Darrah’s determination that Fournier is estopped from arguing infnngement under the doctrine of
equivalents, Because the patent and its prosecution history are the same in this case as in
Novopharm, a determination of prosecution-history estoppel here is identical to that decided by
Judge Darrah in Novepharm. Prosecution-history estoppel was actually litigated in the Novopharm
case, Judge Darrah could not have granted summary judgment to Novopharm without deciding the
prosccution-history estoppel issue, so it was essential to the judgment. Finally, Fournier had a full
and fair opportunity to litigate prosecution-history estoppel. In light of this, the court follows the
Novopharm court in concluding that Fournier cannot establish that Impax’s product literally infringes
the ‘726 patent.

In addition, even if the court were not bound under collateral estoppel, the court is persuaded
by Judge Darrah’s reasoning and would similarly bar Fournier from relying on a doctrine of
equivalents argument. In Novopharm, the court looked to the prosecution history and found that the
patentee of the ’726 patent distinguished its process and product from those achieved by adding a
surfactant or by micronizing the fenofibrate on ifs own or by intimately mixing the separately
micronized fenofibrate and surfactant. Novopharm, 2002 U.S. Dist. LEXIS 4659, at *24. Therefore,
“based on the arguments made during the prosecution of the patent... and the arguments made
during rcexamination,” the court concluded that “Plaintiff [Fournier] relinquished a product and
process that involved either adding a surfactant by itself or by micronizing the fenofibrate on its own
(as done by defendant] or by intimately mixing the separately micronizcd fenofibrate and surfactant.”
Id. at *24-25. Like the defendant in the Novepharm case, Impax’s process uses fenofibrate that has
been micronized by itself. As did the Novepharm court, the court concludes that Fournier is

estopped from arguing infongement under the doctnne of equivalents for claims 1 or 10.

13



2002 U.S. Dist. LEXIS 4659, at *25-26 (N.D. Ill. Mar. 19, 2002). As in this case, the critical issue
in Novopharm was the meaning of“co-micronized” and “‘co-micronization” as used in claims 1 and
10 of the °726 patent. Relying on the ordinary definitions of the prefix “co” and the word
“micronize,” the Novopharm court determined that “the ordinary meaning of the term ‘co-
micronized’ would be ‘to reduce to a fine powder [micronize] with or together.” /d, at *17. The
court held that “co-micronization” and “co-micronized” are distinct from “micronizing fenofibrate
by itself.” Jd. at *25. The court further concluded that one skilled in the art reading the claims,
specification, and prosecution history could conclude that the term “co-micronized” in claims 1 and
10 “mean[s] that fenofibrate and a solid surfactant have been micronized together in the absence of
other excipients.” /d, at* 20-21, Finally, because Novopharm’s product utilized fenofibrate that
has been micronized by itself, and at no time are fenofibrate and a solid surfactant present in the
absence of other excipients, the court granted Novopharm’s motion for summary judgment ofnon-
infringement. /d. at *25-26.
Analysis

Summary judgment is proper “if the pleadings, depositions, answers to interrogatorics, and
admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any
material fact that the moving party is entitled to a judgment as a matter of law.” Fed. R. Civ. P. 56(c).
The moving party has the initial responsibility of demonstrating the absence of a genuine issue of
material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). Summary judgment is proper
when no “reasonable jury could return a verdict for the nonmoving party.” Anderson y, Liberty
Lobby, Inc., 477 U.S, 242, 248 (1986). Because the determination is a question of fact, summary

judgment of infringement is proper ifa reasonable jury could find that every limitation of the claims



rejects Fournier’s argument that /‘esto represents an intervening change in the law.

Finally, Fournier, relying on Blonder-Tongue Labs, 402 U.S. at 333, argues that the
Novopharm court’s decision cannot serve as a basis for collateral estoppel because the Novophurm
court misunderstood the pharmaceutical technology and issues in the ’726 patent.’ Since Blonder-
Tongue, the Federal Circuit has made clear that, in a collateral estoppel analysis, a district court
should not determine whether the prior finding was correct. Stevenson v. Sears, Robuck Co., 713
F.2d 705, 709 (Fed. Cir. 1983). Rather, the court should focus on whether the patentee had a full
and fair chance to litigate the issue in the prior lawsuit. /d. Here, Fournier had such an opportunity.

