# United States **Court of Appeals**  **for the Federal Circuit**

______________________
TYCO HEALTHCARE GROU P LP AND MALLINCKRODT INC., Plaintiffs

- Appellees,

v.

MUTUAL PHARMACEUTICA L COMPANY, INC. AND UNITED RESEARCH LABO RATORIES, INC., Defendants

- Appellants.

______________________

2013

- 1386

______________________ Appeal from the United States District Court for the District of New Jersey in No. 07

- CV

- 1299, Judg e Stanley R. Chesler.

______________________

Decided: August 6 , 2014

______________________

P ETER E. S TRAND , Shook, Hardy & Bacon, L.L.P., of Washington, DC, argued for plaintiffs

- appellees. With him on the brief were J OHN D. G ARRETSON and R EBECCA J. S CHWARTZ , of Kansas City, Missouri.

S TEFFEN N. J OHNSON , Winston & Strawn LLP, of Washington, DC, argued for defendants

- appellants. With him on the brief were C HARLES B. K LEIN , J OHN K. H SU , and E IMERIC R EIG -P LESSIS , of Washington, DC

, and J AMES F. H URST , of Chicago, Illinois.TYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

. 2

______________________

Before N EWMAN , B RYSON , and M OORE , Circuit Judges.
Opinion for the court filed by Circuit Judge B RYSON

. Dissenting opinion filed by Circuit Judge N EWMAN

. B RYSON , 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, “Ty co” ) . 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 permi ssion 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 form ulations 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 L imited in 2001. Th e patents all claim 7.5 mg formulations of temazepam having a specific surface area between 0.65 and 1.1 square meter s per gram (m 2 /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 in to smaller particles

, the specific surface area increases because more of the drug is exposed to the surrounding environment.

The claims of the temazepam patent s do not recite any particular measurement technique . However, the specifications of each of the patents state that “[s]urfaceTYCO HEALTHCARE GROU P 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. 5,211,95 4 (“the ’954 patent”), col. 2, ll. 1

- 4. B.E.T. testing is a gas

- adsorption technique for mea sur ing 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 pe rformed , 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 temper ature can affect the ultimate specific surface area mea surement. Increasing the outgassing temperature speeds the process of cleaning th e test material ’s surface and allow s 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 tem azepam p atents . In both cases, the testers used the B.E.T. proc edure with an outgassing temperature of 105 °C.

In November 2006, Mutual filed an Abbreviated New Drug Application (“ANDA”) with the FDA

, seeking a pproval 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 les s than 2.2

m 2 /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)(v ii) . Mutual’s certification was filed under paragraph IV of section 355(j)(2)(A)(vii) , whichTYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

. 4

permit s 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 inf ringe 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. Th e letter set forth Mutual’s position that the proposed ANDA pr oduct would not infringe the temaz epam patents because the generic product’s specific surface area would not fall within the 0.65

- 1.1 m 2 /g range claimed by those patents

. In response to Mutual’s paragraph IV certification

, Tyco filed an action alleging that Mutual’s ANDA i nfringed 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 a n automa tic 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

w ere 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 jud gment 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 i nfringe the ’954 pate nt under section 271(e) because Mut ual’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 areaTYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

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of not less than 2.2 m 2 /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 e ntered its jud gment of noninfring e ment, Tyco filed a citizen

p etition with the FDA

. The citizen p etition 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 demon strate bioequivalence to Restoril through a series of pharmacokinetic parameters considerably more extensive and complex than th e 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 versi on 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 mark et

. Five months later, the F DA denied Tyco’s citizen p eti tion in its entirety. The FDA conclud ed that Tyco “had not provided adequate evidence to support any of the actions requested in the petition” and that there wa s “no basis” for adopting Tyco’s proposed bio

equivalence criteria. In addition, t he FDA found that the citizen p etition “relie[d] entirely on uncorroborated gene ralities and theoretical speculation .” The FDA explained that it “require[s] additional bioeq uivalence criteria” in “very rare circumstances .” Those circumstances, accor ding to the FDA, have arisen only in the case of “complex extended- release or otherwise modified

- release productsTYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

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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
te maze pam dosage level

. Th at dos age level , however, was disclosed in a 1983 volume of the British National Form ulary (“BNF”) that recommended administering between 5 and 15 mg of temazepam for the treatment of insomnia in the elderly. Id. at 1372

. This co urt rejected Tyco’s arg ument that various prior art references taught away from that 7.5 mg dos age level. See i d. 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 liabilit y 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 m 2 /g and thus outside the range of 0.65 to 1.1 m 2 /g claimed in the ’954 patent. The evidence showed, however, that in testing itsTYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

. 7

proposed ANDA product, Mutual had used an outgassing temperature of 40°C, while Tyco had used an outgassing
t emperature of 105°C in its tests of the product. Because of that differen ce in temperatures used during the mea surement process, the court concluded that it was reason able for Tyco to proceed with its infringement action.

