Kristin Wall
Mar 28, 2012

Prometheus’ patent overturned in Supreme Court, personalized medicine now more publicly available

The US Supreme Court has invalidated a patent claiming observation of drug metabolite levels.After two laps through the federal court system, Prometheus has at last received its final verdict from the US Supreme Court: this patent claiming administration of a therapeutic drug and observation of its metabolite levels is invalid for being based on laws of nature. This verdict is met with mixed responses; those companies holding similar patents fear a blow to innovation as companies are more hesitant to invest in unpatentable research, while health caregivers are relieved to be free to tailor treatments to patients’ individuals needs. 

Prometheus’ now invalidated patents were directed to a method for optimizing therapeutic efficacy and reducing toxicity associated with treatment for Crohn’s disease. These claims are representative of the health care industry’s push towards personalized medicine.  Rather than basing dosages on a patient’s weight or age, these methods of detecting drug metabolite levels after administration allow doctors to adjust the drug amount based on its observed efficacy. Obviously this method makes more sense biologically and financially, in that it will allow patients to receive (and pay for) only as much of a pharmaceutical as they need. 

But while health care professionals are reaping freedom to treat their patients in the wake of the Supreme Court’s decision, the verdict’s opponents are realizing their predicted concerns. The Myriad Genetics case had been waiting in the wings for the Prometheus case to be decided, and has now been remanded to the Federal Circuit to be decided in light of the Prometheus ruling. This is especially disconcerting for big biotech companies, because the Myriad case will determine whether genes are patentable subject matter, a topic that has been the source of much controversy, both ethically and financially. 

Myriad’s representatives are less concerned, pointing out that, while Prometheus’ patents were directed to a method of testing, Myriad’s patents claim compositions of matter -- namely, the genes that predict susceptibility to breast and ovarian cancers. This crucial difference, they say, will render the Prometheus decision inapplicable to Myriad’s case, especially when heard in front of the more patent-friendly Federal Circuit court. 

Yet the Prometheus decision is indicative of a larger movement towards protecting the public from limitations on health care due to companies’ monopolies. Prometheus’ patent disallowed doctors from administering biologically appropriate doses of treatments for Crohn’s and other autoimmune diseases without the company’s permission (and payment). Similarly, Myriad prevents hospitals from administering any test other than Myriad’s to determine whether its patients are genetically predisposed to developing breast and ovarian cancers, thereby precluding any second opinions. Each of these limitations curbs related innovation and restricts the public’s access to effective and competitively priced health care. It is this element of the Prometheus case that may have shifted the bedrock on which Myriad and other gene patent holders stand.