throbber
Case 3:18-cv-00347-CAB-MDD Document 94 Filed 07/10/18 PageID.11888 Page 1 of 19
`
`
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`
`
`
`
`
`
`
`
`
`
`UNITED STATES DISTRICT COURT
`
`SOUTHERN DISTRICT OF CALIFORNIA
`
`NUVASIVE, INC.,
`
`v.
`
`ALPHATEC HOLDINGS, INC.,
`
`Plaintiff,
`
` Case No.: 3:18-CV-347-CAB-MDD
`
`ORDER DENYING MOTION FOR
`PRELIMINARY INJUNCTION
`
`
`Defendant.
`
`[Doc. No. 37]
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`On February 13, 2018, Plaintiff NuVasive, Inc., filed a complaint alleging patent
`
`infringement against Defendants Alphatec Holdings, Inc., and Alphatec Spine, Inc.,
`
`(jointly “Alphatec”). [Doc. No. 1.] The complaint asserts infringement of six patents: U.S.
`
`Patent No. 7,819,801; U.S. Patent No. 8,335,780; U.S. Patent No. 8,439,832; U.S. Patent
`
`No. 9,833,227; U.S. Patent No. 8,735,270; and U.S. Patent No. 8,361,156.1 The ‘801, ’780,
`
`‘832, ‘227 and ‘270 patents are directed toward systems and methods for accessing a
`
`targeted disc space through a lateral, trans-psoas path (“the Access Platform patents”). The
`
`‘156 patent describes a spinal implant that is introduced into the disc space of a patient’s
`
`spine from a lateral approach (“the Implant patent”). [Doc. No. 38, at 8-9.]2
`
`On April 5, 2018, NuVasive filed a motion for preliminary injunction. [Doc. No. 37;
`
`Doc. No. 38 (sealed version).] NuVasive seeks to enjoin sales and use of the accused
`
`
`
`1 The complaint also asserted infringement of two design patents, but the Court granted Alphatec’s motion
`to dismiss those claims with prejudice. [Doc. No. 45.]
`2 Document numbers and page references are to those assigned by CM/ECF for the docket entry.
`
`1
`
`3:18-CV-347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 94 Filed 07/10/18 PageID.11889 Page 2 of 19
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`Battalion™ Lateral System, which includes the Squadron™ Lateral Retractor, and the
`
`Battalion™ Lateral Spacer, during the pendency of the litigation. The parties filed a joint
`
`request on April 12, 2018, to extend the briefing schedule to allow for discovery. [Doc.
`
`No. 39.] Alphatec filed its opposition on May 17, 2018. [Doc. No. 49, Doc. No. 53 (sealed
`
`version).] NuVasive filed a reply on June 14, 2018. [Doc. No. 77, Doc. No. 79 (sealed
`
`version).] A hearing on the motion was held on June 21, 2018. [Doc. No. 87.] For the
`
`reasons set forth on the record at the hearing and as discussed below, the motion is
`
`DENIED.
`
`I.
`
`Background
`
`NuVasive is a medical device company with over $1 billion in annual revenues. In
`
`2003, NuVasive launched a minimally-invasive, lateral access surgical procedure for spinal
`
`surgery, known as XLIF. The patented procedures and tools utilized in XLIF surgery,
`
`including the MaXcess® retractor and CoRoent® XLIF implants, allow for a lateral
`
`approach to a patient’s targeted spinal disc space through the psoas muscle and for the
`
`delivery of a large, oversized implant for spinal fusion. [Doc. No. 38, at 6-7.] For over a
`
`decade, NuVasive has developed, patented and marketed the XLIF procedure and
`
`components. This product line now accounts for conservatively $250-300 million of
`
`18
`
`NuVasive’s annual revenue. [Id., at 8.]
