv) a dialysate-monitoring unit; and
(b) a user/machine interface operably connected to the dialysate-delivery system, the user/machine interface
1 Althin filed the relevant patent applications and introduced the System 1000. Baxter purchased Althin and the patents at issue in March 2000.
2008-1306, -1331 3 comprising a touch screen that displays information corresponding to a setting of a parameter pertinent to operation of the hemodialysis apparatus, the touch screen being operable to display an indicium permitting the user to perform, using the touch screen, at least one step of a procedure for changing the setting of the parameter, and to display a time-variable profile of the operational parameter, the profile being representable as a plot of coordinates, the plot being with respect to an ordinate of values of the operational parameter and a time-based abscissa.
’131 Patent col.36 ll.1–21. Claim 14 additionally requires only that “the touch screen is
operable to display a plurality of indicia, each corresponding to a different time-variable
hemodialysis parameter.” Id. at col.36 ll.64–67. Claim 16 additionally requires that “the
user/machine interface is operable to require the user to verify a parameter after a value
of the parameter is selected.” Id. at col.37 ll.4–6. The additional limitations recited in
claims 2, 3, 13, and 15 were not argued on appeal.
C. The ’434 Patent
Regarding the ’434 patent, independent claim 26 and claims 27–31, which are
dependent on claim 26, are at issue in this appeal. Claim 26 reads:
A hemodialysis machine comprising:
(a) means for controlling a dialysate parameter selected from a group consisting of dialysate temperature and dialysate concentration, and means for delivering the dialysate to a dialysate compartment of a hemodialyzer; and
(b) a user/machine interface operably coupled to said dialysate-delivery means, the user/machine interface comprising a touch screen adapted to display an indicium corresponding to a parameter pertinent to operation of the hemodialysis machine for performing hemodialysis and to permit the user, by touching the indicium, to cause a change in the parameter.
’434 Patent col.40 ll.29–42. Dependent claims 27–31 include additional limitations, but
only the additional limitation in claim 30 is relevant to this appeal. That limitation
2008-1306, -1331 4 requires a “means for delivering an anticoagulant to a patient wherein the touch screen
further provides an indicium soliciting input from the user corresponding to a rate of
anticoagulant delivery.” Id. at col.40 ll.61–64.
II. Litigation Background
Fresenius initially filed suit against Baxter in 2003, seeking a declaratory
judgment that the ’027, ’131, and ’434 patent claims are invalid and not infringed by
Fresenius’s hemodialysis machines. 2 Baxter counterclaimed, alleging that Fresenius
infringes claims 7, 11, and 14–16 of the ’027 patent; claims 1–3 and 13–16 of the
’131patent; and claims 26–31 of the ’434 patent. On Baxter’s motion, the district court
granted partial summary judgment that Fresenius infringes claim 1 of the ’131 patent
and claim 26 of the ’434 patent. Baxter continued to allege that Fresenius infringes the
other asserted claims, and Fresenius continued to allege that all asserted claims are
invalid. Following claim construction, Fresenius stipulated that it infringes Baxter’s
remaining asserted claims. A jury trial on validity followed, and the jury found claims 7
and 14–16 of the ’027 patent invalid as anticipated and all asserted claims invalid as
obvious.
The district court determined that substantial evidence does not support the jury’s
obviousness verdict and granted Baxter’s motion for judgment as a matter of law
(“JMOL”) that its asserted patent claims are not invalid as obvious. Namely, the district
court found that Fresenius had not presented evidence that specified limitations of claim
11 of the ’027 patent, claims 1 and 14 of the ’131 patent, and claims 26–31 of the ’434
2 The original filings included two additional patents—neither of which is relevant to this appeal.
2008-1306, -1331 5 patent were present in the prior art. JMOL Opinion, slip op. at 8–13, 18–19. In addition,
the district court found that Fresenius did not present substantial evidence of a
motivation to combine the elements of the prior art to produce the invention claimed in
the ’131 and ’434 patents. Id. at 13–16. The court did not evaluate the jury’s findings
that claims 7 and 14–16 of the ’027 patent are invalid as anticipated, stating that Baxter
had not challenged the anticipation verdict. Id. at 6 n.1.
After a jury trial on damages, the jury awarded Baxter a total of $14,266,000 in
damages, $91,000 of which was attributable to unpatented disposable products. The
district court, after considering the four factors articulated in eBay Inc. v. MercExchange,
L.L.C., 547 U.S. 388, 391 (2006), concluded that injunctive relief was appropriate and
permanently enjoined Fresenius. Fresenius Med. Care Holdings, Inc. v. Baxter Int’l,
Inc., No. 03-CV-1431, slip. op. at 8–10 (N.D. Cal. March 21, 2008) (“Injunction Order”).
The district court ordered that the injunction take effect on January 1, 2009, because
Fresenius indicated it could develop a non-infringing machine by that date. Id. at 8–9.
The district court also ordered Fresenius to pay an ongoing royalty of 10% of the sales
price for any infringing machines sold before January 1, 2009, and a royalty of 7% of the
sales price for all disposable products linked to infringing machines that were sold from
November 7, 2002, until the patents expire. Id. at 9–10. The district court imposed the
royalty rates without explaining the bases for its calculations.
Fresenius appeals the district court’s grant of JMOL, entry of a permanent
injunction, royalty award, and constructions of specified claim terms. Baxter cross
appeals the jury’s determination that the asserted ’027 patent claims are invalid as
anticipated. This court has jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).
