What biomarker tests can be patented? Don't look here for the answer -- it's going to stay unclear for a while longer, as the U.S. Supreme Court has .
It declined to hear an appeal by Quest Diagnostics's Athena unit to overturn the Mayo Clinic's victory in a lower court against the patent for a test to diagnose myasthenia gravis (MG) based on presence of a muscle-specific tyrosine kinase protein, to which certain MG autoantibodies bind. Mayo had developed a competing test, prompting Athena to sue for infringement.
The Trump administration and the federal appeals court that handles patent cases had both called on the Supreme Court to use the case to clarify how patent eligibility law applies to diagnostics.
Mayo argued that such a patent is invalid because it covers a natural law, that presence of a disease-causing substance correlates with the disease. "Laws of nature, natural phenomena, and abstract ideas" cannot be patented under Section 101 of the Patent Act.
What exactly falls into those areas, or too close to them, has never been defined by legislation and thus has been .
Mayo's case relied on precedent from a also brought by the nonprofit that had affirmed that patents can't be issued for "conventional and routine activities" to detect a natural law.
A number of other important Supreme Court patent cases decided around the same time, such as one that Myriad Genetics couldn't patent the BRCA1 and BRCA2 genes for isolation to assess a patient's cancer risk, "fostered uncertainty" about what is eligible for a patent, according to court filings by the Trump administration.
With the justices' pass on considering the Athena case, "no changes are now likely to the court's Section 101 case law for the foreseeable future, shifting the spotlight back to Congress, which held hearings on the issue last spring and summer," noted Scott Graham .
was introduced in May 2019 that would dramatically broaden patent law to include genes themselves along with other "natural phenomena" and even "laws of nature." The bill was opposed by the American Civil Liberties Union, scientific organizations, and patient advocacy organizations.
However, Congress "is unlikely to pass any legislation in this election year," .