Case 1:14-cv-01171-GMS Document 32 Filed 03/25/15 Page 1 of 22 PageID #: 228
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`Karen E. Keller 
`300 Delaware Avenue, Suite 1120 
`Wilmington, DE 19801 
`(302) 298‐0702‐ Direct 
`kkeller@shawkeller.com 
`
`
`
`March 25, 2015
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`
`
`BY CM/ECF
`The Honorable Gregory M. Sleet
`U.S. District Court for the District of Delaware
`844 N. King Street
`Wilmington, DE 19801
`In Re Copaxone 40 MG Consolidated Cases, C.A. No. 14-1171-GMS (Consolidated)
`Re:
`Teva Pharms. USA, Inc., et al. v. Mylan Pharms. Inc., et al., C.A. No. 14-1278-GMS
`
`Dear Judge Sleet:
`I write on behalf of plaintiffs pursuant to L.R. 7.1.2(b) with subsequent authority relevant
`to the pending motion to dismiss for lack of personal jurisdiction filed by defendants Mylan
`Pharmaceuticals Inc. (“Mylan Pharma”) and Mylan Inc. (“Mylan Inc.”) (D.I. 12), originally filed
`in C.A. No. 14-1278-GMS.
`
`Eli Lilly and Company et al. v. Mylan Pharms., Inc. et al., No. 14-cv-00389, 2015 WL
`1125032 (S.D. Ind. Mar. 12, 2015) (Exhibit A): The court agreed with the analysis set forth in
`this Court’s decision in AstraZeneca AB v. Mylan Pharms., Inc., No. 14-696-GMS, 2014 WL
`5778016 (D. Del Nov. 5, 2014) and found that specific jurisdiction exists over Mylan Inc. and
`Mylan Pharma. Id. at *5. The court rejected the assertion that the act of filing an ANDA is not
`directed to any jurisdiction and found “the logical alternative is to view the act of filing as being
`directed to the state of residence for the patent holder.” Id. at *6. Finally, the court found that
`the “traditional notions of fair play and substantial justice” weighed in favor of exercising
`specific jurisdiction, because of the state’s interest in providing its residents with a convenient
`forum for redressing injuries inflicted by out-of-state actors, plaintiff’s interest in obtaining
`convenient relief in their own state, the lack of burden on Mylan, and the significant burden on
`plaintiffs if required to bring lawsuits against each ANDA filer in the defendants’ respective
`home states. Id. at *7-8.
`
`Novartis Pharms. Corp., et al. v. Mylan Pharms., Inc. et al., C.A. Nos. 14-777-RGA, 14-
`820-RGA (D. Del. Mar. 16, 2015) (Exhibit B): The Court found that Mylan Pharma had
`consented to general jurisdiction by registering to do business in Delaware pursuant to 8 Del. C.
`§§ 371, 376. Slip Op. at 5-7.
`
`Should the Court have any questions, counsel are available at the Court’s convenience.
`
`
`
`
`cc:
`
`
`Respectfully submitted,
`/s/ Karen E. Keller
`Karen E. Keller (No. 4489)
`All Counsel of record (by CM/ECF and e-mail)
`Clerk of Court (by CM/ECF)
`
`

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`Exhibit A
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`Slip Copy, 2015 WL 1125032 (S.D.Ind.)
`(Cite as: 2015 WL 1125032 (S.D.Ind.))
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`Only the Westlaw citation is currently available.
`
`
`United States District Court,
`S.D. Indiana,
`Indianapolis Division.
`ELI LILLY AND COMPANY, et al., Plaintiffs,
`v.
`MYLAN PHARMACEUTICALS, INC., Mylan,
`Inc., Mylan Laboratories, Ltd., et al., Defendants.
`
`No. 1:14–cv–00389–SEB–TAB.
`Signed March 12, 2015.
`
`
`
`
`
`ORDER DENYING THE MYLAN DEFEND-
`ANTS' MOTION TO DISMISS FOR LACK OF
`PERSONAL JURISDICTION
`SARAH EVANS BARKER, District Judge.