`
`In approximately July 2014, Alphatec began developing a competing lateral access
`
`surgical procedure that became known as its Battalion Lateral System. On April 5, 2016,
`
`Alphatec submitted the accused components and procedure for FDA approval, which it
`
`received on September 8, 2016. On February 14, 2017, Alphatec made its first sale and
`
`public surgical use of the accused components. [Doc. No. 79-4, at 7.] In April 2017,
`
`Alphatec launched a limited release of the Battalion Lateral System. Alphatec made a full
`
`launch in October 2017. [Doc. No. 1, ¶ 43.] NuVasive now seeks to enjoin Alphatec from
`
`making, using, selling, offering to sell, or importing into the United States the components
`
`of Alphatec’s Battalion Lateral System, specifically the Squadron Lateral Retractor,
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`2
`
`3:18-CV-347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 94 Filed 07/10/18 PageID.11890 Page 3 of 19
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`Dilators, K-Wire, Intradiscal Shim and Shim Inserter Tool, 4th Blade and Light
`
`Cable/Light Source Connector; and Alphatec’s Battalion Lateral Spacer.
`
`II. Legal Standard
`
`The grant or denial of a preliminary injunction under 35 U.S.C. § 283 is within the
`
`sound discretion of the district court. Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239
`
`F.3d 1343, 1350 (Fed. Cir. 2001). “A preliminary injunction is an extraordinary remedy
`
`never awarded as a matter of right.” Winter v. Natural Resources Defense Council, 555
`
`U.S. 7, 24 (2008). “A plaintiff seeking a preliminary injunction must establish that [it] is
`
`likely to succeed on the merits, that [it] is likely to suffer irreparable harm in the absence
`
`of preliminary relief, that the balance of equities tips in [its] favor, and that an injunction
`
`is in the public interest.” Id. at 20. The district court must weigh and measure each factor
`
`against the other factors and against the form and magnitude of the relief requested. “[A]
`
`movant cannot be granted a preliminary injunction unless it establishes both of the first two
`
`factors, i.e. likelihood of success on the merits and irreparable harm.” Amazon.com, 239
`
`15
`
`F.3d at 1350.
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`III. Likelihood Of Success On The Merits
`
`To demonstrate a likelihood of success on the merits, the movant must show that it
`
`will likely prove infringement of one or more claims of the asserted patents and that at least
`
`one of the same allegedly infringed claims will also likely withstand the validity challenges
`
`presented by the accused infringer. See Amazon.com, 239 F.3d at 1350-51 (holding that if
`
`the non-movant raises a substantial question concerning either infringement or validity that
`
`the patentee cannot prove “lacks substantial merit,” the preliminary injunction should not
`
`issue). Thus, in considering NuVasive’s motion, the Court must assess infringement claims
`
`made by NuVasive as well as any invalidity arguments made by Alphatec.
`
`A.
`
`Infringement
`
`The burden lies with the patentee to establish that the accused product infringes by
`
`a preponderance of the evidence. An infringement analysis involves two steps. First, the
`
`claim scope must be determined. Second, the properly construed claim is compared with
`
`3
`
`3:18-CV-347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 94 Filed 07/10/18 PageID.11891 Page 4 of 19
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`the accused devices to determine whether all the claim limitations are present either
`
`literally or by a substantial equivalent. Amazon.com, 239 F.3d at 1351.
`
`NuVasive asserts the Access Platform patents against Alphatec’s Battalion Lateral
`
`System and the Implant patent against the Battalion Lateral Spacer. A demonstration of
`
`the likelihood of a finding of infringement as to an asserted independent claim of any of
`
`the following patents could support NuVasive’s request to enjoin the sale of the Battalion
`
`Lateral System: the ‘801 Patent (System Claim 1); the ‘780 Patent (System Claim 21); the
`
`‘832 Patent (System Claim 1 or Method Claim 12); and the ‘227 Patent (Method Claims 1
`
`or 16).3 In response to the Court’s request that NuVasive select the claim it considers best
`
`demonstrates its burden on infringement and validity [Doc. No. 86], NuVasive elected to
`
`proceed at argument on Claim 1 of the’832 patent and Claim 1 of the ‘156 patent.
