Case 3:18-cv-00347-CAB-MDD Document 110 Filed 09/13/18 PageID.13532 Page 1 of 162
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`WILSON SONSINI GOODRICH & ROSATI, P.C.
`PAUL D. TRIPODI II (SBN 162380)
`ptripodi@wsgr.com
`GRACE J. PAK (SBN 277705)
`gpak@wsgr.com
`633 West Fifth Street, Suite 1550
`Los Angeles, CA 90071
`Telephone: 323-210-2900
`Fax: 866-974-7329
`WENDY L. DEVINE (SBN 246337)
`wdevine@wsgr.com
`One Market Plaza
`Spear Tower, Suite 3300
`San Francisco, California 94105-1126
`Telephone: 415-947-2000
`Fax: 415-947-2099
`NATALIE J. MORGAN (SBN 211143)
`nmorgan@wsgr.com
`CHRISTINA DASHE (SBN 292360)
`cdashe@wsgr.com
`12235 El Camino Real
`San Diego, CA 92130
`Telephone: 858-350-2300
`Fax: 858-350-2399
`SARA L. TOLBERT (SBN 300945)
`stolbert@wsgr.com
`650 Page Mill Road, Palo Alto, CA 94304
`Telephone: 650-593-9300
`Fax: 650-493-6811
`Attorneys for Plaintiff NuVasive, Inc.
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`SAN DIEGO DIVISION
`CASE NO. 18-cv-00347-CAB-MDD
`NUVASIVE, INC., a Delaware
`corporation,
` Plaintiff,
`
`AMENDED COMPLAINT FOR
`PATENT INFRINGEMENT
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`)))))))))))
`
`v.
`
`ALPHATEC HOLDINGS, INC., a
`Delaware corporation and ALPHATEC
`SPINE, INC., a California corporation,
` Defendants.
`
`NUVASIVE’S AMENDED PATENT
`INFRINGEMENT COMPLAINT
`
`JURY TRIAL DEMANDED
`
`Original Complaint filed:
`2/13/2018
`
`3:18-cv-00347-CAB-MDD
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`

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`Case 3:18-cv-00347-CAB-MDD Document 110 Filed 09/13/18 PageID.13533 Page 2 of 162
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`B.
`C.
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`D.
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`E.
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`TABLE OF CONTENTS
`THE PARTIES ................................................................................................ 1
`JURISDICTION AND VENUE ...................................................................... 1
`FACTUAL BACKGROUND ......................................................................... 2
`A.
`NuVasive—The Pioneer Of Minimally Invasive Spine Surgery
`And Lateral Interbody Fusion Procedures ............................................ 2
`NuVasive’s XLIF Technology .............................................................. 4
`Alphatec Has Struggled Since Its Inception In 2006 And, After
`Failing In Its Introduction Of Guided Lumbar Interbody Fusion
`(“GLIF”), Attempted To Reinvent Itself By Introducing Its
`Battalion™ Lateral Technology ............................................................ 8
`A Full Release Of Alphatec’s BattalionTM Lateral Technology
`Took Place In October Of 2017 .......................................................... 11
`A Comparison Of The Alphatec Surgical Guide And The
`NuVasive XLIF Surgical Technique Guide Shows That
`Alphatec’s BattalionTM Lateral Technology Was Copied From
`NuVasive ............................................................................................. 13
`In October of 2017, A Pioneering Member Of NuVasive’s
`Original XLIF Team And Prolific XLIF Inventor, Mr. Miles,
`Left His Position As NuVasive’s Vice Chairman To Become
`Alphatec’s Executive Chairman ......................................................... 34
`G. With The Undisclosed Assistance Of Mr. Miles As Early As
`March Of 2017, Alphatec Has Attempted To Re-invent The
`Company Not Only By Copying NuVasive’s XLIF Technology,
`But Also By Hiring Other Members Of NuVasive’s Management
`Team And Multiple NuVasive Employees ......................................... 37
`In Light of The Foregoing And Mr. Miles Significant
`Investments In And Leadership At Alphatec, There Has Been
`And Continues to Be A Privity Relationship Between Alphatec
`And Mr. Miles ..................................................................................... 40
`Alphatec Has Been, And Intends to Continue To Infringe On
`NuVasive’s Valuable Patented Technology ....................................... 41
`FIRST CAUSE OF ACTION — INFRINGEMENT OF U.S. PATENT
`NO. 7,819,801 ............................................................................................... 42
`SECOND CAUSE OF ACTION — INFRINGEMENT OF U.S.
