On Jan. 10, the Supreme Court will decide whether it will review the Federal Circuit's decisions in the Athena v. Mayo, HP Inc. v. Berkheimer and Hikma v. Vanda cases. The Solicitor General, at the invitation of the Supreme Court, submitted amicus briefs in which he recommended the Court review the Athena case and clarify the application of the Mayo test to method-of-medical-treatment claims.
The Federal Circuit's July 3, 2019, en banc denial in Athena v. Mayo showcased the wide divergence of viewpoints on the court about whether diagnostics are patent eligible. Nine different Federal Circuit judges in the Athena case called for the Supreme Court to clarify the standard for patent eligibility under the Mayo test, which sets forth the following two-part test: (1) evaluate whether the claims are "directed to" a patent-ineligible concept, such as a natural phenomenon, and (2) if so, whether the limitations of the claim, considered individually and as an ordered combination, transform the nature of the claim into a patent-eligible application.
Recent court decisions have veered away from the language of the Mayo test "as an ordered combination," instead focusing on whether each limitation of a claim is independently known, obvious or conventional in light of the prior art. The danger of this vantage point is it takes away the opportunity to patent inventions that have added a spark of innovation to what was already known in the art — something that no one else had conceived of before, despite the fact that each element, separately, was known. KSR Intern. Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007) ("inventions, in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known").
For example, in INO Therapeutics LLC et al. v. Praxair Distribution Inc., No. 2018-1019, 2019 WL 4023576 (Fed. Cir. Aug. 27, 2019), the Federal Circuit held that method of treatment claims were directed to a natural phenomenon and unpatentable under § 101. Id. at *4-11. The claims were directed to a method of treating respiratory failure in infants by the administration of nitric oxide gas, but excluded infants with a congenital heart condition. Id at *3-4. The Federal Circuit held that this type of claim failed the Mayo test; "the invention does not improve treatment of the underlying conditions in question — pulmonary edema and hypoxic respiratory failure — by taking advantage of the body's natural processes." Id. at *6. And the claimed combination amounts to little more than an instruction to doctors to apply natural law. Id. at *10.
In the INO opinion, the majority evaluated each of the claimed steps in isolation and held that the individual claimed steps of identifying, determining and administering the gas to infants were known in the prior art. Id. at *9. The court also found that not administering the gas to infants with a congenital heart condition was status quo; i.e., leaving the infants in their natural state, which was a "natural phenomenon." Id. at *9-10.
As Judge Newman noted in his dissent, the majority ignored the fact that in combination, the multistep process required the doctor to know whether or not to administer the gas to any particular patient and to avoid affecting the certain group of infants that experience adverse effects. Id. at *13. Before the invention, "no treatment protocol had screened for such an adverse event before," and the use of the new treatment protocol reduced the incidence of severe adverse events by as much as 90 percent. Id. at **4, 13. The invention was the result of a clinical study and Food and Drug Administration approval that took place over the course of five years. Id. at *13.
Simply because the claimed method of treatment concerned a human physiological response and steps in isolation that were known, the majority in the INO case took the position that it was directed to a "natural phenomenon." But in doing so, it did not evaluate the claimed invention as a whole that made the claimed invention patent eligible. By looking at "the whole enchilada," courts and practitioners can avoid being uber-technical in the application of the Mayo test that creates a result entirely inconsistent with the spirit of Section 101.