DCT

1:23-cv-00158

Aortic Innovations LLC v. Edwards Lifesciences Corp

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00158, D. Del., 04/10/2023
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendants are incorporated there, maintain regular and established places of business including affiliated hospitals, employ staff involved in the sales and training for the accused product, and derive substantial revenue from the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Sapien 3 Ultra line of transcatheter heart valves infringes five patents related to sealing technology that uses outwardly extending fibers to prevent leakage around the implanted device.
  • Technical Context: The technology pertains to transcatheter aortic valve replacement (TAVR), a minimally invasive procedure to replace a diseased aortic valve that has become a leading alternative to traditional open-heart surgery.
  • Key Procedural History: The complaint alleges a history of interaction between the parties, including direct communications between the inventor and Defendant’s executives in 2017 regarding the patented technology. Plaintiff also notes that it previously sued Defendant in the same district in 2021 over different but related patents (the "First Action"). The complaint further alleges that Defendant was aware of Plaintiff’s patent applications as early as 2014, having cited them during the prosecution of its own patents.

Case Timeline

Date Event
2011-12-06 Earliest Priority Date for all Patents-in-Suit
2012-01-01 Dr. Shahriari conceives of TAVR devices with outer covering (approx.)
2014-11-14 Edwards cites Aortic Innovations patent publication in an IDS
2017-05-02 Conference call between Dr. Shahriari and Edwards
2017-05-31 Edwards files provisional patent application on TAVR with extending fibers
2018-12-01 FDA approval for Sapien 3 Ultra TAVR (approx.)
2021-09-28 Plaintiff files "First Action" against Defendant
2022-05-24 U.S. Patent No. 11,337,834 Issues
2022-07-01 FDA approval for Sapien 3 Ultra with Resilia leaflets (approx.)
2022-07-19 U.S. Patent No. 11,389,310 Issues
2022-09-01 Launch of Sapien 3 Ultra with Resilia leaflets (approx.)
2022-11-08 U.S. Patent No. 11,491,033 Issues
2022-11-15 U.S. Patent No. 11,497,634 Issues
2022-12-13 U.S. Patent No. 11,523,918 Issues
2023-02-15 Plaintiff sends notice letter to Defendant regarding Patents-in-Suit
2023-04-10 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 11,337,834 - “Transcatheter Valve Repair Having Improved Paravalvular Seal”

  • Patent Identification: U.S. Patent No. 11,337,834, “Transcatheter Valve Repair Having Improved Paravalvular Seal,” issued May 24, 2022 (the “’834 Patent”).

The Invention Explained

  • Problem Addressed: The patent background describes the challenge in endovascular repair of achieving effective seals, particularly avoiding paravalvular leaks, which can occur around an implanted device (’834 Patent, col. 2:45-54). The complaint frames this as a deadly and significant drawback of earlier TAVR devices (Compl. ¶56).
  • The Patented Solution: The invention is a prosthetic heart valve with an external sealing mechanism comprised of a "plurality of fibers that extend away from the frame" (’834 Patent, Abstract). When the valve is expanded inside the patient's aorta, these fibers are designed to be compressed against the native tissue, filling gaps and creating a seal to prevent blood from leaking around the implant (’834 Patent, col. 23:25-col. 24:24 (Claim 18)).
  • Technical Importance: This fibrous sealing approach is presented as a solution to reduce the high rate of paravalvular leakage (PVL), a critical complication that limited the safety and effectiveness of earlier TAVR technologies (Compl. ¶¶56-57).

Key Claims at a Glance

  • The complaint asserts independent claim 18 (’834 Patent, Compl. ¶119).
  • Key elements of claim 18 include:
    • An endovascular prosthetic heart valve for use in a patient.
    • A frame formed of struts cooperating to form a plurality of cells, with at least two rows of cells at an inflow end.
    • The frame is radially expandable from a compressed to an expanded orientation.
    • A leaflet assembly within the frame.
    • A polymer covering carrying the leaflet assembly.
    • A plurality of fibers that extend away from the frame, configured for being pressed against native leaflets.
    • The valve defines a spacing extending through a thickness of the fibers.
    • Compression of the fibers in response to expansion compresses the fibers relative to the spacings to create a seal.
    • The fibers extend over each of the at least two rows of cells.
  • The complaint does not explicitly reserve the right to assert dependent claims for the ’834 Patent.

U.S. Patent No. 11,389,310 - “Device for Aortic Repair and Method of Using the Same”

  • Patent Identification: U.S. Patent No. 11,389,310, “Device for Aortic Repair and Method of Using the Same,” issued July 19, 2022 (the “’310 Patent”).