`PATENT NO. 8,355,780 .............................................................................. 56
`THIRD CAUSE OF ACTION — INFRINGEMENT OF U.S. PATENT
`NO. 8,439,832 ............................................................................................... 68
`
`F.
`
`H.
`
`I.
`
`I.
`II.
`III.
`
`IV.
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`V.
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`VI.
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`NUVASIVE’S AMENDED PATENT
`INFRINGEMENT COMPLAINT
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`X.
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`XI.
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`IX.
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`VII. FOURTH CAUSE OF ACTION — INFRINGEMENT OF U.S.
`PATENT 9,833,227 ....................................................................................... 86
`VIII. FIFTH CAUSE OF ACTION — INFRINGEMENT OF U.S. PATENT
`NO. 8,753,270 ............................................................................................... 96
`SIXTH CAUSE OF ACTION — INFRINGEMENT OF U.S. PATENT
`NO. 8,361,156 ............................................................................................. 105
`SEVENTH CAUSE OF ACTION — INFRINGEMENT OF U.S.
`DESIGN PATENT NO. D750,252 ............................................................. 113
`EIGHTH CAUSE OF ACTION — INFRINGEMENT OF U.S.
`DESIGN PATENT NO. D652,519 ............................................................. 113
`XII. RESERVED PARAGRAPH NUMBERS ................................................... 113
`XIII. NINTH CAUSE OF ACTION — INFRINGEMENT OF U.S.
`PATENT NO. 9,924,859 ............................................................................. 114
`XIV. TENTH CAUSE OF ACTION – INFRINGEMENT OF U.S. PATENT
`NO. 9,974,531 ............................................................................................. 130
`XV. ELEVENTH CAUSE OF ACTION — INFRINGEMENT OF U.S.
`PATENT NO. 8,187,334 ............................................................................. 143
`PRAYER FOR RELIEF ........................................................................................ 153
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`Plaintiff and Counter-Defendant NuVasive, Inc. (“NuVasive”) hereby files
`this Amended Complaint against Defendants Alphatec Holdings, Inc. and Alphatec
`Spine, Inc. (collectively, “Alphatec” or “Counter-Defendants”) for Alphatec’s
`infringement of NuVasive’s U.S. Patent No. 7,819,801; U.S. Patent No. 8,355,780;
`U.S. Patent No. 8,439,832; U.S. Patent No. 9,833,227; U.S. Patent No. 8,753,270;
`U.S. Patent No. 8,361,156; U.S. Patent No. 9,924,859; U.S. Patent No. 9,974,531;
`and U.S. Patent No. 8,187,334 (collectively, “the NuVasive Patents”). On personal
`knowledge as to NuVasive’s own actions and on information and belief as to the
`actions of others, NuVasive alleges as follows:
`I.
`THE PARTIES
`1.
`Plaintiff NuVasive is a Delaware corporation with its principal place
`of business at 7475 Lusk Boulevard, San Diego, California 92121.
`2.
`On information and belief, Defendant Alphatec Holdings, Inc. is a
`Delaware corporation with its principal place of business at 5818 El Camino Real,
`Carlsbad, California 92008.
`3.
`On information and belief, Defendant Alphatec Spine, Inc. is a
`California corporation with its principal place of business at 5818 El Camino Real,
`Carlsbad, California 92008.
`4.
`On information and belief, Defendant Alphatec Spine, Inc. operates as
`a wholly-owned subsidiary of Defendant Alphatec Holdings, Inc.
`II.
`JURISDICTION AND VENUE
`5.
`This Complaint arises under the patent laws of the United States, Title
`35 of the United States Code. This Court has subject matter jurisdiction over this
`action under 35 U.S.C. § 271 et seq., 28 U.S.C. §§ 1331 and 1338(a).
`6.
