throbber
Case 1:21-cv-01445-JPM Document 19 Filed 02/09/22 Page 1 of 23 PageID #: 954
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GLOBUS MEDICAL, INC.,
`
`
`Plaintiff,
`
`
`
`v.
`
`LIFE SPINE, INC.,
`
`
`Defendant.
`
`
`
`
`C.A. No. 21-1445 (JPM)
`
`JURY TRIAL DEMANDED
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`DEFENDANT LIFE SPINE, INC.’S OPENING BRIEF IN SUPPORT
`OF ITS RENEWED MOTION TO DISMISS THE AMENDED COMPLAINT
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`Jack B. Blumenfeld (#1014)
`Jennifer Ying (#5550)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`jying@morrisnichols.com
`
`Attorneys for Defendant
`
`
`
`
`OF COUNSEL:
`
`Brianne M. Straka
`Dave A. Nelson
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`191 North Wacker Drive, Suite 2700
`Chicago, IL 60606
`(312) 705-7400
`
`February 9, 2022
`
`
`
`
`
`
`
`

`

`Case 1:21-cv-01445-JPM Document 19 Filed 02/09/22 Page 2 of 23 PageID #: 955
`
`TABLE OF CONTENTS
`
`Page
`

`I. 
`II. 
`III. 
`IV. 
`
`V. 
`
`VI. 
`
`
`
`
`
`
`NATURE AND STAGE OF PROCEEDINGS ...................................................................1 
`SUMMARY OF ARGUMENT ...........................................................................................1 
`STATEMENT OF FACTS ..................................................................................................2 
`LEGAL STANDARD ..........................................................................................................3 
`A. 
`Motions to Dismiss Under Rule 12(b)(6) ................................................................3 
`B. 
`Induced Infringement ...............................................................................................4 
`C. 
`Enhanced Damages Under Section 284 ...................................................................5 
`ARGUMENT .......................................................................................................................5 
`A. 
`Plaintiff Fails to Adequately Plead Knowledge of the Asserted Patents .................6 
`1. 
`Notice Under 35 U.S.C. § 287(a) .................................................................7 
`2. 
`Citation to Related Patent Applications .......................................................8 
`3. 
`510(k) Submission to the FDA ..................................................................10 
`4. 
`Patents in the Spinal Fusion Space ............................................................11 
`5. 
`Willful Blindness .......................................................................................12 
`Plaintiff Fails to Adequately Plead Pre-Suit Specific Intent to Induce
`Infringement ...........................................................................................................13 
`Plaintiff Fails to Plead That Life Spine Knew (Or Should Have Known)
`That Its Pre-Suit Conduct Amounted to Infringement of the Asserted
`Patents ....................................................................................................................16 
`CONCLUSION ..................................................................................................................17 
`
`B. 
`
`C. 
`
`
`
`
`
`i
`
`

`

`Case 1:21-cv-01445-JPM Document 19 Filed 02/09/22 Page 3 of 23 PageID #: 956
`
`TABLE OF AUTHORITIES
`
`Cases ..................................................................................................................................... Page(s)
`
`Aperture Net LLC v. Cambium Networks, Inc.,
`2022 U.S. Dist. LEXIS 17841 (D. Del. Feb 1, 2022) ..............................................................13
`
`Ashcroft v. Iqbal,
`556 U.S. 662 (2009) .....................................................................................................3, 4, 6, 12
`
`Bayer HealthCare LLC v. Baxalta Inc.,
`989 F.3d 964 (Fed. Cir. 2021)..................................................................................................17
`
`Bell Atlantic Corp. v. Twombly,
`550 U.S. 544 (2007) .........................................................................................................3, 4, 12
`
`Boston Sci. Corp. v. Nevro Corp.,
`415 F. Supp. 3d 482 (D. Del. Nov. 25, 2019) ..........................................................6, 13, 14, 16
`
`Commil USA, LLC v. Cisco Sys., Inc.,
`135 S. Ct. 1920 (2015) ...........................................................................................................4, 5
`
`Deckers Outdoor Corp. v. J.C. Penney Co.,
`45 F. Supp. 3d 1181 (C.D. Cal. 2014) .......................................................................................8
`
`Deere & Co. v. AGCO Corp.,
`2019 WL 668492 (D. Del. Feb. 19, 2019) .................................................................................5
`
`Dodots Licensing Sols. LLC v. Lenovo Holding Co.,
`2018 WL 6629709 (D. Del. Dec. 19, 2018) .................................................................14, 15, 16
`
`Dynamic Data Techs., LLC v. Amlogic Holdings Ltd.,
`2020 WL 4365809 (D. Del. July 30, 2020) .............................................................4, 13, 16, 17
`
`Finjan, Inc. v. Cisco Sys. Inc.,
`2017 WL 2462423 (N.D. Cal. June 7, 2017) .............................................................................8
`
`Fujitsu Ltd. v. Netgear Inc.,
`620 F.3d 1321 (Fed. Cir. 2010)................................................................................................15
`
`Global-Tech Appliances, Inc. v. SEB S.A.,
`131 S.Ct. 2060 (2011) ................................................................................................................4
`
`Halo Elecs., Inc. v. Pulse Elecs., Inc.,
`136 S. Ct. 1923 (2016) ...............................................................................................................5
`
`Helios Streaming, Llc, & Ideahub v. Vudu, Inc.,
`2021 WL 254069 (D. Del. Jan. 26, 2021) (adopted by 2021 WL 1138024 (D.
`Del. March 25, 2021)) ................................................................................................................8
`
`
`
`ii
`
`

