United States Court of Appeals 

For the First Circuit 

No. 17-1714 

UNITED FOOD AND COMMERCIAL WORKERS UNIONS AND EMPLOYERS MIDWEST 

HEALTH BENEFITS FUND; LABORERS HEALTH AND WELFARE TRUST FUND FOR 

NORTHERN CALIFORNIA, on behalf of themselves and others 

similarly situated; AFSCME HEALTH AND WELFARE FUND, on behalf of 

themselves and others similarly situated; MINNESOTA LABORERS 

HEALTH AND WELFARE FUND, on behalf of themselves and others 

similarly situated; PENNSYLVANIA EMPLOYEES BENEFIT TRUST FUND, 

on behalf of themselves and others similarly situated; LOUISIANA 

HEALTH SERVICE & INDEMNITY COMPANY, d/b/a Blue Cross and Blue 

Shield of Louisiana, on behalf of themselves and others 

similarly situated, 

Plaintiffs, Appellants, 

v. 

NOVARTIS PHARMACEUTICALS CORPORATION; 

NOVARTIS CORPORATION; NOVARTIS AG, 

Defendants, Appellees. 

No. 17-1776 

RXDN, INC., on behalf of itself and 

on behalf of the Direct Purchaser Class, 

Plaintiff, Appellant, 

v. 

NOVARTIS PHARMACEUTICALS CORPORATION; 

NOVARTIS CORPORATION; NOVARTIS AG, 

Defendants, Appellees. 

APPEALS FROM THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF MASSACHUSETTS 
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[Hon. Allison D. Burroughs, U.S. District Judge] 

Before 

Lynch, Kayatta, and Barron, 

Circuit Judges. 

Thomas M. Sobol, with whom Hannah W. Brennan, Hagens Berman 

Sobol Shapiro LLP, John D. Radice, Radice Law Firm, P.C., Noah 

Rosmarin, Adkins, Kelston & Zavez, P.C. were on brief, for 

appellants. 

Saul P. Morgenstern, with whom David K. Barr, Mark D. Godler, 

Laura S. Shores, Arnold & Porter Kaye Scholer LLP, William A. 

Zucker, Wyley S. Proctor, McCarter & English LLP, Grant J. 

Esposito, Jessica Kaufman, and Morrison & Foerster LLP were on 

brief, for appellees. 

August 21, 2018 
- 3 - 

BARRON, Circuit Judge. In these consolidated appeals 

from orders dismissing two putative antitrust class actions, 

purchasers of a brand-name, prescription drug allege that the drug 

maker unlawfully delayed the entry of generic versions of the drug 

into the United States market. Specifically, the plaintiffs allege 

that the drug maker committed antitrust violations by obtaining 

through a fraud on the United States Patent and Trademark Office 

("Patent Office") a patent for a particular form of a component 

necessary to manufacture a drug to treat leukemia and by then 

seeking to enforce that patent through "sham" infringement 

litigation against manufacturers trying to enter the market with 

generic versions of that drug. 

The drug maker moved to dismiss the antitrust actions on 

the ground that there was no fraud and that it was immune from 

antitrust liability for merely enforcing its patent through 

litigation. The drug maker claimed this immunity based on the 

Noerr-Pennington doctrine. See United Mine Workers of Am. v. 

Pennington, 381 U.S. 657, 669 (1965); E. R.R. Presidents Conference 

v. Noerr Motor Freight, Inc., 365 U.S. 127, 136 (1961). That 

doctrine provides a party immunity from antitrust liability for 

petitioning the government for redress, in light of the First 

Amendment right to petition the government. And it is clear that 

the petitioning activity within this doctrine's protection 

includes enforcing one's intellectual property rights in court. 
- 4 - 

See Prof'l Real Estate Inv'rs, Inc. v. Columbia Pictures Indus., 

Inc. ("PREI"), 508 U.S. 49, 63-65 (1993) (applying NoerrPennington immunity to copyright infringement litigation); 

Amphastar Pharm. Inc. v. Momenta Pharm., Inc., 850 F.3d 52, 56-58 

(1st Cir. 2017) (applying Noerr-Pennington immunity to patent 

infringement litigation). 

The District Court agreed with the drug maker that NoerrPennington immunity applied to its alleged conduct and, on that 

basis, dismissed the putative class actions under Rule 12(b)(6) of 

the Federal Rules of Civil Procedure for failure to state a claim. 

The District Court acknowledged that Noerr-Pennington immunity has 

two exceptions. An antitrust defendant may not enjoy the immunity 

in enforcing its patent if it obtained that patent through a fraud 

on the Patent Office, Walker Process Equip., Inc. v. Food Mach. & 

Chem. Corp., 382 U.S. 172, 177-78 (1965), or if its suit to enforce 

the patent is a "sham" for impermissible anti-competitive conduct, 

PREI, 508 U.S. at 51. The District Court held, however, that the 

purchasers had not plausibly alleged that either exception applies 

here. We now affirm. 

I. 

The putative class actions at issue in these 

consolidated appeals were brought against Novartis, which 

distributes and holds the patents for Gleevec, a prescription drug 
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for treating leukemia.1 Health plans that purchased Gleevec on 

behalf of their beneficiaries -- so-called end payers -- are the 

plaintiffs in the first action. A party standing in the shoes of 

a direct purchaser of the drug is the named plaintiff in the other 

action.

