February 18, 2020 Articles

Is There a Doctor in the House?: Medical Diagnostic Patent Litigation in Critical Condition

Keys to patent survival as seen in more recent cases of subject matter ineligibility.

By Karen McKenzie
The percentage of medical diagnostic patents allowed by the U.S. Patent and Trademark Office has dropped to less than 35 percent.

The percentage of medical diagnostic patents allowed by the U.S. Patent and Trademark Office has dropped to less than 35 percent.

Photo: shapecharge

The medical diagnostics market is expected to reach $74.2 billion by 2019. In 2012, the U.S. Supreme Court held that the Mayo Clinic had not infringed on Prometheus Labs’ diagnostic patent because the Prometheus patent involved ineligible subject matter. Mayo Collaborative Services v. Prometheus Labs., Inc., 566 U.S. 66, 70 (2012). The Patent Act defines patent-eligible subject matter as “any new and useful process, machine, manufacture, or composition of matter.” 35 U.S.C. § 101 (2012). However, since the Court’s unanimous decision in Mayo, the percentage of medical diagnostic patents allowed by the U.S. Patent and Trademark Office has dropped to less than 35 percent, as compared with 85 percent before Mayo. Kate Gaudry, Leslie Grab & Tina Williams McKeon, “Trends in Subject Matter Eligibility for Biotechnology Inventions,” IPWatchdog, June 12, 2015. Arguably, Mayo and its progeny have had a chilling effect on the multibillion-dollar medical diagnostic industry.

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