2008-1306, -1331 6 DISCUSSION
I. Standard of Review
Following the procedural law of the Ninth Circuit, we review the district court’s
grant or denial of JMOL de novo. Revolution Eyewear, Inc. v. Aspex Eyewear, Inc.,
563 F.3d 1358, 1370 (Fed. Cir. 2009) (citing Theme Promotions, Inc. v. News Am. Mktg.
FSI, 546 F.3d 991, 999 (9th Cir. 2008)); see also Koito Mfg. Co. v. Turn-Key-Tech, LLC,
381 F.3d 1142, 1149 (Fed. Cir. 2004) (reviewing without deference JMOL decisions of a
district court in the Ninth Circuit). “The party requesting the JMOL . . . must show that
substantial evidence did not support the jury’s findings, where substantial evidence is
‘such relevant evidence from the record taken as a whole as might be accepted by a
reasonable mind as adequate to support the finding under review.’” Koito, 381 F.3d at
1149 (quoting Tex. Instruments Inc. v. Cypress Semiconductor Corp., 90 F.3d 1558,
1563 (Fed. Cir. 1996)); see also Revolution Eyewear, 563 F.3d at 1370–71.
As we have explained, “[t]his court reviews a jury’s conclusions on obviousness,
a question of law, without deference, and the underlying findings of fact, whether explicit
or implicit within the verdict, for substantial evidence.” LNP Eng’g Plastics, Inc. v. Miller
Waste Mills, Inc., 275 F.3d 1347, 1353 (Fed. Cir. 2001). Where, as here, the jury made
no explicit factual findings regarding obviousness, we must determine whether the
implicit findings necessary to support the verdict are supported by substantial evidence.
Upjohn Co. v. Mova Pharm. Corp., 225 F.3d 1306, 1310 (Fed. Cir. 2000). “[T]he verdict
of obviousness must be supported by facts of (1) the scope and content of the prior art,
(2) the level of ordinary skill in the art, (3) the differences between the claimed invention
2008-1306, -1331 7 and the prior art, and (4) any objective indicia such as commercial success or long-felt
need.” Id.
Each patent claim is presumed valid, and as the party contending that the
asserted claims are invalid, Fresenius was required to prove invalidity of each claim by
clear and convincing evidence. See 35 U.S.C. § 282; Lisle Corp. v. A.J. Mfg. Co.,
398 F.3d 1306, 1316 (Fed. Cir. 2005). Thus, in reviewing the jury’s verdict, “we must
determine whether the jury had substantial evidence upon which to conclude that [the
party alleging invalidity] met its burden of showing invalidity by clear and convincing
evidence.” Koito, 381 F.3d at 1149.
In this appeal, we also consider the district court’s entry of a permanent
injunction and royalty award. We review the district court’s grant of a permanent
injunction for abuse of discretion. Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363,
1379 (Fed. Cir. 2008); see also eBay, 547 U.S. at 391. Regarding the district court’s
royalty award, “we review the trial court’s determinations for erroneous conclusions of
law, clearly erroneous factual findings, and clear errors of judgment amounting to an
abuse of discretion.” Mitutoyo Corp. v. Cent. Purchasing, LLC, 499 F.3d 1284, 1292
(Fed. Cir. 2007).
II. Baxter’s Cross Appeal Regarding Anticipation of Claim 7 of the ’027 Patent
As the sole issue in its cross appeal, Baxter asserts that substantial evidence
does not support the jury’s finding that claim 7 of the ’027 patent is invalid as
anticipated. By failing to properly raise that argument before the district court, Baxter
has waived it, and we decline to consider it. See Golden Bridge Tech., Inc. v. Nokia,
Inc., 527 F.3d 1318, 1323 (Fed. Cir. 2008) (declining to consider a new argument the
2008-1306, -1331 8 party could have raised before the district court); Sw. Software, Inc. v. Harlequin Inc.,
226 F.3d 1280, 1290 (Fed. Cir. 2000) (“Failing to properly move for JMOL at the close
of the evidence precludes a challenge to the sufficiency of the evidence underlying fact
findings.”); Sage Prods., Inc. v. Devon Indus., Inc., 126 F.3d 1420, 1426 (Fed. Cir.
1997) (declining to consider a novel infringement argument raised on appeal).
In Baxter’s Rule 50(a) motion for JMOL and Rule 50(b) renewed motion for
JMOL, Baxter only briefly mentioned the jury’s anticipation verdict, and in each motion,
Baxter relegated its discussion of that verdict to a single footnote. In its Rule 50(a)
motion, Baxter merely stated that “[t]o preserve its rights, Baxter also moves for JMOL
on Fresenius’ defense that the Seratron System anticipates the asserted claims of the
’027 patent because Fresenius has failed to prove that System is prior art with sufficient
corroborating evidence.” J.A. at 21588. Baxter provided no further explanation in the
Rule 50(a) motion and did little to develop the anticipation argument in its Rule 50(b)
motion. In that motion, also in a footnote, Baxter stated that it “renews its JMOL on
Fresenius’ defense that the Seratron System anticipates and/or renders obvious the
remaining asserted claims of the ’027 Patent,” and then provided a minimal explanation
regarding how “Fresenius failed to prove by clear and convincing evidence that that
Seratron System is prior art with sufficient corroborating evidence.”
