Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 1 of 34 PageID #: 5369
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`CONFORMIS, INC.,
`
`
`
`
`v.
`ZIMMER BIOMET HOLDINGS, INC. and
`ZIMMER, INC.,
`
`
`
`
`Defendants.
`
`Plaintiff,
`
`Plaintiff,
`
`CONFORMIS, INC.,
`
`
`
`
`v.
`MEDACTA USA, INC. and MEDACTA
`INTERNATIONAL SA,
`
`
`
`Defendants.
`
`
`
`
` C. A. No. 19-1528-RGA (CONSOL.)
`
`
`
`
` C. A. No. 19-1618-RGA
`
` JURY TRIAL DEMANDED
`
`SECOND AMENDED COMPLAINT FOR PATENT INFRINGEMENT
`
`For its Second Amended Complaint against Medacta USA, Inc. (“Medacta USA”) and
`
`Medacta International SA (“Medacta International”) (collectively “Medacta” or “Defendants”),
`
`Plaintiff Conformis, Inc. (“Conformis” or “Plaintiff”), by its attorneys, alleges as follows:
`
`NATURE OF THE ACTION
`
`This is a patent infringement action.
`
`Conformis brings this action to seek damages and other relief arising from the
`
`1.
`
`2.
`
`infringement by Medacta of (i) U.S. Patent No. 8,377,129 (“the ʼ129 Patent,” attached hereto as
`
`Exhibit A), entitled “Joint Arthroplasty Devices and Surgical Tools,” (ii) U.S. Patent No.
`
`8,460,304 (“the ’304 Patent,” attached hereto as Exhibit B), entitled “Joint Arthroplasty Devices
`
`and Surgical Tools,” (iii) U.S. Patent No. 9,186,161 (“the ’161 Patent,” attached hereto as
`
`Exhibit C), entitled “Surgical Tools for Arthroplasty,” and (iv) U.S. Patent No. 9,295,482 (“the
`
`’482 Patent,” attached hereto as Exhibit D), entitled “Patient Selectable Joint Arthroplasty
`
`Devices and Surgical Tools” (collectively, “the Patents-In-Suit”).
`
`
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 2 of 34 PageID #: 5370
`
`
`
`PARTIES
`
`3.
`
`Plaintiff Conformis, Inc. is a Delaware corporation with its worldwide
`
`headquarters at 600 Technology Park Drive, Billerica, Massachusetts 01821.
`
`4.
`
`5.
`
`Conformis is the assignee and owner of the Patents-In-Suit.
`
`Upon information and belief, Defendant Medacta International SA is organized
`
`and existing under the laws of Switzerland and has its principal place of business at Strada
`
`Regina, Castel Pietro, Switzerland.
`
`6.
`
`Upon information and belief, Defendant Medacta USA, Inc. is a Delaware
`
`corporation with its principal place of business at 6640 Carothers Parkway, Franklin, Tennessee
`
`37067. Medacta USA is a wholly owned subsidiary of Medacta International.
`
`JURISDICTION AND VENUE
`
`7.
`
`Conformis’ patent infringement claims arise under the Patent Laws of the United
`
`States, Title 35, of the United States Code and under the Declaratory Judgment Act, 28 U.S.C. §§
`
`2201 et seq. Accordingly, this Court has subject matter jurisdiction over such claims pursuant to
`
`28 U.S.C. §§ 1331 (federal question), 1338 (action arising under an Act of Congress relating to
`
`patents), 2201 (creation of remedy), and 2202 (further relief).
`
`8.
`
`This Court has personal jurisdiction over Medacta USA, at least because Medacta
`
`USA is at home in the State of Delaware, where it is incorporated and has a registered agent for
`
`service of process. In addition, upon information and belief, Medacta USA regularly does or
`
`solicits business in the State of Delaware and has committed one or more acts of patent
`
`infringement complained of herein in the District of Delaware.
`
`9.