The Invention Explained

  • Problem Addressed: The patent addresses the need for a device that can treat various aortic conditions, including aortic valve disease, while enabling treatment of possible paravalvular leaks (’310 Patent, col. 2:38-50).
  • The Patented Solution: The invention is a transcatheter aortic heart valve assembly featuring an external "sealing material" that includes a "plurality of outwardly extending, arcuate fibers" (’310 Patent, Abstract). This material is positioned on the outside of the valve's frame and is configured to press against the native aortic leaflets upon expansion, thereby sealing the space between the implant and the patient's anatomy to prevent leaks (’310 Patent, col. 21:13-col. 22:42 (Claim 11)).
  • Technical Importance: By providing an improved external seal, the invention aims to enhance the safety and reliability of TAVR procedures, addressing a primary clinical complication (Compl. ¶¶56-57).

Key Claims at a Glance

  • The complaint asserts independent claim 11 (’310 Patent, Compl. ¶139).
  • Key elements of claim 11 include:
    • A transcatheter aortic heart valve assembly.
    • A graft covering engaging prosthetic heart valve leaflets.
    • A frame formed from a metallic material, defining an open cell configuration, and secured to the graft covering.
    • A sealing material positioned externally to the frame to prevent paravalvular leaks, attached to the frame.
    • The sealing material defines a height extending over at least a first two rows of cells in the frame.
    • The sealing material includes a plurality of outwardly extending, arcuate fibers.
    • The assembly is configured for endovascular deployment and has compressed and expanded orientations.
    • Expansion is configured to press the fibers into engagement with native leaflets.
    • The plurality of fibers is in contact with the frame along the height of the sealing material in both orientations.
  • The complaint does not explicitly reserve the right to assert dependent claims for the ’310 Patent.

Multi-Patent Capsule: U.S. Patent No. 11,491,033

  • Patent Identification: U.S. Patent No. 11,491,033, “Transcatheter Valve Repair Having Improved Paravalvular Seal,” issued November 8, 2022 (the “’033 Patent”) (Compl. ¶23).
  • Technology Synopsis: The ’033 Patent addresses paravalvular leakage by describing a valve assembly with an external sealing assembly containing "arcuate fibers." Upon deployment, the expansion of the valve presses this sealing assembly against the native tissue, while a polymer covering also expands radially outward, with the two actions "cooperatively creat[ing] a paravalvular seal" (Compl. ¶158).
  • Asserted Claims: Independent claim 1 (Compl. ¶158).
  • Accused Features: The accused features are the Sapien 3 Ultra's external fibrous skirt and its polymer graft covering, which are alleged to work together upon expansion to create the claimed cooperative seal (Compl. ¶¶159-167).

Multi-Patent Capsule: U.S. Patent No. 11,497,634

  • Patent Identification: U.S. Patent No. 11,497,634, “Transcatheter Valve Repair Having Improved Paravalvular Seal,” issued November 15, 2022 (the “’634 Patent”) (Compl. ¶24).
  • Technology Synopsis: The ’634 Patent describes a valve assembly with a frame constructed of struts that form apices at the inflow end. A sealing layer of "arcuate, spaced-apart, and outwardly extending" fibers is attached, but the invention specifies that an end of the most proximal apices of the frame remains uncovered by the fibers and graft, extending more proximally than the fibers themselves (Compl. ¶175).
  • Asserted Claims: Independent claim 1 (Compl. ¶175).
  • Accused Features: The accused features include the Sapien 3 Ultra's frame, graft, and fibrous sealing material, with a specific allegation that the device's most proximal apices are uncovered and extend beyond the sealing fibers as claimed (Compl. ¶¶176-186). An annotated image in the complaint shows these "uncovered proximal apices" (Compl. ¶85, p. 54).

Multi-Patent Capsule: U.S. Patent No. 11,523,918

  • Patent Identification: U.S. Patent No. 11,523,918, “Transcatheter Valve Repair Having Improved Paravalvular Seal,” issued December 13, 2022 (the “’918 Patent”) (Compl. ¶25).
  • Technology Synopsis: The ’918 Patent describes an assembly with an external sealing material composed of flexible, arcuate, spaced-apart fibers. These spacings are designed to allow fluid to pass through when the valve is uncompressed but are reduced upon deployment, as the compression of the fibers into these spacings forms a seal against the native tissue and the frame (Compl. p. 87, Claim 1).
  • Asserted Claims: Independent claim 1 (Compl. ¶194).
  • Accused Features: The accused features are the Sapien 3 Ultra's external sealing material and its constituent fibers, which are alleged to be flexible, spaced-apart, and to compress into the defined spacings to create a seal upon deployment (Compl. ¶¶195-206).

III. The Accused Instrumentality

Product Identification

  • The Edwards Sapien 3 Ultra and Sapien 3 Ultra with Resilia leaflets transcatheter heart valve systems (collectively "Sapien 3 Ultra") (Compl. ¶5, ¶65).