The district court also rejecte d 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 inv alidity, 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) (e mphasis in original)

. T he district court next rejec ted Mutual’s claim that Tyco’s citizen p etition 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 ther efore 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 woul d allow the inference that the citizen p etition was an attempt to interfere directly with the business relationship s 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 S upreme Court ’ s decision in Walker Process Equipment

, Inc

. v. Food Machinery & Chemical Co rp

. , 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 ofTYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

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the “Memo for the Record,” which documented a 1984 teleconference between Sandoz and the FDA during which

a n FDA doctor told Sandoz that temazepam doses from 5 to 15 mg were recommend ed in Great Britain for the elderly. That evidence, acco rding 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.” Mutu al subsequently took this appeal from the district court’s summary judgment order

. II

1. A party is ordinarily exempt from antitrust liabi lity 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 Wor kers 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 bus iness relationships of a competitor” (the subjecti ve el ement). 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 d isputed i ssue of fact concerning whether Tyco’s infringement suit was “objectively baseless” s o as to fall within the sham

litigation exception to Noerr

- Pennington immunity. According to Mutual, th e section 271(e) (2)(A) infring e-TYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

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ment claim rejected by this court in Bayer AG v. Elan Pharmaceutical Research Corp.

, 212 F.3d 1241 (Fed. Cir. 2000), is legally a nd 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)

. D espite 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 i d. at 1248

- 50.

Mutual’s argument , which is based on Elan

, ignores other decisions of this court , and language in Elan itself, that c ould give a patentee in Tyco’s position a reasonable expectation of a favorable outcome even though the gene ric 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 ma rket 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. C ir. 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 ev i-TYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

. 10

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), t hat se ction 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 ev idence including the ANDA.” Id. at 1568 (emphasis ad ded) . Nothing in Elan is contrary to that holding. S ee 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

owne r 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 Abbot t Laboratories v. Tor P

harm, Inc. , 300 F.3d 1367 (Fed. Cir. 2002), another post

- Elan case , we stated that

“ other evidence may directly contradict the clear repr esentations 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 , w e agree with Tyco that it is not unreaso nable 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 GROU P v. MUTUAL PHARMACEUTICAL CO

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That does not end our inquiry into whether Tyco’s se ction 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 di spute that the specific surface area of Mutual’s temaze pam falls within the infringing range when the outgassing tempera ture 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 tema zepam 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 di fference 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 t he removal of contaminants from the surface of the tested material. If full outgassing is not achieved, the measured specific surface area may be reduced, bec ause less surface area is available for the test gas to adsorb to. It t herefore stands to reason that, barring physical alteration to Mutual’s temazepam, Tyco’s d emand that Mutual increase the outgassing temperature would not decreas e— but would potentiall y increase

— the specific surface area measureme nt due to the removal of

more surface contaminants

. Barring physical alteration of the material, a n increased outgassing temperature would thus mak e it more likely that Mutual’s commercial product would measur e outside of the infringing range

,TYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

. 12

not more likely that it would measure within the infrin ging range

, as Tyco suggests . Tyco’s theory of why Mut ual’ s as -marketed ANDA product will in fringe th erefore appears to be based on a theory contrary to what the underlying scientific princi ples dictate. Put simply , even if Mutual’s specific sur face 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 furthe r inqui ry 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 proce eding or requires a trial. Accordingly, on remand, the district court should determine whether Tyco’s factual theory of infringement is objective ly baseless. If necessary, the court should then determine whether M utual has shown that the subjective eleme nt 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 t he validity of its patent s. 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 satisfie d 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 underTYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

. 13

antitrust law includes bringing suit to enforce a patent with knowledge that the p atent 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 o f 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 differ ence between the prior

- art 15 mg Restoril capsule

an d the claimed capsules is the 7.5 mg dose of temaz epam . That 7.5 mg dose, Mutual asserts, was clear ly 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 t hat 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 disclose d 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. T olmar, 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 a rt taught away from the claimed invention; (2) there were new and une xpected results relative to the prior art; or (3) there are other pertinent secondary considerations.”); Taurus IP, LLC v. Da i mlerChrysler Corp ., 726 F.3d 1306, 132 2 ( Fed. Cir. 2013) ( “Af ter an accused infringer has put forth a prima facie case of invalidity, the burden of production shifts to the patent owner to produce sufficient rebuttalTYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

