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Globe Editorial

Congress, not courts, must fix flaws in gene-patent system

November 21, 2010

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THE QUESTION of whether to allow the patenting of human genes now seems destined for the Supreme Court, following a lower-court ruling that struck down a company’s patents on genes used to test for the risk of breast and ovarian cancers. There are reasons to be skeptical of gene patents, and many voices, including these pages, have expressed the belief that they often serve to inhibit, rather than encourage, medical research.

But there is more to the question than whether current law allows or disallows such patents. Rather than have a new system develop in a piecemeal fashion through the courts, over a long period of potentially damaging uncertainty for industry, Congress should seek to devise new rules through a panel of experts. A sensible policy would establish ways to protect a company’s investment in extremely costly medical research, while also giving other researchers access to critical information that can advance scientific understanding of deadly diseases.

The issue is coming to a head because of a lawsuit against the Utah-based diagnostics company Myriad Genetics. The suit takes issue with patents owned by Myriad for two genes, BRCA1 and BRCA2, that help identify patients who are likely to develop breast and ovarian cancer. Myriad used the patents to become the sole provider of these tests in the United States while blocking other laboratories from offering tests based on those genes.

But the lawsuit is about much more than just Myriad; it challenges, to quote its first lines, “the legality and constitutionality of granting patents over this most basic element of every person’s individuality” — in other words, our genes. In March, US District Court Judge Robert Sweet sided with the plaintiffs by ruling that Myriad’s claims over “isolated’’ BRCA genes are invalid because the genes are “not markedly different’’ from DNA that exists in nature, and phenomena of nature are unpatentable. Further fueling the fire, the US government filed a “friend of the court” brief late last month seconding this view.

Whatever the principle at stake, one practical effect of Judge Sweet’s ruling, if it isn’t reversed, will be to eliminate part of the legal structure upon which the biotechnology industry was founded. The US might leave the company of Japan, Canada, Australia, and the European Union to become the biggest industrialized nation to consider a gene that’s been discovered, characterized, and isolated through scientific inquiry as categorically non-patentable.

This may not be the disaster that some in the industry fear, but there are good reasons to consider a middle ground. The fact that a woman in this country can’t get a second opinion on her breast cancer test is clearly detrimental to public health and should be stopped. But revoking gene patents isn’t the only way to solve that problem; in numerous instances, companies have licensed their patent rights to others, creating a broader market where multiple tests are available for the same gene. At minimum, the government should take legal steps to ensure that companies don’t use patents to create monopolies — whether over academic research, or over the testing of patients.

A study last year by the University of Leuven in Belgium looked at the patents underlying the 22 most popular genetic diagnostic tests in Europe and found that even though 25 percent of the patents claimed a human gene, only 3 percent of the claims in those patents could be considered as “blocking,’’ meaning that they would exclude others from testing those genes. Those patents — the ones that block others from utilizing the research — should be the first target of reforms.

There is still, of course, the very legitimate, and clearly urgent, question of whether gene patents serve the larger goal of advancing medical research and promoting the creation of therapies. But the best answer to this question is unlikely to arrive through a patent challenge. Determining the benefit to society of gene patents involves much more than just the narrow legal consideration of whether DNA isolated through the process of scientific discovery fits the definition of an invention under the US Patent Act.

To get at this answer, there has to be a thorough assessment of the pros and cons of allowing these kinds of patents to remain valid and continue to be granted, combined with a clear understanding of how crucial, if at all, these patents are to industry today compared to a decade or two ago, when biotechnology was in its infancy. Some evidence suggests the biotechnology and pharmaceutical industries, and even growing segments of the diagnostic industry, rely less and less on these patents to develop their products.

Perhaps the best policy would be to simply do away with these patents. But the issue is of such magnitude that it would be best addressed outside the court system, by an act of Congress.