`The Court has personal jurisdiction over Defendants because each
`Defendant transacts substantial business in the State of California, directly or
`through intermediaries, regularly does or solicits business in California, has
`committed acts in California giving rise to the causes of action alleged in this
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`Complaint, maintains continuous and systematic contacts in California,
`purposefully avails itself of the privileges of doing business in California, and/or
`derives substantial revenue from goods and services provided to individuals in
`California. In addition, each Defendant is registered to do business in the State of
`California and maintains an agent for service of process in California.
`7.
`Venue is proper in this judicial district pursuant to 28 U.S.C.
`§ 1400(b) because each Defendant: (1) resides in this District, and/or (2) has
`committed acts of infringement and has a regular and established place of business
`in this District.
`III. FACTUAL BACKGROUND
`A.
`NuVasive—The Pioneer Of Minimally Invasive Spine Surgery
`And Lateral Interbody Fusion Procedures
`NuVasive, founded in 1997, is a leading medical device company
`8.
`focused on minimally disruptive surgical products and procedurally integrated
`solutions for the spine. NuVasive pioneered the market for minimally invasive
`spine surgery and lateral interbody fusion procedures. NuVasive has established
`itself as the market leader, and has a built a reputation as an innovator, of lateral
`spinal fusion technologies.
`9.
`Spinal fusion surgery, at a basic level, is used to “fuse” two adjacent
`vertebrae of the spine together so that they heal into a single, solid bone. It is
`commonly performed to correct chronic back pain caused by diseased or damaged
`intervertebral discs. The procedure involves removing some, or all, of the diseased
`or damaged disc and inserting a spinal implant in the resulting disc space. The
`inserted implant restores height and induces bone growth between adjacent
`vertebrae.
`10. NuVasive invented a spinal fusion procedure named the eXtreme
`Lateral Interbody Fusion, or “XLIF.” Before XLIF, the surgical community
`believed lateral approaches to the spine (i.e., approaching the spine from the side
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`of the patient) during spine surgeries, which required moving through the nerve-
`rich psoas muscle, posed too high of a risk of nerve damage to be workable. That
`changed, however, when NuVasive invented XLIF: the first spinal surgery using a
`lateral, transpsoas approach to the spine.
`11. NuVasive invented not only the surgical methods, but also the first
`devices for performing lateral spinal surgeries. These devices include access tools
`which are used to create an operative corridor from the side of the patient to the
`spine. These access tools are compatible with neuromonitoring, which NuVasive
`also invented. The neuromonitoring compatible access tools allow a surgeon to
`locate nerves while navigating a path to the spine. NuVasive also invented
`CoRoent® implants, which include implants specially designed for lateral insertion.
`In comparison to spinal fusion procedures using other approaches, XLIF offers a
`number of benefits, including minimal disruption to the soft tissue, reduced
`operative time, shorter postoperative recovery time and less time in the hospital,
`lower complication rates, and smaller incision, among many more.
`12.
`From 2001-2004, NuVasive expended substantial capital (between
`$20,000,000 and $30,000,000) and human resources in developing its innovations
`and in the commercialization of XLIF. Ex. A (IPR2014-00075, July 8, 2014
`Declaration of Patrick Miles) at ¶ 10.
`13. When XLIF was first introduced in 2003, it was met with substantial
`skepticism from the majority of the spine surgeon community. Id. at ¶ 12.
`14. NuVasive put substantial resources into educating the spinal
`community to overcome that skepticism and show that XLIF was indeed a safer
`and more effective solution for spinal fusion, especially in the lower lumbar
`region. Id. at ¶ 14.
`15.
`Through NuVasive’s education efforts, surgeons began adopting
`XLIF into their practices at an ever-increasing rate, and saw improved patient
`outcomes. NuVasive saw the sea-change in attitude in a variety of ways, including
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`through the growth of NuVasive’s business, through the interest at industry
`meetings, through the number of surgeons contacting NuVasive for training on
`XLIF over the years, and through publications regarding XLIF’s revolutionary
`approach. Id. at ¶ 16.
`16. NuVasive created the commercial market for lateral fusion products.
`Id. at ¶ 23. There was no lateral fusion market at the time of launch of the XLIF
`procedure. It is a testament to the procedure (and the instruments which enabled it)
`that NuVasive was able to essentially create a new market. Id. at ¶ 30.
