Just When You Thought It Was Safe: A Brief Update on Medical Treatments and Patent Subject Matter Eligibility
A set of treatment and dosage claims survived a subject matter eligibility attack in the Federal Circuit on Friday, underscoring current law as generally favorable to the patent subject matter eligibility of methods of treatment. However, this morning, a Supreme Court order threw some uncertainty back into the issue.
At the end of last week, the Court of Appeals for the Federal Circuit found in favor of a set of treatment claims, a set of dietary supplement claims, and a set of manufacturing method claims in a decision in Natural Alternatives Intl. v. Creative Compounds, LLC. The decision reversed a district court judgment on the pleadings, which found the claims ineligible.
For those seeking clarity on subject matter eligibility under section 101 of the patent act, particularly in the pharmaceutical and dietary supplement industries, the Federal Circuit opinion contains some helpful points. It compared the method claims to those in Vanda Pharms. Inc. v. West-Ward Pharms. and contrasted them against the method claims at issue in Mayo v. Prometheus. The dietary supplement claims survived on appeal because they recited a combination of amino acids in particular dosage forms, with enough possibility for a synergistic effect to at least outlast judgment on the pleadings. For the claims drawn to manufacturing the supplements, the appeals court stated that a claim drawn to manufacturing an eligible supplement for an eligible treatment should also be eligible.
The reliance on Vanda for the method claims echoes a U.S. Patent and Trademark Office Memorandum on Vanda’s implications. That memo, issued last summer, advises USPTO officials that “‘method of treatment’ claims that practically apply natural relationships should be considered patent eligible.”
This morning, however, the Supreme Court issued an order inviting the Solicitor General to file briefs to aid the high court in its decision on a petition for a writ of certiorari in the Vanda case, rather than simply deny cert. Should the court take up the case for review, the Natural Alternatives decision could face an uncertain future, as could the predictability that many have come to enjoy for method-of-treatment claims following the Federal Circuit’s Vanda decision.