The court notes that even if it were not bound to follow Judge Darrah’s ruling, it would
nonetheless similarly construe the claims. First, the court would look to the ordinary meaning of
“co-micronized” to find that it means “to reduce to a fine powder [micronize] with or together.”
Dorland’s Illustrated Medical Dictionary 368, 389 (29th ed, 2000). Next, as Judge Darrah did, the
court looks to the claim language, specification, and prosecution history and concludes that a “co-
micronized” mixture includes fenofibrate and a solid surfactant that have been micronized together
in the absence of any other cxcipicnts. Nowhere in the claims, specification, or prosecution history
are any other materials identified as being part of this mixture. Further, in the specification and
prosecution history, the patentee distinguished its co-micronized mixture from mixtures obtained
by adding a surfactant to fenofibrate, or micronizing fenofibrate by itself, and/or mixing separatcly

micronized fenofibrate and a surfactant. Like Judge Darrah, this court concludes that “co-

“The court further rejects the argument that it should disregard the Novopharm decision
merely because it is on appeal to the Federal Circuit. Pending post-trial motions do not effect the
finality of a judgment and, therefore, do not prevent its preclusive effect. Pharmacia, 170 F.3d at
1381.



Collateral Estoppel

Impax argues that the doctrine of‘collateral estoppel, also known as issue preclusion, prevents
Fourier from arguing that this court should interpret the pertinent claims differently than did the
Novopharm court. Collateral estoppel “shields a defendant from having to litigate issues that have
been fully and fairly tried in a previous action and decided adversely to a party.” Pharmacia &
Upjohn Co. v. Mylan Pharm., Ine. 170 F.3d 1373, 1379 (Fed. Cir. 1999), Collateral estoppel is
appropriate ift (1) the issues raised in both proceedings are identical; (2) the issucs were actually
litigated; (3) the dctcrmination of the issue was essential to a final judgment in the first action; and
(4) the party against whom estoppcl is invoked had a full and fair opportunity to litigate the issues
in the first action. Adair v. Sherman, 230 F.3d 890, 893 (7th Cir. 2000); Abbott Labs. v. Dey, L.P.,
110 F. Supp. 2d 667, 669 (N.D. Ill. 2000); see also Blonder-Tongue Lab., Inc, v, Univer. of Il.
Found., 402 U.S. 313 (1971) (recognizing the use of collateral estoppel in a patent infringement
case). Collateral cstoppel is not exclusive to patent law and therefore the law of the circuit in which
the district court sits applies, in this case Seventh Circuit law. Pharmacia, 170 F.3d at 1381 n.4,

It is undisputed that all four of the conditions for applying collateral estoppel to the claim
constructions are present here. First, the construction of claims 1 and 10 of the ’726 patent are the
identical issues presented in the Novopharm case. Both parties agree that Judge Darrah construed
the same claim language terms “co-micronized” and “co-micronization” that are in dispute in this
case. Second, the construction of the disputed terms was actually litigated in Novopharm. Fournier
and Novopharm bricfed and argued the claim construction issues before Judge Darrah. Third, Judge

Darrah could not have granted Novopharm summary judgment without first construing the claims

at issue, and then comparing them to Novopharm’s fenofibrate products, and, therefore, the claim



in question would be met by the products that Impax is likely to sell. Bai v. L & L Wings, Inc., 160
F.3d 1350, 1353 (Fed. Cir. 1998),
Summary Judgment of Non-Infringement in Patent Cases

An infringement analysis is a two-step process. The first step is determining the meaning
and scope of the patent claims allegedly infringed, also known as claim construction. Mahurkar v,
Arrow Int'l, Inc., 160 F. Supp. 2d 927, 932 (N.D. Ill. 2001) (citing Markman v. Westview
Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995)), Courts must construe the claims as a matter
of law before turning to the second step, the factual application of those claims to the accused
products. /d. Summary judgment is appropriate where it is shown that the question of infringement
can be reasonably decided only in favor of (he movant, keeping in mind that the burden of proving
infringement rests with the patentee. Bai, 160 F.3d at 1353-54.

In order to interpret a disputed term or phrase, the court first looks to the language of the
patent itsclf, including the claims, the specification, and the prosccution history, as the primary
source for construing patent claims. Mahurkar, 160 F. Supp. 2d at 932. The language of the claim
defines the scope and meaning of that claim. York Products, Inc. v. Central Tractor Farm & Family
Cor, 99 F.3d 1568, 1572 (Fed. Cir. 1996). The language of the claims is to be given its ordinary and
accustomed meaning. Johnson Worldwide Assoc., Inc. v. Zebco Corp., 175 F.3d 985, 989 (Fed. Cir.
1999). The court may also review extrinsic evidence, such as treatises and expert testimony, so long

as that evidence does not vary or contradict the clear meaning of terms in the claims. Altiris, Inc. v.