`

`Case 1:21-cv-01445-JPM Document 19 Filed 02/09/22 Page 4 of 23 PageID #: 957
`
`Helios Streaming, LLC v. Vudu, Inc.,
`2020 WL 2332045 (D. Del. May 11, 2020) (adopted by 2020 WL 3167641
`(D. Del. June 15, 2020)).......................................................................................................9, 12
`
`Lifetime Indus., Inc. v. Trim-Lok, Inc.,
`869 F.3d 1372 (Fed. Cir. 2017)..................................................................................................4
`
`Lippert Components Mfg., Inc. v. MOR/ryde, Inc.,
`2018 WL 345767 (N.D. Ind. Jan. 10, 2018) ....................................................................7, 8, 11
`
`Malvern Panalytical Ltd. v. Instruments-Waters LLC,
`2021 WL 3856145 (D. Del. Aug. 27, 2021) ........................................................................6, 16
`
`MONEC Holding AG v. Motorola Mobility Inc.,
`897 F. Supp. 2d 225 (D. Del. Aug. 3, 2012) .................................................................... passim
`
`NexStep, Inc. v. Comcast Cable Comm’ns., LLC,
`2019 WL 5626647 (D. Del. Oct. 31, 2019) (adopted by 2019 WL 11663798
`(D. Del. Nov. 15, 2019)) ............................................................................................................9
`
`Rehrig Pac. Co. v. Polymer Logistics (Isr.), Ltd.,
`2019 WL 8161141 (C.D. Cal. Aug. 30, 2019) .................................................................7, 8, 10
`
`Robocast, Inc. v. Microsoft Corp.,
`21 F. Supp. 3d 320 (D. Del. 2014) .............................................................................................9
`
`Spherix Inc. v. Juniper Networks, Inc.,
`2015 U.S. Dist. LEXIS 41057 (D. Del. March 31, 2015) ........................................................10
`
`State Indus., Inc. v. A.O. Smith Corp.,
`751 F.2d 1226 (Fed. Cir. 1985)..................................................................................................9
`
`Välinge Innovation AB v. Halstead New England Corp.,
`2018 WL 2411218 (D. Del. May 29, 2018) (adopted by 2018 WL 11013901
`(D. Del. Nov. 6, 2018)) ....................................................................................................4, 5, 16
`
`VLSI Tech., LLC v. Intel Corp.,
`2019 WL 1349468 (D. Del. Mar. 26, 2019) ..............................................................5, 6, 12, 17
`
`Zapfraud, Inc. v. Barracuda Networks,
`2021 U.S. Dist. LEXIS 55658 (D. Del. March 24, 2021) ......................................................4, 6
`
`Statutes
`
`35 U.S.C. § 271(b) .....................................................................................................................4, 15
`
`35 U.S.C. § 284 ........................................................................................................................1, 5, 6
`
`35 U.S.C. § 287(a) ...........................................................................................................................7
`
`
`
`iii
`
`

