`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GLOBUS MEDICAL, INC.
`
`Plaintiff,
`
`v.
`
`LIFE SPINE, INC.
`
`Defendant.
`
`Civil Action No. __________
`
`JURY TRIAL DEMANDED
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Globus Medical, Inc. (“Globus”) respectfully brings this 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
`
`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).
`
`1
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`
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`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 2 of 24 PageID #: 2
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`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.
`
`6.
`
`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
`
`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 spinal 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 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
`
`fusion of the adjacent vertebrae into a single bone, the spine segment is immobilized, eliminating
`
`the cause of the patient’s pain.
`
`2
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`
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`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 3 of 24 PageID #: 3
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`9.
`
`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
`
`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
`
`
`
`B.
`
`The Patents-in-Suit
`
`13.
`
`The technology claimed in this case relates to intervertebral expandable implants,
`
`and surgical systems and methods utilizing such implants.
`
`14.
`
`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.
`
`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.
`
`15.
`
`16.
`
`All of the Patents-in-Suit relate to technology developed in-house by Globus.
`
`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. 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.
`
`17.
`
`The ’732 Patent was issued by the PTO on September 30, 2014, from an
`
`application filed on June 25, 2012, which was a continuation-in-part of application no.
`
`12/875,637 filed on September 30, 2010 (which issued as the ’731 Patent). 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.
`
`4
`
`
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`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 5 of 24 PageID #: 5
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`18.
`
`The ’739 Patent was issued by the PTO on August 2, 2016, from an application
`
`filed on February 7, 2014. 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.
`
`19.
`
`The ’087 Patent was issued by the PTO on May 1, 2018, from an application filed
`
`on May 2, 2016, which was a continuation-in-part of application no. 15/097,466 filed on April
`
`13, 2016, which was a continuation-in-part of application no. 14/802,229 filed on July 17, 2015.
`
`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.
`
`20.
`
`The ’001 Patent was issued by the PTO on November 27, 2018, from an
`
`application 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). 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.
`
`21.
`
`The ’752 Patent was issued by the PTO on February 23, 2021, from an application
`
`filed on September 11, 2018, which was a continuation of application no. 15/158,829 filed on
`
`May 19, 2016, which was a continuation of application no. 14/109,429 filed on December 17,
`
`2013, which was a division of application no. 12/875,818 filed on September 3, 2010. 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.
`
`22.
`
`The ’649 Patent was issued by the PTO on April 13, 2021, from an application
`
`filed on December 21, 2016, which was a continuation of application no. 13/961,603 filed on
`
`May 19, 2016, which was a continuation-in-part of application no. 13/531,844 filed on June 25,
`
`5
`
`
`
`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 6 of 24 PageID #: 6
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`2012, which was a continuation-in-part of application no. 12/875,637 filed on September 3, 2010
`
`(which issued as the ’731 Patent). 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.
`
`23.
`
`Globus currently sells products, such as those described herein, marked with all
`
`Patents-in-Suit.
`
`C.
`
`The Accused Products
`
`24.
`
`Life Spine manufactures and sells expandable implants for spinal fusion surgeries
`
`under at least the PROLIFT product line.
`
`25.
`
`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.
`
`26.
`
`Life Spine studied existing patents in the spinal fusion space when developing
`
`PROLIFT, 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.”
`
`27.
`
`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
`
`System, and PROLIFT Lateral Fixed is sometimes called the ProLift Lateral Fixated Expandable
`
`Spacer System.
`
`28.
`
`Life Spine recently launched the PROLIFT Lateral Helo, sometimes called the
`
`ProLift Lateral Helo Expandable Spacer System.
`
`6
`
`
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`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 7 of 24 PageID #: 7
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`29.
`
`The PROLIFT, PROLIFT Lateral, PROLIFT Lateral Fixated, and PROLIFT
`
`Lateral Helo implants (together, the “Accused Products”) share a few common characteristics.
`
`30.
`
`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
`
`31.
