Court Opinion

ID: 2714537
Source: CourtListenerOpinion
Date Created: 2014-08-06 16:05:06.648374+00
Date Added: 2024-06-11T13:21:33.264353
License: Public Domain

United States Court of Appeals
      for the Federal Circuit
                ______________________

       TYCO HEALTHCARE GROUP LP AND
            MALLINCKRODT INC.,
              Plaintiffs-Appellees,

                           v.

MUTUAL PHARMACEUTICAL COMPANY, INC. AND
  UNITED RESEARCH LABORATORIES, INC.,
           Defendants-Appellants.
           ______________________

                      2013-1386
                ______________________

    Appeal from the United States District Court for the
District of New Jersey in No. 07-CV-1299, Judge Stanley
R. Chesler.
                 ______________________

                Decided: August 6, 2014
                ______________________

   PETER E. STRAND, Shook, Hardy & Bacon, L.L.P., of
Washington, DC, argued for plaintiffs-appellees. With
him on the brief were JOHN D. GARRETSON and REBECCA J.
SCHWARTZ, of Kansas City, Missouri.

   STEFFEN N. JOHNSON, Winston & Strawn LLP, of
Washington, DC, argued for defendants-appellants. With
him on the brief were CHARLES B. KLEIN, JOHN K. HSU,
and EIMERIC REIG-PLESSIS, of Washington, DC, and
JAMES F. HURST, of Chicago, Illinois.
2    TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO.

                  ______________________

     Before NEWMAN, BRYSON, and MOORE, Circuit Judges.
    Opinion for the court filed by Circuit Judge BRYSON.
    Dissenting opinion filed by Circuit Judge NEWMAN.
BRYSON, Circuit Judge.
     Mutual Pharmaceutical Company, Inc., and United
Research Laboratories, Inc., (collectively, “Mutual”)
appeal from a summary judgment entered by the United
States District Court for the District of New Jersey in
favor of Tyco Healthcare Group LP and Mallinckrodt, Inc.,
(collectively, “Tyco”). In the order on appeal, the district
court held that Tyco did not violate the antitrust laws by
filing suit against Mutual or by filing a “citizen petition”
with the Food and Drug Administration (“FDA”) seeking
to bar Mutual from obtaining FDA permission to market
its generic version of one of Tyco’s drugs. We affirm in
part, vacate in part, and remand.
                             I
    Tyco is the owner of several patents directed to formu-
lations or methods of treatment with temazepam, a drug
used to treat insomnia. Tyco markets temazepam under
the brand name Restoril. Tyco acquired Restoril and
several related patents from Sandoz Limited in 2001. The
patents all claim 7.5 mg formulations of temazepam
having a specific surface area between 0.65 and 1.1
square meters per gram (m2/g). Specific surface area is a
measure of the surface area of a drug per unit of weight.
Generally, as chunks of drug material are ground down
into smaller particles, the specific surface area increases
because more of the drug is exposed to the surrounding
environment.
    The claims of the temazepam patents do not recite
any particular measurement technique. However, the
specifications of each of the patents state that “[s]urface
TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO.      3

area measurements are made essentially in accordance
with the standard B.E.T. procedure of Brunauer, Emmet
and Teller.” E.g., U.S. Patent No. 5,211,954 (“the ’954
patent”), col. 2, ll. 1-4.
    B.E.T. testing is a gas-adsorption technique for meas-
uring specific surface area. The procedure measures the
amount of an adsorbate gas that has bound to the surface
of the test material. In order to prepare a sample of a
drug for measurement, a process of outgassing is per-
formed, during which gas or vapor is removed from the
surface of the sample to produce a clean surface that can
be measured accurately. Outgassing is performed at a
particular temperature, and the selection of that tempera-
ture can affect the ultimate specific surface area meas-
urement. Increasing the outgassing temperature speeds
the process of cleaning the test material’s surface and
allows measurements to be obtained more quickly. It is
important, however, to avoid selecting a temperature so
high that the heat physically alters the test material, for
example by softening or melting it.
    Sandoz conducted specific surface area testing while
seeking FDA approval for Restoril. Tyco also performed
testing after acquiring Restoril and the temazepam pa-
tents. In both cases, the testers used the B.E.T. proce-
dure with an outgassing temperature of 105°C.
    In November 2006, Mutual filed an Abbreviated New
Drug Application (“ANDA”) with the FDA, seeking ap-
proval to manufacture and sell a generic 7.5 mg version of
temazepam. Mutual’s ANDA represented that its product
would have a specific surface area of not less than 2.2
m2/g, which was well above the specific surface area range
claimed in the temazepam patents. Mutual’s ANDA
included a certification representing that the generic drug
was not protected by a U.S. patent, as required by 21
U.S.C. § 355(j)(2)(A)(vii). Mutual’s certification was filed
under paragraph IV of section 355(j)(2)(A)(vii), which
4   TYCO HEALTHCARE GROUP     v. MUTUAL PHARMACEUTICAL CO.

permits a generic manufacturer to assert that the patent
or patents at issue are invalid or that the generic product
that is the subject of the ANDA would not infringe those
patents. Such certifications are known as “paragraph IV
certifications.” On February 5, 2007, Mutual sent Tyco a
“paragraph IV certification letter” notifying Tyco of its
ANDA. The letter set forth Mutual’s position that the
proposed ANDA product would not infringe the temaze-
pam patents because the generic product’s specific surface
area would not fall within the 0.65-1.1 m2/g range claimed
by those patents.
     In response to Mutual’s paragraph IV certification,
Tyco filed an action alleging that Mutual’s ANDA in-
fringed Tyco’s patents under 35 U.S.C. § 271(e)(2)(A), the
special infringement provision of the Hatch-Waxman Act.
Pursuant to the automatic stay provision of the Act, 21
U.S.C. § 355(j)(5)(B)(iii), Tyco was entitled to an automat-
ic stay of the FDA’s approval of Mutual’s ANDA until the
earlier of 30 months from the date Tyco filed its complaint
or the date that a court determined that Tyco’s patents
were invalid or not infringed by Mutual’s ANDA. In its
amended answer, Mutual raised antitrust counterclaims,
which the district court temporarily stayed pending the
resolution of Tyco’s infringement claims.
    On August 4, 2009, the district court granted judg-
ment of noninfringement under Fed. R. Civ. P. 52(c). At
that point only the ’954 patent was at issue because
Tyco’s other temazepam patents had expired.
     Based on this court’s decision in Bayer AG v. Elan
Pharmaceutical Research Corp., 212 F.3d 1241 (Fed. Cir.
2000), the district court found that Mutual did not in-
fringe the ’954 patent under section 271(e) because Mutu-
al’s ANDA “defines the proposed temazepam product in a
manner that directly addresses the issue of infringement”
and because a “product manufactured to the ANDA’s
specification,” i.e., a product having a specific surface area
TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO.      5

