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United States Court of Appeals for the Federal Circuit
06-1101
ABBOTT LABORATORIES,
Plaintiff-Appellee,
v.
ANDRX PHARMACEUTICALS, INC.,
Defendant-Appellant,
and
ROXANE LABORATORIES, INC. and TEVA PHARMACEUTICALS USA, INC.,
Defendants.
Jeffrey I. Weinberger, Munger, Tolles & Olson, LLP, of Los Angeles, California,
argued for plaintiff-appellee. With him on the brief was Ted G. Dane. Of Counsel on the
brief were Jason Rantanen and Genevieve A. Cox, of San Francisco, California.
Eric D. Isicoff, Isicoff, Ragatz & Koenigsberg, of Miami, Florida, argued for
defendant-appellant. With him on the brief was Teresa Ragatz. Of counsel on the brief
were Alan B. Clement, Martin P. Endres, and Katharine G. Loving, Hedman & Costigan,
P.C., of New York, New York; and Steven H. Sklar, Leydig, Voit & Mayer, Ltd., of
Chicago, Illinois.
Appealed from: United States District Court for the Northern District of Illinois
Judge David H. Coar
United States Court of Appeals for the Federal Circuit
06-1101
ABBOTT LABORATORIES,
Plaintiff-Appellee,
v.
ANDRX PHARMACEUTICALS, INC.,
Defendant-Appellant,
and
ROXANE LABORATORIES, INC. and TEVA PHARMACEUTICALS USA, INC.,
Defendants.
__________________________
DECIDED: January 5, 2007
__________________________
Before MICHEL, Chief Judge, PROST, Circuit Judge, ELLIS,∗ District Judge.
PROST, Circuit Judge.
Abbott Laboratories (“Abbott”) brought suit against Andrx Pharmaceuticals, Inc.
(“Andrx”) alleging infringement of its patents relating to extended release formulations of
clarithromycin. Abbott moved for a preliminary injunction based on Andrx’s alleged
infringement of claims 1, 4, and 6 of U.S. Patent No. 6,010,718 (“’718 patent”); claim 2
∗
Hon. T.S. Ellis, III, from the United States District Court for the Eastern
District of Virginia, sitting by designation.
of U.S. Patent No. 6,551,616 (“’616 patent”); and claims 8 and 16 of U.S. Patent No.
6,872,407 (“’407 patent”). The district court granted the injunction with respect to all the
asserted claims. The court concluded that Abbott had shown a likelihood of proving
infringement of the ’616 and ’718 patents under the doctrine of equivalents and
infringement of the ’407 patent under literal infringement, and that Andrx had not shown
a likelihood of proving that any of the patents are invalid. Ranbaxy Labs. Ltd. v. Abbott
Labs., Abbott Labs. v. Andrx Pharms. Inc., Nos. 04 C 8078, 05 C 1490 (N.D. Ill. Nov.
10, 2005) (“Ranbaxy-Andrx”).1 Andrx appeals, arguing (1) that Abbott is collaterally
estopped from asserting certain claims in the three patents because of findings of
invalidity and unenforceability of the patents in proceedings against other defendants;
and (2) that the district court erred in finding that Abbott is likely to succeed in proving
infringement with respect to any of the asserted claims of the three patents. Because
we find that collateral estoppel does not apply and the district court did not abuse its
discretion in finding Abbott is likely to succeed on the merits, we affirm.
I. BACKGROUND
Abbott Laboratories accused several manufacturers of infringement of its patents
related to its extended release clarithromycin product, Biaxin XL®. Three such cases
are relevant to this appeal—Abbott’s cases against Teva Pharmaceuticals (“Teva”),
Ranbaxy, and Andrx, the defendant in the instant appeal. Each of these defendants
1
The district court issued a single Memorandum Opinion and Order
resolving two separate motions for preliminary injunction filed against Andrx, and
Ranbaxy Laboratories, Ltd. and Ranbaxy Pharmaceuticals, Inc. (collectively “Ranbaxy”).
The motion against Ranbaxy was filed in case number 04 C 8078 and is discussed at
pages 5-36 of the Memorandum Opinion, the motion against Andrx was filed in case
number 05 C 1490 and is discussed at pages 37-57 of the same Memorandum Opinion.
06-1101 2
sought approval to manufacture and market a generic version of Biaxin XL® and
accordingly filed abbreviated new drug applications (“ANDAs”) with the Food and Drug
Administration (“FDA”). Each of the ANDAs was approved. Abbott’s claims of
infringement against these three defendants are all being heard before a single district
judge in the Northern District of Illinois. Abbott filed motions for preliminary injunctions
against each of the three generic drug manufacturers seeking to enjoin their production
and marketing of extended release clarithromycin. The instant appeal is from the
district court’s grant of a preliminary injunction against Andrx based on the court’s
conclusion that Abbott is likely to prove infringement of the ’718, ’616, and ’407 patents,
and that Andrx is not likely to succeed in proving its defenses.
The ’718 patent describes and claims extended release formulations comprising
erythromycin derivatives combined with a pharmaceutically acceptable polymer. The
extended release formulations enable patients to take one pill per day rather than twice,
as had been required with the immediate release formulation. The ’616 is a
continuation-in-part of the ’718 patent and claims a method of reducing adverse
gastrointestinal side effects, relative to immediate release formulations of erythromycin-
derived drug formulations, by using extended release formulations. The ’407 patent is a
continuation patent of the ’616 patent and claims erythromycin derivative formulations
with certain specified pharmacokinetic properties. The claims at issue in this appeal are
solely those on which Abbott based its motion for a preliminary injunction against Andrx:
claims 1, 4, and 6 of the ’718 patent, claim 2 of the ’616 patent, and claims 8 and 16 of
the ’407 patent.
06-1101 3
Certain holdings in Abbott’s cases against Ranbaxy and Teva are relevant to our
analysis in this appeal. First, in the district court’s order resolving Abbott’s motion for a
preliminary injunction against Ranbaxy, the court held that Ranbaxy had shown that it
was likely to succeed in proving that the ’616 and ’407 patents are unenforceable due to
inequitable conduct. Ranbaxy-Andrx, slip op. at 7. Second, the district court held, in an
order resolving Abbott’s preliminary injunction motion against Teva, that Teva had
raised a substantial question that claim 2 of the ’616 patent was obvious under 35
U.S.C. § 103, and therefore Teva was likely to succeed in proving invalidity of that
claim. Abbott Labs. v. Andrx Pharms., Inc., No. 05 C 1490, slip op. at 22 (N.D. Ill. June
8, 2005) (“Teva I”). Finally, on appeal from Teva I, this court held that Teva had also
raised substantial questions as to the validity of claims 2, 4, and 6 of the ’718 patent.
