throbber
Case 3:18-cv-00347-CAB-MDD Document 350-26 Filed 11/06/21 PageID.32600 Page 1 of
`11
`
`EXHIBIT 25
`
`DECLARATION OF TRENT D. TANNER
`IN SUPPORT OF
`NUVASIVE'S OPPOSITION TO
`DEFENDANTS' MOTIONS IN LIMINE NOS. 1-10
`
`
`
`
`
`
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 350-26 Filed 11/06/21 PageID.32601 Page 2 of
`11
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`SAN DIEGO DIVISION
`
`NUVASIVE, INC.,
`
` Plaintiff,
`
`v.
`
`CASE NO. 18-cv-00347-CAB-MDD
`
`ALPHATEC HOLDINGS, INC. and
`ALPHATEC SPINE, INC.,
`
` Defendants.
`
`SUPPLEMENTAL REBUTTAL EXPERT REPORT OF KEITH R. UGONE, PH.D.
`
`December 18, 2020
`
`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
`
`EXHIBIT 25
`Page 550
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 350-26 Filed 11/06/21 PageID.32602 Page 3 of
`11
`
`SUPPLEMENTAL REBUTTAL EXPERT REPORT OF KEITH R. UGONE, PH.D.
`
`December 18, 2020
`
`I.
`
`II.
`
`III.
`
`IV.
`
`V.
`
`OVERVIEW OF ASSIGNMENT ................................................................................... 1
`
`SUMMARY OF OPINIONS ............................................................................................ 4
`A. Evaluation Of NuVasive’s Claimed Lost Profits Damages As Presented In The
`Inglish Supplemental Damages Report ......................................................................... 5
`
`B. Reasonable Royalty For A License To The Patents-In-Suit ......................................... 9
`
`C. Monetary Damages Are Adequate To Compensate NuVasive For Alphatec’s
`Alleged Infringement .................................................................................................. 11
`
`QUALIFICATIONS AND EXPERIENCE .................................................................. 12
`
`FACTS, DATA, AND INFORMATION RECEIVED ................................................. 13
`
`OVERVIEW OF PARTIES ........................................................................................... 16
`A. NuVasive..................................................................................................................... 16
`
`B. Alphatec ...................................................................................................................... 16
`
`VI.
`
`OVERVIEW OF PATENTS-IN-SUIT ......................................................................... 17
`
`VII. MARKET AND PRODUCT OVERVIEW .................................................................. 19
`A. Overview Of Spinal Fusion Surgery And Market For Lateral Lumbar Interbody
`Fusion Products ........................................................................................................... 19
`
`1. Spinal Fusion Surgery ........................................................................................... 19
`
`2. Market For Lateral Lumbar Interbody Fusion Products ....................................... 23
`
`B. NuVasive’s MAS Platform And Embodying Products .............................................. 26
`
`1. Description Of NuVasive’s MAS Platform And XLIF Offerings ........................ 26
`
`2. NuVasive’s Sales Associated With Its MAS Platform/XLIF Procedure .............. 27
`
`C. Alphatec’s Battalion Lateral System And Accused Products ..................................... 28
`
`1. Description Of Alphatec’s Battalion Lateral System And Accused Products ...... 28
`
`2. Alphatec’s Sales Associated With Its At-Issue Battalion Lateral System ............ 34
`
`VIII. SUMMARY OF NUVASIVE’S CLAIMED DAMAGES AS PRESENTED BY MR.
`INGLISH ......................................................................................................................... 35
`A. Mr. Inglish’s Claimed Lost Profits Opinion ............................................................... 36
`
`B. Mr. Inglish’s Claimed Royalty Opinion ..................................................................... 38
`
`IX.
