Court Opinion

ID: 4150478
Source: CourtListenerOpinion
Date Created: 2017-03-06 22:00:23.411425+00
Date Added: 2024-06-11T14:22:41.845716
License: Public Domain

United States Court of Appeals
                        For the First Circuit

No. 16-2113

                    AMPHASTAR PHARMACEUTICALS INC.;
                INTERNATIONAL MEDICATION SYSTEMS LTD.,

                        Plaintiffs, Appellants,

                                  v.

              MOMENTA PHARMACEUTICALS, INC.; SANDOZ INC.,

                        Defendants, Appellees.

          APPEAL FROM THE UNITED STATES DISTRICT COURT
                FOR THE DISTRICT OF MASSACHUSETTS

         [Hon. Nathaniel M. Gorton, U.S. District Judge]

                                Before

                         Howard, Chief Judge,
                   Lynch and Lipez, Circuit Judges.

     Chul Pak, with whom Jonathan M. Jacobson, Jeffrey C. Bank,
Daniel P. Weick, Seth C. Silber, Elyse Dorsey, Wilson Sonsini
Goodrich & Rosati, P.C., Alan D. Rose, Sr., Meredith W. Doty,
Michael L. Chinitz, and Rose Chinitz & Rose were on brief, for
appellants.
     Robert S. Frank, Jr., with whom Robert M. Buchanan, Jr.,
Sophie F. Wang, Greta A. Fails, Choate Hall & Stewart LLP, Michael
P. Kenny, Teresa T. Bonder, Matthew D. Kent, D. Andrew Hatchett,
and Alston & Bird LLP were on brief, for appellees.
     Deborah L. Feinstein, Director, Bureau of Competition,
Bradley S. Albert, Deputy Assistant Director, Bureau of
Competition, Heather M. Johnson, Attorney, Bureau of Competition,
Rajesh James, Attorney, Bureau of Competition, June Im, Attorney,
Bureau of Competition, David C. Shonka, Acting General Counsel,
Federal Trade Commission, Joel Marcus, Deputy General Counsel,
Federal Trade Commission, and Imad D. Abyad, Attorney, Federal
Trade Commission, on brief for amicus curiae Federal Trade
Commission.
     David A. Balto, Bradley A. Wasser, Matthew C. Lane, and Law
Offices of David A. Balto on brief for amici curiae Consumer
Action, National Health Law Program, and United States Public
Interest Research Group.

                          March 6, 2017
             HOWARD,    Chief      Judge.       Plaintiff-Appellant     Amphastar

Pharmaceuticals Inc. and its wholly owned subsidiary International

Medication Systems Ltd. (collectively, "Amphastar") appeal from

the   district      court's       dismissal   of   their   complaint     alleging

antitrust violations by Defendant-Appellees Sandoz Inc. ("Sandoz")

and Momenta Pharmaceuticals, Inc. ("Momenta").                     Amphastar and

Sandoz are competitors in the United States market for generic

enoxaparin, an anticoagulant.           Momenta serves as Sandoz's contract

laboratory.

             Amphastar's suit is predicated upon the defendants'

alleged misrepresentations to the United States Pharmacopeial

Convention       ("USP"),     a    private    standard-setting       organization

("SSO") charged with ensuring the quality of drugs.                  According to

the complaint, the defendants, in violation of a duty imposed by

the USP, knowingly failed to disclose to the standard-setting body

that a proposed method for testing generic enoxaparin might be

covered by Momenta's pending patent application.                     The USP, in

reliance    on    the   defendants'         misrepresentations,      adopted   the

method, and the Food and Drug Administration ("FDA") required

Amphastar to comply with it.

             The defendants promptly brought an infringement suit

against Amphastar, resulting in a temporary restraining order

("TRO")     and     subsequent       preliminary      injunction      prohibiting

Amphastar    from    selling       enoxaparin.      Although   the   preliminary

                                        - 3 -
injunction was ultimately vacated, it did prevent Amphastar from

selling its generic enoxaparin for a period of roughly three

months.

          Amphastar responded with the instant suit under the

Sherman Act, see 15 U.S.C. §§ 1, 2, seeking damages for profits

lost during the pendency of the TRO and injunction.   The district

court dismissed Amphastar's complaint under the so-called Noerr-

Pennington doctrine, which immunizes good-faith petitioning of

government entities from antitrust liability.   Because its Noerr-

Pennington ruling was dispositive, the court expressly declined to

address the defendants' other arguments for dismissal.    We hold

that the district court erroneously applied Noerr-Pennington.