Symantec Corp., 318 F.3d 1363, 1369 (Fed. Cir, 2003).



The doctrine of equivalents allows a patentee to claim insubstantial alterations in the patented
process that were not captured in drafting the original patent claims, but which could be crcated
through trivial changes. Festo, 122 S. Ct. at 1838. However, prosecution-history estoppel can
prevent a patentee from relying on the doctrine of equivalents when the patentce relinquishes subject
matter during the prosecution of the patent, either by amendment or argument. Pharmacia, 170 F 3d
at 1376-77. Where the original application once embraced a purported equivalent, but the patentee
narrowed the claims to obtain the patent or protect its validity, the patentec cannot later assert those
surrendered equivalents. Festo, 122 8. Ct. at 1839 (describing estoppel by amendment). Ina similar
way, “[a[rguments made voluntarily during prosecution may give rise to prosecution history estoppel
if they evidence a surrender of subject matter.” Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki
Co., Ltd., 234 F.3d 558, 569 (Fed. Cir. 2000), rev'd on other grounds, 122 §. Ct. 1831 (2002)
(describing estoppel by argument). Addressing only estoppel by amendment, the recent Festo
decision did not address (or change) the law regarding argument-bused estoppel. Instead, the esto
court addressed the “absolute bar” precluding application of the doctrine of equivalents as to certain
types of amended claims. Festo, 122 S. Ct. at 1840. Because Judge Darrah’s decision did not rely
upon amendments to claims during prosecution history, Novepharm, 2002 U.S. Dist. LEXIS 4659,
at *24-25 (basing estoppel on the “the arguments made during the prosecution of the patent... and
the arguments made during reexamination”), but rather on arguments made by Fournier during

prosecution of the patent, Festo did not change the law controlling this case.’ Accordingly, the court

3 While the court recognizes that the Novopharm court mentions an amendment to claim
1, the court concludes that the stated bases for Judge Darrah’s application of prosecution-history
estoppel were the arguments made by the patentee during prosecution history. Novepharm, 2002
US. Dist. LEXIS 4659, at *23-24.



Minute Order Form (06/97)

United States District Court, Northern District of Illinois

Name of Assigned Judge Joan B. Gottschall Sitting Judge if Other
or Magistrate Judge . than Assigned Judge

CASE NUMBER 00 C 5 C 7865 DATE 3/26/2003
01 C 1648

CASE Abbott Laboratories, et al. vs. Impax Laboratories, Inc,
TITLE

{In the following hox (a) indicate the party filing the mulion, ¢.g., plaintiff, defendant, 3rd party plaintiff, and (h) state briefly the nature

of the mation being presented. ]

qi)

MOTION:

DOCKET ENTRY:

(1) QO Filed motion of [ usc listing in “Motion” box above.]

(2) Oo Brief in support of motion due

QB) Oo Answer brief to motion duc____.. Reply to answer brief duc__

a Oo Ruling/Hearingon set for__— at,

(5) i) Status hearing|held/continued to] [set for/re-set for]on set for__at 7

(6) a Pretrial conference(held/continued to} [set for/re-set for]on__-setfor__—at_

(7) a] Triul[set for/re-set forlon__ at

(8) oO [Bench/Jury trial] [Hearing] held/continued to___ at

(9) i) This case is dismissed [with/without] prejudice and without costs[by/agreement/pursuant to)
CFRCP4(m) OClLocal Rule 41.1 OFRCP4t(a(1) OO KRCP41(a)(2).

(0) [Other docket entry) ENTER MEMORANDUM OPINION AND ORDER: Defendant’s Motion

for Partial Surmary Judgment of Non-Infringement [71-1 for 00 C 5092, 0-1 for 00 C 7865, 0-1 for 01

C 1648] is granted.

= [For further detail see order attachcd to the original minute order. }

No notices required, advised in open court

No notices required,

Notices mailed by judge's staff.

Notified counsel by telephone.

