Case 1:21-cv-01445-JPM Document 15 Filed 01/10/22 Page 1 of 38 PageID #: 499
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`GLOBUS MEDICAL, INC.,
`
`
`Plaintiff,
`
`Civil Action No. 21-1445 (JPM)
`
`JURY TRIAL DEMANDED
`
`
`
`
`
`
`
`v.
`
`
`LIFE SPINE, INC.,
`
`
`Defendant.
`AMENDED COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Globus Medical, Inc. (“Globus”) respectfully brings this Amended Complaint
`
`for Patent Infringement against Defendant Life Spine, Inc. (“Life Spine”) and alleges as follows:
`
`NATURE OF THE CASE
`
`1.
`
`Globus brings this action for patent infringement under the patent laws of the
`
`United States, 35 U.S.C. § 271 et seq.
`
`PARTIES
`
`2.
`
`Globus is a corporation organized under the laws of the State of Delaware with its
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`principal place of business located at 2560 General Armistead Avenue, Audubon, Pennsylvania
`
`19403.
`
`3.
`
`Life Spine is a corporation organized under the laws of the State of Delaware with
`
`its principal place of business located at 13951 S Quality Drive, Huntley, Illinois 60142.
`
`JURISDICTION AND VENUE
`
`4.
`
`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and
`
`1338(a).
`
`5.
`
`This Court has personal jurisdiction over Life Spine because it is a Delaware
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`corporation and maintains a registered agent in this judicial district.
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`1
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`

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`6.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391(b)(2) and 1400(b) because
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`Life Spine is subject to this Court’s personal jurisdiction and therefore resides in this judicial
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`district pursuant to 28 U.S.C. § 1391(c).
`
`FACTUAL ALLEGATIONS
`
`A.
`
`Technology Background
`
`7.
`
`Globus is one of the world’s leading musculoskeletal implant manufacturers,
`
`developing and selling a wide array of spinal products and prostheses. Founded in 2003,
`
`Globus’s focus on advancing spinal surgery has made it one of the fastest growing companies in
`
`the history of orthopedics. Globus uses superior engineering and technology to achieve pain free,
`
`active lives for all patients with musculoskeletal disorders. Since its inception, Globus has been a
`
`leading innovator and received more than 150 patents in the expandable space.
`
`8.
`
`Globus manufactures and sells expandable spinal implants used in spinal fusion
`
`procedures. A spinal fusion procedure is a type of surgery used to treat painful spine conditions,
`
`such as degenerative disc disease, arising from weakening of the intervertebral discs that cushion
`
`the vertebrae. The goal of a fusion procedure is to restore the distance between the adjacent
`
`vertebrae in the spine segment using an interbody spacer. Once the spacer is in place between the
`
`adjacent vertebrae, bone will grow into and through the area between the adjacent vertebrae
`
`causing a “fusion” of the two adjacent bones into a single bone. The spacer remains in the body
`
`to maintain the distance between the adjacent vertebrae as bone grows and fusion occurs. With
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`fusion of the adjacent vertebrae into a single bone, the spine segment is immobilized, eliminating
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`the cause of the patient’s pain.
`
`2
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`