`

`Case 1:21-cv-01445-JPM Document 19 Filed 02/09/22 Page 5 of 23 PageID #: 958
`
`Rules
`
`Fed. R. Civ. P. 8 .............................................................................................................................12
`
`Fed. R. Civ. P. 12(b)(6)................................................................................................................1, 3
`
`
`
`
`
`iv
`
`

`

`Case 1:21-cv-01445-JPM Document 19 Filed 02/09/22 Page 6 of 23 PageID #: 959
`
`I.
`
`NATURE AND STAGE OF PROCEEDINGS
`
`On October 13, 2021, Plaintiff Globus Medical, Inc. (“Plaintiff” or “Globus”) filed a patent
`
`infringement Complaint against Defendant Life Spine, Inc. (“Defendant” or “Life Spine”) alleging
`
`direct and indirect infringement of seven patents.1 D.I. 1. Life Spine moved to dismiss Plaintiff’s
`
`claims for induced infringement and willful infringement of the Asserted Patents for failure to state
`
`a claim upon which relief may be granted. D.I. 9. On December 16, the Court ordered that
`
`“[s]hould plaintiff elect to amend the complaint,” Life Spine must respond by February 9, 2022.
`
`D.I. 14. On January 10, 2022, Plaintiff filed an Amended Complaint, asserting the same seven
`
`patents and revising its allegations supporting its claims for willful infringement and induced
`
`infringement. D.I. 15. On January 24, 2022, the Court issued an order denying as moot Life
`
`Spine’s Motion to Dismiss and noting that “Life Spine may renew its Motion to Dismiss to address
`
`the new grounds raised in Plaintiff’s Amended Complaint.” D.I. 16.
`
`Pursuant to Fed. R. Civ. P. 12(b)(6) and the Court’s December 16 and January 24 Orders,
`
`Life Spine hereby renews its motion to dismiss Plaintiff’s claims for: (1) induced infringement of
`
`the Asserted Patents and (2) enhanced damages for willful infringement of the Asserted Patents
`
`pursuant to 35 U.S.C. § 284, for failure to state a claim upon which relief may be granted. This is
`
`Life Spine’s opening brief in support of its motion.
`
`II.
`
`SUMMARY OF ARGUMENT
`
`Although Plaintiff’s Amended Complaint purports to add allegations in support of its
`
`claims, those allegations do not move the needle: Plaintiff still fails to satisfy the standards for
`
`
`1 Plaintiff alleges that Defendant infringes U.S. Patent Nos. 8,845,731 (the “’731 Patent”),
`8,845,732 (the “’732 Patent”), 9,402,739 (the “’739 Patent”), 9,956,087 (the “’087 Patent”),
`10,137,001 (the “’001 Patent”), 10,925,752 (the “’752 Patent”), and 10,973,649 (the “’649
`Patent”) (collectively, the “Asserted Patents”).
`
`
`
`1
`
`

`

`Case 1:21-cv-01445-JPM Document 19 Filed 02/09/22 Page 7 of 23 PageID #: 960
`
`pleading induced infringement and willfulness-based enhanced damages. With respect to both
`
`claims, Plaintiff alleges that Life Spine had the requisite knowledge of the Asserted Patents by
`
`way of constructive notice of its patents, knowledge of patent applications related to two of the
`
`Asserted Patents, knowledge of Plaintiff’s products, and a general awareness of patents in the
`
`spinal fusion space. Alternatively, Plaintiff alleges that Life Spine was willfully blind to the
`
`Asserted Patents. None of these allegations support a plausible inference that Life Spine had actual
`
`pre-suit knowledge of the Asserted Patents, as required by the law for both induced and willful
`
`infringement.
`
`Plaintiff’s induced infringement claims fail for the additional reason that the Amended
`
`Complaint alleges nothing more than “Life Spine’s encouragement of surgeons to use the Accused
`
`Products and Accused Methods.” D.I. 15 at ¶¶ 63-80. Plaintiff does not even recite the relevant
`
`legal standard, let alone allege facts to support any inference that Life Spine “encourages” these
`
`surgeons with the specific intent to induce infringement of the Asserted Patents and with the
`
`knowledge that the surgeons’ conduct constituted infringement. Similarly, Plaintiff’s claims for
`
`willfulness-based enhanced damages fail for the additional reason that Plaintiff alleges no facts to
`
`support an inference that Life Spine knew or should have known that its conduct amounted to
`
`infringement of the Asserted Patents. Such threadbare allegations cannot plausibly support a
`
`conclusion that Life Spine induces infringement of the Asserted Patents or that Life Spine’s
`
`conduct constitutes willful infringement of the Asserted Patents.
`
`III.
`
`STATEMENT OF FACTS
`
`Plaintiff’s Amended Complaint alleges that Life Spine infringes the ’731 Patent, ’732
`
`Patent, ’739 Patent, ’087 Patent, ’752 Patent, and ’649 Patent by making, using, offering to sell,
`
`selling, and/or importing the PROLIFT, PROLIFT Lateral, PROLIFT Lateral Fixated, and
`
`
`
`2
`
`