The suits arise from the following events. In 1996, 

Novartis obtained the original patent for Gleevec, or Patent No. 

5,521,184 ("Patent '184"). This patent claimed Gleevec's active 

ingredient -- a compound called "imatinib" -- as well as the 

compound's "corresponding salts." That patent's expiration date 

was July 4, 2015. 

Four years after obtaining that patent, Novartis filed 

an application for another one. This application sought a patent 

that pertained to one of the compound's "corresponding salts," the 

"mesylate" salt of imatinib. Specifically, Novartis's patent 

application claimed a particular crystalline form of that salt 

-- namely, the non-needle or "β-crystalline" form. 

According to the complaints filed in each of the 

antitrust actions against Novartis, chemists commonly modify 

compounds from "free base" to "salt" form during the pharmaceutical 

process in order to enhance the drug's properties, such as its 

 1 "Novartis" refers collectively to all three Novartis 

entities that are defendants: Novartis Pharmaceuticals 

Corporation, Novartis Corporation, and Novartis AG.
- 6 - 

solubility. The complaints further point out that, although a 

salt can be left amorphous, chemists often crystallize salts in 

various shapes to further select for favorable properties. For 

this reason, a patent for a particular crystalline form of one of 

imatinib's corresponding salts, such as the one Novartis claimed, 

could be quite valuable. 

The patent examiner rejected Novartis's patent 

application for the β-crystalline form of imatinib mesylate. The 

examiner concluded that this form of imatinib mesylate was not 

patentable in consequence of the requirements set forth in 35 

U.S.C. § 102, which provides that an invention is not patentable 

if it is entirely anticipated by a single item of prior art, and 

35 U.S.C. § 103, which provides that an invention is not patentable 

if, from a body of prior art, "the differences between the claimed 

invention and the prior art are such that the claimed invention as 

a whole would have been obvious . . . to a person having ordinary 

skill in the art to which the claimed invention pertains." 

With reference to § 102, the patent examiner ruled that 

the β-crystalline form of imatinib mesylate was "anticipated" by 

Patent '184. With reference to § 103, the patent examiner ruled 

that Novartis failed to carry its burden to "show that employing 

routine procedures" would not produce the β-crystalline form of 

the salt. 
- 7 - 

Novartis appealed the patent examiner's ruling to the 

Patent Trial and Appeal Board ("Board"), which reversed. With 

respect to § 102, the Board "assume[d] arguendo, without 

deciding," that Patent '184, which was set to expire in 2015, 

anticipated the mesylate salt of imatinib. But, the Board ruled, 

Patent '184 "contains insufficient disclosure to support a finding 

of anticipation" of the β-crystalline form of imatinib mesylate 

that Novartis claimed in its application for the new patent. With 

respect to § 103, the Board concluded that the patent examiner had 

erroneously "shift[ed] the burden of persuasion to applicants to 

establish that the β-crystalline form recited in their claim 

'cannot be made following routine conditions.'" Moreover, the 

Board explained, "on this record, the examiner has not adequately 

explained how a person having ordinary skill would have been led 

from 'here to there,' i.e., from [imatinib mesylate] to the . . . 

β-crystalline form of that compound." 

The next month, the patent examiner issued a "notice of 

allowance," which issues "[i]f, on examination, it appears that 

the applicant is entitled to a patent" and which specifies the 

fees that must be paid to obtain the patent. 37 C.F.R. § 1.311. 

Thereafter, Novartis made a supplemental disclosure of two prior 

art references that disclosed the mesylate salt of imatinib (but 

not the β-crystalline form of imatinib mesylate for which Novartis 

sought the patent). 
- 8 - 

The Patent Office finally issued Novartis's patent for 

the β-crystalline form of imatinib mesylate, or Patent No. 

6,894,051 ("Patent '051"), on May 17, 2005, with an expiration 

date in 2019.2 Novartis then submitted that patent to the Food 

and Drug Administration ("FDA") for inclusion in what is known as 

the "Orange Book" -- which lists FDA-approved drugs along with 

their corresponding patents -- as one of the patents, along with 

the as-yet-unexpired original '184 patent, that covers Gleevec. 

In 2006, a generic drug manufacturer named Sun Pharma 

filed an abbreviated new drug application ("ANDA") with the FDA. 

Sun Pharma's ANDA sought to market a generic version of Gleevec in 

the United States. In its ANDA, Sun Pharma certified that 

Novartis's second patent for Gleevec, Patent '051, was invalid. 

Sun Pharma thus sought the FDA's approval for marketing generic 

Gleevec as soon as the original Gleevec patent, Patent '184, 

expired on July 4, 2015, even though Novartis's second Gleevec 

patent, Patent '051, would not expire until 2019. 