`
`This Court has personal jurisdiction over Medacta International, because, directly
`
`and through Medacta USA, it has committed acts in the District giving rise to this action for
`
`patent infringement and/or has established minimum contacts with Delaware such that the
`
`
`
`2
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 3 of 34 PageID #: 5371
`
`
`
`exercise of jurisdiction would not offend traditional notions of fair play and substantial justice.
`
`Medacta International manufactures and sells the infringing MyKnee and MyShoulder patient-
`
`specific instruments and systems to Medacta USA. Thus, Medacta International has placed, and
`
`continues to place infringing products into the stream of commerce, via its established
`
`distribution channel through Medacta USA, with the knowledge, intent, and/or understanding
`
`that such products are sold in the State of Delaware and elsewhere in the United States. Medacta
`
`International also has induced and continues to induce infringement in the State of Delaware and
`
`elsewhere in the United States, including by providing surgical technique guides, bearing the
`
`Medacta International name, associated with the infringing products and made available to
`
`United States customers. Moreover, Medacta International has received and continues to receive
`
`revenue from U.S. sales.
`
`10.
`
`The Court has personal jurisdiction over Medacta International for the additional
`
`reason that it utilizes Medacta USA, its wholly owned subsidiary, as its agent for conducting
`
`business in the United States.
`
`11.
`
`On the Medacta International website, Medacta International publicly identifies
`
`Medacta USA’s principal place of business in the United States as the location of its
`
`“representative.” Medacta International’s publicly available Annual Reports further describe
`
`their Executive Management, based in Medacta International’s Swiss headquarters, as being
`
`“responsible for” regional Directors, who oversee and manage each of the Medacta’s
`
`internationally based “branches.” Medacta International also issues press releases on behalf of
`
`Medacta USA. For example, Medacta International’s CEO announced the opening of Medacta
`
`USA’s offices in a press release issued by Medacta International, describing them as “Medacta’s
`
`US headquarters.” On information and belief, Medacta International executive and/or
`
`
`
`3
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 4 of 34 PageID #: 5372
`
`
`
`management teams also have responsibilities with respect to Medacta USA. Medacta
`
`International also appoints senior employees at Medacta USA, including the director of Medacta
`
`USA’s spine division.
`
`12.
`
`In addition, although Medacta International is responsible for the design and
`
`development of the infringing products and submitted 510(k) premarketing submissions to the
`
`U.S. Food and Drug Administration, it is Medacta USA’s Senior Director of Quality and
`
`Regulatory who is listed as the applicant’s “correspondent.” Consistent with Medacta
`
`International’s use of Medacta USA as its agent, Medacta International’s website explains that
`
`“We received the first FDA product clearance and implanted the first prosthesis in the USA.”
`
`13.
`
`Further, Medacta International is involved in the management of Medacta USA,
`
`including approving operating budgeting, planning initiatives, acquisitions, significant capital
`
`expenditures and major U.S. based litigation decisions like settlement or budgets. On
`
`information and belief, Medacta International also dictates to Medacta USA the amount of
`
`revenue it receives from it.
`
`14.
`
`Venue in this Court is proper under the provisions of 28 U.S.C. §§ 1391(b) and
`
`(c) and 28 U.S.C. § 1400. Medacta USA is incorporated in Delaware and thus resides in this
`
`State. In addition, Medacta International is subject to suit in this Court pursuant to 28 U.S.C.
`
`1391(c)(3).
`
`A.
`
`15.
`
`FACTUAL BACKGROUND
`
`Background
`
`Conformis is the world’s leading designer, developer, and manufacturer of
`
`patient-specific instrument systems required to best fit implants into a specific patient’s body.
`
`Conformis also designs and manufactures patient-specific knee and hip replacement implant
`
`systems. Founded by doctors affiliated with Stanford and Harvard Medical Schools, Conformis
`
`
`
`4
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 5 of 34 PageID #: 5373
`
`
`
`began with a revolutionary idea: make the implant and tools fit the patient rather than forcing the
`
`patient to fit the implant and tools.
