Patent eligibility: a fourth category?

The realm of patent eligibility under 35 USC §101 has become more confusing, with the introduction of a possible new definition of admissibility after a decision on Dolly the sheep. Nabeela Rasheed reports.

Recent years have seen a decisive shift in the patent eligibility of biotechnology inventions in the US. At the end of 2011, the medical diagnostic testing industry was comfortable that patent claims relating to diagnostic methods were patent-eligible. Today, that sense of comfort has all but evaporated.

In March 2012, the Supreme Court pronounced in Prometheus v Mayo that a claim to a method of optimising a therapeutic regimen in which the method was defined by specific steps was ineligible for patent protection. Arguably, this decision crippled the validity of thousands of foundational patents that support the diagnostic methods industry and stunted the growth of the newly burgeoning personalised medicine sector of the healthcare industry. 

In arriving at the conclusion that methods of optimisation of a therapeutic regimen are patent ineligible, the Supreme Court not only disagreed with Prometheus and the Federal Circuit, but also specifically disagreed with the position of the US government. The government had urged the court to decide in favour of patent eligibility for such methods. This would have afforded the US Patent and Trademark Office (USPTO) the opportunity to determine patentability using stringent application of the remaining sections of the patent statute (namely 35 USC §§102; 103; and 112).