Several years later, in 2013, while waiting for Patent 

'184 to expire, Sun Pharma sued Novartis in federal court seeking 

a declaratory judgment that the second Gleevec patent, Patent '051, 

 2 Novartis also applied for and obtained a third patent for 

Gleevec -- Patent No. 7,554,799, later reissued as Patent No. RE 

43,932 -- which the complaints allege is invalid for the same 

reasons that Patent '051 is invalid. The plaintiffs discuss only 

Patent '051, however, on appeal. 
- 9 - 

was indeed invalid. Novartis counterclaimed, alleging 

infringement of Patent '051 and seeking a declaratory judgment 

that the patent was valid. 

In May of 2014, before any substantive rulings in that 

litigation, Sun Pharma and Novartis settled. The parties to that 

settlement did not disclose its terms, except to announce that Sun 

Pharma would be permitted to launch its generic version of Gleevec 

on February 1, 2016, some seven months after the expiration of the 

original Gleevec patent, Patent '184.3

The two putative class actions at issue here were filed 

in the wake of that settlement in the United States District Court 

for the District of Massachusetts. Each action alleged that 

Novartis had "engaged in an exclusionary, anticompetitive scheme 

designed to create and maintain a monopoly for Gleevec and its 

generic substitutes" in the United States market. The complaints 

in each case alleged that Novartis carried out this monopolistic 

 3 The plaintiffs allege that other generic drug manufacturers 

also filed ANDAs for generic versions of Gleevec, each of which 

certified that Novartis's second patent for the drug, Patent '051, 

is invalid. Because Novartis sued each of these generic drug 

manufacturers for patent infringement within forty-five days of 

receiving notice of such certifications, Novartis obtained 

automatic thirty-month stays of FDA approval as to each of those 

ANDAs. See 21 U.S.C. § 355(j)(5)(B)(iii). The plaintiffs 

represent on appeal that all of these additional infringement suits 

have been dismissed without prejudice. 
- 10 - 

scheme in the following way in order to delay generic Gleevec's 

entry into the United States market. 

First, the complaints alleged that Novartis fraudulently 

procured Patent '051 from the Patent Office by falsely representing 

that the prior art did not disclose imatinib mesylate and that the 

discovery of its β-crystalline form was "surprising[]." Second, 

the complaints alleged that Novartis listed Patent '051 in the 

Orange Book.4 And, third, the complaints alleged that Novartis 

then pursued infringement litigation against manufacturers of 

generic versions of Gleevec to enforce Patent '051 that was a 

"sham" for anticompetitive conduct -- given that Novartis could 

not reasonably expect the patent to withstand an invalidity 

defense. 

The direct purchaser alleged its monopolization claim in 

its suit under the federal Sherman Act, 15 U.S.C. § 2, while the 

end payers alleged their monopolization claim under the antitrust 

laws of twenty-three states and the District of Columbia. See 

Ill. Brick Co. v. Illinois, 431 U.S. 720, 730 (1977) (holding that 

indirect purchasers generally lack standing to enforce federal 

antitrust laws). The plaintiffs in both actions sought monetary 

 4 The plaintiffs clarified in their papers below that they 

"do not assert the Orange Book listings as a basis for antitrust 

liability." They explained that they instead asserted them as the 

basis of a third exception to Noerr-Pennington immunity. However, 

they have not pressed this argument on appeal. 
- 11 - 

damages as well as class certification on behalf of similarly 

situated direct purchasers and end payers respectively. 

Novartis moved to dismiss the end-payers complaint under 

Rule 12(b)(6). Proceedings in the direct-purchaser action were 

stayed pending adjudication of Novartis's motion to dismiss. 

Novartis contended in that motion that, under Noerr-Pennington, it 

could not incur antitrust liability for exercising its right to 

enforce Patent '051 in court against an infringer. Novartis did 

acknowledge that there are "two relevant exceptions" to NoerrPennington immunity -- namely, the exceptions based on a showing 

of Walker Process fraud and "sham" litigation. But, Novartis 

argued in its motion that the plaintiffs had failed plausibly to 

allege that either exception applied.

In their opposition to the motion to dismiss, the 

plaintiffs accepted that Novartis would be entitled to NoerrPennington immunity unless at least one exception to that immunity 

applied. The plaintiffs asserted, however, that they had plausibly 

alleged that both exceptions did apply. The plaintiffs contended 

that their suit should therefore proceed to discovery, given that 

Novartis was not entitled to Noerr-Pennington immunity and that 

Novartis had not otherwise contested their allegations of "the 

traditional elements of an antitrust claim: causation, antitrust 

injury, and market power." 
- 12 - 

The District Court rejected the plaintiffs' arguments 

about the application of the exceptions and agreed with Novartis 

that it was entitled to Noerr-Pennington immunity. On that basis, 

the District Court granted Novartis's motion to dismiss the endpayers action. The direct-purchaser plaintiff next moved for entry 

of a judgment of dismissal in its own action "in accordance with 

the orders entered in the end payors' case," which the District 

Court granted. 

