Case 1:19-cv-01528-RGA Document 227 Filed 06/03/22 Page 1 of 8 PageID #: 11807
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`CONFORMIS, INC.,
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`Plaintiff,
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`v.
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`ZIMMER BIOMET HOLDINGS, INC., and
`ZIMMER, INC.,
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`Civil Action No. 19-1528-RGA
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`Defendants.
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`CONFORMIS, INC.,
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`Plaintiff,
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`v.
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`MEDACTA USA, INC., and MEDACTA
`INTERNATIONAL SA,
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`Defendants.
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`MEMORANDUM ORDER
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`On October 14, 2020, Conformis filed its Second Amended Complaint (“SAC”), bringing
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`claims of patent infringement against Medacta USA, Inc. (“Medacta USA”) and Medacta
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`International SA (“Medacta International”). (D.I. 85). Defendants move to dismiss Conformis’s
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`claims against Medacta International under Federal Rules of Civil Procedure 12(b)(2), 12(b)(5),
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`and 12(b)(6). (D.I. 107). Conformis also brings a motion for leave to file a sur-reply (D.I. 178), in
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`light of the availability of new evidence relevant to its opposition to Medacta International’s
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`motion to dismiss, which I now GRANT. I have considered the parties’ briefing. (D.I. 108, 118,
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`122, 178, 179, 186, 187).
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`1
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`Case 1:19-cv-01528-RGA Document 227 Filed 06/03/22 Page 2 of 8 PageID #: 11808
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`Medacta International argues for dismissal on three grounds: (1) insufficient service of
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`process under Rule 12(b)(5), (2) lack of personal jurisdiction under Rule 12(b)(2), and (3) failure
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`to state a claim of direct and contributory infringement under Rule 12(b)(6). I address each of these
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`arguments in turn.
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`I.
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`Insufficient Service of Process
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`Medacta International argues Conformis’s claims against it should be dismissed under Rule
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`12(b)(5) for “insufficient service of process” because Conformis did not serve Medacta
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`International with translated copies of all the exhibits attached to the SAC.1 (D.I. 108 at 5-6).
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`Instead, Conformis served a translated copy of the SAC with an index of web links that direct to
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`non-translated copies of the exhibits, some of which Medacta International claims “materially
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`differ[]”2 from the docketed exhibits attached to the SAC. (Id.).
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`Federal Rule of Civil Procedure 4(f)(1) permits service of process on an international
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`defendant through the Hague Convention. Thus, to determine whether service of process was
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`effective here, we must look to the Hague Convention, which sets guidelines for service of judicial
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`documents between signatories, including the United States and Switzerland, where Medacta
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`1
`The SAC, as docketed, has seven attached exhibits: (1) U.S. Patent No. 8,377,129 (“the
`’129 Patent”), (2) U.S. Patent No. 8,460,304 (“the ’304 Patent”), (3) U.S. Patent No. 9,186,161
`(“the ’161 Patent”), (4) U.S. Patent No. 9,295,482 (“the ’482 Patent”), (5) Medacta
`International’s “Surgical Technique” Guide for the MyKnee product, (6) screenshots from
`Medacta’s website describing the MyShoulder product, and (7) screenshots from Medacta’s
`website describing the Medacta Shoulder System. (D.I. 85-1 Ex. A-C, 85-2 Ex. D-G).
`2
`“Whereas D.I. 85-1 provides the ’129 patent with a certificate of correction that modifies
`claim languages . . . the web link Conformis provided Medacta International displays the original
`’129 Patent without this certificate of correction,” and, “in place of D.I. 85-6 and 85-7, which show
`printouts of websites in the past, Conformis has merely provided links to the active website that
`currently exists.” (D.I. 108 at 6).
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`2
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`Case 1:19-cv-01528-RGA Document 227 Filed 06/03/22 Page 3 of 8 PageID #: 11809
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`International resides. Convention on the Service Abroad of Judicial and Extrajudicial Documents
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`in Civil or Commercial Matters, Nov. 15, 1965, 20 U.S.T. 361, 658 U.N.T.S. 163 (1969).