`
`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
`
`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
`
`7
`
`
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`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 8 of 24 PageID #: 8
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`32.
`
`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
`
`33.
`
`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.
`
`34.
`
`Life Spine obtained “a patent for the original ProLift” in October 2017—U.S.
`
`Patent No. 9,801,733 (the “’733 Patent”). 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.
`
`35.
`
`The ’733 Patent includes numerous diagrams depicting the claimed invention,
`
`including two figures providing a cross-sectional view and an exploded perspective view.
`
`8
`
`
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`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 9 of 24 PageID #: 9
`
`
`Figure 6: Cross-sectional view (’733 Patent, Fig. 86)
`
`
`Figure 7: Exploded perspective view (’733 Patent, Fig. 87)
`
`36.
`
`Substantially similar diagrams can be located in U.S. Patent No. 10,172,718 (the
`
`“’718 Patent”), a continuation of the ’733 Patent and lists the same inventors, including Life
`
`Spine’s President and CEO, Michael S. Butler.
`
`37.
`
`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
`
`9
`
`
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`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 10 of 24 PageID #: 10
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`space, the insertion of the implant, the expansion of the implant, and the introduction of bone
`
`graft material.
`
`38.
`
`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.
`
`39.
`
`Life Spine educates and encourages surgeons to use the Accused Products and
`
`Accused Methods. Life Spine employs sales representatives to sell PROLIFT products to
`
`medical professionals and institutions for use in spinal fusion surgeries. These sales
`
`representatives provide information to the surgeons who perform these surgeries on how to use
`
`the PROLIFT products.
`
`40.
`
`Life Spine also maintains a website called XPanding Micro-Invasive Procedures
`
`at https://www.micro-invasive.com to educate surgeons on how to use its PROLIFT products
`
`with minimally invasive surgical techniques. The website includes three clinical case studies
`
`from physicians who have successfully used a PROLIFT implant.
`
`41.
`
`Life Spine’s XPanding Micro-Invasive Procedures website also includes a section
`
`called “MED EDU,” at https://www.micro-invasive.com/med-edu, which describes
`
`the
`
`company’s PULSE program, “Life Spine’s premier program for physician training through
`
`personalized visits highlighted by cadaveric labs and didactic learning sessions.” Through this
`
`program, Life Spine “offers a large variety of faculty led experiences” with the goal of
`
`“educat[ing] surgeons worldwide on all aspects of a surgery” using Life Spine’s products. An
`
`identical description of the PULSE program appears on Life Spine’s main website.
`
`42.
`
`Life Spine and/or its agents, such as third-party distributors, disseminate surgical
`
`technique guides that walk surgeons through methods for installing the Accused Products.
`
`10
`
`
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`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 11 of 24 PageID #: 11
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`43.
`
`Furthermore, Life Spine has admitted that it entered into agreements with
`
`“surgeons, and entities owned in whole or in part by the surgeons” that resulted in payment of
`
`“more than $7 million in consulting fees, royalties, and intellectual property acquisition
`
`payments.” Life Spine made this admission to settle charges by the United States, through the
`
`U.S. Attorney’s Office of the Southern District of New York, that this conduct, which was
`
`allegedly done “with the knowledge, involvement, and participation” of Life Spine CEO Michael
`
`Butler and Vice President Richard Greiber, violated the False Claims Act and Anti-Kickback
`
`Statute.1 In connection with that settlement, Life Spine agreed to pay $5.5 million in restitution
`
`to the United States.
`
`44.
`
`Life Spine also admitted in its settlement agreement with the United States that
`
`“[m]ost of the surgeons who received these payments substantially increased their usage of
`
`Life Spine products after entering into agreements with Life Spine,” and what’s more, these
`
`particular surgeons “were high-volume users” that constituted “21 of the top 30 users of Life
`
`Spine products” during the 7-year period in which Life Spine made these payments. Moreover,
`
`“[w]hen surgeons’ usage decreased, senior sales managers would contact the surgeons, or their
`
`distributors, to urge the surgeons to more frequently use Life Spine products.” (emphases
`
`added).
