Can a gene’s DNA be patented?

In the 1990s Myriad Genetics, collaborating with investigators at the University of Utah Research Foundation and other institutions and companies around the world, isolated the BRCA 1 and BRCA 2 genes, which are linked to both breast and ovarian cancer. In 1997 the U.S. Patent Office, ruling that the isolated DNA of these genes were discrete chemical compounds, granted a patent on the BRCA 1 gene and certain mutations to Myriad and its collaborators. The office later granted similar protection for the BRCA 2 gene.

Over a decade later a science expert employed by the American Civil Liberties Union (ACLU) who was looking into health and medical issues reported that patents were being granted for genes. Impossible, replied Chris Hansen, J.D., an ACLU attorney. They must be patenting the methodology to isolate the genes. No, the researcher assured him, they’re patenting genes, and about 20 percent of known human genes are under patent.

“That’s just wrong,” Hansen replied. “Let’s sue somebody.”

In 2009 the ACLU and the Public Patent Foundation sued the patent office on behalf of the Association for Molecular Pathology and others, challenging the patents for the BRCA genes. They argued that genes are “products of nature” that cannot be patented. In 2010 the United States District Court for the Southern District of New York invalidated the patents. A year later a federal appeals court issued a mixed ruling—companies may obtain patents on genes but not on methods to compare those gene sequences.

On Valentine’s Day 2012, Hansen, the ACLU’s lead attorney in the case, sat on a panel sponsored by the Information Society Project at Yale Law School with Richard Marsh, J.D., Myriad’s general counsel; Rochelle Dreyfuss, J.D., the Pauline Newman Professor of Law at New York University; and Allen Bale, M.D., director of the DNA Diagnostic Lab and professor of genetics at the School of Medicine. Bryan Choi, J.D., the Thomson Reuters Fellow at the Information Society Project, moderated. A decision by the U.S. Supreme Court on whether to hear the case was a week away.

Marsh argued that without patent protection, biotechnology companies would have no incentive to invest in costly research and drug development. Furthermore, he said, Myriad had allowed researchers to study the BRCA genes, had made sure that diagnostic testing involving BRCA was covered by insurance plans, and had reduced prices for uninsured and underinsured patients. “Myriad is trying to be a good steward of the patents it has to promote the testing and make it affordable and accessible, while allowing researchers to do research,” Marsh said. “We are trying to make a win-win out of it all.”

But to other panelists, the very notion of patenting something that occurs naturally and that is not the product of invention or wizardry in the laboratory makes no sense. Gold, said Hansen, could be dug out of the ground, but that doesn’t mean a miner could patent it. And although about 20 percent of human genes are under patent, he continued, only a handful of those patents have ever been enforced. Myriad is one of the few holders of a gene patent to enforce it, Hansen said. That, in turn, reduces competition in diagnostics and therapeutics, driving up the price. It also inhibits research, he said.

“Myriad can sue you if you look at your own BRCA 1 and 2 genes,” Hansen said. “Myriad has the authority under the patent law to stop all research on BRCA 1 and 2 genes. To be fair, Myriad hasn’t exercised that research authority as vigorously as it could have. Myriad has the authority under patent law to stop all clinical testing of BRCA genes, and, for the most part, that is what they have done. The only place you can get tested for BRCA genes is Myriad Genetics.”

Dreyfuss argued that, unlike drugs in the marketplace, genes can’t be “invented around. Everyone needs access to the informational content of those genes.” And having only one source controlling access to those genes limits competition. With a virtual monopoly in place, a company like Myriad, she said, has no incentive to keep up with advances in the field. “Myriad has not put anything into a public database for a number of years now,” Dreyfuss said.

Bale said that scientists routinely share samples from their lab as well as the fruits of their research in the interests of advancing the field. Laboratories all over the world are full of test tubes containing genetic material that may have diagnostic or therapeutic value. No geneticist, he said, would think of discovery of a gene as an invention. “Genes come from people’s bodies and we’re not making them, we’re not inventing them,” he said. “If you actually put together by chemical means a new sequence of DNA that did something that no one had ever seen before, that’s an invention. No one would think about criticizing a patent for that. But we are all very broadly against patenting genes. That is a virtually unanimous opinion.”

In the audience was Ellen Matloff, M.S., director of Cancer Genetic Counseling at Yale Cancer Center, who is a plantiff in the BRCA patent lawsuit. “We all have two copies of BRCA 1 and 2,” she said. “Myriad did not invent them. They came with our bodies. There is no novel test or instrument that Myriad created to look at these genes. They already existed. Every time a patient comes through my door, I have to send the samples to Myriad. … It is unfair. It’s unbalanced. It’s hurting patients.”

A week after the panel the U.S. Supreme Court delayed a decision on whether to hear the case, and in March the court sent the case back to the lower court for further review.