Accordingly, we reverse the dismissal of Amphastar's complaint and

remand for the district court to consider the defendants' other

arguments in the first instance.

                                I.

          In reviewing the district court's dismissal under Fed.

R. Civ. P. 12(b)(6), we take as true the facts from the well-pled

allegations in Amphastar's complaint.   See, e.g., In re Loestrin

24 Fe Antitrust Litig., 814 F.3d 538, 549 (1st Cir. 2016).

          In November 2003, Sandoz and Momenta entered into a

collaboration agreement for the development and commercialization

of enoxaparin.   The agreement granted Sandoz an exclusive license

to Momenta's (as yet unissued) United States Patent No. 7,575,886

                               - 4 -
("'886 patent").      It also created heavy incentives to ensure that

Sandoz remained the sole provider of generic enoxaparin, including

milestone and profit share payments to Momenta.           Sandoz benefited

because, as long as it was the only generic entrant in the market,

it would be able to price enoxaparin at close to brand levels.

           In early 2007, the USP began the process of establishing

standards for enoxaparin, including a testing method to determine

whether the relevant criteria have been met.           Ultimately, in late

2009, the USP would adopt Method <207> ("Method 207") as the

testing   standard.      Federal    law     requires   that     pharmaceutical

products comply with applicable USP standards.                See 21 U.S.C. §

351(b).

           USP policy requires all members and participants in the

standard-setting process to disclose any potential conflicts of

interest, including intellectual property rights.               The USP staff

typically reviews these conflict of interest policies at the

beginning of panel meetings.          Dr. Zachary Shriver, a Momenta

employee who would later be named as an inventor on the '886

patent,   represented     Momenta   on    the   USP    panels    involved   in

developing the enoxaparin standard.           Sandoz also participated in

the panel discussions.

           During the standard-setting process, the USP was unaware

of the pending '886 patent application.           After the patent issued

in August 2009, the defendants would take the position that it

                                    - 5 -
covered Method 207.   Notwithstanding this potential conflict, the

defendants failed to disclose the pending application to the USP.

           The defendants' failure to disclose their own potential

conflict stands in sharp contrast to their vigilance in raising a

similar issue relating to Sanofi-Aventis ("Aventis").     In 1995,

Aventis had obtained approval for the original branded version of

enoxaparin.    During the standard-setting process, the defendants

complained to the USP that Aventis had a pending patent application

that, if issued, would potentially cover Method 207.       The USP

accordingly persuaded Aventis to allow its application to lapse.

Subsequently, the USP staff reported that it was "not aware of any

patent issue that may cover the test."

           In December 2009, the USP approved and adopted Method

207.    The method thus became "the official test method that the

FDA required of Amphastar to test . . . its enoxaparin in order to

obtain and maintain its generic enoxaparin approval."       Sandoz

became the first entity to receive FDA approval to sell generic

enoxaparin in July 2010.   Amphastar received approval in September

2011.

           Just two days after Amphastar's approval, the defendants

filed the suit, mentioned earlier, claiming infringement of the

'886 patent.   The district court issued a TRO on October 7, 2011,

and a preliminary injunction on October 28. The TRO and subsequent

injunction prohibited Amphastar from selling enoxaparin.       The

                               - 6 -
injunction was stayed (and later vacated) on appeal by the Federal

Circuit on January 25, 2012. See Momenta Pharm., Inc. v. Amphastar

Pharm., Inc., 686 F.3d 1348, 1352, 1361 (Fed. Cir. 2012).

            In September 2015, Amphastar filed the instant antitrust

action, seeking damages for profits lost during the pendency of

the TRO and preliminary injunction entered in the infringement

suit.     Amphastar initially filed in the Central District of

California, but the case was later transferred to the District of

Massachusetts.      After the transfer, the district court granted the

defendants' motion to dismiss.

