`
`
`
`
`
`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