PATENT ELIGIBILITY OF DISEASE DIAGNOSIS
Abstract: 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.
Author: Shahrokh Falati, Ph.D., J.D.
PDF: //journals.law.unc.edu\/ncjolt/wp-content/uploads/sites/4/2020/04/Falati_Final.pdf
Volume: Volume 21, Issue 3