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`Under Article 2 of the Convention, each signatory designates a central authority for
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`accepting service, and litigants may serve documents on the central authority, which then forwards
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`them to the recipient. Id., Art. 2. “[T]he Central Authority may require the document to be written
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`in, or translated into, the official language or one of the official languages of the State addressed.”
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`Id., Art. 5. “If the Central Authority considers that the request does not comply with the provisions
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`of the present Convention it shall promptly inform the applicant and specify its objections to the
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`request.” Id., Art. 4.
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`Medacta International argues Switzerland requires documents to be translated into the local
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`language of the authority addressed in order for service to be “official.” HCCH, Switzerland –
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`central
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`Authority
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`&
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`practical
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`information,
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`https://www.hcch.net/en/states/authorities/details3/?aid=276
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`(last visited May 25, 2022)
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`(“Switzerland declares that in cases where the addressee does not voluntarily accept a document,
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`it cannot be officially served on him or her in accordance with Article 5(1), unless it is in the
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`language of the authority addressed, i.e., in German, French or Italian . . .”).
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`It is not clear from the Swiss Guidelines, however, whether this translation requirement
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`applies to all exhibits accompanying the main document, here, the SAC, which was translated into
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`Italian. Regardless, the Central Authority for the Ticino canton of Switzerland did not object to
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`Conformis’s request for service, as it was required to do under Article 4 of the Hague Convention
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`if it found the service did not comply with the provisions of the Convention, and indeed served the
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`Case 1:19-cv-01528-RGA Document 227 Filed 06/03/22 Page 4 of 8 PageID #: 11810
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`summons, the SAC, and an index of the exhibits3 on Medacta International. (D.I. 108 at 4; D.I.
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`112-3). Because the Central Authority completed service on Medacta International without
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`objection, I find that Conformis’s service on Medacta International properly complied with the
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`requirements of the Hague Convention, and, as a result, satisfied the requirements of Federal Rule
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`of Civil Procedure 4.
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`For these reasons, Medacta International’s motion to dismiss for insufficient service of
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`process under Rule 12(b)(5) is DENIED.
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`II.
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`Lack of Personal Jurisdiction
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`Medacta International argues the claims against it should be dismissed under Federal Rule
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`of Civil Procedure 12(b)(2), because “Conformis cannot demonstrate that Medacta International
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`has purposely directed any conduct at Delaware or the United States that gives rise to the asserted
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`infringement claims.” (D.I. 108 at 10). I disagree.
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`I find that this Court’s exercise of specific personal jurisdiction over Medacta International
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`is proper under Federal Rule of Civil Procedure 4(k)(2). For a court to exercise personal
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`jurisdiction over a defendant under Rule 4(k)(2), the following requirements must be met: “the
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`plaintiff’s claim must arise under federal law, the defendant must not be subject to jurisdiction in
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`I am not persuaded by Medacta International’s argument that service of process was
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`ineffective due to the use of a web-linked index rather than attachments, the lack of translated
`exhibits, or the fact that the linked exhibits differed slightly from the exhibits docketed with the
`SAC. Conformis informed Medacta International that copies of the exhibits were available “upon
`request to Conformis.” (D.I. 112-3 at 42, 76). Moreover, all the exhibits are either publicly
`available U.S. patents or informational/promotional material prepared, in English, by Medacta
`International and its related companies. (D.I. 85-1 Ex. A-C, 85-2 Ex. D-G). In this case, Medacta
`International cannot seriously argue that it lacked actual notice of the nature of the suit against it.
`See Burda Media, Inc. v. Viertel, 417 F.3d 292, 301 (2d Cir. 2005) (citing a district court for the
`proposition that “the Hague Convention should be read together with Rule 4, which stresses actual
`notice, rather than strict formalism.”) (cleaned up).
