Lisa A. Haile, Ph.D., a partner at DLA Piper U.S. and co-chair of the firm’s global life sciences sector group, told GEN she does not think a decision upholding Prometheus’ patents is likely to affect product development.
“From the perspective of product development per se, I don’t think it changes anything. I think it’s really just an issue of how you protect what you’re doing, what your tests are, that sort of thing,” Dr. Haile noted.
Where a decision to uphold Prometheus will likely prove most significant is in the writing of patent claims. “I would typically not write the claim saying that you isolate the DNA and then sequence it, and then do the analysis, because anybody could avoid infringing it. But I want to draft a claim that’s going to be valid, so I might have to put in that isolating and sequencing step or steps. At the same time, am I really providing a claim that has value because it’s so easy to avoid infringing it?
“We’re going to have to think hard about strategically how to draft these claims to fit within the court’s requirements while still keeping in mind that you have to capture infringers,” Dr. Haile added. If the Supreme Court upholds the Prometheus v. Mayo decision, she advised, “then I think people may need to go back and look at their existing patents and existing pending applications and seriously consider making amendments to the claims, adding in these additional transformative steps.”
Dr. Loeb agreed, also advising that diagnostics innovators produce methods that involve transformative steps. “The Myriad case provides a bit of a roadmap of what the innovators should be doing when they’re trying to claim these inventions.” He cited the Federal Circuit’s Myriad decision, which contrasted Myriad with Prometheus by noting that Myriad’s claims do not include such transformative steps.
That’s easier said than done, he added, given the development of numerous ways to detect and compare the gene sequences of individuals. “The question becomes, ‘what kinds of steps can you describe that are transformative yet general enough to cover all the different ways that you can test genotypes today and, more importantly, tomorrow?
“Essentially, the heart of these inventions is the particular correlation between a genotype and a disease or the effectiveness of a drug. Once you recognize that correlation, how do you turn that into a patentable invention that includes a method with transformative steps that will cover all the different ways that competitors could later attempt to use the correlation that you discovered but entirely different molecular technologies for assessing genotypes?”
In the worst case, according to Dr. Loeb, the court cases will make it more difficult for diagnostic firms to get strong protections for their inventions than is the case under current law. For as long as the situation is unsettled, though, “diagnostic companies and diagnostic innovators certainly have opportunities to get meaningful patent protection in this area,” Dr. Loeb added.