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Edwards Lifesciences Cardiaq, LLC v. Perry

United States District Court, D. Massachusetts

March 31, 2019




         Plaintiff Edwards Lifesciences CardiAQ, LLC (“CardiAQ”), the owner by assignment of several United States patents related to the development of a transcatheter mitral valve implant (the “Patents-at-Issue”), [1] brings claims for a declaration that Dr. Kenneth Perry (“Perry”) is not a co-inventor of those patents, and that he and his company, EchoBio, LLC, (together “Defendants”) do not own the Patents-at-Issue. See [ECF No. 1]. Perry brings counterclaims for a declaration that he is a co-inventor and co-owner of the Patents-at-Issue pursuant to 35 U.S.C. §§ 256 and 261. See [ECF No. 14 at 6-71]. Before the Court is CardiAQ's motion for summary judgment pursuant to Federal Rule of Civil Procedure 56. [ECF No. 48].

         Perry claims to have conceived of eight “Inventions-at-Issue, ” which are features claimed in one or more of the Patents-at-Issue. See [ECF No. 48-1 (“CardiAQ Facts”) ¶ 1]. In support of this assertion, Perry offers his own testimony and the following notable exhibits: (1) a May 11, 2006 sketch that is unclear, is not specific to a mitral valve, was drawn before Perry was engaged by CardiAQ, and was not shown to CardiAQ during the relevant time period, see Figure 1, but which Perry claims displays two of the Inventions-at-Issue; (2) an undated, unsigned sketch that Perry claims he drew during a meeting with CardiAQ co-founders Dr. Arshad Quadri (“Quadri”) and J. Brent Ratz (“Ratz”) on October 24, 2007 that Perry says displays six of the Inventions-at-Issue (the “TCT Sketch”), see Figure 2; and (3) an August 8, 2008 Provisional Patent Application, Serial No. 61/087, 473 (the “2008 Provisional Application”) that is focused on stent manufacturing methods, is not specific to heart valves, and was not shared with CardiAQ during the relevant time period, see [ECF No. 53-23 at 8-19]. These exhibits are supported by attestations about what they depict and circumstantial evidence related to Perry's, Quadri's, and Ratz' respective experiences, interests, and technical abilities.

         CardiAQ argues that Perry cannot corroborate his purported conception of any of the Inventions-at-Issue, and cannot prove his inventorship by clear and convincing evidence. [ECF No. 49 at 25]. Perry has focused his opposition to the motion for summary judgment on the TCT Sketch, which is the only purported contemporaneous record that may suggest that Perry, Quadri, and Ratz discussed the Inventions-at-Issue. See [ECF No. 69]. Perry supports his assertion that the TCT Sketch was drawn on October 24, 2007 with an ink formulation analysis performed by a forensic chemist, and offers affidavits from his co-worker Dr. Paul Labossiere (“Labossiere”) and his long-time friend Dr. Xiao-Yan Gong (“Gong”) to support his assertion that the TCT Sketch displays six of the Inventions-at-Issue. See [ECF No. 56-1 (“Gong Decl.”); ECF No. 56-2 (“Labossiere Decl.”); ECF No. 56-3 (“Lyter Decl.”)]. The Court finds that, even viewing the evidence in the light most favorable to Perry and taking account of the circumstantial evidence, Perry cannot prove that he is an inventor of the Patents-at-Issue by clear and convincing evidence. What the TCT Sketch depicts, and the communication of whatever it shows to Quadri and Ratz, is unclear. Conversely, CardiAQ has proffered numerous sketches that document Quadri and Ratz' conception and development of the Inventions-at-Issue. For those reasons, as further explained below, CardiAQ's motion for summary judgment is GRANTED.

         I. FACTS[2]

         The following factual summary draws all reasonable inferences in favor of Perry, as the non-movant. This summary notes where Perry has made claims about his conception of relevant inventions, because under the applicable legal standard, Perry must corroborate his own assertions. See infra Section III.

         In 2006, Quadri and Ratz began collaborating on cardiac medical devices. [ECF No. 50 (“Ratz Decl.”) ¶ 3]. Their initial focus was on aortic valve replacements. Id. ¶¶ 11-12. Quadri and Ratz ultimately used their aortic valve ideas in the design of mitral valve replacement technologies. Id. ¶¶ 43-53. Quadri and Ratz believed that Quadri's “universal connector, ” a patented invention with a stent-like structure that foreshortened by using diamonds or ovals that decreased in axial length when the stent expanded radially, could serve as the foundational technology for a replacement heart valve. Id. ¶ 11. They sought to design, develop, and commercialize an effective valve replacement system that could restore long-term heart valve function without the need for open-chest surgery. Id. ¶ 12.

         By July 2007, Quadri and Ratz had conceived of a rapid fixation aortic replacement valve frame, CardiAQ Facts ¶ 116; Ratz Decl. ¶ 12, but had not achieved a final design that could be implanted in humans and lacked the materials and manufacturing expertise necessary to improve and capitalize upon their concept. Perry Facts § II.B.

