DCT

4:19-cv-06593

Edwards Lifesciences Corp v. Meril Life Sciences Pvt Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 4:19-cv-06593, N.D. Cal., 04/06/2020
  • Venue Allegations: Venue is alleged to be proper against Defendant Meril Life Sciences Pvt. Ltd. as a foreign entity that committed acts of infringement in the district. Venue is alleged to be proper against Defendant Meril, Inc. as it is subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Myval transcatheter aortic valve and its associated delivery systems are direct copies of Plaintiff’s SAPIEN products and infringe five U.S. patents related to prosthetic heart valve design, tissue treatment methods, and delivery systems.
  • Technical Context: The technology is in the field of transcatheter aortic valve replacement (TAVR), a minimally invasive medical procedure to replace a diseased heart valve, which serves as an alternative to open-heart surgery.
  • Key Procedural History: The complaint alleges a prior trademark dispute between the parties in 2015, where Defendant sought to register the mark "MAGMA" for artificial surgical implants, which Plaintiff alleged was confusingly similar to its "MAGNA" trademark for heart valves. Defendant ultimately withdrew its applications and undertook to refrain from using the mark.

Case Timeline

Date Event
2002-01-03 Priority Date for ’168 and ’256 Patents
2005-04-12 ’168 Patent Issued
2008-06-06 Priority Date for ’817 Patent
2010-10-05 Priority Date for ’110 Patent
2011-07-27 Priority Date for ’716 Patent
2015-09-01 ’716 Patent Issued
2016-01-01 Approx. Date Meril Began Tests on Myval Valves
2016-07-19 ’110 Patent Issued
2017-01-01 Approx. Date Meril Imported Myval System for Cadaver Implantation in U.S.
2018-08-21 ’256 Patent Issued
2018-11-01 Approx. Date Meril Began Marketing Myval Valves in India
2019-05-21 ’817 Patent Issued
2019-09-25 Meril Exhibited Myval System at TCT Conference in San Francisco
2020-04-06 First Amended Complaint Filed

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

U.S. Patent No. 10,292,817 - "Low Profile Transcatheter Heart Valve"

  • Patent Identification: U.S. Patent No. 10,292,817, "Low Profile Transcatheter Heart Valve," issued May 21, 2019.

The Invention Explained

  • Problem Addressed: The patent describes the clinical importance of reducing the crimped diameter (or profile) of a transcatheter heart valve, as a smaller profile allows the device to be delivered less invasively through a patient's arteries to treat a wider population with greater safety (’817 Patent, col. 2:11-20).
  • The Patented Solution: The invention addresses this problem through a specific valve construction. It features a leaflet structure with a "scalloped" lower edge that is positioned inside a collapsible frame (’817 Patent, col. 7:15-24). This geometry is intended to reduce the amount of tissue material, which in turn helps minimize the valve's profile when crimped for delivery (’817 Patent, col. 7:25-30). Key elements include reinforcing members and a skirt that are assembled with the leaflets before being secured to the frame (’817 Patent, Abstract; Fig. 18).
  • Technical Importance: This design approach contributes to creating smaller, more deliverable TAVR devices, expanding the applicability of this life-saving, minimally invasive therapy.

Key Claims at a Glance

  • The complaint asserts independent Claim 1 and dependent Claims 6, 7, 8, and 17 (Compl. ¶61).
  • The essential elements of independent Claim 1 include:
    • Suturing a reinforcing member to an inner surface of a leaflet structure adjacent a lower edge.
    • Suturing a skirt member to an outer surface of the leaflet structure along a scallop line to form an assembly.
    • Placing the assembly inside a radially collapsible and expandable annular frame made of a plastically deformable material (e.g., stainless steel or nickel-cobalt alloy).
    • Suturing the skirt member to the struts of the frame.
  • The complaint does not explicitly reserve the right to assert other dependent claims.

U.S. Patent No. 9,393,110 - "Prosthetic Heart Valve"

  • Patent Identification: U.S. Patent No. 9,393,110, "Prosthetic Heart Valve," issued July 19, 2016.

