An invention is entitled to a patent if it satisfies several distinct requirements for patentability:
- The invention must be a “useful process, machine, manufacture, or composition of matter” (35 USC 101)
- It must be novel (35 USC 102)
- It must be not obvious (35 USC 103)
- It must be disclosed in sufficient detail to allow others to use the invention after the patent expires (35 USC 112)
Discoveries that are deemed to be abstract ideas or laws of nature are excluded from eligibility.
The distinction between a discovery and an invention is not easy to draw, especially after a series of the recent Supreme Court and Federal Circuit decisions have comingled the distinct requirements for patentability. The diagnostics industry particularly suffers from the muddled state of patent law. In Mayo v. Prometheus, the Supreme Court invalidated a patent directed at dosing a patient, measuring a metabolite, and then titrating the dose of the medication. The previously unknown correlation between the level of a metabolite and the required dose was viewed as an unpatentable law of nature combined with a known method for metabolite measurement. In Association for Molecular Pathology v. Myriad Genetics, the Supreme Court invalidated patents for isolated pieces of DNA coding for previously unknown polypeptide sequences that determined the risk for developing breast cancer. The correlation of the particular DNA sequence to cancer risk was again viewed as an unpatentable law of nature. Then, in Ariosa Diagnostics v. Sequenom, the Federal Circuit invalidated a patent for testing fetal DNA using a sample of maternal blood. The test eliminated the high risks associated with amniocentesis. The court acknowledged that the test in its entirety was novel and useful. However, the presence of the fetal DNA in maternal blood was deemed to be a law of nature combined with a routine detection technique. The court felt bound by the Supre