<img alt=“syringe pic.jpg” src=“https://blogs.nature.com/news/thegreatbeyond/syringe%20pic.jpg” width=“174” height=“240” / align="right">In a ruling that could be a boon to the medical diagnostics industry, a US federal court upheld a series of patent claims covering methods to determine the best dose of a drug to give to a patient.
The decision, issued on 17 December by the US Court of Appeals for the Federal Circuit in Washington, DC, supported San Diego-based Prometheus Laboratories in its patent infringement case against Mayo Clinic Rocester, a medical practice based in Minnesota. “This is a significant boost for the diagnostic industry,” Nick Groombridge, a patent lawyer at Weil, Gotshal in New York, told Bloomberg.
The patents covered a method to titrate the optimum dose of thiopurine drugs, used to treat autoimmune disorders such as rheumatoid arthritis and inflammatory bowel diseases, among other conditions. The drugs are broken down in the body; Prometheus’ method entails measuring break-down products and, based on those results, determining whether a patient should receive higher or lower doses of the drug.
Mayo Clinic Rochester initially bought Prometheus’ test, but rebelled in 2004 by pledging to use and sell its own, very similar test. On 15 June 2004, Prometheus sued Mayo for patent infringement. Mayo never did launch its own test, but the case has been bouncing around the US court system ever since.
In 2008, a district court sided with Mayo. Prometheus appealed, and the Federal Circuit reversed the district court decision, siding with Prometheus in 2009. But the Federal Circuit relied heavily on a criterion called the “machine-or-transformation test”, which dictates that a method is patentable only if it is related to a machine or if it transforms something into a different state. In June, the US Supreme Court ruled that the machine-or-transformation test should not be the sole criterion used to ascertain whether a patent is valid. (See US Supreme Court avoids carifying patent stance.)
And so the case was passed back to the Federal Circuit for reevaluation in light of the Supreme Court’s decision. Realistically, there was little doubt that the court would stick to its earlier ruling. But the diagnostics industry, nerves already jangling after a district court ruled several gene patent claims invalid earlier this year, has learned to take nothing for granted. (See Breast cancer gene patents judged invalid.)
Nevertheless, some may allow themselves a taste of optimism following Friday’s show of support for diagnostics claims: the gene patent case that so shook the diagnostics industry has been appealed and will next appear before the Federal Circuit.
Image: Syringe / yanivba via Flickr