On appeal, Baxter argues that the Seratron System lacks two of the required
claim limitations because “it is not operable to receive non-conductivity data concerning
a particular selection of dialysate, and it does not use non-conductivity data to calculate
an expected conductivity reading.” Cross Appellant’s Rep. Br. at 5–6. Baxter asserts
that its limited statements to the district court preserved those arguments for appeal, but
2008-1306, -1331 9 we disagree. Before the trial court, Baxter argued that it is entitled to JMOL because
Fresenius failed to prove that the Seratron System is prior art—Baxter did not argue that
the Seratron System lacked specified claim limitations. Contrary to Baxter’s assertions,
one specific challenge to an anticipation finding does not preserve all possible
challenges to that finding. If a party fails to raise an argument before the trial court, or
presents only a skeletal or undeveloped argument to the trial court, we may deem that
argument waived on appeal, and we do so here. See CBOCS W., Inc. v. Humphries,
128 S. Ct. 1951, 1963 n.2 (2008) (declining to consider a claim while noting the
appellate court had deemed that claim waived because it was presented as “only a
skeletal argument” to the district court) (citing Humphries v. CBOCS W., Inc., 474 F.3d
387, 407 (7th Cir. 2007)); Golden Bridge Tech., 527 F.3d at 1323 (“This is an appellate
court and as such we abide by the general rule that new arguments will not be decided
in the first instance on appeal.”); SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d
1312, 1320 (Fed. Cir. 2006) (deeming an argument waived because it was not
presented as a developed argument in the opening brief); Sage Prods., 126 F.3d at
1426 (“With a few notable exceptions, such as some jurisdictional matters, appellate
courts do not consider a party’s new theories, lodged first on appeal. If a litigant seeks
to show error in a trial court’s overlooking an argument, it must first present that
argument to the trial court.”).
Moreover, the new anticipation argument Baxter presents on appeal includes
factual assertions regarding the information contained in the Seratron manual. See
Cross Appellant’s Rep. Br. at 7–15. Fresenius contests those factual assertions,
arguing that the technical statements in the Seratron manual cannot be interpreted in
2008-1306, -1331 10 the manner proposed by Baxter. See Appellant’s Rep. Br. at 18–20. Thus, the parties
present a new factual dispute on appeal. Such a factual dispute should have been
presented to the district court for its consideration in the first instance.
For the foregoing reasons, we conclude that Baxter did not properly present its
argument regarding the claim 7 anticipation verdict to the district court, and thus, Baxter
has waived that argument.
III. Obviousness
The district court determined that Fresenius failed to present substantial
evidence that various non-touch-screen limitations of the asserted claims were present
in the prior art. The district court also found that Fresenius did not present substantial
evidence of a motivation to combine the elements of the prior art to achieve the
invention claimed in the ’131 and ’434 patents. Fresenius argues that the non-touch-
screen limitations in the asserted claims were standard in prior art hemodialysis
machines and that it presented substantial evidence of such to the jury. Baxter
contends the asserted claims are nonobvious, or at a minimum, that Fresenius failed to
meet its burden of proving invalidity by clear and convincing evidence. For the following
reasons, we reverse the district court’s grant of Baxter’s JMOL motion, except as to
claims 26–31 of the ’434 patent.
A. Claim 11 of the ’027 Patent
Because claim 11 is dependent on claim 7, it includes all limitations recited in
claim 7. The district court determined that Fresenius had not presented any testimony
regarding the obviousness of claim 7, and thus concluded that Fresenius necessarily
failed to demonstrate that all limitations of claim 11 were in the prior art. JMOL Opinion,
2008-1306, -1331 11 slip op. at 19. Specifically, the district court determined that because Mr. Causey—
Fresenius’s only expert witness to testify that claim 11 is obvious—did not discuss the
claim 7 limitations, Fresenius had failed to meet its burden of proving by clear and
convincing evidence that claim 11 is obvious. Id. We disagree.
As Fresenius notes, although Mr. Causey did not discuss the claim 7 limitations,
Mr. Ragsdale, another expert witness for Fresenius, had previously discussed those
limitations when he testified that claim 7 is invalid as anticipated. In determining
whether Fresenius presented substantial evidence to support the jury’s verdict that
claim 11 is obvious, we must consider all evidence that was before the jury and draw all
reasonable inferences from that evidence in the light most favorable to Fresenius. See
Koito, 381 F.3d at 1149. From Mr. Ragsdale’s testimony, a reasonable jury could
conclude that all limitations of claim 7 were present in the prior art. Claim 7 is divided
into elements (a) and (b), and Mr. Ragsdale separately testified about each element,
explaining how each was present in the prior art Seratron machine. J.A. at 14342–43.
Fresenius also offered the Seratron’s operating manual. Thus, when the jury was
assessing the obviousness of dependent claim 11, it could reasonably conclude that all
limitations of claim 7 were in the prior art based on Mr. Ragsdale’s testimony.
Baxter argues that Fresenius failed to carry its burden because it did not properly
connect all of the evidence regarding the obviousness of claim 11, namely because Mr.
Causey never referred to Mr. Ragsdale’s testimony. Cross Appellant’s Br. at 40. That
argument fails. Although it would have been advisable for Fresenius to ensure that Mr.
Causey discussed all limitations of claim 11 when he testified regarding the
obviousness of that claim, Fresenius was not required to do so. When, as here, the
2008-1306, -1331 12 question of obviousness is submitted to the jury, we must review the jury’s implicit
factual findings for substantial evidence. Upjohn Co., 225 F.3d at 1310. Here, the jury
implicitly found that all limitations of claim 7 were present in the prior art, and as
explained above, substantial evidence supports that finding. Thus, a reasonable jury
could conclude that the non-touch-screen limitations of claim 11 were in the prior art by
considering Mr. Causey’s testimony in combination with Mr. Ragsdale’s testimony and
the Seratron manual. Because substantial evidence supports the jury’s implicit finding,
JMOL was inappropriate.
B. Claims 1–3 and 13–16 of the ’131 Patent
On appeal, the parties limit their arguments to element (a) of claim 1 and
specified additional limitations of claims 14 and 16.