`
`EVALUATION OF NUVASIVE’S CLAIMED LOST PROFITS DAMAGES AS
`PRESENTED IN THE INGLISH SUPPLEMENTAL DAMAGES REPORT......... 40
`A. Alphatec Had Acceptable Non-Infringing Alternatives ............................................. 41
`
`1. Acceptable Non-Infringing Alternatives To The Access Patents ......................... 42
`
`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
`- i -
`
`EXHIBIT 25
`Page 551
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 350-26 Filed 11/06/21 PageID.32603 Page 4 of
`11
`
`2. Acceptable Non-Infringing Alternatives To The Implant Patents ........................ 46
`
`B. Alphatec’s Sales Of The Battalion Lateral System Are Attributable To Factors
`Unrelated To The Patents-In-Suit ............................................................................... 51
`
`1. Safety And Reproducibility Are Not Unique To The Patented Technology ........ 52
`
`2. Experienced Sales Representatives And Strong Relationships With Surgeons
`Are Key Drivers Of Demand For Lateral Spine Surgery Products/Platforms ...... 54
`
`3. Non-Accused Lateral Spine Surgery Products Have Been Commercially
`Successful Without Using The Asserted Claims Of The Patents-in-Suit ............. 62
`
`C. Lack Of Evidence That NuVasive Would Have Made Alphatec’s At-Issue Sales
`Absent The Alleged Infringement .............................................................................. 67
`
`1. Mr. Inglish Inappropriately Assumes NuVasive Would Have Made All Of
`Alphatec’s Alleged “Diverted Sales” (In One Scenario) ...................................... 68
`
`2. NuVasive Does Not Identify Alphatec As A “Significant Competitor” ............... 71
`
`3. Alphatec’s At-Issue Battalion Lateral System Is Differentiated From
`NuVasive’s MAS Platform/XLIF Offerings ......................................................... 73
`
`D. Adjustments to NuVasive’s Claimed Lost Profits ...................................................... 75
`
`1. Adjustments To Mr. Inglish’s Claimed Lost Profits Associated With The Access
`Patents ................................................................................................................... 75
`
`2. Adjustments to Mr. Inglish’s Claimed Lost Profits Associated With The Implant
`Patents ................................................................................................................... 87
`
`E. Conclusion Relating To NuVasive’s Lost Profits Claim ............................................ 95
`
`X.
`
`REASONABLE ROYALTY FOR A LICENSE TO THE PATENTS-IN-SUIT ...... 96
`A. Patent Infringement Royalty Damages ....................................................................... 98
`
`1. Hypothetical Negotiation Framework And The Georgia-Pacific Factors ............ 98
`
`2. Hypothetical Negotiation Date And Parties ........................................................ 100
`
`3. Hypothetical Negotiation Predicates ................................................................... 102
`
`B. NuVasive’s Negotiating Position .............................................................................. 103
`
`1. Claimed Benefits Of The Patents-In-Suit ........................................................... 104
`
`2. The Significant Investment To Develop The Patented Products And MAS
`Platform / XLIF Procedure ................................................................................. 107
`
`3. NuVasive Would Acknowledge That The Sales Of Its Embodying Products Is
`Attributable To Factors Unrelated To The Patents-In-Suit ................................. 108
`
`4. NuVasive Would Assert That Alphatec Would Be A Competitor With Respect
`To NuVasive’s MAS Platform/XLIF Offerings ................................................. 115
`
`C. Alphatec’s Negotiating Position ............................................................................... 116
`
`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
`- ii -
`
`EXHIBIT 25
`Page 552
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 350-26 Filed 11/06/21 PageID.32604 Page 5 of
`11
`
`1. Alphatec Would Have Had Acceptable Non-Infringing Alternatives To The
`Patents-In-Suit..................................................................................................... 116
`
`2. Sales Of Alphatec’s At-Issue Battalion Lateral System Are Not Attributable To
`The Patents-In-Suit ............................................................................................. 117
`
`3. Alphatec Was Under Significant Financial Stress At The Time Of The
`Hypothetical Negotiation .................................................................................... 118
`
`4. Alphatec Would Stress That There Are Numerous Competitors In The Lateral
`Surgery Market ................................................................................................... 119
`
`D. Value Indicators For A License To The Patents-In-Suit .......................................... 120
`
`1. NuVasive’s License Agreements ........................................................................ 120
`
`2. Alphatec’s Agreements ....................................................................................... 123
`
`E. Outcome Of The Hypothetical Negotiation .............................................................. 131
`
`1. Running Royalty Payment Constrained By The Costs Of Implementing Non-
`Infringing Alternatives ........................................................................................ 133
`
`2. Running Royalty Payment Applied To All Sales ............................................... 135
`
`3. Conclusion As To The Outcome Of The Hypothetical Negotiation ................... 137
`
`XI. MONETARY DAMAGES ARE ADEQUATE TO COMPENSATE NUVASIVE
`FOR ALPHATEC’S ALLEGED INFRINGEMENT ................................................ 138
`
`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
`- iii -
`
`EXHIBIT 25
`Page 553
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 350-26 Filed 11/06/21 PageID.32605 Page 6 of
`11
`
`SUPPLEMENTAL REBUTTAL EXPERT REPORT OF KEITH R. UGONE, PH.D.
`
`I.