`*1 This cause is before the Court on the Motion to
`Dismiss [Docket No. 150], filed on May 2, 2014, by
`Defendants Mylan Pharmaceuticals, Inc., Mylan, Inc.,
`and Mylan Laboratories, Ltd. (collectively, “the
`Mylan Defendants”). FN1 The Mylan Defendants con-
`tend that we lack personal jurisdiction over them and
`seek dismissal of the Complaint against them. Plain-
`tiffs Eli Lilly and Company, Daiichi Sankyo Co., Ltd.,
`Daiichi Sankyo, Inc., and Ube Industries, Ltd. (col-
`lectively, “Plaintiffs”) rejoin that this court does have
`personal jurisdiction over the Mylan Defendants, and
`further, if we determine there is no personal jurisdic-
`tion, the proper remedy is not to dismiss, but rather to
`transfer the case to an appropriate forum.
`
`
`FN1. On November 17, 2014, the Mylan
`Defendants filed a Motion for Oral Argument
`[Docket No. 284]. Because we are able to
`rule based on the parties' written submis-
`sions, that motion is DENIED.
`
`On May 30, 2014, Plaintiffs moved for time to
`
`
`
`Page 1
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`conduct jurisdictional discovery regarding the Mylan
`Defendants' contacts with Indiana, and the Magistrate
`Judge granted that request as well as an enlargement
`of time to respond to the Mylan Defendants' motion to
`dismiss. That discovery period has now ended and the
`Mylan Defendants' Motion to dismiss is fully briefed
`and ripe for ruling. For the reasons detailed below, we
`DENY the Mylan Defendants' Motion.
`
`
`Factual Background
`Plaintiffs have brought this claim against the
`Mylan Defendants and others alleging that Defendants
`infringed three of Plaintiffs' patents by filing an Ab-
`breviated New Drug Application (“ANDA”) with the
`FDA seeking approval to sell generic versions of Eli
`Lilly's pharmaceutical product Effient®. Effient® is
`an anti-thrombotic drug approved for use in the United
`States to prevent or reduce the risk of blood clots and
`stent thrombosis in patients suffering from acute
`coronary syndrome who receive stents. The patents at
`issue protect the molecule prasugrel hydrochloride,
`the active ingredient in Effient® (U.S. Patent No.
`5,288,726 (the '726 patent)), and methods of using
`Effient® and aspirin, as directed on the label (U.S.
`Patent No. 8,404,703 and 8,569,325 (the '703 and '325
`patents)).
`
`
`The Mylan Defendants are three of the forty
`original defendants who challenged the validity of
`Plaintiffs' patents that cover Effient®.FN2 Defendant
`Mylan, Inc. (“Mylan”) is one of the world's leading
`generic and specialty pharmaceutical companies with
`over 20,000 employees in its family of companies.
`Mylan markets more than 1,300 separate products in
`approximately 140 different countries and territories.
`Mylan is a Pennsylvania corporation with its principal
`place of business in Canonsburg. Two of Mylan's
`subsidiary corporations—Defendants Mylan Phar-
`maceuticals, Inc. (“Mylan Pharmaceuticals”) and
`Mylan Laboratories, Ltd.
`(“Mylan Laborato-
`
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`Page 2
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`Slip Copy, 2015 WL 1125032 (S.D.Ind.)
`(Cite as: 2015 WL 1125032 (S.D.Ind.))
`ries”)—are named in this litigation and have joined
`Mylan in this motion to dismiss. Mylan Pharmaceu-
`ticals is incorporated in West Virginia with its prin-
`cipal place of business in Morgantown, West Virginia.
`Mylan Laboratories is a corporation organized and
`existing under the laws of India with its principal place
`of business in Hyderabad, India.
`
`
`able, and will not be infringed. Mylan Pharmaceuti-
`cals also directed a Notice Letter to Lilly in Indiana,
`informing Lilly of its Paragraph IV certification as
`required under the Hatch–Waxman Act. Plaintiffs
`then filed in this court their complaint for patent in-
`fringement, alleging, inter alia, that the Mylan De-
`fendants “market[ ] and provide [ ]” generic drugs to
`Indiana residents. Compl. ¶¶ 90–92. Plaintiffs filed
`their complaint in this court within 45 days of re-
`ceiving the Notice Letter, triggering the statutorily
`prescribed 30–month stay during which the Mylan
`Defendants are prohibited from proceeding with sales
`of their generic drug. See 21 U.S.C. § 355(j)(5)(B)(iii).