VA] Rosketing to mail notices.
Mail AO 450 form Lyno3 yopescia “of
Copy to judge/magistrate judge. ite) “)
courtroom apse Ua Leh

deputy's ”
initials . = 4
Baigitirnezedsived (n

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independent infringement defendants. . .[,]” but that clearly refers to an attempt by a plaintiff to have
a favorable construction applicd to a different defendant in a new case. /d. at 391. That simply is
not the issue here.

In light of the lack of authority for the proposition that this court may apply collateral
estoppel and make adjustments to the prior construction, the court will not aller Judge Darrah’s
construction in any way. The purpose of collateral estoppel — relieving parties of the cost of multiple
lawsuits, conserving judicial resources and preventing inconsistent decisions — would not be
furthered by allowing a party to assert estoppel and argue that certain changes should be made to the
prior court’s holding.

Infringement

Having determined that Judge Darrah’s construction of the disputed claims will be applicd
in this matter, the court must now determine whether Impax has infringed the patentee’s rights,
Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1581-82 (Fed, Cir. 1996). An infringement
analysis requires a comparison of the properly-construed claims to the accused device to determine
whether that device has all of the limitations, either literally or under the doctrine of equivalents, as
the claimed invention. Zebco, 175 F.3d at 988. Determination of infringement is a question of fact.
Bai, 160 F.3d at 1353. In order to prove infringement, the burden is on the patentee to show that
each and every limitation of the claims asserted to be infringed is found in the accused device.
Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1565 (Fed. Cir. 1997).

According to the construction of the disputcd claims, fenofibrate and a solid surfactant must
be co-micronized in the absence of other excipients. Impax’s ANDA describes a process whereby

a pre-micronized fenofibrate is added to other excipients, and then a liquid surfactant is added to the

11



micronized” and “co-micronization” means that fenofibrate and a solid surfactant have been
micronized together in the absence of other excipients.

In addition to arguing that this court should adopt Judge Darrah’s construction of claims,
Impax argues that this court should further “augment” those constructions. (Impax Mem. at 10.)
Impax asserts that its proposed additions to the claim construction of the disputed terms are not
inconsistent with Judge Darrah’s determinations, and are only meant to clarify, not contradict, the
prior court’s claim construction. Furthermore, Impax relies on its additional claim constructions as
separate and distinct grounds upon which this court may grant summary judgment of non-
infringement.

In response, Fournier argucs that Impax proposes novel claim constructions that arc
inconsistent with Judge Darrah’s construction, Reasoning that collateral cstoppel is designed to
“relieve parties of the cost and vexation of multiple lawsuits, conserve judicial resources, and, by
presenting inconsistent decisions, encourage reliance on adjudication[,]” Allen v. McCurry, 449 US.
90,94 (1980), Fournier argues that the public policy considerations behind collateral estoppel would
not be met if Impax’s additions and clarifications were considered.

The only case cited by Impax for the proposition that this court may both apply collateral
estoppel and change Judge Darrah’s construction, is Markman v. Westview Instruments, Inc., 547
U.S. 370, 391 (1996). Impax cites that casc for the proposition that “collateral estoppel does not bar
adifferent defendant from asserting any claim construction he wishes.” (Impax Reply at 7 (emphasis
inoriginal).) The court has reviewed that case (which concems a patent relating to the dry cleaning
business) and can find nothing in the case to support Impax’s position. The Marlonan court does,

in the penultimate paragraph, state that “issue preclusion could not be asserted against new and

10



construction issues were “esscntial” to support the final judgment rendered. Jackson Jordan, Ine.
v. Plasser American Corp., 747 F.2d 1567, 1577 (Fed. Cir. 1984). Finally, Fournier had a full and
fair opportunity to litigate the issues in the Novopharm action, As a result, the court concludes that
the doctrine of collateral estoppel applies in this case.

Instead of refuting Impax’s argument that the four conditions are met, Fournier argues that
a district court is not bound by another court’s claim construction. This argument ignores authority
stating that collateral estoppel may be applied in the claim construction context. Abbott Labs., 110
F, Supp. 2d at 669-71; Blonder-Tongue Lab, 402 U.S. at 349-50, Fournier cites to two footnotes in
two related cases to support ils argument that collateral estoppel should not be applied in this case.
In Nilssen v. Motorola, Inc., 80 F. Supp. 2d 921, 924 n.4 (N_D. Ill. 2000), the patentee attempted to
enforce a claim construction from a prior litigation against defendants who were not parties to the
prior case. That case is clearly distinguishable from the present case where Impax, the defendant,
has argued for estoppel. The second case relied upon by Fournier, Nilssen v. Magnetek, Inc., 2000
WL 369747, *1 .3 (N.D. Ill. 2000), is also readily distinguishable as there was no final order issued
after the court construed the claims and, therefore, there was no determination of issues “essential
to a final judgment,”

