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U.S. Appeals Court Finds Prenatal DNA Test Unpatentable - June 12, 2015


This article was written by Summer Associate, Tyler Latcham.

The United States Court of Appeals for the Federal Circuit in the District of Columbia came down with another blow for the patentability of biotech testing products on Friday, June 12, 2015. The Court affirmed the 2013 decision of Judge Susan Illston of the Northern District of California holding that Sequenom Inc.’s patent issued for a hugely popular, non-invasive prenatal test, which uses cell-free fetal DNA (cffDNA) circulating in the blood of pregnant woman was unpatentable subject matter because it is a natural phenomenon. The Appeals Court was apparently not persuaded by the Sequenom’s arguments on appeal, which are laid out in a 2014 online article written by Dennis Crouch, an Associate Professor at the University of Missouri School of Law, and include:

  1. the process is novel and patentable subject matter, even though the analysis is done on the natural phenomenon of fetal-DNA in maternal blood plasma DNA;
  2. the claimed steps in the patent are novel because no-one had ever accomplished the combination of these claimed steps before;
  3. the process actually creates new DNA molecules; and
  4. there are several scientifically validated methods of accomplishing the goals of the invention that do not infringe the patent.

 US Supreme Court

The Appeals Court agreed with Judge Illston that under the analysis framework laid out by the Supreme Court in the landmark case Association for Molecular Pathology v. Myriad Genetics, Inc. the prenatal test, although a significant contribution to science, did not provide enough additional inventive elements to consider the subject matter anything other than a natural phenomenon. This decision is one in a long-line of court rulings invalidating biotech patents after the Supreme Court’s naturally occurring compounds and natural phenomena subject matter restriction decisions in Myriad and Mayo v. Prometheus. Based on these rulings and the subsequent stance of the courts, it appears that, for the time being, obtaining and enforcing biotech patents will be very tough tasks.


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