`
`16.
`
`For decades before Conformis’ innovation, surgeons have been implanting
`
`medical devices using (and many are still using) standard instrument systems that have not been
`
`designed with reference to the anatomy of individual patients. As a result of this imprecise
`
`approach, after surgery, patients commonly suffer loss of movement and function, instability,
`
`and lingering pain.
`
`17.
`
`Conformis recognized that the conventional process of joint repair was
`
`backwards: rather than fitting the patient to the tools, the tools should be designed and developed
`
`specifically for the patient, as this produces a better-seated implant.
`
`18.
`
`Conformis therefore set out to develop patient-specific instrument systems, which
`
`precisely place an implant, reduce surgical time and trauma, and create a reproducible surgical
`
`technique. Conformis’ patient-specific instrument systems eliminate many of the traditional
`
`instruments associated with conventional surgery while concurrently simplifying and improving
`
`surgical technique.
`
`B.
`
`Conformis’ Patents
`
`19.
`
`Conformis has made significant investments in the research, development, and
`
`testing of patient-specific instrument systems for knee and hip replacement surgery.
`
`20.
`
`To protect those investments, Conformis applied for and obtained a number of
`
`patents, including the Patents-In-Suit.
`
`21.
`
`Patent authorities worldwide have recognized that Conformis’ patient-specific
`
`instrument systems are worthy of patent protection, and have granted Conformis over 200
`
`patents on its technologies. These patents, and Conformis’ many additional pending patent
`
`
`
`5
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 6 of 34 PageID #: 5374
`
`
`
`applications, span a range of related technologies including imaging software, image processing,
`
`patient-specific orthopedic implants, patient-specific orthopedic instrumentation, methods of
`
`design and manufacture of patient-specific systems, and related surgical techniques. The
`
`technology and patent portfolio are applicable to all major joint systems, including knee, hip,
`
`shoulder, and ankle joints.
`
`22.
`
`The ’129 Patent was duly and legally issued by the United States Patent and
`
`Trademark Office (“USPTO”) on February 19, 2013, to Wolfgang Fitz, Philipp Lang, Daniel
`
`Steines, Konstantinos Tsougarakis and Rene Vargas-Voracek, after fair and full examination, for
`
`“Joint Arthroplasty Devices and Surgical Tools.” The ’129 Patent is assigned to Conformis.
`
`23.
`
`The ’304 Patent was duly and legally issued by the USPTO on June 11, 2013, to
`
`Wolfgang Fitz, Philipp Lang, Daniel Steines, Konstantinos Tsougarakis and Rene Vargas-
`
`Voracek, after full and fair examination, for “Joint Arthroplasty Devices and Surgical Tools.”
`
`The ’304 Patent is assigned to Conformis.
`
`24.
`
`The ’161 Patent was duly and legally issued by the USPTO on November 17,
`
`2015, to Philipp Lang, Wolfgang Fitz, Ray Bojarski, Daniel Steines, Albert G. Burdulis, Jr., and
`
`Rene Vargas-Voracek, after fair and full examination, for “Surgical Tools for Arthroplasty.”
`
`The ’161 Patent is assigned to Conformis.
`
`25.
`
`The ’482 Patent was duly and legally issued by the USPTO on March 29, 2016, to
`
`Wolfgang Fitz, Philipp Lang, Raymond A. Bojarski and Daniel Steines, after fair and full
`
`examination, for “Patient Selectable Joint Arthroplasty Devices and Surgical Tools.” The ’482
`
`Patent is assigned to Conformis.
`
`
`
`6
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 7 of 34 PageID #: 5375
`
`
`
`26.
`
`Conformis is the owner of all rights, title, and interest in and to the Patents-In-
`
`Suit. Conformis possesses all rights to sue and recover for past and future infringement of the
`
`Patents-In-Suit.
