ALLISON D. BURROUGHS, District Judge.
From June 2009 through April 2010, Plaintiff CardiAQ Valve Technologies, Inc. ("CardiAQ") hired Defendant Neovasc Inc. ("Neovasc") to help construct prototypes of CardiAQ's transcatheter mitral valve implant ("TMVI") device. CardiAQ alleges that Neovasc breached the parties' non-disclosure agreement ("NDA") and misappropriated CardiAQ's trade secrets by using CardiAQ's confidential information to develop its own competing TMVI device. On May 19, 2016, following a two-week trial, a jury found for CardiAQ as to some, though not all, of its claims. The jury returned a verdict finding that Neovasc: (1) breached the NDA; (2) breached the duty of honest performance in the NDA; and (3) misappropriated three of CardiAQ's six claimed trade secrets. [ECF No. 483]. The jury awarded CardiAQ $70,000,000 in damages for Neovasc's theft of trade secrets, with no additional damages for the contract breaches.
The Court has already resolved several post-trial motions. On May 27, 2016, the Court granted Neovasc's motion for judgment as a matter of law with respect to CardiAQ's Chapter 93A claim, finding that Neovasc's alleged wrongful acts had not occurred "primarily and substantially within the commonwealth" of Massachusetts, as is required under the statute. Mass. Gen. L. Ch. 93A, § 11. [ECF No. 495]. On July 28, 2016, the Court denied both parties' renewed motions for judgment as a matter of law with respect to CardiAQ's duty of honest performance claims, declining to overturn the jury's finding that Neovasc had breached the duty of honest performance with regard to the NDA, but not with the parties' purchase orders. [ECF No. 529].
On August 15, 2016, the Court held oral argument on the remaining post-trial motions: CardiAQ's motions for enhanced damages and injunctive relief [ECF Nos. 513, 516] as well as Neovasc's motions for a new trial on damages and trade secrets 4-6 [ECF Nos. 511, 520]. The Court also heard argument on CardiAQ's inventorship claim, which was left for the Court rather than the jury to decide.
Finally, on October 19, 2016, in anticipation of an appeal, Neovasc filed motions and a supporting memorandum [ECF Nos. 571-574] seeking the Pro Hac Vice admission of three additional attorneys. CardiAQ opposed the motions on October 24, 2016 [ECF No. 578]. This Order resolves all of the outstanding motions, as well as CardiAQ's inventorship claim. For the reasons stated herein: (1) CardiAQ's motion for enhanced damages [ECF No. 513] is GRANTED IN PART; (2) CardiAQ's motion for injunctive relief [ECF No. 516] is GRANTED IN PART; (3) Neovasc's motion for a new trial on damages [ECF No. 522] is DENIED; (4) Neovasc's motion for a new trial on trade secrets 4-6 [ECF No. 521] is DENIED; (5); Dr. Quadri and Mr. Ratz are to be added as co-inventors of U.S. Patent No. 8,579,964; and (6) Neovasc's motions for the Pro Hac Vice admission of new attorneys [ECF Nos. 571-573] are DENIED as MOOT.
In its original complaint, filed on June 6, 2014 [ECF No. 1], as well as its amended complaint, filed on January 15, 2015 [ECF No. 64], CardiAQ brought the following seven claims against Neovasc: (1) correction of inventorship under 35 U.S.C. § 256; (2) breach of the NDA; (3) breach of the implied covenant of good faith and fair dealing in the NDA and purchase orders;
In April 2016, the Court granted Neovasc's motion for summary judgment as to the fraud count, finding that Neovasc did not have an affirmative duty to disclose its competitive activities to CardiAQ, and therefore did not commit fraud by failing to disclose such activity once it began. [ECF No. 417]. The Court, however, denied Neovasc's motion for summary judgment as to the inventorship and Chapter 93A counts.
The next month, this action proceeded to trial. Over the course of the two-week trial, the two founders of CardiAQ—Brent Ratz and Dr. Arshad Quadri—testified, as did Rob Michiels, the former CEO of CardiAQ; Randy Lane, Vice President of Research and Development at Neovasc; and Alexei Marko, CEO of Neovasc. The jury also heard the deposition of testimony of several fact witnesses that were not present at trial, including: Colin Nyuli, an intellectual property manager and former project engineer at Neovasc; Krista Neale, the manager of new technology development and former project engineer at Neovasc; Kathleen Hung, a project manager at Neovasc; Dr. Michael Mack, a former member of CardiAQ's scientific advisory board; and Glen Rabito, a senior manager of research and development at Edwards Lifesciences and a former engineering manager and research and development project leader at CardiAQ.
In addition, three experts testified for CardiAQ. Dr. Joseph Bavaria, Vice Chairman of the Department of Cardiovascular Surgery at the University of Pennsylvania and Director of the Transcatheter Valve Program at the University of Pennsylvania, testified as to the anatomy of the heart and specifically, the mitral valve. Dr. Rick Hillstead, a Fellow on the Council of Clinical Cardiology within the American Heart Association, testified generally about the development of medical devices and the customs and practices of vendors, suppliers, and development houses in the medical device field. Finally, Michael J. Wagner, the managing director at Litinomics, Inc., a financial and economic consulting firm, testified as to damages, opining that the reasonable royalty Neovasc owed to CardiAQ was $90 million, based on a hypothetical negotiation taking place in 2010. Three experts also testified for Neovasc. Steven Little, a cardiologist at Houston Methodist Hospital and the medical director of its valve clinic, testified regarding cardiac imaging and the anatomy of the mitral valve, as well as the interaction of CardiAQ's and Neovasc's respective devices within the native mitral valve anatomy. Karl R. Leinsing, a mechanical engineer who develops medical devices, testified regarding CardiAQ's trade secret claims and Neovasc's Tiara development. Lastly, Carla Mulhern, managing principal in the Washington D.C. office of Analysis Group, testified as to damages, and opined that correcting for various errors in Mr. Wagner's analysis, the appropriate royalty figure was no more than $2 million.
