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`RYAN MARTON (SBN 223979)
`ryan@martonribera.com
`HECTOR RIBERA (SBN 221511)
`hector@martonribera.com
`CAROLYN CHANG (SBN 217933)
`carolyn@martonribera.com
`MARTON RIBERA SCHUMANN CHANG LLP
`548 Market Street, Suite 36117
`San Francisco, CA 94104
`Tel.: +1 415 360 2511_
`
`Attorneys for Plaintiff
`Colibri Heart Valve LLC
`
`
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`SOUTHERN DIVISION
`
`Colibri Heart Valve LLC,
`Plaintiff,
`
`v.
`Medtronic CoreValve LLC; and
`Medtronic plc,
`
`Defendants.
`
`
`
`
`Case No.
`
`
`COMPLAINT FOR PATENT
`INFRINGEMENT
`DEMAND FOR JURY TRIAL
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Colibri Heart Valve LLC, Exhibit 2001, Page 1 of 22
`
`

`

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`Plaintiff Colibri Heart Valve LLC (“Colibri” or “Plaintiff”), by and through
`
`the undersigned counsel, brings this action against Defendants Medtronic
`CoreValve LLC and Medtronic plc (together, “Medtronic”) alleging as follows:
`INTRODUCTION
`1.
`This is an action by Colibri against Medtronic for infringement of U.S.
`Patent Nos. 9,125,739 (“the ’739 patent”) and 8,900,294 (“the ’294 patent”), which
`claim groundbreaking artificial heart valves and methods for using them.
`2. Heart disease is the leading cause of death in the U.S. Over five
`million people in the U.S. are diagnosed with heart valve disease annually.
`Sometimes heart valve disease can be treated with medication, or the diseased heart
`valve can be repaired through surgery. In severe cases, however, the heart valve is
`so diseased that it cannot be treated by medication or repaired, and must be replaced
`with an artificial heart valve. Over 100,000 defective heart valves are replaced in
`the U.S. each year.
`3.
`Inventors Drs. David Paniagua and R. David Fish, leading
`interventional cardiologists and innovators in the field of cardiovascular
`intervention, have worked hard to address the need for treatment options for
`patients who suffer from debilitating heart valve disease and require a new heart
`valve. Their work has resulted in the discovery and development of artificial heart
`valves and treatment methodologies that could offer patients an opportunity to
`receive a less invasive heart valve therapy. Drs. Paniagua and Fish co-founded
`Colibri, and their work became the basis for Colibri’s patented inventions.
`4. Colibri’s life-saving inventions include a patented, self-expanding
`heart valve device that includes cross-linked biological tissue and a delivery system
`that can be guided through a patient’s artery to the heart where it is positioned and
`used to replace diseased valves. The patented device and method of controlled
`release, which includes making a small incision through which a thin, flexible tube
`is inserted into the artery, is far less invasive than open heart surgery. The
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Colibri Heart Valve LLC, Exhibit 2001, Page 2 of 22
`
`

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`controlled release capability permits a surgeon to recover the patented heart valve
`device during deployment. For its innovation, Colibri was awarded the ’294 Patent
`and the ’739 Patent, among others.
`5. Medtronic manufactures and sells self-expanding heart valves and
`delivery systems, including transcatheter aortic valve replacement (TAVR)
`products that infringe Colibri’s patents. The Medtronic TAVR devices go by a
`variety of names, including CoreValve, CoreValve Evolut R, CoreValve Evolut
`PRO, and CoreValve Evolut PRO+ (the “CoreValve Products”). Medtronic’s
`infringing CoreValve Products include cross-linked biological tissue and a delivery
`system that can be guided through a patient’s artery to the heart where they are
`positioned and used to replace diseased valves, as taught by Colibri’s patents, and
`are inserted using Colibri’s patented method of controlled release.
`THE PARTIES
`6.
`Plaintiff Colibri Heart Valve LLC is a corporation organized under the
`laws of Delaware, with its principal place of business at 486 South Pierce Avenue,
`Suite B, Louisville, Colorado 80027.
`7. Colibri is a medical device company that researches and develops
`novel heart valve technologies. Colibri was founded in 2010 by Drs. Paniagua and
`Fish.
`
`8. On information and belief, Defendant Medtronic CoreValve LLC is a
`corporation organized under the laws of Delaware, with a principal place of
`business at 1851 East Deere Avenue, Santa Ana, California 92705.