`
`C. Medacta’s Infringing Activities1
`
`27. Medacta offers the MyKnee® “patient-specific” instruments that are “based on CT
`
`or MRI images of the patient’s knee” for knee replacement surgery, including at least MyKnee®
`
`Ligament Balancing System (“MyKnee® LBS”) (see Ex. E at 4), MyKnee® Minimally Invasive
`
`Cutting Blocks (“MyKnee® MIS”), MyKnee® Pin Positioning System (“MyKnee® PPS”) and
`
`MyKnee® Uni Cutting Block (“MyKnee® Uni”) (collectively, “MyKnee®”).
`
`28. MyKnee® is used with different Medacta implants, including Global Medacta
`
`Knee (“GMK”) Primary, GMK Sphere and GMK Uni (collectively, “My Knee® Implants”).
`
`29. Medacta also offers other products that are used with MyKnee®, including at least
`
`the following product lines: GMK Efficiency, Efficiency KneePack, and MyKnee MIKA
`
`instruments.
`
`30. Medacta also offers patient matched technology in the form of patient-specific
`
`instruments for shoulder surgery, including at least MyShoulder products.
`
`31.
`
`On information and belief, MyShoulder can be used with the Medacta Shoulder
`
`System. The Medacta Shoulder System is comprised of various implant components of varying
`
`sizes.
`
`32. Medacta’s instruments and products compete with Conformis’ innovative patient-
`
`specific surgical products.
`
`
`1 Based on Medacta’s representations, Conformis has removed allegations against Medacta’s
`MyHip without prejudice.
`
`
`
`7
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 8 of 34 PageID #: 5376
`
`
`
`33.
`
`On information and belief, Medacta is infringing the Patents-In-Suit by making,
`
`using, providing, offering to sell, importing, and selling (directly or through intermediaries) at
`
`least MyKnee® and MyShoulder patient-specific instruments and implants, including the
`
`MyKnee® Implants and the Medacta Shoulder System, in this District and elsewhere in the
`
`United States.
`
`COUNT I: INFRINGEMENT OF U.S. PATENT NO. 8,377,129
`
`34.
`
`Conformis repeats and realleges each and every allegation set forth in the
`
`preceding paragraphs as if fully set forth herein.
`
`35.
`
`On information and belief, Medacta USA is presently making, using, offering for
`
`sale, and/or selling a patient-specific system for knee surgery, including MyKnee® and MyKnee®
`
`Implants (together, the “MyKnee® System”), that directly infringes one or more claims of the
`
`’129 Patent, literally or under the doctrine of equivalents.
`
`36.
`
`On information and belief, Medacta International is presently making, using,
`
`offering for sale, and/or selling a patient-specific system for knee surgery, including MyKnee®
`
`System, that directly infringes one or more claims of the ’129 Patent, literally or under the
`
`doctrine of equivalents. Medacta International’s direct infringement has included, but is not
`
`limited to, selling its products directly to Medacta USA for further dissemination to United
`
`States customers.
`
`37. Medacta’s system practices at least one claim of the ’129 Patent. For example,
`
`claim 1 recites:
`
`A patient-specific instrument system for surgery of a diseased or damaged knee joint of a
`patient, the instrument system comprising:
`
`a patient-specific surface for engaging at least a portion of a substantially uncut
`joint surface of the diseased or damaged knee joint of the patient,
`
`
`8
`
`
`
`
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 9 of 34 PageID #: 5377
`
`
`
`
`
`the patient-specific surface including cartilage information derived from
`image data of the diseased or damaged knee joint of the patient; and
`
`a guide for directing a surgical instrument,
`
`
`wherein the guide has a predetermined position relative to the
`patient-specific surface and a predetermined orientation relative to
`at least one of an anatomical axis and a biomechanical axis
`associated with said knee joint;
`
`wherein the guide defines a drilling path through at least a portion
`of the knee joint,
`
`
`
`the drilling path having a position based on a
`predetermined internal rotation angle or external rotation
`angle of an orthopedic implant.
`
`38.
