DCT
0:18-cv-02030
Snyders Heart Valve LLC v. St Jude Medical SC Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Snyders Heart Valve LLC (Texas)
- Defendant: Medtronic, Inc. (Minnesota), Medtronic CoreValve LLC (Delaware), et al.
- Plaintiff’s Counsel: Antonelli, Harrington & Thompson LLP; The Stafford Davis Firm; The Ring Law Firm, PLLC
- Case Identification: 4:16-cv-00812, E.D. Tex., 05/03/2017
- Venue Allegations: Plaintiff alleges venue is proper because Medtronic has transacted business in the Eastern District of Texas and has committed acts of patent infringement within the district.
- Core Dispute: Plaintiff alleges that Defendant’s CoreValve line of transcatheter artificial heart valves and associated delivery systems infringes two patents related to minimally invasive replacement heart valves.
- Technical Context: The technology relates to transcatheter aortic valve replacement (TAVR), a field of medical devices that allows for the implantation of a new heart valve via a catheter, thereby avoiding more invasive open-heart surgery.
- Key Procedural History: The complaint alleges an extensive pre-suit history, including disclosures of the "Funnel Valve" invention by the inventor to Medtronic personnel beginning in May 2000 and Medtronic's citation of the application for one of the patents-in-suit in its own patent prosecution in 2007. The patents-in-suit have also been subject to Inter Partes Review (IPR) proceedings at the U.S. Patent and Trademark Office, with IPR certificates indicating that all asserted claims in this complaint have survived these validity challenges.
Case Timeline
| Date | Event |
|---|---|
| 2000-02-02 | Earliest Priority Date for ’782 and ’297 Patents |
| 2000-05 | Inventor discloses "Funnel Valve" design to Medtronic |
| 2003-04-01 | ’782 Patent Issued |
| 2004-11-23 | ’297 Patent Issued |
| 2007-05-07 | Medtronic allegedly cites the application for the ’297 Patent |
| 2017-05-03 | First Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,540,782 - Artificial heart valve, Issued April 1, 2003
The Invention Explained
- Problem Addressed: The patent’s background section describes the significant drawbacks of traditional heart valve replacement, which requires invasive open-chest surgery, cardiopulmonary bypass, and often removal of the damaged native valve, leading to patient stress and slow recovery ('782 Patent, col. 1:21-31).
- The Patented Solution: The invention is an artificial heart valve designed to be implanted without removing the damaged native valve, enabling less invasive procedures. It consists of a "flexibly resilient frame" with peripheral anchors that lodge the device within the existing valve cusps and a separate "flexible valve element" that attaches to the frame's central portion and a perimeter band to regulate blood flow ('782 Patent, Abstract; col. 2:34-62).
- Technical Importance: This technology was aimed at enabling transluminal or endothoracoscopic implantation, which could significantly reduce surgical trauma, especially for patients considered too high-risk for conventional open-heart surgery (Compl. ¶14).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶24).
- Essential elements of independent claim 1 include:
- A flexibly resilient frame sized for insertion between the upstream and downstream regions of a damaged heart valve.
- The frame has a plurality of peripheral anchors and a central portion.
- A band is attached to the frame, limiting the spacing between the anchors.
- A flexible valve element is attached to the central portion of the frame and adjacent to the band, while being "substantially free of connections to the frame" elsewhere.
- The valve element moves between an open and closed position in response to fluid pressure differences to control blood flow.
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
U.S. Patent No. 6,821,297 - Artificial Heart Valve, Implantation Instrument, and Method Therefor, Issued November 23, 2004
The Invention Explained
- Problem Addressed: As a continuation-in-part, the '297 patent addresses the same fundamental problem of needing less invasive options for valve replacement ('297 Patent, col. 1:24-34).
- The Patented Solution: This invention refines the valve design and introduces claims covering the implantation method and instruments. The valve element is described as being "fixedly attached" to the frame, with a specific convex upstream side and concave downstream side. Critically, the claims also introduce an "opening extending through at least one of said frame and the flexible valve element," designed to receive an implement like a guidewire for precise positioning ('297 Patent, Abstract; col. 3:1-4).
- Technical Importance: The inclusion of an opening for a guidewire and claims directed to the implantation method itself represent a key development for enabling the accuracy and control required for successful transcatheter procedures ('297 Patent, col. 13:1-12).
Key Claims at a Glance
- The complaint asserts at least independent claim 22 (Compl. ¶33).
- Essential elements of independent claim 22 include:
- A flexibly resilient frame with peripheral anchors.
