Azurity Pharmaceuticals, Inc. v. Bionpharma Inc.

Opinion

INTHEUNITEDSTATESDISTRICTCOURT FORTHEDISTRICTOFDELAWARE

AZURITYPHARMACEUTICALS,INC., Plaintiff, CivilAction v. Nos. 21-cv-1286,21-cv-1455 BIONPHARMAINC., Defendant.

MEMORANDUMOPINION Goldberg, J.1 January 11, 2023 These cases comprise what the parties refer to as the “Third Wave” in an ongoing patent infringement dispute between Plaintiff Azurity Pharmaceuticals, Inc. (“Azurity”) and Defendant Bionpharma Inc. (“Bionpharma”). The parties’ dispute revolves around Bionpharma’s generic

enalapril oral liquid. Bionpharma’s counterclaims assert antitrust “sham litigation” claims under the Sherman Act, 15 U.S.C. §§ 2, 15, and 15/26" style="color:var(--green);border-bottom:1px solid var(--green-border)">26, alleging that Azurity brought these and other lawsuits in bad faith to stifle competition. Bionpharma claims that these lawsuits were objectively baseless and brought only to force Bionpharma to incur litigation costs and delay market entry for the duration of the 30-month stay applicable to Hatch-Waxman litigation. Before me is Azurity’s motion to dismiss the antitrust counterclaims. For the reasons that follow, Azurity’s motion will be denied.

1 Pursuantto28U.S.C.§292(b),IhavebeendesignatedtoserveasavisitingjudgefortheDistrict ofDelawaretohandlethismatterandotherDistrictofDelawarecases. I. FACTUALANDPROCEDURALBACKGROUND The following facts are taken from Bionpharma’s Answer and Counterclaims, and, where appropriate, matters of public record regrading the litigation history between Azurity and Bion-

pharma. These facts will be viewed in the light most favorable to Bionpharma. See Burtch v. MillbergFactors,Inc.,662F.3d212,221(3dCir.2011). A. Azurity’sEPANEDProductandRelatedPatents Azurity’s brand product EPANED is an oral liquid formulation of the blood pressure medicine enalapril. (Answer2 ¶ 9; Counterclaims ¶¶ 13, 34-35.) EPANED “is the only ready-to- use oral solution of enalapril, which caters to specific populations of patients that have trouble

swallowingsolidoraldosageforms.”(Counterclaims¶38.) From March 2016 to April 2021, Azurity filed nine patent applications for enalapril liq- uids, each a continuation of a prior application, and each with a priority date of March 18, 2016.3 The precise claim limitations differ from patent to patent, but the essence of each is a stable mix- ture of water, enalapril, and other ingredients such as buffers, preservatives, and sweeteners. The followingclaimsfromtwoofthosepatentsareillustrative: Astableoralliquidformulation,comprising: (i) about1mg/mlenalaprilmaleate; (ii) a buffer comprising about 1.82 mg/ml citric acid and about 0.15 mg/mL sodiumcitratedihydrate; (iii) about1mg/mlofapreservativethatissodiumbenzoate;and (iv) water; 2 Paragraph citations to “Answer” refer to Docket Entry 26 in 21-cv-1455. Paragraph citations to “Counterclaims”refertoparagraphsbeginningonpage10ofthatdocument. 3 TheseapplicationsissuedasU.S.PatentNos.9,669,008(the’008patent),11,040,023(the’023 patent), 11,141,405 (the ’405 patent), 9,808,442 (the ’442 patent), 10,786,482 (the ’482 patent), 10,918,621 (the ’621 patent), 10,039,745 (the ’745 patent), 10,772,868 (the ’868 patent), and 10,154,987(the’987patent). whereinthepHoftheformulationislessthanabout3.5;... whereintheformulationisstableatabout5±3°C.foratleast12months;[and] whereinthestableoralliquidformulationhasabout95%orgreateroftheinitial enalaprilamountandabout5%w/worlesstotalimpuritiesorrelatedsubstances attheendofthegivenstorageperiod. (Claim1ofthe’008patent.) Astableoralliquidformulation,comprising: (i) about 0.6 to about 1.2 mg/ml enalapril or a pharmaceutically acceptable saltorsolvatethereof; (ii) a buffer comprising about 0.8 to about 3.5 mg/ml citric acid and about 0.1toabout0.8mg/mlsodiumcitrate; (iii) about0.7toabout1.2mg/mlsodiumbenzoate;and (iv) water; whereintheformulationisstableatabout5±3°C.foratleast12months;and wherein the stable oral liquid formulation has about 95% w/w or greater of the initial enalapril amount and about 5% w/w or less total impurity or related sub- stancesattheendofthegivenstorageperiod. (Claim1ofthe’745patent.) B. Bionpharma’sANDA In August 2018, Bionpharma filed an abbreviated new drug application (ANDA) with the Food and Drug Administration (FDA) for a generic oral enalapril liquid. (Counterclaims ¶¶ 14, 63.) Bionpharma alleges that its ANDA differs from Azurity’s EPANED product in that it does not contain a buffer and uses a preservative consisting of parabens rather than sodium benzoate. (Counterclaims ¶ 61.) Bionpharma alleges it made these alterations to “design ... around” Azu- rity’spatents. (Id.) To date, Azurity has filed seven lawsuits in three separate courts regarding Bionpharma’s generic enalapril liquid—five against Bionpharma and two against Bionpharma’s contract manu- facturer,CoreRx.4 C. Bionpharma’sParagraphIVNoticetoAzurity