`
`Claim 1 of the ‘832 Patent
`
`The ‘832 Patent is for a Surgical Access System and Related Methods. [Doc No. 1-
`
`8, at 2-34.] It is directed at a system for establishing an operative corridor to the spine
`
`through the psoas muscle. Claim 1 claims:
`
`1. A system for forming an operating corridor to a lumbar spine, comprising:
`a distraction assembly to create a tissue distraction corridor in a lateral, trans-
`psoas path to a lumbar spine, wherein said distraction assembly includes an
`elongate inner element and a plurality of dilators, the plurality of dilators being
`configured to sequentially advance along the lateral, trans-psoas path to the
`lumber spine, the elongate inner element being positionable in a lumen of an
`initial dilator of the plurality of dilators, wherein at least one instrument from the
`group consisting of said elongate inner element and said dilators includes a
`stimulation electrode that outputs electrical stimulation for nerve monitoring
`when the at least one instrument is positioned in the psoas muscle;
`
`
`
`
`3 The asserted claims of ‘270 Patent allegedly cover the accused Alphatec Intradiscal Shim device. [Doc.
`No. 1-12, at 32, Col. 14:30-61.] A finding of a likelihood of infringement of the asserted claims would not
`support the request to enjoin sales or use of the whole Battalion Lateral System or the Squadron Retractor,
`just that component.
`
`4
`
`3:18-CV-347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 94 Filed 07/10/18 PageID.11892 Page 5 of 19
`
`
`
`a three-bladed retractor tool slidable over an exterior of an outermost sequential
`dilator of the dilator system toward the targeted spinal disc along the lateral,
`trans-psoas path, the three-bladed retractor assembly including:
`
`a blade-holder assembly, and
`a posterior-most retractor blade, a cephalad-most retractor blade, and a
`caudal-most retractor blade that extend from the blade-holder assembly,
`wherein the posterior-most, cephalad-most, and caudal-most retractor blades
`are slideably advanced over the exterior of the outermost sequential dilator
`while in a first position, wherein the blade-holder assembly is adjustable to
`move the posterior-most, cephalad-most, and caudal-most retractor blades to
`a second position in which the cephalad-most and caudal-most retractor
`blades are spaced apart from the posterior-most retractor blade to define an
`operative corridor,
`
`wherein three-bladed retractor tool is configured to define the operative corridor
`along the lateral, trans-psoas path to the lumber spine in which a space extending
`to the targeted spinal disc between the posterior-most, cephalad-most, and
`caudal-most refractor blades is dimensioned so as to pass an implant through the
`operative corridor along the lateral, trans-psoas path to the lumbar spine.
`
`[Doc. No. 1-8, at 31-32, Col. 14:31- Col. 15:3.]
`
` NuVasive alleges that the limitations of Claim 1 of the ‘832 patent read on
`
`Alphatec’s Battalion Lateral System. See Declaration of Jim A. Youseff, M.D., ¶¶ 171-
`
`191, and Appendix C. [Doc. No. 37-45, at 70-74; Doc. No. 37-71, at 2-21.] Referencing
`
`the Alphatec Battalion Lateral Lumbar Spacer System Thoracolumbar Surgical Technique
`
`Guide and devices disclosed therein, [Doc. No. 1-38, at 2-30], NuVasive demonstrated that
`
`the Battalion Lateral System: (1) forms an operative corridor to the patient’s lumbar spine
`
`through the psoas muscle; (2) uses an initial dilator with neuromonitoring to traverse the
`
`psoas to the disc space; (3) introduces a K-wire (elongate inner element) through the initial
`
`dilator into the disc space; (4) introduces a secondary sequential dilator over the initial
`
`dilator [Id., at 7-9]; and (5) introduces a retractor, called the Squadron Retractor, over the
`
`second dilator and moves it flush to the disc space [Id., at 11.] The Squadron Retractor is
`
`a tool with a blade-holder assembly and three blades, center, right and left. [Id., at 15, 17,
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`5
`
`3:18-CV-347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 94 Filed 07/10/18 PageID.11893 Page 6 of 19
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`30.] The right and left blades can be moved cranially and caudally to open access to the
`
`disc space to introduce the implant. [Id., at 16-17, 21, 25.]