The plaintiffs in both actions then appealed.5 In 

pressing these appeals, the plaintiffs contend that the District 

Court erred in holding that they had not plausibly alleged that 

Novartis had engaged in either fraud within the meaning of Walker 

Process in obtaining Patent '051 or "sham" litigation in enforcing 

that patent and thus that the District Court erred in dismissing 

their suits on the ground that Novartis was immune from antitrust 

liability for enforcing Patent '051. Novartis counters that the 

District Court's ruling with respect to Noerr-Pennington immunity 

was correct, though Novartis does not dispute the plaintiffs' 

assertion that they have otherwise plausibly alleged the elements 

of an antitrust claim. We thus now address the plaintiffs' 

position against Noerr-Pennington immunity by considering the 

 5 The end-payer plaintiffs have filed an unopposed motion to 

amend their notice of appeal, which we provisionally granted and 

now finally grant. 
- 13 - 

strength of their arguments pertaining to whether Novartis had 

engaged in fraud within the meaning of Walker Process in obtaining 

the patent at issue or in "sham" litigation in enforcing that 

patent. 

II. 

In Walker Process, the Supreme Court held that "the 

enforcement of a patent procured by fraud on the Patent Office may 

be violative of [federal antitrust law] provided the other elements 

necessary to a[n] [antitrust] case are present." Walker Process, 

382 U.S. at 174.6 The plaintiffs rely on the following alleged 

misrepresentations in Novartis's patent application to support 

their contention that Novartis fraudulently obtained Patent '051 

from the Patent Office: (1) that the prior art did not disclose 

imatinib mesylate and (2) that Novartis's manufacture of the nonneedle or β-crystalline form of imatinib mesylate was 

"surprising[]." 

 6 Walker Process concerned antitrust liability under the 

federal Sherman Act. 382 U.S. at 173. The parties assume that 

the Walker Process doctrine applies to the state antitrust laws at 

issue in the end-payers action as well. 

We note that the Supreme Court has, since Walker Process, 

reserved the question "whether and, if so, to what extent Noerr 

permits the imposition of antitrust liability for a litigant's 

fraud or other misrepresentations." PREI, 508 U.S. at 61 n.6 

(citing Walker Process, 382 U.S. at 176-77). Neither party 

suggests to us, however, that, in light of PREI, Walker Process is 

not an available exception to Noerr-Pennington. So we proceed on 

the assumption that it is. 
- 14 - 

The plaintiffs' complaints allege that Novartis made 

these allegedly false representations "[w]ith intent to mislead or 

deceive" the Patent Office, "but for which the '051 patent would 

not have issued." Accordingly, the plaintiffs contend that they 

have sufficiently alleged the elements of intent and materiality 

in asserting that they are entitled to take advantage of the Walker 

Process-based fraud exception to the usual rule that a patent 

holder cannot incur antitrust liability for enforcing its patent. 

See Dippin' Dots, Inc. v. Mosey, 476 F.3d 1337, 1346-47 (Fed. Cir. 

2007); C.R. Bard, Inc. v. M3 Systems, Inc., 157 F.3d 1340, 1364-

65 (Fed. Cir. 1998). 

Novartis counters that the District Court rightly 

concluded that the plaintiffs have failed plausibly to allege that 

either of these allegedly false representations by Novartis in its 

application for Patent '051 was material to the issuance of that 

patent or that Novartis made either of these representations with 

the requisite intent to deceive the Patent Office. Accordingly, 

Novartis contends that the plaintiffs have failed plausibly to 

allege Walker Process fraud. 

 We do not need to reach the issue of whether the 

plaintiffs have plausibly alleged that Novartis made either of the 

representations at issue with the requisite fraudulent intent. 

And that is because we agree with Novartis and the District Court 

that the plaintiffs have failed plausibly to allege that either 
- 15 - 

representation, even if false, was material to the issuance of the 

patent. Our review of whether the plaintiffs have sufficiently 

alleged materiality is de novo. SEC v. Tambone, 597 F.3d 436, 441 

(1st Cir. 2010) (en banc). 

A. 

The materiality requirement is a meaningful one. "The 

heightened standard of materiality in a Walker Process case 

requires that the patent would not have issued but for the patent 

examiner's justifiable reliance on the patentee's 

misrepresentation or omission." Dippin' Dots, 476 F.3d at 1347 

(emphasis added) (citing C.R. Bard, 157 F.3d at 1364). 

 In addition, "[l]ike all fraud-based claims, Walker 

Process allegations are subject to the pleading requirements of 

Fed. R. Civ. P. 9(b)." MedImmune, Inc. v. Genentech, Inc., 427 

F.3d 958, 967 (Fed. Cir. 2005), rev'd on other grounds, 549 U.S. 

118 (2007). That means that the party alleging the fraud, with 

respect to elements not bearing on the "conditions of a person's 

mind," "must state with particularity the circumstances 

constituting fraud." Fed. R. Civ. P. 9(b). 

B.

We consider first the plaintiffs' allegations regarding 

Novartis's representation in its patent application that the prior 

art did not disclose the mesylate salt of the imatinib compound. 

Novartis does not dispute that this representation was false. But, 
- 16 - 

Novartis contends, the plaintiffs have failed plausibly to allege 

that this representation was material to the Patent Office's 

decision to issue Patent '051 and so cannot provide the predicate 

for their allegations of fraud under Walker Process. We agree. 

