# Petition for Writ of Certiorari — Forest Laboratories, Inc. v. Abbott Laboratories

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Petition for Writ of Certiorari
- **Published:** January 1, 2004
- **Citation:** 540 U.S. 1109

## Text

Supreme Court, U.S.
FILED

0
No. 03 > B94 NW 5 2003

> TYE FRY

IN THE

Supreme Court of the United States

FOREST LABORATORIES, INC. and ONY INC.,
Petitioners,

v.
ABBOTT LABORATORIES,

Respondent.

ON PETITION FOR A WRIT OF CERTIORARI TO THE
UNITED STATES COURT OF APPEALS
FOR THE FEDERAL CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

HERBERT F. SCHWARTZ
Counsel of Record

KENNETH B. HERMAN

FisH & NEAVE
1251 Avenue of the Americas
New York, New York 10020
(212) 596-9000

Attorneys for Petitioners

183652 ce

COUNSEL PRESS
(800) 274-3321 * (800) 359-6859

1
QUESTIONS PRESENTED

This petition is one of two submitted within one week
in different cases seeking review of the Federal Circuit’s
“bright-line” rule limiting the district courts’ discretion to
award reasonable attorney fees as a result of misconduct by
a party in a patent case. The questions presented here are:

1. Did the Court of Appeals for the Federal Circuit err
in establishing a “bright-line” rule defining only certain
conduct as “exceptional” under 35 U.S.C. § 285 and thereby
limiting the discretion of federal district courts to prevent
gross injustice by awarding attorney fees to a prevailing party
because of pre-litigation misconduct?

2. Did the Court of Appeals for the Federal Circuit err
in holding that clear and convincing evidence of pre-litigation
misconduct that gave rise to a finding of equitable estoppel
cannot, as a matter of law, make a patent case “exceptional”?

=~

ll

CORPORATE DISCLOSURE STATEMENT

Petitioners Forest Laboratories, Inc. and ONY Inc. have
no parent companies. There are no publicly-held companies
that own ten percent or more of the stock of the petitioners.

11

TABLE OF CONTENTS

Questions Presented ............-- eee eeeeeee

Corporate Disclosure Statement ..........-----.

Oe STE eee eee ee ee ee

Table of Cited Authorities ..............ceceee.

Table of Appendices .........--. eee cece renee

Opinions Below .......:..---seee seer eee eeeee

Deeieemeel GO SOTISGICHION 2... 2... eee eee sees

Statutory Provision Involved ..........-.+++++

EEE SN EEE ee ee

Reasons for Granting the Petition .............--

Conclusion

se ae oe ee eo ee ee Se Se ee eS SAS eS Pe Pe

Page

1V

vi

10

20

TABLE OF CITED AUTHORITIES

Page
CASES J

Aromatique, Inc. v. Gold Seal, Inc.,

po OE ge ee ere 17, 18

- Brasseler, U.S.A. I, L.P. v: Stryker Sales Corp.,

267 F.36 1370 (Fed. Cw. 2001). wn. ccc ceees 15
Brennan v. Hawley Prods. Co.,

98 F. Supp. 369 (N.D. Tl. 1951) ............. 13,14
Cambridge Prods., Ltd. v. Penn Nutrients, Inc.,

962 F.2d 1048 (Fed. Cir. 1992)... 66.0 escccs 15, 16
Festo Corp. v. Shoketsu Kinzoku Kogyo

Kabushiki Co.,

ee Sie FR ERED es che oot e este xsesceees 10, 11
Fogerty v. Fantasy, Inc., ;

es AEF CPOE 6h eV eRe eee e eee 17
Hoffmann-La Roche Inc. v. Invamed Inc.,

213 £.36 1599 (POG. Cit, ZO0U) wn i viccss 15
L.A. Gear, Inc. v. Thom McAn Shoe Co.,

966 F.20 1117 (red. Cir. 19935)... «606 se cee es 13
McNeil-PPC, Inc. v. L. Perrigo Co.,

337 F.30 1362 (Fed. Cir. 20035)... 6. es ene 3, 4, 10

Cited Authorities

Page
Rohm & Haas Co. v. Crystal Chem. Co.,
736 F.2d 668 (ed Cir. 1964) ...... 260 cceveess 13
Yarway Corp. v. Eur-Control USA, Inc.,
TTS 8.26 268 Ded. Cie. TIES) jcc cctcccionss 15, 16

STATUTES AND LEGISLATIVE MATERIALS

15 U.S.C. § 1117(a) (Supp. 2003) .............. 6,17
yy, BUR See Be. |) eeeeererrrr errr re ry 2
(Eis tom Bo). Seererrr reese errr 3, ha
35 USL... 6 TORT) ics veveki enters tates 12
35 USL. © 259 CIOS) os vas vine veces eeeeses 6, 12
33 U.S.C. § TES GOGE) sce era eeee re cnvscyees passim

35 U.S.C. § 285, Revision Note, reprinted in 1952
PE CE AM Pe ee 656s cae eda eee 6, 12

Patent Rights — Protection, S. Rep. No. 79-1503
(June 14, 1946), reprinted in 1946 U.S.C.C.A.N.
Pk Ss sppeereretetretr rte. ce 5, 11-12

Patent Rights — Protection, ch. 726, Pub. L. No.
79-587 (Aug. 1, 1946), reprinted in 1946
ts fat oS Sere er ye 5, 12

VI

TABLE OFAPPENDICES

Appendix A — Opinion Of The United States Court
Of Appeals For The Federal Circuit Filed August
i ee re yee ee ee ee ar?

Appendix B — Decision And Order Of The United
States District Court For The Western District Of
New York Filed September 30, 2002 ..........

Appendix C — Decision And Order Of The United
States District Court For The Western District Of
New York Filed September 4, 2001 ...........

Appendix D — Opinion Of The United States
District Court For The Western District Of New
York Decided June 23, 1999 ................

Page

la

l3a

15a

]

No. 03-

IN THE

Supreme Court of the United States

FOREST LABORATORIES, INC. and ONY INC.,

Petitioners,

V.

ABBOTT LABORATORIES,

Respondent.

On PETITION FOR A WRIT OF CERTIORARI TO THE
UNitTED STATES CouRT OF APPEALS
FOR THE FEDERAL CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

Petitioners Forest Laboratories, Inc. and ONY Inc.
respectfully petition for a writ of certiorari to review the
judgment of the United States Court of Appeals for the
Federal Circuit in this case. ~

2

OPINIONS BELOW

The opinion of the court of appeals (Pet. App. 1a-12a)
is reported at 339 F.3d 1324. The opinions of the United
States District Court for the Western District of New York
(Pet. App. 13a-31a and 32a-90a) are unreported.

STATEMENT OF JURISDICTION

The judgment of the court of appeals was entered on
August 7, 2003. The jurisdiction of this Court is invoked
under 28 U.S.C. § 1254(1).

STATUTORY PROVISION INVOLVED

This case presents an issue of how Section 285 of Title
35 of the United States Code is interpreted. Section 285
provides that: —

The court in exceptional cases may award
reasonable attorney fees to the prevailing party.

STATEMENT OF THE CASE

The court of appeals’ decision eviscerates the intent of
35 U.S.C. § 285 to compensate the wronged party. After a
four-month trial, the district court awarded attorney fees to
petitioners Forest Laboratories, Inc. (“Forest”) and ONY Inc.
(“ONY”), under § 285. The district court found by clear and
convincing evidence that respondent Abbott Laboratories
(“Abbott”) had engaged in bad-faith conduct by repeatedly
encouraging Forest and ONY over an eleven-year period to
pursue the development of Infasurf® — a surfactant
replacement drug used to treat the lungs of premature

oi aaa

3

babies. Abbott did so because it “was betting on two horses.”
Pet. App. 22a. Before its own drug — Survanta® — received
regulatory approval, Abbott was encouraging ONY to proceed
with the development of Infasurf® so that it could rely on
Infasurf® as its backup drug in the event that Survanta®
failed to obtain approval. But once Survanta® was approved
by the FDA, Abbott did an about-face and charged ONY and
Forest with infringement, prompting the suit that ultimately
led to the attorney fees award.

The district court found that petitioners did not infringe
and that Abbott was barred by equitable estoppel from
asserting its patents against petitioners. After finding clear
and convincing evidence that Abbott had acted in bad faith,
the district court awarded Forest and ONY fees and expenses
to avoid a “gross injustice” and to deter other companies
from similar conduct in the future.

The court of appeals reversed. Announcing a new
“bright-line” rule, it held that “exceptional cases” are only
those involving misconduct during litigation, inequitable
conduct before the patent office, willful infringement, or
a frivolous suit. It concluded that all other types of pre-
litigation misconduct, such as Abbott’s bad-faith conduct,
which led to a finding of equitable estoppel, cannot, as a
matter of law, be deemed “exceptional.” '

1. In McNeil-PPC, Inc. v. L. Perrigo Co., 337 F.3d 1362 (Fed. Cir.
2003), also a case involving pharmaceuticals, decided six days before
the ruling in this case, the Federal Circuit also reversed a district court’s
award of attorney fees to a prevailing alleged patent infringer for failure
to satisfy its new bright-line test. The Eastern District of Pennsylvania
did not find that McNeil had committed inequitable conduct before the
Patent Office, but awarded attorney fees to Perrigo based on a finding,

(Cont'd)

COASTER 7 ET IT ITE EES

4

The court of appeals’ decision is contrary to the statutory
intent of 35 U.S.C. § 285 and to the treatment by another circuit
court of appeals of the analogous statute in trademark.

The court of appeals justified its treatment of Abbott’s
pre-litigation conduct on the grounds that “the consequence
of estoppel is loss of the cause of action.” Pet. App. 9a. This,
however, does nothing to compensate petitioners for the
substantial fees they incurred and for the time their product was
delayed because of Abbott’s misconduct. The court of appeals’
rationale simply undermines the purpose of § 285, which is to
prevent gross injustice to the harmed party. The award of fees
contemplated by § 285 is not a mere technicality, but rather a
part of a legislative provision that regulates the course of conduct
that ultimately becomes the subject of litigation.

A. Statutory Framework. The question in this case is
straightforward: may the court of appeals create a rigid definition
of “exceptional case” that limits the circumstances under which
the district court may exercise its discretion to award attorney
fees? Section 285 of the Patent Act is the statutory provision
addressed to attorney fees. It provides, in its entirety, that “[t]he
court in exceptional cases may award reasonable attorney fees
to the prevailing party.” 35 U.S.C. § 285 (2001).

(Cont'd)

which the court of appeals found was “not clearly erroneous,” that ~
McNeil prosecuted the pertinent patent applications with “‘studied and
deceptive ignorance.’” Jd. at 1371. The court of appeals, however, held
that because McNceil’s misconduct did not rise to the level of “clear arid
convincing evidence of inequitable conduct [before the PTO] or
misconduct during litigation,” it could not result in an award of attorney
fees because it was not one of its identified bright-line “‘exceptional’”
circumstances. Jd. at 1372. Perrigo has recently filed a petition for a
writ of certiorari also seeking this Court’s review of the court of appeals’
new bright-line rule.

5

Section 285 was enacted to prevent a gross injustice to a
prevailing accused infringer and was not limited simply to
compensate a prevailing patentee. Patent Rights — Protection,
S. Rep. No. 79-1503 (June 14, 1946), reprinted in 1946
U.S.C.C.A.N. 1386-87. Prior to 1946, attorney fees were not

recover only profits and damages. Patent Rights — Protection,
S. Rep. No. 79-1503 (June 14, 1946), reprinted in 1946
U.S.C.C.A.N. 1387.

In 1946, an amendment to the damages section of the patent

the Senate Committee on Patents states that “the provision
relating to attorney’s fees is made discretionary with the court.”
Patent Rights — Protection, S. Rep. No. 79-1503 (June 14, 1946),
reprinted in 1946 U.S.C.C.A.N. 1387. The Committee added
that

the discretion given the court in this respect . . . will
discourage infringement of a patent by anyone
thinking that al! he would be required to pay if he
loses the suit would be a royalty. The provision is
also made general so as to enable the court to
prevent a gross injustice to an alleged infringer.

Id. (emphasis added).

6

The 1952 Patent Act placed the attorney fees provision in
35 U.S.C. § 285 and amended it to its current form.
35 U.S.C. § 285 (1954). It did not substantively change the
provision. 35 U.S.C. § 285, Revision Note, reprinted in 1952
U.S.C.C.A.N. 2403, 2423. The Revised Note states that
§ 285 “is substantially the same as the corresponding provision
in R.S. 4921 [the 1946 version]; ‘in exceptional cases’ has been
added as expressing the intention of the present statute as shown
by its legislative history and as interpreted by the courts.” /d.

Like the patent statute, the Lanham Act provides that
“(t]he court in exceptional cases may award reasonable attorney
fees to the prevailing party” in a trademark action. 15 U.S.C.
§ 1117(a) (Supp. 2003).

B. This Litigation. Petitioner ONY developed Infasurf®,
the first lung surfactant replacement therapy used in the United
States for treating respiratory distress syndrome in premature
babies. Infasurf® utilizes as its active ingredient calf lung
surfactant extract (“CLSE”’). Beginning in 1983, ONY discussed
CLSE with respondent Abbott. Between 1983 and 1991, Abbott
actively encouraged petitioner ONY to pursue the development
and clinical testing of CLSE and was fully aware that they
intended to commercialize it. Abbott also knew in June 1991
that ONY and Forest became partners to further develop and
market Infasurf®.

Abbott is the exclusive licensee of U.S. Patent Nos.
4,338,301 and 4,397,839 owned by Tokyo Tanabe Company
Ltd. (“the Tanabe patents”). Abbott did not raise the question of
possible infringement by CLSE of the Tanabe patents until it
wrote to Forest in June 1994 — eleven years after Abbott first
met with ONY to discuss CLSE. In fact, in 1984, Abbott
conducted a patentability search for Infasurf® and led Forest

7

and ONY to believe that Infasurf® was not covered by any
patents — including the Tokyo Tanabe patents. Abbott was
aware that ONY was then telling the world that Infasurf®
was not covered by patents and Abbott did not say anything
contrary.