`17. NuVasive experienced unprecedented growth for a small spinal
`startup. Id. at ¶ 25. The growth of NuVasive has been a direct result of XLIF
`success. Id. XLIF has redefined minimally disruptive surgery by providing an
`efficient, reproducible lateral procedure that is minimally disruptive with
`associated benefits (e.g., less blood loss, etc.). Id. And, at the center of
`NuVasive’s success has been its XLIF procedure and associated equipment, which
`are at the core of NuVasive’s business. Id. at ¶ 27.
`B.
`NuVasive’s XLIF Technology
`18. One of the key components of NuVasive’s XLIF technology is a
`system of specialized access tools that are compatible with neuromonitoring that
`NuVasive developed as part of the XLIF platform to create a small operative
`corridor through the side of the patient and through the nerve-rich psoas muscle to
`access the spine.
`19.
`The access tools include sequential dilators, which are a series of
`successively larger dilators used to create and then incrementally widen an opening
`to the spine. Specifically, once a smaller dilator has been inserted, a larger dilator
`is slid over the previously inserted smaller dilator. The sequential dilators include
`directional electrodes at their distal ends which electrically stimulate nerves in the
`psoas muscle. The nerve responses are monitored and used by surgeons to assist in
`creating a surgical path to the spine.
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`20. As part of the specialized access tools, NuVasive also developed a
`line of retractors which are referred to as the MaXcess® retractors. During the
`XLIF procedure, the MaXcess® retractor slides over the largest sequential dilator
`and gently enlarges and holds open the operating corridor. The MaXcess®
`retractors include an access driver and three independently adjustable blades: (1) a
`posterior blade (located towards the back of the patient), also referred to as the “C”
`or “central” blade; (2) a caudal blade (located towards the feet of the patient), also
`referred to as the “L” or “left” blade; and (3) a cephalad blade (located towards the
`head of the patient), also referred to as the “R” or “right” blade. The three-bladed
`design allows a surgeon to anchor the posterior blade using an Intradiscal Shim and
`stabilize the position of the retractor using an articulating arm. During the XLIF
`procedure, one end of the articulating arm is attached to the retractor while the
`other end is secured to the operating table. One of the blades of the MaXcess®
`retractor can also be equipped with a neuromonitoring electrode. The special
`design of the MaXcess® retractors provides maximum access to the target area of
`the spine with minimal disruption to the surrounding tissue, as illustrated in the
`figures below (screenshots of “MaXcess SD” video at 0:50, 0:25, 0:41,
`respectively, available at https://www.youtube.com/watch?v=J3aLnVD_ymU).
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`The XLIF surgery also utilizes NuVasive’s CoRoent® line of
`21.
`implants. As depicted below, the CoRoent® XLIF implants are sized to span the
`entire width of the vertebral body to provide maximum vertebral body support. In
`comparison, implants inserted through non-lateral spinal fusion surgeries have a
`much smaller footprint and therefore provide weaker intervertebral support. Due
`to anatomical structures surrounding the spine, inserting implants having
`dimensions as large as CoRoent® using non-lateral spinal fusion surgeries (such as
`ALIF, PLIF, or TLIF)1 would involve unacceptable risk. However, such implants
`are routinely inserted using a lateral approach to the spine with NuVasive’s XLIF
`technology.
`//
`//
`//
`//
`//
`
`1 “ALIF” refers to a spinal fusion surgery utilizing an anterior approach to the
`spine, “PLIF” a posterior approach to the spine, and “TLIF” a “transforaminal,” or
`angled approached to the spine from the posterior.
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`NuVasive’s CoRoent® implant (Ex. B at 7)
`
`Comparison of NuVasive’s CoRoent® implant to Implants Placed in Non-
`Lateral Procedures
`
` XLIF ALIF PLIF TLIF
`22. NuVasive’s CoRoent® line of implants also includes radiopaque
`markers for a surgeon to determine whether the implant is correctly placed in the
`disc space. These markers are specially placed after considering the dimensions of
`CoRoent® and its intended orientation on the vertebral disc.
`23.