         Quadri and Ratz began looking for a third-party vender who was experienced with nitinol[3] and could help evaluate and optimize their valve frame design. Ratz Decl. ¶ 14. They wanted a vender who could assist with the shape-setting process for the valve frame and who had the materials experience to help make the design more robust from a fatigue and fracture standpoint based on finite element analysis (“FEA”). Id. ¶ 14. In July 2007, Ratz asked his colleague, Neil Morgan, whether he had been able to “identify any contacts on the NiTi stent design side.” Perry Response ¶ 1. Morgan suggested Perry at EchoBio, who he described as “excellent with design and FEA and designing the shape set routine etc., ” and “probably the leading expert in this area.” Id.

         On August 8, 2007, Quadri wrote to Perry, “We would like to find a partner that can offer a wide range of capabilities in the areas of design, analysis, and testing of cardiovascular implants so we are very much looking forward to receiving a detailed proposal from you.” [ECF No. 50-32 at 1]. Quadri shared several “design improvements” that CardiAQ was working on “for the next round of prototyping, ” sent Perry a software file showing the prototype design, and noted that “depending on your proposal we are open to other suggestions.” See [id. at 1-2]; see also Ratz Decl. ¶ 12. In August and September 2017, Perry agreed to perform various services for CardiAQ on a fixed cost basis, including optimizing shape-setting and the dimensions of CardiAQ's frame design, as well as constructing prototypes. Ratz Decl. ¶¶ 14-15; [ECF No. 51 ¶ 11 (“Quadri Decl.”)]. Dr. Perry encouraged certain modifications to Quadri and Ratz' design that were ultimately incorporated in the valve frames, but which are not among the Inventions-at-Issue. See Perry Response ¶ 1. These contributions included the shape of the struts in the foreshortening region of the stent, which Perry named “bignroundy, ” and the placement of certain suture holes. Id.

         Ratz learned that Perry planned to attend the Transcatheter Cardiovascular Therapeutics (“TCT”) Conference in October 2007 and arranged to meet with Perry at that conference. Ratz Decl. ¶ 16. On October 24, 2007, Ratz, Quadri, and Perry met as planned and discussed product requirements for the implant itself and ideas for CardiAQ's planned stretch delivery system. Quadri Decl. ¶ 12; [ECF No. 58 (“Perry Decl.”) ¶ 21]. According to Perry, prior to the October 2007 meeting, he had recalled two inventions that he had conceived in 2006 and wanted to share with CardiAQ: (1) reversing anchors, and (2) elongated control members that would allow a delivery catheter to precisely control the placement of a replacement valve. Perry Facts § II.C; see also Labossiere Decl. ¶¶ 6-10. Perry asserts that these two inventions are documented in a May 11, 2006 sketch, shown in Figure 1, which he did not show to Quadri or Ratz.[4] Perry Facts § II.C; CardiAQ Facts ¶ 17. During the October 24, 2007 meeting, Perry claims to have conceived of five additional improvements to Quadri and Ratz' design, including: (3) “V-shaped apical anchors, ” (4) “alternating anchors/circumferential offset, ” (5) “barbs on V-shaped apical anchors, ” (6) transition shoulder “radial flare, ” and (7) transition shoulder “changed diameter of frame.” Perry Facts § II.C; Perry Decl. ¶¶ 31-34. Perry also claims that his contributions ultimately (8) enabled foreshortening. Perry Facts § II.D.

         (Image Omitted)

         Perry says that he drew the TCT Sketch, shown below as Figure 2, at the October 24, 2007 meeting. Perry Decl. ¶ 26. The TCT Sketch is unsigned and undated, no third party witnessed Perry drawing the sketch, Perry never gave Quadri or Ratz a copy of the sketch, and Quadri and Ratz deny seeing the sketch prior to this lawsuit. CardiAQ Facts ¶¶ 6-9; Perry Response ¶¶ 6-9. Nonetheless, Perry attests that the sketch was drawn and shown to Quadri and Ratz at the meeting and there is some corroborating evidence that the TCT Sketch was drawn at least roughly contemporaneously with the meeting, including an affidavit from Perry's co-worker, Dr. Labossiere, attesting that he and Perry discussed the sketch in late October or November 2007. Labossiere Decl. ¶¶ 12-13. Additionally, potential tips for anchoring the replacement valve were drawn in Ratz' notebook with a pen containing the same ink formulation that was used for the TCT Sketch, and Perry has offered an expert opinion that he was most likely the person who drew those potential anchor tips. Perry Facts § II.D; Perry Response ¶ 6.[5]The October 24, 2007 meeting was the only in-person meeting between Perry, Quadri, and Ratz before April 2009. Perry Decl. ¶ 21.

         On October 29, 2007, Ratz emailed Perry a list of open items from their October 24 discussion, attached Ratz' notes and several images related to the CardiAQ prototype, and asked Perry to “let [him] know if [he] missed anything else from our discussion.” [ECF No. 50-28]. The email does not reference the Inventions-at-Issue, nor does Perry respond that anything from the discussion is missing from the email summary. CardiAQ Facts ¶ 14. Although Quadri and Ratz were focused on a stretch delivery system for their replacement aortic valve at the time of the TCT conference, several days after the conference, Perry told a physician that he was working on the development of a percutaneous aortic valve. [ECF No. 90-3].

