Court Opinion

ID: 4305732
Source: CourtListenerOpinion
Date Created: 2018-08-21 17:00:14.989628+00
Date Added: 2024-06-11T07:49:01.978087
License: Public Domain

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
        [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

                              - 2 -
             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.

                                        - 3 -
See Prof'l Real Estate Inv'rs, Inc. v. Columbia Pictures Indus.,

Inc.    ("PREI"),    508     U.S.     49,    63-65     (1993)   (applying      Noerr-

Pennington     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 Noerr-

Pennington 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

                                        - 4 -
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.

                                     - 5 -
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.

                                  - 6 -
          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).

                                - 7 -
           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,

      2Novartis 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.

                                       - 8 -
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

      3The 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.

                                  - 9 -
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

      4The 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.

                                   - 10 -
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 Noerr-

Pennington 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 Noerr-

Pennington 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."

                                  - 11 -
          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 end-

payers 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.

                             - 12 -
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 non-

needle    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.

                               - 13 -
          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

                                  - 14 -
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,

                                        - 15 -
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    β-

crystalline 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

                                         - 16 -
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))).

                              - 17 -
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

                                   - 18 -
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 β-
crystalline 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).

                                - 19 -
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 non-

obviousness.     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

                                - 20 -
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

                               - 21 -
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

                                   - 22 -
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

                                      - 23 -
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

                                         - 24 -
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

                                     - 25 -
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,

       In addition to invoking this "objectively baseless" test
       9

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.

                                        - 26 -
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

                                  - 27 -
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."

                                  - 28 -
             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

      10The 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

                                      - 29 -
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.

                                            - 30 -
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.

                             - 31 -