. 14

evidence to prove entitlement to an earlier invention date. . . . The ultimate burden of proving inv alidity by clear and convincing evidence

— i.e., the burden of persuasion

— however, remains with the accused infringer.”); Novo Nordisk A/S v. C a raco Pharm. Labs., Ltd. , 719 F.3d 1346, 1352

- 53 (Fed. Cir. 2013)

. M utual also ignores the evidence Tyco offered to meet its burden of production

. Tyco argue d that the BNF reference did not teach a dose in the 5 to 15 mg range because it did not provide any efficacy eviden ce 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 sever al 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, Ty co 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. T yco’s teaching away argument was not obje ctively baseless, nor does Mutual suggest on app eal that it

was

. We conclude that Mutual has not met its burden to establish that Tyco’s validity arguments were objectively baseless, even though th ose 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 ult imately 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 t hat the district court erred by granting summary judgment for Tyco wi th respect to Mutual’s claim that Tyco’s citizen p etition to the FDA wasTYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

. 15

a sham that stri pped Tyco of its Noerr

- Pennington i mmunity. 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 applic able 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 petition s ); 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 -p art test is inapplicable to Tyco’s citizen pet ition. Instead, Tyco argues that any error in that regard

was incon sequential because it was not unreasonable for Tyco to file the c itizen petition

. We conclude , however, that there are disputed issues of fact that preclude su mmary judgment with respect to whether the citizen pet ition was objectively baseless

. Particul arly 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 hadTYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

. 16

“ provided no evidence from clinical trials, pharmacokine tic studies, bioequivalence te sting, 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 manufacturer s 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 relea se characteristics and clinical performance” and that “[t]emazepam is not such a drug.”
Mutual’s expert reviewed the citizen petition and co ncluded that “Tyco did not have a scientific basis to co nclude that Mutual’s product would not be bioequivalent to Restoril.” She found that some of the criteria Tyco pr oposed 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 produ ce 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 distr ict c ourt 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 weekTYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

. 17

before the e nd 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 M utual’s ANDA , and thus resulted in a further period of market exclusivity for Tyco

. Tyco argues that anticompetitive intent cannot be i nferred 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 repres entations 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. Speci fically, Tyco points to representations Mutual made in

op en 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 pro duct, however, had already been publicly dis closed 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 un persuasive

. 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 th e email , the research and development department stated that a temazepam formulation that was bioequivalent to Rest oril could be made that would have a particle size and specific surface area different from Restoril. Th e email thus constitutes evidence that could support a finding that Tyco knew the theory in its citizen petition lacked merit.TYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

. 18

The timing of the citizen petition and the email are sufficient evidence from which a reasonable f inder 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.

T here 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 establish ing 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 a pproval was delayed “solely because of Tyco’s petition,” Mutual cites onl y 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 ap proval 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 (“ P TO”) 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 S u1 The dissent states that the majority “effectively holds that Tyco violated the antitrust laws by filing its ‘citizen petition. ’” Th at 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 GROU P 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 I nnovations, Inc. , 141 F.3d 1059, 1068

- 69 (Fed. Cir. 1998).

Mutual contends that Sandoz committed fraud on the P TO by omitting information material to the patentability of temazepam at the 7.5 mg dosage level. First , Mutual alleges that Sandoz con cealed the fact that the claimed invention used the same specific surface area and part icle size as the prior

- art high

- dose version of Restoril . Sandoz disclosed that informat ion to the FDA when seeking approval for Restoril, but allegedly redacted portions of
t he “FDA Approvable Letter” submitted to the P TO 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 th e 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 su pplied 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, the ir prosec ut ion histories, and the record of correspondence with the FDA related to Restoril on multiple occasions, including once before acq uiring the patents and on ce 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 b ecause Tyco r eviewed t hat record and because the record contained the Memo for the Reco rd, the unredacted version of the FDA Approvable Letter, and the redacted version of that letter sent to the P TO.TYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

. 20

The district court focused on the issue of Tyco’s knowledge and found that there was ins ufficient 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 P TO was offered for the limited purpose of overcoming an obviousness rejection. The applicant refer red to the Approvable Letter only to demonstrate that the 7.5 mg dose was effective in treating insomnia, which the appl icant contended was unexpected in light of other prior art. The redac tions were not focused on material related to the Memo for the Record or the characteristics of the prior