`9. On information and belief, Defendant Medtronic plc is a public limited
`company organized under the laws of Ireland, with a principal place of business and
`international headquarters in Dublin, Ireland. Medtronic plc is the successor entity
`to Medtronic, Inc., and operates in the United States and elsewhere through
`Medtronic CoreValve LLC, among other entities. Medtronic plc and Medtronic
`CoreValve LLC are collectively referred to herein as “Medtronic.”
`
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`COMPLAINT FOR PATENT INFRINGEMENT
`
`
`Colibri Heart Valve LLC, Exhibit 2001, Page 3 of 22
`
`

`

`
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`JURISDICTION AND VENUE
`10. This Court has subject matter jurisdiction pursuant to 28 U.S.C.
`§§ 1331 and 1338(a).
`11. Personal jurisdiction over Medtronic is proper because it continuously
`and systematically conducts business in Santa Ana, California, including the
`manufacture and sale of the infringing CoreValve Products.
`12. Venue is proper in the Central District of California under 28 U.S.C.
`§§ 1391(b) and 1400(b) because Medtronic resides in this District and a substantial
`part of the events and omissions giving rise to the claims at issue occurred here,
`including the manufacture and sale of the infringing CoreValve Products.
`FACTUAL BACKGROUND
`
`Background of Colibri
`13. As noted above, Colibri was co-founded by Drs. Paniagua and Fish.
`Dr. Paniagua’s education and training includes completion of his Interventional
`Cardiology Fellowship at the Texas Heart Institute/Baylor College of Medicine
`Program, and training in interventional cardiology at the Texas Heart
`Institute. Amongst Dr. Paniagua’s significant achievements, he is credited with
`having conducted the first retrograde percutaneous aortic heart valve implant in a
`human in the world.
`14. Like Dr. Paniagua, Dr. Fish is a leading interventional cardiologist and
`an innovator in the field of cardiovascular intervention. Among other
`accomplishments, Dr. Fish received the Physician-Scientist Award from the
`National Heart Lung & Blood Institute of the National Institutes of Health.
`Dr. Fish served as Director of Interventional Cardiology Research and Education at
`the Texas Heart Institute, and subsequently became Director of the Heart Valve
`Center there. In 2015, he became the inaugural chair of the Multidisciplinary Heart
`Team at the Baylor St. Luke’s Medical Center.
`
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`COMPLAINT FOR PATENT INFRINGEMENT
`
`3
`
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`Colibri Heart Valve LLC, Exhibit 2001, Page 4 of 22
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`15. Drs. Paniagua and Fish have worked since at least January 4, 2002, on
`developing and improving Colibri’s transcatheter aortic valve implantation system
`(the “Colibri TAVI System”) into today’s pre-mounted, pre-crimped, and pre-
`loaded heart valve that is sterilized and ready for use.
`
`
`The Colibri TAVI System
`
`16. A goal of any artificial heart valve is to deliver as much blood and
`oxygen to the patient as possible. Colibri has demonstrated in its early human
`feasibility study that its valves can deliver approximately twice as much oxygenated
`blood to patients as all of the existing artificial heart valves currently being
`implanted in patients.
`Colibri Meets with Medtronic
`17. On or about May 6, 2014, under the protection of a Non-Disclosure
`Agreement, Colibri’s President and CEO Joseph Horn gave a presentation about
`Colibri’s heart valve accomplishments to several persons whom Mr. Horn
`understood to be Medtronic’s marketing director and senior clinical program
`manager. Among other things, Mr. Horn discussed the successful implementation
`of Colibri’s TAVI System in a patient. Mr. Horn also provided details about
`
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`COMPLAINT FOR PATENT INFRINGEMENT
`
`
`Colibri Heart Valve LLC, Exhibit 2001, Page 5 of 22
`
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`Colibri’s proprietary heart valve products, delivery systems, and methods, including
`the patented Colibri TAVI system. In addition, on July 2, 2014, Colibri and
`Medtronic held a conference call that included discussion of Colibri’s patent
`portfolio. More particularly, Mr. Horn, Eric Schauble (Colibri’s Vice President of
`Business Development), and Colibri’s outside patent counsel Mark Yaskanin,
`discussed Colibri’s patent portfolio with a Medtronic employee in Business
`Development, and a Medtronic patent attorney. Among other topics, the
`participants discussed the recent allowance of a related Colibri patent application
`claiming a heart valve device with flared ends in a trumpet-like configuration, as
`well as other pending patent applications, including Colibri’s then pending U.S.