1. Element (a) of Claim 1
Element (a) of claim 1 requires:
a dialysate-delivery system for supplying dialysate to a hemodialyzer, the dialysate-delivery system comprising at least one unit selected from the group consisting of (i) a dialysate-preparation unit, (ii) a dialysate-circulation unit, (iii) an ultrafiltrate-removal unit, and (iv) a dialysate-monitoring unit.
’131 Patent col.36 ll.1–8. The district court concluded that substantial evidence does
not support the jury’s verdict because Mr. Causey, Fresenius’s expert who testified that
claim 1 is obvious, did not specifically analyze element (a). Because Mr. Causey’s
“testimony did not analyze and explain the claim language and which components of the
prior art embodied each element of the asserted claim,” the district court determined
that Fresenius had not met its burden of proving that claim 1 is invalid. JMOL Opinion,
slip op. at 13. Because all the asserted claims of the ’131 patent contain the element
2008-1306, -1331 13 (a) limitation, the district court granted JMOL for all of the asserted claims. We disagree
with the district court.
Element (a) is written in Markush form, such that the entire element is disclosed
by the prior art if one alternative in the Markush group is in the prior art. See Schering
Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1380 (Fed. Cir. 2003) (holding a claim
invalid as anticipated when it claimed compounds in Markush form and a prior art
reference disclosed one of the claimed compounds); In re Skoll, 523 F.2d 1392, 1397
(CCPA 1975); see also Titanium Metals Corp. v. Banner, 778 F.2d 775, 782 (Fed. Cir.
1985) (“It is also an elementary principle of patent law that when, as by a recitation of
ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if
one of them is in the prior art.”). Thus, a prior art device discloses element (a) if it
contains a dialysate-delivery system for supplying dialysate to a hemodialyzer
comprising only a dialysate-circulation unit (or any one of the other three listed
alternatives).
It is clear that the prior art disclosed a hemodialysis machine containing a
dialysate-circulation unit. Mr. Kelly, Baxter’s witness, admitted and agreed that all
hemodialysis machines—which the jury could reasonably presume would include those
in the prior art—must have “some way of circulating the dialysate through a dialysate
circuit.” J.A. at 14399. In addition, Mr. Ragsdale testified that in his opinion, “the
Seratron system includes a dialysate pump for circulating dialysate . . . through a circuit
including a dialysate compartment for a dialyzer.” J.A. at 14342. Finally, Mr. Causey
testified that the limitations of element (a) of the ’131 patent are present in the CMS 08
prior art hemodialysis machine.
2008-1306, -1331 14 Based on the totality of the testimony presented by Messrs. Kelly, Ragsdale, and
Causey, the jury could reasonably conclude that the limitations of element (a) were
known in the prior art. Specifically, the jury could conclude that the prior art contained a
hemodialysis machine with a dialysate-delivery system that supplies dialysate to a
hemodialyzer and comprises a dialysate-circulation unit. Because substantial evidence
supports the jury’s finding, JMOL was inappropriate.
2. Claim 14
Claim 14 of the ’131 patent depends from claim 1 and adds one additional
limitation: “wherein the touch screen is operable to display a plurality of indicia, each
corresponding to a different time-variable hemodialysis parameter.” ’131 Patent col.36
ll.64–67. Although the district court noted that the manual for the Cobe C3 prior art
machine—which was in evidence and had been submitted to the jury—disclosed “an
indicium corresponding to a time-variable hemodialysis parameter,” the district court
concluded that Fresenius failed to present any evidence that the “plurality of indicia”
limitation of claim 14 was present in the prior art. JMOL Opinion, slip op. at 8–9. We
disagree.
Mr. Causey testified, using an explanatory demonstrative, that the inventors of
the prior art Cobe C3 machine had provided for more than one time-variable parameter.
The demonstrative indicated that the prior art machine allowed for multiple indicia, each
corresponding to a different time-variable hemodialysis parameter. The jury could have
reasonably credited Mr. Causey’s testimony and concluded that the relevant limitation
was present in the prior art Cobe C3 machine. Because substantial evidence supports
2008-1306, -1331 15 the jury’s implicit finding that the plurality of indicia limitation existed in the prior art,
3. Claim 16
Baxter additionally asserts that Fresenius failed to demonstrate that the following
limitation of claim 16 existed in the prior art: “the user/machine interface is operable to
require the user to verify a parameter after a value of the parameter is selected.”
’131 Patent col.37 ll.4–6. That argument is unpersuasive. Fresenius’s expert testified
that the CMS 08 prior art machine contains the limitation described in the claim,
referring specifically to a page of the CMS 08 manual that supports the testimony. J.A.
at 14455, 19935. Thus, substantial evidence supports the jury’s implicit finding that the
claim limitation at issue existed in the prior art.
C. Claims 26–31 of the ’434 Patent
Claims 26–31 contain means-plus-function limitations, and all require a “means
for delivering the dialysate to a dialysate compartment of a hemodialyzer.” ’434 Patent
col.40 ll.33–35. The district court granted Baxter’s motion for JMOL of no invalidity
based in part on its conclusion that Fresenius failed to prove that the means for
delivering dialysate limitation was present in the prior art. We agree, though for
somewhat different reasons than those articulated by the district court. Namely,
Fresenius failed to present any evidence—let alone substantial evidence—that the
structure corresponding to the means for delivering dialysate limitation, or an equivalent
thereof, existed in the prior art.
It is firmly established in our precedent that a structural analysis is required when
means-plus-function limitations are at issue; a functional analysis alone will not suffice.