- A flexible valve element "fixedly attached to the frame so that at least a portion of the element is substantially immobile" with respect to a portion of the frame.
- The valve element has a convex upstream side and a concave downstream side.
- The valve element moves between open and closed positions based on fluid pressure.
- An "opening extending through at least one of said frame and the flexible valve element."
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
III. The Accused Instrumentality
Product Identification
- The accused products include the Medtronic CoreValve, CoreValve Evolut, CoreValve Evolut R, and EnVeo R artificial heart valves, along with the EnVeo R Delivery System and CoreValve Delivery Catheter System (Compl. ¶¶18-19). Specific model numbers for the bioprostheses and catheters are also identified (Compl. ¶21).
Functionality and Market Context
- The complaint alleges the accused products are "rapidly-deployable artificial heart valves" delivered through an artery via a catheter to replace a damaged heart valve without requiring invasive open-heart surgery (Compl. ¶20).
- A visual provided in the complaint identifies the accused valve as being constructed from a "Nitinol Frame" and "Pig Heart Tissue." (Compl. p. 5). This image depicts a self-expanding metal frame holding leaflet tissue, characteristic of TAVR devices (Compl. p. 5).
- The associated delivery system is marketed as having the "Lowest Delivery Profile," a feature that improves access through arteries and reduces the risk of vascular complications, which is a significant commercial advantage in the TAVR market (Compl. p. 6). The complaint includes a marketing image highlighting this feature (Compl. p. 6).
IV. Analysis of Infringement Allegations
’782 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a flexibly resilient frame sized and shaped for insertion in a position between the upstream region and downstream region of the damaged valve | The accused products comprise an artificial heart valve with a flexibly resilient frame. | ¶25 | col. 2:34-35 |
| the frame having a plurality of peripheral anchors for anchoring the frame... and a central portion located between the plurality of peripheral anchors | The frame of the accused valve has peripheral anchors and a central portion. | ¶25 | col. 2:37-40 |
| a band attached to the frame limiting spacing between adjacent anchors | The accused products include a band, and the valve element is adjacent the band. | ¶26 | col. 11:28-30 |
| a flexible valve element... being substantially free of connections to the frame except at the central portion of the frame and adjacent the band | The accused products are alleged to have a flexible valve element attached at the central portion and adjacent the band, and to be substantially free of other connections. | ¶26 | col. 11:33-37 |
| said valve element moves in response to a difference between fluid pressure... between an open position... and a closed position | The valve element of the accused products moves between open and closed positions based on pressure differentials to permit and block blood flow. | ¶27 | col. 2:49-62 |
- Identified Points of Contention:
- Scope Questions: The infringement analysis may focus on the claim limitation "substantially free of connections to the frame except at the central portion of the frame and adjacent the band." A central question will be whether the accused CoreValve's leaflets, which are typically sutured to the vertical posts of the Nitinol frame, can be considered "substantially free." A defendant may argue that such suturing constitutes significant connection beyond the claimed central portion and band.
- Technical Questions: What evidence demonstrates the precise attachment points of the pig heart tissue to the Nitinol frame in the accused products? The complaint's allegation tracks the claim language, but the actual construction will be a key factual issue for discovery (Compl. ¶26).
’297 Patent Infringement Allegations
| Claim Element (from Independent Claim 22) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a flexibly resilient frame sized and shaped for insertion in a position between the upstream region and downstream region of the damaged valve, and the frame having a plurality of peripheral anchors... | The accused products comprise a flexibly resilient frame with peripheral anchors. | ¶34 | col. 21:59-62 |
| a flexible valve element fixedly attached to the frame so that at least a portion of the element is substantially immobile with respect to at least a portion of the frame | The accused products are alleged to have a flexible valve element fixedly attached to the frame, with a portion being substantially immobile relative to the frame. | ¶35 | col. 21:63-65 |
| said element having a convex upstream side... and a concave downstream side... | The valve element of the accused products is alleged to have a convex upstream side and a concave downstream side. | ¶35 | col. 21:66-22:3 |
| said flexible valve element moving in response to a difference between fluid pressure... between an open position... and a closed position | The flexible valve element moves between open and closed positions based on pressure differences. | ¶35 | col. 22:4-15 |
| and an opening extending through at least one of said frame and the flexible valve element | The accused products are alleged to have an opening extending through the frame and valve element. | ¶35 | col. 22:15-17 |
- Identified Points of Contention:
- Scope Questions: This claim requires the valve element be "fixedly attached" such that a portion is "substantially immobile." This language appears to be in direct tension with the "substantially free" language of the '782 Patent. The court will have to determine if the same accused product can infringe both claims. The definition of "substantially immobile" will be critical.