`Patent Application Nos. 14/253,650 and 14/253,656 that correspond to Colibri’s
`issued ’739 and ’294 patents, respectively.
`THE PATENTS-IN-SUIT
`
`The ’739 Patent
`18.
` The ’739 patent, entitled “Percutaneous Replacement Heart Valve and
`a Delivery and Implementation System,” was issued by the United States Patent
`and Trademark Office on September 8, 2015. A true and correct copy of the ’739
`patent is attached hereto as Exhibit 1.
`19. Colibri is the owner of the entire right, title, and interest in and to the
`’739 patent.
`20. Claim 1 of the ’739 patent recites:
`1.
`An assembly to treat a native heart valve in a patient, the
`assembly for use in combination with a guidewire, the assembly
`comprising:
`
`a prosthetic heart valve including:
`a stent member having an inner channel, the stent member
`collapsible, expandable and configured for trans-luminal
`percutaneous delivery, wherein the stent member includes a
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`COMPLAINT FOR PATENT INFRINGEMENT
`
`Colibri Heart Valve LLC, Exhibit 2001, Page 6 of 22
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`

`

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`tubular structure away from a central portion that flares at
`both ends in a trumpet-like configuration; and
`a valve means including two to four individual leaflets made of
`fixed pericardial tissue, wherein the valve means resides
`entirely within the inner channel of the stent member, and
`wherein no reinforcing members reside within the inner
`channel of the stent member;
`a delivery system including a pusher member and a moveable
`sheath, the pusher member including a guidewire lumen,
`wherein the pusher member is disposed within a lumen of the
`moveable sheath, wherein the prosthetic heart valve is
`collapsed onto the pusher member to reside in a collapsed
`configuration on the pusher member and is restrained in the
`collapsed configuration by the moveable sheath, wherein a
`distal end of the prosthetic heart valve is located at a distal end
`of the moveable sheath, and wherein the valve means resides
`entirely within the inner channel of the stent member in said
`collapsed configuration and is configured to continue to reside
`entirely within the inner channel of the stent member upon
`deployment in the patient.
`The ’294 Patent
`21. The ’294 patent, entitled “Method of Controlled Release of a
`Percutaneous Replacement Heart Valve,” was issued by the United States Patent
`and Trademark Office on December 2, 2014. A true and correct copy of the ’294
`patent is attached hereto as Exhibit 2.
`22. Colibri is the owner of the entire right, title, and interest in and to the
`’294 patent.
`23. Claim 1 of the ’294 patent recites:
`6
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`COMPLAINT FOR PATENT INFRINGEMENT
`
`Colibri Heart Valve LLC, Exhibit 2001, Page 7 of 22
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`

`

`
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`A method of controlled release of a percutaneous
`1.
`replacement heart valve at a location of a native heart valve in a patient,
`the method comprising:
`obtaining a replacement heart valve device and a delivery and
`implantation system:
`the replacement heart valve device including:
`a stent member that is collapsible, expandable and
`configured for percutaneous delivery; and
`a valve residing entirely within an inner channel of the stent
`member and attached to a proximal portion of the stent
`member, the valve including two to four individual
`leaflets made of fixed pericardial tissue;
`the delivery and implantation system including:
`a pusher member and a moveable sheath, wherein the
`pusher member includes a guide wire lumen, and wherein
`the moveable sheath includes a lumen configured for
`receiving the pusher member;
`after the obtaining step, loading the replacement heart valve
`device into the lumen of the moveable sheath such that the
`replacement heart valve device is collapsed onto the pusher
`member to reside in a collapsed configuration on the pusher
`member and is restrained in the collapsed configuration by the
`moveable sheath;
`after the loading step, advancing the delivery and implantation
`system transluminally over a guide wire within the patient to
`position the replacement heart valve device for deployment
`within the patient at the location of the native heart valve;
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`COMPLAINT FOR PATENT INFRINGEMENT
`
`7
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`Colibri Heart Valve LLC, Exhibit 2001, Page 8 of 22
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`

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`
`
`after the advancing step, partially deploying a distal portion of
`the replacement heart valve device within the patient by
`pushing out the pusher member from the moveable sheath to
`expose the distal portion of the replacement heart valve
`device;
`after the partially deploying step, restraining the replacement
`heart valve device so that it does not pop out and is held for
`controlled release, with a potential that the replacement heart
`valve device can be recovered if there is a problem with
`positioning; and
`after the restraining step, recovering the distal portion of the
`replacement heart valve device within the moveable sheath
`that was exposed in order to address a problem with the
`position of the replacement heart valve device within the
`patient.
