54:4 The Changing Landscape of Patent Subject Matter Eligibility and its Impact on Biotechnological Innovation


Recent Supreme Court decisions and the subsequent implementation of new policies by the United States Patent and Trademark Office (USPTO) greatly diminish patent protection available to biotechnological innovation. The law recognizes these innovations as a category of subject matter that must meet a judicially-created threshold to be afforded patent protection. The threshold requirement is that technologies involving natural laws, physical phenomena, or abstract ideas must claim an inventive concept that transforms the technology into something new and useful, subject to additional evolving restrictions that remain elusive to lower courts. These evolving restrictions signal a new era where patents once granted by the USPTO involving biotechnology are now invalid. The Federal Circuit case Ariosa Diagnostics, Inc. v. Sequenom, Inc. illustrates the current bleak landscape of patent protection for biotechnological inventions and highlights the judiciary’s frustration with the high threshold set by the Supreme Court. Moving forward, it remains unclear what constitutes patentable subject matter under the new restrictive standards because so few rulings by the Supreme Court uphold patents challenged upon subject matter eligibility grounds. This roadblock to intellectual property protection for biotechnological inventions, due both to the recent restrictions and to the uncertain legal standard, may slow growth of the industry that relies heavily on investment.