`
`45.
`
`In connection with his individual settlement with the United States, Life Spine
`
`CEO Michael Butler admitted that he was personally “involved in identifying and retaining some
`
`of the surgeons who served as paid consultants for Life Spine,” and that he would “on occasion”
`
`
`1 The government’s complaint-in-intervention was filed in July 2019 and can be found at
`https://www.justice.gov/usao-sdny/press-release/file/1186211/download. The quoted language in
`paragraphs 43-44 can be found in the settlement agreement between the United States and Life
`Spine,
`which
`is
`located
`at
`https://www.justice.gov/usao-sdny/press-
`release/file/1215966/download.
`
`11
`
`
`
`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 12 of 24 PageID #: 12
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`contact surgeons whose usage of Line Spine products had decreased “to encourage them to
`
`increase their usage.”2 Butler also agreed to pay $375,000 in restitution to the United States.
`
`46.
`
`All of this conduct further demonstrates Life Spine’s encouragement of surgeons
`
`to use the Accused Products and Accused Methods.
`
`47.
`
`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.
`
`48.
`
`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.”
`
`49.
`
`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.
`
`COUNT I: INFRINGEMENT OF THE ’731 PATENT
`
`50.
`
`Globus restates and incorporates by reference its allegations as set forth in the
`
`preceding paragraphs.
`
`51.
`
`Life Spine has infringed at least claim 1 of the ’731 Patent, pursuant to 35 U.S.C.
`
`§ 271(a), by making, using, offering to sell, and/or selling the Accused Products in the United
`
`States and/or by importing the Accused Products into the United States, directly and/or
`
`
`2 The quoted language in paragraph 45 can be found in the settlement agreement between the
`United States and Butler, which is located at https://www.justice.gov/usao-sdny/press-
`release/file/1215981/download.
`
`12
`
`
`
`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 13 of 24 PageID #: 13
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`indirectly, on its own and/or through its agents. The Accused Products embody every limitation
`
`of these claims literally and/or under the doctrine of equivalents.
`
`52.
`
`As a non-limiting example, a claim chart with a description of Life Spine’s
`
`infringement of exemplary claim 1 of the ’731 Patent by exemplary product PROLIFT is
`
`attached as Exhibit H. Additional infringing products and/or infringed claims of the ’731 Patent
`
`will be disclosed pursuant to the Court’s rules.
`
`53.
`
`Life Spine has also actively induced infringement of the ’731 Patent pursuant to
`
`35 U.S.C. § 271(b) by non-party partners and distributors of the Accused Products, directly
`
`and/or indirectly, on its own and/or through its agents.
`
`54.
`
`55.
`
`The ’731 Patent is valid and enforceable.
`
`Life Spine has been on notice of the ’731 Patent pursuant to 35 U.S.C. § 287(a)
`
`since at least November 2015, when Globus manufactured and sold the RISE® implant marked in
`
`accordance with that provision.
`
`56.
`
`Life Spine also had actual knowledge of the disclosures of the ’731 Patent. For
`
`example, Life Spine cited patent publication no. 2012/0330422—i.e., patent application no.
`
`13/531,943 (which issued as the ’732 Patent), which disclosed that it was a continuation-in-part
`
`of application no. 12/875,637 (which issued as the ’731 Patent)—during prosecution of several
`
`of its own patents, including U.S. Patent Nos. 8,940,048, 9,034,041, 9,801,733, 10,154,911,
`
`10,383,741, and 10,426,632, as well as the ’718 Patent. These patents are assigned to Life Spine,
`
`and its President and CEO, Michael S. Butler, is named as a co-inventor. As another example,
`
`Life Spine has named RISE® as a substantially equivalent product to PROLIFT in its 510(k)
`
`submissions to FDA. As another example, Life Spine engineers studied existing patents in the
`
`spinal fusion space when developing PROLIFT.