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`9.
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`Spacers have been around for decades. Initially, physicians harvested bone from a
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`patient’s hip to use as a spacer. Later, synthetic spacers and “intervertebral cages” became more
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`commonplace.
`
`10.
`
`In January 2011, Globus launched CALIBER®, its first expandable intervertebral
`
`implant. Unlike “static” spacers, which are pre-sized at a fixed height and “hammered” into the
`
`intervertebral space, the CALIBER® implant enters the intervertebral space in a contracted
`
`configuration and is expanded only after placement. This approach is less traumatic for the
`
`adjacent vertebrae.
`
`11.
`
`Globus subsequently released the CALIBER®-L product. Unlike the CALIBER®
`
`implant, which is designed for a transforaminal approach (i.e., from the back of the spine), the
`
`CALIBER®-L expandable implant is designed for a lateral approach (i.e., from the side of the
`
`spine).
`
`12.
`
`Globus continued to innovate and released a number of expandable implant
`
`products including the RISE® and ELSA® families of expandable implant products. The RISE®
`
`IntraLIF® products, for instance, were designed to be delivered laparoscopically via minimally
`
`invasive surgical techniques yet still have a sufficiently wide range of expansion. The ELSA®
`
`products include integrated fixation that allow the implant to be attached to the vertebrae with
`
`screws.
`
`Figure 1: RISE® implant
`
`
`
`3
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`Figure 2: ELSA® implant
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`
`
`13.
`
`Globus has been widely recognized as a leading innovator in the spine industry.
`
`Spinemarket Inc. (“Spinemarket”), a prominent and well-known source of industry news and
`
`analysis, has consistently ranked Globus’s patent portfolio number one in its annual Spine
`
`Market Patent Power Index. In its last report titled “2018 Patent Analysis and Power Index,”
`
`Spinemarket noted that “Globus was superior in every metric used to create the Power Index,
`
`total patent count, growth rate and pipeline impact. The company far outpaces all competitors in
`
`spine, and it appears will continue to dominate based on published patents pending as of August
`
`2019.” The 2018 report further noted that “[m]ore than 60% of Globus interbody patents relate to
`
`expandables.” Similar statements appear in Spinemarket’s 2016 and 2017 reports.
`
`14.
`
`One metric considered in the Spine Market Patent Power Index is “Adjusted
`
`Pipeline Impact,” which measures “the impact of an organization’s patent portfolio on
`
`subsequent technological developments” using the number of citations by later patents, with
`
`adjustments for self-citations (i.e., citations by a company to its own patents). Globus’s Adjusted
`
`Pipeline Impact rating for 2018 was the highest of any company in the spinal space, and
`
`Spinemarket wrote that “Globus dominance continues to grow with a record number of patents
`
`issued and an increase in citations from competitors.” Spinemarket further noted that “[m]ore
`
`than 90% of Globus’ citations were for patents relating to expandable interbody.”
`
`15.
`
`Life Spine’s patent portfolio was ranked 14th in Spinemarket’s 2016 Spine
`
`Market Patent Power Index, with a score of 26, and 17th in the 2018 Spine Market Patent Power
`
`4
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`

