The American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) in their brief on behalf of The Association for Molecular Pathology yesterday asked the court to overturn an August 2012 decision by the Federal Circuit. That ruling for the second time upheld Myriad’s patents on the BRCA1 and BRCA2 genes, which can be used to evaluate the risk of breast and ovarian cancer.
The case was decided by the Federal Circuit in July 2011, and a petition was subsequently granted by the Supreme Court and then put on hold pending the outcome of the Court’s ruling on Mayo v Prometheus. In March, the Supreme Court found the diagnostic method patents owned by Prometheus invalid. The Myriad case was subsequently returned to the Federal Circuit, which affirmed its original decision.
In their brief, the ACLU and PUBPAT argued that Myriad’s patents should be invalidated because genes are laws of nature, and therefore ineligible for patent protection under Section 101.
The brief noted that Myriad defends its claims on the grounds that a gene becomes a human invention when isolated, or removed, from the human body.
“Under this rationale, a kidney ‘isolated’ from the body would be patentable, gold ‘isolated’ from a stream would be patentable, and leaves ‘isolated’ from trees would be patentable,” it said.
The brief also claimed that Myriad has given women inaccurate test results, while its patents prevent other laboratories from testing genes to verify the accuracy of Myriad’s data. The petitioners argued that, although not enforced by Myriad, the patents have had a “proven chilling effect on research” relating to the genes.
The ACLU is being represented by Christopher Hansen, Sandra Park, Steven Shapiro, Aden Fine and Lenora Lapidus. PUBPAT is being represented by Daniel Ravicher and Sabrina Hassan.
Myriad is being represented by a team led by Gregory Castanias, Brian Poissant and Laura Coruzzi of Jones Day.
The case should be argued before the Supreme Court in March or April and a decision is expected before June, which marks the end of the court’s term.