2008-1306, -1331 16 See, e.g., CytoLogix Corp. v. Ventana Med. Sys., 424 F.3d 1168, 1178 (Fed. Cir. 2005)
(“To establish infringement under § 112, ¶ 6, it is insufficient for the patent holder to
present testimony ‘based only on a functional, not a structural, analysis.’” (quoting Alpex
Computer Corp. v. Nintendo Co., 102 F.3d 1214, 1222 (Fed. Cir. 1996))). Just as a
patentee who seeks to prove infringement must provide a structural analysis by
demonstrating that the accused device has the identified corresponding structure or an
equivalent structure, a challenger who seeks to demonstrate that a means-plus-function
limitation was present in the prior art must prove that the corresponding structure—or an
equivalent—was present in the prior art. See In re Donaldson Co., 16 F.3d 1189, 1193
(Fed. Cir. 1994) (en banc) (“[W]e hold that paragraph six applies regardless of the
context in which the interpretation of means-plus-function language arises, i.e., whether
as part of a patentability determination in the PTO or as part of a validity or infringement
determination in a court.”); see also McGinley v. Franklin Sports, Inc., 262 F.3d 1339,
1361 (Fed. Cir. 2001) (Michel, J., dissenting) (“Of course, in the context of a means-
plus-function claim, the invalidating prior art must disclose not simply a means for
achieving the desired function, but rather the particular structure recited in the written
description corresponding to that function, or an equivalent thereof.”).
Here, Fresenius neither identified the structure in the specification that
corresponds to the means for delivering dialysate nor compared it to the structures
present in the prior art. See CytoLogix, 424 F.3d at 1178 (“Here, CytoLogix failed to
identify the structure in the specification that is the ‘temperature controller means’ and
compare it to the structure of the accused device. Accordingly, because CytoLogix
failed to present substantial evidence of infringement of claim 13 of the ’693 patent, the
2008-1306, -1331 17 jury verdict of infringement of claim 13 must be reversed.”). At most, the evidence of
record supports a finding that some structures that could perform the claimed function
existed in the prior art. Under our precedent, it is clear that such a finding is insufficient.
Thus, as in CytoLogix, the jury’s verdict as to claims 26–31 cannot stand.
We note also that there is an additional reason for affirming the district court’s
grant of JMOL regarding dependent claim 30, which requires a “means for delivering an
anticoagulant to a patient.” The district court instructed the jury that the corresponding
structure is a microprocessor and stepper motor. Fresenius USA, Inc. v. Baxter Int’l,
Inc., No. 03-1431, at 21 (N.D. Cal. July 5, 2006) (Dkt. No. 825) (“Jury Instructions”).
Because Fresenius failed to present any evidence that the required stepper motor
structure existed in the prior art, the district court correctly granted JMOL. Fresenius
has cited no testimony wherein any witness discussed a “stepper motor.” Fresenius
contends that the Cobe C3 manual, which was submitted to the jury, discloses the
necessary structure, but notably, Fresenius has cited no manual pages that reference a
“stepper motor.” After independently reviewing the record, this court notes that the
CMS 08 manual briefly mentions a “stepper motor” but does not discuss that structure in
the context of the claimed function—delivering an anticoagulant. Moreover, even if the
CMS 08 manual disclosed a stepper motor for delivering an anticoagulant, it was
Fresenius’s burden to clearly disclose, discuss, and identify for the jury the supporting
evidence upon which it was relying to prove that the claim limitation was present in the
prior art. See Koito, 381 F.3d at 1151 (holding that a challenger failed to meet its
burden of proving a prior art reference anticipated the patent claims when it “failed to
provide any testimony or other evidence that would demonstrate to the jury how that
2008-1306, -1331 18 reference met the limitations of the claims”). Here, as with the means for delivering
dialysate limitation discussed above, the evidentiary burden of proof cannot be carried
without clearly identifying the corresponding structure in the prior art. Thus, substantial
evidence does not support the jury’s implicit finding that the prior art contained a stepper
motor means for delivering an anticoagulant, and the district court correctly granted
JMOL.
For the foregoing reasons, we affirm the district court’s grant of JMOL as to
D. Motivation to Combine
All of the claims on appeal are directed to a hemodialysis machine integrated
with a touch screen user interface, which Baxter contends was novel and nonobvious at
the time the relevant patent applications were filed. Fresenius contends that touch
screens were well-known in the prior art and had been widely employed—even on other
medical devices—such that Baxter’s addition of a touch screen interface to an otherwise
conventional hemodialysis machine would have been obvious and thus unpatentable.
The district court conducted the trial and issued its JMOL opinion before the
Supreme Court decided KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Thus, the district court applied the teaching-suggestion-motivation test for obviousness
as it existed before it was modified by KSR. The district court granted JMOL and
overturned the jury’s verdict that all asserted claims of the ’131 and ’434 patents are
invalid as obvious because it determined that Fresenius had failed to demonstrate the
required motivation to combine.
2008-1306, -1331 19 We first note that it remains appropriate for a post-KSR court considering
obviousness “to determine whether there was an apparent reason to combine the
known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418.
Thus, the jury’s obviousness verdict remains relevant to our review because we will not
overturn the implicit factual findings underlying the jury’s verdict so long as they are
supported by substantial evidence. See LNP Eng’g Plastics, 275 F.3d at 1353. As
explained below, Fresenius presented substantial evidence to support the jury’s implicit
factual finding that the prior art suggested the combination of a touch screen user
interface with known elements of prior art hemodialysis machines. 3 Thus, we reverse
the district court’s grant of JMOL as to the asserted claims in the ’131 patent.
