The United States Supreme Court has issued an important decision limiting the ability to obtain patents on certain medical diagnostic methods. Under the U.S. Patent laws, patents can be obtained for any new and useful process, machine, manufacture, or composition of matter.” However, the courts have started to impose limits on the types of processes that can be patented as more companies have sought to patent their business methods. On March 20, 2012, the Supreme Court held that processes that merely “inform a relevant audience about certain laws of nature” are not entitled to a patent if they merely have additional steps that “consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.”
The Court’s decision, in Mayo Collaborative Services, DBA Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., has important ramifications for both medical professionals and pharmaceutical companies. At issue in the case was the validity of patents that claimed a method of optimizing the efficiency of a drug in the treatment of a medical disorder. The claimed patents recited how to administer the drug and then determine the level in the patient, as well as how to determine the dosage level. The patent owner sold diagnostic tests based on the patents. It brought suit when a former customer said it had developed and would market its own, slightly different diagnostic test. The lower court found that the competing diagnostic test did infringe on the patents, but that the patents were invalid. The Supreme Court agreed to review the case after an appellate court held that the patents were valid and, in reversing, agreed with the lower court that the patents were void because they merely recited the laws of nature.
The Prometheus decision is important because it reaffirmed that “to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words “apply it.” The Court’s decision does not set forth clear standards as to what additional steps may be needed to transform a process of applying a law of nature into a valid patent. However, it does advance the important policy goal of ensuring that the patent laws are not used for “tying up the use of the underlying natural laws,” thus ” inhibiting their use in the making of further discoveries.” In this context, it promotes competition in the marketplace for new discoveries and, in the health care industry, states that health care providers should have the ability to explore treatment options based on generally known natural laws without concern that an entity has monopolized the field with a patent.