Biomedical patents: the quest for balance

The US Supreme Court’s Mayo and Myriad decisions have brought challenges to subject matter eligibility to the forefront in the biomedical industry, but they do not signal the end of biomedical patents. Pat Carson and Mira Atanassova Mulvaney of Kirkland & Ellis report.

The trend of frequent challenges to patent eligibility started with the US Supreme Court’s decision in Bilski v Kappos in 2010. Noting that “business method patents were rarely issued until modern times”, that “some business method patents raise special problems in terms of vagueness and suspect validity”, and that “[i]f a high enough bar is not set when considering [business method patents], patent examiners and courts could be flooded with claims that would put a chill on creative endeavour and dynamic change”, the court in Bilski endeavoured to set the “high enough bar” that it deemed necessary to preserve the stated purpose of the Patent Act in the business method context.

Although Bilski was singularly focused on business methods, its application has not been so limited. Patent eligibility challenges have arisen in a wide variety of subject areas, including in the context of biomedical patents, yielding several additional trips to the Supreme Court. Indeed, some commentators have suggested that medical diagnostic and treatment patents have become particularly vulnerable to §101 challenges.

The Supreme Court decided the first post-Bilski biomedical patent eligibility case, Mayo v Prometheus, only a year after Bilski. At issue in Mayo were patents concerning the use of thiopurine drugs in the treatment of autoimmune diseases, claiming that concentrations in a patient’s blood of certain metabolites correlated with either ineffective or potentially harmful drug dosage levels.  The court struck down the claims at issue, articulating a new framework for §101 analysis.