`
`13
`
`
`
`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 14 of 24 PageID #: 14
`
`57.
`
`Life Spine committed the foregoing infringing activities without license from
`
`Globus and with notice of the ’731 Patent.
`
`58.
`
`Life Spine’s infringement of the ’731 Patent has been and continues to be willful,
`
`as Life Spine had notice of the ’731 Patent and deliberately continued to infringe.
`
`59.
`
`As a result of Life Spine’s infringement of the ’731 Patent, Globus has been
`
`damaged and continues to suffer damages.
`
`60.
`
`The acts of infringement by Life Spine will continue unless enjoined by the Court.
`
`Globus has been and will continue to be irreparably harmed and damaged by Life Spine’s
`
`infringement of the ’731 Patent and has no adequate remedy at law.
`
`COUNT II: INFRINGEMENT OF THE ’732 PATENT
`
`61.
`
`Globus restates and incorporates by reference its allegations as set forth in the
`
`preceding paragraphs.
`
`62.
`
`Life Spine has infringed at least claim 1 of the ’732 Patent, pursuant to 35 U.S.C.
`
`§ 271(a), by making, using, offering to sell, and/or selling the Accused Products in the United
`
`States and/or by importing the Accused Products into the United States, directly and/or
`
`indirectly, on its own and/or through its agents. The Accused Products embody every limitation
`
`of these claims literally and/or under the doctrine of equivalents.
`
`63.
`
`As a non-limiting example, a claim chart with a description of Life Spine’s
`
`infringement of exemplary claim 1 of the ’732 Patent by exemplary product PROLIFT is
`
`attached as Exhibit I.
`
`64.
`
`Additional infringing products and/or infringed claims of the ’732 Patent will be
`
`disclosed pursuant to the Court’s rules.
`
`14
`
`
`
`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 15 of 24 PageID #: 15
`
`65.
`
`Life Spine has also actively induced infringement of the ’732 Patent pursuant to
`
`35 U.S.C. § 271(b) by non-party partners and distributors of the Accused Products, directly
`
`and/or indirectly, on its own and/or through its agents.
`
`66.
`
`67.
`
`The ’732 Patent is valid and enforceable.
`
`Life Spine has been on notice of the ’732 Patent pursuant to 35 U.S.C. § 287(a)
`
`since at least November 2015, when Globus manufactured and sold the RISE® implant marked in
`
`accordance with that provision.
`
`68.
`
`Life Spine also had actual knowledge of the disclosures of the ’732 Patent. For
`
`example, Life Spine cited patent publication no. 2012/0330422—i.e., patent application no.
`
`13/531,943 (which issued as the ’732 Patent)—during prosecution of several of its own patents,
`
`including U.S. Patent Nos. 8,940,048, 9,034,041, 9,801,733, 10,154,911, 10,383,741, and
`
`10,426,632, as well as the ’718 Patent. These patents are assigned to Life Spine, and its President
`
`and CEO, Michael S. Butler, is named as a co-inventor. As another example, Life Spine has
`
`named RISE® as a substantially equivalent product to PROLIFT in its 510(k) submissions to
`
`FDA.
`
`69.
`
`Life Spine committed the foregoing infringing activities without license from
`
`Globus and with notice of the ’732 Patent.
`
`70.
`
`Life Spine’s infringement of the ’732 Patent has been and continues to be willful,
`
`as Life Spine had notice of the ’732 Patent and deliberately continued to infringe.
`
`71.
`
`As a result of Life Spine’s infringement of the ’732 Patent, Globus has been
`
`damaged and continues to suffer damages.
`
`15
`
`
`
`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 16 of 24 PageID #: 16
`
`72.
`
`The acts of infringement by Life Spine will continue unless enjoined by the Court.
`
`Globus has been and will continue to be irreparably harmed and damaged by Life Spine’s
`
`infringement of the ’732 Patent and has no adequate remedy at law.
`
`COUNT III: INFRINGEMENT OF THE ’739 PATENT
`
`73.