Abbott did not raise its infringement allegations until a
decade later. At that time, ONY and Forest provided Abbott
with samples of Infasurf® and a memorandum detailing
why Infasurf® did not infringe. When Abbott continued
threatening litigation for more than one and one-half years,
Forest and ONY filed suit for a declaratory judgment in
March 1996. After more than three years of litigation, the
district court found that Infasurf® did not infringe the Tanabe
patents — on the same grounds set forth in the non-
infringement memorandum — and that Abbott was equitably
estopped from asserting those patents against ONY and
Forest. The court of appeals affirmed the judgment of no
infringement and, having done so, declined to reach the issue
of equitable estoppel.

Following the appeal, the district court granted ONY and
Forest’s motion for attorney fees, finding by clear and
convincing evidence that Abbott had acted in bad faith. Pet.
App. 13a-3la. It held that “Abbott misled ONY and Forest
into reasonably believing that Abbott did not intend to enforce
the Tokyo Tanabe patents against them” (Pet. App. 22a) and
that Abbott had pursued its allegations of infringement “with
a reckless disregard for the facts in an attempt to prevent
Infasurf® from reaching the market.” Pet. App. 25a.

In its separate opinion holding that Abbott was equitably
estopped, which it incorporated by reference into its opinion
awarding attorney fees, the district court concluded that

8

‘“Abbott’s failure to mention possible infringement before
1994 was sufficiently misleading to amount to bad faith.”
Pet. App. 68a. The district court highlighted numerous
specific examples of Abbott’s misleading conduct from
1983 to 1991, and catalogued that conduct as: “Initial
Encouragement and Patentability Search”; “Contacts
Between June 1984 and April 1986”; “April 1986 Meeting”;
and “Contacts Between 1987 and 1991.” Pet. App. 51a-59a.
The district court also described how “Abbott monitored
CLSE, ONY and Forest” for many years but did not allege
infringement. Pet. App. 59a.

The district court, in fact, characterized Abbott’s conduct
as “betting on two horses,” meaning it was seemingly
cooperating with petitioners while developing its own
surfactant product. Pet. App. 22a. Abbott did so to remain
free to finalize a collaboration with petitioners if its own
product — Survanta® — failed to obtain FDA approval.
Pet. App. 22a-23a.

Abbott never offered an adequate explanation for its
conduct. Pet. App. 23a. Abbott declined to call the three
Abbott employees from its witness list who would have been
in the best position to explain Abbott’s actions (if the actions
could have been explained). Pet. App. 23a. As the district
court observed, “once [ONY and Forest] put forth sufficient
evidence to establish an equitable estoppel defense ...
[i]t was up to Abbott to either rebut such evidence or run the
risk of an adverse verdict. Abbott chose the latter option.”
Pet. App. 23a.

The district court concluded that “Abbott’s bad faith
conduct makes this an ‘exceptional’ case for purposes of
§ 285, and that Abbott should be required to pay attorneys’

9

fees in order to prevent a gross injustice to ONY and Forest
and to deter Abbott and other patentees from similar conduct
in the future.” Pet. App. 27a.

On appeal, Abbott argued, among other things, “that its
private pre-litigation conduct was an inappropriate ground
‘on which to base a finding of exceptionality.” Pet. App. 6a.
Forest and ONY maintained that a finding of exceptionality
based on pre-litigation misconduct was within the discretion
of the district court, and that Abbott had presented no legal
support to the contrary. Pet. App. 7a.

The court of appeals reversed. The court of appeals
“agree[d] with Abbott that the district court erred in
awarding attorney fees to ONY and Forest.” Pet. App. 7a.
It “conclude[d] that the court erred finding this case to be
‘exceptional’ under 35 U.S.C. § 285.” Pet. App. 12a.
It reasoned that it had “repeatedly identified as ‘exceptional’
those cases involving ‘inequitable conduct before the [Patent
Office]; litigation misconduct; vexatious, unjustified, and
otherwise bad faith litigation; a frivolous suit or willful
infringement.’” Pet. App. 8a (citations omitted). It found that
the district court’s ruling of exceptionality “due to Abbott’s
bad-faith conduct which led to a holding of equitable
estoppel” amounted to an “expansive reading of § 285.” Id.

Asserting that it had never “upheld a finding of
exceptionality based on a patentee’s bad-faith business
conduct toward an accused infringer prior to litigation,” it
declined “to expand the scope of the statutory term
‘exceptional’ in that manner.” Pet. App. 9a. The court of
appeals ignored the fact that it was, indeed, that “business
conduct” that led directly to the lawsuit. It found that because

Abbott’s suit was not frivolous, it could not be “exceptional”

10

on the basis of bad faith, notwithstanding that “bad faith” and
“frivolous suit” are separate grounds for “exceptionality.” *

REASONS FOR GRANTING THE PETITION

This petition presents an important question of statutory
interpretation that relates to the district court’s ability in its
discretion to punish misconduct, prevent injustice, and to
make whole the party subjected to the bad-faith pre-litigation
conduct. The court of appeals’ new bright-line definition of
“exceptional case” limits the district courts’ exercise of
discretion provided in the broad terms of § 285 as explained
in the statutory history. That decision undermines the words
of the statute, the clear legislative history, and decades of
interpretation by the federal courts, all of which place the
determination of “exceptionality” in the discretion of the
district court on a case-by-case basis.

This Court has cautioned the court of appeals against
too strongly favoring the clarity of new “bright-line” rules
in nettlesome patent questions where Congressional intent
and long-standing controlling precedent command that
the question be left to the discretion of the district court. *

2. Similarly, in McNeil, 337 F.3d at 1372, the court of appeals
reversed an award of attorney fees based on the patentee’s pre-
litigation misconduct in procuring patents because “[w]e have not
previously held [a patentee] liable for attorney fees. . . in the absence
of clear and convincing evidence of inequitable conduct [before the
PTO] or misconduct during litigation. We decline Perrigo’s invitation
to do so on these facts.”

3. For example, in Festo Corp. v. Shoketsu Kinzoku Kogyo

Kabushiki Co., 535 U.S. 722, 730 (2002), the court of appeals
(Cont'd)

ll

11

The court of appeals’ decision also is inconsistent with the
decisions interpreting the attorney fee shifting provisions in
other areas of intellectual property, such as trademark, which
as this Court has explained, is closely related to the patent
attorney fee provision.

1. The statutory provision and its legislative history
provide district courts with discretion to determine if a patent
case is “exceptional” and thereby warrants an award of
attorney fees. Section 285 provides that “[t]he court in
exceptional cases may award reasonable attorney fees to the
prevailing party.” “Exceptional case” is not further defined
by Congress in the statute. Thus, the statute leaves the district
court to determine in its discretion “exceptionality” and the
subsequent awarding of attorney fees based on a case-by-
case analysis of the losing party’s misconduct.

The legislative history makes plain that “exceptionality”
is to be determined by the district court — the court that has
the opportunity to hear the evidence of the misconduct.
The 1946 Patent Act added a punitive fee compensation
provision to the patent law for the first time. Patent Rights —
Protection, S. Rep. No. 79-1503 (June 14, 1946), reprinted

(Cont'd)

concluded that the flexible-bar rule for determining when prosecution
history estoppel foreclosed a patentee’s claim of equivalents “should
be overruled because this case-by-case approach has proved
unworkable.” The court of appeals believed that its new complete-
bar rule “would promote certainty in the determination of
infringement cases.” /d. This Court reversed despite acknowledging
that the new “bright-line rule. . . would have provided more certainty
in determining when estoppel applies.” Jd. at 739. It held “that the
doctrine of equivalents and the rule of prosecution historyestoppel
are settled law” and, therefore, “[t]he responsibility for changing
them rests with Congress.” Jd.

———————————— l OOO

12

in 1946 U.S.C.C.A.N. 1386-87; compare Patent Rights —
Protection, ch. 726, Pub. L. No. 79-587 (Aug. 1, 1946),
reprinted in 1946 U.S.C.C.A.N. 744, with 35 U.S.C. § 70
(1929). Then 35 U.S.C. § 70 provided that “(t]he court may
in its discretion award reasonable attorney’s fees to the
prevailing party upon the entry of judgment on any patent
case.” Patent Rights — Protection, ch. 726, Pub. L. No. 79-
587 (Aug. 1, 1946), reprinted in 1946 U.S.C.C.A.N. 744;
35 U.S.C. § 70 (1951). When the attorney fee provision was
codified in its current form in the 1952 Act, the term
“in exceptional cases” was substituted for “in its discretion.”
35 U.S.C. § 285 (1954). The Revised Note states, however,
that § 285 “is substantially the same as the corresponding
provision in R.S. 4921 [the earlier 1946 provision]; ‘in
exceptional cases’ has been added as expressing the intention
of the present statute as shown by its legislative history and
as interpreted by the courts.” 35 U.S.C. § 285, Revision Note,
reprinted in 1952 U.S.C.C.A.N. 2403, 2423.

The 1946 Note of the Senate Committee on Patents
explains that “the provision relating to attorney’s fees is made
discretionary with the court.” Patent Rights — Protection,
S. Rep. No. 79-1503 (June 14, 1946), reprinted in 1946
U.S.C.C.A.N. 1387. The Committee explained that

the discretion given the court in this respect...
will discourage infringement of a patent by anyone
thinking that all he would be required to pay if he
loses the suit would be a royalty. The provision is
also made general so as to enable the court to
prevent a gross injustice to an alleged infringer.

Id. Thus, the substitution of “in exceptional cases” for
“in its discretion” in 1952 did not in any way limit the

a

13

discretion of the district court to determine “exceptionality”
on a case-by-case basis.

Moreover, since the compensatory and punitive attorney
fee provision entered the patent law in 1946, federal courts
have held that it is to be implemented at the discretion of the
trial court. In Rohm & Haas Co. v. Crystal Chem. Co., 736
F.2d 688, 691 (Fed Cir. 1984), the court of appeals explained
that “[s]ubsequent to the 1946 amendments, attorney fee
awards were granted by the courts, in their discretion,
primarily upon findings of extraordinary circumstances.”
Despite the fact that “the Patent Act of 1952, [which] codified
the attorney fee provision in 35 U.S.C. § 285,... omits
explicit reference to the court’s discretion . . . [c]ases decided
under § 285 have noted that ‘the substitution of the
phrase “in exceptional cases” has not done away with
the discretionary feature.’” Jd. (quoting Hoge Warren
Zimmermann Co. v. Nourse & Co., 293 F.2d 779, 783
(6" Cir. 1961)).?

At least one early case decided the specific question at
issue here, determining that it is within the discretion of a
district court to award attorney fees for pre-litigation
misconduct. In Brennan v. Hawley Prods. Co., 98 F. Supp.
369, 370(N.D. Ill. 1951), the court barred an action for patent
infringement because of laches and the defendant received
an allowance of attorney fees. The trial court’s laches decision

4. See also L.A. Gear, Inc. v. Thom McAn Shoe Co., 988 F.2d
1117, 1128 (Fed. Cir. 1993) (remanded for a determination of whether
to award attorney fees to patentee because “[t]he trial judge is in the
best position to weigh the factors ‘that may contribute to a fair
allocation of the burdens of litigation as between winner and loser,’
in view of the entirety of the litigation circumstances”) (citation
omitted).

———————
—————— Nnn>>n

14

was affirmed by the court of appeals and certiorari was denied
by this Court. /d. The defendant sought an allowance of fees
for legal services rendered on appeal. /d. The court granted
the requested attorney fees because “the record shows not
only a long delay on the part of the plaintiff in instituting
litigation on his claims of infringement, but also such a
change in the condition of the defendant that it would be
inequitable to allow plaintiff to enforce his claim for
infringement.” Jd. The court explained that making such an
award was “‘in its discretion’ ... where one party has been
guilty of some inequitable or unconscionable conduct.” Jd.
(citation omitted). That the bad-faith laches misconduct was

“pre-litigation” was of no consequence.

2. The court of appeals ignored that the statutory

provision and its legislative history afford the district courts

~ with discretion to determine “exceptionality.”’ The court of
appeals said nothing about the Congressional intent that

attorney fees be awarded at the discretion of the district court.

Instead, the court of appeals cited its own precedent for
the limiting proposition that “[w]e have repeatedly identified
as ‘exceptional’ those cases involving ‘inequitable conduct
before the [Patent Office]; litigation misconduct; vexatious,
unjustified, and otherwise bad faith litigation; a frivolous
suit or willful infringement.” Pet. App. 8a. Accordingly, it
concluded “that Abbott’s ‘equitable estoppel’ conduct was
not an appropriate basis for awarding attorney fees under
§ 285 and that the district court’s reliance on that ground
was legal error.” Pet. App. 9a.

The court of appeals did not even explain why awarding
attorney fees has often been deemed appropriate in other types
of pre-litigation conduct, such as inequitable conduct or
willful infringement.

————

15

None of the cases relied on by the court of appeals as
support for its new “bright-line” rule considered whether pre-
litigation misconduct may be a basis for awarding attorney
fees. In Cambridge Prods., Ltd. v. Penn Nutrients, Inc., 962
F.2d 1048, 1051 (Fed. Cir. 1992), the prevailing alleged
infringer was not entitled to attorney fees because its “bare
assertion in its initial brief of entitlement under § 285 is not
accompanied by any attempt at proving that this case is
exceptional.” In Hoffmann-La Roche Inc. v. Invamed Inc.,
213 F.3d 1359, 1365 (Fed. Cir. 2000), the court of appeals
affirmed the district court’s finding that the patentee “made
a reasonable pre-filing inquiry” and, therefore, had not
brought a frivolous suit. In Brasseler, U.S.A. I, L.P. v. Stryker
Sales Corp., 267 F.3d 1370 (Fed. Cir. 2001), the court of
appeals affirmed an award of attorney fees where the patentee
had engaged in inequitable conduct before the PTO.
In Yarway Corp. v. Eur-Control USA, Inc., 775 F.2d 268,
277 (Fed. Cir. 1985), the court of appeals reversed the district
court’s erroneous holding that alleged infringers had to pay
the patentee’s attorney fees because they “acted in bad faith
by attempting to invent around the patent which they had
licensed.” The court of appeals reiterated that “the incentive
to ‘design around’ patents is a positive result of the patent
system.” In other words, there was no misconduct at all.

