Patenting discoveries in the Precision Medicine space is critical so that companies and research institutions can recoup their investments made in this area of innovation. Since the United States Supreme Court’s decision in 2012 in Mayo v. Prometheus, the laws regarding patent eligible subject matter (35 USC § 101) have wreaked havoc on inventions in the personalized medicine space. Developments in Precision or Personalized Medicine rely on the use of unique information from individual patients or a patient population. This information can relate to a patient’s genetic background or biomarkers, the response of a patient to a particular treatment, or other characteristics of a population. The Supreme Court determined that the use of information related to “natural processes” or “natural relationships” -- the information at the core of precision medicine -- cannot be patented unless the claims of the patent integrate the processes or relationships “into a practical application.” What has followed over the past 7 years is a battle between the lower courts, lawmakers, and policy writers at the United States Patent & Trademark Office, each pulling in different directions as they try to make sense of the decision. It has also left researchers and companies practicing in this area continuing to look for clarity and guidance. This talk will provide an update on the moving target that is patent eligibility, including a discussion of where the law stands now, and considerations and guidance for those trying to protect precision medicine-based methods in the United States.
Audience Take Away:
Update on the changing US laws regarding patent eligibility.
How to craft patents for submission in the US regarding personalized medicine methods.
Other types of patent claims to consider until the law becomes clearer.