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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`
`ALPHATEC HOLDINGS, INC. and ALPHATEC SPINE, INC.
`Petitioners,
`
`v.
`
`NUVASIVE, INC.,
`Patent Owner.
`
`_____________________________
`
`Case No. IPR2019-00362
`Patent No. 8,361,156
`_____________________________
`
`
`DECLARATION OF MATTHEW LINK
`
`
`
`NUVASIVE - EXHIBIT 2059
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00362
`
`
`
`
`
`I, Matthew Link, declare as follows:
`
`1.
`
`PERSONAL BACKGROUND
`1.
`I am currently President of NuVasive, Inc. (“NuVasive”), a position I
`
`have held since January 2019. My responsibilities include overseeing NuVasive’s
`
`product and systems development, global marketing, surgeon education, clinical
`
`research, corporate development, and short- and long-term corporate and product
`
`strategy.
`
`2.
`
`I have been employed by NuVasive since June 2006. Prior to my
`
`current position, I served as Executive Vice President of Strategy, Technology, and
`
`Corporate Development from August 2017 to January 2019. I also served as
`
`President of U.S. Commercial from July 2015 to July 2017, President of U.S. Sales
`
`and Service from January 2015 to July 2015, Executive Vice President of U.S.
`
`Sales from January 2013 to December 2014, Senior Vice President of Sales, East
`
`from January 2012 to December 2012, Area Vice President of Sales, South from
`
`April 2010 to December 2011, Sales Director, Atlantic from January 2008 to April
`
`2010, and Area Business Manager, Virginia from June 2006 to January 2008.
`
`3. While employed at NuVasive, I have been involved to varying
`
`degrees in the development, sales, and marketing of NuVasive’s eXtreme Lateral
`
`Interbody Fusion (“XLIF”) products and systems. My work requires me to be
`
`knowledgeable about the development history and technical features of XLIF, as
`
`i
`
`
`
`well as NuVasive’s sales teams, marketing, distribution, position in the
`
`marketplace, customer feedback, customer pricing and demand requirements, and
`
`corporate and product strategy.
`
`VIII. NUVASIVE/XLIF HISTORY
`4.
`NuVasive was established in 1997. In the beginning, it was a
`
`struggling start-up company, operating essentially out of the garage of its
`
`cofounder. Since then, it has grown into a leading medical device company at the
`
`forefront of transforming spine surgery with minimally invasive, procedurally-
`
`integrated solutions. When NuVasive began development of XLIF, it had revenues
`
`of only $2.6 million. Today, NuVasive generates total revenues of approximately
`
`$1 billion, driven to a great extent from widespread adoption of its XLIF product
`
`line.
`
`5.
`
`XLIF is a minimally invasive surgical approach to spinal fusion
`
`surgery that, unlike the traditional approaches, accesses the disc space from the
`
`lateral aspect of the patient. Specifically, the XLIF surgical procedure accesses the
`
`disc space by creating an operative corridor through the psoas muscle. Because
`
`damage to the nerves of the psoas could lead to serious and potentially irreversible
`
`consequences, specialized nerve monitoring is employed during placement and
`
`removal of the instruments used to access the disc space. NuVasive built and tested
`
`an array of specialized instruments and surgical components (e.g., MaXcess®
`
`
`
`retractor, neuromonitoring equipped dilators, specially constructed implants) to
`
`enable the XLIF surgical approach. See generally EX2038.
`
`6.
`
`Prior to XLIF, there were different procedures available for treating
`
`patients in need of spinal fusion that suffered from their own drawbacks. Most
`
`involved approaching the lumbar spine either from the back (the posterior
`
`approach) or from the abdomen (the anterior approach), removing the diseased or
`
`damaged vertebral disc(s), and inserting an implant in the disc space to restore it to
`
`its proper height.
`
`7.
`
`NuVasive recognized the unmet need for an effective spinal fusion
`
`surgery without the disadvantages of these earlier procedures. Before XLIF, lateral
`
`approaches to the spine were avoided because they required traversing the nerve-
`
`rich psoas muscle, and thus carried a high risk of nerve damage that can lead to a
`
`host of medical issues for a patient. That changed, however, when NuVasive
`
`invented XLIF: the first safe and reproducible minimally invasive lateral trans-
`
`psoas approach to the spine.
`
`8.
`
`Developing XLIF required NuVasive to spend significant resources.
`
`NuVasive’s initial expenditures for the development of XLIF were approximately
`
`$20 to $30 million. The CoRoent® XL implant was built to meet the demands of
`
`the XLIF surgical approach innovated by NuVasive.
`
`
`
`I understand that Dr. Jim Youssef has, based on his own review,
`9.
`determined that NuVasive’s CoRoent® XL implants fall within the scope of the
`claims of the ’334 and ’156 patents. The figures below depict the CoRoent® XL
`
`implant.