`MEDTRONIC’S INFRINGING PRODUCTS
`24. Medtronic is the world’s largest medical device company and makes
`the majority of its sales and profits from the U.S. healthcare system. Medtronic
`maintains over 350 locations in more than 150 countries, and has over 86,000
`employees. The company was previously a U.S. corporation but in 2015, moved its
`headquarters to Ireland for tax purposes. Medtronic makes a variety of medical
`instruments or appliances, including products related to vessel sealing, lighted
`retractors, wound closure, and surgical stapling. Out of Medtronic’s approximately
`$30 billion in revenue, $11.4 billion represents revenue from its Cardiac and
`Vascular Group. Medtronic makes four infringing transcatheter aortic valve
`replacement (“TAVR”) products—CoreValve, CoreValve Evolut R, CoreValve
`Evolut PRO, and CoreValve Evolut PRO+.
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`COMPLAINT FOR PATENT INFRINGEMENT
`
`8
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`Colibri Heart Valve LLC, Exhibit 2001, Page 9 of 22
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`25. Like Colibri’s patented technology, the CoreValve, CoreValve
`Evolut R, CoreValve Evolut PRO, and CoreValve Evolut PRO+ Systems are each
`comprised of a transcatheter aortic valve (or bioprosthesis) and a delivery catheter
`system.
`The Medtronic CoreValve System
`26. Upon information and belief, Medtronic began commercial marketing
`of the CoreValve System in 2014.
`27. The Medtronic CoreValve System comprises a transcatheter aortic
`valve (or bioprosthesis) and a delivery catheter system.
`28. The CoreValve transcatheter aortic valve comprises three valve
`leaflets, manufactured from porcine pericardium. Like Colibri’s patented
`technology, these leaflets are sutured onto a collapsible and expandable, multi-
`level, radiopaque stent with flared ends in a trumpet-like configuration. The
`CoreValve transcatheter aortic valve comes or came in at least four models/sizes,
`including Models MCS-P4-23-AOA (23 mm; CoreValve Evolut), MCS-P3-26-
`AOA (26 mm), MCSP3-29-AOA (29 mm), and MCS-P3-31-AOA (31 mm).
`
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`The Medtronic CoreValve transcatheter aortic valve
`29. Like Colibri’s patented technology, the delivery catheter system
`deploys the valve. The delivery catheter system comprises a pusher member and a
`moveable sheath. It also comprises a deployment end and a handle. The
`deployment end has a tip and a capsule that covers and maintains the transcatheter
`
`9
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`COMPLAINT FOR PATENT INFRINGEMENT
`
`
`Colibri Heart Valve LLC, Exhibit 2001, Page 10 of 22
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`

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`aortic valve in a crimped position. The handle loads and deploys the valve. A
`macro slider on the handle opens and closes the capsule and micro knob to facilitate
`the placement of the transcatheter aortic valve.
`
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`The Medtronic CoreValve delivery catheter system
`30. The compression loading system compresses the transcatheter aortic
`valve into the catheter.
`
`
`The Medtronic CoreValve compression loading system
`
`31. Medtronic also provides instructional manuals and videos on how to
`use the CoreValve System. See, e.g., CoreValve Manual; CoreValve Loading
`Video (with Audio), YOUTUBE, https://youtu.be/tCtLqdCOdgc.
`//
`//
`//
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`10
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`Colibri Heart Valve LLC, Exhibit 2001, Page 11 of 22
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`The Medtronic CoreValve Evolut R
`32. The CoreValve Evolut R System is Medtronic’s second device in its
`TAVR product line. Upon information and belief, Medtronic began commercially
`marketing the CoreValve Evolut PRO System in the United States shortly after
`June 22, 2015.
`33. The CoreValve Evolut R System comprises a CoreValve Evolut R
`transcatheter aortic valve (or bioprosthesis) and a delivery catheter system.