Abbott Labs. v. Andrx Pharms., Inc., 452 F.3d 1331, 1348 (Fed. Cir. 2006) (“Teva II”).
Turning to the history of the instant appeal, Abbott’s complaint against Andrx
sought, inter alia, declaratory judgment of infringement of the ’407, ’616, and ’718
patents. On May 18, 2005, Abbott moved to preliminarily enjoin Andrx from marketing
its generic version of extended release clarithromycin (“the Andrx product”). In
opposition to Abbott’s motion, Andrx contended that it does not infringe any of the
asserted patents, either literally or under the doctrine of equivalents. In addition, Andrx
defended against Abbott’s motion by arguing that Abbott’s patents are invalid for
indefiniteness under 35 U.S.C. § 112, ¶ 2 (all three patents), invalid for anticipation
under 35 U.S.C. § 102(b) (the ’718 and ’616 patents), and invalid for obviousness under
35 U.S.C. § 103. Ranbaxy-Andrx, slip op. at 53-58.
06-1101 4
The district court held a hearing on September 21, 2005 on Abbott’s preliminary
injunction motion against Andrx and issued a single order resolving both Abbott’s motion
against Andrx and Abbott’s motion against Ranbaxy. With respect to Andrx, the court
held that Abbott succeeded in proving a likelihood of success on its claims that Andrx
infringes claims 1, 4, and 6 of the ’718 patent under the doctrine of equivalents; induces
and contributes to infringement under the doctrine of equivalents of claim 2 of the ’616
patent; and literally infringes claims 8 and 16 of the ’407 patent. Ranbaxy-Andrx, slip
op. at 39-53. As to Andrx’s invalidity defenses, the district court held that Andrx failed to
meet its burden of raising a substantial question of invalidity as to any of the three
asserted patents. Id., slip op. at 53-58. Accordingly, the court granted Abbott’s motion
for a preliminary injunction based on the ’718, ’616, and ’407 patents.
Andrx appeals the district court’s preliminary injunction order enjoining it from
manufacturing and marketing its extended release clarythromycin product. Because
this court’s opinion in Teva II issued after the filing of briefs in Andrx’s appeal, the
parties’ briefs did not address the estoppel effect, if any, of that opinion on the instant
appeal. We therefore granted Abbott’s motion, made after oral argument, requesting
leave to provide supplemental briefing, requesting the parties to brief the court
regarding the extent to which Teva II has a collateral estoppel or other binding effect on
the instant appeal. Accordingly, both Abbott and Andrx filed supplemental briefs on this
issue.2
We have jurisdiction over this appeal pursuant to 28 U.S.C. § 1292(c)(1).
2
Abbott filed, along with its supplemental brief, a motion to file a
supplemental appendix. The motion is denied.
06-1101 5
II. DISCUSSION
On appeal, Andrx presents two distinct arguments as to why the district court
erred in granting a preliminary injunction. First, Andrx asserts that Abbott is collaterally
estopped from seeking a preliminary injunction based on holdings in the preliminary
injunction proceedings against Teva and Ranbaxy that all of the asserted claims are
invalid or unenforceable. Second, Andrx argues that the district court erred in finding
that it could infringe any of the asserted patents. Specifically, Andrx contends that it
cannot infringe the ’718 and ’616 patents under the doctrine of equivalents because it
does not contain the “pharmaceutically acceptable polymer” required by all the asserted
claims. Andrx also contends that the district court erred in concluding that Abbott
showed a likelihood of prevailing in asserting infringement of the ’407 patent because
the court specifically found that the Andrx product did not satisfy one limitation of the
asserted claims.
We address each of Andrx’s arguments in turn below, reviewing the district
court’s decision to grant a motion for preliminary injunction for an abuse of discretion.
Novo Nordisk of N. Am., Inc. v. Genentech, Inc., 77 F.3d 1364, 1367 (Fed. Cir. 1996).
“To overturn the grant of a preliminary injunction, we must find that the district court
made a clear error of judgment in weighing the relevant factors or based its exercise of
discretion on an error of law or on clearly erroneous factual findings.” Pfizer, Inc. v.
Teva Pharms., USA, Inc., 429 F.3d 1364, 1372 (Fed. Cir. 2005).
The four factors relevant to the district court’s decision to grant or deny a
preliminary injunction are “(1) the likelihood of the patentee’s success on the merits;
(2) irreparable harm if the injunction is not granted; (3) the balance of hardships
06-1101 6
between the parties; and (4) the public interest.” Oakley, Inc. v. Sunglass Hut Int’l, 316
F.3d 1331, 1338-39 (Fed. Cir. 2003) (citing Amazon.com, Inc. v. Barnesandnoble.com,
Inc., 239 F.3d 1343, 1350 (Fed. Cir. 2001)). In order to establish the first preliminary
injunction factor, Abbott must show that it will likely prove that Andrx infringes at least
one valid and enforceable patent claim. Pfizer, 429 F.3d at 1372. Likewise, in order to
defeat the injunction based on invalidity or unenforceability defenses, Andrx, as the
party bearing the burden of proof on the issue at trial, must establish a substantial
question of invalidity or unenforceability, i.e., that it is likely to succeed in proving
invalidity or unenforceability of the asserted patents. See Gonzales v. O Centro Espirita
Beneficente Uniao Do Vegetal, 126 S.Ct. 1211, 1219-20 (2006) (“[T]he burdens at the
preliminary injunction stage track the burdens at trial.”); Ashcroft v. Am. Civil Liberties
Union, 542 U.S. 656, 666 (2004).
A. Collateral Estoppel
Andrx’s contentions regarding collateral estoppel involve the district court
decisions in preliminary injunction proceedings regarding defendants Ranbaxy and Teva
and this court’s decision in Teva’s appeal from those proceedings.
When Abbott moved for preliminary injunctions against Teva, Ranbaxy, and
Andrx, the district court accepted separate arguments and held separate hearings for
each defendant. Abbott presented different infringement contentions specific to the
accused product of each defendant and each defendant presented its own and different
defenses. In particular, Teva argued that claims of the ’616 and ’718 patents were
invalid based on different prior art than that raised by Andrx. The district court did not
find Teva’s invalidity defenses regarding claims 2, 4, and 6 of the ’718 patent
06-1101 7
persuasive and granted an injunction against Teva based on those claims. Teva I, slip
op. at 9-20. The court found that Teva had raised a substantial question of validity as to
claim 2 of the ’616 patent and denied a preliminary injunction based on that claim. Id.,
slip op. at 20-22. In the preliminary injunction proceedings against Andrx, however, the
court granted the requested injunction based partly on claim 2 of the ’616 patent, finding
that Andrx had not raised a substantial question of validity based on its different validity
arguments regarding that claim. Ranbaxy-Andrx, slip op. at 53-58, 62. Andrx argues
that, having found claim 2 of the ’616 patent invalid against Teva, the district court erred
in permitting Abbott to enforce the claim against Andrx.