`

`Case 1:21-cv-01445-JPM Document 19 Filed 02/09/22 Page 8 of 23 PageID #: 961
`
`PROLIFT Lateral Helo implants (collectively referred to in the Amended Complaint as the
`
`“Accused Products”), directly and/or indirectly, on its own and/or through its agents. D.I. 15 at ¶¶
`
`35, 82, 92, 103, 114, 135, 145. The Amended Complaint alleges that Life Spine indirectly
`
`infringes the ’001 Patent because it induces surgeons to use the “Accused Methods” (defined in
`
`the Amended Complaint as the installation of “[e]xpandable implants like the Accused Products”
`
`by “surgical methods . . . that involve the creation of an access path to the intervertebral space, the
`
`insertion of the implant, the expansion of the implant, and the introduction of bone graft material”).
`
`Id. at ¶¶ 42, 125. The Amended Complaint further alleges that Life Spine’s infringement of all of
`
`the Asserted Patents has been willful. Id. at ¶¶ 88, 99, 110, 121, 130, 141, 151.
`
`Both the ’731 Patent and the ’732 Patent issued on September 30, 2014, the ’739 Patent
`
`issued on August 2, 2016, the ’087 Patent issued on May 1, 2018, the ’001 Patent issued on
`
`November 27, 2018, the ’752 Patent issued on February 23, 2021, and the ’649 Patent issued on
`
`April 13, 2021. Id. at ¶¶ 21-27.
`
`IV.
`
`LEGAL STANDARD
`
`A. Motions to Dismiss Under Rule 12(b)(6)
`
`A complaint will survive a motion to dismiss under Federal Rule of Civil Procedure
`
`12(b)(6) if it “contain[s] sufficient factual matter . . . to ‘state a claim to relief that is plausible on
`
`its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atlantic Corp. v. Twombly,
`
`550 U.S. 544, 570 (2007)). Although the Court is to accept the allegations in the complaint as true
`
`and construe them in the light most favorable to Plaintiff, “the tenet that a court must accept as
`
`true all of the allegations contained in a complaint is inapplicable to legal conclusions [because]
`
`[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements,
`
`do not suffice.” Iqbal, 556 U.S. at 678. The Court may therefore begin “by identifying pleadings
`
`
`
`3
`
`

`

`Case 1:21-cv-01445-JPM Document 19 Filed 02/09/22 Page 9 of 23 PageID #: 962
`
`that, because they are no more than conclusions, are not entitled to the assumption of truth.” Id.
`
`at 679. The Court then determines whether the factual allegations in the complaint “plausibly give
`
`rise to an entitlement to relief.” Id. This requires “more than labels and conclusions, and a
`
`formulaic recitation of the elements of a cause of action will not do.” Välinge Innovation AB v.
`
`Halstead New England Corp., 2018 WL 2411218, at *2 (D. Del. May 29, 2018) (adopted by 2018
`
`WL 11013901 (D. Del. Nov. 6, 2018)). If the plaintiff does not “nudge [its] claims across the line
`
`from conceivable to plausible, [its] complaint must be dismissed.” Twombly, 550 U.S. at 570.
`
`B.
`
`Induced Infringement
`
`35 U.S.C. § 271(b) provides that “[w]hoever actively induces infringement of a patent shall
`
`be liable as an infringer.” The Supreme Court has explained that induced infringement liability
`
`“can only attach if the defendant knew of the patent and knew as well that ‘the induced acts
`
`constitute patent infringement.’” Commil USA, LLC v. Cisco Sys., Inc., 135 S. Ct. 1920, 1926-28
`
`(2015) (quoting Global-Tech Appliances, Inc. v. SEB S.A., 131 S.Ct. 2060, 2068 (2011)).
`
`To plead a claim for induced infringement, a plaintiff must plausibly allege facts sufficient
`
`to demonstrate that the defendant’s conduct occurred after the defendant (1) knew of the existence
`
`of the asserted patent and (2) knew that a third party’s acts constituted infringement of the patent.
`
`See 35 U.S.C. § 271(b); Dynamic Data Techs., LLC v. Amlogic Holdings Ltd., 2020 WL 4365809
`
`at *2 (D. Del. July 30, 2020) (quoting Lifetime Indus., Inc. v. Trim-Lok, Inc., 869 F.3d 1372, 1379
`
`(Fed. Cir. 2017)) (“For an allegation of induced infringement to survive a motion to dismiss, a
`
`complaint must plead facts plausibly showing that the accused infringer specifically intended
`
`another party to infringe the patent and knew that the other party’s acts constituted infringement.”);
`
`Zapfraud, Inc. v. Barracuda Networks, 2021 U.S. Dist. LEXIS 55658, at *3, (D. Del. March 24,
`
`2021) (citing Commil, 135 S. Ct. at 1926; Global-Tech, 131 S.Ct. at 2068).
`
`
`
`4
`
`