When a generic manufacturer files an ANDA, it must send a notice (a “Paragraph IV Notice”) to patentholders listed for the brand drug in the FDA’s “Orange Book.” See 21 U.S.C. § 355(j)(2)(B). In October 2018, Bionpharma sent a Paragraph IV Notice to Azurity regarding the ’008,’442,and’745patents. (Counterclaims¶64.) Bionpharma’s Paragraph IV Notice offered to provide Azurity with confidential access to Bionpharma’s ANDA, under terms similar to those used in prior litigation between Azurity and Bionpharma. (Counterclaims ¶ 65.) Bionpharma requested that Azurity agree not to share in-

formation with its patent prosecution counsel (an agreement called a “patent prosecution bar”) becauseAzurityhadpatentprosecutionopenforenalaprilliquidsandBionpharmawasconcerned that Azurity could file new applications targeted to Bionpharma’s ANDA. (Counterclaims ¶ 68.) Azurity declined the offer of confidential access, and Bionpharma alleges that Azurity did so be- cause Azurity was indifferent to the merits of its infringement position. (Counterclaims ¶¶ 65, 70-71.)

4 For reference, Azurity’s seven lawsuits over Bionpharma’s ANDA are summarized in the table below:

DocketNo. Defendant FiledIn FiledOn Patents D.Del.18-1962 Bionpharma D.Del. 12/12/2018 ’008,’442,’745 D.Del.19-1067 Bionpharma D.Del. 6/7/2019 ’987 D.Del.20-1256 Bionpharma D.Del. 9/18/2020 ’868,’482,’621 D.Del.21-1286 Bionpharma D.N.J. 6/22/2021 ’023 D.Del.21-1455 Bionpharma D.Del. 10/15/2021 ’405 M.D.Fla. 21-2515 CoreRx M.D.Fla. 10/26/2021 ’023,’405 D.Del.21-1522 CoreRx D.Del. 10/27/2021 ’023,’405 D. Azurity’sLawsuitsAgainstBionpharma From December 12, 2018 to October 15, 2021, Azurity filed five lawsuits against Bion- pharma only over Bionpharma’s generic enalapril liquid. Collectively, these lawsuits involve all

nine of Azurity’s patents for enalapril liquids. The parties refer to groups of these lawsuits as the the“FirstWave,”“SecondWave,”and“ThirdWave.” TheFirstWave(Nos.18-cv-1962and19-cv-1067)involvedthe’008,’442,’745,and’987 patents. InFebruary2021,theHonorableLeonardStarkheldabenchtrialonthesepatentsandon April27,2021enteredjudgmentforBionpharma,findingthat: (1) Prosecution history estoppel precluded Azurity from claiming that the active ingredient in Bionpharma’s ANDA, enalapril maleate, was equivalent to the citrate buffer limitation in theassertedclaims; (2) Azurityfailedtoprovethatenalaprilmaleateactedasabuffer;and (3) Azuritycouldnotclaimparabensasequivalenttotheclaimedpreservativesodiumbenzoate becauseparabensweredisclosedinthespecificationbutnotclaimed. (See No. 19-1067, Docket Entry 244.) The Court of Appeals for the Federal Circuit affirmed Judge Stark’s findings without an opinion. See Azurity Pharmaceuticals, Inc. v. Bionpharma Inc., No.2021-1926(Fed.Cir.March9,2022). The Second Wave lawsuit (No. 20-cv-1256) involved the ’868, ’482, and ’621 patents. After the Federal Circuit’s affirmance became final in the First Wave suits, Azurity stipulated to dismissaloftheSecondWavelawsuit. The Third Wave lawsuits (Nos. 21-cv-1286 and 21-cv-1455), which are ongoing, involve the ’023 and ’405 patents. One of these lawsuits (No. 21-cv-1286) was originally filed in the