Baxter concedes that Fresenius presented a prior art publication that disclosed
the use of a touch screen interface on a medical device—specifically an anesthesia-
delivery system. That publication noted hemodialysis as one rapidly advancing area of
medicine, stated that complex technologies have fueled such rapid advances, and then
disclosed that the equipment necessary to practice those complex technologies could
benefit from an improved user interface. J.A. at 18048. The publication then
specifically described the integration of a touch screen interface with an anesthesia-
delivery system. Dr. Rau, the author of the publication, explained to the jury where his
publication mentioned hemodialysis and pointed to other sections of the publication that,
in his opinion, suggested the addition of a touch screen to a hemodialysis machine.
J.A. at 14373–75. Specifically, Dr. Rau testified that his publication “gave numerous
3 The jury was instructed that “[t]he claimed invention is not obvious unless there was something in the prior art or within the understanding of a person of ordinary skill in the field that would suggest the claimed invention.” Jury Instructions at 26.
2008-1306, -1331 20 examples of where you can use [touch screen technology] beneficially” and stated that
“one of the examples which I mentioned was hemodialysis and a hemodialysis
machine.” J.A. at 14373–75. Dr. Phares, another Fresenius witness, described the
ease and prevalence of “integrating a touch screen into some kind of a computer-
controlled machine” and opined that as of the relevant filing date, it would not have been
difficult for one to integrate a touch screen interface into a hemodialysis machine. J.A.
at 14321–22.
Under KSR, “if a technique has been used to improve one device, and a person
of ordinary skill in the art would recognize that it would improve similar devices in the
same way, using the technique is obvious unless its actual application is beyond his or
her skill.” 550 U.S. at 417. In addition, “[t]he combination of familiar elements
according to known methods is likely to be obvious when it does no more than yield
predictable results.” Id. at 416. Here, the jury implicitly found that the prior art
suggested combining a touch screen with known elements of a hemodialysis machine.
That finding is supported by substantial evidence because a reasonable jury could
conclude that Dr. Rau’s publication contained an explicit suggestion to combine the
disclosed benefits of a touch screen interface with a hemodialysis machine. In addition,
the jury could reasonably conclude, based on Dr. Phares’s testimony, that an ordinarily
skilled artisan would have known how to make that combination. Thus, substantial
evidence supports the jury’s findings that the limitations of the ’131 patent claims were
known in the prior art, that the prior art suggested combining those elements to arrive at
the claimed invention, and that the ordinarily skilled artisan would have known how to
make that combination. Therefore, JMOL is inappropriate under KSR, and we reverse
2008-1306, -1331 21 the district court’s grant of JMOL regarding all asserted claims of the ’131 patent.
However, as discussed above, Fresenius failed to present evidence that all limitations
present in claims 26–31 of the ’434 patent were present in the prior art—thus, we affirm
the district court’s grant of JMOL as to those claims.
Baxter argues it presented objective evidence sufficient to demonstrate that its
invention was not obvious. However, it was the proper role of the jury to assess the
credibility and weight of Baxter’s evidence regarding the difficulties of integrating a
hemodialysis machine with a touch screen interface and the commercial success of an
embodiment of the patents. The jury was instructed that it must consider that evidence.
Jury Instructions at 26–27. Therefore, to render its verdict on obviousness, the jury
necessarily determined that Baxter’s evidence was insufficient to overcome Fresenius’s
showing that the claims are invalid as obvious. We will not disturb that implicit factual
finding because it is supported by substantial evidence.
IV. The Permanent Injunction and Royalty Award
Fresenius argues that the district court abused its discretion when it permanently
enjoined Fresenius and awarded Baxter a royalty on hemodialysis machines sold before
January 1, 2009, and disposables linked to those machines. Although we hold that the
district court did not err when it determined that injunctive relief is appropriate, we
vacate the injunction and remand for the district court to revise or reconsider the
injunction in light of our reversal of JMOL. We likewise vacate the royalty award and
remand for the district court to reconsider that award in view of this opinion.
A. The Permanent Injunction
To obtain a permanent injunction, the prevailing patentee must demonstrate:
2008-1306, -1331 22 (1) that it has suffered an irreparable injury; (2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury; (3) that, considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction.
eBay, 547 U.S. at 391.
The district court performed the appropriate analysis required by eBay. It
weighed all of the factors and explained why it ultimately determined that injunctive
relief is appropriate. Injunction Order, slip op. at 3–8. Contrary to Fresenius’s
assertion, the district court did not consider the permanent injunction to be “all but
inevitable” following the infringement determination. 4 Fresenius asserts several
additional challenges to the district court’s analysis, but it cites no legal error and fails to
demonstrate that the district court made any clearly erroneous factual determinations.
For example, Fresenius asserts that the district court “ignored” evidence, see
Appellant’s Br. at 50–52, but there is no requirement that the district court’s opinion
discuss every single fact alleged by Fresenius. In addition, the record contains support
for the district court’s factual determinations; the district court did not clearly err. Thus,
4 The district court did discuss an injunction as “all but inevitable,” but it did so in the context of balancing the relative hardships to the parties and did not commit legal error. The district court noted that it was “somewhat bewildering that, having admitted to infringing the patents nearly two years ago and having known for at least a year that an injunction was all but inevitable, Fresenius has apparently done nothing to implement any alternative to the [accused infringing device].” Injunction Order, slip op. at 7 (emphasis added). The district court then found that the balance of hardships favored Baxter because “[i]t is Fresenius’s burden, and not Baxter’s, to taste the bitter fruit of its own inaction.” Id. Read in context, the “all but inevitable” statement does not amount to legal error, particularly in light of the fact that the district court applied the correct four-factor test and explained its analysis. The district court was likely merely acknowledging, as did Chief Justice Roberts in eBay, that “courts have granted injunctive relief upon a finding of infringement in the vast majority of patent cases.” eBay, 547 U.S. at 395 (Roberts, C.J., concurring).