`

`Case 1:21-cv-01445-JPM Document 19 Filed 02/09/22 Page 10 of 23 PageID #: 963
`
`C.
`
`Enhanced Damages Under Section 284
`
`Section 284 of the Patent Act “gives district courts the discretion to award enhanced
`
`damages against those guilty of patent infringement.” Halo Elecs., Inc. v. Pulse Elecs., Inc., 136
`
`S. Ct. 1923, 1935 (2016). Although there is no “rigid formula” for determining if enhanced
`
`damages are warranted (id. at 1927), “in the vast majority of patent cases filed today, claims for
`
`enhanced damages are sought based on allegations of willful misconduct—so much so that, even
`
`though the words ‘willful’ and ‘willfulness’ do not appear in § 284, plaintiffs and courts more
`
`often than not describe claims for enhanced damages brought under § 284 as ‘willful infringement
`
`claims[.]’” Deere & Co. v. AGCO Corp., 2019 WL 668492, at *3 (D. Del. Feb. 19, 2019).
`
`“[I]n order to sufficiently plead willful infringement, a plaintiff must allege facts plausibly
`
`showing that as of the time of the alleged infringement, the accused infringer: (1) knew of the
`
`patent-in-suit; (2) after acquiring that knowledge, it infringed the patent; and (3) in doing so, it
`
`knew, or should have known, that its conduct amounted to infringement of the patent.” Välinge,
`
`2018 WL 2411218 at *13; see VLSI Tech., LLC v. Intel Corp., 2019 WL 1349468, at *1 (D. Del.
`
`Mar. 26, 2019).
`
`V.
`
`ARGUMENT
`
`The Amended Complaint’s allegations of both induced infringement and willfulness-based
`
`enhanced damages are insufficient as a matter of law. As to both claims, Plaintiff has not alleged
`
`facts plausibly showing that Life Spine had the requisite actual knowledge of the Asserted Patents
`
`at the time of the alleged infringement. See Commil, 135 S. Ct. at 1926-28; Välinge, 2018 WL
`
`2411218 at *13. As to induced infringement only (and not willful infringement), Plaintiff
`
`alternatively asserts that Life Spine was “willfully blind” to the disclosures of the Asserted Patents
`
`and their infringement by third parties. However, Plaintiff also fails to allege facts plausibly
`
`
`
`5
`
`

