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Supreme Court declining to hear an appeal from Sequenom, that markets a Prenatal Test based on Screening Fetal DNA – A Natural Biological Process

Reporter: Aviva Lev-Ari, PhD, RN

Supreme Court on Monday left a whole lot of biotech entrepreneurs fearful that their inventions may not be worth all that much after all.

The justices spooked the industry by declining to hear an appeal from Sequenom, a California company that markets a prenatal test based on screening fetal DNA. A lower court had ruled that Sequenom couldn’t patent the test because it was based on a natural biological process.

“This is a huge ruling,” said David O. Taylor, an assistant professor at Southern Methodist University’s Dedman School of Law.

Justices in lower courts were effectively pleading for the Supreme Court to provide some guidance on the issue of patent eligibility in biotech, Taylor said. The top court’s silence leaves an entire industry guessing.

Taylor predicted that companies and investors will be less likely to fund expensive research for fear of having patents invalidated by the courts. Sequenom CEO Dirk van den Boom made a similar argument.

“Their refusal to clarify this area of the law would seem to point in the direction of reduced investment in diagnostic invention, and that is obviously problematic from a public health concern,” Taylor said.

Sequenom’s opponent in the legal case, Ariosa Diagnostics, said the fetal test was not novel enough to deserve a patent. Asking the justices to intervene “is inviting the court to revisit and rewrite decades of jurisprudence covering patent-eligible subject matter,” the company wrote in a brief. “In the future, there may be a case that tests the boundaries” of what’s appropriate to patent, Ariosa wrote, “but this is not that case.”

The tell-tale DNA

Sequenom’s story begins in 1996, when a pair of doctors noted that there were trace amounts of tell-tale fetal DNA in the plasma of expectant mothers. So they created a test that could extract that DNA and determine a baby’s sex and risk of genetic disorders like Down syndrome, without the need for the invasive procedures that were then the norm. They patented the idea the following year, and their test is now sold by Sequenom as MaterniT21. But a lower court invalidated that patent in 2013.

He and others fear that the Supreme Court’s ruling in Mayo was so broad that judges will be able to invalidate a slew of life science patents by picking apart the components of an invention to find the naturally occurring biological process that inspired it.

Even Noonan, however, said courts were unlikely to invalidate patents based on truly novel discoveries, such as CRISPR-Cas9 gene editing, which is about to be tested in humans.

The CRISPR technology harnesses a naturally occurring process, but it’s “so revolutionary,” Noonan said, “that even the Supreme Court wouldn’t overrule it.”

Damian Garde can be reached at damian.garde@statnews.com
Follow Damian on Twitter @damiangarde

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