By: Melanie Szweras and Micheline Gravelle
Intellectual Property
DETERMINING PATENTABLE
Subject Matter
in the United States and Canada
The United States Supreme Court recently held in its Mar. 20, 2012 decision in Prometheus v. Mayo that certain personalized medicine claims were directed to laws of nature and were thus unpatentable despite containing both an administering step and a determining step.
T
he Prometheus claims were based on the identification of particular ranges of metabolites that are associated with drug efficacy and toxicity. Prior to this, it was known that the levels of the metabolites were correlated with efficacy and toxicity. However, the particular ranges recited in the claims were not known to correlate. The Court was asked to consider whether the method claims contained statutory subject matter although many commentators think the issue of inventiveness appeared more relevant. The Court, in rejecting the claims, pointed to the fact that the claimed steps were conventional, well-known and routine. In its decision, the Court iterated a test for patent eligibility that could have broad applicability. For example, the Supreme Court noted that: While it takes a human action (the administration of a thiopurine drug) to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action. The relation is a consequence of the ways in which thiopurine compounds are metabolized by the body – entirely natural processes. And so a patent that simply describes that relation sets forth a natural law. 6 BIOTECHNOLOGY FOCUS June 2012
Such a strict analysis could have serious implications for the biotechnology industry as many biotechnological inventions relate to a natural process in one way or another. The Court was particularly concerned with whether the claims transformed unpatentable natural laws into patent-eligible applications of those laws. The Supreme Court did go on to concede that new drug claims and new uses of existing drugs would be acceptable. Since the Supreme Court did not provide much guidance on what is sufficient to transform a law of nature into an application of a law of nature, we must await the interpretation of this case by the lower courts. There is hope that the lower courts will particularize this decision to its set of facts: that doctors had already been administering patients with thiopurine for the treatment of the particular disease and that the levels of metabolites had already been detected after such treatment. But what would have happened if the case that went on appeal had better facts? For example, if a particular polymorphism had been identified to correlate to a specific disease,
would the determining step be inventive as it would be detecting the presence of the polymorphism in a particular population of patients, a population that was unknown before this correlation was identified, even though routine molecular biology techniques could be used for such detection? In Prometheus, the claim was found to involve steps that involve wellunderstood, routine, conventional activity previously engaged in by researchers in the field. In the example given here, the conventional activity of detecting the presence of the polymorphism would not have been previously engaged in by researchers in the field of that particular disease. The biotechnology community won’t need to wait long to find out how far the reach of the Prometheus decision may extend because on Mar. 26, 2012, the U.S. Supreme Court asked the Federal Circuit to revisit its July 2011 decision in the Myriad Case. The patent at issue in Myriad contained claims to genes, diagnostic methods and screening assays. The Federal Circuit previously held that claims to isolated genes were patentable because the isolated DNA is “markedly different” from that which exists in nature. In particular, the isolated DNA is a distinct chemical entity which has been cleaved or synthesized to consist of a fraction of a naturally occurring DNA molecule.