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`Case 1:19-cv-01528-RGA Document 227 Filed 06/03/22 Page 5 of 8 PageID #: 11811
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`any state’s court of general jurisdiction, and exercise of jurisdiction must comport with due
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`process.” Touchcom, Inc. v. Bereskin & Parr, 574 F.3d 1403, 1412 (Fed. Cir. 2009).4
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`Here, the first two requirements are easily met. Conformis’s claim is for patent
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`infringement, and therefore arises under federal law, and Medacta International has not identified
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`any state in the United States in which it can be sued. Id. at 1415 (“if the defendant contends that
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`he cannot be sued in the forum state and refuses to identify any other where suit is possible, then
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`the federal court is entitled to use Rule 4(k)(2)”) (cleaned up). Therefore, the only remaining
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`question is whether this Court’s exercise of jurisdiction over Medacta International comports with
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`due process. I find that it does, based on the actions Medacta International has taken to conduct
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`business directly with United States customers.
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`To determine whether due process permits the exercise of personal jurisdiction under Rule
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`4(k)(2), “we must consider whether (1) defendant has purposefully directed its activities at
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`residents of the forum, (2) the claim arises out of or relates to the defendant’s activities with the
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`forum, and (3) assertion of personal jurisdiction is reasonable and fair.” Id. at 1416 (cleaned up).
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`“Rule 4(k)(2) contemplates a defendant’s contacts with the entire United States, as opposed to the
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`state in which the district court sits.” Id. (cleaned up).
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`Here, there is ample evidence 5 that Medacta International purposefully directed its
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`activities toward residents of the United States by directly collaborating with surgeons in the
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`4
`A district court should apply Federal Circuit law to determine whether it may exercise
`personal jurisdiction over out-of-state defendants in patent infringement cases. Hildebrand v. Steck
`Mfg. Company, Inc., 279 F.3d 1351, 1354 (Fed. Cir. 2002).
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`that Medacta
`Medacta
`International contends, “Conformis cannot demonstrate
`International has purposely directed any conduct at Delaware or the United States that gives rise
`to the asserted infringement claims.” (D.I. 108 at 10). This is a factual challenge to jurisdiction.
`“In addressing a factual challenge to jurisdiction, the court may consider evidence outside the
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`Case 1:19-cv-01528-RGA Document 227 Filed 06/03/22 Page 6 of 8 PageID #: 11812
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`United States to custom-design the accused products. These activities are integrally related to
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`Conformis’s infringement claims.
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`The process by which Medacta’s MyKnee product, one of the accused products, is designed
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`for a U.S. patient is as follows. First, the U.S. patient’s surgeon uploads scans of the patient’s knee
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`to a portal operated by Medacta International. (D.I. 180-1 Ex. 20 at 66:14-67:14). From there,
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`Medacta International engineers in Switzerland “generate sort of a default plan based upon the
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`surgeon’s default preferences.” (Id.). The surgeon in the United States then has the opportunity to
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`review and propose changes to the plan, before the plan is validated and production of the custom
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`implant begins in Switzerland by Medacta International engineers. (Id.). The design process is
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`overseen entirely by engineers from Medacta International; nobody from Medacta USA is
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`“actually involved in designing the MyKnee product from the images.” (Id. at 74:3-75:4). The
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`accused MyShoulder product is designed according to the same process, where the surgeon in the
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`U.S. “indicates the patient for anatomic or reverse shoulder replacement, sends them – refers them
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`out for a CT scan, scan is executed per the parameters, uploaded to the cloud, off it goes to
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`Switzerland, they work their magic, and then a default plan is produced by the surgeon
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`preferences.” (Id. at 83:2-12).
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`This collaborative process by which Medacta International works directly with U.S.