Fournier also argues that the court should not apply the doctrine of collateral estoppel
because an intervening change in the law, pertinent to the issues in this case, has occurred since the
Novopharm decision. Specifically, Fournier contends that the Supreme Court’s decision in Festo
Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 122 S. Ct. 1831 (2002), changed the law
regarding prosecution-history estoppel’s limitation on the doctrine of equivalents. The court

disagrecs that Festo represents an intervening change in the law that is applicable here.



The three lawsuits were later consolidated as they all relate to the same issues.
The present dispute centers on the proper interpretation of the terms “co-micronized” and
“co-micronizalion” as used in claims 1 and 10 of the ’726 patent, Claim 1 states:
A therapeutic composition, which is presented in the form of gelatin capsules and
which is useful especially in the oral treatment of hyperlipidemia and
hypercholesterolemia, said composition containing a co-micronized mixture of
particles of fenofibrate and a solid surfactant, wherein the mean particle size of said
co-micronized mixture is less than 15 wm.
(’726 patent, col. 5, ll. 6-12 (emphasis added).) Claim 10 states:
A method for improving the bioavailability to fenofibrate in vivo, which comprises
co-micronization of the fenofibrate and a solid surfactant, the said co-micronization
being carried out by micronization of a fenofibrate/solid surfactant mixture until the
particle size of the powder obtained is less than 15 pm.
(d., col. 6, ll, 20-25 (emphasis added).) Fournier argues that Impax’s product, which utilizes pre-
micronized fenofibrate, infringes the °726 patent. Specifically, Fournier argues that Impax’s product
contains a mixture of fenofibrate and a solid surfactant that have been co-micronized, or reduced in
size together. (Fournier Resp. at 2.) Although acknowledging that Impax’s product starts with
already micronized (i.¢., pre-micronized) fenofibrate, Fournier argues that the fenofibrate in Impax’s
product is further micronized (i.¢., co-micronized) with a surfactant during certain steps of the
manufacturing process. (/d. at 5.)
The Novopharm Action
Based on the same claims at issue in this lawsuit, Fournier brought suit against Novopharm,

a generic drug manufacturcr, for infringement of the °726 patent. On March 20, 2002, Judge John

W. Darrah granted Novopharm’s motion for summary judgment of non-infringement of the ’726

patent. Abbott Labs. v. Novopharm Ltd., Consolidated Nos. 00 C 2141, 00 C 5094 and 01 C 1914,



Conclusion
Based on the findings above relating to claims 1 and 10, Impax’s product does not infringe
the ’726 patent. Further, claims 2-7 and 11-12 depend from claim 1. In light of the court’s findings
as to claims 1 and 10, there likewise may be no finding of infringement for the dependent claims.
Wahpeton Canvas Co., Inc. v. Frontier, Inc., 870 F.2d 1546, 1553 (Fed. Cir. 1989) (“It is axiomatic
that dependent claims cannot be found infringed unless the claims from which they depend have
been found to have been infringed.”). For the foregoing reasons, defendant Impax’s motion for

partial summary judgment of non-infringement is granted.

ENTER:

* YhitedStates District Judge

DATED: — March 26,2003 ¥



the bioavailability i vivo.” According to the patent, the invention proposed a novel therapeutic
composition, containing fenofibrate and a solid surfactant that have been co-micronized, which is
used in the oral treatment of hyperlipidemia and hypercholesterolemia. (’726 patent, col. 1, I. 4-10.)
The medication is marketed by Abbott under the name TRICOR®@ in 67 mg, 134 mg, and 200 mg
dosage strengths. According to Fournier, the novelty of the invention derives from the fact that a
co-micronized mixture of fenofibrate and a solid surfactant have better dissolution characteristics,
and therefore better bioavailability, than separately micronized (or non-micronized) {cnofibrate and
surfactant which are mixed, but not micronized, together.