The Invention Explained

  • Problem Addressed: Similar to the ’817 Patent, this patent addresses the need to reduce the crimped profile of a transcatheter heart valve to improve its deliverability through a patient's vasculature (’110 Patent, col. 2:1-8).
  • The Patented Solution: The invention achieves a smaller profile through a frame design that has a tapered shape when mounted for delivery, with the inflow end having a smaller diameter than the outflow end (’110 Patent, Abstract). This can be accomplished by using generally V-shaped leaflets, which reduce the amount of material at the valve's inflow end (’110 Patent, col. 2:25-29). The invention also discloses an outer skirt designed to have axial slack when the valve is expanded, which allows the frame to elongate during crimping without resistance from the skirt (’110 Patent, col. 3:17-31).
  • Technical Importance: The combination of a tapered frame design and a specialized skirt facilitates a more compact crimped profile, which is a critical factor for successful transcatheter valve delivery.

Key Claims at a Glance

  • The complaint asserts independent Claim 1 (Compl. ¶68).
  • The essential elements of independent Claim 1 include:
    • A delivery apparatus with an elongated shaft.
    • A radially expandable prosthetic heart valve mounted on the shaft in a collapsed configuration.
    • The valve includes an annular frame, a leaflet structure, an inner fabric skirt, and an outer fabric skirt.
    • The outer skirt extends from the inflow end of the frame to a frame attachment location.
    • The frame is adapted to shorten axially during radial expansion, which increases axial slack in the outer fabric skirt.
  • The complaint does not explicitly reserve the right to assert other dependent claims.

U.S. Patent No. 9,119,716 - "Delivery Systems for Prosthetic Heart Valve"

  • Patent Identification: U.S. Patent No. 9,119,716, "Delivery Systems for Prosthetic Heart Valve," issued September 1, 2015.
  • Technology Synopsis: The patent describes a delivery apparatus for a prosthetic heart valve, including features such as an inflatable balloon and proximal and distal stops configured to limit the movement of the valve on the balloon during delivery through a patient's vasculature (’716 Patent, Abstract). The design aims to provide precise control and secure placement of the valve.
  • Asserted Claims: At least Claim 1 is asserted (Compl. ¶73).
  • Accused Features: The complaint alleges that Defendant's "Navigator" Delivery System, which is part of the "Myval System," infringes the ’716 Patent (Compl. ¶¶ 36, 72-73).

U.S. Patent No. 6,878,168 - "Treatment of Bioprosthetic Tissues to Mitigate Post Implantation Calcification"

  • Patent Identification: U.S. Patent No. 6,878,168, "Treatment of Bioprosthetic Tissues to Mitigate Post Implantation Calcification," issued April 12, 2005.
  • Technology Synopsis: The patent claims a method for treating biological tissue (used to make valve leaflets) to reduce its tendency to calcify after implantation in a patient (’168 Patent, Abstract). The method involves heating a glutaraldehyde solution to reduce its pH, and then contacting the biological tissue with this pH-reduced solution (’168 Patent, Claim 1).
  • Asserted Claims: At least Claim 1 is asserted (Compl. ¶78).
  • Accused Features: The complaint alleges that the manufacturing processes used by Defendant to create the bioprosthetic tissue for the Myval valve infringes the ’168 Patent (Compl. ¶¶ 84, 86).

U.S. Patent No. 10,053,256 - "Treatment of Bioprosthetic Tissues to Mitigate Post Implantation Calcification"

  • Patent Identification: U.S. Patent No. 10,053,256, "Treatment of Bioprosthetic Tissues to Mitigate Post Implantation Calcification," issued August 21, 2018.
  • Technology Synopsis: Related to the ’168 Patent, this patent claims a method for mitigating calcification of bioprosthetic material (’256 Patent, Abstract). The claimed method includes specific steps of heating a glutaraldehyde solution to about 70° C for 6-8 days, immersing the tissue, and then assembling, packaging, and sterilizing the resulting bioprosthesis (’256 Patent, Claim 1).
  • Asserted Claims: At least Claim 1 is asserted (Compl. ¶90).
  • Accused Features: The complaint alleges that the manufacturing processes used by Defendant for the Myval valve's bioprosthetic tissue infringe the ’256 Patent (Compl. ¶¶ 93-94).