Defendant Ranbaxy also raised different defenses than Andrx. Ranbaxy
defended against a preliminary injunction by arguing, inter alia, that Abbott’s patents
were unenforceable due to Abbott’s inequitable conduct before the United States Patent
and Trademark Office (“PTO”). Id., slip op. at 7. Andrx did not expressly raise
unenforceability defenses to the district court for purposes of fending off a preliminary
injunction.3 The district court issued a single order deciding the preliminary injunction
issues for both Ranbaxy and Andrx. The court found that Ranbaxy showed a likelihood
of success in proving that the ’616 and ’407 patents were unenforceable due to
inequitable conduct and therefore denied a preliminary injunction against Ranbaxy
based on those patents. Id., slip op. at 18. In the order, the court also granted a
3
Andrx asserts that it raised unenforceability due to inequitable conduct as
a defense, pointing to a single statement made at the district court’s preliminary
injunction hearing. The district court opinion only noted that Andrx raised invalidity
defenses, not any unenforceability defenses. Ranbaxy-Andrx, slip op. at 53. Therefore,
we will not consider Andrx as having asserted unenforceability defenses in opposition to
Abbott’s motion for preliminary injunction.
06-1101 8
preliminary injunction against Andrx based on the same two patents. Id., slip op. at 62.
Andrx argues that the district court erred by failing to preclude Abbott from enforcing
these patents against Andrx after finding them unenforceable against Ranbaxy. The
district court’s order did not address this estoppel issue.
At the time the district court issued its order resolving the preliminary injunction
motions against Ranbaxy and Andrx, the preliminary injunction findings in Teva I were
on appeal to this court. When Andrx and Abbott briefed the instant appeal, this court’s
Teva II decision had not issued. In Teva II, this court affirmed the district court’s finding
that Teva had shown a substantial question of validity as to claim 2 of the ’616 patent.
452 F.3d at 1347. This court also reversed the district court, finding that Teva had also
shown a likelihood of proving the invalidity of claims 2, 4, and 6 of the ’718 patent. Id. at
1348. In its appeal, Andrx has extended the scope of its collateral estoppel arguments
to encompass this court’s decision in Teva II, i.e., Andrx argues that Abbott is also
precluded from asserting claim 2 of the ’616 patent and claims 2, 4, and 6 of the ’718
patents because of the finding in Teva II that Teva showed there was a substantial
question as to those claims’ validity.
On appeal, Andrx argues that the Supreme Court’s decision in Blonder-Tongue
Laboratories, Inc. v. University of Illinois Foundation, 402 U.S. 313 (1971), requires that
Abbott cannot assert patents against one party which have been found to be invalid or
unenforceable against another party. In Blonder-Tongue, the Supreme Court permitted
accused infringers to plead collateral estoppel, also known as issue preclusion, when
facing an infringement claim on a patent already declared invalid in a proceeding
against another defendant. Id. at 350. Andrx primarily argues on appeal that Blonder-
06-1101 9
Tongue renders the district court’s decision granting preliminary injunction erroneous as
a matter of law—i.e., after decisions in Ranbaxy-Andrx, Teva I, and Teva II finding that
those defendants had shown a likelihood of proving invalidity or unenforceability of
Abbott’s patents, Abbott should not have been permitted to continue to assert the
patents in preliminary injunction proceedings against Andrx.
In response, Abbott argues that the courts’ findings in the preliminary injunction
proceedings against Teva and Ranbaxy should not be accorded preclusive effect and
that Blonder-Tongue does not compel the application of findings in the other cases to
Abbott’s case against Andrx.
Whether collateral estoppel applies to prevent Abbott from attempting to
preliminarily enjoin Andrx based on decisions in preliminary injunction proceedings
against other defendants is a procedural issue not unique to patent law. We therefore
apply the law of the regional circuit, here the Seventh Circuit.4 Dana v. E.S. Originals,
342 F.3d 1320, 1323 (Fed. Cir. 2003). We first address the parameters for applying
collateral estoppel addressed by the Supreme Court in Blonder-Tongue, followed by an
4
Abbott asserts that the question of whether to extend Blonder-Tongue to
the preliminary injunction context is a question unique to patent law and should be
governed by the law of this court, citing Pharmacia & Upjohn Co. v. Mylan
Pharmaceuticals, Inc., 170 F.3d 1373, 1381 n.4 (Fed. Cir. 1999). We disagree. The
very footnote cited by Abbott from Pharmacia supports application of Seventh Circuit
law in this case:
Application of Blonder-Tongue, being an issue of patent law, is a matter
within our exclusive jurisdiction and is hence subject to this court’s law.
However, because the application of general collateral estoppel principles,
such as finality of judgment, is not a matter within the exclusive jurisdiction
of this court, we must apply the law of the circuit in which the district court
here sits . . . .
170 F.3d at 1381 n.4 (emphasis added).
06-1101 10
analysis of the application of Blonder-Tongue’s collateral estoppel principles in the
Seventh Circuit.
In Blonder-Tongue, the Supreme Court discussed the importance of a final
determination on the merits to application of collateral estoppel. The decision was
limited to the issue of “permitting a patent holder to sue on his patent after it has once
been held invalid following opportunity for full and fair trial.” Blonder-Tongue, 402 U.S.
at 330 (emphasis added). The Supreme Court emphasized
we should keep firmly in mind that we are considering the situation where
the patentee was plaintiff in the prior suit and chose to litigate at that time
and place. Presumably he was prepared to litigate and to litigate to the
finish against the defendant there involved. Patent litigation
characteristically proceeds with some deliberation and, with the avenues
for discovery available under the present rules of procedure, there is no
reason to suppose that plaintiff patentees would face either surprise or
unusual difficulties in getting all relevant and probative evidence before the
court in the first litigation.
Id. at 332. Blonder-Tongue held that, in such situations, a defendant could plead
estoppel if it “identifies the issue in suit as the identical question finally decided against
the patentee in previous litigation.” Id. at 333. Once this showing has been made, the
patentee must be permitted to demonstrate that he did not have a “fair opportunity
procedurally, substantively and evidentially to pursue his claim the first time.” Id.