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`Case 1:21-cv-01445-JPM Document 15 Filed 01/10/22 Page 5 of 38 PageID #: 503
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`Index, with a score of 16. Life Spine was not ranked among the top 20 patent portfolios in 2017.
`
`In comparison, Globus’s scores were almost 6,500 in 2016, over 5,000 in 2017, and over 7,000
`
`in 2018; Globus’s portfolio was top-ranked all three years.
`
`16.
`
`Globus’s patent portfolio has also been consistently recognized outside the spinal
`
`space. For almost 40 years, the Intellectual Property Owners Association (“IPO”) has published a
`
`widely disseminated and well-known listing of the 300 organizations that received the most U.S.
`
`patents over the past year. This “Patent 300” list is typically headed by intellectual property
`
`giants such as IBM, Samsung, and Microsoft. Globus was recognized as one of the “Patent 300”
`
`in 2016, 2018, 2019, and 2020.
`
`17.
`
`Spine manufacturers like Life Spine recognize the significance of intellectual
`
`property in this industry. Life Spine’s CEO, Michael S. Butler, has stated, in connection with the
`
`company’s acquisition of a spine patent portfolio, that “[t]he core of the spine market place is
`
`intellectual property.” Butler has similarly cited Life Spine’s “rich IP portfolio” as “a key driver”
`
`in the company’s success. In a tight-knit industry1 where intellectual property forms the
`
`“foundation” of a company’s business,2 it is common and typical for spine manufacturers like
`
`Life Spine to monitor competitors’ patent portfolios.
`
`B.
`
`The Patents-in-Suit
`
`18.
`
`The technology claimed in this case relates to intervertebral expandable implants,
`
`and surgical systems and methods utilizing such implants.
`
`19.
`
`Globus is the assignee of U.S. Patent No. 8,845,731 (the “’731 Patent”), U.S.
`
`Patent No. 8,845,732 (the “’732 Patent”), U.S. Patent No. 9,402,739 (the “’739 Patent”), U.S.
`
`
`1 According to LinkedIn, many Life Spine employees are alumni of other spine implant
`companies, including prominent manufacturers Zimmer Biomet, NuVasive, and Stryker.
`2 Id. at 1088:12.
`
`5
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`Case 1:21-cv-01445-JPM Document 15 Filed 01/10/22 Page 6 of 38 PageID #: 504
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`Patent No. 9,956,087 (the “’087 Patent”), U.S. Patent No. 10,137,001 (the “’001 Patent”), U.S.
`
`Patent No. 10,925,752 (the “’752 Patent”), and U.S. Patent No. 10,973,649 (the “’649 Patent”)
`
`(together, the “Patents-in-Suit”). Globus owns all right, title, and interest in and to the Patents-in-
`
`Suit and possesses all rights of recovery.
`
`20.
`
`All of the Patents-in-Suit relate to technology developed in-house by Globus. One
`
`of the named inventors on the Patents-in-Suit, Mark Weiman, was recognized by Spinemarket as
`
`the top-ranked inventor in spine in its 2018 Patent Analysis and Power Index.
`
`21.
`
`The ’731 Patent was issued by the U.S. Patent and Trademark Office (“PTO”) on
`
`September 30, 2014, from application no. 12/875,637 filed on September 3, 2010. The
`
`application was published on March 8, 2012 as US 2012/0059470 A1. Under 35 U.S.C. § 154(b),
`
`the term of this patent was extended by 118 days. A true and correct copy of the ’731 Patent is
`
`attached hereto as Exhibit A. The ’731 Patent has been cited over 100 times by other patents
`
`and/or patent applications, including patents and/or patent applications from other major spine
`
`industry participants such as DePuy Synthes (“DePuy”), an affiliate of Johnson & Johnson.
`
`22.
`
`The ’732 Patent was issued by the PTO on September 30, 2014, from application
`
`no. 13/531,943 filed on June 25, 2012, which was a continuation-in-part of application no.
`
`12/875,637 filed on September 3, 2010 (which issued as the ’731 Patent). The application was
`
`published on December 27, 2012 as US 2012/0330422 A1. Under 35 U.S.C. § 154(b), the term
`
`of this patent was extended by 53 days. The patent is also subject to a terminal disclaimer. A true
`
`and correct copy of the ’732 Patent is attached hereto as Exhibit B. The ’732 Patent has been
`
`cited almost 100 times by other patents and/or patent applications, including patents and/or
`
`patent applications from other major spine industry participants such as DePuy.
`
`6
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`23.
`
`The ’739 Patent was issued by the PTO on August 2, 2016, from application no.
`
`14/175,601 filed on February 7, 2014. The application was published on August 13, 2015 as US
`
`2015/0223945 A1. Under 35 U.S.C. § 154(b), the term of this patent was extended by 51 days. A
`
`true and correct copy of the ’739 Patent is attached hereto as Exhibit C. The ’739 Patent has been
`
`cited over two dozen times by other patents and/or patent applications, including patents and/or
`
`patent applications from other major spine industry participants such as DePuy.
`
`24.
`
`The ’087 Patent was issued by the PTO on May 1, 2018, from application no.
`
`15/144,054 filed on May 2, 2016, which was a continuation-in-part of application no. 15/097,466
`
`filed on April 13, 2016 (which issued on June 5, 2018 as U.S. Patent No. 9,987,144), which was
`
`a continuation-in-part of application no. 14/802,229 filed on July 17, 2015 (which issued on July
`
`10, 2018 as U.S. Patent No. 10,016,282). The application was published on January 19, 2017 as
`
`US 2017/0014244 A1. Under 35 U.S.C. § 154(b), the term of this patent was extended by 19
`
`days. A true and correct copy of the ’087 Patent is attached hereto as Exhibit D. The ’087 Patent
`
`has been cited by ten other patents and/or patent applications, including seven that are
`
`unaffiliated with Globus.
`
`25.
`
`The ’001 Patent was issued by the PTO on November 27, 2018, from application
`
`no. 14/466,468 filed on August 22, 2014, which was a continuation of application no. 13/531,943
`
`filed on June 25, 2012 (which issued as the ’732 Patent), which was a continuation-in-part of
`
`application no. 12/875,637 filed on September 3, 2010 (which issued as the ’731 Patent). The
`
`application was published on April 9, 2015 as US 2015/0100123 A1. Under 35 U.S.C. § 154(b),
`
`the term of this patent was extended by 61 days. A true and correct copy of the ’001 Patent is
`
`attached hereto as Exhibit E. The ’001 Patent has been cited almost 100 times by other patents
`
`7
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`