Defendant lnpax is a manufacturer of generic drug products. Pursuant to the Hatch-Waxman
Act, Impax filed an Abbreviated New Drug Application (“ANDA”), 21 U.S.C. § 355(), seeking the
Food and Drug Administration’s approval to market a generic micronized fenofibrate product in
three dosage forms: 67mg, 134 mg, and 200mg. Impax’s ANDA discloses that: (1) Impax uses pre-
micronized fenofibrate in its products; and (2) at no time docs Impax co-micronize fenofibrate and
a solid surfactant in the absence of other excipients, (Impax 56.1(a)(3) St. at |] 52-59.) As part of
the ANDA, Impax submitted a “Paragraph (1V)” certification referring to the 726 patent, stating
“that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug
for which the application is submitted.”? 21 U.S.C. §§ 355(j)(2)(A)(vii)(IV). After receiving the
required notices from Impax, Fournier filed three complaints - one for each of Impax’s three

proposed dosage forms - cach asserting that Impax’s fenofibrate product infringed the '726 patent.

* Paragraph (TV) certification required Impax to give notice of the certification to the
patentee. 21 U.S.C. § 355(j)(2)(B)(I). A Paragraph (IV) certification is often an invitation to a
patent infringement suit. Bayer AG y, Elan Pharmaceutical Research Corp., 212 F.3d 1241,
1244-45 (Fed. Cir. 2000),



IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS

EASTERN DIVISION
ABBOTT LABORATORIES, )
FOURNIER INDUSTRIE ET SANTE, ) DOCKETED
LABORATOIRES FOURNIER S.A. ) MAR 2 7 2003
) 00 C 5092
Plaintiffs, ) 00 C 7865
) 01 C 1648
v. )
) Judge Joan B. Gottschall
IMPAX LABORATORIES, INC. )
)
Defendant. )

MEMORANDUM OPINION AND ORDER

Plaintiffs Abbott Laboratories (“Abbott”), Fournier Industrie Et Sante, and Laboratoires
Fourier S.A. (all three plaintiffs collectively “Fournier”) have brought this patent infringement
action against Impax Laboratorics, Inc. (“Impax”) alleging that Impax has infringed Fournier’s
United States Patent No. 4,895,726 (the '726 patent”), Before the court is defendant Impax’s motion
for partial summary judgment of non-infringement. For the reasons explained below, Impax’s
motion is granted.

Background
Plaintiffs are the owners and a licensee of the '726 patent. The 726 patent is directed to “a

novel dosage form of fenofibrate containing fenofibrate and a solid surfactant' which have been co-

micronized” and “to the method for the preparation of this dosage form and its use for improving

‘ “Surfactant” is an agent that interacts with the surfaces of poorly soluble substances,
such as fenofibrate, to help them dissolve. (Fournier Resp. at 3-4.)

1

as



dry mixture causing wet granulation. (Lmpax Mem. at 13.) Impax does not have a manufacturing
step where there is a mixture of particles consisting solely of fenofibrate and a solid surfactant.
Because Impax’s products do not contain a “co-micronized mixture of particles of fenofibrate and
a solid surfactant,” as recited in claim 1, or a manufacturing process that uses “co-micronization of
the fenofibrate and a solid surfactant,” as recited in claim 10, the court finds as a matter of law that
there is no literal infringement of the ’726 patent.

In addition to literal infringement, a party may infringe another’s patent under the doctrine
of equivalents. As explained above, the doctrine of equivalents allows a patentee to claim
insubstantial alterations that were not captured in drafting the original patent claims, but which could
be created through trivial changes, Festo, 122. Ct, at 1838, However, prosecution-history estoppel
can prevent a patentee from relying on the doctrine of equivalents when the patentee relinquishes
subject matter during the prosecution of the patent, either by amendment or argument. Pharmacia,
170 F.3d at 1376-77. In some cases, such as the one here, the Patent Trademark Office (“PTO”) may
reject one or more of the patentee’s proposed claims. Jd. In response, the patentee may narrow his
claims -- a decision which prevents him from later arguing that the subject matter covered by the
original, broader claim was nothing more than an equivalent (i.¢., prosecution-history estoppel). Jd.
Ina similar way, prosccution-history cstoppel may also be based on arguments made by the patentee
before the PTO.

Impax argues that this court is bound under collateral estoppel principles to follow the
Novopharm court’s decision that the doctrine of prosecution-history estoppel precludes Fournier's
claim of infringement under the doctrine of cquivalents. As with the claim construction

determination, all four considerations for applying collateral estoppel are met with respect to Judge

12