Do companies have the right to patent your genes?
The Supreme Court will wrestle with that highly charged question on Monday, when it hears oral arguments in a case that could have far-reaching implications for the future of medical research.
The federal government itself is divided over the issue. The federal patent office has been approving patents on human genes since the 1980s, but the Justice Department on Monday will ask the court to invalidate those protections and rule that human genes cannot be patented.
The lawsuit deals with patents on two genes that can identify a woman’s risk of developing breast cancer.
Critics, including the Obama administration and a group of cancer survivors, say private companies shouldn’t be able to patent parts of the human body. The patents are standing in the way of important research, they argue.
The company that owns the patents, Myriad Genetics, says its patents protect a highly effective and life-saving method for determining women’s risk of developing cancer.
“The court has gotten itself into what is basically a morality fight,” said Kevin Noonan, a partner at the law firm McDonnell Boehnen Hulbert & Berghoff who specializes in patent law.
The implications for medical research are significant.
Genetic testing has emerged as a major tool in diagnosing risk. Scientists are also trying to develop a new generation of medicines that will respond specifically to the genetic mutations that cause certain diseases — such as breast cancer.
“(At a) gut level, it seems preposterous for a company to be able to patent your genes,” said Sandra Park, a staff attorney with our Women’s Rights Project at the American Civil Liberties Union.
Myriad’s patents are standing in the way of important medical progress, Park argued.
Women who get the genetic test can’t get a second opinion, because no one else is allowed to extract the same gene, Park said. Professional geneticists can’t even examine their own genes without running afoul of Myriad’s patents.
Because Myriad has patented the actual human genes, rather than a test that uses those genes, the company has effectively blocked researchers from even trying to come up with new tests or studying other mutations that might provide new information about cancer risk.
“There’s no way to invent around what they’ve patented,” she said.
The question for the court is whether Myriad has patented an invention, or a law of nature.
The court has ruled in the past that natural phenomena and rules of nature cannot be patented. But it has not directly said whether human genes fall into the category of natural phenomena.
Myriad argues that its patent does not cover a law of nature. Once the genes are “isolated,” they become a human invention eligible for patent protection, the company says in its briefs.
The Association for Molecular Pathology, which is challenging Myriad’s patents, said the company’s defense “defies common sense.”
Genetic mutations occur naturally, and Myriad simply looks for them — it doesn’t change anything about the gene’s makeup, the challengers argue.
“Under this rationale, a kidney 'isolated' from the body would be patentable, gold 'isolated' from a stream would be patentable, and leaves 'isolated' from trees would be patentable,” the association said in a brief to the high court.
Noonan, the patent attorney, dismissed those analogies.
“That’s just ridiculous,” he said.
Unlike leaves on a tree, no one knew these genetic mutations even existed until Myriad discovered them, Noonan said. The company has created a new way of assessing risk, and it’s entitled to patent protection just as any other medical innovation would be, he argued.
Most of the existing patents on human genes — including Myriad’s — are only a few years away from expiring. Companies that have already secured patent protections don’t have much to lose at the court.
“Literally, Myriad does not have any risk at all,” Noonan said.
The risk, he said, is to future innovations. He’s hoping for a narrow ruling specific to these two genes, or to human genes.
If the court approaches the case more broadly and says nothing that occurs in nature is eligible for a patent, Noonan said, its ruling could threaten the development not just of new genetic tests, but also of drugs like antibiotics, which are derived from natural sources.