`
`Claim 1 of the ’129 Patent recites “[a] patient-specific instrument system for
`
`surgery of a diseased or damaged knee joint of a patient,” comprising “a patient-specific surface
`
`for engaging at least a portion of a substantially uncut joint surface of the” knee joint, which
`
`includes “cartilage information derived from image data” of the knee joint and also includes “a
`
`guide for directing a surgical instrument.” Ex. A at Claim 1. Medacta’s MyKnee® is a “patient-
`
`specific” instrument that is “based on . . . MRI images of the patient’s knee” (Ex. E at 4) and is
`
`“designed for a single patient to assist in the positioning of total knee replacement components
`
`intraoperatively and in guiding the marking of bone before cutting.” Id. Additionally, the
`
`MyKnee® is “fixed . . . using . . . cortical pins.” Id. at 14. The images below are illustrative:
`
`
`
`9
`
`
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 10 of 34 PageID #: 5378
`
`
`
`Id.
`
`39.
`
`Claim 1 of the ’129 Patent also recites that “the guide has a predetermined
`
`position relative to the patient-specific surface and a predetermined orientation relative to . . . an
`
`anatomical axis [or] a biomechanical axis associated” with the knee joint and “defines a drilling
`
`path through at least a portion of the knee joint . . . based on a predetermined internal rotation
`
`angle or external rotation angle of an orthopedic implant.” Ex. A at Claim 1. The MyKnee®
`
`technique guide instructs the operator to verify that the points of contact between the cutting
`
`block and the bone are “respected.” Ex. E at 12. The image below is illustrative and the
`
`brochure states that the cutting block contact area is based on the CT and MRI imaging. Id.
`
`Id.. The MyKnee® technique guide instructs that the particular “parameters regarding femoral
`
`and tibial implantation” are planned by the surgeon before the surgical procedure, some of which
`
`include “femoral rotation” and “angles.” Id. at 4. During surgery, which includes MyKnee®
`
`
`
`
`
`10
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 11 of 34 PageID #: 5379
`
`
`
`Implants, “[t]he surgeon can decide to fix the external rotation selected in the pre-operative
`
`planning . . . by inserting a pin in the central hole.” Id. at 17.
`
`40. Medacta’s infringing activities violate one or more subsections of 35 U.S.C. §
`
`271.
`
`41. Medacta USA has also actively induced, and continues to actively induce, others
`
`to infringe at least claim 1 of the ’129 Patent in violation of 35 U.S.C. § 271(b) by causing,
`
`instructing, urging, encouraging and/or aiding others to directly infringe at least claim 1 of the
`
`’129 Patent by making, using, offering to sell, selling, and/or importing in and into the United
`
`States the infringing MyKnee® System, as detailed above. Medacta USA’s active inducement
`
`has included, for example and without limitation, marketing, selling, and offering to sell the
`
`MyKnee® System, providing instructions on how to use the MyKnee® System, selling
`
`instrumentation or devices for use with the MyKnee® System, and promoting the use of the
`
`MyKnee® System. For example, Medacta USA has encouraged customers including scientists,
`
`researchers, and health care professionals to use the MyKnee® System by means of marketing
`
`materials and videos. Medacta USA also has instructed customers on how to use the MyKnee®
`
`System by means of product manuals.
`
`42. Medacta International has also actively induced, and continues to actively induce,
`
`others to infringe at least claim 1 of the ’129 Patent in violation of 35 U.S.C. § 271(b) by
`
`causing, instructing, urging, enabling, encouraging and/or aiding Medacta USA and/or surgeons
`
`to directly infringe at least claim 1 of the ’129 Patent by making, using, offering to sell, selling,
`
`and/or importing in and into the United States the infringing MyKnee® System, as detailed
`
`above. Medacta International’s active inducement has included, for example and without
`
`limitation, marketing, selling, and offering to sell the MyKnee® System, providing instructions
`
`
`
`11
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 12 of 34 PageID #: 5380
`
`
`
`on how to use the MyKnee® System, selling instrumentation or devices for use with the
`
`MyKnee® System, and promoting the use of the MyKnee® System. For example, Medacta
`
`International has encouraged customers including scientists, researchers, and health care
`
`professionals to use the MyKnee® System by means of marketing materials and videos. Medacta
`
`International also has instructed customers on how to use the MyKnee® System by means of
`
`product manuals. Medacta International’s active inducement has further included furnishing
`
`infringing products with surgical guides and other promotional materials for the MyKnee®
`
`System to Medacta USA, and directing Medacta USA to sell those products.