The jury returned a split verdict. [ECF No. 483]. The verdict form contained eight questions. The first four concerned CardiAQ's breach of contract claims. The jury was asked to determine whether CardiAQ had proven, by a preponderance of the evidence that Neovasc had: (1) breached the NDA; (2) breached the duty of honest performance in the NDA; and (3) breached the duty of honest performance in the purchase orders. If the jury answered yes to any of these three questions, they were instructed to then determine the amount of money CardiAQ should receive for Neovasc's breach(es). The jury answered yes to the first two questions, but no to the third: Neovasc had breached the NDA as well as the duty of honest performance in the NDA, but not the purchase orders. As to the fourth question, the jury found that CardiAQ should not receive any money for Neovasc's breaches.
Next, the jury was asked to determine if Neovasc had misappropriated CardiAQ's trade secrets. At trial, CardiAQ maintained that Neovasc had misappropriated six of its trade secrets, and the verdict form asked the jury to make a separate finding as to each one. The six alleged trade secrets were originally identified by CardiAQ during discovery, and were described in trial exhibit 1157. The alleged trade secrets were:
The jury found that that Neovasc had misappropriated trade secrets 4-6, but not trade secrets 1-3, and that CardiAQ should receive $70 million as damages for Neovasc's misappropriation.
The jury was also asked to make factual determinations with respect to the two counts— inventorship and Chapter 93A—reserved for the Court. The jury found that CardiAQ had proven (1) by a preponderance of the evidence that Neovasc engaged in unfair and deceptive acts or practices; and (2) by clear and convincing evidence that the two founders of CardiAQ contributed to the conception of Neovasc's U.S. Patent No. 8,579,964 (the "'964 Patent").
Below is a summary of facts adduced at trial that are relevant to the outstanding issues in this case:
Neovasc and CardiAQ's business relationship began on June 4, 2009, after Brian McPherson, the Vice President of Operations and President of the Surgical Products division at Neovasc, sent an unsolicited email to CardiAQ co-founder Brent Ratz advertising Neovasc's products and services. [Tr. Day 3, 183:7-20; Tr. Ex. 349]. The email stated that Neovasc was the only supplier of "custom pericardial tissue actively supporting companies developing minimally invasive heart valves," and that he was confident CardiAQ could benefit from Neovasc's services. [Tr. Ex. 349] Mr. McPherson attached a 15-page presentation to the email, describing Neovasc's services.
Mr. Ratz responded that same day to indicate his interest in learning more about Neovasc. [ECF No. 304-7 at 32]. Before speaking with Mr. McPherson about a potential business relationship, Mr. Ratz suggested that the parties execute a Non-Disclosure Agreement.
At the time Mr. McPherson reached out to CardiAQ, CardiAQ was a start-up developing a TMVI device—a prosthetic heart valve delivered through a catheter to replace a malfunctioning native mitral valve. Mitral regurgitation, one of the most common forms of heart disease, can be treated by replacing the mitral valve, but, currently, the only way to replace the mitral valve is through open heart surgery. By June 2009, CardiAQ, had developed a prototype of its TMVI device, intended to replace the mitral valve through a catheter procedure, rather than open heart surgery.
CardiAQ's device consists of three elements: the frame, the delivery catheter, and the tissue valve. [Tr. Day 3, 15:20-23]. Between June 2009 and April 2010, Neovasc worked with CardiAQ to manufacture the tissue valve element. [Tr. Day 3, 16:1-3]. During this time, CardiAQ and Neovasc entered into several purchase orders (the "Purchase Orders"), in which they agreed to the work Neovasc would perform. [See e.g., ECF No. 64, Ex. D]. CardiAQ would send metal frames to Neovasc's Vancouver facility [Tr. Day 4, 36:15-37:2; Tr. Ex. 1205], and Neovasc would attach tissue to the frame and assemble the final TMVI prototype. [Tr. Day 3, 24:23-25:2; Tr. Day 3, 35:1-2; Tr. Day 4, 26:1-3]. CardiAQ used the prototypes assembled by Neovasc for several animal studies. [Tr. Day 3, 25:3-9; Tr. Day 4, 48:10-12].
