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GENOMICS

Court Rules that DNA Is Information, Not Intellectual Property

Decision Invalidates Patents for Breast Cancer Genes

This illustration depicts DNA packed tightly into chromosomes, as well as a DNA molecule unwound to reveal its 3-D structure. SOURCE: genome.gov DNA packed tightly into chromosomes, as well as a DNA molecule unwound to reveal its 3-D structure.

A federal judge in New York ruled yesterday that patents on a set of human genes are invalid. U.S. District Court Judge Robert Sweet handed down his decision in favor of the case brought by a coalition of groups including the American Civil Liberties Union and the Public Patent Foundation. The lawsuit argued that patents owned by Myriad Genetics on two genes connected to breast and ovarian cancer both stunt genetic research and limit access to health care for women.

The full implications of the surprise decision are not yet clear, but gene patents are a contentious intellectual property issue both because they underpin significant investments in the biotechnology industry and because they might pose barriers to increasingly complex genomic research. The ruling is also noteworthy because it invalidates both the patents on the genes themselves and patents for the methods of analyzing and comparing genes to identify mutations in the genetic material.

There are about 40,000 patents that currently protect some 20 percent of the human genome.

Some of the patents in question are for the sequences of DNA that make up the BRCA1 and BRCA2 genes. Mutations on these genes are linked to 3 to 5 percent of breast cancer in the United States and 10 to 15 percent of ovarian cancer, according to the Centers for Disease Control and Prevention. But for women with a family history of cancer, genetic testing can be an important medical decision, as BRCA1 and BRCA2 mutations carry a 60 percent lifetime risk of breast cancer and up to a 40 percent risk of ovarian cancer.

Myriad holds patents on the genes along with the University of Utah Research Foundation. As a result, Myriad is the only company that can market a test for the mutations, and it charges as much as $3,000.

Filmmaker Johanna Rudnick spoke with Science Progress in 2008 about her documentary, In the Family, which chronicles her own discovery at age 27 that she carries a mutation on the BRCA1 gene. “There is no other, cheaper test that you could go get in another laboratory, because they have the exclusive patent,” she explained, adding that Myriad also controls the efficacy of the test—there is no other company to turn to for a second opinion.

There are about 40,000 patents that currently protect some 20 percent of the human genome. Last year, a federal advisory panel recommended exceptions from patent infringement liability for genetic research. The proposal came from the Secretary’s Advisory Committee on Genetics, Health, and Society, known as SACGHS, at the U.S. Department of Health and Human Services. But Timothy Caulfield at the University of Alberta argued here at Science Progress that there is little data to back up the claim the gene patents inhibit reserach. “A 2005 study done for the National Academy of Sciences found only 1 percent of the scientists surveyed reported suffering a project delay of more than 1 month due to patents,” he wrote.

Patents are designed to foster innovation, not stand in the way. That’s why patents are public documents that detail the inner workings of a new invention, exposing the idea for anyone to see and understand. Inventors are protected for the life the patent, currently 20 years, from anyone else copying their idea, but in exchange, they share their technology with the rest of the world, advancing knowledge.

Yet the District Court ruling does not hinge on claims about the impact of the patents on research. It deals instead with whether or not the genes and the processes for analyzing them are patentable in the first place.

An analysis of the ruling posted at Genomics Law Report makes it clear that the decision presents DNA as pure information—whether it is part of a complete genome or isolated in the form protected by Myriad’s patents. From the judgment itself:

DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature. It is concluded that DNA’s existence in an ‘isolated’ form alters neither this fundamental quality as it exists in the body not the information it encodes (pp. 3-4).

That is, patents on the chemicals that make up specific sequences of DNA are no different from the information they encode in the human genome. And this naturally occurring information is not eligible for patent protection.

The decision in this trial court for the Southern District of New York is not binding precedent for other trial courts, though it could influence thinking elsewhere. But Myriad has the right to appeal the case the Court of Appeals for the Federal Circuit, and has indicated it will do just that. This process could take more than a year, and ultimately, if the case proceeded to the Supreme Court, the justices there would have the final say on the matter.

The implications for the biotech industry and medical research are uncertain at the moment. “We do not foresee this decision producing any radical changes in commercial, clinical or other activity surrounding Myriad’s BRCA patents, or gene patents more broadly,” write the lawyers at Genomics Law Report. The New York Times quotes Bryan Roberts, a Silicon Valley venture capitalist, who suggests that the work of discovering genes and developing the accompanying diagnostic tests will move to university laboratories: “The government is going to become the funder for content discovery because it’s going to be very hard to justify it outside of academia.”

But the ruling did not merely invalidate the patents on the gene sequences themselves. It went even further and invalidated the method patents on the processes for analyzing the genes. The Supreme Court is currently considering a case involving method patents, and that ruling could have implications for the appeal on yesterday’s decision. The case, referred to as Bilski, focuses on a business method patent on a process for hedging commodities risks.

The current rule for testing method patents laid out by the Federal Circuit in Bilski requires that the process be connected to a particular machine or device or that the process transform an article or piece of matter into something else. In yesterday’s ruling, Judge Sweet found that the Myriad patents fail this test, writing, “because the claimed comparisons of DNA sequences are abstract mental processes, they also constitute unpatentable subject matter” (p. 4).

The Supreme Court’s decision could uphold the test or propose a new set of rules that would become the legal precedent. This, in turn, could shape not just Myriad’s appeal, but future decisions on intellectual property involving innovative biotech processes.

Andrew Plemmons Pratt is the managing editor for Science Progress.

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