`
`43. Medacta USA has also contributed, and continues to contribute, to its customers’
`
`direct infringement of the ’129 Patent in violation of 35 U.S.C. § 271(c) by providing products
`
`that are used in the infringing systems and that are not suitable for any substantial non-infringing
`
`use.
`
`44. Medacta International has also contributed, and continues to contribute, to its
`
`customers’ direct infringement of the ’129 Patent in violation of 35 U.S.C. § 271(c) by providing
`
`products in the United States that are used in the infringing systems and that are not suitable for
`
`any substantial non-infringing use.
`
`45.
`
`Upon information and belief, at least as early as the filing of the original
`
`Complaint (or soon thereafter), both Medacta USA and Medacta International knew and/or were
`
`willfully blind to the fact that Medacta’s actions have infringed and have induced and
`
`contributed to infringement of the ’129 Patent with the knowledge and intent that one or more
`
`claims of the ’129 Patent be infringed.
`
`46. Medacta USA and Medacta International have had notice of the ’129 Patent at
`
`least as early as the filing of the original Complaint (or soon thereafter). On information and
`
`
`
`12
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 13 of 34 PageID #: 5381
`
`
`
`belief, Medacta USA and Medacta International’s direct and indirect infringement of the ’129
`
`Patent have been willful.
`
`47.
`
`Conformis has suffered economic harm as a result of Medacta’s infringing
`
`activities in an amount to be proven at trial, but in no case less than a reasonable royalty.
`
`COUNT II: INFRINGEMENT OF U.S. PATENT NO. 8,460,304
`
`48.
`
`Conformis repeats and realleges each and every allegation set forth in the
`
`preceding paragraphs as if fully set forth herein.
`
`49.
`
`On information and belief, Medacta USA is presently making, using, offering for
`
`sale, and/or selling patient-specific systems for knee surgery, including MyKnee® System, and
`
`shoulder surgery, including MyShoulder products, that directly infringe one or more claims of
`
`the ’304 Patent, literally or under the doctrine of equivalents.
`
`50.
`
`On information and belief, Medacta International is presently making, using,
`
`offering for sale, and/or selling patient-specific systems for knee surgery, including MyKnee®
`
`System, and shoulder surgery, including MyShoulder products, that directly infringe one or more
`
`claims of the ’304 Patent, literally or under the doctrine of equivalents. Medacta International’s
`
`direct infringement has included, but is not limited to, selling its products directly to Medacta
`
`USA for further dissemination to United States customers.
`
`51. Medacta’s systems practice at least one claim of the ’304 Patent. For example,
`
`claim 1 recites:
`
`A surgical instrument for use in surgically repairing a joint of a patient, the surgical
`instrument comprising:
`
`a mold having an internal surface that includes joint information derived from
`image data of the joint of the patient; and
`
`two or more guide holes, each configured to guide a surgical pin,
`
`
`13
`
`
`
`
`
`
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 14 of 34 PageID #: 5382
`
`
`
`wherein at least one of the two or more guide holes has a position based
`on anatomical information of the joint of the patient to facilitate the
`placement of an articular repair system when the internal surface of the
`mold is aligned with the joint of the patient,
`
`
`wherein the articular repair system has a predetermined rotation
`angle and
`
`wherein the position is based on the predetermined rotation angle.
`
`52.
