“The court did not split based on disagreement about what the law should be—in fact, the Federal Circuit broadly agreed that Athena’s claims should be patent-eligible. Rather, the court split based on genuine disputes about how to apply the framework this Court established.” – Athena reply brief

Athena Diagnostics today filed its reply brief to Mayo Collaborative Services at the Supreme Court in the closely-watched petition asking the High Court to clarify U.S. patent eligibility law. The reply reiterates the points made in Athena’s petition for certiorari and dismisses Mayo’s argument in November that “any further action regarding the patentability of medical diagnostic claims such as Athena’s that employ conventional, known techniques should and does rest with Congress.”

The reply also comes three days after the United States Solicitor General recommended that SCOTUS grant cert in Athena or “another such case” rather than in Hikma Pharmaceuticals v. Vanda Pharmaceuticals.

Athena filed its petition for certiorari to the U.S. Supreme Court in October, asking it to fix the United States’ patent eligibility law problem. The question presented is:

Whether a new and specific method of diagnosing a medical condition is patent-eligible subject matter, where the method detects a molecule never previously linked to the condition using novel man-made molecules and a series of specific chemical steps never previously performed.

In its brief in opposition filed November 22, Mayo claimed that the Supreme Court’s precedent in the 2012 case of Mayo v. Prometheus “disposes of this case, as the district court, appellate panel, and en banc Federal Circuit each concluded.” Essentially, Mayo told the Court that there was nothing more for it to do and that Congress should address any confusion or harm that exists.

Athena’s reply says that Mayo’s argument:

“collapses under the weight of the Federal Circuit’s 7-5 split;”

“tees up multiple points of doctrinal uncertainty identified by the Federal Circuit, amici, and government” including “the role of novel man-made molecules in method claims, the level of abstraction at which to view claims, the Federal Circuit’s one-sided approach to preemption, and what it means to view the claims as a whole;”

“loses sight of the procedural posture” since Mayo’s request to “dismiss under Rule 12(b)(6) on the theory that, without any factual development, the asserted claims were categorically ineligible for patent protection as a matter of law” underscores that the case “presents a pure question of law, with no factual disputes to resolve because the record must be viewed in the light most favorable to Athena. In short, it provides a perfect vehicle to clarify the law;” and

“gets things backwards” in arguing that Congress should take the reins. The reply brief says: “The Federal Circuit did not interpret the statutory text; it misapplied this Court’s decisions creating exceptions to that text. If Mayo wants those exceptions expanded, it is the one that should take its policy arguments to Congress. The Court has a special responsibility to ensure that the lower courts do not unduly expand judge-made law by misinterpreting the framework it created.”

The brief also emphasizes the government’s position in Vanda, which supports granting certiorari in Athena or a case like it rather than in Vanda, which the Solicitor General does not consider “an optimal vehicle for bringing greater clarity” on Section 101.

Athena chiefly points to the Federal Circuit’s 7-5 split in its decision to deny rehearing en banc as evidence that Mayo’s claim that “the Federal Circuit has had no problem applying Mayo [v. Prometheus] consistently” is disingenuous. Athena explained:

The court did not split based on disagreement about what the law should be—in fact, the Federal Circuit broadly agreed that Athena’s claims should be patent-eligible. Rather, the court split based on genuine disputes about how to apply the framework this Court established in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012).

Second, Athena points to Mayo’s focus on the facts of this particular case as actually highlighting the broader legal questions the CAFC has struggled to apply:

First, as recognized by Judge Dyk, there is tension between the decision below and this Court’s holding in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 594-595 (2013), that a “molecule that is not naturally occurring” is “not a ‘product of nature’ and is patent eligible under § 101.” Pet. 17, 29-31; App. 69a-71a. Mayo offers no good response. It implicitly concedes (at 25), as it must, that the prior Mayo case involved a drug routinely used before, not a novel manmade molecule as here.

Of Mayo’s contention that Congress must step in to make any necessary changes to Section 101, Athena warns that help from Congress is far off at best, and that Mayo should take its policy arguments to Congress itself if it wants to expand exceptions to Section 101:

The Court should not ignore the lower courts’ confusion in the hope that Congress might intervene. Despite congressional hearings highlighting that confusion and the unsustainable state of the law, Pet. 22-24, there is no legislative solution in sight, Nayak, IP Groups Developing Fresh Patent Eligibility Bill Proposal, Bloomberg Law (Oct. 17, 2019), https://bit.ly/2ONFG4t (“lawmakers have not introduced a bill” in light of “disagreement among stakeholders”). In any event, this Court has a special responsibility to clarify patent-eligibility law and rein in the Federal Circuit’s improper expansion of the exceptions to patent eligibility.

The case will go to Supreme Court conference on January 10.