`NuVasive is the pioneer of XLIF. To that end, NuVasive has and
`continues to offer on-site training sessions for surgeons to learn XLIF first-hand.
`In addition, NuVasive describes and demonstrates the XLIF procedure and
`instrumentation through XLIF Surgical Technique Guides, including a 2003, 2006,
`2007, and 2013 edition. E.g., Ex. D (NuVasive XLIF Surgical Technique (2013)
`(“2013 NuVasive Surgical Guide”)); Ex. E (NuVasive XLIF Surgical Technique
`(2007) (“2007 NuVasive Surgical Guide”)).
`//
`//
`//
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`Over 400 published clinical studies support the XLIF procedure and
`24.
`hundreds of surgeons worldwide have successfully performed the XLIF procedure
`on thousands of patients.
`25.
`In order to protect its investments and cutting-edge intellectual
`property relating to XLIF, as well as other advancements in spinal developments,
`NuVasive regularly seeks and obtains patents from the United States Patent and
`Trademark Office (“USPTO”). As of February 13, 2018, NuVasive has been
`granted over 350 patents in the United States and has numerous pending patent
`applications.
`C.
`Alphatec Has Struggled Since Its Inception In 2006 And, After
`Failing In Its Introduction Of Guided Lumbar Interbody Fusion
`(“GLIF”), Attempted To Reinvent Itself By Introducing Its
`Battalion™ Lateral Technology
`26. Alphatec is a medical device company that provides hardware,
`equipment, and implants for use in spinal surgery. Since its inception, Alphatec
`has incurred net losses every year. In a 2018 corporate presentation, Alphatec
`described its history with phrases such as “Poor Decisions/Challenges,” “Missed
`globalization expectations,” and “Invested in technologies that never
`commercialized.” Ex. F (Alphatec Corporate Presentation (January 2018)) at 4.
`27. Alphatec reported that in 2006, the year that Alphatec went public, its
`net loss was nearly $26 million. Ex. G (Excerpt from Alphatec Holdings Form 10-
`K Annual Report 2006) at 56.
`28. On information and belief, Alphatec tried, but failed, to achieve
`success with a “lateral” spinal procedure and system. That procedure and system
`was named “Guided Lumbar Interbody Fusion,” or “GLIF.” GLIF approached the
`spine at an angle between the side and back of the patient.
`//
`//
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`Ex. H (Alphatec Spine Arc Portal Access
`System Guided Lumbar Interbody Fusion
`Surgical Technique Guide) at 1.
`
`Starting from at least as early as 2008, Alphatec was developing
`29.
`prototypes and designing products for GLIF. Ex. I (Excerpt from Alphatec
`Holdings Form 10-K Annual Report 2008) at 12. Alphatec’s press releases
`mention only one GLIF procedure ever being performed – in 2011. Ex. J (January
`4, 2011 Alphatec Press Release).
`30. On information and belief, Alphatec stopped publicly discussing
`GLIF as of Alphatec’s Annual Report for 2013.
`31. By 2013, Alphatec’s net losses had increased to approximately $82
`million, compared to a net loss of nearly $26 million in 2006, the year that
`Alphatec went public. Ex. K (Excerpt from Alphatec Holdings Form 10-K Annual
`Report 2013) at 41; Ex. G (Alphatec Holdings Form 10-K Annual Report 2006) at
`56. In just seven years, Alphatec’s net losses had grown by over 300%.
`32. Alphatec reported that Alphatec’s debt due to contractual obligations
`(including lines of credit) and commercial commitments increased from $27
`million in 2006 to nearly $190 million in 2013. Ex. G (Alphatec Holdings Form
`10-K Annual Report 2006) at 68; Ex. K (Alphatec Holdings Form 10-K Annual
`Report 2013) at 51.
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`33. Alphatec reported that at the end of 2013, Alphatec’s stock price was
`about $2 dollars, compared to about $5 at the end of 2009. Ex. K (Alphatec
`Holdings Form 10-K Annual Report) at F-28; Ex. L (Excerpt from Alphatec
`Holdings Form 10-K Annual Report 2009) at F-33.
`34.
