Case 3:18-cv-00347-CAB-MDD Document 390 Filed 03/04/22 PageID.34730 Page 1 of 8
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`WILSON SONSINI GOODRICH & ROSATI P.C.
`MORRIS FODEMAN (pro hac vice)
`mfodeman@wsgr.com
`WENDY L. DEVINE (SBN 246337)
`wdevine@wsgr.com
`NATALIE J. MORGAN (SBN 211143)
`nmorgan@wsgr.com
`12235 El Camino Real
`San Diego, CA 92130
`(858) 350-2300
`
`
`HILGERS GRABEN PLLC
`MICHAEL T. HILGERS (pro hac vice)
`mhilgers@hilgersgraben.com
`575 Fallbrook Blvd, Suite 202
`Lincoln, NE 68521
`(402) 218-2106
`
`
`Attorneys for Plaintiff NuVasive, Inc.
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`SAN DIEGO DIVISION
`NUVASIVE, INC., a Delaware
`)
`CASE NO.: 18-cv-00347-CAB-MDD
`corporation,
`)
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`NUVASIVE INC’S BENCH BRIEF
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`)
`REGARDING NEXUS AND XLIF
`)
`
`)
`
`)
`Judge: Hon. Cathy Ann Bencivengo
`
`)
`Magistrate Judge: Mitchell D. Dembin
`)
`Courtroom: 15A
`ALPHATEC HOLDINGS, INC., a
`)
`
`Delaware corporation, and ALPHATEC
`)
`PER CHAMBERS RULES NO ORAL
`SPINE, INC., a California corporation,
`)
`ARGUMENT UNLESS
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`)
`SEPARATELY ORDERED BY THE
`Defendants.
`)
`COURT
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`)
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`)
`Trial: 3/1/2022
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`Plaintiff,
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`v.
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`NUVASIVE’S BENCH BRIEF RE NEXUS
`AND XLIF
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`18-cv-00347-CAB-MDD
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`Case 3:18-cv-00347-CAB-MDD Document 390 Filed 03/04/22 PageID.34731 Page 2 of 8
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`Controlling Federal Circuit law dictates that whether there is nexus,
`including the question of whether there is a presumption of nexus, between
`evidence of secondary considerations and the asserted claims is a question of fact
`for the jury. Teva Pharms. Int'l GmbH v. Eli Lilly & Co., 8 F.4th 1349, 1361 (Fed.
`Cir. 2021); Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373-74 (Fed. Cir.
`2019); WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1331 (Fed. Cir. 2016). The
`Federal Circuit has also “repeatedly stressed” that evidence of secondary
`considerations “must be considered in every case” and it is thus “[legal] error not
`to consider” such evidence when it is presented. WBIP, LLC, 829 F.3d at 1328; In
`re Huai-Hung Kao, 639 F.3d 1057, 1067-68 (Fed. Cir. 2011). Alphatec ignores
`and blatantly mischaracterizes this law, as well as the facts, in an attempt to
`prevent the jury from considering precisely such evidence of nonobviousness
`regarding NuVasive’s patented lateral system. Because Alphatec’s objections
`constitute legal error, they should be overruled.
`I.
`ARGUMENT
`Alphatec asserts that NuVasive’s proprietary NVM5 neuromonitoring
`platform (earlier known as “Neurovision”) is a required component of XLIF, yet is
`allegedly not covered by NuVasive’s asserted claims. Thus (per Alphatec),
`because the surgical procedure that is XLIF is not “coextensive” with the asserted
`claims, there can legally be no nexus between XLIF and the claimed invention, and
`NuVasive should not be permitted to show the jury any evidence of secondary
`considerations related to the procedure or NuVasive’s lateral system that is used to
`perform the procedure. Ex.1 A (2/28/22 Status Conf. Hr’g Tr.) at 4:21-6:19, 7:7-
`8:10 (citing Teva v. Eli Lilly); Ex. B (3/2/22 Hr’g Tr.) at 220:1-4 (citing NuVasive,
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`
`1 “Ex.” refers to the exhibits to the Declaration of Christina Dashe submitted in
`support of the current motion.
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`Case 3:18-cv-00347-CAB-MDD Document 390 Filed 03/04/22 PageID.34732 Page 3 of 8
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`Inc. v. Iancu, 752 F. App’x 985 (Fed. Cir. 2018))2. Alphatec is wrong on both the
`facts and the law.
`As an initial matter, the Teva decision cited by Alphatec, far from requiring
`a legal conclusion of no nexus, instead holds the opposite: the issue of whether
`XLIF is coextensive with the claims and whether there is nexus or a presumption
`of nexus is one for the jury to decide. Specifically, in Teva, the Federal Circuit
`held that a patent owner is entitled to a presumption of nexus for secondary
`considerations if it shows that its evidence is tied to a specific product and the
`product is the invention claimed; this presumption can be rebutted if it is shown the
`product is not “coextensive” with the patented invention. Teva, 8 F.4th at 1360-61
`(citing Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019)).