“Determining whether a patentee has had a full and fair chance to litigate the validity of
his patent in an earlier case is of necessity not a simple matter.” Id. Relevant factors
include which party had the choice of forum; whether the patentee had an incentive to
fully litigate in the prior litigation; and whether the patentee was deprived of crucial
evidence of witnesses in the first litigation through no fault of its own. Id.
06-1101 11
In sum, Blonder-Tongue permitted the use of defensive collateral estoppel when
the accused infringer shows 1) that a patent was found invalid in a prior case that had
proceeded through final judgment and in which all procedural opportunities were
available to the patentee; 2) that the issues litigated were identical; and 3) that the party
against whom estoppel is applied had a full and fair opportunity to litigate. Abbott
argues that none of the Blonder-Tongue requirements for the application of collateral
estoppel are present in this case. According to Abbott, the Teva I, Teva II, and
Ranbaxy-Andrx decisions were not final judgments for purposes of estoppel; the issues
litigated in the current and prior proceedings were not identical because in each
proceeding the issue was whether the particular defendant had shown a likelihood of
succeeding based on its own asserted defenses; and it did not have a full and fair
opportunity to litigate the issue of invalidity in those proceedings.
With respect to the final judgment issue, Abbott argues that the Teva I, Teva II,
and Ranbaxy-Andrx decisions were not final judgments for purposes of estoppel
because they resulted from preliminary injunction proceedings in which either the district
court or this court found only that the defendants had shown a likelihood of proving
invalidity or unenforceability. Abbott argues these findings were based on a limited
record and limited opportunities for collecting or presenting evidence, and were
expressly preliminary rather than final findings on these issues. In response, Andrx
agrees that Blonder-Tongue addressed the case of a final judgment on the merits and
therefore is not directly applicable to a preliminary injunction determination. Andrx
argues, however, that Blonder-Tongue should be extended to estop Abbott from
seeking a preliminary injunction based on patents that have been found to be
06-1101 12
preliminarily unenforceable or invalid against other defendants. Andrx also contends
that the preliminary injunction holdings of invalidity and unenforceability in Teva I,
Teva II, and Ranbaxy-Andrx are “final” in the limited sense of having resolved the issue
of whether substantial questions of invalidity or unenforceability exist.
To determine whether findings made during preliminary injunction proceedings
may invoke collateral estoppel under Blonder-Tongue we look to the law of the Seventh
Circuit. That circuit has clearly held that in “certain rare instances,” a finding need not
be part of a final judgment on the merits in order to be preclusive. A.J. Canfield v. Vess
Beverages, 859 F.2d 36, 38 (7th Cir. 1988) (“Canfield”); see also Miller Brewing v. Jos.
Schlitz Brewing Co., 605 F.2d 990, 996 (7th Cir. 1979). 5
In Miller, Miller Brewing Company sued a competitor based on the trademark
“Lite.” In a prior case, the Seventh Circuit had upheld a district court’s denial of a
preliminary injunction based on the finding that the same asserted trademark was
invalid as generic. Miller, 605 F.2d at 991. In the second case, Miller had sued another
competitor, Schlitz, based on the same trademark. The district court found that the prior
finding of invalidity in the preliminary injunction context collaterally estopped Miller from
asserting the mark against Schlitz. On appeal, the Seventh Circuit considered whether
the prior determination was a final judgment for purposes of issue preclusion, as
required by Blonder-Tongue. Id. at 995-96.
On the question of whether the prior preliminary invalidity finding constituted a
final judgment, the court expressly held that a judgment need not be final in the sense of
5
This court has likewise held that a holding need not be a part of a final
judgment in order to be sufficiently final to invoke issue preclusion. Dana, 342 F.3d at
1323-25.
06-1101 13
28 U.S.C. § 1291. Id. at 996. Rather, “‘[f]inality’ in the context here relevant may mean
little more than that the litigation of a particular issue has reached such a stage that a
court sees no really good reason for permitting it to be litigated again.” Id. The decision
should be “sufficiently firm to be accorded conclusive effect.” Factors to consider in
determining whether a decision was adequately deliberated and firm include whether
the parties were fully heard, the court supported its decision with a reasoned opinion,
and the decision was subject to appeal. Id. But preclusion should be refused, the court
held, if the decision was “avowedly tentative.” Id. In Miller, the court held that the
generic status of the “Lite” mark had been so thoroughly litigated in the first preliminary
injunction proceeding that, as to that issue, there was a sufficient final judgment. Id.
Subsequent to Miller, the Seventh Circuit had occasion to clarify when a
preliminary injunction is a final judgment for purposes of issue preclusion. In Canfield,
the court discussed the preclusive effect of several holdings made in prior proceedings
on the issue of whether Canfield’s trademark “chocolate fudge” was generic for use with
diet sodas. In a first proceeding, a court had granted Canfield a preliminary injunction
against defendant Vess after a preliminary finding that the asserted mark was not
generic. Canfield, 859 F.2d at 37 (citing A.J. Canfield Co. v. Vess Beverages, Inc., 612
F.Supp. 1081 (N.D. Ill. 1985) (“Vess I”)). The Seventh Circuit had affirmed the
preliminary injunction. Id. (citing A.J. Canfield Co. v. Vess Beverages, Inc., 796 F.2d
903 (7th Cir. 1986) (“Vess II”)).
In another court, Canfield sought a preliminary injunction against defendant
Yoo-Hoo based on the same mark. The court in those proceedings found the
trademark generic and denied a preliminary injunction. Id. at 38 (citing Yoo-Hoo
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Chocolate Beverage Corp. v. A.J. Canfield Co., No. 85-3701, 1986 WL 9720, at *1
(D.N.J. Apr. 1, 1986)). Because the district court considered extensive evidence on the
issue during the preliminary injunction proceeding, it determined that Canfield “will not
and cannot succeed on the merits based upon the undisputed facts submitted.”
Yoo-Hoo, 1986 WL 9720 at *18. The court did give Canfield additional time, however,
to come forward with additional evidence that it did not present at the preliminary
injunction hearing on why its mark for “chocolate fudge” should not be found generic.
Canfield, 796 F.2d at 38. When Canfield failed to do so, the court entered a final
judgment in favor of Yoo-Hoo. Id.
In a third proceeding, Canfield sued and sought preliminary relief against another
defendant, Honickman, for use of the same “chocolate fudge” mark. There, the court
held that the term was generic for purposes of granting a preliminary injunction. Id. at
38 (citing A.J. Canfield v. Honickman, 808 F.2d 291 (3d Cir. 1986)).