`
`
`Legal Analysis
`I. Standard of Review
`Federal Rule of Civil Procedure 12(b)(2) requires
`dismissal of a claim where personal jurisdiction is
`lacking. When “[a] defendant moves to dismiss the
`complaint under Federal Rule of Civil Procedure
`12(b)(2) for lack of personal jurisdiction, the plaintiff
`bears the burden of demonstrating the existence of
`jurisdiction.” Purdue Research Found. v. Sano-
`fi–Synthelabo, S.A., 338 F.3d 773, 782 (7th Cir.2003)
`(citations omitted). When a district court rules on a
`defendant's motion to dismiss based on the submission
`of written materials, the plaintiff “need only make out
`a prima facie case of personal jurisdiction” and “is
`entitled to the resolution in its favor of all disputes
`concerning relevant facts presented in the record.” Id.
`(internal quotation marks and citations omitted).
`
`
`FN2. The Mylan Defendants are the only
`defendants to challenge the ' 726 patent,
`however. They are also the only defendants
`who have challenged personal jurisdiction
`over them in Indiana.
`
`
`
`*2 The Mylan Defendants do not have offices or
`facilities in Indiana nor do they have a telephone
`listing or mailing address in Indiana. Although the
`Mylan Defendants assert in their opening brief that
`they have no employees or officers in Indiana (Tighe
`Decl. ¶ 6), deposition testimony establishes that
`Mylan Pharmaceuticals has at least four employees
`who do live in Indiana, including two members of the
`company's eight-to-ten member National Account
`Managers group, which manages Mylan's national
`sales relationships. Exh. 3 at 70–71. Mylan Pharma-
`ceuticals obtained a wholesaler drug license allowing
`it to sell its generic products in Indiana and its Indiana
`sales include dozens of Mylan products. Id. at 63, 201.
`Mylan Pharmaceuticals sells Mylan products directly
`to retailers in Indiana as well as to wholesalers,
`knowing that the wholesalers sell their products in
`Indiana. Id. at 65, 69. Mylan Pharmaceuticals also
`makes sales calls and directs promotional materials to
`residents of Indiana. Exh. 5.
`
`
`On July 10, 2013, Mylan Pharmaceuticals sub-
`mitted an ANDA to the Food and Drug Administra-
`tion (“FDA”) seeking approval to market generic
`prasugrel hydrochloride tablets in the United States.
`The ANDA was prepared in West Virginia and filed in
`Maryland. The ANDA included a “Paragraph IV”
`certification that the '726, '703, and '325 patents ex-
`clusively licensed to Eli Lilly are invalid, unenforce-
`
`*3 Federal Circuit law governs personal jurisdic-
`tion issues in patent infringement cases. See Hilde-
`brand v. Steck Mfg. Co., 279 F.3d 1351, 1354
`(Fed.Cir.2002). A district court may properly exercise
`personal jurisdiction over a non-resident defendant if a
`two-step analysis is undertaken and satisfied. First, the
`party resisting the exercise of jurisdiction must be
`amenable to service of process under the state's
`long-arm statute; second, the exercise of personal
`jurisdiction must comport with the due process clause
`of the Constitution. Id. Because Indiana's long-arm
`
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`Page 3
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`Slip Copy, 2015 WL 1125032 (S.D.Ind.)
`(Cite as: 2015 WL 1125032 (S.D.Ind.))
`statute, Indiana Rule of Trial Procedure 4.4(A), “ex-
`pand[s] personal jurisdiction to the full extent per-
`mitted by the Due Process Clause,” LinkAmerica
`Corp. v. Cox, 857 N.E.2d 961, 966 (Ind.2006), the sole
`question before us is whether due process would be
`offended were we to exercise personal jurisdiction
`over the Mylan Defendants.
`
`
`II. Discussion
`Plaintiffs' Complaint asserts general jurisdiction
`as the sole basis for bringing this ANDA infringement
`action against the Mylan Defendants in Indiana. The
`Mylan Defendants contend that the Supreme Court's
`recent decision in Daimler AG v. Bauman, ––– U.S.
`––––, 134 S.Ct. 746, 187 L.Ed.2d 624 (2014), altered
`the analysis with respect to general jurisdiction such
`that Plaintiffs cannot establish that the Southern Dis-
`trict of Indiana has general jurisdiction over the Mylan
`Defendants in this ANDA lawsuit. The Mylan De-
`fendants further argue that their relationship with
`Indiana and this litigation is insufficient to support the
`exercise of specific jurisdiction in this case.
`
`
`For a court to acquire personal jurisdiction over a
`defendant, due process requires “that the defendant
`have such ‘minimum contacts' with the forum state as
`will make the assertion of jurisdiction over him con-
`sistent with ‘traditional notions of fair play and sub-
`stantial justice[.]’ “ Lakeside Bridge & Steel Co. v.