`
`EX1001, Fig. 2
`
`EX2039 at 4
`
`I1G. 2
`
`19
`
`
`
`IX. SKEPTICISM REGARDING XLIF AND COROENT® XL IMPLANT
`10. Despite the extraordinary time, effort, and resources NuVasive
`invested in development of the XLIF surgical procedure, the majority of the spinal
`surgery community was immediately skeptical. From the beginning, and even
`during my first few years at the company, many surgeons did not believe that
`spinal fusion surgery via a lateral, trans-psoas approach could be done safely and
`reproducibly.
`11. Members of the spinal community published their doubts regarding
`the safety and efficacy of XLIF in the literature. Among these concerns, was the
`large width—18 mm—of the CoRoent® XL implants. For example, Patrick Miles,
`formerly of NuVasive and now Chairman and CEO of Alphatec, testified regarding
`
`
`
`the skepticism in the spinal community regarding the size of NuVasive’s
`
`CoRoent® XL implants. EX2052, ¶7. Specifically, surgeons were concerned that
`
`the safe surgical window was not sufficiently large to accommodate such a wide
`
`implant for lateral surgery. For example, Kelli Howell, formerly of NuVasive and
`
`now Executive Vice President for Clinical Strategies at Alphatec testified as to the
`
`skepticism regarding the large size of the first CoRoent® XL implants.
`
`Q. …why was it that NuVasive didn’t start with an implant that had
`larger footprint?
`
`A. It already seemed larger than most. I think there was concern about
`how big it was. There was, again, a lot of joking in the industry about
`how big the implant was and trying to get it in. Size also affects the --
`demands, then, a bigger access to get it in. So the concern was that if
`you made it wider, that you would put more pressure on the nerves in
`that muscle that you’re traversing.
`EX2036, 102:25-103:11. The testimony of Patrick Miles and Kelli Howell
`
`regarding skepticism in the spinal community of the large size of the CoRoent® XL
`
`implant marketed by NuVasive comports with my own understanding of the
`
`reception the CoRoent® XL implants received upon commercial release. That is,
`
`surgeons were concerned that the large size of the implant would make safe
`
`insertion difficult.
`
`12. NuVasive undertook considerable efforts to overcome the skepticism
`
`expressed by industry professionals, including establishing a cadaver lab in its San
`
`Diego, California headquarters as an XLIF surgeon training center. This facility,
`
`
`
`which had been used to develop and clinically validate the viability of the XLIF
`
`solution, now allowed NuVasive to demonstrate the benefits of XLIF to surgeons
`
`in a hands-on environment.
`
`X. COMMERCIAL SUCCESS
`
`13. From my own experience in the spinal industry and employment at
`
`NuVasive, it is my understanding that there was no minimally invasive lateral
`
`spinal fusion market prior to NuVasive’s XLIF procedure. Only a handful of
`
`highly skilled surgeons had even attempted a minimally invasive lateral approach
`
`for degenerative disc spinal fusion surgery with mixed results at best. These earlier
`
`lateral approaches were not considered safe or reproducible and, as a result, no
`
`particular technique had attained any level of success in the marketplace. In fact,
`
`XLIF was the only minimally invasive lateral procedure commercially available to
`
`surgeons until 2006. EX2052, ¶9. Today, however, NuVasive leads the minimally
`
`invasive lateral spinal fusion commercial market it created, conservatively
`
`estimated as a $250-300 million dollar market, and many surgeons perform XLIF
`
`procedures on thousands of patients every year.
`
`14. The driving force for NuVasive’s growth has been XLIF. The XLIF
`
`procedure historically and still today is a key component to NuVasive’s overall
`
`business success.
`
`
`
`15.
`
`I understand that Mr. Miles has testified that “NuVasive pioneered the
`
`market for lateral, trans-psoas interbody fusion surgeries with the CoRoent XL
`
`implant.” EX2052, ¶10. I have personally heard Mr. Miles make this assertion
`
`numerous times during his tenure at NuVasive. Mr. Miles further testified that the
`
`“CoRoent XL implants were the first commercially available lumbar interbody
`
`implants having a length greater than 40 mm, a maximum width of 18 mm, and
`
`designed for insertion for [sic] a direct lateral transpsoas approach to the lumbar
`
`spine.” EX2052, ¶6. Mr. Miles also testified as to the “tremendous commercial
`
`success” of the CoRoent® XL implant.