Vess, the defendant against whom a preliminary injunction had been entered in
Vess I returned to court for vacatur of the injunction against it based on the holdings in
Honickman and Yoo-Hoo that the asserted mark was generic. Canfield, 859 F.2d at 37.
Canfield countered by arguing that the earlier findings in Vess I and Vess II that the
mark was not generic precluded application of the later-decided Honickman and
Yoo-Hoo holdings that the mark was generic. The Canfield court discussed when it is
appropriate to give preclusive effect to holdings made during preliminary injunction
proceedings.
In general, rulings in connection with grants or denials of preliminary relief
will not be given preclusive effect. Such rulings are often made on an
incomplete record and are inherently tentative in nature. Usually, the
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grant or denial of relief is based not on a conclusive determination, but on
an estimate of the likelihood of success.
Canfield, 859 F.2d at 38 (citations omitted). In “certain rare circumstances,” however,
the court held that decisions granting or denying preliminary injunctions may be
sufficiently final to be given preclusive effect. Id. The exception to the general rule
permits decisions regarding preliminary relief to accord preclusive effect if the decisions
are necessarily based upon a determination that constitutes an “insuperable obstacle”
to the plaintiff’s success on the merits. Id. (citing Miller, 605 F.2d at 995). Such an
insuperable obstacle exists when a prior decision made in connection with a preliminary
injunction proceeding “clearly intended to firmly and finally resolve the issue,” rather
than “estimate the likelihood of success” of proving that issue. Id.; see also Teamsters
Local 705 v. Apex Auto. Warehouse, Inc., No. 90 C 6768, 1991 U.S. Dist. LEXIS 9471
(N.D. Ill. July 8, 1991) (citing Canfield, 859 F.2d at 38) (“When the prior injunction was
based upon the same issue the party seeks to foreclose, and the court in the earlier
decision conclusively determined that issue, then that situation falls within the
insuperable obstacle test.”)
The Canfield court thus had to determine whether each prior case resolved the
issue of whether “chocolate fudge” is generic in a way that intended to firmly and finally
resolve the issue. The court found that in both the Yoo-Hoo case and the Honickman
case, the district court opinions did reach final resolutions on that issue. The Yoo-Hoo
court had given Canfield the opportunity to present further evidence after its preliminary
finding that the mark was generic, and when Canfield did not, entered a final judgment
in Yoo-Hoo’s favor. Such a resolution was “clearly a decision on the merits for
purposes of collateral estoppel.” Id. at 38. The Honickman court had found the term
06-1101 16
generic only for purposes of a preliminary injunction. The opinion, however, showed
that the deciding judge “clearly intended to firmly and finally resolve the issue.” Id.
Therefore, it too was afforded preclusive effect.
The district court’s holding in Vess I, on the other hand, was not considered
sufficiently firm to be accorded preclusive effect. The district court judge in Vess I had
made no explicit finding as to whether the asserted mark was generic. Id. at 38-39.
Also, while the judge had raised the issue, he had not finally resolved it. Id. at 39. The
Canfield court held, therefore, that “any discussion of genericness in Vess I was in
terms of probabilities, not certainties, and the brief mention of the issue was not full
litigation and decision on the merits for purposes of issue preclusion.” Id. at 39.
Applying the principles of Canfield and Miller to the instant appeal, we conclude
that the determinations made in proceedings against defendants Teva and Ranbaxy
were not “full litigation and decision on the merits for purposes of issue preclusion.”
Andrx argues that there has been a final resolution of the limited issue of whether there
is a substantial question of invalidity of Abbott’s patents, but Seventh Circuit law does
not support this view. A determination that there is merely a likelihood of proving
invalidity is a determination made solely in terms of “probabilities, not certainties” and is
therefore not “full litigation and decision on the merits for purposes of issue preclusion.”
Id.
In both the Teva and Ranbaxy cases, the district court judge did not intend to
“firmly and finally resolve the issue” for which preclusion is asserted, the validity or
enforceability of the Abbott patents, in its preliminary injunction proceedings. As with
the opinion in Vess I, the Ranbaxy-Andrx opinion makes conclusions regarding the
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issue solely in terms of “probabilities, not certainties.” For example, the court’s
unenforceability finding with respect to Ranbaxy explicitly “preliminarily finds both the
’616 and the ’407 patents” unenforceable due to inequitable conduct. Ranbaxy-Andrx,
slip op. at 18-19 (emphasis added). Similarly, the invalidity findings with respect to
defendant Teva by both the district court and this court were solely that Teva showed a
“likelihood” of success in proving invalidity and were not conclusive findings. Teva II,
452 F.3d at 1348; Teva I, slip op. at 4. Contrary to the requirement of Miller, the Teva II
panel’s decision on invalidity was “avowedly tentative.” Teva II, 452 F.3d at 1337
(“[O]ur decision today in no way resolves the ultimate question of invalidity.” (emphasis
added)). Under Seventh Circuit precedent, we do not find this case, therefore, to
present the rare circumstance in which a determination made during a preliminary
injunction is sufficiently final to be accorded preclusive effect. Andrx’s arguments
seeking to collaterally estop Abbott from preliminarily enforcing its patents against Andrx
are accordingly rejected.
In light of this conclusion with respect to final judgments, we do not reach the
parties’ arguments regarding whether the issues litigated in the prior and present
proceedings are identical, or whether Abbott had a full and fair opportunity to litigate in
the prior proceedings. The collateral estoppel effect of Teva I, Teva II, and Ranbaxy-
Andrx was the only appealed basis for reversing the district court’s finding that the three
Abbott patents are preliminarily valid and enforceable as to Andrx. Accordingly, we
affirm the district court’s judgment in that regard.
B. Infringement
Andrx also challenges the district court’s finding that Abbott showed a likelihood
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of proving infringement of its asserted claims by Andrx. Irrespective of the conclusion
above regarding whether Abbott is estopped from relitigating the validity and
unenforceability of certain claims in its patents, we must still reach Andrx’s infringement
arguments as to claim 1 of the ’718 patent because it was not at issue in the
proceedings against the other defendants. Cf. Bourns, Inc. v. United States, 537 F.2d
486 (Ct. Cl. 1976) (holding that if the obviousness inquiry as to unadjudicated claims
present identical issues to those already adjudicated in a prior suit in which other claims
were found invalid, the patentee may be estopped from asserting the unadjudicated
claims). However, because of the holding that collateral estoppel does not apply here,
the arguments regarding claims 4 and 6 of the ’718 patent, claim 2 of the ’616 patent,
and claims 8 and 16 of the ’407 patent still require our review.