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`Case 1:21-cv-01445-JPM Document 15 Filed 01/10/22 Page 8 of 38 PageID #: 506
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`and/or patent applications, including patents and/or patent applications from other major spine
`
`industry participants such as DePuy.
`
`26.
`
`The ’752 Patent was issued by the PTO on February 23, 2021, from application
`
`no. 16/127,395 filed on September 11, 2018, which was a continuation of application no.
`
`15/158,829 filed on May 19, 2016 (which issued on October 16, 2018 as U.S. Patent No.
`
`10,098,759), which was a continuation of application no. 14/109,429 filed on December 17,
`
`2013 (which issued on June 21, 2016 as U.S. Patent No. 9,370,434), which was a division of
`
`application no. 12/875,818 filed on September 3, 2010 (which issued on January 21, 2014 as
`
`U.S. Patent No. 8,632,595). The application was published on January 3, 2019 as US
`
`2019/0000640 A1. Under 35 U.S.C. § 154(b), the term of this patent was extended by 14 days. A
`
`true and correct copy of the ’752 Patent is attached hereto as Exhibit F. Even though it was
`
`issued less than a year ago, the ’752 Patent has already been cited almost 100 times by other
`
`patents and/or patent applications, including patents and/or patent applications from other major
`
`spine industry participants such as DePuy.
`
`27.
`
`The ’649 Patent was issued by the PTO on April 13, 2021, from application no.
`
`15/386,286 filed on December 21, 2016, which was a continuation of application no. 13/961,603
`
`filed on May 19, 2016 (which issued on February 7, 2017 as U.S. Patent No. 9,561,116), which
`
`was a continuation-in-part of application no. 13/531,844 filed on June 25, 2012 (which issued on
`
`October 7, 2014 as U.S. Patent No. 8,852,279), which was a continuation-in-part of application
`
`no. 12/875,637 filed on September 3, 2010 (which issued as the ’731 Patent). The application
`
`was published on April 13, 2017 as US 2017/0100257 A1. Under 35 U.S.C. § 154(b), the term of
`
`this patent was extended by 17 days. A true and correct copy of the ’649 Patent is attached hereto
`
`as Exhibit G. Even though it was issued less than a year ago, the ’649 Patent has already been
`
`8
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`

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`Case 1:21-cv-01445-JPM Document 15 Filed 01/10/22 Page 9 of 38 PageID #: 507
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`cited over three dozen times by other patents and/or patent applications, including patents and/or
`
`patent applications from other major spine industry participants such as DePuy.
`
`28.
`
`Globus currently sells products, such as those described herein, marked with all
`
`Patents-in-Suit. In accordance with 35 U.S.C. § 287(a), Globus marks its products with the word
`
`“patent”
`
`and
`
`the URL
`
`for
`
`the
`
`Patents
`
`page
`
`on Globus’s website
`
`(https://www.globusmedical.com/patents), which provides a table of Globus products and the
`
`patents that protect them. The Patents-in-Suit are listed next to various Globus expandable
`
`products, including the ELSA®, ELSA®-ATP, RISE®, RISE® IntraLIF®, and RISE®-L.
`
`Specifically, the ’731 Patent is listed next to the RISE®, RISE® IntraLIF®, and RISE®-L; the
`
`’732 Patent is listed next to the RISE® IntraLIF®; the ’739 Patent is listed next to the RISE®-L;
`
`the ’087 Patent is listed next to the ELSA® and ELSA®-ATP®; the ’001 Patent is listed next to
`
`the RISE®; the ’752 Patent is listed next to the ELSA®, ELSA®-ATP, RISE®, RISE® IntraLIF®,
`
`and RISE®-L; and the ’649 Patent is listed next to the ELSA®, ELSA®-ATP, RISE®, RISE®
`
`IntraLIF®, and RISE®-L. Every Patent-in-Suit appears next to at least one Globus expandable
`
`product.
`
`29.
`
`The Patents page on Globus’s website is publicly accessible. In addition to the
`
`URL provided on Globus’s products, it can also be accessed through links on numerous other
`
`pages on Globus’s website, including the homepage. Globus’s Patents page has received
`
`thousands of total pageviews and unique pageviews, including over a hundred views originating
`
`from Huntley, Illinois, where Life Spine is headquartered.
`
`C.
`
`The Accused Products and Methods
`
`30.
`
`Life Spine manufactures and sells expandable implants for spinal fusion surgeries
`
`under at least the PROLIFT product line.
`
`9
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`