of not less than 2.2 m2/g, “could not literally infringe the
’954 Patent.” Tyco Healthcare Grp. LP v. Mutual Pharm.
Co., No. 2:07-cv-01299, slip op. at 6, 13 (D.N.J. Aug 4,
2009).
    On August 5, 2009, the day after the district court en-
tered its judgment of noninfringement, Tyco filed a citizen
petition with the FDA. The citizen petition urged the
FDA to change the criteria for evaluating the bio-
equivalence of proposed generic temazepam products in
order to “help ensure therapeutic equivalence” of generic
temazepam to Restoril. Tyco proposed guidelines that
would require generic temazepam manufacturers to
demonstrate bioequivalence to Restoril through a series of
pharmacokinetic parameters considerably more extensive
and complex than the parameters traditionally required
by the FDA for a bioequivalence determination. Tyco
reasoned that the safety and efficacy of Restoril was likely
linked to its pharmacokinetic profile, and that changes to
parameters such as specific surface area in a generic
version could alter that profile and thereby affect the
safety and efficacy of the generic version as compared to
Restoril.
     On September 8, 2009, although the citizen petition
was still pending, the FDA approved Mutual’s ANDA,
which allowed Mutual to bring its generic temazepam
product to market. Five months later, the FDA denied
Tyco’s citizen petition in its entirety. The FDA concluded
that Tyco “had not provided adequate evidence to support
any of the actions requested in the petition” and that
there was “no basis” for adopting Tyco’s proposed bio-
equivalence criteria. In addition, the FDA found that the
citizen petition “relie[d] entirely on uncorroborated gener-
alities and theoretical speculation.” The FDA explained
that it “require[s] additional bioequivalence criteria” in
“very rare circumstances.” Those circumstances, accord-
ing to the FDA, have arisen only in the case of “complex
extended-release or otherwise modified-release products
6   TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO.

for which there was a known and clinically significant
connection between release characteristics and clinical
performance.” Temazepam, the FDA explained, “is not
such a drug.”
    On May 5, 2010, the district court granted summary
judgment on Mutual’s invalidity counterclaim, holding
the claims of the ’954 patent invalid for obviousness. This
court affirmed that decision. Tyco Healthcare Grp. LP v.
Mutual Pharm. Co., 642 F.3d 1370, 1377 (Fed. Cir. 2011).
We held that the only feature of the ’954 claims not found
in the prior art 15 mg Restoril capsules was the 7.5 mg
temazepam dosage level. That dosage level, however, was
disclosed in a 1983 volume of the British National Formu-
lary (“BNF”) that recommended administering between 5
and 15 mg of temazepam for the treatment of insomnia in
the elderly. Id. at 1372. This court rejected Tyco’s argu-
ment that various prior art references taught away from
that 7.5 mg dosage level. See id. at 1374-76. We also
rejected Tyco’s argument that the BNF reference did not
teach the 7.5 mg dose because it did not provide evidence
of the efficacy of that dose. See id. at 1373-74.
    After our disposition of the first appeal, the district
court lifted the stay of Mutual’s antitrust counterclaims.
The court then granted summary judgment to Tyco on all
of those counterclaims. Tyco Healthcare Grp. LP v. Mu-
tual Pharm. Co., No. 2:07-cv-1299 (D.N.J. Jan. 18, 2013).
    The district court first rejected Mutual’s claim that
Tyco’s section 271(e)(2)(A) infringement claim constituted
sham litigation that subjected Tyco to antitrust liability
for using illegitimate means to keep the product of its
competitor, Mutual, off the market. The court noted that
the dispute over infringement turned on the specific
surface area limitation. Mutual claimed that the specific
surface area of its generic product was 2.2 m2/g and thus
outside the range of 0.65 to 1.1 m2/g claimed in the ’954
patent. The evidence showed, however, that in testing its
TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO.      7

proposed ANDA product, Mutual had used an outgassing
temperature of 40°C, while Tyco had used an outgassing
temperature of 105°C in its tests of the product. Because
of that difference in temperatures used during the meas-
urement process, the court concluded that it was reasona-
ble for Tyco to proceed with its infringement action.
     The district court also rejected Mutual’s argument
that no reasonable litigant could have expected Tyco’s
patents to withstand a validity challenge. The court
reasoned that, given the presumption of validity and the
clear-and-convincing evidence standard for proving inva-
lidity, Mutual had failed “to submit evidence sufficient to
demonstrate a material factual question about whether
Plaintiffs objectively had a reasonable basis to believe
that they had a chance to succeed.” Tyco, No. 2:07-cv-
1299, slip op. at 9 (D.N.J. Jan. 18, 2013) (emphasis in
original).
    The district court next rejected Mutual’s claim that
Tyco’s citizen petition was a sham. The court reasoned
that Mutual had put forward an inadequate legal theory
because, according to the court, antitrust liability for
sham claims “is expressly limited to litigation” and there-
fore does not apply to conduct such as the filing of an
administrative petition. The court also found that Mutual
had failed to put forward evidence that would allow the
inference that the citizen petition was an attempt to
interfere directly with the business relationships of a
competitor.
    Finally, the district court rejected Mutual’s claim that
Tyco was subject to antitrust liability because its action
was the product of fraud within the meaning of the Su-
preme Court’s decision in Walker Process Equipment, Inc.
v. Food Machinery & Chemical Corp., 382 U.S. 172 (1965).
The court found that Mutual’s evidence supported two
factual assertions: (1) that Tyco had read the relevant
patents’ prosecution histories and (2) that Tyco knew of
8   TYCO HEALTHCARE GROUP    v. MUTUAL PHARMACEUTICAL CO.