Other decisions of the court of appeals make plain
that, until recently, there was no such “bright-line” rule.
In Cambridge Prods., 962 F.2d at 1050-51, and Brasseler,
267 F.3d at 1380 (emphasis added), it stated that “[iJn the
case of awards to prevailing accused infringers ...
‘exceptional cases’ are normally those of bad faith litigation
or those involving fraud or inequitable conduct by the
patentee in procuring the patent.” In Hoffmann-La Roche,
213 F.3d at 1365 (emphasis added; citation omitted), it stated

16

that “‘/a/mong the types of conduct which can form a basis
for finding a case exceptional are willful infringement,
inequitable conduct before the P.T.O., misconduct during
litigation, vexatious or unjustified litigation, and frivolous
suit.””

Moreover, unlike this case, the cases relied on by the
court of appeals frequently start their analysis with an
acknowledgement that “[t]he award of attorney fees under
§ 285 is within the discretion of the court.” Cambridge
Prods., 962 F.2d at 1050; Yarway Corp., 775 F.2d at 277
(Section 285 “provide[s] the authority for the district court
to act under its discretion” as long as “the exercise of
discretion not be in conflict with the policies of the Patent
Act”).

3. The court of appeals reformulated the district court's
discretion to award attorney fees by instituting its new
“bright-line” rule as the “proper legal standard under
§ 285” and reviewing de novo the district court's application
of it. The court of appeals’ decision interferes with the district
court’s exercise of discretion by combining its new “bright-
line” rule to its previous statements that it must review the
legal application of § 285 de novo. Specifically, the court of
appeals refused to consider bad-faith pre-litigation conduct
as a basis for attorney fees. Thus, the court of appeals has
changed the first step in its standard of review — it must
“review de novo whether the [district] court applied the
proper legal standard under § 285” — by sua sponte
eliminating an entire class of conduct from the analysis.
Pet. App. 5a. As a practical matter, the court of appeals has
given itself de novo authority to determine whether the district
court followed its new “bright-line” rule.

17

Here, by reviewing the application of its new rule
de novo, the court of appeals determined that the district court
committed “legal error.” Pet. App. 9a. In doing so, the court
of appeals never reached the real issues of whether the district
court’s factual findings on which it based a conclusion
that Abbott’s estoppel misconduct rendered the case
“exceptional” were clear error or whether the district court’s
award of attorney fees based on its factual findings was an
abuse of discretion. By adopting this legal standard that it
reviews de novo, the court of appeals has given itself a vehicle
with which to substitute its own judgment regarding the
award of attorney fees for that of district courts — which it
did in this case.

4. Federal district courts exercise their discretion to
determine whether a trademark case is “exceptional” and
thereby warrants an award of attorney fees; instances of pre-
litigation misconduct are considered in determining the
“exceptionality” of trademark cases. Like the Patent Act,
the Lanham Act provides that “[t]he court in exceptional cases
may award reasonable attorney fees to the prevailing party”
in a trademark action. 15 U.S.C. § 1117(a). This Court has
recognized that the fee shifting provision in the patent law is
closely related to that in trademark. Fogerty v. Fantasy, Inc.,
510 U.S. 517, 525 n.12 (1994). Like the patent provision,
the determination of an “exceptional” case is left to the
district court’s discretion. Aromatique, Inc. Vv. Gold Seal, Inc.,
28 F.3d 863, 876 (8th Cir. 1994). Federal courts “have defined
the characteristics of exceptional cases with adjectives
suggesting egregious conduct by a party,” e.g., “groundless,
unreasonable, vexatious, or pursued in bad faith.” /d. at 877.

Such conduct is not limited to specifically identified
circumstances, but rather is “one in which one party’s

18

behavior went beyond the pale of, acceptable conduct.”
Id. Pre-litigation misconduct may lead to a finding of
exceptionality. In Aromatique, the court of appeals reversed
a holding of trademark infringement and awarded attorney
fees to the alleged infringer because the plaintiff, among other
things, twice wrote the alleged infringer prior to litigation
alleging infringement and falsely asserting that the plaintiff’s
trade dress was federally registered. 28 F.3d at 878. The court
of appeals held that “(t]his record compels the conclusion
that [the alleged infringer] has shown that [the plaintiff’s]
conduct was exceptional within the meaning of Section 35
of the Lanham Act.” Jd. at 879.

5. The court of appeals’ decision is inconsistent with
its own rule; “bad faith” is different from “frivolous suit”
or “vexatious litigation.” The court of appeals’ bright-line
rule identifies, in part, “litigation misconduct; vexatious,
unjustified, and otherwise bad faith litigation; [and] a
frivolous suit” as conduct that “repeatedly” rendered a case
“exceptional.” Pet. App. 8a (emphasis added). The court
of appeals’ bright-line rule conflates the rule itself by
making “bad faith” mean the same thing as “misconduct
during litigation,” “frivolous suit” and “vexatious litigation.”
For example, the court of appeals states that “[a]lthough a
lawsuit pursued in bad faith is a sufficient basis for imposing
attorney fees under § 285, such bad faith requires not
misleading pre-litigation conduct, but vexatious, unjustified,
or frivolous litigation.” Pet App. 10a. This ignores that the
plain meaning of otherwise bad-faith conduct encompasses
more than litigation misconduct or bringing a frivolous suit.
It also is contradicted by the court of appeals’ analysis of
whether Abbott’s suit was frivolous in which it acknowledges
that the bad faith equitable estoppel events are separate and
apart from a consideration of whether the suit was frivolous.

19

Pet. App. 10a-11a (“The record, however, does not support
the district court’s finding that Abbott maintained its
infringement counterclaim in bad faith. Even if Abbott
had knowledge of the events that would ultimately lead to a
holding of equitable estoppel, its litigation position was not
frivolous or baseless.”).

The plain words of the statute and the legislative history
show that “bad faith” should be interpreted to mean all
dealings between the parties that relates to the litigation. Here,
the court of appeals did not reverse a single one of the district
court’s numerous fact findings in support of its conclusion
that Abbott’s “equitable estoppel” business conduct was in
bad faith and that Abbott provided no evidence of good faith.
Rather, the court of appeals legislated a change to the statute
to prevent recovery of attorney fees in cases of bad-faith pre-
litigation conduct.

20

CONCLUSION

The petition for a writ of certiorari should be granted.
Congress, in 35 U.S.C. § 285, gave discretionary authority
to the district courts to award attorney fees in “exceptional”
patent cases to prevent a gross injustice to an abused party.
The court of appeals, however, through its new bright-line
rule defining the legal standard of § 285 and de novo review
of the district courts’ application of it, has removed the
discretion of the district court and decided the specific
circumstances under which attorney fees may be awarded.
Its bright-line rule also has undone the distinction between
“bad-faith” misconduct and bringing a “frivolous suit.” Here,
this has resulted in a fundamentally unfair result. The district
court, which was in the best position to determine if
respondent’s conduct rendered the case “exceptional” after
adjudicating years of litigation and a four-month trial,
exercised its discretion to award fees to petitioners to
compensate them for their substantial and unjustified loss
incurred in successfully defending this suit. That
compensation has now been taken from them because of
second-guessing by the court of appeals.

Respectfully submitted,

HERBERT F. SCHWARTZ
Counsel of Record

KENNETH B. HERMAN

FisH & NEAVE

1251 Avenue of the Americas
New York, New York 10020
(212) 596-9000

Attorneys for Petitioners

APPENDIX

eR Nett aE, oA RATE MRR dos

la

APPENDIX A — OPINION OF THE UNITED STATES
COURT OF APPEALS FOR THE FEDERAL
CIRCUIT FILED AUGUST 7, 2003

UNITED STATES COURT OF APPEALS
FOR THE FEDERAL CIRCUIT

03-1067

FOREST LABORATORIES, INC. AND ONY, INC.,
Plaintiffs-Appellees,
v.
ABBOTT LABORATORIES,
Defendant-Appellant,
and

TOKYO TANABE COMPANY, LTD.,

Defendant.
DECIDED: August 7, 2003

Before LOURIE, RADER, and DYK, Circuit Judges.

LOURIE, Circuit Judge.

Abbott Laboratories appeals from the decision of the
United States District Court for the Western District of
- New York awarding attorney fees and expenses to ONY, Inc.

2a

Appendix A

and Forest Laboratories, Inc. based on Abbott’s conduct that
led to a holding of equitable estoppel. Forest Labs., Inc. v.
Abbott Labs., No. 96-CV-159A (W.D.N.Y. Sept. 4, 2001)
(“Forest IV’). Because we conclude that the court erred in
finding this case to be “exceptional” under 35 U.S.C. § 285,
we reverse.

BACKGROUND

Tokyo Tanabe Company, Ltd. owns U.S. Patents
4,338,301 and 4,397,839, which are directed to a lung
surfactant composition for treating respiratory distress
syndrome in premature babies. Pursuant to an exclusive
license of the ’301 and °839 patents, Abbott developed a
commercial product known as Survanta® in the 1980s. At
about the same time, ONY developed its own product. for
treating neonatal respiratory distress syndrome called Calf
Lung Surfactant Extract (“CLSE”). In June 1991, ONY
entered into an agreement with Forest for Forest to further
develop and market CLSE under the trade name Infasurf®.

From 1983 until 1991, Abbott and ONY maintained
contact regarding the development of CLSE. Abbott met with
ONY in November 1983 to discuss the development,
composition, and testing of CLSE, and later informed ONY
that it had opted to develop the Tanabe product instead of
CLSE because the Tanabe product had patent protection. In
April 1984, at Abbott’s request, ONY submitted a
memorandum of invention to Abbott disclosing “everything
known about CLSE” for Abbott to conduct a patentability
search. Upon completion of the search, Abbott informed ONY
that CLSE was likely not patentable in light of two “pertinent

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references,” but did not mention the °301 and ’839 patents;
nonetheless, Abbott encouraged ONY that it “look[ed]
forward to working with [ONY] in the future.” In April 1986,
Abbott again met with ONY to discuss the possibility of joint
development of CLSE and suggested that “some future
collaboration” might still be possible. Abbott continued to
monitor the development of CLSE until 1991, while
internally expressing concern that ONY might receive FDA
approval for CLSE before Abbott could do so for Survanta®.

In July 1991, Abbott received both FDA approval and
orphan drug status (providing seven years’ market
exclusivity) for Survanta®, which it then proceeded to market.
Several years later, Abbott informed ONY and Forest that it
had reason to believe that Infasurf® would infringe the °301
and °839 patents if it were to be marketed. Nonetheless, in
March 1995, ONY filed a new drug application for approval
to market Infasurf®. The FDA then notified ONY that
Infasurf® was the “same drug” as Survanta® under the Orphan
Drug Act, 21 U.S.C. 88 360aa-360dd (1994), and that it
therefore could not be approved for sale until Abbott's period
of exclusivity expired in July 1998.

In light of Abbott’s June 1994 letter claiming
infringement and the FDA’s notification that Infasurf® and
Survanta® were the “same drug,” ONY and Forest sued
Abbott and Tanabe in the U.S. District Court for the Western
District of New York, seeking a declaratory judgment of
noninfringement and invalidity of the °301 and ’839 patents.
Abbott and Tanabe counterclaimed for infringement. A jury
found both patents infringed and not invalid and, in an
advisory verdict, rejected ONY and Forest’s defense of

4a

Appendix A

equitable estoppel. The district court, however, granted ONY
and Forest a judgment of noninfringement as a matter of law
(“JMOL”) on the ground that Abbott and Tanabe had failed
to present any evidence at trial to show that CLSE met the
water content limitations of the patents in suit either literally
or under the doctrine of equivalents. Forest Labs., Inc. v.
Abbott Labs., No. 96-CV-159A, 1999 U.S. Dist. LEXIS
23217, at *20-21 (W.D.N.Y. June 23, 1999) (“Forest I’). In
a separate opinion, the court also ruled that Abbott, and
Tanabe by imputation, was equitably estopped from asserting
infringement of the ’301 and ’839 patents against ONY and
Forest because: (1) Abbott, in bad faith, misled ONY and -~
Forest to believe that it would not assert infringement by
encouraging their development of Infasurf® and by neglecting
its duty to inform them of any possible infringement;
(2) ONY and Forest reasonably relied on Abbott’s misleading
conduct; and (3) ONY and Forest would suffer economic
and evidentiary prejudice if Abbott were permitted to proceed
with its infringement counterclaim. Forest Labs., Inc. v.
Abbott Labs., No. 96-CV-159A, 1999 U.S. Dist. LEXIS
23215, at *25-26 (W.D.N.Y. June 23, 1999) (“Forest IT’).
On appeal, we affirmed the JMOL of noninfringement and,
having done so, declined to consider the equitable estoppel
issue. Forest Labs., Inc. v. Abbott Labs., 239 F.3d 1305, 1314
(Fed. Cir. 2001) (“Forest IT’).

The district court subsequently granted ONY and Forest’s
motion for attorney fees and expenses against Abbott, but
not Tanabe. The court found the case to be “exceptional”
under 35 U.S.C. § 285 because Abbott, in bad faith,
encouraged ONY to develop CLSE, disregarded its duty to
advise ONY and Forest of possible infringement, and pursued

5a

Appendix A

its infringement counterclaim with a “reckless disregard for
the facts in an attempt to prevent Infasurf from reaching the
market.” Forest IV, slip op. at 12. In so finding, the court
rejected Abbott’s argument that fees could not be awarded
for bad-faith conduct that occurred prior to litigation and
held that, in any event, Abbott had acted in bad faith during
litigation by bringing suit with knowledge of its prior bad-
faith conduct toward ONY and Forest. /d. at 11. Having found
the case to be exceptional, the court then chose to exercise
its discretion and award attorney fees in order to avoid a
“sross injustice” and to deter patentees from similar bad-
faith conduct in the future. Jd. at 15. Upon the parties’
stipulation as to the amount of any fee award, the court
entered an award against Abbott of $6.5 million in attorney
fees and expenses. Forest Labs., Inc. v. Abbott Labs., No.
96-CV-159A (W.D.N.Y. Sept. 30, 2002).

Abbott timely appealed the fee award to this court. We
have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).