Over the course of the 10-month relationship, Mr. Ratz regularly exchanged emails and phone calls with Neovasc employees. Through these emails and phone calls, Neovasc employees, including engineer Randy Lane, learned about the specifications, ongoing animal testing, and development history of CardiAQ's TMVI device. [
On October 20, 2009, in the middle of CardiAQ and Neovasc's business relationship, Mr. Lane drew the first sketch of what would become Neovasc's own TMVI device, now known as the "Tiara." [Tr. Day 8, 99:10-12; Day 9, 67:9-17; Tr. Ex. 1121]. After sketching the concept in his lab notebook, Mr. Lane told Neovasc's CEO Alexi Marko about the idea [Tr. Day 8,100:11-21], and Mr. Marko instructed Mr. Lane to proceed with an in-house mitral valve program, which he did. [Tr. Ex. 343; Tr. Day 8, 122:9-123:11]. Mr. Marko advised Mr. Lane not to tell CardiAQ about Neovasc's internal project, explaining in an October 21, 2009 email that, "when appropriate we may need to disclose to [CardiAQ] that we are working on something, but let's cross that bridge when we come to it." [Tr. Ex. 343].
Neovasc and CardiAQ's business relationship ended in April 2010, after CardiAQ leased its own manufacturing facility in California and no longer needed Neovasc's services. [Tr. Day 4, 46:9-16; Tr. Day 7, 119:14-25; Tr. Day 9, 107:19-22]. Until Neovasc's relationship with CardiAQ ended in April 2010, Mr. Lane worked on both Neovasc's internal TMVI project and CardiAQ's valve assembly. [Tr. Day 9, 113:10-19]. Mr. Lane used the same lab notebook to document his development of Neovasc's valve and his assembly of CardiAQ's valve, at times including notes on adjacent pages. [Tr. Ex. 1121]. Neovasc did not restrict any of its engineers from working on both the Tiara project and the CardiAQ project, and several did. [Tr. Day 9, 113:14-24].
In December 2009, Neovasc began to prepare its first patent application relating to the Tiara design. [Tr. Day 9, 107:23-108:5]. Neovasc filed the application on May 5, 2010 [Tr. Day 9, 107:23-25], naming Mr. Lane as the sole inventor. [Tr. Ex. 2756]. The U.S. Patent Office issued the '964 Patent on November 12, 2013, naming Mr. Lane and Colin Nyuli, a Neovasc employee who joined Neovasc in September 2010, as joint inventors. [Tr. Ex. 115]. The '964 Patent is a method patent for a transcatheter mitral valve prosthesis.
Neovasc formally announced its internal TMVI project in a June 20, 2011 press release. [Tr. Ex. 347; Tr. Day 9, 206:11-17]. Since then, Neovasc's device has been implanted in over 100 animals. [Tr. Ex. 2533 at 57]. On February 3, 2014, Neovasc announced the first in-human implantation of its device by physicians at St. Paul's Hospital in Vancouver. [Tr. Ex. 2315]
Neovasc never told CardiAQ about its internal TMVI program. [Tr. Day 4, 51:14-18; Tr. Day 9, 112:23-113:1]. Mr. Ratz and Dr. Quadri first learned of Neovasc's development of a TMVI device in December 2011, after Neovasc's patent application became public. [Tr. Day 3, 68:2-23; Day 4, 51:19-25]. Soon thereafter, in February 2012, counsel for CardiAQ contacted Mr. Marko to express concern that Neovasc may have incorporated CardiAQ's confidential information into its Tiara device, in violation of the NDA. [Tr. Ex. 1389]. In June —, after counsel for the parties exchanged multiple letters [
CardiAQ's two pending motions request enhanced damages [ECF No. 513] and injunctive relief [ECF No. 516] in addition to the $70 million already awarded by the jury. The motion for enhanced damages asks the Court to double the jury's $70 million damages award. The motion for injunctive relief requests that the Court order Neovasc to: (1) destroy all information that CardiAQ sent to Neovasc between June 2009 and April 2010; (2) return to CardiAQ any CardiAQ prototypes, or portions thereof, that CardiAQ provided to Neovasc and that Neovasc still has in its possession, custody, or control; (3) without the written consent of CardiAQ, not prosecute claims covering subject matter that is either described in CardiAQ's Trade Secret Number 4, or described in claims of U.S. Patent No. 8,579,964, for which the Court determines Dr. Quadri and Mr. Ratz significantly contributed; and (4) with certain limitations, suspend all of its TMVI programs, including, but not limited to, its Tiara program, for eighteen months.
Following oral argument, CardiAQ submitted a supplemental memorandum regarding both motions [ECF No. 562], in which it suggested that the Court issue an injunction with contingencies, for example, that the injunction be contingent on whether or not Neovasc satisfies the $70 million verdict and further argued that the Court should enhance damages by at least 33%, or $23.3 million. Neovasc responded to the supplemental memorandum on September 8, 2016. [ECF No. 567].
CardiAQ's request for enhanced damages arises under Mass. Gen. L. ch. 93, § 42, which states that:
Mass. Gen. L. ch. 93, § 42 (emphasis added). This provision, which gives the Court discretion to double the jury's damages award in a trade secret case, has been applied sparingly in both state and federal court. In
Neovasc argues that enhanced damages are precluded by the SJC's decision in
The Court agrees with CardiAQ that the SJC's decision in
Further, Neovasc's misappropriation was willful, such that some amount of enhanced damages is appropriate.
Enhanced damages are particularly appropriate here, where the jury awarded reasonable royalty damages. It is unlikely that in 2009 or 2010, CardiAQ would have actually licensed its trade secrets to Neovasc, had Neovasc asked. The reasonable royalty, therefore, is based on a legal fiction and does not fully compensate CardiAQ. Because of Neovasc's misappropriation, which now cannot be undone, CardiAQ was compelled to license its technology to Neovasc, at the rate determined by the jury.
The Court therefore enhances damages by 30%, and Neovasc is ordered to pay $21 million in addition to the $70 million awarded by the jury.
The permanent injunction requested by CardiAQ has four components, but the parties' arguments have largely focused on the single most punitive aspect of the proposed injunction— that with certain limitations, Neovasc be ordered to suspend all of its TMVI programs, including, but not limited to, its Tiara program, for eighteen months. CardiAQ contends that "without an injunction to reverse the unfair head start that Neovasc obtained by its breach and misappropriation, CardiAQ will continue to be irreparably harmed" [ECF No. 527 at 11] and that Neovasc will unfairly retain the competitive advantage it obtained by breaching the NDA and misappropriating its trade secrets. Neovasc responds that the proposed injunction duplicates the money remedy sought and obtained by CardiAQ, that there is no basis for CardiAQ's 18-month head start argument, and that both the balance of hardships and public interest disfavor the injunction. [ECF No. 537-1]. In a supplemental memorandum filed after oral argument, CardiAQ added that an injunction is necessary and not duplicative, because there is a chance Neovasc will not be able to pay the $70 million previously awarded by the jury. [ECF No. 562].
Based on "well-established principles of equity," to obtain a permanent injunction, "[a] plaintiff must demonstrate: (1) that it has suffered an irreparable injury; (2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury; (3) that, considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction."
Having considered the four-factor test for a permanent injunction, the Court will not suspend Neovasc's TMVI program for any amount of time. The $70 million already awarded by the jury, together with the enhanced damages granted in this Order, adequately compensate CardiAQ for its injury. The proposed 18-month suspension would be duplicative of the monetary relief, and is not warranted given the uncertainty in the TMVI market, the impact the injunction would have on Neovasc, and the public's interest in having access to a potentially life-saving technology.
The first two factors of the injunction analysis ask whether the plaintiff has suffered irreparable injury from the defendant's actions and next, whether remedies available at law, such as monetary damages, are inadequate to compensate for the injury. "The first two of the four factors are satisfied on a showing of `substantial injury that is not accurately measurable or adequately compensable by money damages.'"
As noted earlier, CardiAQ pursued a reasonable royalty theory of damages. At trial, its expert testified that Neovasc would have agreed to pay CardiAQ $90 million following a hypothetical negotiation between CardiAQ and Neovasc in 2010. The jury accepted some of this testimony by awarding CardiAQ $70 million.
The reasonable royalty remedy is imperfect and necessarily inexact.
In other cases, plaintiffs have sought a reasonable royalty for defendants' past use of trade secrets, and then a permanent injunction to prevent any future use.
Further, to arrive at the $90 million figure, Mr. Wagner made several assumptions, including that, by misappropriating CardiAQ's trade secrets and confidential information, Neovasc obtained an 18 month "head start" on its TMVI project—meaning that but for its misappropriation, Neovasc would have been 18 months behind on the development of its TMVI device. He "assumed that Neovasc could have come up with an equivalent product to CardiAQ's device, but it would have taken 18 months longer to do so without using the alleged CardiAQ trade secrets." [Tr. Day 8 at 50:15-21]. His reasonable royalty thus placed a value on this 18-month head start. The requested injunction is premised on the same 18-month head start, and is therefore duplicative of the monetary relief already awarded. By now asking for Neovasc's project to be suspended for 18 months, CardiAQ is trying to have it both ways—it has already received damages that approximate the value of the 18-month head start to Neovasc, and now it seeks an injunction that would eliminate the 18-month head start.
The third and fourth factors of the injunction analysis, the balance of the hardships and the public interest, each weigh against the injunction. First, the balance of the hardships disfavors granting the injunction. CardiAQ complains that if Neovasc is not enjoined, CardiAQ will have to compete with Neovasc for hospitals at which to perform studies, and for the attention of prominent surgeons known as "Key Opinion Leaders." [ECF No. 517 ¶¶ 15-36]. The parties dispute whether this is true. Regardless, this potential hardship is far less severe than that Neovasc would face if the injunction were granted. The Court credits the testimony of Neovasc's CEO that dozens of Neovasc employees would be laid off as a result of the injunction, given that more than half of Neovasc's workforce is dedicated to the Tiara program. [ECF No. 538-13 ¶¶ 31-32]. Moreover, because of Neovasc's small size and how central the Tiara is to its business, Neovasc might not remain as a going concern following the 18-month suspension.
The public would also be disserved by the injunction. As evidenced at trial, Neovasc and CardiAQ's prototypes now differ in several respects and it is unknown which one will be most effective at treating malfunctioning mitral valves. No TMVI device has received regulatory approval, and it is impossible to know which device(s) will or will not be approved. By imposing the 18-month injunction, the Court could potentially delay the progress of the one TMVI device that works, and thereby keep a lifesaving device off the market for an additional year-and-a-half. While there is a countervailing interest in protecting trade secrets and disincentivizing trade secret misappropriation, that interest is largely addressed by the damages Neovasc must pay, and is outweighed by the public's interest in getting the most effective TMVI device to the market as fast as possible.
"An injunction is a drastic and extraordinary remedy, which should not be granted as a matter of course."
In addition to the 18-month suspension, CardiAQ's motion for injunctive relief also requests that the Court order the following:
[ECF No. 516 ¶¶ 1-4].