- art high -dose Resto ril . In stead, large sections of the letter irrelevant to the applicant’s main point were re moved

, leaving just two pages of material from the original sevenpage letter. That redacted material include s 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 t he specific surface area for 15 mg and 30 mg Restoril. A reasonable finder of fact could not conclude that Tyco had k nowledge of an y alleged fraud by Sandoz just because Tyco had reviewed the record and there by 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 t hat Tyco had knowledge

— constructive or oth erwise

— of Sandoz’s alleged fraud, especially in light of Mutual ’s burden to show “no less than clear, convincingTYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

. 21

proof of intentional fraud involving affirmative dishone sty

. ” 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 allo wed 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 probati ve 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 counte rclaim.
In summary, we affirm the judgment of the district court with respect to Mutual’s c laim that Tyco’s assertion of the validity of its patents was a sham and with respect
to Mutual’s Walker Process fra ud 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 diffe rences 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 proce edings, including a determination as to whether the citizen petition cause dTYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO

. 22

any injury to Mutual in the form of a delay in the appro val 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 GROU P LP AND MALLINCKRODT INC., Plaintiffs

- Appellees,

v.

MUTUAL PHARMACEUTICA L COMPANY, INC. AND UNITED RESEARCH LABO RATORIES, INC., Defendants

- Appellants.

______________________

2013

- 1386

______________________

N EWMAN , Circuit Judge, dissenting.

With its reversal of the district court’s summary judgment dismi ssing Mutual’s antitrust counterclaims

, this court now cr e at es several new grounds of antitrust liability

. Th e panel majority hold s that an titrust issues are raised by Tyco’s Hatch

- Waxman suit , although the suit is for infringement of presumptively valid patent s asserted against a product whose ANDA and Paragraph IV C ertification constituted a technical act of infring ement under 35 U.S.C. §271(e). T he constitutional right to petition government, a s well as the patent right to e xclude

, do es 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 doesTYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO 2

not convert routine patent litigation into a n antitrust

cause

. And by remand ing 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 Constitut ion

. They do not raise Sherman Act issues

. F rom the court’s conversion of routine patent litigation into antitrust violation

, I respectfully dissent.

D ISCUSSION

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 me rits, its Hatch

- Waxman suit was not “ sham .” Enforcement of a presumptively valid patent against a product that infringes by statute cannot be deemed objectively bas el ess

. 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 init iate 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 A bbreviated 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 i nfringement suit in response to a Pa ragraph IV filing. It is also plain that Tyco ha d the right to communicate with the FDA co ncerning public information on matters within the agency’s authority and responsibility without incu rring anti trust liability.TYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO 3

The panel majority insert s a strong a ntitrust 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
attorne y fee awards under 35 U.S.C. §285; t he Court explained the antitrust view of “ sham ” l itigation:

We crafted the Noerr

–

Pennington doctrine

— and carved out only a narrow exception for “sham” li tigation

— to avoid chilling the exercise of the First Amendment righ t to petition the government for the redress of grievances. But to the extent that patent suits are similarly protected as acts of pet itioning, 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 fi ling of a lawsuit was actually unlawful; here, they seek immuni ty 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 Cal ifornia

, 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 infring e-TYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO 4

ment, validi ty, and communication to the government

, c ontravening preceden t and the C onstitution

. A. I nfringement
Tyco filed this Hatch

- Waxman suit in response to M utual’s Paragraph IV Certification for its generic counte rpart to Tyco’s patented drug Restoril®. The district court granted summary judgment on the antitrust count e rclaims

, applying the Court’s exhortation to “ ‘ resist the understandable temptation to engage in post hoc reaso ning 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 acknowledge s 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

. N one theless, 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 su rface 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 in formation 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 r esolved. I nstead

, my colleagues seek new findings and authorize further trial , now to provide evidence of ant itrust violation

. While the difference in the measured surface area was the basis for the district court’s holdingTYCO HEALTHCARE GROU P 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 eff ic acy

. The panel majority focuse s on asserted “ sham ” litig ation in its antitrust “inquiry into whether Tyco’s §271(e)(2)(A) infringement claim was objectively bas eless

. ” Id. at 1 1. However, o n Mutual’s representation that its product meets the ANDA requirements, accomp anied 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 curiosi ty as to the scientific e ffect of changes in outgassing temperature on the mea surement 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 instit ute 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 ant itrust 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 n ew 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 i nfringement case into a n antitrust cause.TYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO 6

B. V alidity
Mutual also argue d in the district court that Tyco should have known that it would not succeed in defending the validity of its patent s

. 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.