DistrictofNewJerseyandtransferredtothisCourtonBionpharma’smotion. AlloftheselawsuitswerereassignedtomeonMarch2,2022. E. Azurity’sAcquisitionofandLawsuitsAgainstCoreRx Bionpharma contracted with a third party, CoreRx, Inc. (“CoreRx”) to develop and manu- facturer the enalapril oral liquid that became Bionpharma’s ANDA. (Counterclaims ¶ 13.) In Jan-

uary2021,Azurity’scorporateparent,NovaQuestCapitalManagement(“NovaQuest”)acquireda controlling interest in CoreRx. (Counterclaims ¶ 17.) As of February 2022, Azurity and CoreRx hadseveraldirectorsincommonontheirrespectivecorporateboards. (Counterclaims¶¶19-22.) After NovaQuest acquired CoreRx, Azurity sued its new corporate sister twice, in two dif- ferent courts, for infringing Azurity’s patents by manufacturing Bionpharma’s ANDA. See Azu- rity Pharmaceuticals, Inc. v. CoreRx, Inc., No. 21-cv-2515 (M.D. Fla. filed October 26, 2021);

Azurity Pharmaceuticals, Inc. v. CoreRx, Inc., No. 21-cv-1522 (D. Del. filed October 27, 2021). Bionpharma alleges that Azurity and CoreRx were not genuinely adverse parties in these law- suits because their common parent, NovaQuest, could have simply “direct[ed] CoreRx to cease manufacturingforBionpharmawithoutinvolvingthecourts.”(Counterclaims¶157.) Bionpharma moved to intervene in the Florida CoreRx lawsuit, allegedly “in order to protect itself against the feignedthreatofaninjunctionagainstCoreRx’sperformanceofitscontractualobligationtosupply BionpharmawithBionpharma’sANDAproduct.”(Counterclaims¶162.) Azuritythensettledwith

CoreRx,whereinCoreRxagreedtostopsupplyingthegenericenalapriloralliquidtoBionpharma. (Counterclaims¶164.) Based on all the allegations set forth above, Bionpharma claims that Azurity sought to improperly maintain a monopoly in enalapril liquids by punishing generic competition through burdensome and costly litigation. Bionpharma also contends that Azurity brought the First Wave suits solely to obtain the Hatch-Waxman 30-month stay even though Azurity had no expectation

ofsucceedingonthemerits. Azurityhasmovedtodismisstheseantitrustcounterclaims. II. LEGALSTANDARD To survive a motion to dismiss pursuant to Rule 12(b)(6), a complaint must “contain suf- ficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’”

Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544,570(2007)). Conclusoryallegationsdonotsuffice. Id.TwomblyandIqbal’splausibilitystan- dardrequiresmorethana“sheerpossibilitythatadefendanthasactedunlawfully.”Id.Plausibility requires “enough facts to raise a reasonable expectation that discovery will reveal evidence of the necessaryelementsofaclaim.”Phillipsv.County.OfAllegheny,515F.3d224,234(3dCir.2008). To determine the sufficiency of a complaint under Twombly and Iqbal, a court must (1)

“tak[e] note of the elements a plaintiff must plead to state a claim”; (2) identify the allegations that are not entitled to the assumption of truth because they are no more than conclusions; and (3) “where there are well-pleaded factual allegations, . . . assume their veracity and then determine whether they plausibly give rise to an entitlement for relief.” Burtch v. Millberg Factors, Inc., 662 F.3d212,221(3dCir.2011). Courtsmustconstruetheallegationsinacomplaint“inthelightmost favorabletotheplaintiff.”Id.at220. When deciding a motion to dismiss, “courts generally consider only the allegations con-

tained in the complaint, exhibits attached to the complaint and matters of public record.” Schmidt v.Skolas,770F.3d241,249(3dCir.2014). III. DISCUSSION Azurity contends that Bionpharma’s antitrust claims should be dismissed for six separate