`34. The CoreValve Evolut R transcatheter aortic valve comprises three
`valve leaflets, manufactured from porcine pericardium. Like Colibri’s patented
`technology, these leaflets are sutured onto a collapsible and expandable, multi-
`level, radiopaque stent with flared ends in a trumpet-like configuration. The
`CoreValve Evolut R transcatheter aortic valve comes in at least four models/sizes,
`including Models EVOLUTR-23-US (23 mm), EVOLUTR-26-US (26 mm),
`EVOLUTR-29-US (29 mm), and EVOLUTR-34-US (34 mm).
`
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`The Medtronic CoreValve Evolut R transcatheter aortic valve
`
`35. Like Colibri’s patented technology, the delivery system catheter
`deploys the valve. The deployment system catheter comprises a pusher member
`and a moveable sheath. In addition, the delivery system catheter utilizes a catheter
`with an integrated handle that loads, deploys, and recaptures the transcatheter aortic
`valve. The CoreValve Evolut R catheter comes in two models. For each, the
`
`
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`COMPLAINT FOR PATENT INFRINGEMENT
`
`11
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`Colibri Heart Valve LLC, Exhibit 2001, Page 12 of 22
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`deployment end of the system comprises a catheter tip and a capsule that covers and
`maintains the transcatheter aortic valve in a crimped position. The delivery system
`has a pusher member that includes a guidewire lumen and a moveable sheath with a
`lumen that enables the valve to be recaptured after partial deployment.
`
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`The Medtronic CoreValve Evolut R delivery catheter system
`
`
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`36. The loading system compresses the transcatheter aortic valve into the
`catheter. The loading system comes in two models.
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`The Medtronic CoreValve Evolut R loading systems
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`The Medtronic CoreValve Evolut PRO
`37. Medtronic’s CoreValve Evolut PRO System is its third TAVR
`product. Upon information and belief, Medtronic began commercially marketing
`the CoreValve Evolut PRO System in the United States shortly after March 20,
`2017.
`
`
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`COMPLAINT FOR PATENT INFRINGEMENT
`
`12
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`Colibri Heart Valve LLC, Exhibit 2001, Page 13 of 22
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`38. The Medtronic CoreValve Evolut PRO System comprises a CoreValve
`Evolut PRO transcatheter aortic valve and a delivery catheter system.
`39. The CoreValve Evolut PRO transcatheter aortic valve comprises three
`valve leaflets, manufactured from porcine pericardium. Like Colibri’s patented
`technology, these leaflets are sutured onto a collapsible and expandable, multi-
`level, radiopaque stent with flared ends in a trumpet-like configuration. The
`CoreValve Evolut PRO transcatheter aortic valve comes in at least three
`models/sizes, including Models EVOLUTPRO-23-US (23 mm), EVOLUTPRO-26-
`US (26 mm), and EVOLUTPRO-29-US (29 mm).
`
`
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`
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`The Medtronic CoreValve Evolut PRO transcatheter aortic valve
`
`40. Like Colibri’s patented technology, the CoreValve Evolut PRO
`delivery catheter system deploys the valve. The deployment system catheter
`comprises a pusher member and a moveable sheath. In addition, the delivery
`catheter system utilizes a catheter with an integrated handle that loads, deploys, and
`recaptures the transcatheter aortic valve. The CoreValve Evolut PRO catheter
`comes in two models. For each, the deployment end of the system comprises a
`catheter tip and a capsule that covers and maintains the transcatheter aortic valve in
`a crimped position. The delivery system has a pusher member that includes a
`
`
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`COMPLAINT FOR PATENT INFRINGEMENT
`
`13
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`Colibri Heart Valve LLC, Exhibit 2001, Page 14 of 22
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`guidewire lumen and a moveable sheath with a lumen that enables the valve to be
`recaptured after partial deployment.
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`The Medtronic CoreValve Evolut PRO delivery catheter system
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`41. The loading system compresses the transcatheter aortic valve into the
`catheter. The loading system comes in two models.
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`The Medtronic CoreValve Evolut PRO loading systems
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`The Medtronic CoreValve Evolut PRO+
`42. Medtronic’s fourth iteration of its TAVR product line is called the
`CoreValve Evolut PRO+ System. Upon information and belief, Medtronic began
`commercially marketing the CoreValve Evolut PRO+ System in the United States
`shortly after September 19, 2019.