Andrx makes two arguments as to why it cannot infringe Abbott’s asserted claims
in any of the three patents. First, Andrx argues that it cannot infringe the ’718 and ’616
patents because its product does not satisfy the “pharmaceutically acceptable polymer”
limitation in the patents either literally or under the doctrine of equivalents. Second,
Andrx argues that the district court erred in finding that Abbott showed a likelihood of
proving infringement of the ’407 patent because the district court explicitly found that
Andrx’s product did not meet one of the pharmacokinetic property requirements recited
in the claims.
Turning to the first of these arguments, Andrx asserts that the district court erred
in granting a preliminary injunction based on the ’718 and ’616 patents because Abbott
did not show that it is likely to succeed in proving infringement of the “pharmaceutically
acceptable polymer” claim limitation. Andrx asserts that it cannot infringe literally or
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under the doctrine of equivalents because its product does not include a
“pharmaceutically acceptable polymer” as required by the claims. All of the asserted
claims of the ’718 patent—claims 1, 4, and 6—and claim 2 of the ’616 patent contain
this limitation.
The “pharmaceutically acceptable polymer” in the ’718 and ’616 patent serves as
the release controlling agent for the claimed extended release clarithromycin
compositions. ’718 patent, col. 1. l. 67 – col. 2 l. 2. Both sides concede that Andrx’s
product does not contain a polymer, but instead uses glyceryl monostearate (“GMS”) as
its release controlling ingredient. Abbott therefore does not assert that Andrx infringes
the claims of the ’718 and ’616 patents literally, but solely under the doctrine of
equivalents. The parties dispute whether GMS is properly referred to as a wax or a fat
and whether it can be found to be an equivalent of the claimed polymer.
1. Claim Construction
When determining whether the Andrx product is likely to infringe the
“pharmaceutically acceptable polymer” claim limitation as an equivalent, we start with
construction of that claim term. The district court construed the term “pharmaceutically
acceptable polymer” in its preliminary injunction order for defendant Teva.
The ’718 patent description of the “pharmaceutically acceptable polymer”
uses a closed term. Claim drafters often use the term “group of” to signal
a Markush group, which lists specified alternatives in a patent claim . . . .
By its nature, a Markush group is closed. The ’718 patent describes the
“pharmaceutically acceptable polymer” as “a water-soluble hydrophilic
polymer selected from the group consisting of polyvinylpyrrolidine,
hydroxypropyl cellulose, hydroxypropylmethyl cellulose, methyl cellulose,
vinyl acetate/crotonic acid copolymers, methacrylic acids copolymers,
maleic anhydride/methyl vinyl ether copolymers and derivatives and
mixtures thereof.” . . . The term excludes other forms of polymers, such as
hydrophobic or water insoluble substances (e.g., wax).
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Teva I, slip op. at 11. The court subsequently adopted that construction for purposes of
the preliminary injunction proceedings against Andrx despite Abbott’s protest that the
district court’s construction in Teva I was overly narrow.
Abbott urges this Court to modify its construction of the phrase
“pharmaceutically acceptable polymer” from its previous opinion in the
related Teva matter. . . . When a term is undefined, the first place a court
is to look for a definition is the specification. This Court followed that
procedure, looked in the specification, and read the Markush group
containing definition there. It is not persuaded by the case law Abbott
cites that it erred in so doing and declines to alter its construction.
Ranbaxy-Andrx, slip op. at 40-41 (citation omitted).
Abbott argues, as it did to the district court, that the district court erred in its claim
construction because it relied on “Markush group” language in the specification, i.e.,
language indicating that the claimed pharmaceutically acceptable polymer is “selected
from the group consisting of” the polymers expressly identified in the specification.
Given that the specification used the “selected from the group of” language, the district
court limited the pharmaceutically acceptable polymers to those listed. Abbott argues
that this was erroneous because limiting claim scope based on Markush language only
applies when the phrase is used in the claims, not in the written description.
Abbott also disagrees with Andrx’s contention that the written description
provides an explicit definition of “pharmaceutically acceptable polymer” that should
overcome the canon that the term should be given its ordinary meaning to one of skill in
the art in the context of the patent. Further, Abbott argues that the patent does not
include any intentional disclaimer or disavowal of claim scope of the polymer limitation.
It urges that the specification merely identifies exemplary polymers that are suitable for
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use in the invention and does not provide a definition. It notes that when defining other
terms in the patent, the ’718 patent explicitly states what the term “means.”
The district court’s claim construction, Abbott argues, would also violate the
doctrine of claim differentiation because claims 2 and 3, which depend from claim 1
expressly claim the more specific types of polymers to which the court limited the term.
Accordingly, Abbott asserts that the correct construction of “pharmaceutically
acceptable polymer” is according to the plain and ordinary meaning that one of skill
would understand it to have in the context of the patent—“any polymer, suitable for use
in pharmaceutical compositions to be administered in humans that, alone or together
with other polymers, is capable of forming a matrix to control and extend drug-
dissolution release into the bloodstream.”
Andrx responds that Abbott wrongly relies on these principles of claim
construction to argue that the district court’s construction was impermissibly narrow.
First, Andrx argues that Markush language is just as limiting when used in the written
description as when it is used in a claim. Second, Andrx argues that Abbott misapplies
the doctrine of claim differentiation. Finally, Andrx asserts that Abbott’s construction
ignores an express definition of the term “pharmaceutically acceptable polymer” given in
the specification and instead imports limitations from preferred embodiments.
This court reviews the district court’s claim construction de novo on appeal.
Cybor Corp. v. FAS Techs, Inc., 138 F.3d 1448, 1454 (Fed. Cir. 1998). “[T]he words of
a claim ‘are generally given their ordinary and customary meaning.’” Philips v. AWH
Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp. v.
Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). Further, “the ordinary and
06-1101 22
customary meaning of claim term is the meaning that the term would have to a person
of ordinary skill in the art in question.” Id. at 1313. The court looks to sources such as
the words of the claims themselves, the written description of the patent, and extrinsic
evidence to ascertain the meaning of the term “pharmaceutically acceptable polymer.”
Id. at 1314.
First, “the claims themselves provide substantial guidance as to the meaning of
particular claim terms.” Id. at 1314. Claim 1 of the ’718 patent requires a composition
that includes only a “pharmaceutically acceptable polymer.” ’718 patent, col. 11 ll. 31-
32. Claim 2, not asserted here, depends from claim 1 and further requires that the
pharmaceutically acceptable polymer “is a hydrophilic water-soluble polymer.” Id., col.