Cutting against the alleged materiality of this 

statement in the patent application is the fact that Patent '051 

covers only a particular form of imatinib mesylate, the βcrystalline form, and not the mesylate salt itself. That feature 

of the patent application is significant to our assessment of the 

plaintiffs' allegations concerning materiality because the Board 

reversed the patent examiner's initial rejection of Novartis's 

claim to the β-crystalline form even though the Board appears to 

have assumed that the mesylate salt of the imatinib compound had 

been previously prepared. In such circumstances, we find it 

difficult to conclude that, but for Novartis's inaccurate 

representation that the prior art did not disclose the mesylate 

salt of the imatinib compound, the patent would not have issued. 

But there is also another reason to reach that 

conclusion, which, at least when combined with the one that we 

have just given, is fatal to the plaintiffs' claim that they have 

plausibly alleged the materiality of the representation at issue. 

And that reason is that, as the District Court observed and as 

even the plaintiffs accept, Novartis eventually actually did 

submit prior art to the Patent Office that disclosed imatinib 
- 17 - 

mesylate, although Novartis did so -- to use the plaintiffs' word 

-- "belatedly." 

Specifically, Novartis submitted this prior art to the 

Patent Office via form PTO-1449. And there is no basis for 

disputing that the patent examiner, in issuing Patent '051, then 

considered this subsequently submitted prior art. The patent 

examiner initialed and signed form PTO-1449, and these "initials 

when placed adjacent to the considered citations . . . on a form 

PTO-1449 . . . provide a clear record of which citations have been 

considered by the Office." U.S. Patent and Trademark Office, 

Manual of Patent Examining Procedure § 609 (8th ed. May 2004). In 

addition, Patent '051 itself lists the publications referencing 

the prior art disclosing imatinib mesylate among the publications 

that the examiner considered in issuing the patent. See id. 

§ 1302.12 ("All references which have been cited by the examiner 

during the prosecution . . . will be printed in the patent.").7 

It is true that the patent examiner had already issued 

the notice of allowance for Patent '051 by the time that Novartis 

 7 The complaints allege that there was additional prior art 

disclosing imatinib mesylate that was never provided to the Patent 

Office. But, the plaintiffs do not contend that these references 

disclosed anything of relevance to Novartis's patent application 

other than the mesylate salt of imatinib that the submitted 

references had already disclosed. See Rothman v. Target Corp., 

556 F.3d 1310, 1326 (Fed. Cir. 2009) ("A piece of prior art is not 

material to patent prosecution when it is cumulative of information 

already before the examiner." (citing 37 C.F.R. § 1.56(b))). 
- 18 - 

had submitted this prior art. But, the plaintiffs make no argument 

that the examiner could not have withdrawn this allowance in light 

of the submission of this prior art and the disclosure of the 

corresponding salt that it made. In fact, the notice of allowance 

stated, while citing to 37 C.F.R. § 1.313, that "this application 

is subject to withdrawal from issue at the initiative of the office 

or upon petition by the applicant." 

Simply put, the record shows that the patent covers only 

a particular form of imatinib mesylate, that the Board reversed 

the patent examiner's initial ruling denying the patent even after 

assuming that the mesylate salt of the imatinib compound had been 

previously prepared, that Novartis ultimately did submit prior art 

disclosing that salt, and that the patent examiner considered that 

prior art in ultimately issuing the patent for a particular form 

of that salt. In light of these features of the record, we do not 

see how Novartis's earlier allegedly false representation that the 

prior art did not disclose imatinib mesylate to the Patent Office 

could plausibly be said to be material to the Patent Office's 

ultimate decision to issue the patent for the particular 

crystalline form of the salt. 

C. 

We next turn to the plaintiffs' allegations concerning 

a section of Novartis's patent application titled "BACKGROUND TO 

THE INVENTION," in which Novartis stated that "[i]t has now been 
- 19 - 

surprisingly found that a crystal form may under certain conditions 

be found in the [mesylate] salt of [the imatinib] compound, which 

is described hereinafter as β-crystal form" (emphasis added). The 

plaintiffs contend that Novartis's description of its manufacture 

of the β-crystalline form of imatinib mesylate as "surprising[]" 

was false. The plaintiffs further contend that Novartis made the 

statement "in order to avoid the inevitable conclusion that the 

non-needle form of imatinib mesylate was obvious" and that the 

statement was material to the Patent Office's decision to issue 

Patent '051.8

The District Court disagreed. The District Court noted 

that it is "unclear whether such a statement qualifies as a 

misrepresentation." The District Court explained in this regard 

 8 At oral argument, the plaintiffs asserted that Novartis's 

representation in this portion of its patent application from 2000 

as to the timing of the β-crystalline discovery -- namely, that it 

had just "now" been made and that it was thus a "new" crystalline 

form -- also effected a fraud on the Patent Office, independent of 

the use of the word "surprisingly." The plaintiffs argue that the 

use of the words "now" and "new" meant Novartis was presenting a 

false chronology, given the complaints' allegation that the βcrystalline form, "upon information and belief, was used by 

Novartis from August 1993 forward." But, although the plaintiffs' 

opposition brief below did allude to that allegation, the 

plaintiffs did not sufficiently raise below a Walker Process 

argument that, but for Novartis's use of the words "now" and "new," 

the patent would not have issued. See United States v. Slade, 980 

F.2d 27, 30 (1st Cir. 1992) (explaining that "[p]assing allusions 

are not adequate to preserve an argument"). Nor was this argument 

developed in their briefs to us. See Shell Co. (P.R.) Ltd. v. Los 

Frailes Serv. Station, Inc., 605 F.3d 10, 19 (1st Cir. 2010) 

(holding that an argument developed at oral argument but not in a 

party's briefs is deemed waived).
- 20 - 

that "[t]he examiner was free to reach [her] own opinion about 

whether such a discovery was in fact 'surprising' based on the 

prior art that was available to her before the patent issued." 

