Mayo Clinic announced Wednesday that it had won a lengthy legal battle against Prometheus Laboratories Inc., based in California, with the Supreme Court unanimously agreeing with its argument that natural bodily responses to medical treatment are not patent eligible.
Up until 2004, the Minnesota healthcare provider bought and used a blood test from Prometheus that allowed doctors to decide the proper dosage for a drug called thiopurine, which is used to treat gastrointestinal maladies. But when Mayo researchers developed a test of their own, they stopped purchasing the test, which led Prometheus to sue for patent infringement and to block Mayo from using its own test.
But the nine justices ruled that simply stating a natural process and asking that it be applied as Prometheus was demanding is not covered by U.S. patent law.
“Prometheus’ patents set forth laws of nature — namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm,” read the Supreme Court opinion. “Einstein, we assume, could not have patented his famous law by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa).”
The opinion drew sharp responses from organizations that either hailed or decried the decision.
“Medical innovations that provide insight into natural human biology must remain freely accessible and widely disseminated. Blocking this information from physicians and researchers inhibits future discoveries,” said Dr. Robert M. Wah, chair of the American Medical Association, in a statement.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
On the other side was BIO, a trade and lobby organization, which like the AMA had presented an amicus brief, but against Mayo’s argument and in favor of Prometheus’.
“We are surprised and disappointed in the court’s decision, which disregarded the considered judgment of the executive branch experts and numerous amici such as BIO, who warned about the unintended consequences of attempting to use patent eligibility as a basis to strike down these patents for biomarker-based diagnostic methods,” said Hans Sauer, deputy general counsel for intellectual property, in a statement.
