NEW YORK (GenomeWeb News) – The American Civil Liberties Union and the Public Patent Foundation have asked the US Supreme Court to take up the question of gene patenting for a second time by looking again at the patentability of Myriad Genetics' claims on genes that predict risk of breast and ovarian cancer.
The ACLU and PubPat want the high court to review the recent mixed decision of the US Court of Appeals for the Federal Circuit which affirmed the patentability of isolated genes but which also suggested that some methods of comparing or analyzing gene sequences may not be patentable.
The CAFC took the case up for a second time after the Supreme Court asked it to reconsider its earlier decision on the Myriad gene patents, which upheld the patents and overturned an earlier district court ruling, in light of a separate Supreme Court decision, Mayo Collaborative Services v. Prometheus Laboratories.
In Mayo v. Prometheus, the Supreme Court invalidated patents held by Prometheus because they merely described laws of nature and did not apply those laws of nature in such a markedly different manner as to warrant a patent.
The CAFC in its 2 to 1 ruling in August decided that the Prometheus decision does not apply to Myriad's patents. The judges maintained that although isolated gene sequences may be derived from naturally occurring substances, their isolation requires human intervention in order to make them useful in medical care and so are deserving of patent protection.
Now, twice-decided by the CAFC, the Association for Molecular Pathology v. the US Patent and Trademark Office and Myriad Genetics case will return to the Supreme Court, which could lay down a precedent for gene patenting and for claims on diagnostic and predictive tests that are based on isolated DNA and methods of comparing and analyzing it.
"In our view, the court of appeals did not fully consider or correctly apply the Supreme Court's most recent and relevant patent law decisions," Chris Hansen, staff attorney with the ACLU Speech, Privacy and Technology Project, said in a statement today.
"DNA occurs naturally in the human body and cannot be patented by a single company that can then use its patents to limit scientific research and the free exchange of ideas," Hansen said.
In its petition filed with the Supreme Court, the ACLU and PubPat state that the patentability of human genes is the "central issue" in the case. The petition states that Myriad's claims give the company "exclusive control over the genes" after they have been isolated, and that the patent claims "include every single natural variation of the genes, including those that have not yet been isolated."
"The patenting of human genes, even in isolated form, has the effect of giving ownership over human genes to corporations, allowing them to decide who is allowed to know what they have inside their own body," added Daniel Ravicher, executive director of PUBPAT and co-counsel in the lawsuit, in the ACLU statement.
Myriad has maintained throughout the litigation process that its gene patents have not thwarted research, that the cost of its test is not prohibitive and is covered through insurance for most "appropriate" patients, and that second opinion tests are available in many US labs.
"Importantly, the court agreed with Myriad that isolated DNA is a new chemical matter with important utilities which can only exist as the product of human ingenuity," Myriad's President and CEO Peter Meldrum said in a statement in response to the CAFC ruling last month.