the “Memo for the Record,” which documented a 1984
teleconference between Sandoz and the FDA during which
an FDA doctor told Sandoz that temazepam doses from 5
to 15 mg were recommended in Great Britain for the
elderly. That evidence, according to the district court, “at
most . . . supports the inference that Plaintiffs were aware
that relevant prior art existed that could impact the
validity or enforceability of the patents.” According to the
district court, however, that was “a far cry . . . from
demonstrating that [Tyco] knew that Sandoz had engaged
in a deliberately planned and carefully executed scheme
to defraud the Patent Office.” Mutual subsequently took
this appeal from the district court’s summary judgment
order.
                             II
    1. A party is ordinarily exempt from antitrust liabil-
ity for bringing a lawsuit against a competitor. That
principle is known as “Noerr-Pennington immunity,”
because it originated with the Supreme Court’s decisions
in Eastern Railroad Presidents Conference v. Noerr Motor
Freight, Inc., 365 U.S. 127 (1961), and United Mine Work-
ers of Am. v. Pennington, 381 U.S. 657 (1965). There is a
recognized exception to Noerr-Pennington immunity for
“sham litigation,” which the Supreme Court has defined
as litigation that (1) is “objectively baseless in the sense
that no reasonable litigant could realistically expect
success on the merits” (the objective element), and (2) is
motivated by a desire “to interfere directly with the busi-
ness relationships of a competitor” (the subjective ele-
ment). Prof’l Real Estate Investors, Inc. v. Columbia
Pictures Indus., Inc., 508 U.S. 49, 60-61 (1993) (“PRE”).
     On appeal, Mutual asserts that there is a disputed is-
sue of fact concerning whether Tyco’s infringement suit
was “objectively baseless” so as to fall within the sham-
litigation exception to Noerr-Pennington immunity.
According to Mutual, the section 271(e)(2)(A) infringe-
TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO.      9

ment claim rejected by this court in Bayer AG v. Elan
Pharmaceutical Research Corp., 212 F.3d 1241 (Fed. Cir.
2000), is legally and factually indistinguishable from
Tyco’s claim. In Elan, we held that an ANDA that recited
a drug’s specific surface area falling outside the range
claimed in the relevant patents could not infringe those
patents under section 271(e)(2)(A). Despite the patent
owner’s argument that the generic manufacturer had not
specified a validated test protocol in its ANDA to measure
specific surface area, we found that the only drug the
generic manufacturer could legally produce under the
ANDA was a drug that does not infringe. See id. at 1248-
50.
    Mutual’s argument, which is based on Elan, ignores
other decisions of this court, and language in Elan itself,
that could give a patentee in Tyco’s position a reasonable
expectation of a favorable outcome even though the gener-
ic manufacturer’s ANDA application describes a generic
drug with characteristics that take it outside the patent’s
claims. The question addressed in Elan and similar cases
is whether the product that the ANDA applicant will
likely market if its application is approved will infringe.
Elan, 212 F.3d at 1248. That can occur in spite of the
ANDA specification if, for example, the ANDA is based on
faulty testing or screening procedures.
    In Bayer AG v. Biovail Corp., 279 F.3d 1340 (Fed. Cir.
2002), this court addressed infringement, under section
271(e)(2)(A), of the same patent at issue in Elan, by the
same generic drug at issue in Elan, but for a different
dose of that drug. Although the legal and factual issues
in Biovail were similar to those in Elan, we found that the
factual evidence proffered in Biovail called for a different
result. In Elan, neither party submitted evidence that
the commercial ANDA product would contain active
ingredients falling within the patent’s specific surface
area range and outside the range specified in the ANDA.
In Biovail, however, the patent owners “introduced evi-
10   TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO.

dence of actual infringement by a commercial tablet made
under the specifications of an allegedly identical ANDA.”
Biovail, 279 F.3d at 1346. That evidence “raise[d] a
legitimate question” under section 271(e)(2)(A) whether
the generic manufacturer would “make a . . . product that
literally infringes Bayer’s . . . patent upon approval of the
ANDA.” Id. at 1346-47.
    Even before Elan, this court held in Glaxo, Inc. v. No-
vopharm, Ltd., 110 F.3d 1562 (Fed. Cir. 1997), that sec-
tion 271(e)(2) “requires an infringement inquiry focused
on what is likely to be sold following FDA approval,” an
inquiry that “must be based on all of the relevant evi-
dence including the ANDA.” Id. at 1568 (emphasis add-
ed). Nothing in Elan is contrary to that holding. See
Elan, 212 F.3d at 1248-49 (in considering infringement
under section 271(e)(2)(A), “it is proper for the court to
consider the ANDA itself, materials submitted by the
ANDA applicant in support of the ANDA, and any other
relevant evidence submitted by the applicant or patent
holder”). We found it significant in Elan that the patent
owner did not allege that the generic manufacturer’s
commercial product would infringe in spite of the ANDA
specification. See 212 F.3d at 1249 & n.6. Similarly, in
Abbott Laboratories v. TorPharm, Inc., 300 F.3d 1367
(Fed. Cir. 2002), another post-Elan case, we stated that
“other evidence may directly contradict the clear repre-
sentations of the ANDA and create a dispute of material
fact regarding the identity of the compound that is likely
to be sold following FDA approval.” Id. at 1373.
    Therefore, we agree with Tyco that it is not unreason-
able for a patent owner to allege infringement under
section 271(e)(2)(A) if the patent owner has evidence that
the as-marketed commercial ANDA product will infringe,
even though the hypothetical product specified in the
ANDA could not infringe.
TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO.    11

     That does not end our inquiry into whether Tyco’s sec-
tion 271(e)(2)(A) infringement claim was objectively
baseless, however. Tyco’s infringement claim is based on
its theory that Mutual’s use of 40°C as the outgassing
temperature was inappropriate and that 105°C—the
temperature at which Tyco and Sandoz tested Restoril—
should have been used instead. The parties do not dis-
pute that the specific surface area of Mutual’s temazepam
falls within the infringing range when the outgassing
temperature is set at 105°C. However, expert testimony
and other evidence, including images from a scanning
electron microscope, suggest that exposing Mutual’s
temazepam to a temperature of 105°C physically alters
the temazepam material itself, resulting in larger temaz-
epam particles and decreased specific surface area.
    In addition, testimony from Mutual’s expert tends to
establish that lower outgassing temperatures result in
measurements that underestimate specific surface area.
If that is true, the difference between the actual specific
surface area of the tested product and the infringing
range would actually be greater than indicated by the
measurement of the tested product obtained at a lower
outgassing temperature. According to Mutual’s expert,
increasing the outgassing temperature merely serves to
accelerate the removal of contaminants from the surface
of the tested material. If full outgassing is not achieved,
the measured specific surface area may be reduced,
because less surface area is available for the test gas to
adsorb to. It therefore stands to reason that, barring
physical alteration to Mutual’s temazepam, Tyco’s de-
mand that Mutual increase the outgassing temperature
would not decrease—but would potentially increase—the
specific surface area measurement due to the removal of
more surface contaminants. Barring physical alteration
of the material, an increased outgassing temperature
would thus make it more likely that Mutual’s commercial
product would measure outside of the infringing range,
12   TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO.

