Diagnostics patent eligibility: a turning point approaches

As reflected in numerous recent court opinions, the broad Supreme Court rulings of Mayo, Myriad and Alice have drastically changed the landscape of patent-eligibility in diagnostics. Jenny Shmuel and Megan Chacon of Fish & Richardson review the situation and discuss some future scenarios.

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.

Where we have come from

More than 35 years ago, the Supreme Court in Diamond v Chakrabarty (1980) held that a live, human-made microorganism was patent-eligible subject matter, setting the tone for the next 30 years for the liberal grant of a multitude of life sciences-related patents. However, the Supreme Court’s recent rulings on patent eligibility have moved in a very different direction.