11 ll. 39-40. Claim 3, also not asserted in this case, depends from claim 2 and more
specifically requires that
the polymer is selected from the group consisting of polyvinylpyrrolidine,
hydroxypropyl cellulose, hydroxypropylmethyl ceullulose, methyl cellulose,
vinyl acetate/crotonic acid copolymers, methacrylic acid copolymers,
maleic anhydride/methyl vinyl ether copolymers and derivatives and
mixtures thereof.
Id., col. 11 ll. 42-47. Therefore, the language of the claims and claim differentiation
imply that the “pharmaceutically acceptable polymer” term in claim 1 is likely broader
than the “hydrophilic water-soluble polymer” described in claim 2 and encompasses
more compounds than those listed in claim 3.
Next, the claims “‘must be read in view of the specification, of which they are a
part.’ . . . [I]t is the single best guide to the meaning of a disputed term.” Phillips, 415
F.3d at 1315 (citations omitted). Here, the specification describes:
The pharmaceutically acceptable polymer is a water-soluble hydrophilic
polymer selected from the group consisting of polyvinylpyrrolidine,
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hydroxypropyl cellulose, hydroxypropyImethyl cellulose, methyl cellulose,
vinyl acetate/crotonic acid copolymers, methacrylic acid copolymers,
maleic anhydride/methyl vinyl ether copolymers and derivatives and
mixtures thereof. Preferably, the polymer is selected from hydroxypropyl
cellulose, hydroxypropylmethyl cellulose, and methyl cellulose. More
preferably, the polymer is hydroxypropylmethylcellulose. Most preferably,
the polymer is a low viscosity hydroxypropylmethyl cellulose with viscosity
ranging from about 50 cps to about 200 cops. The most preferred low
viscosity polymer is a hydroxypropylmethyl cellulose with a viscosity of
about 100 cps, commercially available under the Tradename Methocel™ K
100 LV from The Dow Chemical Company.
’718 patent, col. 3 l. 65 – col. 4 l. 14.
The district court focused on the “selected from the group consisting of” phrase in
the specification to hold that there was a Markush group and therefore Abbott was
limited to the listed polymers. A Markush group is a form of drafting a claim term that is
approved by the PTO to serve a particular purpose when used in a claim—to limit the
claim to a list of specified alternatives. Gillette Co. v. Energizer Holdings, Inc., 405 F.3d
1367, 1372 (Fed. Cir. 2005); Manual of Patent Examining Procedure § 803.2 (8th ed.
2001). The term “Markush group” does not have any meaning within the context of a
written description of a patent and therefore to the extent the district court relied on the
Markush group language to limit its construction to the compounds listed in the written
description, it erred.
The district court also appears to have grounded its claim construction on the
theory that the “pharmaceutically acceptable polymer” is explicitly defined in the written
description when it states, “The pharmaceutically acceptable polymer is a water-soluble
hydrophilic polymer . . . .” ’718 patent, col. 1 ll. 65-66 (emphasis added). Although a
term may have an ordinary meaning to one of ordinary skill in the art, the patentee may
“expressly define terms used in the claims.” Phillips 415 F.3d at 1321 (quoting
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Vitronics, 90 F.3d at 1582. The patentee here states in the written description that “a
pharmaceutically acceptable polymer is” a specific subset of polymers. The word “is”
may signify that a patentee is serving as its own lexicographer. However, there is
significant evidence at this stage of the litigation to believe that the patentee here was
not providing a definition of the “pharmaceutically acceptable polymer” claim term in the
written description. First, the ’718 patent unambiguously provides definitions of other
claim terms, that may be different from the ordinary understanding of a person of skill in
the art, by stating that the term has a particular meaning within the patent. See, e.g.,
’718 patent, col. 3 ll. 34-35 (“‘Erythromycin derivative’ as used herein, means . . . .”
(emphasis added)); col. 3, ll. 40-41 (“‘Pharmaceutically acceptable’ as used herein,
means . . . .” (emphasis added)). In contrast, the written description states that the
“pharmaceutically acceptable polymer is . . . ,” which does not as unambiguously signify
that the description provided is definitional. Further, neither party’s expert declared that
the language in the written description is purely definitional from the point of view of one
of skill in the art. Indeed, the two experts offer differing constructions as to how the term
“pharmaceutically acceptable polymer” would be understood by one of ordinary skill in
the art, neither construction limiting the polymer to hydrophilic, water-soluble
substances. Decl. of Arthur H. Kibbe Ph.D. in Opp’n to Abbott Labs. Mot. for a Prelim.
Inj. Against Andrx Pharms. at 21-22, ¶ 46, 48 (“Kibbe Declaration”); Decl. of Gilbert
Stephen Banker, Ph.D, D.Sc., in Supp. of Abbott Labs.’ Application for a TRO and Mot.
for a Prelim. Inj. Against Andrx Pharms., Inc. at 12. Also, it appears that if the
“pharmaceutically acceptable polymer” is defined to be “a water-soluble hydrophilic
polymer,” that definition would not cover some of the very polymers listed because they
06-1101 25
are not water-soluble. See Kibbe Declaration at 22, ¶ 49. Finally, as noted above, the
claims of the ’718 patent do not support a conclusion that the “pharmaceutically
acceptable polymer” in claim 1 is limited by the “hydrophilic” or “water-soluble”
limitations in claim 2, or to the specific compounds listed in claim 3. We therefore
conclude that the district court erred at this preliminary stage in limiting the
“pharmaceutically acceptable polymer” term to hydrophilic, water-soluble compounds
selected from a list given in the written description of the ’718 and ’616 patents.
2. Infringement
Turning to infringement, Andrx argues that, under the district court’s claim
construction, the Andrx product cannot infringe the “pharmaceutically acceptable
polymer” claim limitation. The parties conceded below that there is no literal
infringement of the limitation by the GMS ingredient in the Andrx product. Ranbaxy-
Andrx, slip op. at 37. The district court found, however, that Abbott did show a
likelihood of success of proving that the Andrx product infringes under the doctrine of
equivalents. On appeal, Andrx argues that GMS cannot be an equivalent of the
“pharmaceutically acceptable polymer” term for two reasons: first, because it would
violate the specific exclusion principle; and second, because a finding of equivalence
would vitiate the claim limitation. We address each of these arguments in turn.