The Court hereby approves the first two requests for relief. Neovasc is ordered to destroy all information that CardiAQ sent to Neovasc between June 2009 and April 2010 and to return to CardiAQ any CardiAQ prototypes, or portions thereof, that CardiAQ provided to Neovasc and that Neovasc still has in its possession, custody, or control, including but not limited to prototypes fabricated by Neovasc to test any CardiAQ prototype designs. Neovasc has no valid reason to keep this information. To the extent the information is public, which would allow Neovasc to use it even under the NDA, Neovasc can use public sources to obtain the information. Neither the public nor CardiAQ has an interest in Neovasc retaining CardiAQ's information and prototypes. Regardless of the fact, as Neovasc argues, that the NDA has expired, Neovasc does not have a right to retain CardiAQ's confidential information and the injunction is necessary to "protect the secrecy of misappropriated information, to eliminate the unfair advantage obtained by the wrongdoer, and to reinforce the public policy of commercial morality."
The Court will not order the third request for relief. As explained further below,
That being said, just because this matter has been resolved, and judgment will soon be entered against Neovasc, Neovasc does not have free rein to claim CardiAQ's trade secrets and inventive concepts as its own. Any future TMVI patents that are issued to Neovasc will be subject to scrutiny under 35 U.S.C. § 256—consistent with the Court's ruling on the '964 Patent, Mr. Ratz and Dr. Quadri should not be excluded from any patents that they contributed to.
In its two pending motions, Neovasc requests a new trial on damages [ECF No. 522] and a new trial on CardiAQ's trade secret claims 4, 5, and 6. [ECF No. 521]. Neovasc claims that once the jury determined that Neovasc misappropriated some, but not all, of CardiAQ's trade secrets, Mr. Wagner's expert testimony regarding the reasonable royalty became useless and the jury had no basis for determining damages. In addition, Neovasc argues that the jury's finding of misappropriation with respect to trade secret claims 4, 5, and 6 is unsupported by the evidence and contrary to governing law.
Under Fed. R. Civ. P. 59, following a jury trial, a court may grant a motion for a new trial "for any reason for which a new trial has heretofore been granted in an action at law in federal court." Fed. R. Civ. P. 59(a)(1)(A). The trial court may order a new trial if "the verdict is against the clear weight of the evidence, is based upon evidence that is false, or resulted from some trial error and amounts to a clear miscarriage of justice."
"In reviewing an award of damages, the district court is obliged to review the evidence in the light most favorable to the prevailing party and to grant remittitur or a new trial on damages only when the award exceeds any rational appraisal or estimate of the damages that could be based upon the evidence before it."
Most of the arguments raised by Neovasc in its motion for a new trial on damages were previously rejected, when the Court denied Neovasc's motion to exclude Mr. Wagner's testimony. [ECF No. 418]. In a motion in limine filed on the eve of trial, Neovasc argued that Mr. Wagner's testimony on a reasonable royalty should be excluded because he: (1) had no basis to assume that the information CardiAQ shared with Neovasc gave Neovasc an 18-month head start in the development of its Tiara device; (2) inappropriately incorporated financial information that arose after the date of the hypothetical negotiation; and (3) improperly relied on Neovasc's sales of securities to calculate a baseline royalty. [ECF Nos. 344, 346]. The Court rejected each of these arguments. First, the 18-month head start assumption, which was only one piece of Mr. Wagner's larger reasonable royalty analysis, did not warrant excluding Mr. Wagner's testimony, given that there was some evidence in the record to support the 18-month head start assumption, and that CardiAQ intended to present evidence at trial, through fact witnesses, to establish the facts assumed by Mr. Wagner. [ECF No. 418 at 6-7]. Second, though Mr. Wagner's
To the extent Neovasc attempts to rehash any of these arguments in its motion for a new trial, its efforts are unavailing. CardiAQ presented sufficient evidence at trial to support the 18-month head start assumption. It took CardiAQ about 20 months to develop the trade secrets at issue in this case, [Tr. Day 4, 127:16-19, 134:7-25], and Mr. Wagner was justified in assuming it would take Neovasc approximately the same amount of time. Over the course of the trial, the jury heard considerable testimony about the value of CardiAQ's trade secrets, from which they could reasonably conclude that possessing them gave Neovasc an 18-month head start. The 18-month head start was supported by the evidence—namely, CardiAQ's own development time, as well as Dr. Ratz' testimony—and was not based on speculation or guesswork. Likewise, as the Court has already held, Mr. Wagner could consider data from 2015 to calculate a reasonable royalty based upon a hypothetical negotiation in 2010. At trial, Mr. Wagner testified as to all of the
The one new argument raised by Neovasc in its motion for a new trial on damages, which was not raised in its pre-trial motion to exclude Mr. Wagner's testimony, is that the jury's split verdict on damages—finding that Neovasc misappropriated trade secrets 4-6, but not 1-3— renders Mr. Wagner's testimony useless. According to Neovasc, there was not evidence from which the jury could determine the value of trade secrets 4 and 6, since Mr. Wagner did not testify as to the reasonable royalty for each individual trade secret.