`
`Claim 1 of the ’304 Patent requires that the “surgical instrument for use in
`
`surgically repairing a joint of a patient . . . ha[s] an internal surface that includes joint
`
`information derived from image data of the joint of the patient.” Ex. B at Claim 1. Medacta’s
`
`MyKnee® is a “patient-specific” instrument that is “based on CT or MRI images of the patient’s
`
`knee” (Ex. E at 4) and is “designed for a single patient to assist in the positioning of total knee
`
`replacement components intraoperatively and in guiding the marking of bone before cutting.”
`
`Id.
`
`53.
`
`Claim 1 of the ’304 Patent also recites that the claimed instrument has “two or
`
`more guide holes, each configured to guide a surgical pin.” Ex. B at Claim 1. Similarly, the
`
`MyKnee® is “fixed . . . using . . . cortical pins.” Ex. E at 14. The images below are illustrative:
`
`Id.
`
`54.
`
`In addition, claim 1 of the ’304 Patent requires that “at least one of the two or
`
`more guide holes has a position based on anatomical information of the joint of the patient to
`
`
`
`
`
`14
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 15 of 34 PageID #: 5383
`
`
`
`facilitate the placement of an articular repair system when the internal surface of the mold is
`
`aligned with the joint of the patient.” Ex. B at Claim 1. The MyKnee® technique guide instructs
`
`the operator to verify that the points of contact between the cutting block and the bone are
`
`“respected.” Ex. E at 12. The image below is illustrative and the brochure states that the cutting
`
`block contact area is based on the CT and MRI imaging. Id.
`
`
`
`Id.
`
`55.
`
`Lastly, claim 1 of the ’304 Patent recites that the “articular repair system has a
`
`predetermined rotation angle and . . . the position is based on the predetermined rotation angle.”
`
`Ex. B at Claim 1. The MyKnee® technique guide instructs that the particular “parameters
`
`regarding femoral and tibial implantation” are planned by the surgeon before the surgical
`
`procedure, some of which include “femoral rotation” and “angles.” Ex. E at 4. During surgery
`
`
`
`15
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 16 of 34 PageID #: 5384
`
`
`
`including MyKnee® Implants, “[t]he surgeon can decide to fix the external rotation selected in
`
`the pre-operative planning . . . by inserting a pin in the central hole.” Id. at 17.
`
`56.
`
`The MyShoulder instrument system as used with the Medacta Shoulder System
`
`infringes the ’304 Patent in a similar manner.
`
`57.
`
`As stated above, claim 1 of the ’304 patent recites “[a] surgical instrument for use
`
`in surgically repairing a joint of a patient.” Ex. B at Claim 1. Medacta’s MyShoulder instrument
`
`system is a surgical instrument for use in surgically repairing a joint of a patient. MyShoulder
`
`allows “a surgeon to realize the pre-operative 3D planning and deliver accurate implant
`
`placement using CT based 3D printed cutting and pin guides” (Ex. F at 1) and is used with the
`
`Medacta Shoulder System components. Ex. G at 1-2.
`
`58.
`
`Claim 1 of the ’304 patent requires the surgical instrument to have “a mold having
`
`an internal surface that includes joint information derived from image data of the joint of the
`
`patient.” Ex. B at Claim 1. MyShoulder relies on CT images of the patient’s shoulder to prepare
`
`patient-specific guides and virtually position the implant before surgery. Ex. F at 1-2.
`
`59.
`
`Claim 1 of the ’304 patent additionally requires that the surgical instrument have
`
`“two or more guides holes, each configured to guide a surgical pin.” Ex. B at Claim 1.
`
`MyShoulder has two or more guide holes, each of which is configured to guide a surgical pin:
`
`
`
`16
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 17 of 34 PageID #: 5385
`
`
`
`
`
`See https://www.youtube.com/watch?v=qvT0Ml-KiNk. Claim 1 of the ’304 patent further
`
`requires that “at least one of the two or more guide holes has a position based on anatomical
`
`information of the joint of the patient to facilitate the placement of an articular repair system
`
`when the internal surface of the mold is aligned with the joint of the patient” and that the
`
`articular repair system has a predetermined rotation angle, on which the position is based. Ex. B
`
`at Claim 1. MyShoulder is used with the Medacta Shoulder System components. Ex. G at 1-2.