reasons,eachofwhichisaddressedbelow. A. CompulsoryCounterclaims AzurityfirstarguesthatBionpharma’santitrustclaimsshouldbebarredbecausetheywere compulsory counterclaims that Bionpharma should have asserted when the First Wave suits were

filed. A counterclaim is compulsory if it “bears a logical relationship” to the primary claim. Xe- rox Corp. v. SCM Corp., 576 F.2d 1057, 1059 (3d Cir. 1978). A logical relationship, in turn, depends on whether the two claims “involve many of the same factual issues, or the same factual and legal issues, or where they are offshoots of the same basic controversy between the parties.” Id. Under this standard, Azurity argues that the First Wave suits were for patent infringement and

that Bionpharma’s antitrust claims in the present lawsuit include allegations that bear a logical relationshiptotheFirstWavesuits. “WhetheraShermanActantitrustclaimisacompulsorycounterclaiminapatentinfringe- mentactionisaquestionofconsiderabledebate.”P&MServices,Inc.v.Gubb,No.07-cv-12816, 2008 WL 4185903, at *3 (E.D. Mich. Sept. 8, 2008). The closest binding precedent on this is- sue is the Supreme Court’s decision in Mercoid Corp. v. Mid-Continent Investment Co., 320 U.S. 661(1944). There,withlittlediscussionregardingthecompulsorycounterclaimtest,theSupreme

Courtappearedtoassumethatanantitrustclaimallegingthatthepatenteehadattemptedtoexpand its patent to cover an unpatented component of the invention by suing a user of such a component was not a compulsory counterclaim to the infringement suit. See id. at 671. In a clearer pro- nouncement,theNinthCircuithasinterpretedMercoidasholdingthataclaimof“predatorypatent litigation” is not a compulsory counterclaim to a claim of infringement. Hydranautics v. FilmTec Corp.,70F.3d533,536-37(9thCir.1995)(“Mercoidleavesopenthepossibilityofraisingantitrust

claims...inaseparateandsubsequentaction.”). TheSecondCircuit,bycontrast,viewsMercoidasan“exception”tothecompulsorycoun- terclaim rule that has been “subject to serious criticism” and has opined that Mercoid should be “limitedto[its]facts.”Critical-VacFiltrationCorp.v.MinutemanInternational,Inc.,233F.3d697,

701, 702 n.6 (2d Cir. 2000). However, for claims alleging patent misuse (as opposed to miscon- duct before the Patent and Trademark Office), the Second Circuit acknowledged that Mercoid is binding and thus permits such claims to be raised in a subsequent litigation. Id. at 704; see also Rohm & Haas Co. v. Brotech Corp., 770 F. Supp. 928, 932 (D. Del. 1991) (recognizing a similar distinction). The Second and Ninth Circuits also agree that it is relevant that, when antitrust claims are

broughtascounterclaimsinaninfringementaction,courtsoftenbifurcatetheantitrustclaims. This commonpracticeweighsagainstviewingtheantitrustclaimsascompulsorycounterclaims: If patent infringement claims are frequently bifurcated from antitrust counter- claimsandtriedseparatelyunderRule42(b),itwouldseemthatthesameunder- lying logic would apply equally to Rule 13(a). In other words, if judicial econ- omy is promoted by severing two claims and trying them separately, it would seeminappropriateandillogicaltoregardeitherclaimasacompulsorycounter- claimtotheotherandrequireconsolidation. Critical-Vac, 233 F.3d at 703 (quoting Teague I. Donahey, Antitrust Counterclaims in Patent In- fringement Litigation: Clarifying the Supreme Court’s Enigmatic Mercoid Decision, 39 IDEA: J.L.&Tech. 225,249-50(1999));Hydranautics,70F.3dat536. An additional reason for not treating antitrust counterclaims as compulsory is that they resembletraditionalmaliciousprosecutionclaims,whicharegenerallynotconsideredcompulsory. Hydranautics,70F.3dat536-37;seealsoT.C.R.Realty,Inc.v.Cox,372A.2d721,728(Pa.1977). A malicious prosecution claim, like a sham litigation claim, “arises from the [allegedly wrongful] legal proceeding, not from the same transactions or occurrences from which [that proceeding] arose.”T.C.R.Realty,372A.2dat728. Also instructive is the accrual rule for antitrust damages. “[F]uture damages that might arise from the conduct sued on are unrecoverable if the fact of their accrual is speculative or their

amountandnatureunprovable.”ZenithRadioCorp.v.HazeltineResearch,Inc.,401U.S.321,339 (1971). “In these instances, the cause of action for future damages, if they ever occur, will accrue onlyonthedatetheyaresuffered[.]”Id. At this juncture, it is unnecessary for me to resolve the disagreement between Azurity and Bionpharma over whether Bionpharma’s antitrust counterclaims actually accrued when the First Wave suits were filed. The possibility that antitrust claims might not accrue until sometime after