`
`1.
`
`December 18, 2020
`
`OVERVIEW OF ASSIGNMENT
`
`I have been retained as an economics and damages expert for Alphatec Holdings, Inc. and
`
`Alphatec Spine, Inc. (“Alphatec” or “Defendants”) in the matter of NuVasive, Inc. v.
`
`Alphatec Holdings, Inc. and Alphatec Spine, Inc. 1 NuVasive, Inc. (“NuVasive” or
`
`“Plaintiff”) alleges that Alphatec has infringed certain claims of its “Access Patents” and
`
`certain claims of its “Implant Patents” as identified in Table 1 (collectively, the “Patents-
`
`in-Suit”). According to NuVasive, Alphatec has infringed the Patents-in-Suit by providing
`
`various components of its Battalion Lateral System (“Accused Products”).
`
`2.
`
`The original reports issued in this matter pertained to the Access Patents. On November
`
`8, 2019, Mr. Blake Inglish issued an expert report (“the Inglish Damages Report”) in
`
`support of claimed damages associated with the Access Patents-related allegations made
`
`by NuVasive. I submitted an expert report on December 4, 2019 (the “Ugone Rebuttal
`
`Report”) in which I, among other things, (a) independently assessed the claimed royalty
`
`damages owed by Alphatec should the Access Patents be found to be valid, enforceable,
`
`and infringed and (b) evaluated NuVasive’s claimed damages presented in the Inglish
`
`Report.
`
`1 Amended Complaint for Patent Infringement dated September 13, 2018 (“Amended Complaint”).
`
`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
`- 1 -
`
`EXHIBIT 25
`Page 554
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 350-26 Filed 11/06/21 PageID.32606 Page 7 of
`11
`Supplemental Rebuttal Expert Report of Keith R. Ugone, Ph.D.
`December 18, 2020
`_____________________________________________________________________________________________
`
`and Section X.C), and the identified value indicators of a reasonable royalty payment
`
`(detailed in Section X.D), the likely outcome of a February 2017 hypothetical negotiation
`
`between NuVasive and Alphatec would be a non-exclusive, freedom-to-operate, U.S.-only
`
`license to the Patents-in-Suit. I have considered two alternative outcomes: (1) an outcome
`
`that is constrained by the costs of implementing acceptable non-infringing alternatives to
`
`the Access Patents and the Implant Patents and (2) an outcome of a running royalty applied
`
`to all sales (unconstrained by the costs of non-infringing alternatives).
`
`173. At the hypothetical negotiation, the parties would agree that “the industry standard of using
`
`the implant as the currency for the procedure”502 would also be appropriate for the to-be-
`
`negotiated license to the Patents-in-Suit. At the hypothetical negotiation, the parties also
`
`would look to the January 2016 Warsaw / Alphatec Agreement as a framework to establish
`
`the appropriate royalty base. The Warsaw / Alphatec Agreement specifies that the royalty-
`
`bearing products “shall consist of the primary implant used during a given surgical
`
`procedure that is inserted via such retractor.” 503 The Warsaw / Alphatec Agreement
`
`indicates a running royalty rate of no more than 8% to 9% applied to the net sales of the
`
`royalty-bearing products, which would translate to approximately 6% applied to the gross
`
`sales of the royalty-bearing products
`
`174.
`
`For the Access Patents (other than the ’270 Patent), the parties would look to the sales of
`
`implants (including PEEK and titanium implants) included in the allegedly infringing
`
`502 Inglish Supplemental Damages Report, p. 190.
`
`503 Nonexclusive Patent License Agreement between Warsaw Orthopedic, Inc. and Alphatec Spine, Inc. dated January
`22, 2016, pp. 2 – 3. (ATEC_LLIF000262386 – 404, at 387 – 388.) In addition, under the first amendment, the
`“Royalty-Bearing Products” were amended to include: IdentiTi LIF Porous Ti Spacers, Transcend LIF PEEK Spacers,
`and Battalion PEEK LLIF Spacers. (First Amendment to Nonexclusive Patent License Agreement between Alphatec
`Spine, Inc. and Warsaw Orthopedic, Inc. dated January 1, 2020, Exhibit B. (ATEC_LLIF000965645 – 714, at 648 –
`714.))
`
`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
`- 132 -
`
`EXHIBIT 25
`Page 555
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 350-26 Filed 11/06/21 PageID.32607 Page 8 of
`11
`Supplemental Rebuttal Expert Report of Keith R. Ugone, Ph.D.