`

`Case 1:21-cv-01445-JPM Document 19 Filed 02/09/22 Page 11 of 23 PageID #: 964
`
`showing Life Spine’s willful blindness. Malvern Panalytical Ltd. v. Instruments-Waters LLC,
`
`2021 WL 3856145, at *4 (D. Del. Aug. 27, 2021); VLSI, 2019 WL 1349468 at *2; MONEC
`
`Holding AG v. Motorola Mobility Inc., 897 F. Supp. 2d 225, 234 (D. Del. Aug. 3, 2012). Plaintiff’s
`
`failure to sufficiently plead knowledge of the Asserted Patents alone dooms its induced and willful
`
`infringement claims. Moreover, as to induced infringement, Plaintiff also fails to allege facts
`
`plausibly showing that Life Spine had the specific intent to induce infringement. As to willful
`
`infringement, Plaintiff fails to allege facts plausibly showing that Life Spine knew or should have
`
`known that its conduct amounted to infringement of the Asserted Patents.
`
`A.
`
`Plaintiff Fails to Adequately Plead Knowledge of the Asserted Patents
`
`Plaintiff’s allegations with respect to Life Spine’s pre-suit knowledge of the Asserted
`
`Patents fail to “plausibly give rise to an entitlement to relief.” Iqbal, 556 U.S. at 678. Thus,
`
`Plaintiff’s claims for both induced infringement and willful infringement of all Asserted Patents
`
`based on Life Spine’s pre-suit conduct should be dismissed. Boston Sci. Corp. v. Nevro Corp.,
`
`415 F. Supp. 3d 482, 494 (D. Del. Nov. 25, 2019) (Willful infringement “should not require a
`
`lesser showing of culpability for enhanced damages under § 284 than for induced infringement
`
`under§ 271(b).”).
`
`Further, courts in this district have previously held that “the complaint itself cannot be the
`
`source of the knowledge required to sustain claims of induced infringement and willfulness-based
`
`enhanced damages.” Zapfraud, 2021 U.S. Dist. LEXIS 55658 at *4. Thus, Plaintiff’s induced
`
`infringement claims and enhanced damages claims for willful infringement should be dismissed
`
`for all Asserted Patents as to post-suit conduct as well. See id. at *8.
`
`It is unclear which of Plaintiff’s kitchen sink allegations it intends to apply to which
`
`Asserted Patent. Life Spine therefore addresses each of its allegations to the extent they
`
`specifically apply to each Asserted Patent.
`
`
`
`6
`
`

`

`Case 1:21-cv-01445-JPM Document 19 Filed 02/09/22 Page 12 of 23 PageID #: 965
`
`1.
`
`Notice Under 35 U.S.C. § 287(a)
`
`Plaintiff alleges that Life Spine was “on notice” of the Asserted Patents since “Globus
`
`manufactured and sold” either its RISE®, RISE-L®, or ELSA® products “marked in accordance
`
`with” 35 U.S.C. § 287(a).2 See D.I. 15 at ¶¶ 86, 97, 108, 119, 128, 139, 149. Plaintiff also asserts
`
`that Life Spine’s alleged infringement was willful because it “had notice of” the Asserted Patents.
`
`D.I. 15 at ¶¶ 88, 99, 110, 121, 130, 141, 151. However, constructive “notice” by marking does not
`
`establish that Life Spine had actual knowledge of any of the Asserted Patents, as required for both
`
`induced and willful infringement.3 See Lippert Components Mfg., Inc. v. MOR/ryde, Inc., 2018
`
`WL 345767, at *2 (N.D. Ind. Jan. 10, 2018) (“[W]hile marking may satisfy the notice requirement
`
`for damages, alleging marking doesn’t allow the court to infer a defendant’s knowledge of the
`
`patent-in-suit.”).
`
`In Rehrig Pac. Co. v. Polymer Logistics (Isr.), Ltd., the court rejected plaintiff’s argument
`
`that defendants were aware of the asserted patents when plaintiff marked its product with one of
`
`the patents. 2019 WL 8161141, at *4 (C.D. Cal. Aug. 30, 2019). The court noted that plaintiff
`
`did “not explain whether Defendants had access to its products [or] whether it was marked at the
`
`time Defendants had such access . . . .” Id. Here, Plaintiff also does not allege when Life Spine’s
`
`access to the RISE®, RISE-L®, or ELSA® product, if any, occurred, nor does Plaintiff allege
`
`
`2 Specifically, Globus alleges that Life Spine was “on notice” of: the ’731 Patent and the ’732
`Patent “since at least November 2015, when Globus manufactured and sold the RISE® implant
`marked in accordance with that provision;” the ’739 Patent “since at least December 2018, when
`Globus manufactured and sold the RISE-L® implant;” the ’087 Patent “since at least November
`2018, when Globus manufactured and sold the ELSA® implant marked in accordance with that
`provision;” the ’001 Patent “since at least November 2018, when Globus manufactured and sold
`the RISE® implant marked in accordance with that provision;” and the ’752 Patent and the ’649
`Patent “since at least July 2021, when Globus manufactured and sold the RISE® implant marked
`in accordance with that provision.” D.I. 15 at ¶¶ 86, 97, 108, 119, 128, 139, 149.
`3 Plaintiff does not allege that Life Spine ever had access to a marked RISE®, RISE-L®, or
`ELSA® implant.
`
`
`
`7
`
`