`
`Using the MyShoulder workflow, CT images of the patient’s shoulder are taken to prepare a
`
`patient-specific guide, engage in preoperative planning and virtually position the implant. Ex. F
`
`at 1-2. Therefore, at least one of the two or more MyShoulder guide holes has a position based
`
`on anatomical information of the patient to facilitate the placement of the articular repair system
`
`when the mold is aligned with the patient’s joint.
`
`60. Medacta’s infringing activities violate one or more subsections of 35 U.S.C. §
`
`271.
`
`
`
`17
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 18 of 34 PageID #: 5386
`
`
`
`61. Medacta USA has also actively induced, and continues to actively induce, others
`
`to infringe at least claim 1 of the ’304 Patent in violation of 35 U.S.C. § 271(b) by causing,
`
`instructing, urging, encouraging and/or aiding others to directly infringe at least claim 1 of the
`
`’304 Patent by making, using, offering to sell, selling, and/or importing in and into the United
`
`States the infringing MyKnee® System and MyShoulder products, as detailed above. Medacta
`
`USA’s active inducement has included and/or will include, for example and without limitation,
`
`marketing, selling, and offering to sell the MyKnee® System and MyShoulder; providing
`
`instructions on how to use the MyKnee® System and MyShoulder; selling instrumentation or
`
`devices for use with the MyKnee® System and MyShoulder; and promoting the use of the
`
`MyKnee® System and MyShoulder. For example, Medacta USA has encouraged and/or will
`
`encourage customers including scientists, researchers, and health care professionals to use the
`
`MyKnee® System and MyShoulder by means of marketing materials and videos. Medacta also
`
`has instructed and/or will instruct customers on how to use the MyKnee® System and
`
`MyShoulder by means of product manuals.
`
`62. Medacta International has also actively induced, and continues to actively induce,
`
`others to infringe at least claim 1 of the ’304 Patent in violation of 35 U.S.C. § 271(b) by
`
`causing, instructing, urging, enabling encouraging and/or aiding Medacta USA and/or surgeons
`
`to directly infringe at least claim 1 of the ’304 Patent by making, using, offering to sell, selling,
`
`and/or importing in and into the United States the infringing MyKnee® System, as detailed
`
`above. Medacta International’s active inducement has included, for example and without
`
`limitation, marketing, selling, and offering to sell the MyKnee® System, providing instructions
`
`on how to use the MyKnee® System, selling instrumentation or devices for use with the
`
`MyKnee® System, and promoting the use of the MyKnee® System. For example, Medacta
`
`
`
`18
`
`

`

`Case 1:19-cv-01528-RGA Document 85 Filed 10/14/20 Page 19 of 34 PageID #: 5387
`
`
`
`International has encouraged customers including scientists, researchers, and health care
`
`professionals to use the MyKnee® System by means of marketing materials and videos. Medacta
`
`International also has instructed customers on how to use the MyKnee® System by means of
`
`product manuals. Medacta International’s active inducement has further included furnishing
`
`infringing products with surgical guides and other promotional materials for the MyKnee®
`
`System to Medacta USA, and directing Medacta USA to sell those products.
`
`63. Medacta USA has also contributed, and continues to contribute, to its customers’
`
`direct infringement of the ’304 Patent in violation of 35 U.S.C. § 271(c) by providing products
`
`that are used in the infringing systems and that are not suitable for any substantial non-infringing
`
`use.
`
`64. Medacta USA has also contributed, and continues to contribute, to its customers’
`
`direct infringement of the ’304 Patent in violation of 35 U.S.C. § 271(c) by providing products
`
`that are used in the infringing systems and that are not suitable for any substantial non-infringing
`
`use.
`
`65.
`
`Upon information and belief, at least as early as the filing of the original
`
`Complaint (or soon