Patents and laboratory medicine: what is required to turn an unpatentable natural phenomenon or law of nature into a patentable invention?

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.Twocurrentcasesinvolvinglaboratorymedicine 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. 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 (breast cancer 1, early onset) and BRCA2 (breast cancer 2, early onset) genes. A large majority of patents, in some form or another, describe and claim natural phenomena or laws of nature. The question in both the Prometheus and Myriad cases is whether the claimed subject matter does substantially more than describe these laws of nature. In the first case, Prometheus owned several patents on the administration of thiopurine drugs for the treatment of gastrointestinal diseases, more specifically on the correlation between thiopurine metabolite concentrations and the toxicity and efficacy of the thiopurine drugs. At the time of the discoveries that led to the patents, thiopurine drugs were in use. It was known that metabolite concentrations in a patient’s blood were correlated to the likelihood that a dosage of the thiopurine would be high enough to cause harm or low enough to lack efficacy, and it was known that different patients metabolized thiopurines at different rates. The patents covered (a) administering the drug and (b) measuring the concentration of the metabolite, wherein a concentration of 230 pmol per 8 10 red blood cells indicates a need to increase the dosage and a concentration of 400 pmol per 8 10 red blood cells indicates a need to decrease the dosage. The trial court found that the accused methods infringed the patents but held that the patents were invalid because they essentially claimed unpatentable laws of nature. The appeals court reversed this ruling, finding that the patent claims satisfied the court’s machine-or-transformation test, under which a process is patentable if it is tied to a particular machine or apparatus or if it transforms a particular article into a different state or thing (8 ). Shortly thereafter, however, the Supreme Court held that the machine-or-transformation test is not the exclusive test of patentable subject matter but only an important clue (9 ), and the Supreme Court asked the appeals court to reconsider the Prometheus opinion. 1 Idaho Technology, Salt Lake City, UT. † J.T. Powlick, Esq., is legal counsel and a patent attorney at Idaho Technology. * Address correspondence to the author at: Idaho Technology, Inc., 390 Wakara Way, Salt Lake City, UT 84124. Fax 801-588-0705; e-mail [email protected]. Received April 2, 2012; accepted April 4, 2012. Previously published online at DOI: 10.1373/clinchem.2012.187534 2 Human genes: BRCA1, breast cancer 1, early onset; BRCA2, breast cancer 2, early onset. Clinical Chemistry 58:8 000 – 000 (2012) Opinion