Hatch-Waxman infringement litigation plays out suggests that they do not “bear[] a logical rela- tionship” to that infringement suit. Xerox Corp., 576 F.2d at 1059. When Bionpharma filed its answer to the First Wave suits, there was no guarantee that the FDA would ever approve Bion- pharma’sANDA.ItwasthusarguablyunknownatthetimewhethertheFirstWavelawsuitswould ever suppress competition, even if they were brought in bad faith. Cf. AstraZeneca AB v. Glen- mark Generics, Ltd., No. 14-cv-665, 2014 WL 5366050, at *1 n.1 (D. Del. Oct. 9, 2014) (finding no antitrust claim where generic was unable to enter the market). And, if Azurity had prevailed in

theFirstorSecondWavesuits,Bionpharmacouldnotallegeitsufferedanantitrustinjurybecause Azurity would have lawfully kept Bionpharma off the market. It would not serve “fairness and considerations of convenience and of economy” to require Bionpharma to plead, speculatively, upon being sued in the First Wave, that it would someday have a viable, noninfringing product. XeroxCorp.,576F.2dat1059. AzurityreliesonU.S.PhilipsCorp.v.SearsRoebuck&Co.,55F.3d592(Fed.Cir.1995),

forthepropositionthat“theplacetochallengelitigationasshamisintheassertedshamlitigation,” but Philips involved highly unusual facts that are distinguishable from the case before me. In Philips, the antitrust claimant (Izumi) was a defendant in two simultaneous infringement suits in two different courts. See id. at 593. In the first suit, a codefendant raised antitrust counterclaims,

which were tried together with the patent claims at Izumi’s insistence. Id. When Izumi attempted to assert similar antitrust counterclaims in the second lawsuit, the court denied that request but invitedIzumitoassertthoseclaimsinthefirstlawsuit. Id.TheFederalCircuitaffirmedtherefusal to let Izumi litigate its antitrust counterclaims in the second lawsuit, reasoning that because Izumi hadsuccessfullyarguedinthefirstlawsuitthattheantitrustandinfringementclaimsmustbetried together,itwasjudiciallyestoppedfromsplittingthoseclaimsinthesecondlawsuit. Id.at596-97.

In short, Philips dealt with parallel, simultaneous lawsuits and judicial estoppel. That case is thus inapplicable to the situation before me, and, moreover, the Federal Circuit expressly disavowed holdingthatashamlitigationclaimwas“‘compulsory’inthetechnicaldefinitionofthisterm.”Id. at595. Given all of the above, I find the Ninth’s Circuit’s reasoning in Hydranautics persuasive, and conclude that in viewing the present allegations as true, Bionpharma’s antitrust claims were notcompulsorycounterclaimsintheFirstWavesuits.

B. AntitrustInjury Azurity next argues that Bionpharma cannot show antitrust injury because Azurity’s law- suits failed to keep Bionpharma’s generic product off the market. In Azurity’s view, even if those lawsuits harmed Bionpharma by forcing Bionpharma to incur litigation costs, the antitrust laws onlyprotectcompetition,notindividualcompetitors. SeeAtlanticRichfieldCo.v.USAPetroleum