Functionality and Market Context

  • The Sapien 3 Ultra is a balloon-expandable prosthetic heart valve delivered via catheter through a femoral artery to replace a diseased native aortic valve (Compl. ¶72, ¶74). The complaint alleges that a key feature of the device is a "heightened outer skirt" made of "radially or outwardly extending fibers" designed to reduce paravalvular leakage (PVL) (Compl. ¶60). This outer skirt is described as being made of "textured polyethylene terephthalate (PET)" (Compl. ¶74). An annotated image from Defendant's brochure shows this "Sealing skirt technology," noting it is approximately 40% taller than the predecessor valve's skirt (Compl. ¶81, p. 44).
  • The complaint alleges the Sapien 3 Ultra is a major commercial success, representing over two-thirds of Defendant's global TAVR sales by the end of 2020 and generating approximately $3.1 billion in sales in 2021 (Compl. ¶61). The reduction in PVL afforded by the outer skirt is alleged to be a "highly marketed feature" and a primary reason for the product's rapid market adoption (Compl. ¶63).

IV. Analysis of Infringement Allegations

'834 Patent Infringement Allegations

Claim Element (from Independent Claim 18) Alleged Infringing Functionality Complaint Citation Patent Citation
a frame formed of a plurality of struts that cooperate to form a plurality of cells, wherein the plurality of cells defines at least two rows of cells at an inflow end of the frame The Sapien 3 Ultra includes a cobalt-chromium frame formed by struts that create multiple rows of open cells at its inflow end. ¶121-122 col. 7:45-51
wherein the frame is radially expandable from a radially compressed orientation to a radially expanded orientation The Sapien 3 Ultra is a balloon-expandable valve designed to be delivered in a radially compressed state and expanded to a deployed state within the patient. ¶123 col. 7:42-44
a polymer covering carrying the leaflet assembly and positioned radially inwardly of the frame and radially outwardly of the leaflet assembly The Sapien 3 Ultra includes a PET polymer graft covering that houses the valve leaflets and is positioned inside the metallic frame. ¶125 col. 23:40-45
a plurality of fibers that extend away from the frame The textured PET outer skirt of the Sapien 3 Ultra is alleged to constitute a plurality of fibers that extend outwardly from the frame. ¶126 col. 11:15-21
wherein the plurality of fibers is configured for being pressed against native leaflets of the patient... The device is designed such that upon balloon expansion, the outer skirt with its fibers is pressed into engagement with the native aortic leaflets. ¶128 col. 12:44-50
wherein the prosthetic heart valve defines a spacing extending through a thickness of the plurality of fibers... through the plurality of cells of the frame The complaint alleges spacings are defined between the fibers of the outer skirt, which extend radially through the thickness of the skirt and through the cells of the frame. ¶129 col. 12:4-10
wherein, compression of the plurality of fibers in response to expansion... compresses the plurality of fibers relative to the spacings to create a seal thereabout The complaint alleges that expansion of the valve compresses the fibers of the outer skirt into the alleged spacings, creating a seal against the native tissue and frame. ¶130 col. 12:50-55

'310 Patent Infringement Allegations

Claim Element (from Independent Claim 11) Alleged Infringing Functionality Complaint Citation Patent Citation
a graft covering engaging prosthetic heart valve leaflets, wherein the graft covering extends around the prosthetic heart valve leaflets for providing sealing The Sapien 3 Ultra has an inner polymer graft covering made of PET that extends around and engages the valve leaflets. ¶141 col. 21:14-17
a frame formed from a metallic material and defining an open cell configuration, and being secured to the graft covering The device has a metallic, open-cell cobalt-chromium frame, which is secured to the graft covering by stitches. ¶142 col. 21:18-21
a sealing material positioned externally to the frame for providing sealing... wherein the sealing material is attached to the frame The device includes an external PET outer skirt, which constitutes the sealing material and is attached to the frame. ¶143-144 col. 21:22-26
wherein the sealing material defines a height that extends over at least a first two rows of cells in the frame The external sealing skirt extends over at least two rows of cells at the inflow end of the frame. ¶145 col. 21:27-29
wherein the sealing material includes a plurality of outwardly extending, arcuate fibers that extend outwardly of the frame The textured surface of the external PET skirt is alleged to comprise a plurality of arcuate fibers that extend outwardly. ¶146 col. 21:30-32
wherein the heart valve assembly has a radially compressed orientation and a radially expanded orientation The Sapien 3 Ultra is designed to be delivered in a compressed state and deployed to an expanded state via balloon expansion. ¶148 col. 22:1-3
wherein expansion... is configured to press the outwardly extending fibers into engagement with native leaflets of the aorta The complaint alleges the device is designed so that expansion presses the outer skirt's fibers against the native aortic leaflets to create a seal. ¶149 col. 22:4-8
wherein the plurality of fibers is in contact with the frame along the height of the sealing material when the heart valve assembly is in the radially compressed orientation and the radially expanded orientation The fibers of the sealing skirt are alleged to be in contact with the frame along the skirt's height in both the compressed and expanded states. ¶150 col. 22:9-13