DISCUSSION

A determination whether to award attorney fees under
35 U.S.C. § 285 involves a two-step process. First, a district
court must determine whether the prevailing party has proved
by clear and convincing evidence, Ruiz v. A.B. Chance Co.,
134 F.3d 654, 669 (Fed. Cir. 2000), that the case iS
“exceptional.” 35 U.S.C. § 285 (2000); Cybor Corp. v. FAS
Techs., 138 F.3d 1448, 1460 (Fed. Cir. 1998) (en banc). We
review de novo whether the court applied the proper legal
standard under § 285, and we review the court’s factual
findings, including whether the case is exceptional, for clear

6a

Appendix A

error. Brasseler, U.S.A. I, L.P. v. Stryker'Sales Corp.,
267 F.3d 1370, 1378 (Fed. Cir. 2001). A finding is clearly
erroneous when, despite some supporting evidence, “the
reviewing court on the entire evidence is left with the definite
and firm conviction that a mistake has been committed.”
United States v. U.S. Gypsum Co., 333 U.S. 364, 395 (1948).
Second, if the district court finds the case to be exceptional,
it must then determine whether an award of attorney fees is
appropriate. Cybor Corp., 138 F.3d at 1460. We review that
determination for an abuse of discretion. /d. A district court
abuses its discretion when “its decision is based on clearly
‘erroneous findings of fact, is based on erroneous
interpretations of the law, or is clearly unreasonable, arbitrary
or fanciful.” Jd. (citation omitted).

On appeal, Abbott first argues that the district court
improperly found this case to be exceptional. Abbott contends
that the court’s underlying determination of equitable
estoppel was clear error and, in any event, was based on only
a preponderance of the evidence, whereas a finding that a
case is exceptional under § 285 requires clear and convincing
evidence. Abbott also argues that its private pre-litigation
conduct was an inappropriate ground on which to base a
finding of exceptionality and that it did not engage in bad-
faith conduct during litigation because its legal position was
neither frivolous nor baseless. Abbott further maintains that
the district court’s decision to award attorney fees was an
abuse of discretion in light of the court’s erroneous, or at
least debatable, holding of equitable estoppel; the absence
of any allegation of litigation misconduct; and the jury’s
advisory rejection of ONY and Forest’s equitable estoppel
defense. Finally, Abbott argues that the fee award serves

ORO, UNE Gee io Gn ee Paes

7a

Appendix A

neither of the intended purposes of § 285 in that it does not
deter unwarranted infringement claims or prevent injustice
to those falsely accused of infringement.

ONY and Forest respond that the district court properly
found that Abbott’s bad-faith conduct, viz., its failure to raise
the issue of infringement with ONY and Forest between 1983
and 1994, while encouraging the development of Infasurf®
as an alternative until it received FDA approval for Survanta®,
makes this case exceptional. They point out that the court
did not need to find by clear and convincing evidence that
the elements of an equitable estoppel defense were proved,
but only that this case was exceptional. ONY and Forest also
maintain that a finding of exceptionality was appropriate
because Abbott should have recognized that its pre-litigation
conduct precluded it from bringing suit. They further argue
that Abbott’s bad-faith conduct continued during litigation
because Abbott persisted with its counterclaim of
infringement in complete disregard of its history of dealings
with ONY and Forest. In addition, ONY and Forest contend
that Abbott’s failure to offer any evidence of infringement
with respect to the water content limitations of the asserted
patents renders this case exceptional. Finally, ONY and Forest
argue that the district court did not abuse its discretion in
awarding fees in this case because, as the court explained,
the holding of equitable estoppel alone did not make ONY
and Forest whole, and not awarding fees could encourage
other patentees that have engaged in similar bad-faith conduct
to bring unwarranted infringement claims.

We agree with Abbott that the district court erred in
awarding attorney fees to ONY and Forest. Section 285

8a
Appendix A

provides that a “court in exceptional cases may award
reasonable attorney fees to the prevailing party.” 35 U.S.C.
§ 285 (2000). We have repeatedly identified as “exceptional”
those cases involving “inequitable conduct before the [Patent
Office]; litigation misconduct; vexatious, unjustified, and
otherwise bad faith litigation; a frivolous suit or willful
infringement.” Brasseler, 267 F.3d at 1380 (citation omitted);
e.g., Hoffman-La Roche Inc. v. Invamed Inc., 213 F.3d 1359,
1365 (Fed. Cir. 2000). None of those circumstances is present
here, yet the district court found that this case was exceptional
due to Abbott’s bad-faith conduct which led to a holding of
equitable estoppel. Forest IV, slip op. at 9-H. We disagree
with the court’s expansive reading of § 285.

In interpreting § 285, we have been mindful of the limited
circumstances in which an award of attorney fees is
appropriate. See Mach. Corp. of Am. v. Gulifiber AB, 774
F.2d 467, 472 (Fed. Cir. 1985). The Senate Report
accompanying § 285’s predecessor statute, which is
applicable to the present statute as well, states that “‘[i]t is
not contemplated that the recovery of attorney’s fees will
become an ordinary thing in patent suits.’” Rohm & Haas
Co. v. Crystal Chem. Co., 736 F.2d 688, 690-91 (Fed. Cir.
1984) (quoting S. Rep. No. 79-1503 (1946)). Indeed, we have
recognized that § 285 is an exception to the American Rule
and a change to the pre-1946 practice of not awarding
attorney fees based upon equitable considerations in patent
cases. Jd. at 690. In the context of fee awards to prevailing
accused infringers, we have observed that § 285 is limited to
circumstances in which it is necessary to prevent “a gross
injustice” to the accused infringer, see Mach. Corp., 774 F.2d
at 472 (quoting S. Rep. No. 79-1503 (1946)), and have upheld

9a

Appendix A

findings of exceptionality to prevent such an injustice only
when the patentee has procured its patent in bad faith (7.e.,
committed inequitable conduct before the Patent Office) or
has litigated its claim of infringement in bad faith.
See Cambridge Prods., Ltd. v. Penn Nutrients, Inc., 962
F.2d 1048, 1050-51 (Fed. Cir. 1992); Mach. Corp., 774 F.2d
at 472.

We have not, however, upheld a finding of exceptionality
based on a patentee’s bad-faith business conduct toward an
accused infringer prior to litigation, and we decline to expand
the scope of the statutory term “exceptional” in that manner.
Cf. Yarway Corp. Vv. Eur-Control USA, Inc., 775 F.2d 268,
277-78 (Fed. Cir. 1985) (reversing a finding of exceptionality
premised on an accused infringer’s bad-faith conduct of
attempting to design around a patent in order to circumvent
a license agreement). Equitable estoppel may be imposed in
a patent case when a patentee induces another party to believe
that it will not sue that party for infringement. A.C. Aukerman
Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020, 1042 (Fed.
Cir. 1992) (en banc). Reliance by the other pafty as well as
prejudice are required in order to estop the patentee from
later suing. Jd. at 1042-43. The consequence of estoppel is
loss of the cause of action, id. at 1028, and we have not
extended the consequences to include attorney fees under
the rubric of exceptional case. Such business conduct, even
though sufficiently relied upon and prejudicial to lead to
estoppel, does not make any subsequent lawsuit exceptional.
Accordingly, we conclude that Abbot’s “equitable estoppel”
conduct was not an appropriate basis for awarding attorney
fees under § 285 and that the district court’s reliance on that
ground was legal error.

10a

Appendix A

We also agree with Abbott that the district court clearly
erred in finding that Abbott engaged in bad-faith litigation.
Although a lawsuit pursued in bad faith is a sufficient basis
for imposing attorney fees under § 285, such bad faith
requires not misleading pre-litigation conduct, but vexatious,
unjustified, or frivolous litigation. See, e.g., Aptix Corp. v.
Quickturn Design Sys., Inc., 269 F.3d 1369, 1375 (Fed. Cir.
2001) (affirming an award of attorney fees under § 285 for
the “extreme litigation misconduct” of falsifying evidence);
Eltech Sys. Corp. v. PPG Indus., Inc., 903 F.2d 805, 810-11
(Fed. Cir. 1990) (affirming an award of attorney fees under
§ 285 for pursuing a baseless claim of infringement). There
is no suggestion that Abbott engaged in vexatious litigation
tactics; the pertinent inquiry is thus whether Abbott knew or
should have known that it would be estopped from asserting
the °301 and ’839 patents against ONY and Forest, but
pursued its infringement counterclaim anyway. See Haynes
Int'l Inc. v. Jessop Steel Co., 8 F.3d 1573, 1579 (Fed. Cir.
1993) (“A frivolous infringement suit is one which the
patentee knew or, on reasonable investigation, should have
known, was baseless.’’), reh'g granted on other grounds, 15
F.3d 1076 (1994). The district court answered that question
in the affirmative, observing that Abbott “obviously knew
of its own bad faith conduct prior to the commencement of
the lawsuit,” Forest IV, slip op. at 11, and nevertheless
pursued its infringement counterclaim with a “reckless
disregard” for the facts of the case and the validity of ONY
and Forest’s equitable estoppel defense, id. at 12.

The record, however, does not support the district court’s
findings that Abbott maintained its infringement counterclaim
in bad faith. Even if Abbott had knowledge of the events

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Appendix A

that would ultimately lead to a holding of equitable estoppel,
its litigation position was not frivolous or baseless. Indeed,
based on the facts of this case, it was far from a foregone
conclusion that ONY and Forest would be able to establish
their equitable estoppel defense successfully. Abbott never
expressly communicated to Forest or ONY that it did not
intend to enforce its patents; instead, the district court had
to infer a misleading statement from Abbot's conduct and
did so only after finding that Abbott had a duty to advise
ONY and Forest of any possible infringement when it
provided ONY with a patentability opinion. See ABB
Robotics, Inc. v. GMFanuc Robotics Corp., 52 F.3d 1062,
1063 (Fed. Cir. 1995); see also A.C. Aukerman Co., 960 F.2d
at 1041 (“[E]quitable estoppel is not limited to a particular
factual situation nor subject to resolution by simple or hard
and fast rules.”). Although the equitable estoppel issue 1s
not before us, we note that it was never finally resolved, for
we declined to consider Abbott’s appeal of that issue when
we affirmed the JMOL of noninfringement. Forest III, 239
F.3d at 1314. Once it had been concluded that ONY and
Forest were not infringing the Abbott-Tanabe patents,
whether Abbott would be estopped from enforcing those
patents against ONY and Forest became moot. In any event,
we cannot even say with confidence that the equitable
estoppel determination would have been affirmed had we
reached the issue on appeal. Moreover, the district court’s
denial of ONY and Forest’s motion for JMOL at the close of
the evidence and the jury’s advisory verdict of no equitable
estoppel suggest that Abbott’s position was not baseless.
In light of these considerations, we conclude that Abbott’s
litigation position with respect to the equitable estoppel issue
cannot be characterized as clearly and convincingly

12a

Appendix A

vexatious, unjustified, or frivolous. Accordingly, the district
court’s finding that Abboti engaged in bad-faith litigation
was Clearly erroneous.

Finally, we reject ONY and Forest’s argument that an
award of attorney fees is appropriate because Abbott failed
to offer any evidence of infringement regarding the water
content limitations of the asserted patents. Although Abbott
ultimately lost its infringement counterclaim on that ground,
id., we cannot say that such a lack of proof is clear and
convincing evidence that Abbott, acting in bad faith, asserted
a baseless or frivolous counterclaim of infringement. Indeed,
the jury’s finding of infringement suggests otherwise.
Moreover, the district court expressly disclaimed reliance on
Abbott’s failure to prove infringement as a basis for imposing
attorney fees, noting that Abbott presented “plausible yet
untenable arguments regarding claim construction and the
doctrine of equivalents.” Forest IV, slip op. at 16-17. Thus,
even if Abbott’s lack of evidence of infringement could
support a findings exceptionality under § 285, the district
court did not abuse its discretion in choosing not to award
fees on that ground.

CONCLUSION

For the foregoing reasons, we conclude that the district
court erred in finding this case to be “exceptional” under
35 U.S.C. § 285 based on Abbott’s pre-litigation conduct
toward ONY and Forest. Accordingly, the decision of the
district court is

REVERSED.

ety Sand <a : , a a” 2
LORS RO Seer er eT Oe RE SCE

13a

APPENDIX B — DECISION AND ORDER OF THE
UNITED STATES DISTRICT COURT FOR THE
WESTERN DISTRICT OF NEW YORK
FILED SEPTEMBER 30, 2002

UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF NEW YORK

96-CV-159A
FOREST LABORATORIES, INC. and ONY, INC.,
Plaintiffs,
v.

ABBOTT LABORATORIES and
TOKYO TANABE COMPANY, LTD.,

Defendants.
DECISION AND ORDER

On September 4, 2001, this Court issued a Decision and
Order in this case granting the motion of plaintiffs Forest
Laboratories, Inc. (“Forest”) and ONY, Inc. (“ONY”) for
attorneys’ fees, pursuant to 35 U.S.C. § 285, against
defendant Abbott Laboratories (“Abbott”). The Court denied
the motion with respect to defendant Tokyo Tanabe Company,
Ltd. The Court also appointed Michael R. McGee, Esq.,
pursuant to Rule 53 of the Federal Rules of Civil Procedure,
as Special Master to hear and report on the reasonable amount
of attorneys’ fees and expenses that Abbott should pay,

14a

Appendix B

defendants’ objections to the plaintiffs’ bill of costs, the
amount of prejudgment and/or post-judgment interest and
any other related issues.

On September 6, 2002, the Special Master filed a Report
and Recommendation, informing the Court that the parties
had entered into Joint Stipulation Regarding the Amount of
Fees and Expenses (“Joint Stipulation’’). The Special Master
finds that the Joint Stipulation is a reasonable resolution of
all the issues referred to the Special Master by the Court’s
September 4, 2001 Decision and Order.

There being no timely objections filed to the Special
Master’s Report and Recommendation, the Court hereby
adopts the Report and Recommendation in all respects,
pursuant to Rule 53(e)(2). Pursuant to Rules 54(d)(2)(C)
and 58 of the Federal Rules of Civil Procedure, the Court
hereby orders the Clerk of Court to enter judgment in favor
of Forest and ONY consistent with the Court’s September 4,
2001 Decision and Order, this Decision and Order, the Special
Master’s Report and Recommendation and the Joint
Stipulation, and to take all steps necessary to close the case.

The Court commends the Special Master on assisting
the parties in reaching an agreeable resolution to these
complex issues and thanks him for a job well done.