2008-1306, -1331 23 we conclude that the district court did not abuse its discretion when it granted
permanent injunctive relief. Nonetheless, we vacate the injunction and remand for the
district court to revise or reconsider the injunction in light of our reversal of the district
court’s grant of JMOL regarding the ’027 and ’131 patents.
B. The Royalty Award
The district court ordered Fresenius to pay an ongoing royalty of 10% of the
sales price for any infringing machines sold before January 1, 2009, and a royalty of 7%
of the sales price for all disposable products linked to infringing machines that were sold
from November 7, 2002, until the patents expire. Injunction Order, slip op. at 9–10.
Fresenius argues the district court abused its discretion by imposing the ongoing royalty
without explaining the bases for its royalty rate determinations. See Paice LLC v.
Toyota Motor Corp., 504 F.3d 1293, 1315 (Fed. Cir. 2007) (remanding because, absent
an explanation of the selection of the royalty rate, this court cannot determine whether
the district court abused its discretion) (citing Hensley v. Eckerhart, 461 U.S. 424, 437
(1983) (“It [is] important . . . for the district court to provide a concise but clear
explanation of its reasons for the fee award.”)).
We do not decide today whether the district court’s royalty award was proper.
Instead, we vacate the royalty award and remand for the district court to consider
whether the previous award is proper in light of this court’s modification of the district
court’s judgment. In particular, we note that our reversal of JMOL may affect the district
court’s consideration of the putative royalty rate that would result from a hypothetical
negotiation between Baxter and Fresenius. That analysis is influenced by the Georgia
Pacific factors, see Minks v. Polaris Indus., 546 F.3d 1364, 1372 (Fed. Cir. 2008), and
2008-1306, -1331 24 our decision here may affect how the district court weighs one of more of those factors,
see Georgia-Pac. Corp. v. U.S. Plywood Corp., 318 F. Supp. 1116, 1120 (S.D.N.Y.
1970).
Fresenius also argues that the district court erred by imposing a royalty on post-
verdict sales of disposables linked to machines that were sold pre-verdict. According to
Fresenius, that portion of the royalty is inappropriate because the jury had already
awarded Baxter damages based on machines sold pre-verdict. We disagree because
the district court acted within its discretion. A damages award for pre-verdict sales of
the infringing product does not fully compensate the patentee because it fails to account
for post-verdict sales of repair parts. See Carborundum Co. v. Molten Metal Equip.
Innovations, Inc., 72 F.3d 872, 881–82 (Fed. Cir. 1995). Although the jury had awarded
damages for Fresenius’s pre-verdict sales of machines and disposable products,
Fresenius cites no evidence indicating that the jury also considered post-verdict sales of
disposable products linked to machines sold pre-verdict. The district court was within its
discretion to impose a royalty on those sales of disposable products in order to fully
compensate Baxter for the infringement.
V. Other Arguments
We have considered the parties’ other arguments and find them unpersuasive.
For example, Fresenius asserts that the district court erred in construing two claim
terms: the “means for controlling a dialysate parameter” term in claim 26 of the
’434 patent and the “time variable profile” term in all asserted claims of the ’131 patent.
We decline to consider those arguments. First, Fresenius failed to clearly explain what
result would occur if this court adopted Fresenius’s proposed claim constructions.
2008-1306, -1331 25 Fresenius gave this court little guidance and cited no record support regarding why a
modified claim construction would affect the infringement judgment, the validity
judgment, or both. For that reason alone, we may decline to consider Fresenius’s claim
construction arguments. See Jang v. Boston Sci. Corp., 532 F.3d 1330, 1336 (Fed. Cir.
2008) (“The Supreme Court has explicitly held that Article III does not permit the courts
to resolve issues when it is not clear that the resolution of the question will resolve a
concrete controversy between interested parties.” (citing Coffman v. Breeze, 323 U.S.
316, 322–24 (1945))). In addition, to the extent Fresenius contends a modified claim
construction may affect the infringement judgment, we disagree. Fresenius
unconditionally stipulated that its accused infringing device contains each and every
element of the claims, J.A. at 13721, and then proceeded to argue invalidity at trial.
That stipulation in no way stated or indicated that it was conditioned upon the district
court’s claim construction, and thus, the infringement judgment cannot be altered by a
modified claim construction. Finally, to the extent Fresenius’s proffered claim
constructions would support its invalidity arguments, we note that we have not relied on
the contested claim terms for any holdings adverse to Fresenius, and thus, the claim
construction arguments are moot as to the issue of validity.
Baxter asserts that it is entitled to a new trial if this court determines that the
district court’s grant of JMOL was erroneous. We disagree. We have decided the
invalidity issues as a matter of law, and no new trial is warranted.
VI. CONCLUSION
Because Fresenius failed to demonstrate that the structures corresponding to
certain means-plus-function claim limitations were present in the prior art, we affirm the
2008-1306, -1331 26 district court’s judgment that Fresenius failed to prove that claims 26–31 of the
’434 patent are invalid. We reverse the district court’s grant of JMOL as to all other
asserted claims. In addition, although we hold that the district court did not abuse its
discretion when it permanently enjoined Fresenius, we vacate the injunction and
remand so that the court may revise or reconsider the injunction in light of the fact that
only claims 26–31 of the ’434 patent remain valid and infringed. Finally, we vacate the
royalty award entered by the district court and remand for further proceedings
consistent with this opinion.
