Diagnostics patent eligibility: a turning point approaches

The patent eligibility landscape under 35 USC §101 has shifted in the past few years, with the courts issuing a series of decisions which threaten to undermine a system designed to encourage and reward innovation and development. The application of this law in one particular area—screening and diagnostic testing during and after pregnancy—highlights the unprecedented difficulty faced by those seeking patent protection in the life sciences arena and points to a potential turning point in the law.