`December 18, 2020
`_____________________________________________________________________________________________
`
`
`orders to determine the appropriate royalty base. The ’270 Patent does not claim a
`
`retractor, but instead is related to intradiscal shims. Thus, for orders that are alleged to
`
`infringe the ’270 Patent, the parties would agree that the relevant royalty base would be
`
`determined based upon sales of Alphatec’s allegedly infringing intradiscal shims. For the
`
`Implant Patents, the parties would agree that that the relevant royalty base would be
`
`determined based upon sales of Alphatec’s allegedly infringing PEEK implants.504
`
`1. Running Royalty Payment Constrained By The Costs Of Implementing Non-
`Infringing Alternatives
`
`175. The parties (as prudent and reasonable negotiators to a license agreement) likely would
`
`agree to a running royalty payment that is constrained by the costs of implementing (a) a
`
`non-infringing alternative to the Access Patents and (b) a non-infringing alternative to the
`
`Implant Patents. Thus, at the hypothetical negotiation, the parties would have incorporated
`
`the costs of implementing non-infringing alternatives into the determination of a reasonable
`
`royalty payment, as detailed below.
`
`a. Access Patents. As discussed in Section IX.A.1, I understand that Alphatec could have
`designed, developed, and manufactured a non-infringing two-bladed retractor
`according to the Warsaw patents within a year or less.505, 506 According to Mr. Scott
`Robinson, Alphatec’s costs of developing a two-bladed retractor according to the
`Warsaw patents would have included costs related to an engineer’s salary and
`additional costs related to prototypes and other administrative costs. These costs would
`
`
`504 Mr. Inglish opined “for all the patents-in-suit (other than the ’270 Patent), implant sales would be the agreed upon
`royalty base at the hypothetical negotiations for each of the patents-in-suit.” For the ’270 Patent, Mr. Inglish opined
`to a royalty base of “sales of accused intradiscal shims, rather than implants.” (Inglish Supplemental Damages Report,
`p. 253.)
`505 Based upon a discussion with Mr. Scott Robinson, I understand that Alphatec likely would have gone through
`approximately three rounds of development for the non-infringing two-bladed retractor, including the production and
`testing of several prototypes.
`506 Moreover, based upon an alternative hypothetical negotiation date of January 2016, it is reasonable that Alphatec
`could have had a two-bladed retractor prior to any of its actual Battalion Lateral System sales. Assuming a
`hypothetical negotiation date of January 2016, the reasonable royalty payment would be equal to $190,000 (i.e., the
`cost of implementing the two-bladed retractor).
`
`
`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
`- 133 -
`
`EXHIBIT 25
`Page 556
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 350-26 Filed 11/06/21 PageID.32608 Page 9 of
`11
`Supplemental Rebuttal Expert Report of Keith R. Ugone, Ph.D.
`December 18, 2020
`_____________________________________________________________________________________________
`
`Table 28
`Summary Of Reasonable Royalty Damages
`For The Patents-In-Suit Individually And Jointly
`February 2017 – September 2020
`
`Damages
`Start Date
`Patent
`Individual Access Patent
`
`Applicable Product For
`Royalty Base
`
`Royalty Base
`
`Royalty Rate
`(Gross Sales)
`
`Royalty
`Payment
`
`’801 Patent
`
`2/14/2017
`
`’780 Patent
`
`2/14/2017
`
`PEEK /Titanium Implant
`PEEK /Titanium Implant
`
`’832 Patent
`
`2/14/2017
`
`PEEK /Titanium Implant
`
`’227 Patent
`
`2/13/2018
`
`PEEK /Titanium Implant
`
`’859 Patent
`
`9/13/2018
`
`PEEK /Titanium Implant
`
`’531 Patent
`
`9/13/2018
`
`PEEK /Titanium Implant
`
`$12,502,709
`
`$15,454,456
`
`$11,015,243
`
`$14,624,386
`
`$14,011,284
`
`$13,236,642
`
`’270 Patent
`
`2/14/2017
`
`Intradiscal Shim
`
`$481,482
`
`All Access Patents Combined
`
`Individual Implant Patent
`
`’334 Patent
`
`2/14/2017
`
`PEEK Implant
`
`’156 Patent
`
`2/14/2017
`
`PEEK Implant
`
`All Implant Patents Combined
`
`$16,710,580
`
`$5,354,325
`
`$9,904,884
`
`$9,904,884
`
`6%
`
`6%
`
`6%
`
`6%
`
`6%
`
`6%
`
`6%
`
`6%
`
`6%
`
`6%
`
`6%
`
`All Patents-in-Suit Combined514
`
`$750,163
`
`$927,627
`
`$660,915
`
`$877,463
`
`$840,677
`
`$794,199
`
`$28,889
`
`$1,002,635
`
`$321,260
`
`$594,293
`
`$594,293
`
`$1,080,477
`
`3. Conclusion As To The Outcome Of The Hypothetical Negotiation
`
`178. Given these considerations and an assessment of the Georgia-Pacific factors as presented
`
`throughout my report and exhibits, the likely outcome of the hypothetical negotiation
`
`between NuVasive and Alphatec would be a non-exclusive, freedom-to-operate, U.S.