AFFIRMED-IN-PART, REVERSED-IN-PART, VACATED-IN-PART, and REMANDED
COSTS
No costs.
2008-1306, -1331 27 United States Court of Appeals for the Federal Circuit
FRESENIUS USA, INC. and FRESENIUS MEDICAL CARE HOLDINGS, INC., Plaintiffs-Appellants,
BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION, Defendants-Cross Appellants.
Appeals from the United States District Court for the Northern District of California in Case no. 03-CV-1431, Judge Saundra Brown Armstrong.
NEWMAN, Circuit Judge, concurring.
I join the court’s opinion, but I write separately to respond to Judge Dyk’s
separate opinion, in which he proposes that the district court should stay completion of
this litigation, in view of the pending reexamination proceeding. Although this proposal
is not adopted it warrants response, for at this stage in this protracted litigation, after full
trial and decision in the district court, after full appeal and ruling of the appellate court
and with only a modified remedy remaining on remand, such an action would be
inappropriate. Further, this question has been neither briefed nor debated. Its sua
sponte presentment as available at this stage is irregular. This litigation began in 2003. Only an issue of adjustment of damages and a
modification of the permanent injunction to reflect our reversal of JMOL remain on
remand. Meanwhile, the reexamination has yet to be finally decided at the PTO, and
remains subject to judicial review, on the same issues of validity as have been litigated.
The proposal would entail several years’ additional delay, if the court were now to stay
the action at this final stage. 1
The relationship between reexamination and litigation is not new to the courts,
and precedent reflects the variety of responses in particular situations, as summarized
in Slip Track Systems, Inc. v. Metal Lite, Inc., 159 F.3d 1337, 1341 (Fed. Cir. 1998) with
respect to concurrent proceedings including PTO reexamination and PTO interference
proceedings. It is established that a “court is not required to stay judicial resolution in
view of the reexaminations.” Viskase Corp. v. American Nat’l Can Co., 261 F.3d
1316,1328 (Fed. Cir. 2001). The corollary rule is that the PTO has no authority to stay
reexamination pending the outcome of district court litigation. Ethicon, Inc. v. Quigg,
1 Our colleague in concurrence appears to believe that a PTO decision on reexamination will override a judicial decision reached after trial and appeal. That is incorrect. All that can be accomplished is delay. In exercising its discretion to deny or grant a stay pending reexamination, a district court should consider the effect of delay upon a patentee. With respect to inter partes reexamination, 35 U.S.C. §318 commits the grant of a stay to the district court’s discretion with special heed to the concerns of the patentee:
Once an order for inter partes reexamination of a patent has been issued under section 313, the patent owner may obtain a stay of any pending litigation which involves an issue of patentability of any claims of the patent which are the subject of the inter partes reexamination order, unless the court before which such litigation is pending determines that a stay would not serve the interests of justice.
(emphasis added).
2008-1306,-1331 2 849 F.2d 1422 (Fed. Cir. 1988). A stay of finality, after the issues of validity and
infringement have been litigated and decided by the district court and appealed to the
Federal Circuit, is a distortion of the role of reexamination.
I remain a strong supporter of the principle of reexamination. It can be a useful
and powerful tool for the benefit of both patentees and those interested in restricting or
eliminating adversely held patents. However, if routinely available to delay the judicial
resolution of disputes, the procedure is subject to inequity, if not manipulation and
abuse, through the delays that are inherent in PTO activity. The statistical data of the
Patent and Trademark Office place this aspect in sharp relief, for the number of
reexamination requests is increasing, as is the time for completion of reexamination and
appeal in the PTO, as well as the right of judicial review. In its recent statistical
summaries, the PTO reports a 54% increase in filing of ex parte reexaminations since
2004 (from 441 in 2004 to 680 in 2008, and with 481 filings through June 2009). See
USPTO, Reexamination Operational Statistics (June 30, 2009), available at
http://www.uspto.gov/web/patents/documents/reexam_operations_06-09.pdf. Of these
filings 31% were reported to be in litigation. Id. Inter partes reexaminations are
increasing rapidly, from 168 in 2008 to 195 filings through June of 2009, with 66%
reported to be in litigation. Id. The PTO also reports that as of the third quarter of 2009,
the average pendency for ex parte reexamination is 36.1 months, an increase from the
34.6 months at December 2008. Id. The pendency of inter partes reexamination is
reported to average 41.7 months. Id.
Decisions on reexamination can be appealed to the Board and are subject to
judicial review. The PTO reports that the Board is still experiencing a heavy increase in
2008-1306,-1331 3 appeals and the backlog of appeals. In contrast, the present case is over but for review
of the remedy on remand. The suggestion that the district court should now stay the
proceedings, at this final stage, is contrary to the precepts of expeditious and just
resolution of disputes.
2008-1306,-1331 4 United States Court of Appeals for the Federal Circuit
FRESENIUS USA, INC. and FRESENIUS MEDICAL CARE HOLDINGS, INC.,
BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION,
Appeals from the United States District Court for the Northern District of California in case no. 03-CV-1431, Judge Saundra Brown Armstrong.
DYK, Circuit Judge, concurring.
I join the majority opinion on the understanding that it does not foreclose the
district court in its discretion from staying further proceedings pending the outcome of
the reexamination before the U.S. Patent and Trademark Office. While Fresenius did
not establish the invalidity of claims 26–31 of the ’434 patent in the district court
proceeding, those claims on their face are of dubious validity in light of our holding that
claims 1–3 and 13–16 of the ’131 patent and claim 11 of the ’027 patent are invalid. It is
entirely possible that the U.S. Patent and Trademark Office will finally conclude that
claims 26–31 of the ’434 patent are also invalid.