            In   dismissing     the   complaint,     the     court    relied

exclusively upon the Noerr-Pennington doctrine, which immunizes

from    antitrust   liability   "valid    efforts   to    elicit   favorable

government action . . . even if the ultimate purpose or incidental

consequence of the efforts is an anti-competitive restraint on

trade." The court noted that Amphastar's claimed injuries resulted

from the injunction issued in the patent infringement case.              It

then went on to find "that the asserted injuries arise from the

FDA's purported adoption of the 207 Method" and, for that reason,

Noerr-Pennington barred the antitrust claims.            The court rejected

Amphastar's argument that the defendants' misrepresentations to

the USP deprived them of immunity.         Finally, the district judge

expressly "decline[d] to address [the defendants'] other arguments

                                  - 7 -
for     dismissal"   because      its     Noerr-Pennington     ruling    was

"dispositive."

                                    II.

            We review the dismissal of Amphastar's complaint de

novo.     See, e.g., Loestrin, 814 F.3d at 549.               Applying this

standard, we hold that the district court erred in dismissing the

complaint under Noerr-Pennington.

            The Noerr-Pennington doctrine provides that a Sherman

Act violation cannot be "predicated upon mere attempts to influence

the passage or enforcement of laws." E. R.R. Presidents Conference

v. Noerr Motor Freight, Inc., 365 U.S. 127, 135 (1961); see also

United Mine Workers v. Pennington, 381 U.S. 657, 670 (1965) ("Joint

efforts to influence public officials do not violate the antitrust

laws even though intended to eliminate competition."). While Noerr

and Pennington dealt with petitioning of the legislative and

executive    branches,   the    Court   later   held   that    "[t]he   same

philosophy governs the approach of citizens . . . to administrative

agencies . . . and to courts."      Cal. Motor Transp. Co. v. Trucking

Unlimited, 404 U.S. 508, 510 (1972).          Here, the defendants argue

that Noerr-Pennington protects their petitioning of the federal

court in the infringement suit.

            At oral argument, the defendants expressly declined to

take the position that Noerr-Pennington separately immunizes their

conduct before the USP.        Indeed, the Supreme Court has held that

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petitioning of a private SSO, like the USP, generally does not

trigger Noerr-Pennington protection.            See Allied Tube & Conduit

Corp. v. Indian Head, Inc., 486 U.S. 492, 500 (1988).               And we need

not decide whether "the context and nature of the activity" at

issue here is sufficiently distinct from that addressed in Allied

Tube to warrant a different result.             Id. at 507 n.10.        This is

because, even assuming the questionable proposition that Noerr-

Pennington      immunity   would    otherwise    apply,    it   has    a   well-

established exception for knowing "[m]isrepresentations," at least

in the administrative and adjudicatory contexts.             Cal. Motor, 404
U.S. at 513; see also, e.g., Allied Tube, 486 U.S. at 500.

Amphastar's allegations, if proven, are sufficient to establish

such an intentional misrepresentation.

              The defendants similarly do not rely on the FDA's alleged

adoption of Method 207 in support of their immunity argument.

While the district court appeared to base its dismissal order, at

least    in   part,   on   the   FDA's   involvement,     neither     party   has

identified any direct petitioning activity before that agency.

Indeed, the defendants did not even raise this theory for dismissal

in district court.          Accordingly, the district court erred in

applying Noerr-Pennington on this ground.1

     1 It     is true that, under another line of cases, antitrust
liability     cannot be predicated upon government action. See, e.g.,
Tri-State     Rubbish, Inc. v. Waste Mgmt., Inc., 998 F.2d 1073, 1076
(1st Cir.      1993) (citing Parker v. Brown, 317 U.S. 341 (1943)).

                                     - 9 -
           Before reaching the merits, we are confronted with a

choice-of-law question.    The defendants assert that we must apply

the law of the Federal Circuit.          See, e.g., Nobelpharma AB v.

Implant Innovations, Inc., 141 F.3d 1059, 1067 (Fed. Cir. 1998)

(holding that "[w]hether conduct in the prosecution of a patent is

sufficient to strip a patentee of its immunity from the antitrust

laws" implicates the Federal Circuit's "exclusive jurisdiction"

and, accordingly, should be decided under the law of that circuit).

As an initial matter, Nobelpharma is not binding on us.        And, in

any event, the present dispute involves conduct before a private

SSO, not patent prosecution or any other issue within the Federal

Circuit's exclusive jurisdiction.         See generally 28 U.S.C. §

1295(a).   Accordingly, we apply our own precedent.2

           Turning to substance, the defendants primarily contend

that, regardless of whether Noerr-Pennington applies to their

conduct    during   the   standard-setting    process,   the   doctrine

precludes Amphastar from recovering damages resulting from the TRO

and injunction issued in the infringement suit.          This argument

conflates the alleged antitrust violation with the damages caused

The defendants, however, do not develop any argument on this point,
and we, therefore, decline to address the applicability of this
distinct basis for immunity.
     2 We also note that the parties have failed to demonstrate
any meaningful difference between our own law and that of the
Federal Circuit on the issues relevant to this appeal.