`
`Globus restates and incorporates by reference its allegations as set forth in the
`
`preceding paragraphs.
`
`74.
`
`Life Spine has infringed at least claim 1 of the ’739 Patent, pursuant to 35 U.S.C.
`
`§ 271(a), by making, using, offering to sell, and/or selling the Accused Products in the United
`
`States and/or by importing the Accused Products into the United States, directly and/or
`
`indirectly, on its own and/or through its agents. The Accused Products embody every limitation
`
`of these claims literally and/or under the doctrine of equivalents.
`
`75.
`
`As a non-limiting example, a claim chart with a description of Life Spine’s
`
`infringement of exemplary claim 1 of the ’739 Patent by exemplary product PROLIFT Lateral is
`
`attached as Exhibit J.
`
`76.
`
`Additional infringing products and/or infringed claims of the ’739 Patent will be
`
`disclosed pursuant to the Court’s rules.
`
`77.
`
`Life Spine has also actively induced infringement of the ’739 Patent pursuant to
`
`35 U.S.C. § 271(b) by non-party partners and distributors of the Accused Products, directly
`
`and/or indirectly, on its own and/or through its agents.
`
`78.
`
`79.
`
`The ’739 Patent is valid and enforceable.
`
`Life Spine has been on notice of the ’739 Patent pursuant to 35 U.S.C. § 287(a)
`
`since at least December 2018, when Globus manufactured and sold the RISE-L® implant marked
`
`in accordance with that provision.
`
`16
`
`
`
`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 17 of 24 PageID #: 17
`
`80.
`
`Life Spine also had actual knowledge of the disclosures of the ’739 Patent. For
`
`example, Life Spine cited patent publication no. 2015/0223946—i.e., patent application no.
`
`14/449428, which disclosed that it was a continuation-in-part of application no. 14/175,601
`
`(which issued as the ’739 Patent)—during prosecution of several of its own patents, including
`
`U.S. Patent Nos. 9,610,172 and 10,251,759. These patents are assigned to Life Spine, and its
`
`President and CEO, Michael S. Butler, is named as a co-inventor.
`
`81.
`
`Life Spine committed the foregoing infringing activities without license from
`
`Globus and with notice of the ’739 Patent.
`
`82.
`
`Life Spine’s infringement of the ’739 Patent has been and continues to be willful,
`
`as Life Spine had notice of the ’739 Patent and deliberately continued to infringe.
`
`83.
`
`As a result of Life Spine’s infringement of the ’739 Patent, Globus has been
`
`damaged and continues to suffer damages.
`
`84.
`
`The acts of infringement by Life Spine will continue unless enjoined by the Court.
`
`Globus has been and will continue to be irreparably harmed and damaged by Life Spine’s
`
`infringement of the ’739 Patent and has no adequate remedy at law.
`
`COUNT IV: INFRINGEMENT OF THE ’087 PATENT
`
`85.
`
`Globus restates and incorporates by reference its allegations as set forth in the
`
`preceding paragraphs.
`
`86.
`
`Life Spine has infringed at least claim 1 of the ’087 Patent, pursuant to 35 U.S.C.
`
`§ 271(a), by making, using, offering to sell, and/or selling the Accused Products in the United
`
`States and/or by importing the Accused Products into the United States, directly and/or
`
`indirectly, on its own and/or through its agents. The Accused Products embody every limitation
`
`of these claims literally and/or under the doctrine of equivalents.
`
`17
`
`
`
`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 18 of 24 PageID #: 18
`
`87.
`
`As a non-limiting example, a claim chart with a description of Life Spine’s
`
`infringement of exemplary claim 1 of the ’087 Patent by exemplary product PROLIFT Lateral
`
`Fixated is attached as Exhibit K.
`
`88.
`
`Additional infringing products and/or infringed claims of the ’087 Patent will be
`
`disclosed pursuant to the Court’s rules.
`
`89.