A lthough the panel majority recites the presumption of validity and the placement of the burden of proof , the majority introduce s a new concept of antitrust liability. The majority now creates a “burden of production” wher eby the patent owner must come forward with affirmative evidence of validity , such as of “teaching away” or “une xpected results” or “other pertinent secondary cons id er ations

, ” 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.

Th us the panel majority creates a nother new ant itrust 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 t hat 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 c ould have violated the Sherman Act.

Alt h ough th is unprecedented new ground of antitrust liability is not clearly developed, the implication is only
too clear . This court hold s that a patentee’s validity argument s are subject to routine consideration not only for their effect on the validity debate, bu t for their strength on Sherman Act criteria. Heretofore, patent validity was not of antitrust interest unless the patentTYCO HEALTHCARE GROU P 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 patent s 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 anti trust cr iteria of “sham ” litigation as set forth in PRE into routine patent validity litigation, adding a de facto adverse infe rence if the patentee chooses to rely on the presumption of validity and does not meet my colleagues’ newly contrived antitrust s tandard of “burden of production .” Maj. O p. at 13

- 14

. My colleagues again import the “chilling effect” of antitrust litigation, Octane Fitness , 134 S. Ct. at 1 757
, into routine patent debates.

This further insertion of antitrust issues into patent cases is as unnecessary as the court’s r easoning is u nclear. The only thing that is clear is that it will be the rare patent suit that will not inc lude assertions of She rman Act violation patterned on the court’s theories today. So dramatic a n enlargement of patent litigation should not be casually made, even in dictum

. C. T he 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 asserte dly different product, and that Mutual should not be permitted to rely on data for the Tyco product.

Mutual ’s counterclaim charged that Tyco’s commun ica tion to the FDA violated the antitrust laws. My co lleagues state that “a reasonable finder of fact couldTYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO 8

conclude that Tyco’s citizen petition w as objectively baseless ,” M aj. O p. at 1 6 , and re mand to the district court for determination of antitrust injur y. The panel majority mis states that the Tyco petition is “seeking to bar Mutual from obtaining FDA permission to market its generic version of one of Tyco’s dru g s.” 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, th is court remand s for determination of

a ntitrust injury flowing from the filing of this petition

, an action effectively requiring the predicate determination of violation of antitrust law. 1 Id. at 1 8 (“On remand, the district co urt 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.”). A ntitrust violation is a prere quisite to determination of antitrust injur y. 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 mu st exist before consideration of antitrust injury becomes applicable. See

, Atl. Richfield Co. v. USA Petrol. Co.

, 495 U.S. 328, 342 (1990) (“T he purpose of the antitrust injury requirement . . . . ensures that the harm claimed by the plaintiff corresponds to the rationale for finding a viol ation of the antitrust laws in the first place . . . .” ). Thus

m y colleagues “effectively” find antitrust violation in remanding for determination of antitrust injury.TYCO HEALTHCARE GROU P 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 conside r the sufficiency of petitioner’ s ev idence of injury in light of the cases discussed above.” ).

No antitrust law wa s violated by Tyco’s communic ation to the FDA . T he FDA is charged with establishing and securing drug safety and efficacy, for a new drug and for its generic counterparts. There can be n o 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 freedom s.” 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 rel ationship.
The majority protests that it is not finding antitrust liability for Tyco’s petition, b ut only that “Mutual’s ev idence was sufficient to withstand Tyco’s motion for su mmary judgment.” Maj. O p. at 18 n.1. It is plain that Tyco ha d the right to communicate with the FDA concerning this matter within the agency’s authority and responsibi lity

. 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 ant itrust liability,” PRE , 508 U.S. at 56, although competitors may be affected, s ee 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 rightTYCO HEALTHCARE GROU P v. MUTUAL PHARMACEUTICAL CO 10

to petition the government for redress of grievances” with the imposition of t his antitrust liability. Cf. Octane Fitness , 134 S. Ct. at 1757.

C ONCLUSION 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 unreason ableness. ”). My colleagues now hold otherwise , although th e nation’s history of innovation has been built on the balanced foundation that :

T he patent and antitrust laws are compleme ntary, the patent system serving to encourage i nvention 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 ruling s today are contrary to law

, prec edent , and the Constitution . I respectfully dissent.