`
`license to the Patents-in-Suit for a reasonable royalty payment of 6% applied to gross sales
`
`of the royalty-bearing products. In addition, given the facts and circumstances of this case,
`
`the parties likely would have incorporated the costs of implementing non-infringing
`
`alternatives into the determination of an overall reasonable royalty payment. Under this
`
`outcome, the royalty payment would be equal to the sum of running royalties over the time
`
`514 The (a) reasonable royalty damages for the Access Patents and (b) the reasonable royalty damages for the Implant
`Patents do not sum to (c) the royalty damages for the Patents-in-Suit combined due to the overlap in certain implant
`units (and associated components) that allegedly infringe both the Access Patents and Implant Patents.
`
`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
`- 137 -
`
`EXHIBIT 25
`Page 557
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 350-26 Filed 11/06/21 PageID.32609 Page 10 of
`11
`Supplemental Rebuttal Expert Report of Keith R. Ugone, Ph.D.
`December 18, 2020
`_____________________________________________________________________________________________
`
`period it would have taken to implement the non-infringing alternatives plus the costs of
`
`implementing such alternatives. This outcome yields a total royalty payment of $288,366
`
`for a license to all Access Patents and Implant Patents over the life of the patents.
`
`179.
`
`I also provide an alternative calculation applying the reasonable royalty to the sales of
`
`royalty-bearing products over the February 14, 2017 through September 16, 2020 time
`
`period (without incorporating the constraints of acceptable non-infringing alternatives).
`
`This alternative outcome yields total royalty damages of $1,080,477 through September
`
`16, 2020 time period assuming all Access Patents and Implant Patents are found valid and
`
`infringed.
`
`XI. MONETARY DAMAGES ARE ADEQUATE TO COMPENSATE NUVASIVE FOR
`ALPHATEC’S ALLEGED INFRINGEMENT
`
`180. Mr. Inglish opined that there are some factors that “would make it difficult, if not
`
`impossible, to fully quantify the future economic harm caused by Alphatec’s alleged
`
`infringement of the patents-in-suit.”515 However, at a high-level, Mr. Inglish’s opinions
`
`relating to irreparable harm and the adequacy of monetary damages fail to account for the
`
`following:
`
`a. NuVasive is an industry leader in the LLIF market, 516 whereas Alphatec is still
`operating at a loss (Section X.C.3);
`
`b. NuVasive, despite Alphatec’s presence in the market, has seen consistent growth and
`expects to see consistent growth over the next few years;517
`
`c. NuVasive does not view Alphatec as a significant competitor (Section IX.C.2); and
`
`515 Inglish Supplemental Damages Report, p. 259.
`
`516 Inglish Supplemental Damages Report, p. 67. See also U.S. Market Report Suite for Minimally Invasive Spinal
`Implants, iData Research, June 2019, p. 220. (NUVA_ATEC0310060 – 159, at 156.)
`
`517 See Inglish Supplemental Damages Report, pp. 135 – 136.
`
`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
`- 138 -
`
`EXHIBIT 25
`Page 558
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 350-26 Filed 11/06/21 PageID.32610 Page 11 of
`11
`Supplemental Rebuttal Expert Report of Keith R. Ugone, Ph.D.
`December 18, 2020
`_____________________________________________________________________________________________
`
`reliably calculated through royalty payments based upon the data available from
`Alphatec.
`
`* * * * * *
`
`182. My analyses and opinions contained in this report are based upon information available to
`
`date. I reserve the ability to review documents, deposition transcripts, or other information
`
`still to be produced by the parties to this dispute and to supplement my opinions based upon
`
`that review.
`
`__________________
`Keith R. Ugone, Ph.D.
`December 18, 2020
`
`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY
`- 142 -
`
`EXHIBIT 25
`Page 559
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket