It’s easy ’til it’s hard: Health care and patent eligibility

An important patent decision is pending in the United States Supreme Court: Prometheus Laboratories, Inc. v. Mayo Collaborative Services and Mayo Clinic Rochester [hereinafter “Prometheus” and “Mayo”]. Although this decision will address patent eligibility of a medical process, it is relevant to all industries.

The patent law contains four categories of patent eligible subject matter: compositions of matter, manufactured items, machines, and processes. The U.S. Supreme Court has consistently stated that abstract ideas are never patent eligible by themselves. The same is true for laws of nature and natural phenomena. For example mathematical expressions of abstract ideas are never patent eligible in and of themselves. More recently a federal appellate court stated the transformation test: if subject matter of a process is physically transformed, then that process is patent eligible.

A problem arises when the claim sentence [request for protection in the patent], includes patent-ineligible subject matter as patent eligible features, such as an upgraded manufacturing method for curing rubber. This problem often occurs when a process (or method) is the purported invention.

In the pending case, Prometheus alleged that Mayo infringed its patent for a medical diagnostic process. This process compares a baseline of known concentrations of particular metabolites to the levels measured in a patent ingesting a specific drug. The physician is advised of the patient’s drug concentration by comparison with the calibrated baseline. In this manner the physician acquires information to determine whether to modify the patent’s dose of this specific drug.

The Supreme Court must decide whether a process for administrating and calibrating the specific drug is a patent eligible process. In its decision for Prometheus, the federal appeals court stated that this method as drafted contains the proper process steps. It also concluded that the method applies a natural phenomenon, but only to determine a particular level of specific metabolites. As a result the drafted process does not improperly include all medical methods with calibrated baselines. The court also stated that the process was transformative because it requires drug ingestion that (i) changes a person’s body, and (ii) results in new chemical substances in that body.

On the other hand, Mayo maintains that the process as drafted reflects an exclusively natural phenomenon: that is, Prometheus purports to own the naturally occurring relationship between particular metabolites in the body when a particular drug is ingested. As to the steps in the drafted claim, Mayo’s position is that these are mere mental and data gathering steps. Without clear answers to these contentions at this time, the Supreme Court decision will determine the commercial potential of discoveries in medical laboratories nationwide.

© 2012 Adrienne B. Naumann
Ms. Naumann does not sponsor or endorse the advertisements at adriennebnaumann.wordpress.com or linked in sites.

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