Researchers and tech transfer leaders were shaken by the recent Mayo v. Prometheus decision handed down by the U.S. Supreme Court, which suggests that any research development based on a law of nature is not patentable. If the decision is interpreted broadly, an untold number of promising research projects could have no prospects for commercialization.
But is the situation that dire? Some experts, like Mark J. Nuell, PhD, a partner with the law firm of Birch Stewart Kolash Birch in San Diego, CA, say the decision could have a devastating impact on what is increasingly seen as a promising avenue of research.
“It’s a disaster as far as I can tell for the biotechnology industry as a whole,” he says. “It’s going to push development of diagnostics back to the universities and privately funded research institutes that don’t care if they sell a new product or not. They’re just interested in finding new knowledge. People operating for a profit won’t be able protect what they’re doing without falling prey to copycats.”
The decision effectively raises the bar for any patent claim derived from a natural law, Nuell says. The Court has made clear that simply adding a known technology to the natural law is not enough to make the process patentable. “If you’re going to write a diagnostic claim now, you’re into a realm where you need some sort of a new reagent for affecting that test,” he says. “Saying that you achieve the end result through polymerase chain reaction won’t pass muster. You’re going to have to show that you’re using some kind of new, super reagent in the polymerase reaction or something like that. Diagnostic claims will have to rely on a new reagent or a wholly new methodology in order to become patent-eligible subject matter.”
Commercialization efforts at research institutions will shift more to the incremental improvements in diagnostics, reagents, and analytic methods, Nuell predicts. Those could be patentable in their own right, he notes. A detailed article on the decision’s impact appears in the April issue of Technology Transfer Tactics. To subscribe and access the full article, along with a five-year archive of best practices and success strategies for TTOs, CLICK HERE.