IT IS SO ORDERED.

s/ Richard J. Arcara
HONORABLE RICHARD J. ARCARA
UNITED STATES DISTRICT COURT

Dated: September 30, 2002.

ee
SUR TES

15a

APPENDIX C — DECISION AND ORDER OF THE
UNITED STATES DISTRICT COURT FOR THE
WESTERN DISTRICT OF NEW YORK
FILED SEPTEMBER 4, 2001

UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF NEW YORK

96-CV-159A
FOREST LABORATORIES, INC. AND ONY, INC.,

Plaintiffs,

V.

ABBOTT LABORATORIES AND
TOKYO TANABE COMPANY, LTD.,

Defendants.
DECISION AND ORDER
INTRODUCTION

Currently before the Court is the motion of plaintiffs,
Forest Laboratories, Inc. (“Forest”) and ONY, Inc. (“ONY”),
for an award of attorneys’ fees and expenses, pursuant to
35 U.S.C. § 285, against defendants Abbott Laboratories
(“Abbott”) and Tokyo Tanabe Company, Ltd. (“Tokyo
Tanabe”).! By Order filed July 20, 1999, the Court ordered

1. Plaintiffs have also submitted a Bill of Costs pursuant to Local
Rule 54, Rule 54(d) of the Federal Rules of Civil Procedure 54(d),
and 28 U.S.C. § 1920. Defendants have filed objections to the
Bill of Costs.

16a
Appendix C

the parties to brief the issues of whether plaintiffs are entitled
to attorneys’ fees and expenses pursuant to § 285, and held
in abeyance the issue of whether the amount of attorneys’
fees and expenses requested by plaintiffs is reasonable. Oral
argument on the issue of whether plaintiffs are entitled to
attorneys’ fees and expenses was held on July 19, 2001.

After reviewing the submissions of the parties and
hearing argument from counsel, the Court grants plaintiffs’
motion for attorneys’ fees and expenses with regard to
defendant Abbott, but denies the motion with regard to
defendant Tokyo Tanabe.

BACKGROUND

Tokyo Tanabe is the assignee of U.S. Patents 4,338,301
and 4,397,839, which relate to a lung surfactant composition
for treating Respiratory Distress Syndrome (“RDS”) in
premature babies. Abbott developed a commercial product
known as “Survanta®” after receiving an exclusive U.S.
license to these patents from Tokyo Tanabe. ONY developed
a competing product for treating RDS, which it called
“Infasurf®.” ONY eventually entered into an agreement with
Forest under which Forest would further develop and market
Infasurf®. ONY and Abbott maintained collaborative contacts
throughout the development of these products from 1983 until
Abbott received FDA approval to market Survanta® in 1991,
during which time Abbott never gave ONY any reason to
believe that its Infasurf® product would infringe any patents
of Abbott. In fact, Abbott performed a patentability search
for ONY in 1984 and never mentioned the Tokyo Tanabe
patents under which Abbott was exclusively licensed.

17a

Appendix C

However, in 1994, Abbott informed ONY that it had reason
to believe that Infasurf® might infringe the Tokyo Tanabe
patents.

In 1996, ONY and Forest sued Abbott, seeking a
declaratory judgment of non-infringement and patent -
invalidity. Abbott counterclaimed for infringement. After suit
was brought, ONY and Forest added Tokyo Tanabe as a
defendant, which also counterclaimed for infringement. ONY
and Forest later raised the additional defense of equitable
estoppel, alleging that Abbott had led ONY to believe that
Abbott would not assert the Tokyo Tanabe patents against it.

A jury returned a verdict in favor of Abbott and Tokyo
Tanabe on all issues except willfulness. The jury also returned
an advisory verdict in favor of Abbott on the issue of equitable
estoppel. ONY and Forest then moved for a post-trial
judgment of equitable estoppel and judgment as a matter of
law (“JMOL”) of non-infringement. The Court, stating that
it was not bound by the advisory verdict, applied equitable
estoppel after concluding that Abbott had misled ONY into
believing that it did not infringe the Tokyo Tanabe patents
and that ONY had relied on Abbot’s conduct and was
prejudiced by it. See Forest Labs. v. Abbott Labs., 1999
WL 33299123 (W.D.N.Y. Jun. 23, 1999) (“Equitable Estoppel
Decision”). The Court also granted ONY’s and Forest’s
motion for JMOL of non-infringement and its motion for a
conditional new trial, because it found that Abbott and Tokyo
Tanabe had failed to prove that CLSE (“Calf Lung Surfactant
Extract,” the “dry” form of Infasurf®) met the claim
limitatioris requiring specific water content percentages.
See Forest Labs. v. Abbott Labs., 1999 WL 33290607

18a

Appendix C

(W.D.N.Y. Jun. 23, 1999). Finally, the Court rejected
defendant’s claim of infringement under the doctrine of
equivalents for lack of evidence of equivalence. /d.

Abbott and Tokyo Tanabe appealed the Court’s judgment
applying equitable estoppel and its grant of JMOL of
non-infringement. The Federal Circuit Court of Appeals
affirmed the Court’s grant of JMOL of non-infringement,
agreeing that there was no proof that CLSE, based on its dry
weight, possessed the percentages of water claimed by the
patents. See Forest Labs. v. Abbott Labs., 239 F.3d 1305
(Fed. Cir. 2001).? Because it affirmed this Court decision on
the basis of its grant of JMOL of non-infringement, the
Federal Circuit did not decide the equitable estoppel issue.

DISCUSSION
A. Law Regarding § 285

Under 35 U.S.C. § 285, “[t]he court in exceptional cases
may award reasonable attorney fees to the prevailing party.”
The purpose of the statute is “‘to compensate the prevailing
party for its monetary outlays in the prosecution or defense
of the suit.’” Automated Business Cos. v. NEC Am., Inc., 202
F.3d 1353, 1355 (Fed. Cir. 2000) (quoting Central Soya Co.
v. Geo. A. Hormel & Co., 723 F.2d 1573, 1578 (Fed. Cir.
1983)). “In addition, § 285 serves as a deterrent to ‘improper
bringing of clearly unwarranted suits’ for patent
infringement.” Jd. (quoting Mathis v. Spears, 857 F.2d 749,
754 (Fed. Cir. 1988)).

2. The Court hereby incorporates by reference, and assumes
familiarity with, all of its prior decisions in this case. The Court also
assumes familiarity with the Federal Circuit’s decision.

19a
Appendix C

Whether to award attorneys’ fees under § 285 rests with
the sound discretion of the trial court. Modine Mfg. Co. v.
Allen Group, Inc., 917 F.2d 538, 543 (Fed. Cir. 1990),
cert. denied, 500 U.S. 918 (1991). Congress intended that
courts use their discretion under § 285 sparingly as the statute
is a departure from the usual “American rule” that counsel
fees are not awarded to the prevailing party in an action
at law. See Victus Ltd. v. Collezione Europa U.S.A., Inc.,
26 F. Supp. 2d 772, 787 (M.D.N.C. 1998) (citation omitted).

Thus, the payment of attorney’s fees for the victor
is not to be regarded as a penalty for failure to
win a patent infringement suit. The exercise of
discretion in favor of such an allowance should
be bottomed upon a finding of unfairness or bad
faith in the conduct of the losing party, or some
other equitable consideration of similar force,
which makes it grossly unjust that the winner of
the particular lawsuit be left to bear the burden
of his own counsel fees which prevailing litigants
normally bear.

Rohm & Haas Co. v. Crystal Chem. Co., 736 F.2d 688, 691
(Fed. Cir. 1984) (emphasis in original) (quoting Park-In-
Theaters, Inc. v. Perkins, 190 F.2d 137, 142 (9" Cir. 1951)).

Deciding a motion for attorneys’ fees under § 285
requires a two-step analysis. J.P. Stevens Co. v. Lex Tex Ltd.,
822 F.2d 1047, 1050 (Fed. Cir. 1987). The court “must
determine whether the case is ‘exceptional,’ if it is, then it is
within the court’s discretion to award attorneys’ fees to the
prevailing party. It is only after a specific finding of

20a

Appendix C

exceptional circumstances has been made that the discretion
to award attorneys’ fees can be exercised.” Jd. (citations
omitted).

The determination that a case is “exceptional” is a factual
one and should be made in light of the totality of the
circumstances. See Interspiro USA, Inc. v. Figgie Int'l Inc.,
18 F.3d 927, 933 (Fed. Cir. 1994); L.A. Gear, Inc. v. Thom
McAn Shoe Co., 988 F.2d 1117, 1128 (Fed. Cir.), cert. denied,
510 U.S. 908 (1993). A prevailing party seeking an award of
attorneys’ fees has the burden of establishing the exceptional
character of the case by clear and convincing evidence.’
See B. Braun Medical, Inc. v. Abbott Labs., 124 F.3d 1419,
1429 (Fed. Cir. 1997). For an alleged infringer to recover
attorneys’ fees under § 285, “[t]here must be some finding
of unfairness, bad faith, or inequitable conduct on the part
of the unsuccessful patentee.” Stevenson v. Sears, Roebuck
& Co., 713 F.2d 705, 713 (Fed. Cir. 1983) (citations omitted);
see also Badalamenti v. Dunham's, Inc., 896 F.2d 1359,
1364-65 (Fed. Cir.), cert. denied, 498 U.S. 851 (1990);
Advance Transformer Co. v. Levinson, 837 F.2d 1081, 1085

3. Clear and convincing evidence is a more exacting sandard
than proof by a preponderance of the evidence, but is not as high a
standard as the burden of proof applied in criminal cases which is
proof beyond a reasonable doubt. Clear and convincing proof leaves
no substantial doubt in the fact finder’s mind. It is proof that
establishes in the fact finder’s mind not only that the proposition at
issue is probable, but also that it is highly probable. It is enough if
the party with the burden of proof establishes its claim beyond any
substantial doubt. It does not have to dispel every reasonable doubt.
See Sand, Siffert, Loughlin & Reiss, Modern Federal Jury
Instructions, Instruction No. 73-3.

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21a
Appendix C

(Fed. Cir. 1988). The alleged infringer must demonstrate
evidence of either wrongful intent or gross negligence.
Machinery Corp. of Am. v. Gullfiber AB, 774 F.2d 467, 473
(Fed. Cir. 1985).

Even if the case is found to be “exceptional,” the court,
in its discretion, may decline to award attorneys’ fees. “After
the district court determines that a case is exceptional there
remains in every case its freedom to exercise its discretion
informed by the court’s familiarity with the matter in
litigation and the interest of justice.” Gardco Mfg., Inc. v.
Herst Lighting Co., 820 F.2d 1209, 1215 (Fed. Cir. 1987)
(internal quotations and citations omitted).

Even an exceptional case does not require in all
circumstances the award of attorney fees. Many
factors could affect this result. The trial judge is
in the best position to weigh considerations such
as the closeness of the case, tactics of counsel,
the conduct of the parties, and any other factors
that may contribute to a fair allocation of the
burdens of litigation as between winner and looser.

S.C. Johnson & Son, Inc. v. Carter- Wallace, Inc., 781 F.2d
198, 201 (Fed. Cir. 1986).

B. Application of Law to Facts

Applying the above principles to the instant case, the
Court finds that with respect to Abbott, ONY and Forest have
shown by clear and convincing evidence that this is an
“exceptional” case within the meaning of § 285, and that

22a
Appendix C

they should be awarded their attorneys’ fees and expenses.
With respect to Tokyo Tanabe, however, the Court finds that
this is not an “exceptional” case and therefore an award of
attorneys’ fees is not appropriate.

1. Abbott

As discussed in detail in the Court’ Equitable Estoppel
Decision, Abbott misled ONY and Forest into reasonably
believing that Abbott did not intend to enforce the Tokyo
Tanabe patents against them. This is not, as Abbott contends,
a case involving mere silence or inaction on the part of the
patentee. To the contrary, the evidence shows that between
1983 and 1994, Abbott was fully aware of ONY’s and Forest’s
activities and that up until 1991, Abbott actively encouraged
Dr. Edmund A. Egan, the president of ONY, in his efforts to
develop CLSE. Such conduct created a duty on the part of
Abbott to advise ONY and Forest about possible infringement
of the Tokyo Tanabe patents, yet Abbott never mentioned
infringement until June of 1994, eleven years after it first
learned about CLSE.

The evidence adduced at trial shows that the reason
Abbott kept encouraging ONY to develop CLSE, even though
it was a possible competitor, was because Abbott wanted to
keep its options open in the event Survanta®, the product
that Abbott had developed based on the Tokyo Tanabe patents,
was not approved by the FDA for commercial sale or did not
work out for some other reason. In other words, Abbott was
betting on two horses—if efforts to develop Survanta® failed,
Abbott could return to ONY and CLSE. Once Abbott finally
got FDA approval of Survanta®, however, it stopped stringing

23a
Appendix C

Dr. Egan along, cut off all contact with him and eventually
asserted an infringement claim against ONY and Forest. Such
conduct amounts to bad faith on the part of Abbott and makes
this an “exceptional” case for purposes of § 285.4

Abbott put forth no persuasive evidence at trial to
contradict ONY’s and Forest’s evidence of its bad faith.
Interestingly, three of the witnesses who would have been in
the best position to provide such evidence, attorneys Donald
Nickey and Margaret O’Brien, and Dr. Jack Gold, were listed
as potential witnesses on Abbott’s witness list but were never
called to testify. Although the Court recognizes that the
burden of proof on the issue of equitable estoppel was on
ONY and Forest, once they put forth sufficient evidence to
establish an equitable estoppel defense. It was up to Abbott
to either rebut such evidence or run the risk of an adverse
verdict. Abbott chose the latter option.

Abbott argues that the “bad faith” necessary for a finding
of exceptional circumstances under § 285 is not the same
“bad faith” necessary for purposes of equitable estoppel.
In other words, according to Abbott, “bad faith” for purposes
of § 285 must be bad faith in the conduct of the litigation of
the iawsuit, not bad faith by a party prior to the lawsuit
commencing. The Court finds this argument without merit.

Although it is true that cases awarding a prevailing
accused infringer attorneys’ fees have normally been those

4. Although the Court’s findings of fact regarding Abbot’s bad
faith contained in its Equitable Estoppel Decision were based on a
preponderance of the evidence standard, the Court finds that the same
evidence also supports a finding of bad faith by clear and convincing
evidence.

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24a

Appendix C

involving bad faith litigation or fraud or inequitable conduct
by the patentee in procuring the patent, Abbott has failed to
cite, nor has the Court found, any cases prohibiting an award
of attorneys’ fees based on the bad faith conduct of the
patentee prior to the lawsuit.