`43. The CoreValve Evolut PRO+ comprises a CoreValve Evolut PRO+
`transcatheter aortic valve and a delivery catheter system.
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`COMPLAINT FOR PATENT INFRINGEMENT
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`14
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`Colibri Heart Valve LLC, Exhibit 2001, Page 15 of 22
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`44. The CoreValve Evolut PRO+ transcatheter aortic valve comprises
`three valve leaflets, manufactured from porcine pericardium. Upon information and
`belief, like Colibri’s patented technology, these leaflets are sutured onto a
`collapsible and expandable, multi-level, radiopaque stent with flared ends in a
`trumpet-like configuration. The CoreValve Evolut PRO+ transcatheter aortic valve
`comes in at least four models/sizes, including Models EVPROPLUS-23US (23
`mm), EVPROPLUS-26US (26 mm), EVPROPLUS-29US (29 mm), and
`EVPROPLUS-34US (34 mm).
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`The Medtronic CoreValve Evolut PRO+ transcatheter heart valve
`45. Like Colibri’s patented technology, the Evolut PRO+ delivery catheter
`system comprises a pusher member and a moveable sheath. The delivery catheter
`system deploys the valve:
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`The Medtronic Evolut PRO+ Delivery Catheter Systems
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Colibri Heart Valve LLC, Exhibit 2001, Page 16 of 22
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`46. The Evolut PRO+ Loading System compresses the transcatheter aortic
`valve into the catheter. This loading system comes in two models:
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`The Medtronic Evolut PRO+ Loading Systems
`CLAIM I
`(Infringement of the ’739 Patent)
`47. Colibri repeats and realleges the foregoing allegations as if fully set
`forth herein.
`48. The ’739 patent is valid and enforceable.
`49. Medtronic has had actual notice of the ’739 patent no later than the
`date of filing and service of this Complaint and prior to that was at least aware of
`the patent family from which the ’739 patent would ultimately issue since May 6,
`2014.
`
`50. Each of the CoreValve, CoreValve Evolut R, CoreValve Evolut PRO,
`and CoreValve Evolut PRO+ Systems, including their use in accordance with the
`guidance and instructions that Medtronic provides for these products, infringes one
`or more claims of the ’739 patent, including, without limitation, claim 1, either
`literally or under the doctrine of equivalents.
`51.
`In violation of 35 U.S.C. § 271(a), Medtronic has been and is directly
`infringing the ’739 patent, either literally or under the doctrine of equivalents, by
`making, using, selling, and/or offering to sell in the United States, and/or importing
`into the United States, without license or authority, the CoreValve, CoreValve
`Evolut R, CoreValve Evolut PRO, and CoreValve Evolut PRO+ Systems.
`52.
`In violation of 35 U.S.C. § 271(b), Medtronic has been and is
`indirectly infringing the ’739 patent by inducing infringement of this patent by
`
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`COMPLAINT FOR PATENT INFRINGEMENT
`
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`Colibri Heart Valve LLC, Exhibit 2001, Page 17 of 22
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`others, such as surgeons, other medical professionals, and patients, in the United
`States.
`53. Medtronic’s affirmative acts of making, selling, and offering to sell its
`services and/or products, or components thereof, cause the CoreValve, CoreValve
`Evolut R, CoreValve Evolut PRO, and CoreValve Evolut PRO+ Systems to be used
`in a manner that infringes the ’739 patent. Medtronic further provides guidance and
`instruction to third parties to use the CoreValve, CoreValve Evolut R, CoreValve
`Evolut PRO, and CoreValve Evolut PRO+ Systems in their normal and customary
`way to infringe the ’739 patent.
`54. Medtronic specifically intends that surgeons and other third parties
`infringe the ’739 patent. Medtronic performs the acts that constitute induced
`infringement with knowledge of the ’739 patent and with knowledge or willful
`blindness that the induced acts would constitute infringement.
`55.