The District Court went on to explain that the plaintiffs "have 

not sufficiently alleged that if Novartis had avoided using the 

word 'surprising,' the patent would not have issued in light of 

the relevant prior art." 

In arguing on appeal that the District Court erred in 

finding that Novartis's use of the word "surprising" was not 

material to the patent's issuance, the plaintiffs assert that it 

would have been obvious to any pharmaceutical chemist of ordinary 

skill how to convert the mesylate salt from its non-needle to 

needle form through "routine" steps and that the process might 

even occur naturally. The plaintiffs thus suggest that Novartis's 

representation misled the Patent Office into concluding that the 

crystalline form of the salt at issue was not obvious, when it 

was. 

But, the plaintiffs have not shown that Novartis's 

characterization of the existence of the crystalline form of that 

salt as "surprising" was anything more than an assertion of nonobviousness. And the bare assertion that an invention is not 

obvious -- which, of course, is implicit in any patent application 

-- is not in and of itself a material misrepresentation for 

purposes of Walker Process. Rather, it is merely a legal assertion 
- 21 - 

that the patent examiner is free to assess in light of the prior 

art that is available to the examiner. See Akzo N.V. v. U.S. Int'l 

Trade Comm'n, 808 F.2d 1471, 1482 (Fed. Cir. 1986) ("The mere fact 

that [a patent applicant] attempted to distinguish [its claim] 

from the prior art does not constitute a material omission or 

misrepresentation. The examiner was free to reach his own 

conclusion regarding the [claim] based on the art in front of 

him."). 

The case on which the plaintiffs rely to contend that 

the use of the word "surprising" was more than a standard assertion 

of non-obviousness, Purdue Pharma L.P. v. Endo Pharms., Inc., 438 

F.3d 1123 (Fed. Cir. 2006), is readily distinguishable. For one 

thing, that case concerned a claim that a patent was invalid 

because it was obtained through "inequitable conduct" in violation 

of a patent applicant's "duty to prosecute patents in the [Patent 

Office] with candor and good faith." Id. at 1128. And, at that 

time, the materiality standard for an inequitable-conduct claim 

was lower than the but-for standard that we must apply here. See 

id. at 1129, 1132. 

In addition, Purdue Pharma did not purport to hold that 

a patent application's isolated description of a drug's new form 

as "surprising[]" could, standing alone, constitute a material 

misrepresentation under circumstances like those at issue here. 

The patent application at issue in Purdue Pharma described the 
- 22 - 

improved effects of a drug's new dosage-release mechanism, where 

those effects constituted "a prominent, and at times, the only, 

argument in favor of [the drug's] patentability." Id. at 1130 

(internal quotation marks omitted). The Federal Circuit explained 

that, in the context of a patent application of that sort, the 

applicant, by consistently representing to the Patent Office that 

the effects were a "surprising discovery," was clearly 

representing that the alleged effects were "based on the results 

of clinical studies," when that was not in fact true. Id. at 1131. 

In fact, in finding no clear error in the trial court's conclusion 

that these representations were therefore material to 

patentability, id., the Federal Circuit emphasized that Purdue 

Pharma was an "unusual" case, in which -- by "repeatedly rel[ying] 

on that discovery to distinguish its invention from other prior 

art . . . while using language that suggested the existence of 

clinical results" -- the patent applicant "did much more than 

characterize [its invention] as a surprising discovery." Id. at 

1133. 

Here, by contrast, Novartis's use of the word 

"surprising" gives rise to no similarly misleading implication. 

The representation at issue in Novartis's application concerns 

only the existence of the salt's crystalline form; it does not 

concern the form's "effects." Thus, Novartis's use of the word 

"surprising," in this context, does not suggest the presence of 
- 23 - 

underlying clinical data in the way that the use of that word, in 

the Purdue Pharma context, was found to have falsely implied the 

same. 

For these reasons, the plaintiffs' second Walker Process 

argument, like their first one, fails to provide a basis from which 

we could conclude that the plaintiffs have satisfied the but-for 

materiality standard. And thus, this Walker Process argument fails 

as well. 

D. 

In a final attempt to challenge the District Court's 

Walker Process ruling, the plaintiffs contend that Novartis's 

inclusion in its patent application of each of the alleged 

misrepresentations that we have just addressed amounted to the 

type of "egregious misconduct" that, like "the filing of an 

unmistakably false affidavit," makes the inclusion of such 

representations per se material to a patent's issuance. 

Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1292 

(Fed. Cir. 2011) (en banc); see also Intellect Wireless, Inc. v. 

HTC Corp., 732 F.3d 1339, 1342 (Fed. Cir. 2013) (explaining that 

an "unmistakably false" declaration "alone establishes 

materiality" if not cured). But, we do not agree. 