`
` In response, Alphatec contends that NuVasive cannot demonstrate that the accused
`
`system infringes Claim 1 of the ‘832 patent because the Battalion Lateral System does not
`
`meet the limitation of “a distraction assembly” that includes an elongate inner element and
`
`plurality of dilators. [Doc. No. 53, at 13.] Alphatec’s expert, Dr. Barton Sachs, opines that
`
`“assembly” in this claim should be construed as pre-assembled components that allow the
`
`parts to be introduced simultaneously. See Declaration of Barton L. Sachs, M.D., ¶¶ 122-
`
`125. [Doc. No. 49-5, at 45-46.] Dr. Sachs points out that in connection with the
`
`reexamination of the ‘801 patent, NuVasive’s expert Dr. Youssef distinguished prior art by
`
`defining the “handle assembly” of that invention as pre-assembled components that
`
`introduce the parts of the assembly simultaneously. [Doc. No. 49-5, ¶ 124.]
`
`The Court is not persuaded, at least for the purposes of the instant motion, that the
`
`limitation of a distraction assembly in the ‘832 patent must be construed as a “pre-
`
`assembled” set of components for simultaneous introduction. The distraction assembly is
`
`a collection of components, including the elongate inner element and a plurality of dilators.
`
`The claim language states that the plurality of dilators included in the assembly are
`
`sequentially advanced along the trans-psoas path, indicating they are introduced in
`
`sequence not simultaneously. [Doc. No. 1-8, Col. 14:35-38.] Neither the claim language
`
`nor the specification support a construction that this assembly of components is
`
`preassembled to be introduced into the patient simultaneously.
`
` Alphatec asserted no other challenge to NuVasive’s infringement analysis of Claim
`
`1 of the ‘832 patent. Thus, for purposes of this motion, the Court finds that NuVasive has
`
`demonstrated a likelihood of success with regard to its allegation that the Battalion Lateral
`
`System and Squadron Retractor infringe Claim 1 of the ‘832 Patent.
`
`
`
`
`
`Claim 1 of the ‘156 Patent
`
`According to the abstract, the ‘156 Patent is a “system and method for spinal fusion
`
`comprising a spinal fusion implant of non-bone construction releasably coupled to an
`
`6
`
`3:18-CV-347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 94 Filed 07/10/18 PageID.11894 Page 7 of 19
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`insertion instrument dimensioned to introduce the spinal fusion implant into any of a
`
`variety of spinal target sites. [Doc. No. 1-14, at 2.] Claim 1 claims:
`
`1. A spinal fusion implant of non-bone construction positionable within an
`interbody space between a first vertebra and a second vertebra, said implant
`comprising:
`an upper surface including anti-migration elements to contact said first vertebra
`when said implant is positioned within the interbody space, a lower surface
`including anti-migration elements to contact said second vertebra when said
`implant is positioned within the interbody space, a distal wall, a proximal wall, a
`first sidewall, and a second sidewall generally opposite from the first side wall,
`wherein said distal wall, proximal wall, first sidewall and second sidewall
`comprise a radiolucent material;
`
`wherein said implant has a longitudinal length extending from a proximal end of
`said proximal wall to a distal end of said distal wall, said implant has a maximum
`lateral width extending from said first sidewall to said second sidewall along a
`medial plane that is generally perpendicular to said longitudinal length, and said
`longitudinal length is greater than said maximum lateral width;
`
`at least a first fusion aperture extending through said upper surface and lower
`surface and configured to permit bond growth between the first vertebra and the
`second vertebra when said implant is positioned within the interbody space, said
`first fusion aperture having: a longitudinal aperture length extending generally
`parallel to the longitudinal length of said implant, and a lateral aperture width
`extending between said first sidewall and said second sidewall, wherein the
`longitudinal aperture length is greater than the lateral aperture width; and
`
`at least first and second radiopaque markers oriented generally parallel to a height
`of the implant, wherein said first radiopaque marker extends into said first
`sidewall at a position proximate to said medial plane, and said second radiopaque
`marker extends into said second sidewall at a position proximate to said medial
`plane.