         There were no notable communications between Perry, Ratz, and Quadri between November 2007 and September 2008. Although Perry completed prototypes and other work that CardiAQ had requested in December 2007, and Ratz and Perry exchanged several phone calls and numerous emails during this period, CardiAQ had limited resources and was focused on fundraising. Ratz Decl. ¶ 41. In connection with its fundraising efforts, CardiAQ listed Perry prominently on materials for investors and listed his responsibilities as “Contributor to brainstorming sessions - Nitinol implant expertise / Oversight of CAD design / Oversight of Finite Element Analysis / Oversight of Nitinol tube processing, laser cutting, and heat setting.” [ECF No. 59-6 at 24]. On August 8, 2008, Perry filed the 2008 Provisional Application, which was “focused on manufacturing methods, ” but which Perry argues shows several of the Inventions-at-Issue. See Perry Facts § II.F n.12; see also [ECF No. 35-1].[6] Perry did not show the 2008 Provisional Application to Quadri or Ratz. CardiAQ Facts ¶ 18.

         (Image Omitted)

         Quadri and Ratz reengaged Perry on or about September 30, 2008, after they had shifted their focus from designing an aortic valve replacement to a mitral valve replacement. Perry Decl. ¶ 37. Perry claims that between September 2008 and January 2009 he again reminded Ratz of the Inventions-at-Issue and “worked with CardiAQ virtually every day in early 2009 to develop [Perry's] ideas.” Id. ¶¶ 38-46. Quadri and Ratz met with Perry in April 2009 for a “brainstorming session” concerning their frame design and asked Perry and Labossiere to continue brainstorming alternative approaches to the valve frame. Id. ¶¶ 21, 47. Although Perry has suggested that Ratz' notes from January 2009 may reflect his input, see id. ¶ 40, no records clearly corroborate any discussion about the Inventions-at-Issue between Perry and either Quadri or Ratz after the October 24, 2007 TCT meeting.[7]

         Perry believed that CardiAQ was seeking patents for its valve frame inventions at least as early as mid-2009, but did not assert that he should be named an inventor on any patents. CardiAQ Facts ¶¶ 120-21. In August 2009, Perry informed CardiAQ that he had been developing a wire form valve frame, as opposed to one cut out of nitinol, and CardiAQ began to rely on other venders, in part because it did not want to share ideas with Perry if he was developing competing technology. Ratz Decl. ¶ 71. Although CardiAQ's patent applications, which disclosed all of the Inventions-at-Issue and listed Quadri and Ratz as inventors, were published no later than November 2010, Perry did not see the applications at issue until September 2015. CardiAQ Facts ¶¶ 124-27; Perry Response ¶ 127. In 2015, Edwards LifeSciences Corp. acquired CardiAQ for in excess of $350 million. [ECF No. 49 at 2]. In September 2015, Perry was subpoenaed to give a deposition in an intellectual property lawsuit between CardiAQ and Neovasc. Perry Decl. ¶ 48. Through the process of preparing for and being deposed in connection with that lawsuit, Perry recognized that he might have a claim to be an inventor of the Patents-at-Issue. Id. Perry now claims to be a co-inventor of the following eight Inventions-at-Issue:

1. Reversing Anchors: anchors extending from the distal end of the valve frame and shaped to reverse back towards the proximal end of the frame
2. Locking Members extending from the proximal end of the valve frame and consisting of a plurality of longitudinally extending struts that temporarily frame to a catheter delivery device during deployment.[8]
3. V-shaped Proximal Anchors: proximal anchors formed at V-shaped apices of zigzagging circumferential struts in the nonforeshortening region of the valve frame.
4. Barbs extending from V-shaped proximal anchors.
5. Circumferentially Alternating Anchors: circumferentially offsetting the proximal anchors from the distal anchors.
6. Transition Shoulder - Radial Flare: creating an outward flare in the diameter of the valve frame to form a “transition shoulder” for proximal anchoring.
7. Transition Shoulder - Changed Diameter of Frame: creating a transition shoulder for proximal anchoring by reducing the diameter of the frame.
8. Enabling Foreshortening in the distal portion of the frame.

         CardiAQ Facts ¶ 1; Perry Response ¶¶ 1a-1h.

         Perry asserts that, as shown in Figure 3, he sketched at least six of the Inventions-at-Issue in the TCT Sketch, and supports his assertion with a declaration from Gong. See Gong Decl. Gong attests that he was able to identify the location in the TCT Sketch of the six inventions that Perry claims are depicted, based on “word description - not pictures - of the features.” Gong Decl. ¶ 10. Perry asserts that his conception of barbs extending from V-shaped proximal anchors, which are not shown in the TCT Sketch, is corroborated by his 2008 ...

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