Co. 495 U.S. 328, 344 (1990). Therefore, Azurity reasons, Bionpharma cannot show that there was harm to competition in the enalapril liquid market, and Bionpharma’s antitrust claims should bedismissed. The Federal Circuit addressed this situation in TransWeb, LLC v. 3M Innovative Proper-

ties Co., 812 F.3d 1295 (Fed. Cir. 2016). In that patent infringement lawsuit, the alleged infringer brought an antitrust counterclaim alleging that the patent was fraudulently obtained (a so-called “Walker Process claim”). Id. at 1306. The infringement suit was unsuccessful but the antitrust claim succeeded, with the district court awarding attorneys’ fees as antitrust damages. Id. In af- firming the damages award, the Federal Circuit held that those attorneys’ fees constituted “an antitrust injury” even though “[the patentee] fail[ed] to prevail in [its] lawsuit” and thus failed to

keep the accused product off the market. Id. at 1308-12. TransWeb therefore directly addressed andrejectedtheargumentAzuritymakeshere. Azurity relies on Otsuka Pharmaceutical Co. v. Torrent Pharmaceuticals Limited, 187 F. Supp. 3d 483 (D.N.J. 2016), which distinguished TransWeb on the ground that “TransWeb, LLC addressed itself to the issue of recoverable antitrust damages” as opposed to whether there had been an antitrust injury at all. Otsuka, 187 F. Supp. 3d at 486 n.6 (emphasis in original). Aside from the fact that I am not bound by Otsuka, TransWeb did in fact hold that attorneys’ fees were

an“anantitrustinjury.”812F.3dat1299. C. Causation AzurityalsochallengesBionpharma’sallegationthattheFirstWavesuitsdelayedtheentry of Bionpharma’s generic enalapril liquid to market. Specifically, Bionpharma alleges that the automatic 30-month stay that applies in Hatch-Waxman litigation, and which remained in effect

fromtheFirstWavesuitsuntilApril30,2021,delayedBionpharma’sabilitytomarketitsenalapril liquid until August 17, 2021. (Counterclaims ¶¶ 193, 201.) Azurity responds that because there was a three-and-a-half-month gap between the expiration of the 30-month stay and Bionpharma’s market entry, it cannot be inferred that Bionpharma could have entered the market sooner but for

thestay. Bionpharma’s allegation that the 30-month stay delayed its entry must be accepted as true atthepleadingsstage. Iqbal,556U.S.at678. ItisalsoplausibleundertheTwomblystandardthat alegalprohibitionontheFDAgrantingfinalapprovalwoulddelaylaunchoftheproduct. Azurity’s counterargument implicates a factual dispute that is not appropriate for resolution at this stage of thelitigation.

Azurity also asserts that its lawsuits could not have harmed competition because it had an alternative way to keep Bionpharma’s generic enalapril liquid off the market. Namely, Azurity’s parent NovaQuest could have simply asked Azurity’s corporate sister CoreRx to stop manufac- turing the product for Bionpharma. (See Azurity’s Brief at 18 (“[Bionpharma’s] but-for world is the same as the real world[.]”).) This is an unusual argument that appears to suggest that because Azurity could have suppressed competition some other way, it should not be held liable for the methoditinfactchose. Unsurprisingly,Azuritycitesnoauthorityforthisargument.

D. Noerr-PenningtonPart1: ObjectiveBaselessness Azurity’s next argument for dismissal is that its lawsuits were protected under the Noerr- Pennington doctrine. “The filing of a lawsuit carries significant constitutional protections, impli- cating the First Amendment right to petition the government for redress of grievances, and the rightofaccesstocourts.”Hoeberv.Local30,UnitedSlate,Tile&CompositionRoofers,Damp&

Waterproof Workers Ass’n, 939 F.2d 118, 126 (3d Cir. 1991). Under the Noerr-Pennington doc- trine, such lawsuits “are generally immune from antitrust liability” unless certain exceptions are met. FTC v. AbbVie Inc., 976 F.3d 327, 359-60 (3d Cir. 2020). To overcome Noerr-Pennington immunity, an antitrust plaintiff must show that: (1) “the lawsuit [was] objectively baseless in the

sense that no reasonable litigant could [have] realistically expect[ed] success on the merits”; and (2) “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—asananticompetitiveweapon.”Id.at360. AzuritycontendsthatcertaineventsthatoccurredintheFirstWaveshowthatthoselawsuits were not objectively baseless. According to Azurity, those events are: (1) Judge Stark denying

leavetofileamotionforjudgmentonthepleadings;(2)JudgeStarkhearingfivedaysoftestimony and authoring a 70-page opinion; (3) Bionpharma not seeking leave to file a motion for summary judgment; and (4) the Federal Circuit granting oral argument in the appeal from the First Wave suits. Whether these events show that Azurity’s lawsuits were not objectively baseless is a factual questionthatcannotberesolvedonamotiontodismiss. Azurity also takes issue with the substance of Bionpharma’s reasons for calling Azurity’s seven lawsuits objectively baseless. Bionpharma alleges that Azurity’s lawsuits were objectively

