San Diego – In a unanimous decision by the United States Supreme Court, two medical patents for a test that could help doctors set drug doses for autoimmune afflictions like Crohn’s disease, was thrown out, which could likely affect the profitability of personalized medicine. The patents were developed by San Diego-based Prometheus Laboratories, which was acquired last year by Switzerland’s Nestle.
The Supreme Court judges made its decision that the medical tests were not available for patent protection because they determined that the patents were based on the laws of nature, which are unpatentable.
The patents at issue involve a method for monitoring a patient’s blood to determine the best dosage for a drug, thiopurine, for doctors to treat gastrointestinal and non-gastrointestinal autoimmune illnesses. The test covered by the patent would determine the levels of the thiopurine or its metabolites (what is left after the liver metabolizes the drug) in the patient’s red blood cells. Doctor’s would then be able to use the data from the test to make adjustments to the amount of medicine needed for that patient.
Mayo Medical Laboratories, a unit of the Mayo Clinic, had originally used the test from Prometheus, however announced in 2004 that it was developing a similar test for the healthcare market. Prometheus sued Mayo Labs for patent infringement, but a federal judge invalidated the original patent. According to the federal judge, natural phenomenon cannot be patented, but that decision was overturned by the U.S. Court of Appeals for the Federal Circuit. Mayo Labs appealed that decision to the Supreme Court.
“The question before us is whether the claims do significantly more than simply describe these natural relations,” wrote Justice Stephen Breyer in his opinion. “To put the matter more precisely, do the patent claims add enough to their statements of their correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural law? We believe the answer to this question is no,” he added.
With advances from stem cell research, the field of personalized medicine has become quite promising in the United States, with biotech companies racing to find the best way to use a patient’s genetic makeup to customize their healthcare and discover the most effective individualized treatments for cancer and other diseases. The High Court’s recent decision has sent a chilling effect across the biotech industry, with its concern being that courts could misapply the decision as a broad requirement to invalidate any patent that uses the laws of nature as one of its bases.