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`Case 1:21-cv-01445-JPM Document 15 Filed 01/10/22 Page 10 of 38 PageID #: 508
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`31.
`
`Life Spine launched the initial PROLIFT implant in 2016. The PROLIFT implant
`
`is available in at least three different sizes: 8 millimeters, 10 millimeters, and 12 millimeters. The
`
`initial PROFLIT is sometimes called the ProLift Expandable Spacer System.
`
`32. When designing PROLIFT, Life Spine’s engineers “stud[ied] publicly available
`
`information about existing expandable cages through the internet.” Life Spine also studied
`
`existing patents in the spinal fusion space, which “show[ed] devices that feature an upper
`
`endplate, lower endplate, base ramp, nose ramp, and a screw that is used to expand” the implant.
`
`Life Spine then “included these same features in its design of the ProLift.”3 Indeed, Life Spine’s
`
`former Engineering Manager, Madeline Wolters, was responsible for designing the PROLIFT
`
`and has testified about the process:
`
`Okay. Did you and the team go online to look at what other cages existed
`Q.
`on the market?
`
`There – yes, there was -- we would look at other systems, yes.
`
`Okay. Would you also look at patents for expandable cages?
`
`Yes.
`
`A.
`
`Q.
`
`A.
`
`. . .
`
`And so when you’re looking at the patents for other expandable cages,
`Q.
`why are you doing that?
`
`A lot of it is trying to decipher, you know, certain functions and features
`A.
`of the cage that would help for our development.4
`
`33.
`
`Life Spine subsequently launched the PROLIFT Lateral and PROLIFT Lateral
`
`Fixated implants. The PROLIFT Lateral and PROLIFT Lateral Fixated implants are also sold in
`
`various sizes. PROLIFT Lateral is sometimes called the ProLift Lateral Expandable Spacer
`
`
`3 Life Spine, Inc. v. Aegis Spine, Inc., No. 19 CV 7092, 2021 WL 963811, at *2 (N.D. Ill. Mar.
`15, 2021), aff’d, 8 F.4th 531 (7th Cir. 2021).
`4 Transcript of Preliminary Injunction Hearing at 555:6-25, Life Spine v. Aegis, No. 19 CV 7092
`(N.D. Ill. July 26, 2021), D.I. 281 (Oct. 2, 2020 testimony of Madeline Wolters).
`
`10
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`

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`Case 1:21-cv-01445-JPM Document 15 Filed 01/10/22 Page 11 of 38 PageID #: 509
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`System, and PROLIFT Lateral Fixed is sometimes called the ProLift Lateral Fixated Expandable
`
`Spacer System.
`
`34.
`
`Life Spine recently launched the PROLIFT Lateral Helo, sometimes called the
`
`ProLift Lateral Helo Expandable Spacer System.
`
`35.
`
`Life Spine, either directly or through the activities of its agents including third-
`
`party distributors, makes, uses, sells, offers for sale, and/or imports throughout the United States,
`
`the PROLIFT, PROLIFT Lateral, PROLIFT Lateral Fixated, and PROLIFT Lateral Helo
`
`implants (together, the “Accused Products”). The Accused Products also include any products
`
`that are substantially similar to those enumerated in this paragraph, such as the recently
`
`announced PROLIFT Micro. See infra paragraph 50.
`
`36.
`
`The Accused Products share a few common characteristics. First, the Accused
`
`Products comprise two endplates connected by two “wedge-shaped components,” which have
`
`also been called the base ramp and nose ramp. According to Life Spine, the expansion
`
`mechanism for these products draws these wedge-shaped components “together as a means of
`
`securely pushing the implant’s endplates further apart.” In other words, the two ramps are closer
`
`together when the device is expanded than when it is compressed.
`
`Figure 3: PROLIFT implant in compressed and expanded form
`
`37.
`
`Second, the base ramp and nose ramp are connected to each other by an actuator
`
`assembly, which includes a screw. The screw fits within a threaded opening at one end of the
`
`
`
`11
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`