not more likely that it would measure within the infring-
ing range, as Tyco suggests. Tyco’s theory of why Mutu-
al’s as-marketed ANDA product will infringe therefore
appears to be based on a theory contrary to what the
underlying scientific principles dictate. Put simply, even
if Mutual’s specific surface area measurements are wrong,
they would appear to be wrong in a way that does not
help Tyco.
    Based on the evidence of record and this analysis, we
conclude that further inquiry is needed into the effect of
the outgassing temperature on the specific surface area of
Mutual’s generic product. We leave it to the district court
to determine whether that inquiry can be performed
within the context of a summary judgment proceeding or
requires a trial. Accordingly, on remand, the district
court should determine whether Tyco’s factual theory of
infringement is objectively baseless. If necessary, the
court should then determine whether Mutual has shown
that the subjective element of the sham-litigation test has
been satisfied.
    2. Mutual next argues that the district court erred by
granting summary judgment for Tyco with respect to
Mutual’s sham-litigation claim because Tyco lacked a
reasonable prospect of success in defending the validity of
its patents. On that issue, we uphold the district court’s
ruling.
    Given the presumption of patent validity and the
burden on the patent challenger to prove invalidity by
clear and convincing evidence, it will be a rare case in
which a patentee’s assertion of its patent in the face of a
claim of invalidity will be so unreasonable as to support a
claim that the patentee has engaged in sham litigation.
Only if the exacting standards of PRE are satisfied will
the patentee lose its Noerr-Pennington immunity in that
setting. C.R. Bard, Inc. v. M3 Sys., Inc., 157 F.3d 1340,
1368-69 (Fed. Cir. 1998) (“Conduct prohibited under
TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO.     13

antitrust law includes bringing suit to enforce a patent
with knowledge that the patent is invalid or not infringed
. . . . In such events the antitrust immunity of [Noerr and
Pennington] does not apply to those who seek redress
through judicial process. . . . [A]bsent the PRE criteria,
the patentee must have the right of enforcement of a duly
granted patent . . . .”).
     Mutual contends that a reasonable litigant in Tyco’s
position would have known that the asserted patents
would be found invalid for obviousness because the only
difference between the prior-art 15 mg Restoril capsule
and the claimed capsules is the 7.5 mg dose of temaze-
pam. That 7.5 mg dose, Mutual asserts, was clearly
disclosed in the prior art BNF reference and the Memo for
the Record, both of which disclosed temazepam doses in
the 5 to 15 mg range. Mutual contends that a reasonable
litigant would not have sought to defend against an
invalidity challenge because the claimed invention fell
within a range disclosed in the prior art, giving rise to a
presumption of obviousness.
    Mutual’s argument is both legally and factually
flawed. When an invention falls within a range disclosed
in the prior art, the burden of production shifts to the
patent holder, but not the burden of proof, which remains
with the patent challenger throughout. See Galderma
Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 737-38 (Fed. Cir.
2013) (“[W]here there is a range disclosed in the prior art,
and the claimed invention falls within that range, the
burden of production falls upon the patentee to come
forward with evidence that (1) the prior art taught away
from the claimed invention; (2) there were new and unex-
pected results relative to the prior art; or (3) there are
other pertinent secondary considerations.”); Taurus IP,
LLC v. DaimlerChrysler Corp., 726 F.3d 1306, 1322 (Fed.
Cir. 2013) (“After an accused infringer has put forth a
prima facie case of invalidity, the burden of production
shifts to the patent owner to produce sufficient rebuttal
14   TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO.

evidence to prove entitlement to an earlier invention date.
. . . The ultimate burden of proving invalidity by clear and
convincing evidence—i.e., the burden of persuasion—
however, remains with the accused infringer.”); Novo
Nordisk A/S v. Caraco Pharm. Labs., Ltd., 719 F.3d 1346,
1352-53 (Fed. Cir. 2013).
    Mutual also ignores the evidence Tyco offered to meet
its burden of production. Tyco argued that the BNF
reference did not teach a dose in the 5 to 15 mg range
because it did not provide any efficacy evidence for such a
dose. See Tyco, 642 F.3d at 1373-74. Mutual does not
address whether that argument was objectively baseless.
Likewise, Tyco argued that several prior-art references
taught away from the 7.5 mg dose because such a low
dose was thought to be ineffective. See id. at 1374-76.
For example, Tyco argued that one prior-art reference
taught away from a 10 mg dose because it reduced sleep
onset latency but did not increase total sleep time. See id.
at 1374. Tyco’s teaching away argument was not objec-
tively baseless, nor does Mutual suggest on appeal that it
was.
    We conclude that Mutual has not met its burden to
establish that Tyco’s validity arguments were objectively
baseless, even though those arguments were ultimately
unsuccessful. See PRE, 508 U.S. at 60 n.5 (“[W]hen the
antitrust defendant has lost the underlying litigation, a
court must ‘resist the understandable temptation to
engage in post hoc reasoning by concluding’ that an ulti-
mately unsuccessful ‘action must have been unreasonable
or without foundation.’”). We therefore affirm the district
court’s grant of summary judgment for Tyco with respect
to the invalidity portion of Mutual’s sham-litigation
counterclaim.
   3. Mutual next argues that the district court erred by
granting summary judgment for Tyco with respect to
Mutual’s claim that Tyco’s citizen petition to the FDA was
TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO.     15

a sham that stripped Tyco of its Noerr-Pennington im-
munity. Because the district court applied the wrong
legal standard and because disputed issues of material
fact remain, we vacate that portion of the district court’s
judgment.
    The district court concluded that the sham exception
to Noerr-Pennington immunity and the test set forth in
PRE are “expressly limited to litigation” and that Mutual
had therefore failed to set forth a legal standard applica-
ble to sham administrative petitions. PRE’s two-part test,
however, is not limited to court litigation; it has been
applied to administrative petitions, including FDA citizen
petitions. See Cheminor Drugs, Ltd. v. Ethyl Corp., 168
F.3d 119, 122 (3d Cir. 1999) (applying PRE to petitions to
the International Trade Commission and the Department
of Commerce); In re DDAVP Direct Purchaser Antitrust
Litig., 585 F.3d 677, 686 (2d Cir. 2009) (PRE applies to
FDA citizen petitions); In re Lipitor Antitrust Litig., 2013
WL 4780496, at *22 (D.N.J. Sept. 5, 2013) (FDA citizen
petition); In re Flonase Antitrust Litig., 795 F. Supp. 2d
300, 310 n.11 (E.D. Pa. 2011) (collecting cases and noting
that “every court that has considered whether a petition
to the FDA is entitled to Noerr-Pennington immunity has
applied the PRE test”).
    Tyco does not defend the district court’s ruling that
PRE’s two-part test is inapplicable to Tyco’s citizen peti-
tion. Instead, Tyco argues that any error in that regard
was inconsequential because it was not unreasonable for
Tyco to file the citizen petition. We conclude, however,
that there are disputed issues of fact that preclude sum-
mary judgment with respect to whether the citizen peti-
tion was objectively baseless.
    Particularly probative of whether the citizen petition
was reasonable is the FDA’s response, which denied the
petition in terms indicating that, in the FDA’s view, it
was wholly without merit. The FDA found that Tyco had
16   TYCO HEALTHCARE GROUP    v. MUTUAL PHARMACEUTICAL CO.