III. The Accused Instrumentality

Product Identification

  • The accused products are Defendant’s “Myval” transcatheter aortic valve repair devices and associated “Navigator” delivery systems and components (the “Accused Products”) (Compl. ¶22, 36).

Functionality and Market Context

  • The Myval system is a transcatheter heart valve designed for implantation in the human anatomy to treat aortic stenosis (Compl. ¶¶ 21, 36). The complaint alleges that the Myval valve is "substantially a copy of Edwards' SAPIEN 3 transcatheter heart valve" (Compl. ¶32). To support this, the complaint includes side-by-side photographic comparisons from a "tear down" analysis, alleging that Meril copied the SAPIEN 3's valve frame structure, tissue leaflet structure, and inner and outer fabric skirts (Compl. ¶¶ 33-34). One such visual shows the separated frame and leaflet components of both the SAPIEN 3 and Myval products, highlighting their alleged structural similarities (Compl. p. 10). The complaint positions Defendant as attempting to capitalize on Plaintiff’s innovation and market leadership in the TAVR field by producing a "blatantly copycat product" (Compl. ¶26).

IV. Analysis of Infringement Allegations

U.S. Patent No. 10,292,817 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a leaflet structure comprising three leaflets, each of the leaflets having a curved lower edge The Myval valve includes a tissue leaflet structure that the complaint alleges was copied from the SAPIEN 3. ¶34 col. 7:8-14
suturing a reinforcing member to an inner surface of a leaflet structure adjacent a lower edge of the leaflet structure The Myval valve includes an "Inner Reinforcing Strip" that is alleged to be a copy of the SAPIEN 3's reinforcing member. ¶34 col. 8:56-61
suturing a skirt member to an outer surface of the leaflet structure along a scallop line that tracks the lower edge of the leaflet structure to form an assembly The Myval valve includes inner and outer skirts that are alleged to be copies of the SAPIEN 3's skirts and are assembled with the leaflets. ¶34 col. 8:1-8
placing the assembly inside of a radially collapsible and expandable annular frame... The Myval valve assembly, comprising the leaflets and skirts, is placed inside the Myval's metal frame. ¶34 col. 7:1-4
suturing the skirt member to struts of the frame The Myval's skirts are attached to its frame structure. ¶33-34 col. 8:65-col. 9:2

U.S. Patent No. 9,393,110 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a radially expandable prosthetic heart valve mounted on the shaft in a collapsed configuration, the prosthetic heart valve comprising an annular frame...a leaflet structure...an inner fabric skirt...and an outer fabric skirt... The Myval valve is a transcatheter heart valve system comprising a frame, leaflets, and inner and outer skirts, and is delivered via a catheter. ¶32-34 col. 1:19-24
the outer fabric skirt extending from the inflow end of the frame to a frame attachment location The Myval valve includes an outer skirt attached to its frame. The complaint alleges direct copying of the SAPIEN 3's construction. ¶33 col. 3:17-21
wherein the frame is adapted to shorten axially during radial expansion of the prosthetic valve, thereby increasing axial slack in the outer fabric skirt The complaint alleges the Myval frame is a copy of the SAPIEN 3 frame, which is designed to function as claimed. This functionality is thus alleged to be present in the Myval product. ¶33 col. 3:26-31

Identified Points of Contention

  • Scope Questions: For the ’817 Patent, a central question may be whether the Myval valve’s components, such as its "Inner Reinforcing Strip," meet the specific definitions and structural requirements of a "reinforcing member" as construed from the patent's specification. The complaint's infringement theory rests heavily on visual similarity, which may be contested on finer technical grounds.
  • Technical Questions: For the ’110 Patent, a key question will be one of functional operation: does the Myval frame actually "shorten axially during radial expansion" in a way that "increas[es] axial slack in the outer fabric skirt" as required by the claim? Infringement will depend on evidence of how the accused device physically behaves during deployment, not just its static appearance. The complaint's infringement allegations for the tissue treatment patents (’168 and ’256) rely on inferring Defendant's manufacturing process from its Indian patents; a central issue will be discovering and proving what process is actually used for the imported products (Compl. ¶¶ 79-86, 91-94).