`Entirely contrary to Alphatec’s description of Teva, the Federal Circuit also
`explicitly held that: (a) the mere presence of unpatented components in a patented
`product – even ones that might materially affect the functioning of that product –
`do not themselves defeat the presumption of nexus; and (b) most importantly,
`“whether a product is coextensive with the patented invention, and therefore
`whether a presumption of nexus is appropriate in a given case, is a question of
`fact.” Teva, 8 F.4th at 1361-62 (rejecting the argument for a bright-line rule that
`the presumption of nexus is defeated whenever a patented product contained
`unpatented components that materially affected the workings of that product)
`(emphasis added). Thus, the precedent Alphatec relies upon rejects the very
`bright-line rule Alphatec insists should be applied here. Instead, the Teva Court
`expressly stated that a rule precluding a nexus finding when the patented product
`contains additional components not covered by the claims that materially affects
`functionality “would be unsound.” Id. at 1361. This is because if there was such a
`
`2 In subsequent correspondence between counsel, Alphatec confirmed the
`Federal Circuit decision cited during the March 2, 2022 hearing was NuVasive v.
`Iancu. Ex. C.
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`Case 3:18-cv-00347-CAB-MDD Document 390 Filed 03/04/22 PageID.34733 Page 4 of 8
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`bright-line rule “nexus would rarely, if ever attach because virtually every
`innovative product inevitably has some unclaimed feature that materially affects
`its functionality.” Id. (emphasis added). Accordingly, the Court “emphasize[d]
`that the question [of] whether the presumption of nexus applies in each case turns
`on the nature of the claims and the specific facts” which must be determined by the
`fact finder, here the jury.3 Id.
`Moreover, even if this Court chose to take what the Federal Circuit has said
`is a factual issue from the jury and decide that there is no presumption of nexus
`(which NuVasive contends is contrary to such authority), the Federal Circuit has
`further recognized that “a finding that a presumption of nexus is inappropriate does
`not end the inquiry into secondary considerations…[t]o the contrary, the patent
`owner is still afforded an opportunity to prove nexus.” Fox Factory, 944 F.3d at
`1373-74, 1378. Indeed, Courts recognize that, in view of Fox Factory and other
`controlling Federal Circuit law, it is reversible error to prevent the patent owner
`from presenting secondary considerations evidence to the jury on the grounds of no
`nexus. Leviton Mfg. Co. v. Pass & Seymour, Inc., No. 17-cv-46 (BMC), 2021 WL
`1648229, at *4-6 (E.D.N.Y. Apr. 27, 2021) (ordering a new trial and finding that
`“[t]he Court’s rulings [excluding secondary considerations evidence] encroached
`into the province of the fact-finder, for the jury should have been the one to decide
`whether there was a sufficient nexus between the proffered evidence and the
`[claims] to warrant affording any weight to that evidence”); see also CIVIX-DDI,
`LLC v. Hotels.com, L.P., No. 05 C 6869, 2012 WL 6591684, at *6 (N.D. Ill. Dec.
`
`3 Alphatec also noted, without any further explanation, that NuVasive “ha[s]
`patents” on its proprietary neuromonitoring platform. Ex. A at 6:1. However, the
`Federal Circuit has also explicitly recognized that the mere presence of separate
`patents does not by itself defeat the presumption of nexus; instead, the fact finder
`must compare the specific inventions claimed in each patent. Fox Factory, 944
`F.3d at 1377-78. Yet Alphatec has not cited a single patent purportedly covering
`NuVasive’s NVM5 platform, let alone explain how any such patent relates to the
`asserted ones here. Nor has Alphatec ever asserted any such position in any
`discovery response or expert disclosure.
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`Case 3:18-cv-00347-CAB-MDD Document 390 Filed 03/04/22 PageID.34734 Page 5 of 8
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`18, 2012) (“the Court will not strip the jury of the question of whether a sufficient
`nexus exists between [the patent owner’s] evidence and the invention simply
`because [the accused infringer] argues [the patent owner] will not ultimately
`prevail on this issue”). Thus, regardless of whether the tools used to perform an
`XLIF are “coextensive” with the claims due to the use of certain unpatented
`neuromonitoring components in the procedure, NuVasive is still entitled to prove
`to the jury that its “evidence of secondary consideration is the direct result of the
`unique characteristics of the claimed invention” within its patented lateral system
`rather than any unpatented elements. Fox Factory, 944 F.3d at 1373-74, 1378.
`Alphatec’s assertion that the Federal Circuit held that “XLIF requires
`Neurovision” (“NVM5”) (Ex. B at 220:1-4) again misstates the law and the facts.