`In an effort to accumulate cash, Alphatec implemented major changes
`to its business in 2014-2015, including shifting its research and development
`resources, and refocusing its product portfolio pipeline, toward the lateral market
`for spine, the market that NuVasive had created. Ex. M (Excerpt from Alphatec
`Spine 2014 Annual Report) at 1. According to Alphatec’s public statements, a few
`years later, in April 2017, Alphatec made a limited release of a lateral spinal
`surgery system, named the “Battalion™ Lateral System.” Ex. N. On information
`and belief, it took Alphatec several years to launch Battalion™ Lateral System
`after initiating its lateral development program in part because Alphatec was
`distracted by financial hardships and efforts to restructure its business.
`35. At the end of 2015, Alphatec’s financial circumstances had become
`dire. Alphatec reported that at the end of 2015, Alphatec failed to comply with its
`financial covenants under its credit facility agreements, constituting an event of
`default. Ex. O (Excerpt from Alphatec Holdings Form 10-K Annual Report 2015)
`at 28. Alphatec’s 2015 Annual Report expressly stated “[t]here is substantial doubt
`concerning our ability to continue as a going concern.” Id. at 27.
`36. Alphatec reported that in 2015, Alphatec incurred an annual net loss
`of approximately $178 million, and its stock prices declined to $0.30. Id. at 39, 50.
`Alphatec was in danger of being delisted for failing to comply with NASDAQ’s
`requirement of maintaining a closing bid of $1.00 per share. Id. at 31-32.
`However, Alphatec negotiated with NASDAQ and was able to obtain an extended
`deadline of September 2016 to regain compliance. Ex. P (Excerpt from Alphatec
`Holdings Form 10-Q Quarterly Report for the Period Ending June 30, 2016) at 31.
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`37. Meanwhile, Alphatec continued to face financial hardships. It failed
`to comply with its financial covenants with its credit facilities in 2016 for the
`months of January, February, March, April, May, and June. Ex. Q (Excerpt from
`Alphatec Holdings Form 10-K Annual Report 2016) at 29.
`38. Alphatec reported that in July 2016, Alphatec sold its international
`business to Globus Medical, Inc. in exchange for $80 million in cash and a credit
`line of $30 million (the “Globus Transaction”). Id. at 8.
`39. Alphatec reported that as part of the Globus Transaction, Alphatec
`agreed to exit the international market for a certain period of time. Id.
`40. Alphatec reported that in 2016, Alphatec reduced its workforce to
`“reduce operating expenses” and “more appropriately size the Company’s
`resources to better reflect the needs of a U.S.-focused organization.” Ex. R
`(October 5, 2016 Alphatec Press Release).
`41. Alphatec reported that after the Globus Transaction, Alphatec
`regained compliance with NASDAQ’s listing requirements. Ex. Q (Alphatec
`Holdings Form 10-K Annual Report 2016) at 32.
`42. Alphatec reported that in connection with the Globus Transaction,
`“[t]his enhanced liquidity will enable the company to support the continued
`expansion in the U.S. of … the launches of our new Battalion Lateral System ….”
`Ex. S (July 26, 2016 Alphatec Press Release).
`A Full Release Of Alphatec’s BattalionTM Lateral Technology
`D.
`Took Place In October Of 2017
`43. According to Alphatec’s public statements, Alphatec made a limited
`release of the Battalion™ Lateral System with the Squadron™ Lateral Retractor,
`which is specifically designed for use in a lateral, transpsoas procedure (“Alphatec
`Lateral Procedure”) in April 2017. Ex. N (April 7, 2017 Alphatec Press Release).
`On information and belief, Alphatec initiated a full launch of its Battalion™
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`Case 3:18-cv-00347-CAB-MDD Document 110 Filed 09/13/18 PageID.13546 Page 15 of 162
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`Lateral System with the Squadron™ Lateral Retractor in October of 2017. Exhibit
`T (November 9, 2017 Alphatec Press Release) at 1.
`44.
`The Alphatec Battalion™ Lateral Thoracolumbar Surgical Technique
`Guide (“Alphatec Surgical Guide”), attached hereto as Exhibit U, describes the
`Battalion™ Lateral System and the Alphatec Lateral Procedure.
`45.
