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 formulations 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 measuring 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 performed, 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 temperature can affect the ultimate specific surface area measurement. 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 patents. In both cases, the testers used the B.E.T. procedure with an outgassing temperature of 105°C. 

In November 2006, Mutual filed an Abbreviated New 

Drug Application (“ANDA”) with the FDA, seeking approval 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 temazepam 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 infringed 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 automatic 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 judgment 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 infringe the ’954 patent under section 271(e) because Mutual’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 entered 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 bioequivalence 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 bioequivalence criteria. In addition, the FDA found that the 

citizen petition “relie[d] entirely on uncorroborated generalities and theoretical speculation.” The FDA explained 

that it “require[s] additional bioequivalence criteria” in 

“very rare circumstances.” Those circumstances, according 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 Formulary (“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 argument 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. Mutual 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 measurement process, the court concluded that it was reasonable 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 invalidity, 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-cv1299, 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 therefore 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 Supreme 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 liability 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 Workers 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 business relationships of a competitor” (the subjective element). 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 issue of fact concerning whether Tyco’s infringement suit 

was “objectively baseless” so as to fall within the shamlitigation 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 generic 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. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir. 1997), that section 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 evidence including the ANDA.” Id. at 1568 (emphasis added). 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 representations 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 unreasonable 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 section 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 dispute 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 temazepam 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 demand 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 infringing range, as Tyco suggests. Tyco’s theory of why Mutual’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 temazepam. 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 unexpected 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 objectively 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 ultimately 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 immunity. 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 applicable 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 petition. 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 summary judgment with respect to whether the citizen petition 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, pharmacokinetic 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 concluded that “Tyco did not have a scientific basis to conclude that Mutual’s product would not be bioequivalent to

Restoril.” She found that some of the criteria Tyco proposed 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 sufficient 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 inferred 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. Specifically, 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 product, 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 Restoril 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 approval 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 Su1 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 supplied 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 prosecution 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 reviewed 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 applicant 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 sevenpage 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 dishonesty.” 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 Nobelpharma, 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 counterclaim.

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 differences 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 approval 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 infringement under 35 U.S.C. §271(e). The constitutional right to 

petition government, as well as the patent right to exclude, 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 merits, its Hatch-Waxman suit was not “sham.” Enforcement 

of a presumptively valid patent against a product that 

infringes by statute cannot be deemed objectively baseless. 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 initiate 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 Abbreviated 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 infringement 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 incurring 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” litigation—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 petitioning, 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 significantly 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 filing 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 improperly 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 Mutual’s Paragraph IV Certification for its generic counterpart to Tyco’s patented drug Restoril®. The district court 

granted summary judgment on the antitrust counterclaims, applying the Court’s exhortation to “‘resist the 

understandable temptation to engage in post hoc reasoning 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 HatchWaxman 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 surface 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 resolved. Instead, my colleagues seek new findings and 

authorize further trial, now to provide evidence of antitrust 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 efficacy. The panel majority focuses on asserted “sham” litigation in its antitrust “inquiry into whether Tyco’s 

§271(e)(2)(A) infringement claim was objectively baseless.” Id. at 11. However, on Mutual’s representation 

that its product meets the ANDA requirements, accompanied 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 correctly so held. 

The panel majority’s curiosity as to the scientific effect of changes in outgassing temperature on the measurement 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 antitrust 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 HatchWaxman suit. 

This court errs in converting this routine patent infringement 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” whereby the patent owner must come forward with affirmative

evidence of validity, such as of “teaching away” or “unexpected results” or “other pertinent secondary considerations,” 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 antitrust 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 criteria of “sham” litigation as set forth in PRE into routine 

patent validity litigation, adding a de facto adverse inference 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 unclear. The only thing that is clear is that it will be the 

rare patent suit that will not include assertions of Sherman 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 communication to the FDA violated the antitrust laws. My colleagues 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 FDAapproved 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 prerequisite 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 violation 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 evidence of injury in light of the cases discussed above.”).

No antitrust law was violated by Tyco’s communication 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 relationship.

The majority protests that it is not finding antitrust 

liability for Tyco’s petition, but only that “Mutual’s evidence was sufficient to withstand Tyco’s motion for summary 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 responsibility. 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 antitrust 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 unreasonableness.”). 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 complementary, the patent system serving to encourage invention 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, precedent, and the Constitution. I respectfully dissent.