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`implant and a non-threaded opening at the other end, from which it can be turned to expand or
`
`compress the implant.
`
`
`Figure 4: PROLIFT Lateral Fixated implant with non-threaded opening visible
`
`38.
`
`Third, the outer surfaces of both endplates are textured. Texturing helps the
`
`implant grip onto the adjacent vertebral bodies. The Accused Products are also designed to allow
`
`the introduction of bone graft material in situ within and around the implant.
`
`
`Figure 5: PROLIFT Lateral implant with textured surface and bone graft material visible
`
`39.
`
`Life Spine obtained “a patent for the original ProLift” in October 2017—U.S.
`
`Patent No. 9,801,733 (the “’733 Patent”).5 The ’733 Patent is assigned to Life Spine; the
`
`inventors are listed as Madeline Wolters, Daniel Predick, and Michael S. Butler. Butler is Life
`
`Spine’s founder and currently serves as its President and CEO. Wolters is a former Life Spine
`
`Engineering Manager who was responsible for the design of the PROLIFT.
`
`
`5 Life Spine, 2021 WL 963811, at *3.
`
`12
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`Case 1:21-cv-01445-JPM Document 15 Filed 01/10/22 Page 13 of 38 PageID #: 511
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`40.
`
`The ’733 Patent includes numerous diagrams depicting the claimed invention,
`
`including two figures providing a cross-sectional view and an exploded perspective view.
`
`
`Figure 6: Cross-sectional view (’733 Patent, Fig. 86)
`
`
`Figure 7: Exploded perspective view (’733 Patent, Fig. 87)
`
`41.
`
`Substantially similar diagrams can be located in U.S. Patent No. 10,172,718 (the
`
`“’718 Patent”), a continuation of the ’733 Patent, which lists the same inventors, including Life
`
`13
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`Case 1:21-cv-01445-JPM Document 15 Filed 01/10/22 Page 14 of 38 PageID #: 512
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`Spine’s President and CEO, Michael S. Butler, and former Engineering Manager, Madeline
`
`Wolters.
`
`42.
`
`Expandable implants like the Accused Products can be installed by surgical
`
`methods (the “Accused 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.
`
`43.
`
`Surgical instruments used for the installation of the Accused Products can include
`
`a tapered dilator for accessing the intervertebral space and a cannula for insertion of the implant.
`
`44.
`
`The Accused Products have been extremely successful and lucrative for Life
`
`Spine. In January 2021, the company reported that it had reached sales of over 20,000 PROLIFT
`
`units. Its President and CEO, Michael Butler, described the “rapid adoption” of Life Spine’s
`
`expandable technology and projected further increases in expandable technology over the next
`
`five years.
`
`45.
`
`Life Spine has described PROLIFT as its “top performing line of devices” and the
`
`company’s products as being used by “more than a thousand surgeons in forty-eight states.”
`
`According to Life Spine’s CEO, PROLIFT is Life Spine’s “number one product,” “our pièce de
`
`resistance,” and “our jewel.”6
`
`46.
`
`Life Spine also announced in January 2021 that it had achieved 23% revenue
`
`growth for the first quarter of 2021 compared to the previous quarter for its lateral expandable
`
`products, the PROLIFT Lateral and PROLIFT Lateral Fixated.
`
`D.
`
`Knowledge of the Patents-in-Suit and Infringement Thereof
`
`
`6 Transcript of Preliminary Injunction Hearing at 73:10-11, Life Spine v. Aegis, No. 19 CV 7092
`(N.D. Ill. July 26, 2021), D.I. 279 (Sept. 30, 2020 testimony of Michael S. Butler).
`
`14
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`

