Impact on Personalized Med
“The Prometheus case erases the bright line that the Federal Circuit gave us with the transformation of the method of treatment and sort of leaves us to figure out where the next line can be drawn,” said Courtenay C. Brinckerhoff, a partner with Foley & Lardner. “If you have claims that are optimizing the dosage of known drugs, maybe you’re going to have to take a look at those, whereas if you have claims that relate to a new drug or a new metabolite of that drug, maybe your claims are not really impacted.”
Flattmann noted, “The decision is not terribly surprising given the odd and idiosyncratic way the claims at issue were written. If applied narrowly as limited to its facts by the District Courts and Federal Circuit, the holding ought not have any major negative effect on patentees and, in particular, on innovation in the field of personalized medicine.”
One potential danger, he added, is that courts may misapply the Mayo decision as broadly requiring invalidation of any claim that recites a law of nature among its steps: “Such misapplication would have a profound negative impact on innovation in the field of personalized medicine and beyond since, of course, all invention is on some level based on the practical application of natural discoveries.”
Dr. Haile advises companies to examine their IP and consider pursuing reissues of patents, which if rewritten to narrow claims, such as adding steps, can be done during the life of existing patents; patents can only be broadened within two years of issue.
Predicting more challenges for industry from Prometheus is Hans Sauer, Ph.D., deputy general counsel, intellectual property at the Biotechnology Industry Organization (BIO). “We have member companies who are incredulous that the patent claims that are built around these discoveries would now be subjected to this new analysis that the Supreme Court promulgated,” Dr. Sauer said.
“You take out the very principle that a claim is built around—say, a new biological discovery of why your drug works—and you eliminate that from consideration. You look at the rest of the patent claim, and you ask, is the rest of this inventive or not? Of course it’s not. Your invention was just eliminated from the claim, so of course the rest looks unimpressive and old.”
Dr. Sauer said it was hard to say how the Prometheus opinion will play out, let alone its likely effect on the Myriad case. “Because this opinion is going to be very, very difficult to implement in practice, maybe its impact is going to be limited for that reason. There’s not a lot of guidance. There’s only more uncertainty in this opinion for patent law.
The Supreme Court decision won’t derail personalized medicine, Dr. Sauer said, but will make it harder for companies to find additional investor capital. For companies seeking capital, he said, the options will likely include taking less money, accepting more strings, or switching to safer, less innovative development programs.
That doesn’t bode well, for example, for companies seeking to transform failed drugs into successful, more targeted medicines through biomarker screening. “The scientist who discovers why the drug only worked in 10% of all patients, that scientist didn’t discover a law of nature. What that is, is the difference between a failed drug and a drug that reaches the marketplace and benefits real people,” Dr. Sauer said.
In Prometheus, the Supreme Court answered one question but created another legal riddle concerning method-claim patentability that maybe Myriad can resolve. According to the court: “A patent must do more than simply state the law of nature while adding the words ‘apply it.’ It must limit its reach to a particular, inventive application of the law.” But just what is a particular inventive application? The court missed an opportunity to answer that question and in so doing ensured another lengthy legal wrangle for personalized medicine.