`In violation of 35 U.S.C. § 271(c), Medtronic has been and is
`indirectly infringing the ’739 patent by contributing to the infringement of this
`patent by others, such as surgeons, other medical professionals, and patients, in the
`United States. Medtronic has offered to sell and sell in the United States, and
`imported into the United States, the CoreValve, CoreValve Evolut R, CoreValve
`Evolut PRO, and CoreValve Evolut PRO+ Systems, which are a material part of the
`claimed invention of the ’739 patent. Medtronic knows that the CoreValve,
`CoreValve Evolut R, CoreValve Evolut PRO, and CoreValve Evolut PRO+
`Systems are especially made or especially adapted for use in an infringement of the
`’739 patent, and not a staple article or commodity of commerce suitable for
`substantial noninfringing use.
`56. Medtronic has willfully infringed the ’739 patent by deliberately and
`egregious engaging in acts of infringement on an ongoing basis with knowledge of
`Colibri’s patent.
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Colibri Heart Valve LLC, Exhibit 2001, Page 18 of 22
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`CLAIM II
`(Infringement of the ’294 Patent)
`57. Colibri repeats and realleges the foregoing allegations as if fully set
`forth herein.
`58. The ’294 patent is valid and enforceable.
`59. Medtronic has had actual notice of the ’294 patent no later than the
`date of filing and service of this Complaint and prior to that was at least aware of
`the patent family from which the ’294 patent would ultimately issue since May 6,
`2014.
`
`60. The use of each of the CoreValve Evolut R, CoreValve Evolut PRO,
`and CoreValve Evolut PRO+ Systems, in accordance with the guidance and
`instructions that Medtronic provides for these products, infringes one or more
`claims of the ’294 patent, including, without limitation, claim 1, either literally or
`under the doctrine of equivalents.
`61.
`In violation of 35 U.S.C. § 271(a), Medtronic has been and is directly
`infringing the ’294 patent, either literally or under the doctrine of equivalents, by
`using, without license or authority, the CoreValve Evolut R, CoreValve Evolut
`PRO, and CoreValve Evolut PRO+ Systems in the United States.
`62.
`In violation of 35 U.S.C. § 271(b), Medtronic has been and is
`indirectly infringing the ’294 patent by inducing infringement of this patent by
`others, such as surgeons, other medical professionals, and patients, in the United
`States.
`63. Medtronic’s affirmative acts of making, selling, and offering to sell its
`services and/or products, or components thereof, cause the CoreValve Evolut R,
`CoreValve Evolut PRO, and CoreValve Evolut PRO+ Systems to be used in a
`manner that infringes the ’294 patent. Medtronic further provides guidance and
`instruction to third parties to use the CoreValve Evolut R, CoreValve Evolut PRO,
`
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Colibri Heart Valve LLC, Exhibit 2001, Page 19 of 22
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`and CoreValve Evolut PRO+ Systems in their normal and customary way to
`infringe the ’294 patent.
`64. Medtronic specifically intends that surgeons and other third parties
`infringe the ’294 patent. Medtronic performs the acts that constitute induced
`infringement with knowledge of the ’294 patent and with knowledge or willful
`blindness that the induced acts would constitute infringement.
`65.
`In violation of 35 U.S.C. § 271(c), Medtronic has been and is
`indirectly infringing the ’294 patent by contributing to the infringement of this
`patent by others, such as surgeons, other medical professionals, and patients, in the
`United States. Medtronic has made, offered to sell and sells in the United States,
`and imported into the United States, CoreValve Evolut R, CoreValve Evolut PRO,
`and CoreValve Evolut PRO+ Systems, which are a material part of the claimed
`invention of the ’294 patent. Medtronic knows that the CoreValve Evolut R,
`CoreValve Evolut PRO, and CoreValve Evolut PRO+ Systems are especially made
`or especially adapted for use in an infringement of the ’294 patent, and not a staple
`article or commodity of commerce suitable for substantial noninfringing use.
`66. Medtronic has willfully infringed the ’294 patent by deliberately and
`egregious engaging in acts of infringement on an ongoing basis with knowledge of
`Colibri’s patent.
`
`PRAYER FOR RELIEF
`WHEREFORE, Colibri respectfully requests that this Court enter judgment
`in its favor and grant the following relief against Medtronic as follows:
`A.
`Judgment that Medtronic infringed and continues to infringe the ’739
`patent;
`Judgment that Medtronic infringed and continues to infringe the ’294
`patent;
`Judgment that Medtronic’s infringement was and is willful;
`
`B.
`
`C.
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Colibri Heart Valve LLC, Exhibit 2001, Page 20 of 22
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`F.
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`G.
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`D. Award Colibri damages in an amount a