baseless for numerous reasons, involving issues of infringement, validity, licensing, and jurisdic- tion. At this stage of the litigation, it is not necessary to analyze all of Bionpharma’s allegations that Azurity’s lawsuits were objectively baseless. Instead, because two of these allegations in- volve all seven lawsuits, for purposes of a motion to dismiss analysis it is sufficient to examine two of these allegations, which claim: (1) that the First and Second Wave suits were objectively baseless because Bionpharma’s ANDA does not contain an equivalent to a citrate buffer; and (2)

that the Third Wave and CoreRx suits were objectively baseless because the Third Wave patents’ specificationdoesnotdescribeliquidswithoutbuffers. Before analyzing the substance of these allegations, it is necessary to make two prelim- inary points. First, while Judge Stark entered judgment in Bionpharma’s favor as to some of

Bionpharma’s allegations, the mere fact that Azurity lost on these grounds does not mean that its position was objectively baseless from the start. Professional Real Estate Investors, Inc. v. Columbia Pictures Industries, Inc. (PRE), 508 U.S. 49, 60 n.5 (1993). Indeed, Azurity contends that the positions it took in the First Wave were colorable even if Judge Stark did not ultimately agreewiththem. Second, although it is sometimes possible to decide whether a lawsuit was objectively

baseless “as a matter of law,” PRE, 508 U.S. at 63, not all of the facts underlying Bionpharma’s antitrust allegations are undisputed. For example, it is a factual question whether Azurity had a basis to believe that certain ingredients in Bionpharma’s ANDA could act as a buffer. In addition, whilelegalissuesunderlyingBionpharma’sallegationsmightberesolvableatthepleadingsstage, Azurity’s motion contains only a cursory analysis of those issues, which is inadequate for me to conclude,atthisjuncture,thatBionpharma’sallegationsnecessarilyfailasamatteroflaw. With those points in mind, I consider whether two of Bionpharma’s allegations plausibly

give rise to an inference that the First Wave, Second Wave, Third Wave, and CoreRx suits were objectivelybaseless. 1. LackofClaimedBufferinBionpharma’sANDA The patents asserted in the First Wave suits claimed buffers made from citric acid and sodium citrate. As to some of those claims, the language was amended during the prosecution

history to add sodium citrate. Bionpharma argued in the First Wave suits that the amendment triggered amendment-based prosecution history estoppel—such that Azurity could not claim so- lutions lacking sodium citrate. Bionpharma alleges that Azurity’s position that it could overcome thisdefensewasobjectivelybaseless,suchthatNoerr-Penningtonimmunitydoesnotapply.

Initspresentmotion,Azurityassertsit“believedtheamendmentwasmadeforclarification purposes and was not a narrowing amendment,” but Azurity does not explain why the pleadings compel the conclusion that this belief was objectively colorable. It therefore remains a factual dispute whether Azurity had an objective basis for alleging that Bionpharma’s ANDA infringed theFirstWavepatents,andIthusdeclinetodismissBionpharma’scounterclaimsastothisground. 2. LackofWrittenDescriptionSupportingLiquidsWithoutBuffers

The Third Wave patents differ from the First Wave patents in that the Third Wave patents claim formulations that lack buffers. Bionpharma alleges that the specification does not support formulations without buffers and that, therefore, the Third Wave patents are invalid for lack of written description. And Bionpharma asserts that it was objectively baseless for Azurity to claim thatitcouldovercomethisinvaliditydefense. Azurityrespondsonlythatthereisapresumptionthatanissuedpatentisvalidanddoesnot

address the substance of Bionpharma’s argument. I therefore cannot conclude, at this stage, that Azurity necessarily had an objective basis to assert the Third Wave patents against Bionpharma’s ANDA. For these reasons, Bionpharma has plausibly alleged the first prong of the exception to Noerr-Pennington immunity by alleging that Azurity’s seven lawsuits were objectively baseless. Whethertheselawsuitswereinfactobjectivelybaselessremainsanissueforfactualdevelopment. E. Noerr-PenningtonPart2: SubjectiveMotivation Azurity next contends that Bionpharma has not adequately pled the subjective component necessary to overcome Noerr-Pennington immunity. “Under the subjective motivation prong, a

