Should We Patent Human Genes? the Supreme Court Ponders the Intersection of Biology and Intellectual Property

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SHOULD HUMAN DNA be patentable? That's the central question in Association for Molecular Pathology v. Myriad Genetics, a case argued before the U.S. Supreme Court in April. The lawsuit was organized by the American Civil Liberties Union on behalf of several professional organizations that have long opposed such patents, which the U.S. Patent and Trademark Office has been granting since the 1980s.

Patent law is arcane, and arguments about it can sound a lot like squabbling over the number of angels that can dance on the head of a pin. But in this case, it affects tens of billions of dollars in research, products, and profits.

At issue are several patents related to two breast cancer genes, BRCA 1 and BRCA 2. In the 1990s, researchers at Myriad Genetics identified and isolated two genes in which certain mutations dramatically increase the risk of breast and ovarian cancer. The company then offered a product, called BRhCAnalysis, which compares patients' BRCA genetic sequences to the company's reference sequence to identify the mutations. Armed with the knowledge that they are at greater risk, patients can then engage in protective actions ranging from more frequent mammograms and ultrasound examinations to having their breasts and ovaries surgically removed.

The Supreme Court must decide if Myriad is merely using products that exist in nature (which cannot be patented) or if it has invented a "new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof" (which can).

Why do the plaintiffs want to invalidate human gene patents? As a matter of policy, mainly because they believe such patents impede rather than speed valuable research and development. The Association for Molecular Pathology, for example, cites estimates that "about 20 percent of the human genome is under patent" and argues that "scientific research has been delayed, limited or even shut down due to concerns about gene patents."

As a matter of law, the plaintiffs argue that a gene isolated by Myriad conveys the same genetic information as a gene found in a human body and that it thus "represents the same laws of nature as genomic DNA." Myriad, the ACLU concludes, "is in effect arguing that it may obtain a patent on a product or law of nature itself if it finds a new use for it."

In its brief, Myriad counters that no one would contest a patent on a new chemical that could be applied to a blood or tissue sample to detect a higher cancer risk. "That is what Myriad's patented molecules are," the company claims, "and they were never available to the world until Myriad's scientists applied their faculties to a previously undistinguished mass of genetic matter in order to identify, define, and create the isolated DNA molecules."

Who is right? It's illuminating to consider how the patent office applies the product-of-nature doctrine. In one training example, the office notes that exposure to sunlight is known to affect some people's moods. If someone tried to patent a method for treating seasonal affective disorder that involved exposing a patient to sunlight, the application would be rejected, since it "is no more than the law of nature plus telling people to 'apply it.'" Nor would the office issue a narrower patent on exposing the patient to a source of white light, since the sun is also a source of white light. But it would patent a treatment in which a patient is precisely positioned for a specified length of time near a white light source from which ultra-violet rays have been filtered. …