How Might U.S. Supreme Court Ruling Impact Personalized Medicine

Dr. Anita Goel, M.D., Ph.D., chairman and CEO for Nanobiosym, recently called me about her current project – integrating physics, biomedicine, and nanotechnology to accelerate the FDA approval process. Apparently her company has developed the NBSDx, a portable nanotechnology platform that can rapidly and accurately detect genetic fingerprints from any biological organism. Goel likened the device to a blood sugar machine, and if used during clinical trials, it could actively monitor how a drug is performing within a patient and how the patient is responding to various doses, which could then be adjusted. The question I have is how might the recent United States Supreme Court ruling impact companies like Nanobiosym and entrepreneurs like Goel seeking to capitalize on technologies geared toward improving personalized medicine?

Mayo Collaborative Services v. Prometheus Labs

Goel had not heard about the March 20, 2012, United States Supreme Court unanimous decision in Mayo Collaborative Services v. Prometheus Labs. The finding invalidated Prometheus's patent claims relating to methods of optimizing the dosage of a drug. The Supreme Court precedent has consistently placed laws of nature outside the scope of patentable subject matter. The decision further defines the scope of patentable subject matter and could have significant implications for the pharmaceutical, biotech, and diagnostic industries.  Here’s why.

Apparently, the patents at issue in this case relate to methods of optimizing the dosage of a particular drug to treat autoimmune conditions. The claimed treatment regimen takes into account the toxicity of the drug and responsiveness of the patient in some cases. Sounds similar to what Goel’s team has developed with their nanotechnology. In order to optimize treatment, the Prometheus’ patents disclose a method of adjusting a drug dosage based on the level of a metabolite in patients treated with a drug. Mayo developed its own diagnostic test for a patient's metabolism of a drug, for which Prometheus brought suit claiming patent infringement. The Supreme Court found that Prometheus' claims set forth a law of nature — the relationship between a patient metabolizing a particular drug and the resulting determination and administration of an effective dose of that drug. Further, the Supreme Court found that the steps to determine the metabolite concentration and administer the drug according to the metabolite concentration were conventional activities used previously by those of skill in the art of medicine. In other words, the conventional steps of determining and administering did not present a patentable application of the law of nature.

Claims Covering Natural Laws Inhibit Innovation
In reaching this conclusion, the Supreme Court raised the concern that claims covering natural laws would inhibit, rather than promote, innovation — particularly acute when the claim simply instructs the public to apply a law of nature. The Supreme Court also addressed the concern of several amici that a decision against Prometheus would reduce the ability of biomedical researchers to protect discoveries in medical diagnostics, an especially important concern for scientists working in the growing field of personalized medicine, i.e. Dr. Anita Goel. The Mayo decision serves as a strong reminder that laws of nature are excluded from patent-eligible subject matter. When you consider that some of the most famous natural laws include Isaac Newton’s theories of classical mechanics, Albert Einstein’s theory of relativity, Boyle’s law of gases, conservation laws and the four laws of thermodynamics, it would seem that this ruling truly opens a Pandora’s box for future patent battles over products developed which could revolutionize and improve personalized medicine but may not be considered patentable if based on natural law.