`Mountain State Constr. Co., 597 F.2d 596, 600 (7th
`Cir.1979) (quoting Int'l Shoe Co. v. State of Wash.,
`326 U.S. 310, 316, 66 S.Ct. 154, 90 L.Ed. 95 (1945)).
`In other words, defendants must have “fair warning
`that a particular activity may subject them to the ju-
`risdiction of a foreign sovereign.” Burger King Corp.
`v. Rudzewicz, 471 U.S. 462, 472, 105 S.Ct. 2174, 85
`L.Ed.2d 528 (1985) (quotation marks and citation
`omitted).
`
`
`Personal jurisdiction may be either specific or
`general. A court exercises specific jurisdiction over a
`defendant where the cause of action arises out of or
`relates to a defendant's purposefully established con-
`tacts with the forum state. Helicopteros Nacionales de
`Columbia, S.A. v. Hall, 466 U.S. 408, 414, 104 S.Ct.
`1868, 80 L.Ed.2d 404 (1984); Burger King Corp., 471
`U.S. at 472. General jurisdiction, on the other hand,
`does not require that the cause of action arise out of
`contacts with the forum state. Helicopteros, 466 U.S.
`at 416. General jurisdiction exists where the defend-
`ant's contacts with the forum “are so continuous and
`systematic as to render it essentially at home in the
`forum State.” Daimler AG v. Bauman, ––– U.S. ––––,
`––––, 134 S.Ct. 746, 761, 187 L.Ed.2d 624 (2014)
`(quoting Goodyear Dunlop Tires Operations, S.A. v.
`Brown, ––– U.S. ––––, ––––, 131 S.Ct. 2846, 2851,
`180 L.Ed.2d 796 (2011)).
`
`
`*4 Given the Mylan Defendants' jurisdictional
`challenge, Plaintiffs bear the burden of showing the
`basis for this court's jurisdiction. Plaintiffs now ap-
`parently concede that this court cannot exercise gen-
`eral personal jurisdiction over any of the Mylan De-
`fendants on the basis of their being “at home” in In-
`diana, as that concept is defined in Daimler.FN3 Plain-
`tiffs instead contend that the Mylan Defendants pur-
`posefully directed their conduct toward Indiana in this
`case by: (1) making a Paragraph IV ANDA filing that
`knowingly challenges intellectual property rights held
`by Lilly in Indiana and directing a Notice Letter to
`Lilly in Indiana; and (2) intending to sell their generic
`Effient® product in Indiana. It is Plaintiffs' position
`that these purposeful contacts with Indiana are suffi-
`cient to support the exercise of specific personal ju-
`risdiction in this forum.
`
`
`FN3. In Daimler, the Supreme Court made
`clear that in assessing whether general juris-
`diction is available, courts must determine
`not just whether a defendant's “in-forum
`contacts can be said to be in some sense
`‘continuous and systematic,’ “ but rather
`whether the defendant's “ ‘affiliations with
`the State are so “continuous and systematic”
`as to render [it] essentially at home in the
`forum state.’ “ 134 S.Ct. at 761 (quoting
`
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`Page 4
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`Slip Copy, 2015 WL 1125032 (S.D.Ind.)
`(Cite as: 2015 WL 1125032 (S.D.Ind.))
`Goodyear, 131 S.Ct. at 2851 (2011). The
`Daimler Court further clarified that in all but
`“exceptional cases,” a corporation is “at
`home” only in its “place of incorporation and
`principal place of business,” which are the
`“paradig[m] ... bases for general jurisdic-
`tion.” 134 S.Ct. at 760 (alterations in origi-
`nal) (internal quotation marks omitted).
`
`
`A. General Jurisidiction
`In ANDA litigation prior to Daimler, “general
`jurisdiction traditionally provided the basis to assert
`jurisdiction over generic drug company defendants.”
`AstraZeneca AB v. Mylan Pharm., Inc., ––– F.Supp.3d
`––––, No. 14–696–GMS, 2014 WL 5778016, at *3
`(D.Del. Nov.5, 2014) (citation omitted); see, e.g., Eli
`Lilly and Co. v. Mayne Pharma (USA) Inc., 504
`F.Supp.2d 387 (S.D.Ind.2007) (focusing on the de-
`fendant's regular business solicitation and distribution
`of substantial quantities of pharmaceuticals in the
`forum as well as substantial revenues from those
`sales); Eli Lilly and Co. v. Sicor Pharm., Inc., No.
