The Supreme Court has left biotech entrepreneurs worrying that their inventions may not be worth very much, according to an article posted on the STAT website. The justices have shaken up the industry by declining to hear an appeal from Sequenom, Inc., a California-based 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.
Now that the Supreme Court won’t hear the case, the prior ruling stands—to the dismay not only of Sequenom, but of startups and giants across the life sciences, including Pfizer, Eli Lilly, and Novartis, all of which had asked the justices to intervene.
Sequenom’s story begins in 1996, when doctors noted trace amounts of tell-tale fetal DNA in the plasma of expectant mothers. They created a test that could extract that DNA and determine a baby’s sex and risk of genetic disorders, such as Down syndrome, without the need for invasive procedures. The inventors patented their idea the following year, and the test is now being sold by Sequenom as MaterniT21.
But a lower court invalidated that patent in 2013.
That ruling was based on a Supreme Court decision from 2012, in a case known as Mayo Collaborative Services v. Prometheus Labs. In that case, the justices ruled that any patent stemming from a natural process—such as fetal DNA in maternal blood—must “more than simply state the law of nature while adding the words ‘apply it.’”
Sequenom’s MaterniT21 test doesn’t clear that hurdle, according to the lower courts, because the methods it uses to analyze fetal DNA were already well known when the test was invented.
Such logic is dangerous in the life sciences, according to Kevin Noonan, a biotech patent lawyer at McDonnell Boehnen Hulbert & Berghoff. While Sequenom didn’t invent DNA analysis, it was the first to apply it to maternal plasma, and that should count for something, he said.
Noonan noted that courts are unlikely to invalidate patents based on truly novel discoveries, such as CRISPR-Cas9 gene editing, which is about to be tested in human subjects.
Sources: STAT; June 27, 2016; and Sequenom; June 27, 2016.