`
`[Doc. No. 1-14, at 30, Col. 12:32-67.]
`
`
`
`NuVasive alleges that the limitations of claim 1 read on the Battalion Lateral Spacer.
`
`[Doc. No. 38, at 16-17]. See Youseff Declaration ¶¶ 317-334, and Appendix F. [Doc. No.
`
`37-45, at 103-108; Doc. No. 37-74, at 2-24.] The Battalion Lateral Spacer is a spinal fusion
`
`implant made of non-bone material with anti-migration ridges on both sides of the implant.
`
`7
`
`3:18-CV-347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 94 Filed 07/10/18 PageID.11895 Page 8 of 19
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`[Doc. No. 1-39, at 2.] It is manufactured from a radiolucent material, poly-ether-ether–
`
`ketone (“PEEK”). [Doc. No. 1-38, at 29.] It has a distal wall generally opposite a proximal
`
`wall and a first sidewall generally opposite a second sidewall. The longitudinal length from
`
`proximal wall to the distal wall is greater than the maximum lateral width from the first
`
`sidewall to the second sidewall. [Doc No. 1-39, at 2.] It has a first fusion aperture extending
`
`through the upper and lower surface, having a longitudinal length extending generally
`
`parallel to the longitudinal length of the implant and a width extending between the first
`
`and second sidewall, the length of the aperture being greater than the width. [Id.] The
`
`Battalion Lateral Spacer has radiopaque markers extending into the first and second
`
`10
`
`sidewalls at a position proximate to the medial plane (i.e., near the middle of the implant).
`
`11
`
`[Doc. No. 37-47, at 8.]
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
` Alphatec did not challenge Dr. Youseff’s infringement analysis of Claim 1 of the
`
`‘156 patent in its opposition brief. [Doc. No. 53, at 15.] Consequently, for purposes of
`
`this motion, the Court finds that NuVasive has demonstrated a likelihood of success with
`
`regard to its allegation the Battalion Lateral Spacer infringes this claim.
`
`B.
`
` Validity
`
` Having established a likelihood of success on the merits with regard to infringement
`
`of Claim 1 of the ‘832 patent and Claim 1 of the ‘156 patent, NuVasive must also
`
`demonstrate that those claims are likely to withstand the validity challenges presented by
`
`Alphatec. Amazon.com, 239 F.3d at 1350-51. In the context of a motion for preliminary
`
`injunction, the patentee must present a clear case supporting the validity of the patent in
`
`suit. Id. at 1359 (“for example by showing that the patent in suit had successfully withstood
`
`previous validity challenges in other proceedings”).
`
` In resisting a preliminary injunction, “one need not make out a case of actual
`
`invalidity. Vulnerability is the issue at the preliminary injunction stage, while validity is
`
`the issue at trial.” Id. “Validity challenges during preliminary injunction proceedings can
`
`be successful, that is, they may raise substantial questions of invalidity, on evidence that
`
`would not suffice to support a judgment at trial.” Id. at 1358.
`
`8
`
`3:18-CV-347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 94 Filed 07/10/18 PageID.11896 Page 9 of 19
`
`
`
`
`
`
`
`‘832 Patent
`
`The ‘832 patent is a continuation of U.S. Patent 7,691,057. [Doc.No.1-8, at 1.] The
`
`‘057 Patent was the subject of an inter partes reexamination (“IPR”), and in its Final
`
`Decision on Appeal, the Patent Trial and Appeal Board (“PTAB”) found method claims
`
`17-22 and 24-27 unpatentable over certain prior art. [Doc. No. 49-5, at 121, ¶ 423; Doc.
