The biotechnology industry gave a sigh of relief when the patentability of diagnostic methods and tools was confirmed in a recent US Court of Appeals for the Federal Circuit case, Prometheus Laboratories, Inc. v. Mayo Collaborative Services, Fed. Cir. No. 2008-1403 (September 16, 2009).

While the biotechnology industry has benefited greatly from the US Supreme Court’s liberal interpretation of 35 U.S.C. 101, which permitted the patenting of “anything under the sun that is made by man.”  Diamond v. Chakrabarty, 447 US 303, 309 (1980), it recently has been traumatized by the potential impact from cases like In re Bilski, 545 F.3d 943, 953 (Fed. Cir. 2008) (en banc), cert. granted 129 S. Ct. 2735 (June 1, 2009), involving the patentability of business methods, because many biotechnology inventions are similar to business methods in that they involve correlating data and making decisions based on those correlations.

In Prometheus, the invention was a method for calibrating the proper dosage of thiopurine drugs to be administered for use in treating autoimmune diseases based on levels of thiopurine metabolites detected in a patient.  The accused infringer argued that the patents covering this subject matter were not valid because the inventions were natural phenomenon.  The US District Court for the Southern District of California agreed, stating that the invention involved mere “data-gathering,” “mental steps” and natural phenomenon.  On review, the Federal Circuit considered the In re Bilski test, i.e. that in order to determine if a particular application of a fundamental principle is patentable, an assessment must be conducted to determine if (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular thing into a different state or thing.  In its decision, the Federal Circuit ignored the first prong and stated that the invention involved a “transformation” and was therefore patentable under the second prong.  The patents covering this transformation were therefore valid.

Although the Federal Circuit reversed the district court’s decision, the biotechnology industry’s sigh of relief might be short-lived; the next biotechnology case invoking In re Bilski could have a different result.  This is so not only because the facts in each case are so different, but because the test set forth in In re Bilski is notoriously difficult to apply.    

For further information on the implications of the Prometheus v. Mayo decision, and updates regarding this evolving area of law, contact any Arent Fox patent attorney.

Pat Granados
202.775.5755
granados.patricia@arentfox.com

Ron Kamis
202.715.8488
kamis.ronald@arentfox.com

Dawn Russell
202.775.5771
russell.dawn@arentfox.com