Based on the evidence before it, including Mr. Wagner and Mr. Ratz' testimony, the jury rationally appraised the value of the misappropriated trade secrets, and Neovasc has not demonstrated that it is entitled to a new trial on damages. Mr. Wagner valued the trade secrets based on the challenges they solved and the head start they gave to Neovasc. It was not erroneous for Mr. Wagner to assume, or the jury to conclude, that the combination of trade secrets 1 and 2, as well as the individual trade secrets 3, 4, and 6 solved the same challenges and gave Neovasc the same head-start. Whether in the form of physical prototypes (trade secrets 1-3), design features (trade secret 4), or historical developments (trade secret 6), each disclosed the key inventive concepts behind CardiAQ's TMVI device, including its anchoring system, and how CardiAQ had gone about solving the challenges facing TMVI developers at the time.
As the Court instructed the jury, for each trade secret claim, CardiAQ needed to prove by a preponderance of the evidence the following three elements: (1) that CardiAQ's information was a trade secret; (2) that CardiAQ took reasonable steps to preserve the secrecy of its information; and (3) that Neovasc used the trade secret through improper means. [Day 13 Tr. at 165:2-9]. In its motion for a new trial on trade secrets 4-6, Neovasc does not take issue with the Court's jury instructions. Rather, Neovasc contends that the "[t]he jury's finding of misappropriation with respect to TS Claims 4, 5, and 6 is unsupported by the evidence and contrary to governing law." [ECF No. 521 at 1]. Neovasc's principal argument is that CardiAQ did not prove that trade secrets 4, 5, and 6 were in fact trade secrets, as defined under Massachusetts law and in the Court's instructions.
First, Neovasc argues that it is entitled to a new trial on trade secret number 4 since there was insufficient evidence to show that trade secret 4 was either a secret or a unified process, as is required of all trade secrets under Massachusetts law. Trade secret 4 described CardiAQ's TMVI device generally. Trade secret 4 consists of:
[Tr. Ex. 1157 at 14-17]. Neovasc's motion for a new trial focuses on the six features listed at the end of trade secret 4. Neovasc claims that CardiAQ did not prove that these features were secret or that they constituted a unified process. According to Neovasc, "CardiAQ did not merely fail to establish secrecy of the individual features: it ultimately agreed that they were not secret," and further that "CardiAQ offered no evidence that combining some or all of the features resulted in a unified process." [ECF No. 521 at 5].
Neovasc's motion for a new trial takes the six features listed at the end of trade secret number 4 out of context. CardiAQ did not claim that these features were themselves trade secrets. Instead, trade secret 4 consists of CardiAQ's TMVI design, which contains one or more of the six listed features. As the Court instructed the jury without objection, "A trade secret can exist in a combination of characteristics and components, even if some or all of the characteristics and components are in the public domain, as long as the unified process, design, and operation of the combination constitutes a unique combination that is a trade secret." [Tr. Day 13 at 166:4-9]. Though sugar is not a trade secret, a secret recipe containing sugar can be. Likewise, though mushroom-shaped locking tabs (one of the six listed features) may have been well-known in the industry and therefore not a trade secret, the jury could reasonably find that a TMVI device containing mushroom-shaped locking tabs was a trade secret.
Neovasc presented evidence that the individual elements of trade secret 4 were publically known, but not in the context of a fully conceptualized TMVI device. For example, Neovasc's expert Mr. Leinsing cited to a patent on non-heart valve stents to show that variable strut dimension was publicly known [Tr. Day 11, 109:2-12; Ex. 2075], to a patent for a transcatheter aortic valve to show that V-shaped, atraumatic anchors were publicly known [Tr. Day 11, 110:11-24; Ex. 2086], and to a patent on a stomach implant and aortic device to show that mushroom-shaped locking tabs were publicly disclosed. [Tr. Day 11, 110:25-111:18; Exs. 2079 and 2091]. Neovasc did not show, however, that these elements were included or combined in a previously disclosed transcatheter mitral valve device. CardiAQ revealed to Neovasc TMVI prototypes that embodied all of the features identified in CardiAQ's Trade Secret 4, [Tr. Day 4, 86:14-16; Tr. Day 7, 12:17-17:21], and the jury could reasonably conclude that a TMVI device with these features was both a secret and a unified process.
Neovasc is also not entitled to a new trial on trade secret number 5. Trade secret number 5 was the CardiAQ Mandrel, a tool created by CardiAQ to help construct its TMVI device. During their business relationship, and pursuant to the NDA, CardiAQ gave the Mandrel to Neovasc, so that Neovasc could build CardiAQ's prototypes. Krista Neale, a Neovasc project engineer, admitted to using the Mandrel on an unrelated project after CardiAQ had cut ties with Neovasc. [Neale Depo. 115:04-117:18].
Neovasc claims that it is entitled to a new trial on trade secret number 5 because CardiAQ ascribed no value to the Mandrel and because CardiAQ disclosed the Mandrel in an April 2010 patent application. The patent application, however, did not provide as much information as Neovasc received by holding the physical Mandrel and by viewing CAD files for the Mandrel that were not included in any patent applications. [Tr. Day 9 at 109:6-110:23; Tr. Ex. 1163]. Further, while it is true that the Mandrel was not included in Mr. Wagner's reasonable royalty calculation, the jury could still find that it was a valuable trade secret, given that it was covered by the NDA, not publically available, and necessary to construct CardiAQ's device.
Lastly, Neovasc is not entitled to a new trial on trade secret number 6. Trade secret number 6 was the development history of CardiAQ's TMVI device. In its trade secret disclosure, CardiAQ identified trade secret number 6 as:
[Tr. Ex. 1157 at 18]. According to Neovasc, this development history is not protectable as a trade secret because it does not satisfy the continuous use or unified process requirements under Massachusetts law. In addition, Neovasc claims that CardiAQ did not show that Neovasc improperly used or disclosed CardiAQ's development history.
