Biotech patent applicants are finding themselves in uncharted waters.
After the Supreme Court’s decisions in Mayo Collaborative Svs. v. Prometheus Labs and Ass’n for Molecular Pathology v. Myriad Genetics, companies have been trying to understand how these decisions will impact the industry.
A recent study supported by BIO, in collaboration with Bloomberg BNA and the law firm of Robins, Kaplan, Miller & Ciresi analyzed how Mayo and Myriad have changed patent eligibility for biotechnology. The report provides new insights into the U.S. Patent and Trademark Office interpretations of these decisions, and how patent applicants must proceed in the wake of new guidelines.
How Recent Patent Applications Measure Up
The Mayo and Myriad decisions wiped clean many prior conditions for patentable subject matter. In addition, the PTO remains unsure as to how to interpret the court’s analysis. This report was compiled with the intention of understanding how the PTO is now examining claims. Have there been trends in their patent eligibility examinations? Is the PTO being consistent in those examinations?
The study analyzed biotech patent applications, focusing on those which contain patent claims similar to the ones under scrutiny in the Mayo and Myriad cases. Of the 1,000 applications in this sample:
- Almost 40% of applications that had undergone review received a Section 101 rejection.
Of those applications which received a Section 101 rejection:
- 35% were characterized as “Mayo” rejections
- 23% were characterized as “Myriad” rejections
The report found that those patent applications rejected under Mayo for claiming a “law of nature” were related to inventions that focused on a correlation between a particular health condition with a biological molecule. If the applicant then amended the claim based on the suggestions of a PTO examiner to make it patent eligible, there were heavy limitations on the claims’ validity and enforcement.
Claims rejected under Myriad focused on chemical structures present in nature. It’s no longer enough for such materials (e.g. medicinal substances, fermentation products, enzyme preparations) to be manufactured to be patent eligible- after Myriad, that such materials must be “markedly different” from that which is found in nature.
What the Industry can do with this Information
One of the most important conclusions in this report is that many more patent applications are affected than most observes would have thought possible. It is critically important that biotech patent applicants become more involved with PTO examination policy.
The future of patent eligible subject matter is still uncertain. Active participation with the PTO, and the courts, will help to protect intellectual property and innovations that are crucial to advancements in agriculture, health, and other applications.
Stopped at the Threshold: The Practical Impact of the Supreme Court’s Mayo and Myriad Decisions on Biotechnology Patent Practices is available through Bloomberg BNA. The full report is available here.