`
`No. 49-63, at 7.] While an appeal of the PTAB’s final decision was pending before the
`
`Federal Circuit, NuVasive and the third party that brought the IPR reached a settlement.
`
`As a result, the PTAB’s determination of invalidity was neither affirmed nor reversed.
`
`Alphatec’s expert, Dr. Sachs, submitted an analysis demonstrating the similarities
`
`between claim 1 of the ‘832 patent and the claims of the ‘057 patent that were found to be
`
`obvious (claims 17, 18 and 27) by the PTAB. [Doc. No. 49-5, at 122-24, ¶ 427.] In light
`
`of the PTAB finding of obviousness of the method claims of the ‘057 and those claims’
`
`similarity to claim 1 of the ‘832 patent, a continuation of the ‘057 patent, Alphatec has
`
`raised substantial question of invalidity as to claim 1 of the ‘832 patent.
`
`NuVasive offers no specific response to the challenge to the validity of the ‘832
`
`patent. [Doc. No. 79, at 13-14.] NuVasive’s general arguments that all Alphatec’s
`
`invalidity arguments are based on hindsight and do not discuss the objective indicia of non-
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`obviousness4 are insufficient to present a clear case supporting validity, as is NuVasive’s
`
`19
`
`20
`
`burden here. Consequently, for purposes of this motion, the Court finds that NuVasive
`
`has not demonstrated a likelihood of success with regard to Alphatec’s challenge to the
`
`21
`
`validity of claim 1 of the ‘832 patent.
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`
`
`4 NuVasive relies upon Plantronics, Inc. v. Aliph, Inc. 724 F.3d 1343 (Fed. Cir. 2013), to support its
`assertion that for Alphatec’s validity challenge to be sufficient it required a discussion of indicia of non-
`obviousness. However a preliminary injunction was not at issue in Plantronics and the case offers no
`support for NuVasive’s contention that such an analysis by the party contesting validity is required to
`oppose a motion for preliminary injunction.
`
`9
`
`3:18-CV-347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 94 Filed 07/10/18 PageID.11897 Page 10 of 19
`
`
`
`
`
`
`
`‘156 Patent
`
`With regard to the ‘156 patent, Alphatec has raised a substantial question as to the
`
`validity of claim 1. The ‘156 patent was the subject of an IPR proceeding and in its Final
`
`Written Decision, the PTAB concluded claim 1, among others, was unpatentable, finding
`
`it obvious in light of certain prior art references. The Federal Circuit vacated the decision
`
`and remanded because the PTAB failed to articulate the motivation to combine the prior
`
`art references to place the radiopaque markers on the medial plane (i.e., near the middle of
`
`the insert). In re NuVasive, Inc, 842 F.3d 1376, 1384-85 (Fed. Cir. 2016). [Also Doc. No.
`
`49-5, at 168, ¶¶ 625-629; Doc No. 49-69.] On remand the PTAB was directed to make
`
`additional findings and explanations regarding the motivation to combine. In re NuVasive,
`
`Inc, 842 F.3d at 1385. The parties to the IPR settled before the PTAB reached a
`
`determination on remand leaving the matter unresolved. [Doc. No. 49-5 at 168, ¶629.]
`
`Thus, the challenge raised by Alphatec to the validity of claim 1 of the’156 patent remains
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`a substantial question.
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`With its opposition, Alphatec included an analysis by Dr. Sacks of the obviousness
`
`of claim 1 of the ‘156 patent, including his explanation of the motivation for one of skill in
`
`the art to combine the references. [Doc. No. 49-5, at 159-165, 168, ¶¶ 578-597, 625-629.]
`
`In response NuVasive must present a clear case supporting the validity of the patent in suit.
`
`Amazon.com, 239 F.3d at 1359. It does not.
