In Mayo Collaborative Servs. v. Prometheus Labs, the Supreme Court established a standard for analyzing the patent eligibility of diagnostic inventions. The standard does not allow patents for newly discovered laws of nature, nor for any practical applications of these laws if the applications merely use methods already known in the art. The industry fears that such an overbroad holding will have the unintended consequence of rendering truly innovative discoveries unpatentable.
The fears were justified in Ariosa Diagnostics, Inc. v. Sequenom, where the Federal Circuit held that Dr. Dennis Lo’s invention was ineligible for patent protection under Mayo. Dr. Lo discovered that a fetus sheds small DNA fragments into maternal blood. This discovery was revolutionary to the field of prenatal diagnostics. Based on his discovery, Dr. Lo patented a method of detecting fetal chromosomal defects by analyzing maternal blood using standard diagnostic techniques. This test thereby eliminates the need for amniocentesis, which carries a small risk of inducing miscarriage. Sequenom in-licensed Dr. Lo’s patent and developed a commercial test, which Ariosa argued was ineligible for patent protection under Mayo. The Federal Circuit judges acknowledged the revolutionary nature of Dr. Lo’s invention but felt constrained by the rigidity of the Mayo standard.
In requesting the Supreme Court review of the Federal Circuit’s decision, Sequenom argued that the Mayo standard was written too broadly and had the unintended consequences of making numerous diagnostic patents unenforceable and new inventions ineligible for patent protection. The nature of the medical diagnostics industry is such that most inventions would not satisfy the standard as written in Mayo. For example, correlations of genotype and phenotype, the presence or absence of a marker and therapeutic outcome, and sensitivity to a particular drug are often viewed as laws of nature not eligible for patents under Mayo. Twenty two briefs from industry groups and academics were filed in support of Sequenom. No briefs were filed in support of Ariosa. The Federal Circuit’s decision in Ariosa Diagnostics was viewed by many as an ideal opportunity for the Supreme Court to narrow its ruling in Mayo. Yet, on June 27, 2016, the Supreme Court denied Sequenom’s request for review, leaving the diagnostic industry in continued limbo.
With no clarification from the Supreme Court, it is now up to the Federal Circuit to define what falls outside of the sweeping ruling in Mayo. Recently, in Rapid Litigation Management Ltd. v. Cellzdirect, Inc., the Federal Circuit decided that a method for producing a pure cell culture for use in diagnostics may still be patentable despite being based on the discovery of a law of nature. It held that the process resulted in a tangible material as opposed to information, thereby placing it out of the scope of Mayo.
Additional litigation will be required to fully elucidate the boundaries of the Mayo standards. As of now, the diagnostics industry continues to face significant uncertainty.