Identified Points of Contention

  • Scope Questions: A central dispute may arise over whether the accused product’s "textured polyethylene terephthalate (PET) outer skirt" (Compl. ¶74) meets the claimed limitation of "a plurality of fibers" (’834 Patent) or "a plurality of outwardly extending, arcuate fibers" (’310 Patent). The litigation may focus on whether this claim language can be construed to read on an integrated textured fabric, as opposed to the discrete, hair-like strands depicted in certain patent figures (e.g., ’834 Patent, Fig. 8).
  • Technical Questions: The complaint alleges that expansion of the Sapien 3 Ultra "compresses the plurality of fibers relative to the spacings to create a seal" (’834 Patent, Compl. ¶130). A key factual question will be whether the accused product's skirt actually operates by compressing fibers into defined "spacings," or if it achieves a seal through a different mechanism, such as material bulk or passive billowing.

V. Key Claim Terms for Construction

  • The Term: "a plurality of fibers" (’834 Patent) and "a plurality of outwardly extending, arcuate fibers" (’310 Patent).

  • Context and Importance: The definition of this term is critical, as it forms the basis of the infringement allegation against the accused product's textured PET outer skirt. Practitioners may focus on this term because its construction will likely determine whether a textured fabric surface falls within the scope of claims that, in some embodiments, depict distinct, individual strands.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification of the ’834 patent refers to "collagen fibers" as one possible material, but also more broadly discusses using fibers to "aid in preventing paravalvular leaks and migration" (’834 Patent, col. 11:15-21), a functional description that could support a broader reading beyond a specific physical structure.
    • Evidence for a Narrower Interpretation: Figures in the asserted patents, such as Figure 8 of the ’834 Patent, illustrate element 234 as discrete, hair-like strands extending from a base material. Defendant may argue that these specific embodiments limit the term "fibers" to such distinct structures, excluding the integrated texture of a woven or non-woven fabric.

  • The Term: "spacings" (e.g., "wherein the prosthetic heart valve defines a spacing extending through a thickness of the plurality of fibers") (’834 Patent, Claim 18).

  • Context and Importance: This term is tied to the claimed sealing mechanism, which requires the compression of fibers "relative to the spacings" to create the seal. The existence and nature of these "spacings" in the accused product will be a primary point of contention.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The term is defined functionally by its role in the compression and sealing process. Plaintiff may argue that any interstitial voids within a textured fabric that are reduced upon compression meet this functional definition.
    • Evidence for a Narrower Interpretation: The ’834 patent specification describes the fibers being "spaced-apart to define spacings in a radially extending direction" (’834 Patent, col. 12:4-6). This language, particularly when read in light of figures showing discrete strands, could support an interpretation requiring literal, open gaps between individual fiber elements, not merely the microscopic pores of a fabric.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement based on Defendant's promotional materials, instructions for use, and training of physicians, which allegedly direct others to use the Sapien 3 Ultra in an infringing manner (Compl. ¶¶93, 134). The complaint also pleads contributory infringement, alleging the Sapien 3 Ultra has no substantial non-infringing uses and is a material part of the patented inventions (Compl. ¶¶135, 154).
  • Willful Infringement: The complaint alleges willful infringement based on Defendant's purported knowledge of the patented technology long before the suit was filed. The alleged bases for knowledge include: (1) Defendant's citation to Plaintiff's patent applications during its own patent prosecution beginning in 2014; (2) direct discussions in 2017 between Defendant's executives and the inventor concerning the technology; (3) Plaintiff's prior lawsuit filed in 2021 on related patents; and (4) explicit notice letters sent in 2021 and 2023 identifying the infringing product and relevant patents (Compl. ¶¶30-40, 51, 53, 100-102, 113-114).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of definitional scope: can the term "plurality of fibers," which is illustrated in patent figures with distinct, hair-like strands, be construed broadly enough to read on the integrated "textured" fabric skirt of the accused Sapien 3 Ultra device? The outcome of this claim construction dispute may be dispositive for infringement.
  • A second key question will be one of technical mechanism: assuming the claim terms are construed in Plaintiff's favor, does the accused device's sealing skirt function as claimed? Specifically, does it operate by creating defined "spacings" that are reduced upon radial expansion to form a seal, or is there a fundamental mismatch in its technical operation compared to that described in the patents?
  • Finally, a central question for damages will be willfulness: given the extensive history of alleged interactions and notices detailed in the complaint, including Defendant’s citation of Plaintiff’s own patent applications years before the patents-in-suit issued, the court will have to determine whether Defendant’s alleged infringement, if proven, was willful and egregious.