Before and during its relationship with Neovasc, CardiAQ modified the design of its TMVI device. At the outset of the parties' relationship, both Mr. Ratz and Dr. Quadri told Neovasc about CardiAQ's earliest TMVI work. [Tr. Day 3, 21:2-8; Tr. Ex. 1158 (showing Rev. A at p. 12, and Rev. B at p. 11)]. During their relationship, CardiAQ asked Neovasc to build frames with different designs, as CardiAQ modified the anchoring mechanism and other features of its device.
The jury, which was instructed on the Massachusetts continuous use requirement [Day 13 Tr. at 165:17-19], had a sufficient basis to conclude that CardiAQ continues to use trade secret 6 in the operation of its business. As it develops its TMVI device and works towards FDA approval, CardiAQ continues to use its past discoveries about what works and what does not. Its development history has influenced the current design of its TMVI device, and will likely influence any future modifications to it. [
The one issue that remains outstanding is CardiAQ's inventorship claim. On November 12, 2013, the United States Patent and Trademark Office issued U.S. Patent No. 8,579,964 (the "'964 Patent") to Neovasc. The '964 Patent, directed to a method of anchoring a valve into the heart, lists Randy Lane and Colin Nyuli, both Neovasc employees, as the inventors. The '964 Patent contains one independent claim (Claim 1) and 27 dependent claims (Claims 2-28). CardiAQ contends that Dr. Quadri and Mr. Ratz invented the subject matter of independent Claim 1 and dependent Claims 2 through 28 of the '964 Patent, either by themselves or in collaboration with Mr. Lane and Mr. Nyuli, and seeks an order, pursuant to 35 U.S.C. § 256, requiring Neovasc and the Director of the United States Patent and Trademark Office to take all steps necessary to correct the named inventor on the '964 Patent.
35 U.S.C. Section 256 creates a cause of action in the district courts to correct the non-joinder of an inventor on a patent. Under Section 256, a district court "may order correction of the patent on notice and hearing of all parties concerned and the Director shall issue a certificate accordingly." 35 U.S.C. § 256. "Conception is the touchstone to determining inventorship."
Joint inventorship requires collaboration. "[C]o-inventors must collaborate and work together to collectively have a definite and permanent idea of the complete invention."
Alleged co-inventors "must prove their contribution to the conception of the invention with more than their own testimony."
Mr. Lane first sketched an idea for what would become the Tiara on October 20, 2009, and he first communicated to patent counsel his ideas for a transcatheter mitral valve replacement device in December 2009. [Tr. Day 9, 107:19-108:8]. On May 5, 2010, Mr. Lane and Neovasc filed provisional patent application No. 61/331,799, claiming the Tiara design [Tr. Day 9, 107:19-108:8; Tr. Ex. 565]. On April 28, 2011 Mr. Lane and Neovasc filed non-provisional application No. 13/096,572, which claimed priority to the May 5, 2010 application, as well as to two intermittent provisional applications (Nos. 61/393,860 and 61/414,879). [Tr. Ex. 565]. On November 12, 2013, application No. 13/096,572 issued as the '964 Patent.
Claim 1 of the '964 Patent claims a method of anchoring a prosthetic valve in a patient's heart, said method comprising:
[ECF No. 293-11 at 60-61].
The parties agree that before getting to the inventorship question, the Court must engage in claim construction. The parties' chief dispute, which was a central theme at trial, is the meaning of "trigonal anchoring tab" mentioned in Claim 1. Claim 1 describes a prosthetic valve, "wherein the ventricular skirt comprises a first trigonal anchoring tab" and involves "anchoring the first trigonal anchoring tab against a first fibrous trigone on a first side of an anterior leaflet of the native mitral valve." According to CardiAQ, the term "trigonal anchoring tab" means a tab capable of anchoring on a fibrous trigone when deployed. [ECF No. 512 at 2]. According to Neovasc, it means a tab designed for anchoring on a fibrous trigone when deployed. [ECF No. 535 at 9].
The following is a picture of the mitral valve from the '964 Patent:
The figure shows that the mitral valve has two fibrous trigones, a left fibrous trigone and a right fibrous trigone. "AN" points to the mitral valve annulus. At trial and in their inventorship briefs, the parties have disputed whether the fibrous trigones are part of the native mitral valve annulus or not. According to Neovasc, the fibrous trigones are adjacent to, but separate from, the native mitral valve annulus. This is consistent with the '964 Patent, which stated that the fibrous trigones consist of "two regions adjacent an anterior portion of the annulus." [Tr. Ex 115 at 53]. CardiAQ counters that that the fibrous trigones are a continuous part of the annulus, and not separate from it. At trial, CardiAQ's expert, Dr. Bavaria, testified that fibrous trigones are part of the native mitral annulus. [Tr. Day 6 at 34:23-35:22].