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`Case 1:21-cv-01445-JPM Document 15 Filed 01/10/22 Page 15 of 38 PageID #: 513
`
`47.
`
`Life Spine is well aware of Globus, its products, and its patents. Life Spine’s
`
`management team considers Globus a “direct competitor with Life Spine.”7
`
`48.
`
`As discussed above, Globus’s website includes a Patents webpage disclosing
`
`Globus’s products and the patents that protect them.
`
`49.
`
`Life Spine has applied for and received Food & Drug Administration (“FDA”)
`
`approval to market the Accused Products under section 510(k) of the Food, Drug, and Cosmetic
`
`Act, which provides an abbreviated process for reviewing medical devices shown to be
`
`substantially equivalent to existing devices that have already been approved. At 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. Life Spine’s General Manager,
`
`Dennis Randall Lewis, Jr., is responsible for the 501(k) process at the company and has testified
`
`that he reviewed patents as part of that process:
`
`Q.
`
`And was this your testimony at your deposition:
`
`“Question: Have you ever looked at a patent for a device that was not owned by
`Life Spine?
`
`“Answer: I believe so.
`
`“Question: Was it a medical device?
`
`“Answer: Yes.
`
`“Question: Why would you look at that patent?
`
`“Answer: Probably it was most likely in my role as regulatory, trying to
`understand what other devices could be out there in the market as potential
`predicates.”
`
`Was that your truthful testimony, sir?
`
`
`7 Transcript of Preliminary Injunction Hearing at 941:12-16, Life Spine v. Aegis, No. 19 CV 7092
`(N.D. Ill. July 26, 2021), D.I. 283 (Oct. 6, 2020 testimony of Jennifer Lynn Jesse, Life Spine’s
`Corporate Compliance Officer and Manager of Contracting Operations).
`
`15
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`

`

`Case 1:21-cv-01445-JPM Document 15 Filed 01/10/22 Page 16 of 38 PageID #: 514
`
`It was. I think I’m calling attention to the distinction here of me looking at
`A.
`a patent to ascertain if it has a feature that could be useful in a 510(k) verse [sic]
`conducting a patent search. I don’t even know that I would know how to do that.
`But observing a single patent for a feature, I have a distinction there.
`
`Q. Well, to find out information about patents, you just search the Internet,
`right?
`
`A.
`
`Q.
`
`A.
`
`I would most likely look for a device name and see what was there to find.
`
`By doing a search on the Internet?
`
`Yes.8
`
`50.
`
`On October 8, 2021, Life Spine received a letter from the FDA approving its
`
`section 501(k) submission for a new PROLIFT product. According to a press release issued by
`
`Life Spine on October 12, 2021, this newly approved product is to be marketed as the PROLIFT
`
`Micro. The only predicate product for PROLIFT Micro submitted by Life Spine that was not a
`
`prior version of PROLIFT was the “Globus Rise Spacer System.”
`
`51.
`
`The top result in Google searches for “Globus Rise patent” and “Globus Elsa
`
`patent” is the Patents page on Globus’s website, which includes a table of Globus products and
`
`the patents that protect them, including the Patents-in-Suit. The Globus Patents page is also the
`
`top result in a Google search for “Globus Caliber patent.”
`
`52.
`
`Life Spine employees regularly attend industry conferences, including the North
`
`American Spine Society (“NASS”) annual conference, at which competitors such as Globus
`
`display their expandable implant products. Both companies were present at the annual NASS
`
`conference at least from 2016 through 2019, as well as the International Society for the
`
`Advancement of Spine Surgery conference in 2017. On information and belief, both companies
`
`were also present at various conferences of the Society for Minimally Invasive Spine Surgery
`
`8 Transcript of Preliminary Injunction Hearing at 1340:12-1341:14, Life Spine v. Aegis, No. 19
`CV 7092 (N.D. Ill. July 26, 2021), D.I. 285 (Oct. 29, 2020 testimony of Dennis Randall Lewis,
`Jr.).
`
`16
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`