`

`Case 1:21-cv-01445-JPM Document 19 Filed 02/09/22 Page 13 of 23 PageID #: 966
`
`whether the product was marked at the time of any alleged access. Thus, Plaintiff has not pleaded
`
`facts sufficient to plausibly allege that Life Spine had actual knowledge of any of the Asserted
`
`Patents prior to the filing of the Complaint. See id.; see also Helios Streaming, Llc, & Ideahub v.
`
`Vudu, Inc., 2021 WL 254069, at *2 (D. Del. Jan. 26, 2021) (adopted by 2021 WL 1138024 (D.
`
`Del. March 25, 2021)) (“Actual knowledge or willful blindness may satisfy the knowledge
`
`requirement.”) (citation omitted); Deckers Outdoor Corp. v. J.C. Penney Co., 45 F. Supp. 3d 1181,
`
`1188 (C.D. Cal. 2014) (“Actual knowledge—not constructive knowledge—is the criterion.”);
`
`MONEC, 897 F. Supp. 2d at 236 (failure to sufficiently plead actual knowledge of the asserted
`
`patents was fatal to both induced infringement and willful infringement claims).
`
`2.
`
`Citation to Related Patent Applications
`
`Plaintiff also alleges that Life Spine was aware of the Asserted Patents because Life Spine,
`
`during prosecution of some of Life Spine’s own patents, cited to a handful of Globus’s patents or
`
`published patent applications that ultimately lead to issued patents in “Globus’s patent portfolio.”
`
`D.I. 15 at ¶¶ 53-60. See Finjan, Inc. v. Cisco Sys. Inc., 2017 WL 2462423, at *5 (N.D. Cal. June
`
`7, 2017) (“[T]he FAC never ties this general knowledge of [plaintiff’s] patent portfolio to the
`
`Asserted Patents, nor makes any factual allegations that [defendant] specifically learned of the
`
`Asserted Patents. Knowledge of a patent portfolio generally is not the same thing as knowledge
`
`of a specific patent.”). To be clear, throughout its multiple pages of alleged facts, Plaintiff does
`
`not point to a single instance when Life Spine cited to any of the Asserted Patents as issued. And
`
`the vast majority of published patent applications and issued patents that Plaintiff mentions are not
`
`asserted in this case. These bare bones allegations are insufficient to establish knowledge of the
`
`Asserted Patents for two primary reasons.
`
`First, Plaintiff’s allegations are insufficient as a matter of law to establish that Life Spine
`
`had knowledge of any of the Asserted Patents. It is well settled in this District that knowledge of
`
`
`
`8
`
`

`

`Case 1:21-cv-01445-JPM Document 19 Filed 02/09/22 Page 14 of 23 PageID #: 967
`
`a patent application does not establish knowledge of a patent that later issues from that application.
`
`See, e.g., Helios Streaming, LLC v. Vudu, Inc., 2020 WL 2332045, at *3 (D. Del. May 11, 2020)
`
`(adopted by 2020 WL 3167641 (D. Del. June 15, 2020)) (“A patent application does not provide
`
`notice of the resulting patent for indirect . . . infringement.”) (citation omitted); see also State
`
`Indus., Inc. v. A.O. Smith Corp., 751 F.2d 1226, 1236 (Fed. Cir. 1985) (“To willfully infringe a
`
`patent, the patent must exist and one must have knowledge of it. … Filing an application is no
`
`guarantee any patent will issue ... [and] the scope of claims in patents that do issue ... is something
`
`totally unforeseeable.”). Thus, regardless of whether Life Spine was actually aware of the
`
`application that ultimately led to any of the Asserted Patents (which Plaintiff does not plausibly
`
`allege), such knowledge is insufficient to establish knowledge of the patent itself.
`
`Second, Plaintiff’s allegations are factually insufficient to infer Life Spine had actual
`
`knowledge of any of the Asserted Patents. Plaintiff alleges no facts to infer that Life Spine learned
`
`that any of the referenced patent applications ever led to issued patents that are asserted in this
`
`case. See NexStep, Inc. v. Comcast Cable Comm’ns., LLC, 2019 WL 5626647, at *3 (D. Del. Oct.
`
`31, 2019) (adopted by 2019 WL 11663798 (D. Del. Nov. 15, 2019) (“To willfully infringe a patent,
`
`the patent must exist and one must have knowledge of it. . . . . Filing an application is no guarantee
`
`any patent will issue and a very substantial percentage of applications never result in patents.”)
`
`(citation omitted).
`
`While Plaintiff alleges that Life Spine cited patent applications that ultimately led to the
`
`’732 and ’739 patents asserted in this case (see D.I. 15 at ¶¶ 54, 60), Plaintiff alleges no facts to
`
`show that Life Spine had any awareness that any of those applications were connected to the as
`
`issued ’732 or ’739 Patents. Knowledge of an application does not equate to knowledge of a
`
`patent. See Robocast, Inc. v. Microsoft Corp., 21 F. Supp. 3d 320, 335 (D. Del. 2014) (“There
`
`
`
`9
`
`

