The U.S. Supreme Court’s recent decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., may affect the ability of companies to protect valuable innovations emerging from basic research. The Court, on March 20, 2012, found that Prometheus Laboratories Inc.’s claimed method was unpatentable because it attempted to monopolize a law of nature. The U.S. Patent Office has advised patent examiners that patent claims must amount to “significantly more” than a law of nature, natural phenomenon, or abstract idea.

The patent in dispute in Mayo covered a method including administering a drug, determining a metabolite level, and correlating the metabolite level to a level of toxicity resulting from the administering of thioprurine drugs. The Court held that because laws of nature are not patentable, a process which recites such laws is likewise unpatentable unless it includes features which ensure that the claim will not simply monopolize the law of nature. The correlation between metabolite level and toxicity was considered a law of nature and the additional steps recited in the claim – administering a drug, and determining the metabolite level – were found to be “well-understood, routine, conventional activities previously engaged in by scientists in the field.” Therefore, the Court concluded that the claims failed to transform the unpatentable natural laws into patentable applications of those laws.

The decision has implications for companies in all fields conducting basic research and seeking patent protection for the commercial exploitation of the research. Abstracted, information-related technologies including software and bioinformatics are likely also implicated. Patent applications will need to describe and claim something more than a routine application of a newly-discovered law of nature or natural phenomenon. The available breadth of patent protection for inventions emerging from core research may be increasingly limited.

While it is yet to be seen whether the Mayo decision will have the far reaching impact that it has the potential to have, the U.S. Patent Office in the mean time has issued a memorandum to its examining corps with preliminary guidance attempting to capture the implications of Mayo. The Patent Office has instructed Examiners that unless the claim includes elements or a combination of elements, such that, in practice, the product or process amounts to significantly more than a law of nature, a natural phenomenon, or an abstract idea with conventional steps specified at a high level of generality, the claim is effectively directed to ineligible subject matter, and should be rejected. While the PTO indicates that further guidance is expected, these preliminary guidelines read uncomfortably similar to instructions to dissect claims into individual elements, rather than examining the claim as a whole.

Companies involved in basic research and abstract, information–related technologies, should be prepared to defend their patent applications against rejections from the patent office pertaining to patentable subject matter. Patent-holding companies should be prepared to defend their intellectual property against charges that the claims seek to monopolize a law of nature.