- Technical Questions: Does the accused CoreValve device contain an "opening extending through... the frame and the flexible valve element" as claimed? The complaint alleges this element is met, but provides no specific evidence, such as a technical diagram of the valve's apex, to support the allegation (Compl. ¶35).
V. Key Claim Terms for Construction
Term 1 (’782 Patent, Claim 1): "substantially free of connections to the frame except at the central portion of the frame and adjacent the band"
- Context and Importance: This term is central to the infringement analysis for the '782 Patent. Practitioners may focus on this term because TAVR valves like the accused CoreValve typically have tissue leaflets sutured along the height of the frame's posts, not just at a single central point. The viability of the infringement claim depends on whether this construction is considered "substantially free."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's objective is to allow the valve element to move freely in response to pressure changes ('782 Patent, col. 2:49-53). A party could argue that any connections that do not meaningfully restrict this primary motion are incidental, leaving the element "substantially free."
- Evidence for a Narrower Interpretation: The specification's primary embodiment shows the valve element attached at the apex (junction 32) and the perimeter band (40), with the flaps (58) between these points appearing unconnected to the U-shaped frame elements (30) ('782 Patent, Fig. 2-3). A party could argue the claim is limited to this disclosed attachment configuration.
Term 2 (’297 Patent, Claim 22): "fixedly attached to the frame so that at least a portion of the element is substantially immobile with respect to at least a portion of the frame"
- Context and Importance: This term is pivotal for the '297 Patent and presents an interesting contrast to the key term in the '782 Patent. Practitioners may focus on this term because its interpretation will determine whether the same suturing pattern on the accused valve that might escape the '782 patent's "substantially free" language could fall within the scope of this "fixedly attached" language.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The phrase "at least a portion" suggests that only a small part of the valve element needs to be immobile relative to a small part of the frame. This could be interpreted to mean any suture point that anchors the leaflet tissue to a frame strut meets the limitation.
- Evidence for a Narrower Interpretation: A party could argue that "substantially immobile" implies a rigid, non-yielding connection, and that the flexible nature of both the suture material and the leaflet tissue allows for micro-movements at all times, meaning no portion is ever truly "immobile." The patent consistently describes the valve element as "flexible" and responsive to fluid pressure, which could suggest that immobility is not the overarching design principle ('297 Patent, Abstract).
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is based on allegations that Medtronic actively instructs and encourages medical professionals to use the accused products in an infringing manner through its "Instructions for Use," training programs, and promotional materials (Compl. ¶¶39-40). Contributory infringement is based on allegations that the accused valves are a material part of the patented invention, are specially designed for an infringing use, and have no substantial non-infringing uses (Compl. ¶41).
- Willful Infringement: Willfulness is alleged based on Medtronic’s purported pre-suit knowledge of the patents and the infringing nature of its activities (Compl. ¶¶42-43). The complaint details a long history of alleged communications, starting in May 2000, between the inventor and Medtronic, where Medtronic personnel allegedly praised the invention as "ingenious" (Compl. ¶¶47, 49). The complaint further alleges that Medtronic had knowledge of the technology as of at least May 7, 2007, when it cited the published application that led to the '297 Patent in one of its own patent applications (Compl. ¶54).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of claim construction and factual mapping: Can Plaintiff prove that the structure of the accused CoreValve—specifically, how its tissue leaflets are affixed to its metal frame—simultaneously meets the "substantially free of connections" limitation of the ’782 Patent and the seemingly contradictory "fixedly attached" and "substantially immobile" limitations of the ’297 Patent? The resolution of this tension will be fundamental to the direct infringement analysis.
- A key evidentiary question will concern willfulness and pre-suit knowledge: The complaint makes highly specific allegations of a long history of communications between the inventor and Medtronic about the patented technology, years before the lawsuit was filed. A primary focus of the case will be to establish through discovery the extent of this knowledge and what steps, if any, Medtronic took to assess the risk of infringement, which will be dispositive for the willfulness claim.
- A final question will relate to the impact of prior post-grant proceedings: Both patents-in-suit have had their asserted claims confirmed as patentable in IPRs initiated by a third party. While this strengthens the presumption of validity and may limit the arguments a defendant can raise, it does not preclude a new invalidity challenge in district court. The extent to which the court credits the outcome of these prior proceedings will significantly shape the litigation landscape.