`

`Case 1:21-cv-01445-JPM Document 19 Filed 02/09/22 Page 15 of 23 PageID #: 968
`
`appears to be no controlling case law for the proposition that [defendant] was obligated to have
`
`undertaken an affirmative investigation to determine if [plaintiff’s] application had matured into a
`
`patent. . . . It seems contrary [to existing case law] to . . . require a defendant to undertake a search
`
`to see if a patent existed in the first place.”). Furthermore, courts in this District have found that
`
`“[t]he fact that the [asserted] patent was referenced during prosecution of two of defendant’s over
`
`1,700 patents is not compelling evidence of knowledge.” Spherix Inc. v. Juniper Networks, Inc.,
`
`2015 U.S. Dist. LEXIS 41057, *6 (D. Del. March 31, 2015). Life Spine’s citations to a handful
`
`of patent applications among hundreds of references submitted to the USPTO during prosecution
`
`of multiple patents simply does not support the conclusion that Life Spine had knowledge of any
`
`patents that might have issued from those applications.
`
`Therefore, Plaintiff has not sufficiently plead actual knowledge of any of the Asserted
`
`Patents.
`
`3.
`
`510(k) Submission to the FDA
`
`Next, Plaintiff alleges that “[a]t various times, Life Spine has cited the Globus CALIBER®,
`
`RISE®, and ELSA® products as substantially equivalent predecessor devices in its 510(k)
`
`submissions to FDA.” D.I. 15 at ¶ 49. Plaintiff does not specifically allege any facts regarding
`
`Life Spine’s actual knowledge of the individual Asserted Patents, but to the extent Plaintiff intends
`
`this argument to apply to any of the Asserted Patents, Plaintiff fails to adequately plead actual
`
`knowledge. Plaintiff fails to explain how knowledge of Globus’s products allegedly resulted in
`
`Life Spine’s knowledge of the Asserted Patents.4 See Rehrig, 2019 WL 8161141, at *4 (allegations
`
`
`4 Similarly, Plaintiff’s assertion that “Globus and Life Spine’s product booths were immediately
`adjacent to each other, for instance, at the most recent NASS annual meeting” and that “Globus
`regularly includes its expandable implant products, such as RISE® and ELSA®, in its
`presentations at these types of events” says nothing about Life Spine’s knowledge of any of the
`Asserted Patents.
`
`
`
`10
`
`

`

`Case 1:21-cv-01445-JPM Document 19 Filed 02/09/22 Page 16 of 23 PageID #: 969
`
`that defendant copied plaintiff’s product did not establish knowledge of the asserted patents). And
`
`as explained in section V.A.1, Plaintiff does not plead facts showing Life Spine ever had access to
`
`a marked RISE®, RISE-L®, or ELSA® product, and in any event, allegations regarding
`
`constructive “notice” by marking do not establish that Life Spine had actual knowledge of the
`
`Asserted Patents. Furthermore, the testimony cited by Plaintiff regarding Life Spine’s general
`
`review of patents in no way indicates that Life Spine was aware of any of the Asserted Patents
`
`specifically. D.I. 15 at ¶ 49; see Lippert, 2018 WL 345767, at *2 (allegations that defendant
`
`“activ

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