Patents and Laboratory Medicine: What Is Required to Turn an Unpatentable Natural Phenomenon or Law of Nature into a Patentable Invention?

Abstract

According to the US Patent Act, “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” (1). The courts have construed this statement as covering “anything under the sun made by man” (2). Although this language is very encompassing, not everything is patentable. The invention must be novel (3) and nonobvious (4). In addition, “laws of nature, natural phenomena, and abstract ideas” are not patentable (5), but novel applications of laws of nature, natural phenomena, and abstract ideas can be patentable. The courts have been struggling with just how much application is required to turn an unpatentable natural phenomenon or law of nature into a patentable invention. Two current cases involving laboratory medicine illustrate this difficulty. The “Prometheus” case (6), decided recently by the US Supreme Court, relates to the patentability of using a patient's metabolite concentrations to provide proper drug dosing. The “Myriad” case (7) has been decided by the US Court of Appeals for the Federal Circuit (the US appeals court that handles all patent appeals), but the Supreme Court has asked the appeals court to reconsider its ruling in light of the Prometheus decision. The Myriad case involves the patentability of gene targets. Table 1 shows how the 2 cases have progressed through the courts. View this table: Table 1. Court decisions in the Prometheus and Myriad cases. The patents involved in both the Prometheus and Myriad cases certainly describe natural phenomena and laws of nature. The Prometheus patents set forth a specific metabolite concentration above which would cause harm and another metabolite concentration below which would prove ineffective. The Myriad patents involve various aspects of the BRCA1 2 (breast cancer 1, early onset) and BRCA2 (breast cancer 2, early onset) genes. A …