The Court does not need to resolve this anatomical dispute in order to define Claim 1. Regardless of whether the fibrous trigones are part of the annulus or not, the "trigonal anchoring tab" mentioned in Claim 1 is designed to anchor specifically on the fibrous trigones. In view of the '964 Patent claim language and specification, "Anchoring the first trigonal anchoring tab against a first fibrous trigone on a first side of an anterior leaflet of the native mitral valve" means "positioning the trigonal anchoring tab in order to anchor it against a fibrous trigone on either the left or right side of the native anterior leaflet." CardiAQ's proposed construction would read the word "trigonal" out of Claim 1. A "trigonal anchoring tab" that anchors anywhere other than on a fibrous trigone is not described in the '964 patent, and CardiAQ's proposed construction is unduly broad.
Even accepting this proposed claim construction, however, as well as all of the others proposed by Neovasc, CardiAQ has still demonstrated, by clear and convincing evidence, that it contributed to the conception of the '964 Patent and that Mr. Ratz and Dr. Quadri should be added as co-inventors.
While it is true that CardiAQ did not share with Neovasc any TMVI prototypes containing anchors specifically designed to anchor on the fibrous trigones, the prototypes that CardiAQ did discuss and share with Neovasc had equally spaced anchors, intended to anchor on the annulus generally. Given the number of anchors and size of the fibrous trigones, it was likely that at least one of CardiAQ's anchoring tabs would anchor against a fibrous trigone, but this was more a coincidence than on purpose.
A joint inventor, however, "does not need to contribute to every single element of every single claim in the patents—`some' contribution is sufficient."
Accordingly, even if Neovasc independently conceived of trigonal anchoring tabs designed to anchor on the fibrous trigone, CardiAQ still made a significant contribution to the conception of the '964 Patent. CardiAQ retained Neovasc to facilitate its TMVI development. During their ten-month business relationship, CardiAQ collaborated with Neovasc and shared with Neovasc the designs, prototypes, and development history of its device. Mr. Lane admits that he had never designed a TMVI device prior to working on the CardiAQ device, and his earliest sketches of a TMVI device do not appear until October 2009, months after he started working with Mr. Ratz and Dr. Quadri. [Tr. Day 9 at 60:25-61:3; Ex. 346 at 148]. The progression of TMVI ideas sketched in Mr. Lane's notebook reflects a trend towards the designs of CardiAQ: Mr. Lane began in October 2009 with a grommet-style TMVI device with no distinct anchors, and he progressed to extended vertical anchors in March 2010, after Mr. Lane first received the Rev E design earlier, in February 2010. [
Mr. Ratz and Dr. Quadri's contribution to the invention and collaboration with Neovasc is corroborated not only by their own testimony, but also the testimony of Mr. Lane, the email communications between the parties [Tr. Exs. 1158-1219], and the physical prototypes of CardiAQ's devices still in Neovasc's possession. [Tr. Exs. 331-333];
Neovasc relies on the prosecution history of the '964 Patent to argue that anchoring on the fibrous trigones was the key inventive aspect of the patent, and that because CardiAQ did not contribute to this novel part of the patent, it should not be named as a co-inventor. In a first Office Action dated June 4, 2013, the examiner found independent Claim 1 of the '964 Patent anticipated by a prior art reference, US Patent Publication No. 2006/0259136 to Nguyen et al ("Nguyen"), that disclosed individual features similar to the elements of Claim 1. [Tr. Ex. 2779 at 1037-1045]. In response, Neovasc informed the Patent Office, and the Patent Office agreed, that the prior art reference did not teach "securing an anchoring tab against a first fibrous trigon[e]." [Ex. 2779 at 1085]. This, however, was not the only argument made by Neovasc and accepted by the Patent Office. In addition, Neovasc noted that the prior art disclosed the elements of Claim 1 in the context of a transcatheter aortic valve replacement device, not a mitral valve device. As Neovasc wrote to the Patent Office in response to the June 4, 2013 Office Action, "Nguyen discloses prosthetic valve for treating aortic stenosis or aortic regurgitation (para 001). Thus it is clear that Nguyen's prosthetic valve is implanted in the patient's aortic valve not the mitral valve as currently claimed. Nowhere in Nguyen is there teaching or suggestion that Nguyen's prosthetic valve is implanted in the mitral valve. In fact terms such as `mitral valve,' `chordae tendinae,' `atrium,' and `trigone' do not even appear in Nguyen's specification."
Neovasc also claims that a single prior art reference called Chau, a patent for a prosthetic mitral valve, disclosed all of the elements of the '964 patent contributed by CardiAQ. [ECF No. 535 at 5-6]. The parties agree, however, that the Chau reference was not public at the time Dr. Quadri and Mr. Ratz worked with Mr. Lane. Chau therefore does not detract from CardiAQ's contribution to the '964 Patent. At the time Dr. Quadri and Mr. Ratz collaborated with Mr. Lane—sharing designs and prototypes of CardiAQ's TMVI device—they were not "merely explain[ing] . . . well-known concepts and/or the current state of the art."
On October 19, 2016, Neovasc filed motions and a supporting memorandum [ECF Nos. 571-574] seeking the Pro Hac Vice admission of three additional attorneys. CardiAQ opposes the admission of these attorneys on grounds wholly unrelated to their fitness or qualifications. Because this Memorandum and Order resolves all of the other pending motions in the case, thereby effectively ending this litigation in the District Court, there is no reason for any attorney to "practice in this court" in this "particular case," as required by Local Rule 83.5.3. The pending motions for Pro Hoc Vice admission will therefore be denied as moot.
For the reasons stated herein:
[Tr. Day 13 at 165-66].