`
`NuVasive offers no specific response to the challenge to the validity of the ‘156
`
`patent. [Doc. No. 79, at 13-14.] To oppose a preliminary injunction Alphatec does not
`
`need to make out a case of actual invalidity, only vulnerability. Id. NuVasive’s contention
`
`that “Alphatec has not demonstrated likelihood that they will prove invalidity by clear and
`
`convincing evidence,” improperly shifts the burden to Alphatec in the context of this
`
`motion. For purposes of this motion, the Court finds that NuVasive has not demonstrated
`
`a likelihood of success with regard to Alphatec’s challenge to the validity of claim 1 of the
`
`27
`
`‘156 patent.
`
`28
`
`10
`
`3:18-CV-347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 94 Filed 07/10/18 PageID.11898 Page 11 of 19
`
`
`
`Assignor Estoppel
`
`NuVasive’s foremost contention regarding Alphatec’s challenges to the validity of
`
`the Access Platform patents, including the ‘832 patent, is that Alphatec should be barred
`
`by the doctrine of assignor estoppel from contesting validity.5 Assignor estoppel is an
`
`equitable remedy that prohibits an assignor of a patent, or one in privity with an assignor,
`
`from attacking the validity of that patent when he is sued for infringement by the assignee.
`
`MAG Aerospace Indus. v. B/E Aerospace, 816 F.3d 1374, 1379-80 (Fed. Cir. 2016). As an
`
`equitable doctrine, the application of assignor estoppel is within the sound discretion of the
`
`trial court. Checkpoint Sys., Inc. v. All-Tag Sec. S.A., 412 F.3d 1331, 1337 (Fed. Cir. 2005).
`
`NuVasive contends Alphatec is in privity with Patrick Miles, an inventor of the
`
`Access Platform patents. Whether Alphatec is in privity and should be bound by the
`
`doctrine of assignor estoppel depends on the equities dictated by the relationship between
`
`the inventor and the company in light of the act of infringement. Shamrock Tech., Inc. v.
`
`Med. Sterilization, Inc., 903 F.2d 789, 793-94 (Fed. Cir. 1990).
`
`To determine whether a finding of privity is appropriate, the Court considers a
`
`number of factors identified in Shamrock Technologies: (1) the assignor’s leadership role
`
`at the employer; (2) the assignor’s ownership stake in the defendant company; (3) whether
`
`the defendant company changed course from manufacturing non-infringing goods to
`
`infringing activity after the inventor was hired; (4) the assignor’s role in the infringing
`
`activities; (5) whether the inventor was hired to start the infringing operations; (6) whether
`
`the decision to manufacture the infringing products was made partly by the inventor; (7)
`
`whether the defendant company began manufacturing the accused product shortly after
`
`hiring the assignor; and (8) whether the inventor was in charge of the infringing operation.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`MAG Aerospace Indus., 816 F.3d at 1380.
`
`25
`
`26
`
`27
`
`28
`
`
`
`5 The doctrine of assignor estoppel does not apply to the ‘156 patent.
`
`11
`
`3:18-CV-347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 94 Filed 07/10/18 PageID.11899 Page 12 of 19
`
`
`
`Mr. Miles has 25 years of industry experience, and was a “central figure” in
`
`NuVasive’s history. [Doc No. 1-43, at 2.] Just prior to joining Alphatec, he was
`
`NuVasive’s Vice Chairman responsible for strategic plans for the future of spine surgery
`
`and supporting technical development. [Doc. No. 1-3, at 7.] A named inventor on all the
`
`asserted Access Patents, Mr. Miles assigned all his right, title and interest in those patents
`
`to NuVasive.
`
`On October 2, 2017, Mr. Miles joined Alphatec as Executive Chairman and on
`
`March 8, 2018, he assumed the role of Chief Executive Officer. [Doc No. 1-43 at 2.] It is
`
`undisputed that Mr. Miles holds a leadership role at Alphatec and was recruited to further
`
`define and implement Alphatec’s strategic initiatives, expand relationships with surgeon
`
`customers and lead new technology development. [Id.] His leadership position supports a
`
`finding of privity, but it is not dispositive. See e.g., HWB, Inc. v. Braner, Inc., 869 F.Supp.