`

`Case 1:21-cv-01445-JPM Document 15 Filed 01/10/22 Page 17 of 38 PageID #: 515
`
`and the Scoliosis Research Society between 2017 and 2019. It is not unusual for spine implant
`
`companies to have displays in close proximity at such industry events; Globus and Life Spine’s
`
`product booths were immediately adjacent to each other, for instance, at the most recent NASS
`
`annual meeting. Globus regularly includes its expandable implant products, such as RISE® and
`
`ELSA®, in its presentations at these types of events.
`
`53.
`
`In addition, Life Spine has consistently cited Globus’s patent portfolio—including
`
`the Patents-in-Suit—to the PTO as prior art during prosecution of the ’733 Patent, ’718 Patent,
`
`and many of its other patents and patent applications, particularly those that concern expandable
`
`implants.
`
`54.
`
`During prosecution of the ’733 Patent before the PTO, Life Spine submitted
`
`numerous Globus patents and/or patent applications to the PTO as prior art in information
`
`disclosure statements (“IDS”). Specifically:
`
`a. May 18, 2015: Life Spine cited three published Globus patent applications
`
`(2011/0319997 A1, 2012/0059474 A1, 2012/0330422 A1) in an IDS, all of which
`
`had already issued as patents at the time of Life Spine’s submission (U.S. Patent
`
`Nos. 8,865,098, 8,435,298, 8,845,732). One of these was the ’732 Patent.9
`
`b. November 19, 2015: Life Spine cited a published Globus patent application
`
`(2013/0085572 A1) in an IDS. This application had already issued as a patent at
`
`the time of Life Spine’s submission (U.S. Patent No. 8,864,833).
`
`55.
`
`During prosecution of the ’718 Patent before the PTO, Life Spine submitted
`
`numerous Globus patents and/or patent applications to the PTO as prior art in information
`
`
`9 Life Spine has cited this application in numerous additional prosecutions, including
`prosecutions of U.S. Patent Nos. 8,940,048, 9,034,041, 9,801,733, 10,154,911, 10,383,741, and
`10,426,632.
`
`17
`
`

`

`Case 1:21-cv-01445-JPM Document 15 Filed 01/10/22 Page 18 of 38 PageID #: 516
`
`disclosure statements (“IDS”). Globus patents and/or patent applications were also cited by the
`
`PTO examiner in office actions concerning Life Spine’s application. Specifically:
`
`a. October 30, 2017: Life Spine cited four published Globus patent applications
`
`(2011/0319997 A1, 2012/0059474 A1, 2012/0330422 A1, 2013/0085572 A1) in
`
`an IDS, all of which had already issued as patents at the time of Life Spine’s
`
`submission (U.S. Patent Nos. 8,865,098, 8,435,298, 8,845,732, 8,864,833). One
`
`of these was the ’732 Patent.
`
`b. March 1, 2018: The examiner cited a Globus patent (U.S. Patent No. 8,353,963)
`
`in an office action rejecting Life Spine’s application.
`
`c. July 12, 2018: Life Spine cited three published Globus patent applications
`
`(2015/0100128 A1, 2016/0242927 A1, 2017/0056197 A1) in an IDS, all of which
`
`later issued as patents (U.S. Patent Nos. 10,327,917, 10,359,081, 10,137,009).
`
`56. Many of Life Spine’s other patents and/or patent applications also reference
`
`Globus’s patent portfolio.
`
`57.
`
`For example, Life Spine is the assignee of U.S. Patent No. 10,383,741 (the “’741
`
`Patent”). During prosecution of the ’741 Patent before the PTO, Life Spine submitted numerous
`
`Globus patents and/or patent applications to the PTO as prior art in information disclosure
`
`statements (“IDS”). Specifically:
`
`a. April 27, 2017: Life Spine cited four published Globus patent applications
`
`(2011/0319997 A1, 2012/0059474 A1, 2012/0330422 A1, 2013/0085572 A1) in
`
`an IDS, all of which had already issued as patents at the time of Life Spine’s
`
`submission (U.S. Patent Nos. 8,865,098, 8,435,298, 8,845,732, 8,864,833). One
`
`of these was the ’732 Patent.
`
`18
`
`

`

`Case 1:21-cv-01445-JPM Document 15 Filed 01/10/22 Page 19 of 38 PageID #: 517
`
`b. March 20, 2018: Life Spine cited a Globus patent (U.S. Patent No. 8,353,963) in
`
`an IDS.
`
`c. July 12, 2018: Life Spine cited three published Globus patent applications
`
`(2015/0100128 A1, 2016/0242927 A1, 2017/0056197 A1) in an IDS, all of which
`
`later issued as patents (U.S. Patent Nos. 10,327,917, 10,359,081, 10,137,009).
`
`58.
`
`For example, Life Spine is the assignee of U.S. Patent No. 11,103,362 (the “’362
`
`Patent”). During prosecution of the ’362 Patent before the PTO, Life Spine submitted numerous
`
`Globus patents and/or patent applications to the PTO as prior art in information disclosure
`
`statements (“IDS”). Globus patents and/or patent applications were also cited by the PTO
`
`examiner in office actions concerning Life Spine’s applic