`The Battalion™ Lateral System includes the Battalion™ Lateral
`Spacer (i.e., an implant). Ex. U at 2, 28.
`46.
`The Battalion™ Lateral System includes the Initial Dilator. Id. at 6.
`47.
`The Battalion™ Lateral System includes the Secondary Dilator. Id. at
`
`8.
`
`The Battalion™ Lateral System includes the Squadron™ Lateral
`48.
`Retractor Body. Id. at 17.
`49.
`The Battalion™ Lateral System includes the Squadron™ Lateral
`Retractor Right Blade. Id. at 6-7, 13.
`50.
`The Battalion™ Lateral System includes the Squadron™ Lateral
`Retractor Left Blade. Id.
`51.
`The Battalion™ Lateral System includes the Squadron™ Lateral
`Retractor Posterior Blade. Id.
`52.
`The Battalion™ Lateral System includes the Squadron™ Lateral
`Retractor Left Handle Arm. Id. at 9.
`53.
`The Battalion™ Lateral System includes the Squadron™ Lateral
`Retractor Right Handle Arm. Id.
`54.
`The Battalion™ Lateral System includes the Intradiscal Shim. Id. at
`
`19.
`
`55. On information and belief, through at least the Alphatec Surgical
`Guide, Alphatec instructs surgeons to implement the Battalion™ Lateral System.
`//
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`56. On information and belief, Alphatec conducts in-person training and
`education courses for surgeons demonstrating the Alphatec Lateral Procedure
`using the Battalion™ Lateral System with the Squadron™ Lateral Retractor.
`E.
`A Comparison Of The Alphatec Surgical Guide And The
`NuVasive XLIF Surgical Technique Guide Shows That Alphatec’s
`BattalionTM Lateral Technology Was Copied From NuVasive
`The Alphatec Surgical Guide (Ex. U) and the NuVasive XLIF
`57.
`Surgical Technique Guides (Exs. D and E) are compared below.
`58. On information and belief, Alphatec’s research and development of
`the Alphatec Lateral Procedure and related instrumentation commenced in 2014.
`At that time, Alphatec was aware of NuVasive, XLIF, and NuVasive’s extensive
`XLIF patent portfolio.
`59. On information and belief, all editions (from 2003-2013) of the
`NuVasive XLIF Surgical Technique Guides were also known to Alphatec
`throughout development of the Alphatec Lateral Procedure and related
`instrumentation.
`60.
`The cover of the 2013 edition of NuVasive’s XLIF Surgical
`Technique Guide (“2013 NuVasive Surgical Guide”) illustrates a top view of the
`MaXcess® retractor (as seen by the surgeon performing the operation) providing
`access to the target intervertebral disc. Ex. D at 1.
`61.
`In a similar manner, the Alphatec Surgical Guide illustrates the
`Squadron™ Lateral Retractor providing access to the target intervertebral disc.
`Ex. U at 1.
`//
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`Case 3:18-cv-00347-CAB-MDD Document 110 Filed 09/13/18 PageID.13548 Page 17 of 162
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`2013 NuVasive Surgical Guide Cover
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`Alphatec Surgical Guide Cover
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`The 2013 NuVasive Surgical Guide describes the following XLIF
`62.
`procedure steps: (1) Patient Positioning & Operating Room setup, (2) Anatomic
`Identification And Initial Incisions, (3) Retroperitoneal Access, (4) Retroperitoneal
`Approach, (5) Transpsoas Approach, (6) Retractor Assembly, (7) Access, (8)
`Annulotomy And Disc Space Preparation, (9) Implant Sizing, and (10) Implant
`Placement. See Ex. D.
`63.
`The Alphatec Surgical Guide instructs surgeons how and when to
`perform these steps. See Ex. U.
`(i)
`XLIF Patient Positioning And Operating Room Setup
`64. NuVasive first instructs that the patient should be placed in the lateral
`decubitus position with the greater trochanter over a table break and secured to the
`operating room table by tape at specific locations: (A) below the iliac crest, (B)
`over the thoracic region, (C) from the iliac crest to the knee, then secured to the
`table, and (D) from the table to the knee, past the ankle, then secured to the table.
`E.g., Ex. E (2007 NuVasive Surgical Guide) at 12.
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