`1:06–cv–238–SEB–JMS,
`2007 WL
`1245882
`(S.D.Ind. Apr.27, 2007) (same); Abbott Labs. v. Mylan
`Pharm., Inc., No. 05 C 6561, 2006 WL 850916
`(N.D.Ill. Mar.28, 2006) (same). However, the Su-
`preme Court's decision in Daimler has altered the
`general jurisdiction analysis such that the factors on
`which courts have traditionally focused in ANDA
`cases, to wit, a history of business solicitation and
`substantial past sales and revenue generated in the
`forum, in most cases are no longer sufficient without
`more to support an exercise of general jurisdiction.
`See 134 S.Ct. at 761–62 (finding that a test under
`which general jurisdiction existed in every forum in
`which a defendant's sales are sizable would be “un-
`acceptably grasping” and “exorbitant”).
`
`
`Although the Daimler Court noted that it was not
`“foreclose[ing] the possibility that in an exceptional
`case ... a corporation's operations in a forum other than
`its formal place of incorporation or principal place of
`business may be so substantial and of such a nature as
`
`to render the corporation at home in that State,” ( id. at
`761 n. 19), Plaintiffs make no attempt to argue that
`this is such an exceptional case nor does the evidence
`before us support that conclusion. Accordingly, we
`agree with the Mylan Defendants that Plaintiffs have
`failed to establish that general jurisdiction exists here
`under the framework set forth in Daimler.
`
`B. Specific Jurisdiction
`*5 Whether Plaintiffs have demonstrated that
`there is a basis to assert specific jurisdiction over the
`Mylan Defendants FN4 in this case is a stickier issue.
`Only a few district courts have had occasion to address
`specific jurisdiction in the context of ANDA litigation
`since Daimler, including Acorda Therapeutics, Inc. v.
`Mylan Pharamceuticals Inc., –––F.Supp.3d ––––,
`2015 WL 186833 (D.Del. Jan.14, 2015) and Astra-
`Zeneca AB v. Mylan Pharmaceuticals, Inc., –––
`F.Supp.3d ––––, 2014 WL 5778016 (D.Del. Nov.5,
`2014).FN5 In both of these cases, the District Court for
`the District of Delaware focused at least to some de-
`gree on the unique nature of ANDA litigation to
`support its exercise of specific jurisdiction over the
`defendants. We agree with the analysis set forth in
`these opinions,FN6 and find for the reasons detailed
`below that specific jurisdiction exists here over the
`Mylan Defendants.
`
`
`FN4. We are mindful that in cases involving
`multiple defendants such as this, “personal
`jurisdiction must be assessed separately as to
`each defendant....” Sicor Pharm., Inc., 2007
`WL 1245882, at *5 (citing Rush v. Savchuk,
`44 U.S. 320, 331–32 (1980)). Here, Plaintiffs
`assert that “Mylan, Inc. and Mylan Labs are
`subject to specific jurisdiction to the same
`extent as Mylan Pharmaceuticals, given their
`joint roles in the purposefully directed con-
`duct that precipitated the lawsuit.” Pls.' Resp.
`at 13. The Mylan Defendants have not
`meaningfully differentiated among the three
`entities in their motion to dismiss and they
`concede that the “Mylan Defendants” col-
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`Slip Copy, 2015 WL 1125032 (S.D.Ind.)
`(Cite as: 2015 WL 1125032 (S.D.Ind.))
`lectively “prepared the ANDA.” Defs.' Op-
`position to Motion for Jurisdictional Dis-
`covery at 9. The Mylan Defendants have also
`not challenged Plaintiffs' contention that
`Mylan, Inc. “directed and participated in the
`strategy for approval of this ANDA” and that
`Mylan Labs was “heavily involved with
`Mylan Pharmaceuticals in preparing the
`ANDA filing.” Pls.' Resp. at 14. For these
`reasons, we are persuaded that Mylan Phar-
`maceutical's relevant contacts can and should
`be attributed to Mylan, Inc. and Mylan Labs.