Moreover, even if bad faith in litigating the lawsuit is
necessary for a case to be “exceptional,” such bad faith is
present here. Abbott obviously knew of its own bad faith
conduct prior to the commencement of the lawsuit, yet
persisted in bringing an infringement claim against Forest
and ONY.

Particularly pertinent here is the case of Nordek Corp. v.
Garbe Ironworks, Inc., 1983 WL 223, 221 U.S.P.Q. 632 (N.D.
Ill. April 25, 1983). In Nordek, the district court awarded the
alleged infringer its attorneys’ fees because the patentee
persisted in the litigation in the fact of compelling laches
and estoppel defenses. The patentee pursued the litigation
even though it knew or should have known that the suit was
barred by its own misleading conduct and foot dragging. The
Court concluded that the patentee’s behavior made the case
exceptional:

Prosecution of this lawsuit without investigation
into possible laches and estoppel defenses was
recklessness amounting to bad faith. Plaintiff’s
failure to change its course as defendants’
evidence mounted is clear and convincing
evidence of plaintiff’s bad faith.

See also Encomp, Inc. v. L-com, Inc., 999 F. Supp. 264,
269-70 (D. Conn. 1998) (granting alleged infringer’s motion

25a

Appendix C

for attorneys’ fees because the patentee’s “suit was frivolously
brought in that it failed to access [laches and equitable
estoppel] defenses that would have essentially precluded its
claims.’’).

Similarly, Abbott’s conduct renders this case
“exceptional.” The evidence concerning ONY’s and Forest’s
estoppel defense was in Abbott’s own files and was well
known by Abbott’s own employees well before Abbott sent
its first letter to ONY and Forest asserting infringement.
Nevertheless, Abbott pursued its infringement claim with a
reckless disregard for the facts in an attempt to prevent
Infasurf® from reaching the market. Such disregard for the
validity of claims and defenses is at the core of the definition
of an “exceptional” case under § 285. See Mathis, 857 F.2d
at 753-54.

Having determined that this case is “exceptional” for
purposes of § 285, the Court must next determine whether
to exercise its discretion in awarding attorneys’ fees. -
The Court finds that attorneys’ fees should be awarded in
this case. Under the facts present here, it would be grossly
unjust if ONY and Forest were left to bear the burden of
their own counsel fees. Abbott acted in bad faith and injured
ONY and Forest by subjecting them to an unwarranted
infringement claim and an unwarranted appeal, thereby
forcing them to defend at great expense their right to compete
freely. The provision for attorneys’ fees under § 285 is
available as a deterrent to such conduct.

Abbott contends that attorneys’ fees are not appropriate
in this case because ONY and Forest have already received a

26a

Appendix C

remedy for Abbott’s bad faith conduct, i.e., a judgment
of estoppel prohibiting Abbott from enforcing its patents.
Such an argument, however, ignores § 285 and the purpose
behind it. Section 285 is intended to be a deterrent to
unwarranted infringement claims and to prevent injustice to
those falsely accused of infringing. Although it is true that
the Court’s judgment of equitable estoppel allowed Forest
and ONY to sell Infasurf® without interference from Abbott,
that judgment did not make Forest and ONY whole.
They were forced to a substantial amount of money in counsel
fees before they could obtain that judgment. Failure to award
attorneys’ fees under such circumstances could encourage
other patentees who are guilty of bad faith conduct similar
to Abbott’s to bring unwarranted infringement claims in the
hope of forcing the alleged infringer to settle the claims rather
than expend substantial financial resources litigating them.

Abbott also argues that the Court should decline to award
attorneys’ fees because this was a close case for equitable
estoppel, as evidenced by the advisory jury verdict finding
no estoppel. The Court finds this argument unpersuasive. The
Court rejected the jury’s advisory verdict because in the
Court’s view, it was not consistent with the evidence
presented at trial. The Court has made specific findings of
fact in its Equitable Estoppel Decision regarding Abbott’s
bad faith conduct. These facts show by clear and convincing
evidence that Abbott was acting in bad faith before the
litigation and continued acting in bad faith by pursuing its
infringement claim in the fact of such facts. Simply because
the jury failed to come to the same conclusion as the Court
does not necessarily make this a close case.

27a
Appendix C

Finally, Abbott argues that attorneys’ fees should not be
awarded because it was ONY and Forest, not Abbott, who
brought the lawsuit. This situation was addressed by the
Federal Circuit in Machinery Corp. of Am., 774 F.2d at 474.
There, the Circuit Court considered the situation where a
declaratory judgment action is brought against a patentee by
an erroneously accused infringer and concluded that the trial
court could consider whether the patentee acted in bad faith
in making the threats of infringement that led to the filing of
the declaratory judgment action and whether the alleged
infringer reasonably believed its only or best recourse was
to file suit. Jd.

Here, as already stated, the Court finds that Abbott was
acting in bad faith by making its threats of infringement.
Forest and ONY acted reasonably when confronted with these
threats. Accordingly, the fact that it was ONY and Forest
that brought the lawsuit rather than Abbott is of no
consequence.

In sum, the Court finds that Abbott’s bad faith conduct
makes this an “exceptional” case for purposes of § 285, and
that Abbott should be required to pay attorneys’ fees in order
to prevent a gross injustice to ONY and Forest and to deter
Abbott and other patentees from similar conduct in the future.

2. Tokyo Tanabe

The Court finds that ONY and Forest have failed to
establish that this is an “exceptional” case for purposes of
§ 285 with regard to Tokyo Tanabe. As the Court found in its
Equitable Estoppel Decision, ONY and Forest failed to show

28a

Appendix C

at trial any misleading or bad faith conduct on the part of
Tokyo Tanabe. Although Tokyo Tanabe was aware of Forest’s
and ONY’s activities, there was no relationship between
Tokyo Tanabe and ONY which created a clear duty to speak,
as there was between Abbott and ONY. Tokyo Tanabe simply
stated in the background and remained silent. Such conduct,
without more, does not make this an “exceptional” case under
§ 285.

Forest and ONY also argue that this is an “exceptional”
case for purposes of § 285 because, as both this Court and
the Federal Circuit found, Abbott and Tokyo Tanabe failed
to present any evidence regarding the water content of CLSE,
and therefore could not have possibly succeeded on their
infringement claim. Though this is a close call, the Court
finds that an award of attorneys’ fees based on Abbott’s and
Tokyo Tanabe’s failure to prove their infringement claim is
not warranted in this case. Although Abbott and Tokyo Tanabe
failed to present any direct evidence to prove the water
content of CLSE, they did present plausible yet untenable
arguments regarding claim construction and the doctrine of
equivalents. “Mere error [in concluding that a patent was
infringed] does not approach the level of bad faith or gross
negligence necessary to characterize a case as exceptional.”
Machinery Corp. of Am., 774 F.2d at 474.

In sum, the Court finds that an award of attorneys’ fees
against Tokyo Tanabe is not warranted under the facts and
circumstances present here.

PSE g TT ee ee CN eT AT ee i

29a
Appendix C

CONCLUSION .

For the reasons stated, the Court grants plaintiffs’ motion
for attorneys’ fees and expenses with regard to defendant
Abbott, but denies the motion with regard to defendant Tokyo
Tanabe. In order to assist the Court in determining the proper
amount of attorneys’ fees and costs to which plaintiffs are
entitled, it is hereby

ORDERED that, pursuant to Rules 53 and 54(d)(2)(D)
of the Federal Rules of Civil Procedure, Michael R. McGee,
Esq., of the law firm of McGee & Gelman, 200 Summer
Street, Buffalo, New York 14222, is appointed as a Special
Master for the purpose of hearing evidence and reporting on
the reasonable amount of attorneys’ fees and expenses that
Abbott should pay plaintiffs; defendants’ objections to the
plaintiffs’ Bill of Costs; the amount of pre-judgment and/or
post-judgment interest, if any, to which plaintiffs are entitled;
and other related matters; and

IT IS FURTHER ORDERED that the Special Master
shall have all the rights, powers and duties set forth in this
Order and in Rules 53 and 54 of the Federal Rules of Civil
Procedure; and

IT IS FURTHER ORDERED that the Special Master
may communicate with the Court ex parte, either orally
or in writing, and may divulge to the Court, in such
communications, confidential information related to him by

-the parties, which confidences shall be preserved by the
Court; and

30a

Appendix C

IT IS FURTHER ORDERED that the Special Master
shall submit his report, pursuant to Rule 53(e), including
recommended findings of fact and conclusions of law, by no
later than April 1, 2002, whereupon this reference shall
terminate, unless extended by further order of the Court; and

IT IS FURTHER ORDERED that the Special Master
shall be compensated for his services at a rate of $325
per hour for time spent at any hearing, meeting or conferences
with counsel and at a rate of $225 per hour for all other time,
together with all reasonable and necessary expenses incurred
by him in the performance of his duties, and may employ an
associate attorney of his firm, whose services shall be charged
at the rate of $165 per hour; and |

IT IS FURTHER ORDERED that within thirty (30) days
following the termination of this reference, the Special Master
shall provide the Court and the parties with a statement
itemizing his hours worked and expenses incurred in
connection with this reference; and

IT IS FURTHER ORDERED that the Special Master’s
fee and expenses shall be assessed or apportioned amongst
the parties as justice may require at the termination of the
reference, except that the Special Master may apply for
interim compensation if the reference is extended; and

IT IS FURTHER ORDERED that the parties shall
forthwith submit to the Special Master a copy of all previous
submissions regarding attorneys’ fees and costs; and

3la

Appendix C

IT IS FURTHER ORDERED that the Clerk of the Court
shall furnish the Special Master with a copy of this Order;
shall make the file in this matter available to the Special
Master for his review upon request; and shall provide copies
of materials therein as needed, without cost.

IT IS SO ORDERED

s/ Richard J. Arcara
RICHARD J. ARCARA
UNITED STATES DISTRICT COURT

Dated: September 4, 2001

32a

APPENDIX D — OPINION OF THE UNITED STATES
DISTRICT COURT FOR THE WESTERN DISTRICT
OF NEW YORK DECIDED JUNE 23, 1999

UNITED STATES DISTRICT COURT FOR THE
WESTERN DISTRICT OF NEW YORK.

CASE NUMBER: 96-CV-159-A
FOREST LABORATORIES, INC. AND ONY, INC.,
Plaintiffs,

¥.

ABBOTT LABORATORIES AND
TOKYO TANABE COMPANY, LTD.,

Defendants.
INTRODUCTION

Currently before the Court is plaintiffs’ motion following
trial for entry of a judgment that defendants are equitably
estopped from asserting infringement of the patents in suit.!
Oral argument on the motion was held on January 15, 1999.
After carefully considering the evidence adduced at trial,
reviewing the submissions of the parties, and hearing
argument from counsel, the Court finds that defendants are

1. Also pending are the parties’ post-trial motions, pursuant to
Federal Rules of Civil Procedure 50(b) and 59, on the issues of claim
construction, infringement, validity, and willful infringement. The
Court will address those motions in a separate Decision and Order. -

33a

Appendix D

equitably estopped from asserting infringement of the patents
in suit. The following discussion constitutes the Court’s
findings of fact and conclusions of law pursuant to Federal
Rule of Civil Procedure 52(a).

DISCUSSION
I. General Background

The following is a summary of the Court’s findings of
fact regarding the general background of this case.

A. Patents in Suit

This case involves two patents owned by defendant
-Tokyo Tanabe Company, Ltd. (“Tokyo Tanabe”’). U.S. Patent
No. 4,338,301 (the “ 301 patent”), entitled “Lung Tissue
Extract Useful For Treating Hyaline- Membrane Disease And
Method For Producing The Extract,” was issued on July 6,
1982 to Tokyo Tanabe as assignee. U.S. Patent No. 4,397,839
(the “ °839 patent’), entitled “Surface Active Material And
Process For Preparing Same,” was issued on August 9, 1983
to Tokyo Tanabe as assignee. Both patents relate to
pharmaceutical compositions used to treat Respiratory
Distress Syndrome in premature babies. The ’301 patent
expires on May 21, 2000, and the ’839 patent expires on
June 1, 2005.”

2. The ’301 and ’839 patents are referred to collectively herein
as the “Tokyo Tanabe patents.”

34a

Appendix D

B. RDS and Lung Surfactant

Respiratory Distress Syndrome (“RDS”) is, when
untreated, an often fatal condition that afflicts thousands of
premature infants throughout the world each year. Until
relatively recently, RDS was the leading cause of mortality
in premature infants.

The search for a cure for RDS was the subject of research
by scientists throughout the world for almost 35 years.
In 1959, Dr. Mary Ellen Avery discovered that premature
infants suffering from RDS had an insufficient amount of a
substance known as “pulmonary surfactant” in their lungs.
Dr. Avery theorized that surfactant might be produced by
specialized cells in the lung and that the lungs of premature
babies might not be developed enough to produce a sufficient
amount of surfactant. Subsequent research has shown that
Dr. Avery’s theory was correct.

Today, it is accepted that lung surfactant is essential to
respiration. During the process of breathing, air is inhaled
into the lung and passes through a tree-like network of
bronchial tubes which branch and divide again into smaller
and smaller passages. The most diminutive “twigs” in the
bronchial passages are bronchioles which are under one
millimeter in diameter. The bronchioles end in tiny air ducts
which lead to groupings of microscopic air sacs called alveoli,
each of which is a mere one thousandth of an inch across.
A developed lung contains hundreds of millions of alveoli
which are arrayed on bronchial passages like tiny clusters of

grapes.

35a

Appendix D

It is through the alveoli that oxygen and carbon dioxide
are exchanged in the bloodstream. Each alveolus is lined with
a watery fluid that enables oxygen and carbon dioxide to
diffuse through the single-cell alveolar walls. The gasses then
pass through the alveoli into an entwining network of
extremely small blood vessels called capillaries. During
respiration, the alveoli expand and contract as fresh air is
inhaled and oxygen-depleted air is exhaled.

