Current Court decisions are promoting life sciences innovation now

The Patent Act of 1952 largely codified and clarified longstanding caselaw related to the U.S. patent system. Congress would do well to follow the example of the Patent Act of 1952 and seek to codify and clarify existing caselaw on patent subject matter eligibility rather than the approach embodied in PERA which is the wholesale abandonment of decades of Supreme Court jurisprudence coupled with ambiguous standards that will destabilize the field of patent subject matter eligibility for many years while the courts work out new tools applying the new standards.

Some commentators on the state of Supreme Court jurisprudence on patent subject matter eligibility since the Mayo v. Prometheus decision in 2013 have complained, sometimes literally, that the “sky is falling.” Here we are ten years later and the sky has most definitely not fallen. The life sciences industry has thrived, entire new classes of therapeutics and vaccines have been approved such as CRISPR-based gene therapies and the RNA vaccines that are the foundation of the nation’s response to the COVID-19 crisis. As discussed below, the genetic testing industry has blossomed and we are beginning to reap the fruits of precision medicine and will continue to do so unless we take a misguided step backward by jettisoning the standards for patent subject matter eligibility that have been articulated by the Supreme Court in the unanimous Mayo, Myriad, and Alice decisions.