`
`context of ANDA litigation, however, given the nature
`of the process created by the Hatch–Waxman Act. The
`statute was enacted with the purpose of balancing
`“two competing interests in the pharmaceutical in-
`dustry: ‘(1) inducing pioneering research and devel-
`opment of new drugs and (2) enabling competitors to
`bring low-cost, generic copies of those drugs to mar-
`ket.’ “ Janssen Pharmaceutica, N.V. v. Apotex, Inc.,
`540 F.3d 1353, 1355 (Fed.Cir.2008) (quoting Andrx
`Pharms., Inc. v. Biovail Corp., 276 F.3d 1368, 1371
`(Fed.Cir.2002)). In order to achieve that balance, in
`addition to creating the ANDA process, the Act
`amended the patent laws to exempt pre-ANDA testing
`and development activity, but to make the filing of a
`Paragraph IV Certification an act of patent infringe-
`ment, thus allowing brand drug companies the right to
`initiate an infringement lawsuit before a generic drug
`is marketed. 540 F.3d at 1356.
`
`
`The difficulty in applying the specific jurisdiction
`analysis arises in part because the Supreme Court has
`recognized that a Paragraph IV act of patent in-
`fringement is “a highly artificial act .” Eli Lilly & C. v.
`Medtronic, Inc., 496 U.S. 661, 678, 110 S.Ct. 2683,
`110 L.Ed.2d 605 (1990). Because the act is “a statu-
`tory creation, distinct from making, using, or selling a
`patented technology” it therefore “has no readily ap-
`parent situs of injury for the purpose of finding spe-
`cific jurisdiction.” AstraZeneca, 2014 WL 5778016, at
`*6. At the same time, litigation is expected to follow a
`Paragraph IV filing as, under the Hatch–Waxman Act,
`patent holders are given forty-five days following
`receipt of notice of the filing of the certification to
`initiate an infringement lawsuit thereby triggering the
`automatic thirty-month stay for FDA-approval of the
`generic drug. Thus, as the court in AstraZeneca ex-
`plained, under the Hatch–Waxman framework: “The
`injury is abstract, making it difficult to point to a lo-
`cation out of which the injury ‘arises' for jurisdictional
`purposes. At the same time, defending against an
`infringement lawsuit is an inherent and expected part
`of the ANDA filer's business. To put it simply: a
`lawsuit is often inevitable, but it is not clear where it
`
`
`
`FN5. The District Court for the Eastern Dis-
`trict of Texas also addressed this issue in
`Allergan,
`Inc. v. Actavis,
`Inc., No.
`2:14–CV–188, 2014 WL 7336692 (E.D.Tex.
`Dec.23, 2014). However, the court limited its
`holding on specific jurisdiction to the plain-
`tiff's declaratory judgment claims. Because
`such claims are not at issue here, the Texas
`case has limited applicability to our analysis.
`
`FN6. We note that, on December 17, 2014,
`Judge Sleet certified an interlocutory appeal
`of his order in AstraZeneca to the Federal
`Circuit, reasoning that the existence of per-
`sonal jurisdiction in ANDA cases following
`Daimler is “a controlling (and novel) ques-
`tion of law for which there is substantial
`ground for difference of opinion.” Astra-
`Zeneca AB v. Aurobindo Pharma Ltd., No.
`14–664–GMS, 2014 WL 7533913, at *1 n. 1
`(D.Del. Dec.17, 2014). We share that view
`that this question is an important matter of
`first impression in the ANDA context.
`
`
`
`
`
`Specific jurisdiction exists where “the defendant
`has ‘purposefully directed’ his activities at residents of
`the forum, and the litigation results from alleged in-
`juries that ‘arise out of or relate to’ those activities.”
`Burger King, 471 U.S. at 472–73 (internal citations
`omitted). This standard can be difficult to apply in the
`
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`Slip Copy, 2015 WL 1125032 (S.D.Ind.)
`(Cite as: 2015 WL 1125032 (S.D.Ind.))
`should be held.” FN7 Id.
`
`
`FN7. The uniqueness of this type of patent
`infringement litigation is likely a reason why
`specific jurisdiction has not traditionally
`been favored in ANDA cases. However, the
`narrowing of the general jurisdiction doctrine
`in Daimler (which was not an ANDA case)
`may well shift the focus toward specific ju-
`risdiction in these cases.
