Patent saga persists
WASHINGTON, D.C.—Pop quiz: What do the Southern Baptist Convention (SBC), Dr. James ("double helix") Watson and the American Civil Liberties Union (ACLU) have in common? Answer: They all oppose the federal circuit courts' decision upholding Myriad Genetics' patents on genetic tests for breast cancer.
The ACLU and the Public Patent Foundation (PUBPAT) have filed a writ of certiorari— supported by amicus curiae briefs from the SBC, Watson and 100 other organizations and individuals—asking the U.S. Supreme Court to invalidate patents for two genes associated with hereditary breast and ovarian cancer which allow Myriad Genetics to control access to crucial genetic tests that could lead to life-saving treatment.
The lawsuit against Myriad and the University of Utah Research Foundation, which hold the patents on the genes, charges that the challenged patents are illegal and restrict both scientific research and patients' access to medical care. The ACLU claims that under well-established law, patents cannot be obtained on either "laws of nature" or "products of nature." The lawsuit contends that patents on human genes violate this core principle of patent law and the U.S. Constitution.
"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," says Chris Hansen, staff attorney for the ACLU's Speech, Privacy and Technology Project. "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."
The patents granted to Myriad give the company the exclusive right to perform tests on the BRCA1 and BRCA2 genes, and thus to control the diagnostic care provided to hereditary breast and ovarian cancer patients and people at high risk for these diseases. Myriad's monopoly on the BRCA genes allows it to set the terms and cost of testing and makes it impossible for women to access tests that provide more comprehensive information about their genes or get a second opinion about their results. It also allows Myriad to prevent researchers from even looking at the genes without first getting permission from Myriad.
A federal district court previously had invalidated all of the challenged patents, finding that in isolating the gene, Myriad did not "alter its essential characteristic—its nucleotide sequence that is defined by nature and central to both its biological function within the cell and its utility as a research tool." In August, a federal appeals court ruled for the second time that companies could obtain patents on the genes. Its 2-1 ruling followed a Supreme Court order directing the appeals court to reconsider its initial decision in light of a related patent case, Mayo v. Prometheus, decided by the court last spring.
Upon remand following Mayo, each circuit court judge adhered to his or her previous views and the court again upheld the validity of Myriad's patents by the same two-to-one vote. Judge Alan D. Lourie expressed the view that isolated DNA is patentable because it is structurally different, since in the process of being removed from the body a covalent bond has been broken. A second judge, Kimberly A. Moore, also upheld Myriad's claims, reasoning that genes have historically been granted patent status by the U.S. Patent and Trademark Office and industry relies on this practice. Judge William C. Bryson dissented and held that the genes were not patentable.
"Has the applicant made an 'inventive' contribution to the product of nature?" he asked. "Does the claimed invention involve more than 'well-understood, routine, conventional' elements? Here, the answer to those questions is no."
Among the reasons the ACLU cites for granting its writ is its "paramount importance to the future of patent law, the advancement of medical science and the health of patients." The writ states one conclusion with which few are likely to disagree: "The scientific, medical and legal communities need guidance from this court regarding the scope of Section 101 as it applies to compositions of matter and DNA. Four federal judges in this case have written opinions on the patentability of human genes. Each has adopted a different method of analyzing the issues … in reaching these various conclusions, the district court and Judge Bryson found it highly relevant that Myriad's entire business is based on the fact that isolated genes have the identical nucleotide sequence as genes in the body—because otherwise, any diagnostic conclusions drawn from the 'isolated' gene would be impossible." And finally, "until the patent eligibility of isolated genes is clarified, important stakeholders will be forced to act—or will be chilled from acting— without clear legal guidance.