V. Key Claim Terms for Construction

Claim Term: "reinforcing member" (’817 Patent, Claim 1)

Context and Importance

  • This term is central to the structural claim of the ’817 Patent. The complaint alleges the Myval "Inner Reinforcing Strip" is the infringing component. The dispute may turn on whether this component performs the same structural role and is attached in the same manner as the "reinforcing member" disclosed in the patent. Practitioners may focus on this term because the strength and durability of the leaflet assembly is a critical aspect of prosthetic heart valve design.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: Claim 1 requires only "suturing a reinforcing member to an inner surface of a leaflet structure adjacent a lower edge" (’817 Patent, col. 12:2-4). This language does not limit the member's shape or material beyond its function of reinforcing.
  • Evidence for a Narrower Interpretation: The specification describes the element as a "reinforcing strip 68" and shows it as a thin "ribbon or sleeve" that "enables a secure suturing and protects the pericardial tissue" (’817 Patent, col. 8:1-3, 56-61). A defendant may argue that the term should be limited to this specific embodiment or its structural equivalents.

Claim Term: "outer fabric skirt" (’110 Patent, Claim 1)

Context and Importance

  • The functionality of this skirt—specifically, its interaction with the frame during expansion to manage slack—is a key limitation of the asserted claim. The infringement analysis will depend on whether the Myval's outer skirt is structurally and functionally equivalent to the claimed element. Practitioners may focus on this term as sealing against perivalvular leak is a primary function of the skirt, and its mechanical behavior during deployment is critical to achieving that seal.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: Claim 1 describes the element as an "outer fabric skirt extending from the inflow end of the frame to a frame attachment location" which has increased axial slack upon frame expansion (’110 Patent, col. 22:15-22). The claim language itself does not specify a particular weave or construction.
  • Evidence for a Narrower Interpretation: The detailed description discloses a specific embodiment where the skirt is made of "diagonally woven" fibers that are "non-perpendicular to the upper and lower edges of the skirt," a design that "allows the skirt to elongate along the length of the struts" during crimping (’110 Patent, col. 9:35-51). A defendant may argue that the term should be construed to require this specific elongating property, which is linked to the claimed function.

VI. Other Allegations

Indirect Infringement

  • The complaint does not plead separate counts for indirect infringement. The infringement counts focus on direct infringement by importation under 35 U.S.C. § 271(g) and direct infringement under § 271(a) through acts within the district (Compl. ¶¶ 61, 68, 73, 86, 94).

Willful Infringement

  • The complaint requests a judgment that Defendant has willfully infringed and seeks exemplary damages (Compl. p. 37, ¶ XIV.k, l). The basis for willfulness appears to be an alleged "intentional and intensive campaign to copy Edwards' products" (Compl. ¶58). The complaint supports this with allegations of component-by-component copying of the SAPIEN 3 valve (Compl. ¶¶ 32-34), verbatim copying of Plaintiff's copyrighted Instructions for Use ("IFU") for the SAPIEN 3 in Europe (Compl. ¶54), and a prior trademark dispute where Defendant allegedly attempted to adopt a mark confusingly similar to Plaintiff's (Compl. ¶¶ 55-57).

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

  • A core issue will be one of evidentiary proof of copying: The complaint's narrative is built on extensive allegations of direct copying, supported by visual comparisons. A key question will be whether the technical details of the accused Myval products, once revealed in discovery, map onto every limitation of the asserted claims, or if there are subtle but material differences that negate literal infringement.
  • A second central issue will be one of proving infringing acts for method claims: For the ’168 and ’256 patents, which claim methods of treating tissue, infringement depends on manufacturing processes allegedly occurring in India. A key evidentiary question will be whether Plaintiff can obtain sufficient evidence through discovery to prove Defendant performs every step of these claimed methods, a challenge that is often central to litigating process patents against foreign manufacturers.
  • A third question will be the impact of the willfulness allegations: The complaint alleges a pattern of copying that extends beyond the patented technology to include instructional manuals and trademarks. This raises the question of whether this alleged pattern will be sufficient to support a finding of willful infringement and enhanced damages, even if Defendant can establish non-infringement or invalidity for some of the asserted patents.