plaintiffmustshowthedefendantbroughtbaselessclaimsinanattempttothwartcompetition(i.e., inbadfaith).”FTCv.AbbVie,976F.3dat360(quotationmarksomitted). Bionpharma alleges several facts that it argues raise a plausible inference that Azurity in- tendedtothwartcompetition: First, Bionpharma alleges that Azurity turned down an opportunity to view Bionpharma’s ANDA before filing the First Wave suits, suggesting that Azurity was disinterested in learning

whetherthosesuitswereviable. SeeFTCv.AbbVie,976F.3dat360(arelevantfactoris“whether the defendant was indifferent to the outcome on the merits of the suit” (alterations and quotation marksomitted)). Second, Bionpharma points to the number of lawsuits—seven across three courts—and reasons that Azurity’s nine patents on enalapril liquids enabled it to file new lawsuits as patents were issued. Bionpharma notes that the FDA has raised concerns that “the practice of filing ‘continuation’ patent applications ... can allow companies to create ‘patent thickets’ by obtaining

multiple patents on different aspects of the same product within a patent application,” a prac- tice which “increases litigation burdens and potentially delays the approval of generics ... .” See September 10, 2021 Letter from Acting Commissioner Woodcock to the USPTO at 3, https://www.fda.gov/media/152086/download. Third, Bionpharma alleges that because Azurity’s lawsuits were baseless, an experienced litigant like Azurity would only bring them for a reason other than eventual success on the merits.

See FTC v. AbbVie, 976 F.3d at 369 (“Evidence that a defendant knew its claims were meritless may help a plaintiff to show a defendant was indifferent to the outcome on the merits of the suit and decided to sue primarily for the benefit of collateral injuries inflicted through the use of legal process.”(alterationsandquotationmarksomitted)).

Azurity responds to these allegations primarily by identifying contrary facts that it claims show a proper motivation for filing suit, such as that it spent time and resources litigating an appeal. Azurity also notes that the Hatch-Waxman Act gives a patentholder a short window to decide whether to file a lawsuit and states that it had a legitimate, unspecified reason to turn down Bionpharma’s offer of confidential access. Whether these countervailing reasons will ultimately demonstrate that Azurity’s lawsuits were brought in good faith is a factual question that cannot be

resolvedatthisstage. Azurity also objects to consideration of the number of lawsuits it filed, citing authority that an accusation of “serial petitioning” is inapplicable to Hatch-Waxman lawsuits because Con- gressional policy favors prompt resolution of property rights. See In re Wellbutrin XL Antitrust Litigation, 868 F.3d 132, 157-58 (3d Cir. 2017). But Azurity’s cited authority is addressed to the situation where a brand manufacturer sues multiple different generic competitors, as Hatch- Waxmanrequiresitto. Seeid.;KaiserFoundationHealthPlan,Inc.v.AbbottLabs.,Inc.,552F.3d

1033, 1047 (9th Cir. 2009) (finding repeated Hatch-Waxman lawsuits were not sham litigations because “the volume of [the patentee’s] suits was dependent on the number of generic companies attemptingtoenterthe...marketplace,amatteroverwhich[thepatentee]hadnocontrol”). Here, Azurity filed seven lawsuits over the same generic product and has not pointed to anything in the Hatch-WaxmanActthatendorsessuchapractice. For these reasons, Bionpharma has plausibly alleged that Azurity filed its seven lawsuits

tointerferewithcompetitioninenalaprilliquidsthroughmeansotherthaneventualsuccessonthe merits. WhetherthatwasAzurity’sactualmotivationremainsanissueforfactualdevelopment. F. IntenttoMonopolize

Lastly,andsomewhatcursorily,AzurityassertsthatBionpharma“failstosufficientlyallege a specific intent to monopolize.” Azurity also states that Bionpharma’s “allegations amount to, at most,anintenttoexcludeinfringingproducts,whichisinsufficient.” Largely for the reasons set out in the previous section, Bionpharma’s allegations raise a plausible inference that Azurity “ha[d] the specific intent to ... monopolize the [enalapril liquid] Market.” (Counterclaims ¶ 257.) Whether Bionpharma’s product was infringing such that Azurity couldlegitimatelyexcludeitisasubjectofongoingdisputethatcannotberesolvedatthistime.

IV. CONCLUSION Forthereasonssetoutabove,Azurity’smotiontodismisswillbedenied. Anappropriateorderfollows.