In the absence of surfactant, the high surface tension of
the watery coating in the interior of the alveolus tends to
pull the alveolar walls inward until the alveolus collapses.
In normally developed lungs, the stability of the alveoli is
regulated by the presence of lung surfactant. Surfactant
possesses “surface active properties,” which simply means
that it reduces surface tension. These properties are inversely
related to surface area. Thus, surfactant has proportionately
greater surface tension-reducing effects on smaller areas and
diminished effects on larger areas. These characteristics make
respiration possible. The reduction of surface tension created
by the presence of lung surfactant keeps the alveoli relatively
rigid and prevents them from collapsing as they are deflated.’
Conversely, the diminished effect of surfactant in larger areas
results in relatively higher surface tension in the expanded
alveolus causing it to recoil rapidly during exhalation.

The lungs of babies with RDS have not developed to the
point that they produce surfactant naturally. As a result, the
high surface tension in the alveoli requires a tremendous

3. Surfactant molecules disperse themselves between fluid
molecules, reducing the cohesive force between them. The term
surfactant is derived from the phrase “surface active.”

36a

Appendix D

amount of energy to inflate them. During exhalation, the
increased surface tension of the contracted alveoli tends to
cause the alveoli to collapse entirely, making it exceedingly
difficult for them to reopen and causing extremely labored
breathing and inefficient respiration. As a result, the skin of
babies with RDS often has a bluish cast because of the lack
of oxygen in the blood and tissues. Left untreated, a premature
baby suffering from RDS will usually not survive.

C. Development of a Treatment for RDS

In the decades that followed Dr. Avery’s research,
researchers throughout the world worked on developing a
treatment for RDS. Early treatments for RDS included:
(1) forcing air or oxygen into the airway of the patient through
a tube; (2) using steroid treatments; and (3) forcing
supplements of certain components believed to be present in
the pulmonary surfactant into the patients. Unfortunately,
these treatments did not significantly reduce RDS mortality
rates. The use of respirators, in fact, tended to damage the
structure of the fragile lungs of the premature infants.

During the 1960’s, 1970’s and 1980’s, different groups
of researchers investigated what has come to be known as
“surfactant replacement therapy.” Surfactant replacement
therapy involves replacing the surfactant missing from a
premature baby’s lungs with surfactant from some other
source.

Different groups of researchers studied the possibility
of using surfactant from animals, such as cows and sheep, as
a possible source of replacement surfactant. However, it was
thought that the presence of a significant amount of animal
protein in such surfactant might be harmful to humans. One

2

37a

Appendix D

team of researchers headed by Dr. John Clements tried to
solve this dilemma by developing an entirely synthetic
surfactant, but the compound proved ineffective.

D. Dr. Fujiwara and the Tokyo Tanabe Patents

During the 1960’s and 1970’s, Dr. Tetsuro Fujiwara, a
Japanese pediatrician and biochemist, worked together with
Dr. Forrest Adams at the University of California at Los
Angeles Medical School to study surfactant in large animals.
Their research built on studies done by Dr. Goran Enhorning
of the University of Western Ontario, Canada, on surfactant
in smaller animals. When funding for Dr. Fujiwara’s research
in the United States ended, he returned to Japan and continued
his research there.

After his return to Japan, Dr. Fujiwara began working
with researchers at defendant Tokyo Tanabe, a pharmaceutical
company in Tokyo, Japan. With the assistance of Dr. Yuji
Tanaka and Dr. Tsunetomo Takei of Tokyo Tanabe,
Dr. Fujiwara researched cow-lung surfactant and eventually
developed a surfactant replacement composition derived from
cows’ lungs. More specifically, under the method invented
by Dr. Fujiwara, the lungs of freshly-slaughtered cows are
removed and then minced. The minced cow-lung material is
then processed and the surfactant is extracted.

In October 1978, at a hospital in Japan, Dr. Fujiwara
attempted for the first time to use his newly-developed
surfactant composition to treat a premature human baby with
RDS. The treatment was effective and the baby survived.

38a

Appendix D

Dr. Fujiwara and the Tokyo Tanabe researchers
immediately conducted additional testing of the composition
and its effectiveness in treating RDS. On June 2, 1979,
Dr. Fujiwara and Tokyo Tanabe filed a patent application for
their new surfactant composition in Japan. On May 21, 1980,
a patent application was filed in the United States naming
Drs. Fujiwara, Tanaka and Takei as inventors. As stated
above, the United States Patent and Trademark Office
(“PTO”) issued the 301 patent on July 6, 1982.

After additional research, Dr. Tanaka of Tokyo Tanabe
discovered that adding certain lipids known as free fatty
acids enhanced the surface activity of the °301 composition
thereby making it more effective. Dr. Tanaka filed for a patent
on his discovery in Japan on September 10, 1981 and
subsequently filed for a patent in the United States. As stated
above, the PTO issued the ’839 patent on August 9, 1983.

E. Dr. Egan, Dr. Notter, CLL, CLSE and Infasurf

Dr. Edmund A. Egan is a pediatric physician, a faculty
member at the State University of New York at Buffalo
(“U.B.”) Medical School, and president of plaintiff ONY,
Inc. (“ONY”). Dr. Egan is certified in neonatology, which is
the branch of pediatrics dealing with newborn infants, and
was formerly head of the Newborn Medical Program at
Children’s Hospital in Buffalo, New York and chief of the
Neonatology Division in the Department of Pediatrics at the
U.B. Medical School.

Dr. Egan first began researching the functions and
diseases of the lung in about 1973. In the spring of 1980, he

39a

Appendix D

began collaborating with Drs. Donald Shapiro and Robert
Notter, who were both associated with the University of
Rochester Medical School and Strong Memorial Hospital in
Rochester, New York, for the purpose of developing a
surfactant replacement composition for treating premature
babies with RDS. Prior to this time, Dr. Egan had been
researching lung function and lung disease in premature
lambs and Dr. Notter had been researching lung surfactant
generally. Dr. Shapiro was chief of neonatology at Strong
Memorial Hospital in Rochester and was Dr. Notter’s
supervisor.

Dr. Notter’s research responsibility was to formulate,
manufacture, and conduct biophysical testing of the
surfactants. Dr. Egan’s responsibility was then to evaluate
the surfactants biologically in premature lambs. Dr. Shapiro
acted as a consultant. The research by Drs. Egan and Notter
followed on the research done by Drs. Enhorning, Adams,
and Fujiwara.

-In January 1981, Dr. Notter developed a surfactant
replacement composition derived from surfactant extracted
from the lungs of newborn calves. He called the composition
Calf Lung Lipids or “CLL.” The surfactant extract was
obtained by lavaging, or washing it out of, the alveolar spaces
of the lungs of freshly slaughtered newborn calves. The name
of the extract was eventually changed from CLL to “CLSE,”
which stands for Calf Lung Surfactant Extract.

In late January or early February 1981, Dr. Notter
provided Dr. Egan with CLSE for testing in premature lambs
with RDS. In March 1981, Dr. Egan administered the CLSE

40a

Appendix D

to premature lambs and it proved dramatically effective in
allowing the lambs to breath normally. Drs. Egan and Notter
subsequently published several articles regarding their
experiments and laid the groundwork for testing in human
babies.

In June 1983, at Children’s Hospital in Buffalo, Dr. Egan
first used CLSE to treat a premature human baby with RDS.
The treatment was successful and marked the first time a
human baby was successfully treated with a bovine-derived
surfactant in the United States. Dr. Egan thereafter published
the results of his work and commenced extensive clinical
trials of CLSE over the next several years. Dr. Egan ultimately
named the pharmaceutical composition made from CLSE
“Infasurf.”

F. Commercial Development of Tokyo Tanabe
Patents

In early 1983, defendant Abbott Laboratories (“Abbott”),
a large pharmaceutical manufacturer headquartered near
Chicago, Illinois, began investigating the possibility of
commercial development of a lung surfactant composition
for treating RDS in premature babies. Abbott already had a
large presence in neonatal pharmaceuticals, manufacturing
nutritional and other drug products for newborns. Abbott
assigned Dr. Alan J. Gold, its Medical Director of
Pharmaceuticals, to conduct the investigation.

As part of his investigation, Dr. Gold considered whether
Abbott should enter into a licensing agreement with Tokyo
Tanabe to develop a surfactant based on the ’301 and ’839

af”

4la

Appendix D

patents. In August 1983, Dr. Gold spent two days in Japan
meeting with Dr. Fujiwara and representatives of Tokyo
Tanabe regarding their, work on pulmonary surfactants.

During his investigation, Dr. Gold also became aware
of CLSE and the work of Drs. Egan and Notter and arranged
a meeting with them. In November 1983, Dr. Gold met with
Drs. Egan, Notter, and Shapiro in Rochester and learned from
them “virtually everything” about CLSE, including the
development, composition and testing of the surfactant. Trial
Transcript (“Tr.”) at 4938. At that meeting, Dr. Gold told the
three doctors that Abbott wanted to produce a product that
would be protected by a patent. Drs. Egan, Notter and Shapiro
hoped that Abbott would take over the commercial
development of CLSE. Eventually, however, Abbott decided
to proceed with the Tokyo Tanabe product instead because,
unlike CLSE, it was covered by patents. Abbott subsequently
informed Drs. Egan, Notter and Shapiro of its decision.

On February 3, 1984, Tokyo Tanabe granted Abbott an
exclusive license for the Tokyo Tanabe patents in the United
States. Plaintiffs’ Trial Exhibit (“PTX”) 20. After being
granted the license, Abbott developed a commercial product,
based on the Tokyo Tanabe patents, called “Survanta.” Abbott
first used Survanta in clinical trials in the United States in
1985, more than two years after the first baby in this country
was treated with CLSE. Abbott eventually sought approval
from the United States Food and Drug Administration
(“FDA”) to market Survanta. On July 1, 1991, the FDA
approved Survanta for the treatment of RDS in premature
babies. At the same time, the FDA granted Abbott a seven-

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Appendix D

year period of market exclusivity under the Orphan Drug
Act, 21 U.S.C. §§ 360aa-360dd.4

G. Formation of ONY, ONY’s Agreement With
Forest, and Abbott’s Claim of Infringement

In 1985, Dr. Egan formed ONY,’ a small pharmaceutical
company, for the sole purpose of developing CLSE and
making it available to children. ONY has a manufacturing
plant in Amherst, New York and employs approximately
20 employees. ONY manufactures only Infasurf and has no
plans to manufacture any other type of drug. Dr. Egan gave
up his full-time job at Children’s Hospital and his full-time
position at the U.B. Medical School in order to run ONY.

4. The Orphan Drug Act creates a financial incentive for the
development of drugs for rare diseases or conditions. A “rare disease
or condition” is one which affects less than 200,000 persons in the
United States or which affects more than 200,000 persons and for
which there is no reasonable expectation that the cost of developing
and marketing the drug will be recovered from sales in the United
States. 21 U.S.C. § 360bb(a)(2).

The most important financial incentive under the Act is a seven-
year period of market exclusivity granted to the first designated drug
that is approved by the FDA for a particular disease or condition.
21 U.S.C. § 360cc(a). The FDA enforces this market exclusivity by
denying all subsequent applications for the “same drug” used for the
same therapeutic purpose. 21 C.F.R. § 316.3(b)(12).

5. ONY stands for Ontario/ New York. Dr. Egan chose this name
because the scientists who were helping to organize ONY were from
Ontario, Canada and New York State.

43a m

Appendix D

In June 1985, the FDA granted ONY’s request for
preliminary designation of Infasurf as an Orphan Drug. By
March 1986, ONY had received Investigational New Drug
(“IND”) status from the FDA and was granted what is
commonly referred to as a “treatment IND,” which allowed
ONY to conduct clinical trials using Infasurf.

In June 1991, ONY entered into an agreement with
plaintiff Forest Laboratories, Inc. (“Forest’’) to develop and
market Infasurf. Forest is a pharmaceutical company located
in New York City. In the agreement, ONY warranted to Forest
that ONY was the sole and exclusive owner of the rights to
Infasurf and agreed to indemnify Forest for the cost of settling
any Claims brought by any third parties.

In June 1994, Carl A. Spalding, Vice President and
General Manager of Abbott’s Pediatric Products Division,
wrote a letter to Forest’s President, Howard Solomon, stating
that, in Abbott’s opinion, there was reason to believe that
Infasurf might infringe the Tokyo Tanabe patents. Prior to
this letter, neither Abbott nor Tokyo Tanabe had ever
mentioned to Dr. Egan, ONY, or Forest that Infasurf might
infringe the Tokyo Tanabe patents. :

On March 13, 1995, ONY submitted a new drug
application (“NDA”) to the FDA for approval to market
Infasurf. On May 24, 1996, the FDA notified ONY that
Infasurf and Survanta are the “same drug” for purposes of
the Orphan Drug Act. See 21 C.F.R. § 316.3(b)(13).
Accordingly, under the Act, the FDA would not approve the
sale of Infasurf until July 1, 1998, the date on which Abbott’s
seven-year period of market exclusivity was to expire.

44a

Appendix D

H. Instant Lawsuit

On March 8, 1996, ONY and Forest commenced the
instant action seeking a declaratory judgment that Infasurf
does not infringe the Tokyo Tanabe patents. They also seek a
declaratory judgment that the Tokyo Tanabe patents are
invalid or that, in the alternative, Tokyo Tanabe and Abbott
should be estopped from enforcing the patents under the
doctrine of equitable estoppel.

Tokyo Tanabe and Abbott counterclaimed that Infasurf
infringes the Tokyo Tanabe patents. They claim that such
infringement is willful. They seek a permanent injunction
that would prevent ONY and Forest from manufacturing and
marketing Infasurf until after both patents expire.

A jury trial commenced on June 12, 1998. Prior to trial,
defendants moved to strike plaintiffs’ equitable estoppel
defense. By Decision and Order filed June 12, 1998, the Court
denied defendants’ motion and ruled, pursuant to Federal
Rule of Civil Procedure 39(c), that it would use the jury in
the case as an advisory jury on the issue of equitable estoppel.
On August 10, 1998, the Court issued a Decision and Order
explaining its reasoning for the June 12, 1998 Decision
and Order.

On July 1, 1998, during the trial, the FDA approved the
sale of Infasurf, but plaintiffs agreed to maintain the status
quo until the end of the trial. On September 11, 1998, the
jury returned a verdict in favor of the defendants, Abbott
and Tokyo Tanabe, on the issues of infringement and validity.
The jury also rendered an advisory verdict in favor of

45a

Appendix D

defendants on the issue of equitable estoppel. The jury also
determined, however, that plaintiffs’ infringement was not
willful.

