Partner Stephen Maebius was quoted in the Bloomberg Law article, “COVID-19 Spotlights Ruling’s Chilling Effect on Diagnostic Tests,” about how the 2012 U.S. Supreme Court decision in Mayo v Prometheus has discouraged drug makers from developing new diagnostic tests for diseases like COVID-19 by limiting patent eligibility for some diagnostic tests. Many IP lawyers have said that the problem resulting from the decision needs to be addressed.
Post-Mayo, some drug makers may be afforded new avenues of protection in light of the U.S. Court of Appeals for the Federal Circuit’s recent ruling in Illumina v Ariosa Diagnostics, which held that Illumina’s patents for a way to detect fetal DNA in the mother’s bloodstream aren’t invalid—even though they involve a natural phenomenon. The court also held the patents are valid because they are related to a method for utilizing, not just detecting, fetal DNA.
Although another Federal Circuit panel, in a different case, held that a patent that amplified and detected fetal DNA was invalid, the Illumina panel said the act of physically separating out the DNA was enough to patent the inventions.
The Illumina decision was a big deal in the world of diagnostics, even though it’s still subject to a potential appeal and rehearing, Maebius said. “This isn’t the last word, but it’s a snapshot into the evolution that’s taking place.”