“provided no evidence from clinical trials, pharmacokinet-
ic studies, bioequivalence testing, or any other source . . . .
Instead the petition relies entirely on uncorroborated
generalities and theoretical speculation to support its
critical point.” The FDA also concluded that the petition
“fail[ed] to provide any evidence at all about the existence,
extent, or significance of surface area variations for any
other generic temazepam products at any dosage
strength.” Furthermore, the FDA noted that it has not
required generic manufacturers to demonstrate additional
bioequivalence criteria except in “very rare instances,” all
of which have involved “complex extended-release or
otherwise modified-release products for which there was a
known and clinically significant connection between
release characteristics and clinical performance” and that
“[t]emazepam is not such a drug.”
    Mutual’s expert reviewed the citizen petition and con-
cluded that “Tyco did not have a scientific basis to con-
clude that Mutual’s product would not be bioequivalent to
Restoril.” She found that some of the criteria Tyco pro-
posed had “limited to no application in bioequivalence
studies” because they “have no relationship to the process
of drug absorption.” The testimony of Mutual’s expert
and the FDA’s response to the citizen petition are suffi-
cient evidence from which a reasonable finder of fact could
conclude that Tyco’s citizen petition was objectively
baseless.
     With respect to the subjective element of the PRE
test, the district court found that Mutual did not produce
any evidence “to support an inference that [the citizen
petition] was an attempt to interfere directly with the
business relationships of a competitor.” Mutual, however,
produced evidence that the citizen petition was filed just
one day after the district court granted Mutual summary
judgment of noninfringement—an event that results in
lifting the automatic stay of the FDA’s approval of the
ANDA, 21 U.S.C. § 355(j)(5)(B)(iii)(I)—and just one week
TYCO HEALTHCARE GROUP    v. MUTUAL PHARMACEUTICAL CO.     17

before the end of the 30-month stay period. According to
Mutual, filing the citizen petition at that late date caused
the FDA to delay the approval of Mutual’s ANDA, and
thus resulted in a further period of market exclusivity for
Tyco.
     Tyco argues that anticompetitive intent cannot be in-
ferred from the timing of the citizen petition because a
protective order was in effect that limited Tyco’s ability to
disclose information about Mutual’s ANDA product.
According to Tyco, it was unable to file the citizen petition
until Mutual made representations in open court about
the ANDA product and its increased surface area. Those
representations, according to Tyco, had the effect of
releasing Tyco from its confidentiality obligations. Specif-
ically, Tyco points to representations Mutual made in
open court on July 16, 2009, that the proposed ANDA
product was a “different product” from Restoril and that
its specific surface area was more than twice that of
Restoril. That information about Mutual’s ANDA prod-
uct, however, had already been publicly disclosed on the
district court’s docket as early as January 22, 2008.
Tyco’s argument that it had to wait until after July 16,
2009, to file the citizen petition is therefore unpersuasive.
    Mutual also points to an email from Tyco’s research
and development department to Tyco’s vice president of
intellectual property. That email assessed the strength of
the temazepam patents in aid of Tyco’s decision whether
to purchase those patents from Sandoz. In the email, the
research and development department stated that a
temazepam formulation that was bioequivalent to Resto-
ril could be made that would have a particle size and
specific surface area different from Restoril. The email
thus constitutes evidence that could support a finding
that Tyco knew the theory in its citizen petition lacked
merit.
18   TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO.

    The timing of the citizen petition and the email are
sufficient evidence from which a reasonable finder of fact
could determine that Mutual had satisfied the subjective
element necessary to show that Tyco’s citizen petition was
a sham. It was therefore error for the district court to
grant summary judgment against Mutual on the citizen
petition issue.
     There remains an open issue, however, as to whether
the filing of the citizen petition caused any antitrust
injury to Mutual. In this court, neither party has pointed
to anything in the record establishing that the citizen
petition was the cause of a delay in the approval of the
ANDA. In support of its contention that the FDA’s ap-
proval was delayed “solely because of Tyco’s petition,”
Mutual cites only the ANDA approval letter. The letter,
however, does not say anything about a delay due to the
citizen petition. On remand, the district court should
determine whether Mutual suffered an anticompetitive
harm in the form of a delay in the approval of its ANDA
due to the filing of Tyco’s citizen petition with the FDA.
Tyco would be entitled to summary judgment if there is
no evidence that the citizen petition caused a delay in the
approval of Mutual’s ANDA. 1
    4. Mutual’s final claim is that Sandoz fraudulently
obtained the temazepam patents from the Patent and
Trademark Office (“PTO”) and that Tyco had knowledge
of that fraud when it sought to enforce the patents
against Mutual in this lawsuit. Asserting that Tyco was
aware of the fraud, Mutual argues that under the Su-

     1   The dissent states that the majority “effectively
holds that Tyco violated the antitrust laws by filing its
‘citizen petition.’” That is incorrect. We have made no
finding of antitrust liability, but hold only that Mutual’s
evidence was sufficient to withstand Tyco’s motion for
summary judgment.
TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO.    19

preme Court’s decision in Walker Process, filing the suit
stripped Tyco, as a patent holder, of its immunity from
the antitrust laws. See Walker Process, 382 U.S. at 177 &
n.5; Nobelpharma AB v. Implant Innovations, Inc., 141
F.3d 1059, 1068-69 (Fed. Cir. 1998).
    Mutual contends that Sandoz committed fraud on the
PTO by omitting information material to the patentability
of temazepam at the 7.5 mg dosage level. First, Mutual
alleges that Sandoz concealed the fact that the claimed
invention used the same specific surface area and particle
size as the prior-art high-dose version of Restoril. Sandoz
disclosed that information to the FDA when seeking
approval for Restoril, but allegedly redacted portions of
the “FDA Approvable Letter” submitted to the PTO that
would have revealed that information. Second, Mutual
alleges that Sandoz knew about the use of temazepam
doses in the 5-15 mg range in Great Britain for the elderly
from its 1984 teleconference with the FDA, which was
documented in the Memo for the Record. References to
the Memo for the Record were also redacted from the
version of the FDA Approvable Letter that Sandoz sup-
plied to the PTO.
    According to Mutual, Tyco had at least constructive
knowledge of Sandoz’s fraud because Tyco conducted a
careful due-diligence review of the patents, their prosecu-
tion histories, and the record of correspondence with the
FDA related to Restoril on multiple occasions, including
once before acquiring the patents and once before filing
this lawsuit. Mutual argues that a reasonable finder of
fact could conclude that Mutual had at least constructive
knowledge of Sandoz’s alleged fraud because Tyco re-
viewed that record and because the record contained the
Memo for the Record, the unredacted version of the FDA
Approvable Letter, and the redacted version of that letter
sent to the PTO.
20   TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO.

