[author: Kevin E. Noonan]
On May 30th, Myriad Genetics filed a motion in the remand of Association for Molecular Pathology v. U.S. Patent and Trademark Office case ("Myriad") to the Federal Circuit, styled "Appellant's Suggestion of Mootness, or, in the alternative, Motion to Remand," to address the fundamental question of whether the Federal Circuit, or any U.S. court, has jurisdiction to hear the case. This issue is based on the Federal Circuit's determination, in its now-vacated decision, that only one plaintiff, Dr. Harry Ostrer, had standing to bring the lawsuit, coupled with Myriad's contention that the basis for jurisdiction was abolished when Dr. Ostrer changed his academic affiliation. This issue was brought to the Court's attention two days before it handed down its now-vacated decision, and was not sufficient to induce the Federal Circuit to rehear the case either before the original panel or en banc. After remand from the Supreme Court's decision granting certiorari and vacating the Federal Circuit's opinion for reconsideration in view of the Court's Mayo v. Prometheus decision, the Federal Circuit did not include this issue in the questions to be addressed by the parties or interested amici.
Plaintiffs have responded in a brief that contains three arguments. The first is that Dr. Ostrer was sued personally, so that his change in employment status is not relevant to the standing issue. This argument is factual in nature, alleging that Dr. Ostrer remains capable of performing BRCA genetic testing in his new position at Albert Einstein College of Medicine/Montefiore Hospital but has not done so due to Myriad's threat of patent infringement liability. The brief challenges Myriad's contention that the threat of infringement liability was directed to Dr. Ostrer's prior employer, New York University (NYU), because Myriad's "threatening" letter was directed towards Dr. Ostrer personally and NYU was not named as a plaintiff in the lawsuit. (While it is true that the letter was addressed to Dr. Ostrer, the brief notes that Myriad in fact sued the employer of two other putative plaintiffs, Drs. Ganguly and Kazazian, and it should be remembered that the ACLU and PubPat, the sponsors of the litigation were responsible for what parties were named, not Myriad.) The brief contends that finding his change of employment to have stripped Dr. Ostrer of standing could be contrary to the Court's original finding that he had standing as an individual; this argument does not address Myriad's position that regardless of his subjective intent of being "ready" and "willing" to infringe he would only be "able" to do so if Montefiore Hospital permits him to be. In this regard, the brief states that Myriad's citation to the Montefiore Hospital website as evidence that Dr. Ostrer's is not unable to provide BRCA genetic testing services is "outdated" and provides an updated citation (Laboratory Services, Montefiore Medical Center). Finally, the brief resists the suggestion that the Court remand to the District Court for a factual determination of the standing issue, stating that such action would be appropriate only if Myriad were to make an adequate proffer regarding a change in Dr. Ostrer's ability to infringe, which (of course) the brief contends Myriad has not done.
Plaintiffs' second argument is that, even under the standard enunciated by the Federal Circuit in its now-vacated decision, other plaintiffs, including Ms. Reich and Ms. Matloff also have standing, being themselves "personally" threatened with suit. Ms. Reich is an NYU employee, and Ms. Matloff works at Yale. The brief argues that, insofar as the Court's earlier decision is read as holding that standing is predicated on the ability to perform BCRA testing, then Ms. Reich's continued employment at NYU confers standing upon her. This argument does not address whether Ms. Reich has the professional capacity to perform BRCA testing in a milieu other than a lab (Dr Ostrer's) where the testing can be performed, a concern that echoes Myriad's argument (unrebutted in Plaintiffs' brief) that Dr Ostrer no longer has standing because Montefiore does not have regulatory approval (from New York State, for example) to perform the tests. As for Ms. Matloff, Myriad's "threat" was conveyed not by a formal letter (as were the "threats" to Dr. Ostrer at NYU and Drs. Ganguly and Kazazian at Penn) but in a telephone call initiated by Ms. Matloff; it can reasonably be assumed that the call was for the express intent to garner the "threat" and create standing, a tactic that can only kindly be said should not be encouraged.
The final (and most lengthy) argument advanced by Plaintiffs is that the Federal Circuit erred with regard to the other named plaintiffs, who according to the brief also have standing. The brief specifically addresses this argument to one organizational plaintiff, the American College of Medical Genetics and Genomics (formerly, the American College of Medical Genetics), reiterating its position that standing should lie because "gene patenting is germane to ACMG's purpose." These plaintiffs have organizational standing, according to the brief, under Warth v. Seldin, 422 U.S. 490, 511 (1975). As for the other plaintiffs, the brief takes the opportunity to renew its attack on the standing standards imposed by the Federal Circuit, which Plaintiffs contend are "more stringent" than the "reasonable apprehension of suit" test abrogated (in a footnote) in the Supreme Court's MedImmune, Inc. v. Genentech, Inc. decision. 549 U.S. 118, 127 (2007). The brief characterizes what it fashions the "personally threatened" test as being a "bright line rule" that the Supreme Court "instruct[ed] [in MedImmune] are inappropriate when analyzing a plaintiff's standing in a declaratory judgment action." The brief supports this assertion by citing a portion of the earlier, now-vacated Federal Circuit decision, where the Court found that "every other similarly situated researcher and institution" ceased BRCA testing as the result of Myriad's patent enforcement actions, that there was no evidence that any other researcher or institution had successfully challenged Myriad's assertion of its patent rights, nor was there evidence that Myriad's intention to assert those rights had changed. This pattern should be enough to make Myriad's actions sufficiently "proximate" to raise standing, according to Plaintiffs. The brief also cites several cases where the Supreme Court and other appellate courts (including the Federal Circuit) have found standing without direct action against individual plaintiffs, including Doe v. Bolton, 410 U.S. 179, 188 (1973); Virginia v. Am. Booksellers Ass'n, Inc., 484 U.S. 383, 393 (1988); Vt. Right to Life Comm., Inc. v. Sorrell, 221 F.3d 376, 382 (2d Cir. 2000); and Biotech. Indus. Org. v. District of Columbia, 496 F.3d 1362, 1370 (Fed. Cir. 2007). However, these were all cases involving government action in enforcing a statute. The brief recognizes this, but calls it a "difference without a distinction" (seemingly contrary to similar distinctions made by Justice Scalia in the MedImmune opinion and garbling in the process Learned Hand's famous aphorism). According to the brief, "[t]he elements required for Article III standing do not differ based on the public or private nature of the potential enforcer. A party can show a substantial controversy based on impending injury resulting from an invalid law or patent. A requirement that the law or patent be enforced against a party before they can seek judicial alleviation of that injury is contrary to the law." The brief provides no legal basis for equating a statute with a patent or government with private action.
Opening party briefs and briefs by any amici remain due on June 15th.