`
`
`
`*6 The Federal Circuit has recognized that the
`fact that the Supreme Court has viewed the act of
`submitting an ANDA to be “ ‘highly artificial’ ... is not
`a proper reason ... to conclude that the ANDA filing is
`not a ‘real act’ with ‘actual consequences.’ “ Zeneca
`Ltd. v. Mylan Pharm., Inc., 173 F.3d 829, 833–34
`(Fed.Cir.1999) (quoting Medtronic, 496 U.S. at
`663–664). The question then becomes, where are
`those “actual consequences” felt? In Zeneca, the
`Federal Circuit held that Maryland—the location of
`the FDA and the place where ANDAs must be
`filed—could not exercise specific jurisdiction over
`ANDA filers; this conclusion clearly was to avoid the
`Maryland district court having jurisdiction in all
`ANDA cases. 173 F.3d at 832. The Mylan Defendants
`argue here that their filing of the Paragraph IV certi-
`fication was not “intentionally targeted” at the state of
`Indiana where Lilly resides, nor was the State the
`“focal point” of the alleged infringement.FN8 Defs.'
`Reply at 4–5. However, given the holding in Zeneca,
`our acceptance of Defendants' argument would sug-
`gest a conclusion that the act of filing an ANDA is not
`directed to any jurisdiction, a result we find illogical.
`See AstraZeneca, 2014 WL 5778016, at *7. Thus, the
`logical alternative is to view the act of filing as being
`directed to the state of residence for the patent holder.
`Id.
`
`
`FN8. The Mylan Defendants argue that the
`appropriate factor on which to focus for de-
`termining where specific jurisdiction exists is
`the location(s) “where the ANDA was stud-
`
`ied, drafted, compiled, and signed,” (Defs.'
`Reply at 12), which in this case would be
`West Virginia. It is true that a number of
`district courts have found that it is proper to
`exercise specific jurisdiction in the forum in
`which the ANDA is prepared or the state in
`which the generic drug was developed and
`tested. See, e.g., Pfizer Inc. v. Synthon
`Holding, B.V., 386 F.Supp.2d 666, 675–76
`(M.D.N.C.2005) (finding specific jurisdic-
`tion existed because “the preparation of the
`ANDA ... was conducted primarily in North
`Carolina” and rejecting argument that such
`activities should not be considered for juris-
`dictional purposes because the preparation of
`an ANDA is not considered “infringement”
`under 35 U.S.C. § 271(e)); Intendis, Inc. v.
`River's
`Edge
`Pharm.,
`LLC, No.
`11–2838(FSH)(PS), 2011 WL 5513195, at
`*3–*4 (D.N.J. Nov. 10, 2011) (finding that
`ANDA infringement claim arose in Georgia
`where product was “conceived,” “devel-
`oped,” and “tested” and not the plaintiffs'
`“home forum”); Pfizer Inc. v. Apotex, Inc.,
`No. 08–cv–00948–LDD, 2009 WL 2843288,
`at *3 n. 5 (D.Del. Aug.13, 2009) (“We find
`more significant the location of the operative
`facts—the preparation and submission of the
`ANDA—giving rise to this action.”); Bris-
`tol–Meyers Squibb Co. v. Andrx Pharm.,
`LLC, No. 03 Civ. 2503(SHS), 2003 WL
`22888804, at *3 (S.D.N.Y. Dec.5, 2003)
`(holding that location of design and devel-
`opment is location of operative facts in
`ANDA infringement case). However, like the
`AstraZeneca court, we are not persuaded that
`these factors should be the focus of the spe-
`cific jurisdiction analysis in ANDA cases.
`2014 WL 5778016, at *8 n. 13. As noted
`above, the Hatch–Waxman Act changed the
`patent laws to exempt generic drug devel-
`opment activity as a basis for infringement
`claims. It does not makes sense, therefore, to
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`Page 7
`
`Slip Copy, 2015 WL 1125032 (S.D.Ind.)
`(Cite as: 2015 WL 1125032 (S.D.Ind.))
`treat such activity as an injury in order to
`base a finding of specific jurisdiction in
`ANDA cases. See id. Nor do we believe that
`the forum in which the ANDA application is
`prepared is a particularly relevant or even
`important fact, since it is the act of filing the
`ANDA and sending the Paragraph IV notice
`not the preparation of the ANDA that creates
`harm by triggering a patent holder's for-
`ty-five days to initiate litigation. See id.
`(citing § 271(e)(2).
`
`by that decision, nor are we certain of its
`continuing viability, particularly considering
`that Glaxo was decided before Zeneca and
`the North Carolina court's ultimate decision
`to transfer the case to the District of Mary-
`land is the same result that was later rejected
`by the Federal Circuit in Zeneca.