Novartis correctly points out that the plaintiffs 

forfeited this argument by not making it to the District Court, 

and the plaintiffs do not contend that the issue was preserved or 
- 24 - 

that the District Court plainly erred. See Chestnut v. City of 

Lowell, 305 F.3d 18, 20 (1st Cir. 2002) (en banc) (per curiam) 

(describing the four prongs of plain error: "error, plainness, 

prejudice, and miscarriage of justice or something akin to it"). 

Moreover, the alleged misrepresentations here, which the 

complaints allege to be merely "misleading, if not false," do not 

rise to the level of an "unmistakably false" affidavit or 

declaration. Intellect Wireless, 732 F.3d at 1342; Therasense, 

649 F.3d at 1292. And so, for this reason, too, we reject this 

attempt by the plaintiffs to show that they have plausibly alleged 

the element of materiality in alleging Walker Process fraud. 

III. 

Independent of Walker Process, the plaintiffs separately 

contend that Novartis is subject to antitrust scrutiny for 

enforcing Patent '051 on the ground that its patent infringement 

litigation was "a mere sham to cover what is actually nothing more 

than an attempt to interfere directly with the business 

relationships of a competitor." Noerr, 365 U.S. at 144 (emphasis 

added). But, we do not agree. 

A. 

The Supreme Court has announced a two-part test for 

determining whether a suit to enforce intellectual property rights 

is a "sham" that is not entitled to Noerr-Pennington immunity from 

antitrust scrutiny. PREI, 508 U.S. at 60. First, "the lawsuit 
- 25 - 

must be objectively baseless in the sense that no reasonable 

litigant could realistically expect success on the merits." Id. 

If the challenged suit is objectively baseless, a court then 

proceeds to consider the alleged monopolist's "subjective 

motivation" under the second part of the test. Id. Under this 

second prong, "the court should focus on whether the baseless 

lawsuit conceals 'an attempt to interfere directly with the 

business relationships of a competitor' through the 'use [of] the 

governmental process -- as opposed to the outcome of that process 

-- as an anticompetitive weapon.'" Id. at 60-61 (quoting Noerr, 

365 U.S. at 144; City of Columbia v. Omni Outdoor Advert., Inc., 

499 U.S. 365, 380 (1991)). 

 In order to make a "sham" showing with respect to a 

suit to enforce an intellectual property right, a plaintiff must 

allege that both prongs of the test are met. Id. Novartis's 

motion to dismiss the plaintiffs' antitrust claim challenged the 

plaintiffs' "sham" litigation argument by contending only that the 

plaintiffs had failed to plausibly allege that Novartis's 

litigation to enforce Patent '051 was "objectively baseless." We 

thus focus on the plausibility of the plaintiffs' allegations with 

respect to the "objectively baseless" prong, as the parties agree 

that, at least under PREI, the antitrust actions cannot go forward 
- 26 - 

unless the plaintiffs have plausibly alleged that Novartis's 

litigation to enforce Patent '051 was objectively baseless.9

B. 

Wholly apart from their allegations concerning Walker 

Process fraud, the plaintiffs argue, for the following reasons, 

that the only reasonably foreseeable outcome of Novartis's 

infringement litigation was dismissal on patent-invalidity grounds 

and thus that the infringement litigation was "objectively 

baseless." The plaintiffs contend that Novartis's patent was 

clearly invalid on either anticipation or obviousness grounds 

because "the non-needle crystal was an inherent characteristic of 

imatinib mesylate or else entirely obvious." See 35 U.S.C. §§ 102, 

103. In this regard, the plaintiffs point to their complaints' 

"key factual allegation," as described by the District Court: "that 

the two techniques Novartis described in its patent application, 

 9 In addition to invoking this "objectively baseless" test 

from PREI, the plaintiffs also urge us to apply the test from 

California Motor Transport Co. v. Trucking Unlimited, 404 U.S. 508 

(1972), which they argue is a different test that applies to 

allegations that a pattern of petitioning activity, as opposed to 

a single petition, was a "sham." The plaintiffs contend that this 

case involves such a pattern because their complaint alleges that 

Novartis sued not only Sun Pharma but also other generic 

manufacturers that had filed ANDAs for generic versions of Gleevec. 

However, the plaintiffs concede in their reply brief that "Novartis 

rightly points out that the end payers did not argue below that 

California Motor should apply." And, contrary to their assertion 

otherwise, our recent decision in Puerto Rico Telephone Co. v. San 

Juan Cable LLC, 874 F.3d 767 (1st Cir. 2017), does not excuse the 

forfeiture of that argument, which was no less available to them 

to make before that decision. 
- 27 - 

which produced the β-crystalline form, were commonly known methods 

for developing alternate crystalline forms at the time." 

Our review of whether the plaintiffs have plausibly 

alleged "sham" litigation is de novo. Tambone, 597 F.3d at 441. 

We proceed on the understanding that a suit to enforce a patent, 

like a suit to enforce any intellectual property right, could be 

"objectively baseless." See PREI, 508 U.S. at 63-65 (considering 

whether the underlying copyright infringement litigation in the 

case was potentially a "sham" because it was "objectively 

baseless"). But, here, the only ground that the plaintiffs assert 

to support their contention that Novartis's infringement 

litigation to enforce Patent '051 was "objectively baseless" is 

that the patent was invalid on anticipation or obviousness grounds. 

