MACHINE-OR-TRANSFORMATION TEST

Oral argument: Dec. 7, 2011

Appealed from: United States Court of Appeals for the Federal Circuit (Dec. 17, 2010)

In this case, the Supreme Court will evaluate the validity of two patents held by Respondent Prometheus Laboratories. Prometheus had marketed a multistep medical test based on these patents, which describe the proper dosage range of powerful immunosuppressive drugs. However, after Petitioner Mayo Medical Laboratories announced its intention to market a competing medical test in 2004, Prometheus sued for patent infringement. Mayo now argues that the patents are invalid because they seek to monopolize a natural phenomenon, preempting all other uses of a naturally occurring correlation between metabolites and patient health. Prometheus, on the other hand, argues that the patents are valid because they involve concrete applications and cover patentable correlations, not just natural phenomena. The decision in this case may affect the cost and quality of patient health care, as well as the incentives for research and development in the medical industry.

Oral argument: Nov. 9, 2009

Appealed from: United States Court of Appeals for the Federal Circuit (Oct. 30, 2008)

PATENT LAW, PATENTABLE SUBJECT MATTER, INVENTIONS, INTELLECTUAL PROPERTY, MACHINE-OR-TRANSFORMATION TEST

In 1997, the United States Patent and Trademark Office denied Bernard Bilski's patent application for a method of hedging risk in commodities trading. Affirming the rejection on appeal, the Federal Circuit held that a process must be tied to a particular machine or transform an article into a different state to be patentable. The Supreme Court will consider the validity of the machine-or-transformation test for patentability. This case will have implications for the validity of current process patents as well as the availability of future patent protection for business methods. If the court decides that business-methods are not patentable, this would invalidate numerous patents and may curb innovation in the biotechnology and software industry. If, however, the court overturns the machine-or-transformation test and declares that Bilski’s idea is patent-eligible, expensive litigation may continue and uncertainty will mount regarding business-method patents.