     The district court focused on the issue of Tyco’s
knowledge and found that there was insufficient evidence
that Tyco knew at the time it initiated this suit that it
was “seeking to enforce patents which had been procured
by knowing and willful fraud.” Tyco, No. 2:07-cv-1299,
slip op. at 13 (D.N.J. Jan. 18, 2013). The district court
determined that Mutual’s evidence “at most . . . supports
the inference that [Tyco was] aware that relevant prior
art existed that could impact the validity or enforceability
of the patents.” Id. We agree with the district court.
    The redacted FDA Approvable Letter submitted to the
PTO was offered for the limited purpose of overcoming an
obviousness rejection. The applicant referred to the
Approvable Letter only to demonstrate that the 7.5 mg
dose was effective in treating insomnia, which the appli-
cant contended was unexpected in light of other prior art.
The redactions were not focused on material related to the
Memo for the Record or the characteristics of the prior-art
high-dose Restoril. Instead, large sections of the letter
irrelevant to the applicant’s main point were removed,
leaving just two pages of material from the original seven-
page letter. That redacted material includes a passing
reference to the November 29, 1984, teleconference that
resulted in the Memo for the Record and a reference to an
FDA recommendation for the specific surface area for 15
mg and 30 mg Restoril. A reasonable finder of fact could
not conclude that Tyco had knowledge of any alleged
fraud by Sandoz just because Tyco had reviewed the
record and thereby presumably had knowledge of those
redactions from the materials supplied to the PTO. Even
under Tyco’s proposed constructive-knowledge theory, the
redaction evidence is insufficient.
    Likewise, the fact that the record reviewed by Tyco
included the Memo for the Record does not support an
inference that Tyco had knowledge—constructive or
otherwise—of Sandoz’s alleged fraud, especially in light of
Mutual’s burden to show “no less than clear, convincing
TYCO HEALTHCARE GROUP    v. MUTUAL PHARMACEUTICAL CO.     21

proof of intentional fraud involving affirmative dishones-
ty.” C.R. Bard, Inc. v. M3 Sys., Inc., 157 F.3d 1340, 1364
(Fed. Cir. 1998). Mutual’s evidence supports at most an
inference that Tyco knew that its temazepam patents
would be subject to a strong validity challenge. See No-
belpharma, Inc., 141 F.3d at 1069 (“[A] distinction must
be maintained between patents procured by ‘deliberate
fraud’ and those rendered invalid or unenforceable for
other reasons.”).
    Mutual argues that its ANDA notice letter put Tyco
on notice that the examiner had originally allowed the
temazepam patents based on a mistaken belief that the
claimed specific surface area and particle size were novel.
To support that argument, Mutual points to a single
sentence in its notice letter that refers to the examiner’s
reasons for allowance. The notice letter did not claim,
however, that the examiner’s statement was based on a
mistake, that Mutual was challenging the validity of the
temazepam patents, or that the patents were obtained by
fraud. Accordingly, the notice letter is not probative
evidence that Tyco had knowledge of Sandoz’s alleged
fraud. We therefore affirm the judgment of the district
court with respect to Mutual’s Walker Process counter-
claim.
    In summary, we affirm the judgment of the district
court with respect to Mutual’s claim that Tyco’s assertion
of the validity of its patents was a sham and with respect
to Mutual’s Walker Process fraud claim. We vacate the
summary judgment that Tyco’s infringement claims were
not a sham and remand for further proceedings on that
issue, with particular attention to the effect of the differ-
ences in outgassing temperatures on the specific surface
area of Mutual’s product. We also vacate the summary
judgment that Tyco’s citizen petition to the FDA was not
a sham and remand for further proceedings, including a
determination as to whether the citizen petition caused
22    TYCO HEALTHCARE GROUP    v. MUTUAL PHARMACEUTICAL CO.

any injury to Mutual in the form of a delay in the approv-
al of Mutual’s ANDA.
      Each party shall bear its own costs for this appeal.
     AFFIRMED IN PART, VACATED IN PART, AND
                   REMANDED
  United States Court of Appeals
      for the Federal Circuit
                ______________________

       TYCO HEALTHCARE GROUP LP AND
            MALLINCKRODT INC.,
              Plaintiffs-Appellees,

                           v.

MUTUAL PHARMACEUTICAL COMPANY, INC. AND
  UNITED RESEARCH LABORATORIES, INC.,
           Defendants-Appellants.
           ______________________

                      2013-1386
                ______________________

NEWMAN, Circuit Judge, dissenting.
    With its reversal of the district court’s summary
judgment dismissing Mutual’s antitrust counterclaims,
this court now creates several new grounds of antitrust
liability. The panel majority holds that antitrust issues
are raised by Tyco’s Hatch-Waxman suit, although the
suit is for infringement of presumptively valid patents
asserted against a product whose ANDA and Paragraph
IV Certification constituted a technical act of infringe-
ment under 35 U.S.C. §271(e). The constitutional right to
petition government, as well as the patent right to ex-
clude, does not dissipate between competitors.
    My colleagues search for a Sherman Act violation in
the evidence concerning how surface area measurement is
affected by outgassing temperature. Such an issue does
2    TYCO HEALTHCARE GROUP    v. MUTUAL PHARMACEUTICAL CO

not convert routine patent litigation into an antitrust
cause. And by remanding for determination of antitrust
injury based on Tyco’s report to the FDA, this court holds
that such communication can violate antitrust law.
    Tyco’s Hatch-Waxman litigation and Tyco’s report to
the FDA are in accordance with law and the Constitution.
They do not raise Sherman Act issues. From the court’s
conversion of routine patent litigation into antitrust
violation, I respectfully dissent.
                        DISCUSSION
     The district court correctly held that this case did not
raise antitrust issues, and summarily dismissed Mutual’s
antitrust counterclaims. Although Tyco lost on the mer-
its, its Hatch-Waxman suit was not “sham.” Enforcement
of a presumptively valid patent against a product that
infringes by statute cannot be deemed objectively base-
less. The district court held that the criteria were not
met, criteria whereby litigation is deemed “sham” when
“‘no reasonable litigant could realistically expect success
on the merits’” and there was no “probable cause to initi-
ate suit.” Tyco Healthcare Grp. LP v. Mutual Pharm. Co.,
No. 2:07-cv-1299, slip op. at 5, 6 (D.N.J. Jan. 18, 2013)
(quoting and citing Prof’l Real Estate Investors, Inc. v.
Columbia Pictures Indus., Inc. [hereinafter PRE], 508
U.S. 49, 60-62 (1993)).
    The filing of a Paragraph IV Certification with an Ab-
breviated New Drug Application (ANDA) in and of itself
constitutes probable cause to initiate suit, see id., for the
Hatch-Waxman statute authorizes the filing of an in-
fringement suit in response to a Paragraph IV filing. It is
also plain that Tyco had the right to communicate with
the FDA concerning public information on matters within
the agency’s authority and responsibility without incur-
ring antitrust liability.
TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO        3