                                - 10 -
by that violation.      Courts have recognized that "[t]here is an

important     difference,    for   purposes      of   the   Noerr-Pennington

doctrine, between using litigation . . . as a basis of antitrust

liability and awarding damages for efforts to use the courts to

carry out private cartel agreements."            Premier Elec. Constr. Co.

v. Nat'l Elec. Contractors Ass'n, Inc., 814 F.2d 358, 374 (7th

Cir. 1987) (Easterbrook, J.); see also McGuire Oil Co. v. Mapco,

Inc., 958 F.2d 1552, 1561 (11th Cir. 1992) (citing Premier for the

proposition    that   "the   institution    of    state     court   litigation

against the Sherman Act plaintiff . . . could furnish the source

of the antitrust injury . . . even if it could not provide a basis

for a Sherman Act violation under the Noerr-Pennington doctrine").

The mere existence of a lawsuit does not retroactively immunize

prior anti-competitive conduct.      See, e.g., Walker Process Equip.,

Inc. v. Food Mach. & Chem. Corp., 382 U.S. 172, 177 (1965); United

States v. Singer Mfg. Co., 374 U.S. 174, 196-97 (1963); Primetime

24 Joint Venture v. Nat'l Broad. Co., Inc., 219 F.3d 92, 102-03

(2d Cir. 2000).3

            Applying these principles to the present context, the

defendants' infringement suit "cannot itself be the antitrust

     3The Federal Trade Commission, in its amicus brief, similarly
takes the position that "Noerr does not retroactively protect
unlawful agreements or schemes to acquire, maintain, or jointly
exercise market power that defendants subsequently exploit through
litigation."

                                   - 11 -
violation without invoking Noerr."                        2 Hovenkamp et al., IP &

Antitrust § 35.05[B] (3d ed. 2017).                         But where "the antitrust

violation          is    intentional       deception       of     the    standard-setting

organization," the mere fact that the alleged damages are based,

in part, on a lawsuit seeking an injunction does not "defeat the

antitrust         claim     based    on    conduct      before    the    standard-setting

organization."4               Id.     (quoting          Microsoft       Mobile    Inc.    v.

Interdigital, Inc., No. 15-723-RGA, 2016 WL 1464545, at *3 (D.

Del.       Apr.    13,     2016)).        In   essence,     the   mere    fact    that   the

defendants brought protected patent litigation against Amphastar

does not immunize them from liability for the full amount of

damages           caused      by     their        alleged        antitrust       violation.

Significantly, the antitrust violation need not be the "sole cause"

of Amphastar's injury, so long as it was a "material cause."

Sullivan v. Nat'l Football League, 34 F.3d 1091, 1103 (1st Cir.

1994) (citation omitted).

                  Aside from the question of immunity, the defendants

argue on appeal that Amphastar's complaint is insufficient with

respect to certain elements of an antitrust claim, including

       4
       As explained below, we hold only that the defendants are
not protected by Noerr-Pennington immunity and otherwise express
no opinion on whether Amphastar's allegations are sufficient to
state a claim. We do, however, note that intentional deception of
an SSO may, at least in some circumstances, constitute an antitrust
violation. See, e.g., Broadcom Corp. v. Qualcomm Inc., 501 F.3d
297, 314 (3d Cir. 2007); 2 Hovenkamp et al., IP & Antitrust
§ 35.05[B] (3d ed. 2017).

                                               - 12 -
causation.   They   also   contend   that   the    alleged   Sherman   Act

violations were compulsory counterclaims, which had to be raised,

if at all, in the infringement suit.        Because it found that the

defendants were protected by Noerr-Pennington, the district court

expressly declined to rule on these issues.        Accordingly, we leave

the defendants' additional arguments for the district court to

address in the first instance on remand.

                                III.

          For the foregoing reasons, we REVERSE the dismissal of

Amphastar's complaint and remand to the district court for further

proceedings consistent with this opinion.         No costs are awarded.

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