`
`For example, after NuVasive pioneered the market for lateral, trans-
`psoas interbody fusion surgeries with the CoRoent XL implant,
`NuVasive’s revenues associated with CoRoent XL implants in 2006
`was more than 295% greater than those from 2005 (the first full year
`of sales). In another example, NuVasive’s revenues associated with
`CoRoent XL implant in 2007 was more than 302% greater than those
`from 2006. Or, taking a longer view of the growth in revenue
`associated with CoRoent XL implants, NuVasive’s revenues
`associated with CoRoent XL implants in 2013 was more than 3,900%
`greater than those from 2005. In sum, in the years since NuVasive
`pioneered the market for lateral, trans-psoas interbody fusion
`surgeries with the CoRoent XL implant, the total CoRoent XL implant
`revenues from 2005 through 2013 totaled hundreds of millions of
`dollars, which (based upon my knowledge and experience in product
`marketing and development for spine surgery) is considered to be a
`tremendous commercial success and which I believe to be greater than
`any other competitor lateral, trans-psoas interbody implant in this
`market (e.g., Medtronic Clydesdale implant, Globus Transcontinental
`implant, and others).
`EX2052, ¶10; see also id., ¶9.
`
`
`
`16.
`
`I have personal knowledge of the revenue the CoRoent® XL implant
`
`generates for NuVasive. Mr. Miles prior testimony regarding the rapid growth of
`
`CoRoent® XL implant revenue is in accord with my own understanding. I agree
`
`with Mr. Miles that CoRoent® XL implants dominate the market for lateral
`
`implants. For example, upon reviewing the relevant financial documents, I can
`
`attest to the fact that between 2008 and 2016 the CoRoent® XL implant generated
`
`between $20 and 50 million dollars of revenue every year for NuVasive. As of the
`
`end of 2017, the CoRoent® XL implant had generated about $400 million in
`
`revenue for NuVasive. 1 These revenue numbers reflect NuVasive’s dominance in
`
`the lateral spinal fusion market. In sum, I agree with Mr. Miles that the CoRoent®
`
`XL implant has been a tremendous commercial success.
`
`XI. COPYING BY ALPHATEC
`
`17. Alphatec is a medical device company that provides hardware,
`
`equipment, and implants for use in spinal surgery. Alphatec has long been in the
`
`spinal surgery market. Around 2008, I became aware that Alphatec was developing
`
`its own lateral product – GLIF – that was designed to compete with XLIF.
`
`However, Alphatec’s GLIF procedure was significantly different than NuVasive’s
`
`XLIF procedure and never gained any real traction in the market.
`
`
`1 These revenue numbers are for the 18 mm wide CoRoent® XL implant.
`
`
`
`18. Following GLIF’s failure, Alphatec changed its approach. In April
`
`2017, Alphatec first introduced its Battalion™ Lateral Access System to a limited
`
`release. On October 2, 2017, Alphatec announced that it had hired Mr. Miles as
`
`CEO and later that same month made a full launch of its Battalion™ Lateral
`
`Access System at the 2017 NASS Annual Meeting.
`
`19. As opposed to its previous failed GLIF product, which involved
`
`completely different instruments and techniques than XLIF to achieve lateral
`
`fusion surgery, Alphatec’s new lateral offering is very similar to XLIF. Based on
`
`my own personal review of Alphatec’s published materials and surgical guide,
`
`Alphatec’s new lateral offering consists of strikingly similar access tools, dilators,
`
`three-bladed retractor with specialized handle, releasable intradiscal shim, and
`
`implants as XLIF.
`
`20. As to Alphatec’s implants, they look to be a virtual copy of
`
`NuVasive’s CoRoent® XL implant. The below side-by-side comparison, for
`
`example, illustrates the striking similarities between NuVasive’s CoRoent® XLand
`
`Alphatec’s Battalion™ implants.
`
`
`
`EX2038 at 24 (CoRoent®)
`
`EX2033 (BattalionTM)
`
`4
`
`21.
`
`I understand that Dr. Jim Youssef has, based on his own review,
`
`determined that Alphatec’s Battalion™ Lateral Spacers fall within the scope of the
`
`
`
`challenged claims of the ’334 and ’156 patents.
`
`XII. CONCLUDING STATEMENTS
`
`22.
`
`In signing this declaration, I understand that the declaration will be
`
`filed as evidence in a contested case before the Patent Trial and Appeal Board of
`
`the United States Patent and Trademark Office. I acknowledge that I may be
`
`subject to cross-examination in this case and that cross-examination will take place
`
`within the United States. If cross-examination is required of me, I will appear for
`
`cross-examination within the United States during the time allotted for cross-
`
`examination.
`
`23.
`
`I declare that all statements made herein of my knowledge are true,
`
`and that all statements made on information and belief are believed to be true, and
`
`that these statements were made with the knowledge that willful false statements
`
`
`
`and the like so made are punishable by fine or imprisonment, or both, under
`
`Section 1001 of Title 18 of the United States Code.
`
`
`Dated: October 30, 2019
`
`
`
`By: _______________________
`
`Matthew Link
`
`
`
`/Matthew Link/
`
`
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