`
`Life Spine has also actively induced infringement of the ’087 Patent pursuant to
`
`35 U.S.C. § 271(b) by non-party partners and distributors of the Accused Products, directly
`
`and/or indirectly, on its own and/or through its agents.
`
`90.
`
`91.
`
`The ’087 Patent is valid and enforceable.
`
`Life Spine has been on notice of the ’087 Patent pursuant to 35 U.S.C. § 287(a)
`
`since at least November 2018, when Globus manufactured and sold the ELSA® implant marked
`
`in accordance with that provision.
`
`92.
`
`Life Spine also had actual knowledge of the disclosures of the ’087 Patent. For
`
`example, Life Spine has named ELSA® as a substantially equivalent product to PROLIFT
`
`Lateral Fixated in its 510(k) submissions to FDA.
`
`93.
`
`Life Spine committed the foregoing infringing activities without license from
`
`Globus and with notice of the ’087 Patent.
`
`94.
`
`Life Spine’s infringement of the ’087 Patent has been and continues to be willful,
`
`as Life Spine had notice of the ’087 Patent and deliberately continued to infringe.
`
`95.
`
`As a result of Life Spine’s infringement of the ’087 Patent, Globus has been
`
`damaged and continues to suffer damages.
`
`18
`
`
`
`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 19 of 24 PageID #: 19
`
`96.
`
`The acts of infringement by Life Spine will continue unless enjoined by the Court.
`
`Globus has been and will continue to be irreparably harmed and damaged by Life Spine’s
`
`infringement of the ’087 Patent and has no adequate remedy at law.
`
`COUNT V: INFRINGEMENT OF THE ’001 PATENT
`
`97.
`
`Globus restates and incorporates by reference its allegations as set forth in the
`
`preceding paragraphs.
`
`98.
`
`Life Spine has actively induced infringement of at least claim 1 of the ’001 Patent
`
`pursuant to 35 U.S.C. § 271(b). Life Spine actively induced surgeons to infringe the ’001 Patent
`
`by using the Accused Methods to perform spinal fusion surgeries with the Accused Products.
`
`99.
`
`As a non-limiting example, a claim chart with a description of Life Spine’s
`
`infringement of exemplary claim 1 of the ’001 Patent is attached as Exhibit L. Additional
`
`infringed claims of the ’001 Patent will be disclosed pursuant to the Court’s rules.
`
`100. The ’001 Patent is valid and enforceable.
`
`101. Life Spine has been on notice of the ’001 Patent pursuant to 35 U.S.C. § 287(a)
`
`since at least November 2018, when Globus manufactured and sold the RISE® implant marked in
`
`accordance with that provision.
`
`102. Life Spine also had actual knowledge of the disclosures of the ’001 Patent. For
`
`example, Life Spine has named RISE® as a substantially equivalent product to PROLIFT in its
`
`510(k) submissions to FDA.
`
`103. Life Spine committed the foregoing infringing activities without license from
`
`Globus and with notice of the ’001 Patent.
`
`104. Life Spine’s infringement of the ’001 Patent has been and continues to be willful,
`
`as Life Spine had notice of the ’001 Patent and deliberately continued to infringe.
`
`19
`
`
`
`Case 1:21-cv-01445-UNA Document 1 Filed 10/13/21 Page 20 of 24 PageID #: 20
`
`105. As a result of Life Spine’s infringement of the ’001 Patent, Globus has been
`
`damaged and continues to suffer damages.
`
`106. The acts of infringement by Life Spine will continue unless enjoined by the Court.
`
`Globus has been and will continue to be irreparably harmed and damaged by Life Spine’s
`
`infringement of the ’001 Patent and has no adequate remedy at law.
`
`COUNT VI: INFRINGEMENT OF THE ’752 PATENT
`
`107. Globus restates and incorporates by reference its allegations as set forth in the
`
`preceding paragraphs.
`
`108. Globus restates and incorporates by reference its allegations as set forth in the
`
`preceding paragraphs.
`
`109. Life Spine has infringed at least claim 1 of the ’752 Patent,
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