Hikma has petitioned the Supreme Court for review of this important eligibility case. In its decision, the Federal Circuit drew a fine line between Vanda’s personalized medical treatment claims (adjudged eligible) and the methods found in Mayo and Ariosa (adjudged ineligible). Question presented (long form):
This Court has repeatedly held that “natural phenomena and abstract ideas are not patentable” under Section 101 of the Patent Act. E.g., Alice Corp. Pty. Ltd. v. CLS Bank, Int’l, 573 U.S. 208, 216 (2014). Thus, “a process that focuses upon the use of a natural law” must also contain other elements or a combination of elements, sometimes referred to as an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.” Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 72-73 (2012). Mayo, for example, invalidated a medical diagnosis method patent that was just “an instruction to doctors to apply the applicable laws when treating their patients.” Id. at 79.
In the decision below, a divided Federal Circuit panel did exactly what Mayo forbids: it exempted all patent claims that are drafted as reciting a method of medically treating patients from this analysis. Citing the ruling, the Patent and Trademark Office has directed its examiners that “(1) ‘method of treatment’ claims that practically apply natural relationships should be considered patent eligible under * * * the USPTO’s subject matter eligibility guidance; and (2) it is not necessary for ‘method of treatment’ claims that practically apply natural relationships to include nonroutine or unconventional steps to be considered patent eligible under [Section 101].”
The question presented is whether patents that claim a method of medically treating a patient automatically satisfy Section 101 of the Patent Act, even if they apply a natural law using only routine and conventional steps.