II. Jury’s Advisory Verdict on Equitable Estoppel is not
Binding

Equitable estoppel is an equitable defense to a claim of
patent infringement and, as such, must ultimately be decided
by the Court, not a jury. ABB Robotics, Inc. v. GMFanuc
Robotics, Inc., 52 F.3d 1062, 1063 (Fed. Cir. 1995) (“estoppel
is an equitable defense to a charge of patent infringement
... Being an equitable doctrine, estoppel is committed to
the sound discretion of the trial judge”), cert. denied, 516
U.S. 917 (1995); cf. Paragon Podiatry Lab. v. KLM Labs.,
984 F.2d 1182, 1190 (Fed. Cir. 1993) (“defense of inequitable
conduct in a patent suit, being entirely equitable in nature, is
not an issue for the jury to decide’’). In this case, the Court
used an advisory jury on the issue of equitable estoppel. The
jury found that equitable estoppel does not apply.

Federal Rule of Civil Procedure 52(a) provides that “in
all actions tried upon the facts without a jury or with an
advisory jury, the court shall find the facts specially and state
separately its conclusions of law thereon.” The use of an
advisory jury does not replace the Court as the true trier of
fact. The responsibility for rendering a decision always
remains with the Court. The verdict of an advisory jury has
no binding effect; the Court may accept the advisory verdict
in whole or in part, or disregard it completely. See Ragin v.
Harry Macklowe Real Estate Co., 6 F.3d 898, 907 (2d Cir.
1993).

46a -
Appendix D

Here, the Court rejects the jury’s advisory verdict on
equitable estoppel because it finds that the proof at trial
established by a preponderance of the evidence that Abbott
and Tokyo Tanabe should be estopped from asserting a claim
of patent infringement against ONY and Forest.

III. Legal Standards for Equitabie Estoppel

Equitable estoppel is not limited to a particular factual
situation, or subject to simple, hard and fast rules.
Nevertheless, the Federal Circuit has articulated a three-part
test to guide courts in determining whether the doctrine of
equitable estoppel should to be applied to bar recovery.
See Gasser Chair Co. v. Infanti Chair Mfg. Co., 60 F.3d 770,
775 (Fed. Cir. 1995); A.C. Aukerman Co. v. R.L. Chaides
Constr. Co., 960 F.2d 1020, 1041 (Fed. Cir. 1992). First, the
alleged infringer must show that the patentee, through
misleading conduct, led the alleged infringer to reasonably
infer that the patentee did not intend to enforce its patent
against the infringer. Second, the alleged infringer must
demonstrate reliance on that conduct. Finally, the alleged
infringer must show that it will be materially prejudiced if
the patentee is permitted to proceed with an enforcement
claim against the alleged infringer. A.C. Aukerman, 960 F.2d
at 1028, 1041. In order to prevail, the alleged infringer must
establish each of these elements by a preponderance of the
evidence. /d. at 1045-46. Once established, this defense bars
all relief on the patentee’s claims of infringement. /d. at 1028,
1041.

47a

Appendix D

A. Misleading Conduct

The first element of equitable estoppel that the alleged
infringer must show is that the patentee, through misleading
conduct, led the alleged infringer to reasonably infer that the
patentee did not intend to enforce its patent against the
infringer. In order to prove misleading conduct, the alleged
infringer must show that the patentee somehow
communicated to the alleged infringer that it did not intend
to press an infringement claim. /d. at 1042. The alleged
infringer may satisfy this requirement by producing evidence
of affirmative statements or conduct by the patentee from
which it is reasonable to infer that the patentee was not going
to pursue an infringement claim. /d.

Misleading conduct by the patentee may also take the
form of silence, if the patentee had a clear duty to speak or
such silence was accompanied by some other factor indicating
that the silence was sufficiently misleading to amount to bad
faith. ABB Robotics, 52 F.3d at 1064; A. C. Aukerman, 960
F.2d at 1042-44. For example, in the most common scenario,
the patentee expressly objects to the alleged infringer’s
activities, but does not follow up with an infringement lawsuit
for some period of years. This is not the only way, however,
that silence can be misleading conduct for equitable estoppel
purposes. ABB Robotics, 52 F.3d at 1064. Rather, inaction
“combined with other facts respecting the relationship or
contacts between the parties” may “give rise to the necessary
inference that the claim against the [alleged infringer] is
abandoned.” /d. (quoting A. C. Aukerman, 960 F.2d at 1042);
see also Scholle Corp. v. Blackhawk Molding Co., 133 F.3d
1469, 1472 (Fed. Cir. 1998) (“When the course of dealings

48a

Appendix D

between a patentee and an alleged infringer is such that the
alleged infringer reasonably infers from the patentee’s
misleading conduct or inaction that the patentee has waived
its patent rights, then the first element of equitable estoppel
has been established absent a statement to the contrary by
the patentee.”); R2 Med. Sys. v. Katecho, Inc., 931 F. Supp.
1397, 1417 (N.D. Ill. 1996) (“For instance, such a duty [to
speak] may arise . . . where the patentee’s conduct encourages
the subsequently challenged activity.”); Stambler v. Diebold,
Inc., 11 U.S.P.Q.2d 1709, 1715 (E.D.N.Y. 1988) (finding that
patent owner had a duty to speak and its silence was
intentionally misleading where it had long known of the
alleged infringement and permitted the conduct to continue),
aff'd without op., 878 F.2d 1445 (Fed. Cir. 1989).

In order to satisfy the misleading conduct
requirement, the alleged infringer need not prove that the
patentee’s misleading of the alleged infringer was intentional.
A. C. Aukerman, 960 F.2d at 1043. The question is whether
the alleged infringer was, in fact, misled. Of course, if there
is evidence of an intent to mislead, that weighs in favor of
applying equitable estoppel. Jd.

B. Reliance

The second element of equitable estoppel that an alleged
infringer must show is reliance. In order to prove reliance,
the alleged infringer must show that it “had a relationship or
communication with the [patentee] which lulled the infringer
into a sense of security” that the infringer’s conduct would
not invite an infringement suit. Jd.; see also ABB Robotics,
52 F.3d at 1064. The fact that an alleged infringer failed to

49a

Appendix D

take affirmative actions to protect itself from an infringement
lawsuit is evidence of its reliance. See ABB Robotics, Inc. v.
GMFanuc Robotics Corp., 828 F. Supp. 1386, 1398-1400
(E.D. Wis. 1993), aff’d, 52 F.3d 1062 (Fed. Cir. 1995);
Wafer Shave, Inc. v. Gillette Co., 857 F. Supp. 112, 124
(D. Mass. 1993), aff’d without op., 26 F.3d 140 (Fed. Cir.
1994).

C. Prejudice

The third element of equitable estoppel that the alleged
infringer must show is that it will be materially prejudiced if
the patentee is permitted to proceed with an enforcement
claim against the alleged infringer. Prejudice may be either
economic or evidentiary. A.C. Aukerman, 960 F.2d at 1033,
1043. Economic prejudice may be a change of economic
position during the period of delay. /d. For example,
economic prejudice may arise where the alleged infringer
will suffer the loss of monetary investments or incur damages
which likely would have been prevented had the patentee
asserted its infringement claim earlier. Jd. at 1033.

Evidentiary prejudice occurs where an alleged infringer
is unable “to present a full and fair defense on the merits,
due to the loss of records, the death of a witness, or the
unreliability of memories of long past events.” Jd.; Advanced
Hydraulics, Inc. v. Otis Elevator Co., 525 F.2d 477, 482
(7th Cir.) (finding prejudice where crucial witness died), cert.
denied, 423 U.S. 869 (1975); Wafer Shave, 857 F. Supp. at
126 (holding that lost opportunity to preserve important
documentary and testimonial evidence constitutes prejudice);
Motorola, Inc. v. CBS, Inc., 672 F. Supp. 1033, 1037

~~

*

50a

Appendix D

(N.D. Ill. 1986) (holding that a long time lag leads inevitably
to some lossof memory and documentation).

IV. Findings of Fact Regarding Equitable Estoppel

Applying the above legal principles to the instant case,
the Court finds by a preponderance of the evidence that
Abbott misled ONY and Forest into believing that Abbott
would not assert an infringement claim against them, that
ONY and Forest reasonably relied on Abbott’s misleading

conduct, and that ONY and Forest will be materially
prejudiced if Abbott is now permitted to proceed with an
infringement claim against them. The following facts are
those the Court finds have been established that support this
conclusion.

A. Misleading Conduct

ONY and Forest have shown by a preponderance of the

evidence that Abbott, through misleading conduct, led them
to reasonably infer that Abbott did not intend to enforce the
Tokyo Tanabe patents against them. This is not, as defendants
contend, a case involving mere silence or inaction on the
part of the patentee. To the contrary, the evidence shows that
between 1983 and 1994, Abbott was fully aware of ONY’s
and Forest’s activities and, in fact, up until 1991, Abbott
actively encouraged Dr. Egan and ONY in their efforts to
“develop CLSE. Such conduct created a duty on the part of
Abbott to advise ONY and Forest about possible infringement
of the Tokyo Tanabe patents. Yet, Abbott never mentioned
infringement until June of 1994, eleven years after it first
learned about CLSE.

Sla
Appendix D

The evidence also shows that the reason Abbott kept
encouraging Dr. Egan in his efforts to develop CLSE, even
though he was developing a potentially competing product,
was because Abbott wanted to keep its options open in case
Survanta did not succeed for some reason. After Survanta
finally obtained FDA approval, Abbott stopped stringing
along Dr. Egan and asserted its infringement claim against
ONY and Forest.

1. Abbott’s Contacts with Drs. Egan and Notter

a. Initial Encouragement and Patent-
ability Search

Even after Abbott decided in February 1984 to proceed
with development of the Tokyo Tanabe product rather than
CLSE, Abbott encouraged Drs. Egan, Notter and Shapiro to
continue their work and solicited from them more information
about CLSE. In March 1984, Dr. Gold sent ‘a confidential
disclosure form to Dr. Shapiro seeking information about
CLSE for the purpose of evaluating its patentability.
Defendants’ Trial Exhibit 473. The last sentence of Dr. Gold’s
letter states, “once again, I appreciate your willingness to
work with us and I look forward to developing a productive
relationship.” The attached confidentiality agreement says
“this letter will confirm the interest of Ross Laboratories
Division of Abbott Laboratories (‘Ross’) in receiving certain
information from you. ...” At this time, Abbott had not yet
started clinical trials with the Tokyo Tanabe product and was
pessimistic about receiving a treatment IND from the FDA
to allow such testing. See PTX 317.

52a

Appendix D

In April 1984, pursuant to Abbott’s request, Drs. Egan,
Notter, and Shapiro submitted a Memorandum of Invention
(“MOI”) to Abbott. The MOI disclosed the details of
everything known about CLSE, including its use and its
method of manufacture. See PTX 665. The MOI explained
that aqueous suspensions of CLSE had first been used
successfully with lambs in March 1981 and that at the time
of the MOI, CLSE was being used in ongoing clinical trials
in human babies. Upon receipt of the MOI, Dr. Gold arranged
for Abbott’s patent department to do a patentability search.

Dr. Gold had previously told Drs. Egan and Notter that
Abbott was concerned about patentability and was only
interested in a product that had patent protection. He also
told them that Abbott had elected to commercialize the Tokyo
Tanabe product instead of CLSE because the Tokyo Tanabe
product had patent protection and CLSE did not. Thus,
Drs. Egan and Notter submitted the MOI to Abbott in the
hope that there would be something patentable about CLSE
and, as a result, Abbott would develop it.

Dr. Egan explained that he and Drs. Notter and Shapiro
“were hoping that we would convince Abbott to
commercialize CLL and make it available to children.”
Tr. 6003-04. He also testified that he understood that, as far
as Abbott was concerned, patent protection “would seem to
be the deciding and crucial difference, as far as the corporate
people were concerned. So we were trying to see if we could
get something, some patent protection for our material.”
Tr. 6004.

53a

Appendix D

On May 29, 1984, Abbott’s patent counsel, Margaret M.
O’Brien, responded by letter to the MOI (the “O’Brien
letter”). Ms. O’Brien concluded that “the chances of obtaining
significant patent protection” for the CLSE product itself or
the process for making CLSE was minimal. PTX 41. Ms.
O’Brien also enclosed “the pertinent references” she found.
Those references were a 1982 article by Dr. Notter and an
April 1981 abstract by John A. Smyth and others. PTX 41.
Despite the fact that in February 1984, Abbott had become
the exclusive licensee of the Tokyo Tanabe patents and
therefore had a vested interest in ensuring that those patents
were not infringed, Ms. O’Brien did not mention the Tokyo
Tanabe patents in her letter and did not attach them as
“pertinent references.” She gave no indication whatsoever
of possible infringement of the Tokyo Tanabe patents. Even
though she purported to have completed a patentability search
for the “surfactant extract,” that is; CLSE, she did not indicate
in any way that CLSE was not patentable due to the existence
of the Tokyo Tanabe patents.

Ms. O’Brien did, however, compliment the work of
Drs. Egan and Notter as “outstanding” and concluded:
“we look forward to working with you in the future.”
PTX 41. In short, she encouraged Drs. Egan and Notter to
continue their work on CLSE even though in February 1984,
Abbott had just obtained an exclusive license to the Tokyo
Tanabe patents.°

6. Ms. O’Brien’s letter stated in its entirety:

We have completed a patentability search for your

surfactant extract and process for making the extract.
(Cont'd)

54a

Appendix D

Dr. Egan testified that when his group received the
O’Brien letter, “we were very disappointed. We really wanted
Abbott to commercialize our material.” Tr. 6007. He also
explained his understanding that:

there was no real patentability of our product. And
we also concluded that our product was not
covered under whatever patents covered the
surfactant that Abbott had licensed from Tokyo
Tanabe. Because if our material had been covered
by those patents, that would have solved our
problem. Then there would have been patent
protection for our material, and that would have
been great with us.

Tr. 4976.

Dr. Egan also testified that as a result of the O’Brien
letter:

I was given to understand that neither the process
nor the material was patentable. And that it was

(Cont'd)
We are enclosing copies of the pertinent references found
in our search.

Based on these references, we believ

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386015_2396%3A1. Public record. Not legal advice.
