On Monday, March 21, San Diego-based Sequenom Inc. asked the United States Supreme Court to review the controversial 2015 appeals court decision invalidating its patent on noninvasive prenatal testing for fetal abnormalities in maternal blood. The outcome of this case will significantly impact the speed of medical innovation, investment in cutting-edge diagnostics and healthcare opportunities for pregnant women.
Sequenom’s petition for certiorari asks the Supreme Court to revisit its Mayo ruling to clarify that it did not intend to block patents for inventors who apply a new combination of known techniques to their own discoveries of new natural phenomena. The petition explains this clarification is consistent with the Supreme Court’s previous statements that more latitude should be allowed when a discoverer of a new law of nature comes up with an inventive method applying that discovery.
“We think that there is a compelling case for the Supreme Court to step in,” said Sequenom’s counsel, Thomas Goldstein. “The issue turns entirely on how to read the Court’s cases. The stakes could not be higher for the life sciences industry. And, this is undoubtedly a breakthrough invention that illustrates the harm from the Federal Circuit’s ruling.”
Sequenom owns the patent for Dennis Lo’s and Dennis Wainscoat’s method for detecting fetal genetic characteristics by isolating the paternally-inherited genes in maternal blood plasma. This revolutionary breakthrough enabled doctors to test for fetal abnormalities without resorting to invasive and potentially dangerous procedures like amniocentesis. Sequenom invested tens of millions of dollars to develop and bring to market the now-widely-used MaterniT21 test, of which Ariosa Diagnostics and Natera started selling copycat products that undercut Sequenom’s pricing. Sequenom sued them for patent infringement. Relying on the 2012 Supreme Court case of Mayo v. Prometheus Laboratories, a San Francisco federal district court judge invalidated the Sequenom patent, finding that it applied well-known laboratory techniques to a natural phenomenon.
Said co-counsel Michael Malecek of Kaye Scholer: “Working with what had previously been discarded as waste material, the inventors of Sequenom’s patent discovered that cell free fetal DNA circulates in the pregnant mother’s blood. They then came up with a new method combining various known lab techniques, and applied that method to their discovery to isolate the fetus’ paternally-inherited DNA, which could then be tested for genetic characteristics and abnormalities. It is critically important that each step of their method can be done another way—you can use whole blood, you can do it without amplifying, you can do it without detecting paternally inherited traits—so Sequenom’s method does not preempt the practical use of cell free fetal DNA by others. The only reason we have these common law exceptions to the statute is to protect against preemption. The lower courts erred by treating preemption as “moot” and the Supreme Court needs to fix this problem by returning the focus to the motivating reason for having exceptions from the statute in the first place—preemption."
The biotechnology and pharmaceutical industries, university research foundations, venture capital and many patent law commentators have expressed considerable concerns that the Federal Circuit’s split decision could have a devastating effect on the incentives for pursuing breakthrough discoveries and inventions in medical diagnostics—as in August 2015, when a who’s who of biotech thought leaders submitted amici briefs in support of the petition for an en banc rehearing.
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