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`customers to custom-design the accused products is precisely the sort of purposeful activity
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`pleadings and is free to weigh the evidence and satisfy itself as to the existence of its power to hear
`the case.” Creative Compounds, LLC v. Starmark Lab’ys, 651 F.3d 1303, 1315 (Fed. Cir. 2011)
`(citing Lawrence v. Dunbar, 919 F.2d 1525, 1529 (11th Cir. 1990)); Gould Elec. Inc. v. U.S., 220
`F.3d 169, 176 (3d Cir. 2000).
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`Case 1:19-cv-01528-RGA Document 227 Filed 06/03/22 Page 7 of 8 PageID #: 11813
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`directed toward the United States that fairly and reasonably subjects a defendant to jurisdiction in
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`the United States.
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`For these reasons, Medacta International’s motion to dismiss for lack of personal
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`jurisdiction is DENIED.
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`III.
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`Failure to State a Claim
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`Medacta International argues Conformis has failed to state a claim against it for direct and
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`contributory infringement.6 (D.I. 108 at 18-19). In its answering brief, Conformis concedes to
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`dismissal of its contributory infringement claim. (D.I. 118 at 17 n.11). Therefore, Conformis’s
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`claim of contributory infringement is DISMISSED.
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`35 U.S.C. § 271(a) creates a cause of action for direct infringement against “whoever
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`without authority makes, uses, offers to sell, or sells any patented invention, within the United
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`States, or imports into the United States any patented invention during the term of the patent . . .
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`.” Conformis argues it has adequately pled direct infringement by alleging, “Medacta International
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`is presently making, using, offering for sale, and/or selling [the accused products],” and, “Medacta
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`International’s direct infringement has included, but is not limited to, selling its products directly
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`to Medacta USA for further dissemination to United States customers.” (D.I. 118 at 17-18 (citing
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`D.I. 85 ¶¶ 36, 50, 70, 90)). The only other portion of the SAC Conformis cites in support of its
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`direct infringement claim is paragraph B of its Prayer for Relief, where it asks the Court for
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`declaratory judgment “that Medacta International’s importing, making, using, offering to sell
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`6
`Conformis also brings a claim of induced infringement against Medacta International.
`Medacta International does not argue for the dismissal of that claim.
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`Case 1:19-cv-01528-RGA Document 227 Filed 06/03/22 Page 8 of 8 PageID #: 11814
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`and/or selling at least MyShoulder products in the United States are and would be acts of
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`infringement of one or more claims of [the Asserted Patents].” (Id. at 19 (citing D.I. 85 at 33 ¶ B)).
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`These bare, conclusory allegations are no more than a “formulaic recitation of the elements
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`of a cause of action” and are therefore inadequate to survive a motion to dismiss. Bell Atl. Corp.
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`v. Twombly, 550 U.S. 544, 555 (2007). Nowhere does Conformis specifically allege infringing
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`activity by Medacta International taking place in the United States, as required by § 271(a).
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`Conformis asks that I read between the lines of its allegations regarding Medacta International’s
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`sales to Medacta USA to find an implicit allegation of importation, because, it argues, these
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`allegations “strongly imply that Medacta International imports the accused products.” (D.I. 118 at
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`19). I decline to do so. While the standard for evaluating a plaintiff’s allegations on a motion to
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`dismiss requires accepting all of plaintiff’s factual allegations as true and viewing them in the light
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`most favorable to the plaintiff, it does not require a court to reach beyond what is actually alleged.
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`Because Conformis has failed to specifically allege any infringing activity by Medacta
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`International occurring in the United States, Conformis’s claim of direct infringement by Medacta
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`International is DISMISSED without prejudice.7
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`IT IS SO ORDERED.
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`Entered this 3rd day of June, 2022.
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`/s/ Richard G. Andrews____
`United States District Judge
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`7
`Conformis asks for leave to amend its complaint “to clarify its direct infringement
`allegations.” (D.I. 118 at 20). If Conformis wants to file an amended complaint, it has two weeks
`from the date of this Memorandum to file a motion for leave to do so.
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