Patent saga persists

WASHINGTON, D.C.—Pop quiz: What do the Southern BaptistConvention (SBC), Dr. James ("double helix") Watson and the American CivilLiberties Union (ACLU) have in common? Answer: They all oppose the federalcircuit courts' decision upholding Myriad Genetics' patents on genetic testsfor 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. SupremeCourt to invalidate patents for two genes associated with hereditary breast andovarian cancer which allow Myriad Genetics to control access to crucial genetictests 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 areillegal and restrict both scientific research and patients' access to medicalcare. The ACLU claims that under well-established law, patents cannot beobtained on either "laws of nature" or "products of nature." The lawsuitcontends that patents on human genes violate this core principle of patent lawand the U.S. Constitution.

"In our view, the court of appeals did not fully consider or correctly applythe Supreme Court's most recent and relevant patent law decisions," says ChrisHansen, staff attorney for the ACLU's Speech, Privacy and Technology Project."DNA occurs naturally in the human body and cannot be patented by a singlecompany that can then use its patents to limit scientific research and the freeexchange of ideas."

The patents granted to Myriad give the company the exclusiveright to perform tests on the BRCA1 and BRCA2 genes, and thus to control thediagnostic care provided to hereditary breast and ovarian cancer patients andpeople at high risk for these diseases. Myriad's monopoly on the BRCA genesallows it to set the terms and cost of testing and makes it impossible forwomen to access tests that provide more comprehensive information about theirgenes or get a second opinion about their results. It also allows Myriad toprevent researchers from even looking at the genes without first gettingpermission from Myriad.

A federal district court previously had invalidated all of the challengedpatents, finding that in isolating the gene, Myriad did not "alter itsessential characteristic—its nucleotide sequence that is defined by nature andcentral to both its biological function within the cell and its utility as aresearch tool." In August, a federal appeals court ruled for the second timethat companies could obtain patents on the genes. Its 2-1 ruling followed aSupreme Court order directing the appeals court to reconsider its initialdecision in light of a related patent case, Mayov. 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 againupheld the validity of Myriad's patents by the same two-to-one vote. Judge AlanD. Lourie expressed the view that isolated DNA is patentable because it isstructurally different, since in the process of being removed from the body acovalent bond has been broken. A second judge, Kimberly A. Moore, also upheldMyriad's claims, reasoning that genes have historically been granted patentstatus by the U.S. Patent and Trademark Office and industry relies on thispractice. Judge William C. Bryson dissented and held that the genes were notpatentable.

"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, theadvancement of medical science and the health of patients." The writ states one conclusion with which feware likely to disagree: "The scientific, medical and legal communities needguidance from this court regarding the scope of Section 101 as it applies tocompositions of matter and DNA. Four federal judges in this case have writtenopinions on the patentability of human genes. Each has adopted a differentmethod of analyzing the issues … in reaching these various conclusions, thedistrict court and Judge Bryson found it highly relevant that Myriad's entirebusiness is based on the fact that isolated genes have the identical nucleotidesequence as genes in the body—because otherwise, any diagnostic conclusionsdrawn from the 'isolated' gene would be impossible." And finally, "until thepatent eligibility of isolated genes is clarified, important stakeholders willbe forced to act—or will be chilled from acting— without clear legal guidance.