Andrx first contends that permitting its product to infringe would violate the
specific exclusion principle. This principle limits what can be claimed under the doctrine
of equivalents by mandating that “the concept of equivalency cannot embrace a
structure that is specifically excluded from the scope of the claims.” Athletic
Alternatives, Inc. v. Prince Mfg. Inc., 73 F.3d 1573, 1582 (Fed. Cir. 1996). According to
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Andrx, the district court’s claim construction consistently held that the pharmaceutically
acceptable polymer excludes other forms of polymers such as hydrophobic or water
insoluble substances such as waxes. Therefore, any equivalence that encompasses
hydrophobic or water insoluble substances, Andrx argues, would violate the specific
exclusion principle. As discussed above, we hold that the district court erred by limiting
the scope of pharmaceutically acceptable polymers covered by the claims to hydrophilic
or water-soluble substances. Therefore, we need not consider Andrx’s argument that
specific exclusion bars the application of the doctrine of equivalents because GMS is a
hydrophobic, water-insoluble substance.
Andrx also argues that permitting its product to infringe the “pharmaceutically
acceptable polymer” term under the doctrine of equivalents would vitiate that claim
limitation. A finding of equivalence of the Andrx product is erroneous as a matter of law,
Andrx contends, because the Andrx product “employs a material[, GMS] that is the
exact opposite of the material recited in the claims of the ’718 patent (polymer vs.
nonpolymer (or even further, hydrophilic water soluble polymer vs. hydrophobic water
insoluble nonpolymer)).” Andrx argues that, regardless of whether GMS meets the test
for factual equivalence by performing substantially the same function in substantially the
same way to achieve substantially the same result, a finding of equivalence by
something that is the opposite of the claimed limitation would essentially read the
limitation out of the claim. Andrx also argues that GMS was well known in the prior art,
but not claimed by Abbott in its claims. Therefore, Andrx contends, allowing GMS to
infringe as an equivalent would seriously undermine the public notice function required
by patent claims.
06-1101 27
Abbott responds that under either its asserted claim construction or that adopted
by the district court, the equivalence of GMS to the claimed “pharmaceutically
acceptable polymer” would not vitiate the claim limitation because the district court
found that GMS was an equivalent of the polymer limitation under the function-way-
result test. Andrx did not appeal the factual equivalence, so Abbott argues that Andrx
has no basis for arguing that the claim term is vitiated by a finding of equivalence.
Andrx replies that Abbott’s arguments regarding factual equivalence are immaterial to
the issue on appeal, whether a water insoluble hydrophobic non-polymeric substance,
can be considered insubstantially different from its antithesis, the claimed water soluble
hydrophilic polymer.
On the issue of vitiation, the district court held
Andrx argues that a finding of equivalency vitiates the claim by reading the
pharmaceutically acceptable polymer limitation out of it. That is incorrect.
A finding of equivalency under the doctrine of equivalents is a fact-specific
inquiry. It does not require a revision of the claim language or limitation.
Ranbaxy-Andrx, slip op. at 44 n.17.
A claim element is not vitiated merely because it does not literally exist in the
accused product—“such an interpretation of the ‘all elements’ rule would swallow the
doctrine of equivalents entirely.” Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
469 F.3d 1005, 1018 (Fed. Cir. 2006). Rather,
[a] holding that the doctrine of equivalents cannot be applied to an
accused device because it ‘vitiates’ a claim limitation is nothing more than
[(1)] a conclusion that the evidence is such that no reasonable jury could
conclude that an element of an accused device is equivalent to an
element called for in the claim, or [(2)] that the theory of equivalence to
support the conclusion of infringement otherwise lacks legal sufficiency.
Id. at 1018-19.
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Here, Andrx appears to argue the second type of vitiation described by Depuy
Spine—that Abbott’s theory as to the “polymer” claim element is legally insufficient to
prove equivalence. Specifically, Andrx argues that GMS, a hydrophobic, non-polymeric
substance, is the antithesis of the required polymer. See Planet Bingo v. Gametech
Int’l, No. 05-1476, slip op. at 13 (Fed. Cir. Dec. 12, 2006) (explaining that a theory of
equivalence may be legally insufficient when the accused product contains the
antithesis of the claim limitation). Therefore, Abbott’s assertion that it can avoid a
finding of vitiation because it showed factual equivalence does not address Andrx’s
argument that Abbott’s theory of equivalence is legally insufficient. It also appears that
the district court did not consider this aspect of vitiation. Rather, the court addressed
only whether GMS could factually be an equivalent of the polymer limitation.
Nevertheless, as discussed above, we hold that the district court erred in
construing the “pharmaceutically acceptable polymer” claim term as only covering
hydrophilic, water-soluble substances. Because this erroneous construction forms the
basis for Andrx’s vitiation arguments that GMS cannot be an equivalent of the required
polymer, we reject those arguments.
We are left with the district court finding that GMS could be factually equivalent to
the required polymer under its erroneous claim construction—that GMS performs the
same function, in the same way, to achieve the same result as the “pharmaceutically
acceptable polymer” in the claims. Ranbaxy-Andrx, slip op. at 44. Andrx does not
argue in this appeal that the district court erred in this finding of factual equivalence.
Although the district court’s equivalence analysis applied an erroneous claim
construction, its conclusion regarding equivalence would clearly also apply under a
06-1101 29
claim construction that was not erroneously narrowed as explained above. Therefore,
we affirm the district court’s finding, based on the preliminary record, that Abbott
showed a likelihood of success in proving infringement of claims 1, 4, and 6 of the ’718
patent and claim 2 of the ’616 patent under the doctrine of equivalents.
3. Infringement of the ’407 Patent
Because we hold that the district court did not err in granting a preliminary
injunction based on the ’718 and ’616 patents, we need not reach whether the court
erred in also basing its preliminary injunction on the ’407 patent.
C. Other Preliminary Injunction Factors
Other than likelihood of success on the merits, the other factors relevant to the
district court’s decision to grant or deny a preliminary injunction are (1) irreparable harm
if the injunction is not granted; (2) the balance of hardships between the parties; and (3)
the public interest. As Andrx does not challenge the district court’s findings on these
factors on appeal, we do not disturb the district court’s conclusion that these factors
weigh in Abbott’s favor.
CONCLUSION
Because Abbott has shown a likelihood of success in proving infringement of at
least one claim and the district court found that Andrx did not show it was likely to
prevail in its defense, which was a finding unchallenged on appeal, we affirm.6
AFFIRMED
6
Nothing in this opinion precludes either Abbott or Andrx from seeking in
district court either vacation of the injunction currently appealed or a new injunction
based on matters not previously presented to the district court.
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