Whether an invention is the sort that can be patented is determined by §101 of the patent statute. That section states:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The issue of patentable subject matter is not a problem for physical inventions in the mechanical or electrical arts, but can present thorny problems for less concrete inventions, such as processes in the pharmaceutical, software and financial fields.
The U.S. Supreme Court has interpreted §101 several times, most recently in Mayo Collaborative Services v Prometheus Laboratories, 132 S. Ct. 1289 (2012). The invention before the Court was a method of treating a particular disease by administering a particular drug, monitoring levels of breakdown products of the drug in the patient’s blood, and adjusting the dosage to achieve a specified range of concentrations. The Court held that the invention was nothing more than an unpatentable ‘natural law;’ namely, the natural process occurring in the patient’s body of breaking down the drug in a way that indicated the effectiveness of the drug. The other steps of the invention were not enough to convert this unpatentable ‘natural law’ into a patentable invention. In considering whether the other steps were sufficient, the Court found persuasive that the drug, the breakdown products and the tests were old and well known. The Court was concerned that patenting this or any other ‘natural law’ would preclude other researchers from utilizing the same law.
The Court specifically refused to adopt the PTO’s argument that whether an invention was old, obvious or vague should be considered under other sections of the patent law and not under §101. The Court flatly stated that those concepts are incorporated into §101.
The net result of Prometheus and other Supreme Court precedent is that at the margins patentable subject matter is a bit like pornography – the Supreme Court justices know it when they see it. This approach makes life unpredictable for the PTO, for the Federal Circuit Court, and particularly for inventors in the pharmaceutical, computer software and financial services industries. The dust from the Prometheus decision still has not settled and several cases are pending in the Federal Circuit that will apply the decision.
— Robert Yarbrough, Esq.