`Alphatec identified NuVasive v. Iancu as supposedly supportive of this assertion,
`but Alphatec is wrong. See Ex. C. The Federal Circuit in NuVasive v. Iancu
`merely noted that multiple components are needed to perform an XLIF procedure,
`only one of which is NVM5, and it expressly listed NuVasive’s lateral access
`system as another component needed. 725 F. App’x. at 995. Moreover, many of
`NuVasive’s lateral system components are indisputably patented and needed to
`perform (and integral to performing) an XLIF surgical procedure. For example,
`this lateral system specifically includes patented components that allow for “the
`big hurdles [to] be overcome” of navigating around the nerves in the psoas muscle,
`such as: (a) the neuromonitoring-enabled dilators, without which the
`neuromonitoring itself will not work; and (b) a retractor specifically designed to
`integrate with these dilators and be inserted and opened in a specific way that also
`assists in avoiding nerve damage. See Ex. B at 218:9-219:19, 220:9-11. Alphatec
`is thus entirely wrong when it asserts the unpatented NVM5 is the only thing that
`“enabled XLIF to succeed.” Ex. A at 8:3-5.
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`Case 3:18-cv-00347-CAB-MDD Document 390 Filed 03/04/22 PageID.34735 Page 6 of 8
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`Regardless, Alphatec’s assertions regarding NuVasive v. Iancu and NVM5
`are also legally irrelevant. Under Teva and Fox Factory, the mere fact that XLIF
`may contain both patented and unpatented components (even if these unpatented
`components may be material to the functioning of the claimed invention, which
`NuVasive disputes) does not compel any sort of conclusion that there is no nexus
`between evidence of secondary considerations arising from the XLIF procedure
`and the use of the components and tools to perform that procedure, and the asserted
`claims, let alone preclude NuVasive from entirely presenting such evidence to the
`jury. Teva, 8 F.4th at 1361-62; Fox Factory, 944 F.3d at 1373-74. Instead, the
`Federal Circuit has recognized that it is up to the jury to decide nexus based on
`“the nature of the claims and the specific facts.” Teva, 8 F.4th at 1362.
`Finally, and most importantly, NuVasive v. Iancu, consistent with Teva and
`Fox Factory, found that even if NuVasive’s evidence of secondary considerations
`related NuVasive’s lateral system and procedure “did not come entirely” from the
`patented elements of the claims but also from unpatented elements, “this does not
`mean that there is no nexus between the claimed invention and the XLIF
`procedure.” NuVasive v. Iancu, 725 F. App’x at 995-996 (finding there was
`nexus). That is why in this case NuVasive should be permitted to (and intends to)
`put on evidence regarding why the unique features of XLIF are the “direct result”
`of the overall patented lateral system, which includes a specific retractor with
`specific features, a releasable intradiscal shim, and neuromonitoring enabled access
`equipment. NuVasive is also entitled to rebut Alphatec’s assertions that the unique
`features of XLIF are instead due to any unpatented components of NVM5 (e.g., the
`specific source of the electrical stimulation). Because it is plainly a factual matter
`for the jury to decide whether NuVasive’s evidence is persuasive, the jury is
`entitled to hear it.
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`Case 3:18-cv-00347-CAB-MDD Document 390 Filed 03/04/22 PageID.34736 Page 7 of 8
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`II. CONCLUSION
`For the foregoing reasons, NuVasive respectfully requests that the Court
`overrule Alphatec’s objections and permit NuVasive to present its evidence of
`secondary considerations relating to NuVasive’s patented lateral system.
`WILSON SONSINI GOODRICH & ROSATI
`Dated: March 4, 2022
`By: /s/ Wendy Devine
`
`
`Wendy L. Devine
`
`Morris Fodeman (pro hac vice)
`mfodeman@wsgr.com
`1301 Avenue of the Americas, 40th Floor
`New York, NY 10019-6022
`(212) 999-5800
`
`Wendy L. Devine (SBN 246337)
`wdevine@wsgr.com
`One Market Plaza
`Spear Tower, Suite 3300
`San Francisco, California 94105-1126
`(415) 947-2000
`
`Natalie J. Morgan (SBN 211143)
`nmorgan@wsgr.com
`12235 El Camino Real
`San Diego, CA 92130
`(858) 350-2300
`
`HILGERS GRABEN PLLC
`Michael T. Hilgers (pro hac vice)
`mhilgers@hilgersgraben.com
`575 Fallbrook Blvd., Suite 202
`Lincoln, NE 68521
`(402) 218-2106
`
`
`
`
`Attorneys for Plaintiff NuVasive, Inc.
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`Case 3:18-cv-00347-CAB-MDD Document 390 Filed 03/04/22 PageID.34737 Page 8 of 8
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`CERTIFICATE OF SERVICE
`The undersigned certifies that a true and correct copy of the foregoing
`document has been served on this date to all current and/or opposing counsel of
`record, if any to date, who are deemed to have consented to electronic service via
`the Court’s CM/ECF system per Civ.L.R. 5.4(d). Any other counsel of record will
`be served by electronic mail, facsimile and/or overnight delivery.
`I declare under penalty of perjury under the laws of the United States of
`America that the above is true and correct. Executed this 4th day of March 2022 at
`San Diego, California.
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`By: /s/ Arlene Apodaca
`ARLENE APODACA
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`CERTIFICATE OF SERVICE
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