And that presents a problem for the plaintiffs. 

A patent is "presumed valid" and thus its validity can 

be challenged only with clear and convincing evidence. Microsoft 

Corp. v. i4i Ltd., 564 U.S. 91, 95 (2011) (quoting 35 U.S.C. 

§ 282). Against that background, we do not see how on this record 

plaintiffs can satisfy the "objectively baseless" prong in light 

of the fact that the Patent Office issued the patent following the 

Board's earlier ruling reversing the patent examiner's rulings as 

to anticipation and obviousness. 

Although the Board did not have all of the prior art 

before it at the time of its decision reversing the decision of 
- 28 - 

the patent examiner, the Board had assumed what the subsequently 

disclosed prior art showed: that imatinib mesylate was known prior 

to Novartis's claim to the development of its β-crystalline form. 

And, in ruling for Novartis notwithstanding that assumption, the 

Board indicated that it was not clear on the face of the prior art 

either that the β-crystalline form of imatinib mesylate was 

inherently anticipated or that it was obvious how to get "from 

here to there" in terms of developing it. That ruling was 

significant for purposes of determining whether Novartis could 

have reasonably expected success in its patent infringement 

litigation, insofar as any defense to that infringement litigation 

was based on the invalidity of Novartis's patent. 

After all, invalidation of a patent on anticipation 

grounds "requires that every element and limitation of the claim 

was previously described in a single prior art reference, either 

expressly or inherently, so as to place a person of ordinary skill 

in possession of the invention." Sanofi-Synthelabo v. Apotex, 

Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). And the plaintiffs do 

not dispute the District Court's conclusion that the prior art 

"neither describes the β-crystalline form of the imatinib mesylate 

salt nor a method to produce it. The prior art only mentions 

imatinib mesylate itself, . . . which has many different 

crystalline forms." 
- 29 - 

Moreover, with respect to obviousness, the analysis 

involves "several basic factual inquiries": 

[T]he scope and content of the prior art are 

to be determined; differences between the 

prior art and the claims at issue are to be 

ascertained; and the level of ordinary skill 

in the pertinent art resolved. Against this 

background, the obviousness or nonobviousness 

of the subject matter is determined. Such 

secondary considerations as commercial 

success, long felt but unsolved needs, failure 

of others, etc., might be utilized to give 

light to the circumstances surrounding the 

origin of the subject matter sought to be 

patented. 

Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 17-18 (1966). 

And, in the face of the Board's ruling and the patent's subsequent 

issuance, the complaints' mere allegations that "the two 

techniques Novartis described in its patent application, which 

produced the β-crystalline form, were commonly known methods for 

developing alternate crystalline forms at the time" and that a 

pharmaceutical chemist of ordinary skill would have been motivated 

to develop an advantageous crystalline form of imatinib mesylate 

are insufficient to allege plausibly that Novartis was 

unreasonable in expecting that Patent '051's presumed validity 

could withstand an obviousness challenge.10 Rather, those 

 10 The plaintiffs do point to the Supreme Court of India's 

2013 decision not to issue what they describe as Novartis's "Indian 

equivalent" of Patent '051. But, this effort fails. As indicated 

by a copy of that decision in the record, the India Supreme Court 

was applying a different patentability standard than under United 
- 30 - 

allegations merely demonstrate that Novartis would have been 

subject to a serious defense to its infringement litigation, as 

Novartis would have had to demonstrate that, despite those 

allegations, it was not obvious how, as the Board had put it in 

reversing the patent examiner's ruling as to obviousness, to get 

"from here to there," i.e., from the mesylate salt of imatinib to 

its β-crystalline form. 

Nor have the plaintiffs identified any authority to 

support their contention that their allegations are sufficient to 

plausibly allege that, despite the Board's ruling and the patent's 

issuance, Novartis's litigation to enforce that patent was a sham. 

In fact, the plaintiffs have not identified a single precedent 

that permitted an antitrust "sham" litigation claim to go forward 

based on an allegation that the infringement litigation was 

objectively baseless because the underlying patent was alleged to 

be invalid due to anticipation or obviousness. 

 We therefore reject the plaintiffs' contentions that 

they have plausibly alleged that they may take advantage of the 

"sham" litigation exception to Noerr-Pennington immunity 

 

States law. As the court explained there, under Indian law, "the 

mere discovery of a new form of a known substance" is not a "new 

product" "unless they differ significantly in properties with 

regard to efficacy." By contrast, under our law, a patent may be 

obtained so long as the differences between the claimed invention 

and the prior art were not so minimal that the invention was 

"obvious . . . to a person having ordinary skill in the art to 

which the claimed invention pertains." 35 U.S.C. § 103. 
- 31 - 

recognized in PREI. And thus, in light of our rejection of the 

plaintiffs' Walker Process-based arguments for subjecting Novartis 

to antitrust scrutiny, we see no reason to disturb the District 

Court's ruling dismissing the plaintiffs' antitrust suits for 

failure to state a claim. 

IV. 

For the foregoing reasons, the judgments of the District 

Court in both actions are affirmed.