    The panel majority inserts a strong antitrust presence
into routine patent litigation, adding the potential of
antitrust penalties for patent enforcement. Recently the
Supreme Court reviewed a case where this court imported
antitrust criteria into patent litigation, in the context of
attorney fee awards under 35 U.S.C. §285; the Court
explained the antitrust view of “sham” litigation:
   We crafted the Noerr–Pennington doctrine—and
   carved out only a narrow exception for “sham” lit-
   igation—to avoid chilling the exercise of the First
   Amendment right to petition the government for
   the redress of grievances. But to the extent that
   patent suits are similarly protected as acts of peti-
   tioning, it is not clear why the shifting of fees in
   an “exceptional” case would diminish that right.
Octane Fitness, LLC v. ICON Health & Fitness, Inc., 134
S. Ct. 1749, 1757-58 (2014). The Court referred to the
chilling effect of the threat of antitrust liability:
   The threat of antitrust liability (and the attendant
   treble damages, 15 U.S.C. §15) far more signifi-
   cantly chills the exercise of the right to petition
   than does the mere shifting of attorney’s fees. In
   the Noerr–Pennington context, defendants seek
   immunity from a judicial declaration that their fil-
   ing of a lawsuit was actually unlawful; here, they
   seek immunity from a far less onerous declaration
   that they should bear the costs of that lawsuit in
   exceptional cases.
Id. My colleagues again intermingle antitrust and patent
issues, distorting the balance stated in Simpson v. Union
Oil Co., of California, 377 U.S. 13, 24 (1964), that the
patent laws “are in pari materia with the antitrust laws
and modify them pro tanto.” The panel majority improp-
erly inserts antitrust issues into the issues of infringe-
4    TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO

ment, validity, and communication to the government,
contravening precedent and the Constitution.
                    A. Infringement
    Tyco filed this Hatch-Waxman suit in response to Mu-
tual’s Paragraph IV Certification for its generic counter-
part to Tyco’s patented drug Restoril®. The district court
granted summary judgment on the antitrust counter-
claims, applying the Court’s exhortation to “‘resist the
understandable temptation to engage in post hoc reason-
ing by concluding that an ultimately unsuccessful action
must have been unreasonable or without foundation.’”
Tyco, No. 2:07-cv-1299, slip op. at 8 (quoting PRE, 508
U.S. at 60 n.5).
     The basis for Tyco’s infringement suit was Mutual’s
challenge to Tyco’s patents in accordance with the Hatch-
Waxman Act. The panel majority acknowledges that
“[t]he parties do not dispute that the specific surface area
of Mutual’s temazepam falls within the infringing range
when the outgassing temperature is set at 105ºC.” Maj.
Op. at 11. Nonetheless, the majority revives the antitrust
counterclaim that the infringement suit was “objectively
baseless,” and remands for “further inquiry . . . into the
effect of the outgassing temperature on the specific sur-
face area of Mutual’s generic product.” Id. at 12. The
panel majority orders the district court to make findings,
if need be with additional trial proceedings, stating that
this information is needed for the court to determine
whether this Hatch-Waxman suit violates antitrust law
as “sham” litigation. Id.
    The purpose of this remand is not to elucidate the
question of infringement, for that issue was finally re-
solved. Instead, my colleagues seek new findings and
authorize further trial, now to provide evidence of anti-
trust violation. While the difference in the measured
surface area was the basis for the district court’s holding
TYCO HEALTHCARE GROUP    v. MUTUAL PHARMACEUTICAL CO       5

of non-infringement, the role of outgassing temperature in
surface area measurement is not antitrust fodder. Here,
Mutual is seeking ANDA approval for a product that is
required to be identical to Tyco’s FDA-approved product
in order to rely on that product’s data of safety and effica-
cy. The panel majority focuses on asserted “sham” litiga-
tion in its antitrust “inquiry into whether Tyco’s
§271(e)(2)(A) infringement claim was objectively base-
less.” Id. at 11. However, on Mutual’s representation
that its product meets the ANDA requirements, accompa-
nied by a Paragraph IV Certification challenging Tyco’s
patent, a Hatch-Waxman infringement suit in accordance
with §271(e)(2)(A) is not “sham.” The district court cor-
rectly so held.
    The panel majority’s curiosity as to the scientific ef-
fect of changes in outgassing temperature on the meas-
urement of surface area is neither appropriate appellate
process, nor a matter for invoking the Sherman Act. See
PRE, 508 U.S. at 62 (“The existence of probable cause to
institute legal proceedings precludes a finding that an
antitrust defendant has engaged in sham litigation.”). As
this court reiterated in FilmTec Corp. v. Hydranautics, 67
F.3d 931, 938 (Fed. Cir. 1995), “[t]he [Supreme] Court
requires an inquiry into the reasonableness of the anti-
trust defendant’s litigation when filed.” Despite clear
precedent that any question of “sham” litigation is decided
as of when the complaint is filed, the panel majority
remands for trial and possibly new evidence that might
support the majority’s argument that Tyco misunderstood
the role of temperature in outgassing, and that this is
evidence of antitrust violation in the filing of this Hatch-
Waxman suit.
    This court errs in converting this routine patent in-
fringement case into an antitrust cause.
6    TYCO HEALTHCARE GROUP    v. MUTUAL PHARMACEUTICAL CO

                       B. Validity
    Mutual also argued in the district court that Tyco
should have known that it would not succeed in defending
the validity of its patents. The district court correctly
dismissed this argument. Tyco, No. 2:07-cv-1299, slip op.
at 9. The presumption of validity of a duly granted patent
negates ruling that the routine defense of a patent’s
validity constitutes “sham” litigation.
    Although the panel majority recites the presumption
of validity and the placement of the burden of proof, the
majority introduces a new concept of antitrust liability.
The majority now creates a “burden of production” where-
by the patent owner must come forward with affirmative
evidence of validity, such as of “teaching away” or “unex-
pected results” or “other pertinent secondary considera-
tions,” whereby if this burden of production is not met
with “an argument that is not objectively baseless” then
the patentee becomes a violator of antitrust law. Maj. Op.
at 13-14.
    Thus the panel majority creates another new anti-
trust dimension of patent litigation, whereby failure to
meet some general “burden of production” converts the
defense of one’s patent into a ground of antitrust liability.
Although the panel majority finds that in this case Tyco’s
“teaching away argument was not objectively baseless,
nor does Mutual suggest on appeal that it was,” id. at 13-
14, the majority’s premise is that if this criterion were not
met, Tyco could have violated the Sherman Act.
    Although this unprecedented new ground of antitrust
liability is not clearly developed, the implication is only
too clear. This court holds that a patentee’s validity
arguments are subject to routine consideration not only
for their effect on the validity debate, but for their
strength on Sherman Act criteria. Heretofore, patent
validity was not of antitrust interest unless the patent
TYCO HEALTHCARE GROUP    v. MUTUAL PHARMACEUTICAL CO       7

