Patent Eligibility of Disease Diagnosis

The U.S. Supreme Court effectively redefined the scope of patent eligible subject matter when it decided Mayo.1 This decision focused on medical diagnostic technology and has had a profound effect on the biotechnology and personalized medicine industries in the United States. Subsequent back-to-back decisions by the Supreme Court in Myriad2 and Alice3 have made it unequivocally clear that there is now wholesale broadening of the judicially created exceptions to statutory laws governing patent eligible subject matter. This has caused havoc in the biopharmaceutical industry by not only making it a near impossibility to obtain a patent in certain fields, but also by vastly increasing the number of medical diagnostic patents being invalidated based on Section 101 of Title 35 of the U.S. Code. This major change in law has had unintended consequences, discouraging research and development necessary for new medical diagnostic and therapeutic methods to come to market.

This article analyzes the patent eligibility legal landscape and focuses on emerging medical diagnostic technologies to explain why the Supreme Court’s recent rulings were made in error. I end by discussing how Congress could either abolish, as unnecessary, the non-statutory, Supreme Court-created, exceptions to Section 101, or to amend the statute. Only by doing so can our laws once again encourage and reward creative thinkers and entrepreneurs who take risk and innovate new medical diagnostic technologies in the U.S.