`
`579, 581-82 (N.D. Ill. 1994) (“the relevant knowledge and assistance of which the
`
`defendant company avails itself is knowledge and assistance associated with the
`
`manufacture of the infringing product”).
`
`Alphatec had embarked on the development and marketing of the accused systems
`
`and devices long before Mr. Miles joined the company. Mr. Miles was not brought on
`
`board to initiate the allegedly infringing activity, but rather for his expertise to promote and
`
`increase Alphatec’s share in the spine surgery market. [Doc. No. 38, at 19.] On or about
`
`December 27, 2017, Mr. Miles closed on the purchase of Alphatec common stock directly
`
`and through his company, MOM, LLC, resulting in his ownership of approximately 11.6%
`
`of Alphatec’s common stock. [Doc Nos. 1-3 at 6; 1-42 at 6, 8; 1-43 at 3.] Mr. Miles’
`
`investment reflects his commitment to Alphatec’s initiative to compete in the spinal
`
`surgery market, but does not demonstrate effective control over Alphatec’s operations. The
`
`timing of his investment and his percentage of interest does not demonstrate that he
`
`financially enabled the alleged development of the accused system as suggested by
`
`NuVasive. See Mentor Graphics Corp. v. Quickturn Design Sys., 150 F.3d 1374, 1379
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`12
`
`3:18-CV-347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 94 Filed 07/10/18 PageID.11900 Page 13 of 19
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`(Fed. Cir. 1998) (Meta, the assignor, sold all its stock Mentor, the party found in privity,
`
`to obtain the capital so Meta could manufacture the accused devices.)
`
`The remaining factors in a privity analysis focus on the role that assignor had at the
`
`defendant company in the decision to engage in the manufacture of the accused device.
`
`MAG Aerospace Indus., 816 F.3d at 1380 (change course to infringing activity after
`
`inventor was hired; role in the infringing activities; hired to start infringing operations;
`
`decision to manufacture infringing products made in part by inventor; began manufacturing
`
`shortly after hiring inventor; and inventor in charge of the infringing operation). Mr. Miles
`
`was not affiliated with Alphatec when these decisions were made.
`
`Alphatec began research and development of the Battalion Lateral System in 2014.
`
`[Doc. No. 1, at ¶ 58; Doc. No. 1-30, at 3.] In 2016, Alphatec sought and received FDA
`
`clearance for the accused system. [Doc. No. 37-9, at 6.] The Alphatec Surgical Guide
`
`[Doc No. 1-38, at 2-30] that provided the basis for many of NuVasive’s infringement
`
`contentions, was published January 5, 2017. [Id., at 30.] On February 14, 2017, Alphatec
`
`made its first sale and public surgical use of the accused components. [Doc. No. 79-4, at
`
`7.] In April of 2017, Alphatec launched a limited release of the Battalion Lateral System.
`
`Alphatec made a full launch in October of 2017. [Doc. No. 1, ¶ 43.] Mr. Miles joined
`
`Alphatec on October 2, 2017. By the time he became an officer at Alphatec, the company
`
`was already deeply committed to, manufacturing and promoting the accused system.
`
`Based on the evidence presently before the Court, the Court finds that Mr. Miles’
`
`role at Alphatec is to promote the sale and any future development of the accused system.
`
`Alphatec however had embarked on its competing technology, and it was fully developed
`
`well before it sought any of Mr. Miles’ expertise. Mr. Miles’ status at Alphatec, and the
`
`expertise he brings in sales and marketing, does not compel a finding of assignor estoppel
`
`based on privity. Accordingly, for purposes of the motion for preliminary injunction,
`
`NuVasive has not demonstrated a likelihood of success with regard to its position that the
`
`doctrine of assignor estoppel bars Alphatec from asserting invalidity defense

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