News Detail Banner
All News & Events

Article: September 2019: Life Sciences Update

Business Litigation Reports

Federal Circuit Denies Rehearing En Banc in Contentious Case Involving Patentability of Diagnostic Testing

On July 3, 2019, in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, 927 F.3d 1333 (Fed. Cir.), the Court of Appeals for the Federal Circuit denied Plaintiff Athena’s petition for rehearing en banc.

The denial of the petition, however, led to eight separate concurring and dissenting opinions from active Federal Circuit judges, an unusually large number, demonstrating significant splits of opinion regarding the patentability of diagnostic test kits, as well as express requests for either Supreme Court or Congressional clarification regarding such patentability.

In the original panel decision, the Federal Circuit affirmed the dismissal of a patent infringement complaint pursuant to Federal Rule of Civil Procedure 12(b)(6) on the ground of subject matter ineligibility. See Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743, 753-54 (Fed. Cir. 2019). The patent at issue was directed to a diagnostic test for an autoimmune disease that involved testing for the presence of certain antibodies by contacting the sample with a radioactive labeled protein. In the panel decision, the Court affirmed the district court’s dismissal based on 35 U.S.C. § 101, following Supreme Court precedent in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 77 (2012).

The patent holder moved for rehearing en banc, which the Federal Circuit denied, accompanied by eight opinions. 927 F.3d 1333 (Fed. Cir. 2019).

  • Lourie (joined by Judges Reyna and Chen) Judge Lourie concurred with the denial of rehearing because, according to Judge Lourie “we can accomplish little in doing so” as the court is bound by Supreme Court precedent in Mayo. at 1335. Judge Lourie noted that concerns have been expressed about this precedent and wrote that if he were to “write on a clean slate” only claims directed to natural laws themselves would be outside of patent eligibility. Id.
  • Hughes (joined by Judges Prost and Taranto): Judge Hughes concurred with the denial and echoed Judge Lourie that Mayo controls and forecloses a decision different than that of the panel. Judge Hughes, however, requested additional clarification about patent eligibility for diagnostic testing patents from either the Supreme Court or Congress. at 1337.
  • Dyk (joined by Judge Hughes, and joined by Judge Chen for portions): Judge Dyk concurred with the denial and provided an overview of the importance of Section 101 eligibility analysis. at 1338–39. Additionally, Judge Dyk expressed concern for the natural law approach of the Supreme Court’s Mayo precedent. Id. at 1339. Judge Chen joined in the portion of Judge Dyk’s opinion in which Judge Dyk wrote that it would be desirable for the Supreme Court to revisit and refine the Mayo framework. Id. at 1340. Judge Dyk further stated that Athena’s case would be a good case to revisit the issue. Id. at 1343-44.
  • Chen: Judge Chen concurred with the denial but wrote that further Supreme Court guidance would be helpful for diagnostic patents. Judge Chen provided an overview of Supreme Court 101 precedent, describing how recent cases such as Mayo deviate from the core rationale of earlier precedent as articulated in Diamond v. Diehr, 450 U.S. 175 (1981). at 1344. Judge Chen argued that the analytical approach set forth in Mayo is “considerably harder to apply consistently than the Diehr framework, and more aggressive in its reach.” Id. at 1348.
  • Moore (joined by Judges O’Malley, Wallach and Stoll): Judge Moore dissented from the denial and argued that the patent claims at issue are distinguishable from the Supreme Court’s Mayo Judge Moore argued that “[w]e have turned Mayo into a per se rule that diagnostic kits and techniques are ineligible.” Id. at 1354. Judge Moore further stated that there are strong economic incentives for patent protection for diagnostic inventions. See id. at 1357 (“Unless one opposes the notion of patent protection entirely, it cannot be reasonably disputed that claims to diagnostic kits and techniques, like pharmaceuticals, which require enormous initial investments in terms of both time and money, are the reason we suffer the promise of a monopoly.”).
  • Newman (joined by Judge Wallach): Judge Newman dissented from the denial and highlighted the importance of diagnostic testing patents, arguing that Supreme Court precedent is being applied too broadly. at 1364.
  • Stoll (joined by Judge Wallach): Judge Stoll dissented from the denial and argued that the Federal Circuit has “established a bright-line rule of ineligibility for all diagnostic claims” that is based on an overly-broad and flawed test for eligibility. at 1370. Judge Stoll further argued that the Federal Circuit has applied Mayo too rigidly and should instead “create judicial doctrine geared toward the practical application of Mayo’s principles.” Id. at 1371.
  • O’Malley: Judge O’Malley dissented from the denial and argued that the Supreme Court has ignored Congress’s direction to the courts to apply Section 101 as written. Judge O’Malley further called for Congress to intervene. at 1373.