The American Civil Liberties Union (ACLU) is again asking the Supreme Court to invalidate Myriad Genetics’ patents on two human genes associated with hereditary breast and ovarian cancers. The lawsuit contends that the patents are illegal because genes are “products of nature.”
The ACLU asked the Supreme Court to review the case last year. Rather than settling the dispute, the justices sent the case back to the U.S. Court of Appeals for the Federal Circuit. The high court ordered the appeals court to reconsider its July 2011 decision upholding the patents in light of a ruling last spring by the Supreme Court in a related patent case (Mayo Collaborative Services v. Prometheus Labs) that companies cannot patent observations about natural phenomena.
By a 2-1 vote, the appeals court ruled again in August that companies can obtain patents on human genes (C&EN, Aug. 27, page 8). The Supreme Court will now decide whether to hear the case or let the appeals court ruling stand.
“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,” ACLU attorney Chris Hansen says.
Myriad asserts that the appeals court properly “confirmed that isolated DNA is patentable.” The biotech company says it “strongly believes that its patents are valid and enforceable.”
Since a 1980 landmark Supreme Court decision involving genetically engineered microorganisms, the Patent & Trademark Office has granted tens of thousands of gene-related patents, which cover a large number of pharmaceutical and diagnostic products.