was obtained by fraud. Walker Process Equip., Inc. v.
Food Mach. & Chem. Corp., 382 U.S. 172 (1965). The
district court referred to “the presumption of validity of an
issued patent” and held that the Tyco patents were not
obtained by fraud. Tyco, No. 2:07-cv-1299, slip op. at 9,
12. The court held that the Sherman Act was not here
invoked.
    The panel majority now transplants the antitrust cri-
teria of “sham” litigation as set forth in PRE into routine
patent validity litigation, adding a de facto adverse infer-
ence if the patentee chooses to rely on the presumption of
validity and does not meet my colleagues’ newly contrived
antitrust standard of “burden of production.” Maj. Op. at
13-14. My colleagues again import the “chilling effect” of
antitrust litigation, Octane Fitness, 134 S. Ct. at 1757,
into routine patent debates.
    This further insertion of antitrust issues into patent
cases is as unnecessary as the court’s reasoning is un-
clear. The only thing that is clear is that it will be the
rare patent suit that will not include assertions of Sher-
man Act violation patterned on the court’s theories today.
So dramatic an enlargement of patent litigation should
not be casually made, even in dictum.
                C. The Citizen Petition
    After Tyco lost its infringement case, it informed the
FDA of Mutual’s successful position that the generic
product is not the same as the Tyco patented product.
Tyco proposed to the FDA that additional tests should be
required of Mutual’s assertedly different product, and
that Mutual should not be permitted to rely on data for
the Tyco product.
    Mutual’s counterclaim charged that Tyco’s communi-
cation to the FDA violated the antitrust laws. My col-
leagues state that “a reasonable finder of fact could
8       TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO

conclude that Tyco’s citizen petition was objectively
baseless,” Maj. Op. at 16, and remand to the district court
for determination of antitrust injury. The panel majority
misstates that the Tyco petition is “seeking to bar Mutual
from obtaining FDA permission to market its generic
version of one of Tyco’s drugs.” Id. at 2. The petition
communicated to the FDA the public information that the
Mutual generic product is not the same as the FDA-
approved Tyco product. An accurate communication
cannot be an antitrust violation, even if it relates to
competitors, as firmly established by Noerr-Pennington.
    Nonetheless, this court remands for determination of
antitrust injury flowing from the filing of this petition, an
action effectively requiring the predicate determination of
violation of antitrust law. 1 Id. at 18 (“On remand, the
district court should determine whether Mutual suffered
an anticompetitive harm in the form of a delay in the
approval of its ANDA due to the filing of Tyco’s citizen
petition with the FDA.”). Antitrust violation is a prereq-
uisite to determination of antitrust injury. See, e.g., J.
Truett Payne Co., Inc. v. Chrysler Motors Corp., 451 U.S.
1    The panel majority, responding to this dissent,
protests that it has not ruled that Tyco’s filing of the
citizen petition is “effectively” an antitrust violation, even
as the majority remands for determination of antitrust
injury. The law is clear that antitrust violation must
exist before consideration of antitrust injury becomes
applicable. See, Atl. Richfield Co. v. USA Petrol. Co., 495
U.S. 328, 342 (1990) (“The purpose of the antitrust injury
requirement . . . . ensures that the harm claimed by the
plaintiff corresponds to the rationale for finding a viola-
tion of the antitrust laws in the first place . . . .”). Thus
my colleagues “effectively” find antitrust violation in
remanding for determination of antitrust injury.
TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO      9

557, 568 (1981) (“If the court determines on remand that
respondent did violate the [antitrust statute], the court
should then consider the sufficiency of petitioner’s evi-
dence of injury in light of the cases discussed above.”).
     No antitrust law was violated by Tyco’s communica-
tion to the FDA. The FDA is charged with establishing
and securing drug safety and efficacy, for a new drug and
for its generic counterparts. There can be no doubt as to a
citizen’s right to communicate with the government on
matters of concern. “The right of petition is one of the
freedoms protected by the Bill of Rights, and we cannot, of
course, lightly impute to Congress an intent to invade
these freedoms.” E. R.R. Presidents Conference v. Noerr
Motor Freight, 365 U.S. 127, 138 (1961). Such right is not
eliminated when the petitioner is in a competitive rela-
tionship.
    The majority protests that it is not finding antitrust
liability for Tyco’s petition, but only that “Mutual’s evi-
dence was sufficient to withstand Tyco’s motion for sum-
mary judgment.” Maj. Op. at 18 n.1. It is plain that Tyco
had the right to communicate with the FDA concerning
this matter within the agency’s authority and responsibil-
ity. The majority’s remand for determination of antitrust
injury is necessarily premised on the position that the
communication was contrary to antitrust law. Id. at 18
(“There remains an open issue, however, as to whether
the filing of the citizen petition caused any antitrust
injury to Mutual.”).
    The Court has reminded that “[t]hose who petition
government for redress are generally immune from anti-
trust liability,” PRE, 508 U.S. at 56, although competitors
may be affected, see Noerr Motor Freight, 365 U.S. at 139;
United Mine Workers v. Pennington, 381 U.S. 657, 669
(1965). My colleagues offer the archetype for failing to
“avoid chilling the exercise of the First Amendment right
10    TYCO HEALTHCARE GROUP   v. MUTUAL PHARMACEUTICAL CO

to petition the government for redress of grievances” with
the imposition of this antitrust liability. Cf. Octane
Fitness, 134 S. Ct. at 1757.
                      CONCLUSION
    The intrusion of antitrust issues into routine patent
cases has been controlled in precedent. See FilmTec, 67
F.3d at 938 (“As noted, the Supreme Court has forbidden
us to equate loss on the merits with objective unreasona-
bleness.”). My colleagues now hold otherwise, although
the nation’s history of innovation has been built on the
balanced foundation that:
     The patent and antitrust laws are complemen-
     tary, the patent system serving to encourage in-
     vention and the bringing of new products to
     market by adjusting investment-based risk, and
     the antitrust laws serving to foster industrial
     competition.
Intergraph Corp. v. Intel Corp., 195 F.3d 1346, 1362 (Fed.
Cir. 1999).
   The court’s rulings today are contrary to law, prece-
dent, and the Constitution. I respectfully dissent.