`
`
`
`
`
`The Mylan Defendants argue that this approach
`improperly focuses on Plaintiffs' contacts with Indi-
`ana, not theirs. Our analysis does not ignore the clear
`rule that for purposes of the jurisdictional analysis,
`“[t]he proper question is not where the plaintiff expe-
`rienced a particular injury or effect but whether the
`defendant's conduct connects him to the forum in a
`meaningful way.” Walden v. Fiore, ––– U.S. ––––,
`––––, 134 S.Ct. 1115, 1125, 188 L.Ed.2d 12 (2014).
`Although the Mylan Defendants characterize their
`contacts with Indiana as no more than accidental, we
`are not so persuaded. Indeed, the Mylan Defendants
`purposefully directed their activities at Indiana by
`sending a Paragraph IV certification notice letter to
`Lilly in Indiana,FN9 which act they knew would trigger
`the forty-five-day period within which Plaintiffs were
`empowered to file suit under the Hatch–Waxman
`framework.FN10
`
`
`
`
`FN9. The Mylan Defendants also directed
`notification letters in this case to five other
`Plaintiffs, including parties in New Jersey
`and Japan.
`
`FN10. We recognize that this idea, to wit,
`that the Paragraph IV statutory notice letter
`constitutes a purposeful act directed at the
`state to which it is mailed, was rejected by the
`district court in Glaxo Inc. v. Genpharm,
`Pharmaceuticals, Inc., 796 F.Supp. 872
`(E.D.N.C.1992). However, we are not bound
`
`There can be no dispute that the Mylan Defend-
`ants, as generic drug companies well-versed in ANDA
`litigation, understood the purpose and known conse-
`quences of filing the ANDA and Paragraph IV certi-
`fication. As noted above, such a filing constitutes an
`act of patent infringement with “actual consequenc-
`es.” Zeneca, 173 F.3d at 833–34. Thus, Plaintiffs'
`cause of action, “artificial” as it may seem, arose in
`significant part out of the Mylan Defendants' contact
`with Plaintiff Lilly in Indiana. See AstraZeneca, 2014
`WL 5778016, at *7 (finding same). Given the fact that
`“[fJiling a paragraph IV certification means provoking
`litigation,” Caraco Pharm. Labs., Inc. v. Novo
`Nordisk A/S, ––– U.S. ––––, ––––, 132 S.Ct. 1670,
`1677, 182 L.Ed.2d 678 (2012), we see no basis on
`which to conclude that the Mylan Defendants could
`not “reasonably anticipate being haled into court” in
`Indiana. See Burger King, 471 U.S. at 474 (quoting
`World–Wide Volkswagen Corp. v. Woodson, 444 U.S.
`286, 295, 100 S.Ct. 559, 62 L.Ed.2d 490 (1980)).
`Accordingly, we hold that the Mylan Defendants' act
`of filing an ANDA and directing a Paragraph IV no-
`tice letter to Indiana provide sufficient minimum
`contacts with this district to satisfy the requirements of
`an exercise of specific jurisdiction.FN11
`
`
`FN11. We note that there is authority sup-
`porting the contention that injury in a patent
`infringement case occurs where “the in-
`fringing activity directly impacts on the in-
`terests of the patentee,” such as the place of
`infringing sales. Beverly Hills Fan Co. v.
`Royal Sovereign Corp., 21 F.3d 1558, 1571
`(Fed.Cir.1994); see also Acorda Therapeu-
`tics, 2015 WL 186833, at *18 n. 26. While
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`Page 8
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`Slip Copy, 2015 WL 1125032 (S.D.Ind.)
`(Cite as: 2015 WL 1125032 (S.D.Ind.))
`there have not yet been sales in this ANDA
`case, if such sales are made in the future, the
`record before us is clear that they will be
`made nationwide, including in Indiana. See
`Exh. 3 at 159–160, 186.
`
`
`
`*7 Having found that minimum contacts exist, we
`turn to address whether the exercise of jurisdiction in
`this case comports with “traditional notions of fair
`play and substantial justice.” Int'l Shoe, 326 U.S. at
`316. We balance five factors in determining whether
`an exercise of jurisdiction in a particular case is rea-
`sonable and fair: (1) the burden on the defendant; (2)
`the forum state's interest in adjudicating the dispute;
`(3) the plaintiff's interest in obtaining convenient and
`effective relief; (4) the inte