Should Genes Be Patented? ACLU Says No

By Karen Weintraub
Guest Contributor

Every cell in your body holds about 20,000 active genes. Companies hold patents on more than 20 percent of them.

The companies argue that patents reward their investment in gene discovery, and encourage drug development. But those patents also mean that you have to pay them to read your genetic code, second opinions are limited and researchers may not be able to study or diagnose them.

The American Civil Liberties Union this week launched a public campaign against such gene patenting, as it awaits a Supreme Court decision that could come as soon as Monday.

Mutations in these genes have been linked to dramatically higher rates of breast and ovarian cancer. 
The rights organization is collecting stories of people who believe they have been harmed by gene patents, and posting them on its website.

In 2009, the ACLU filed suit against Myriad Genetics Inc., of Salt Lake City, which holds a series of patents on the breast cancer genes BRC1 and 2. Mutations in these genes have been linked to dramatically higher rates of breast and ovarian cancer. Women who find out they have this mutation are often convinced to have both breasts removed – rather than just a lump – as well as their ovaries.

But before they know whether they have a dangerous mutation, they need a genetic scan only offered by Myriad, at a cost of more than $3,000.

Myriad spokeswoman Rebecca Chambers said via e-mail that the “cost of the BRACAnalysis test is not prohibitive and patient access is extensive.” Patients can get second opinions from other companies, and Myriad’s patents have not impeded academic research, she wrote.

“Myriad has never denied, opposed or impeded any research studies on these, or any other, genes,” said Chambers, director of Investor Relations and Corporate Communications.

Newton mom Lisbeth Ceriani, who filed suit with the ACLU, had a different experience with Myriad. Ceriani said she spent 18 months trying to get a BRCA test from Myriad, which she could not afford to pay out of pocket and which would have been covered by her insurance had Myriad accepted it. (Myriad only accepts about half of American insurance coverage.)

Ceriani said she wanted the test before deciding whether to have her ovaries removed, after being diagnosed with breast cancer in her mid-30s.

“Who wants to take their ovaries out at 40 if you don’t have to?” she said. The test “gives you all the information you need to make an educated choice. Without that test, you’re really left in the dark.”

After fighting for 18 month, Ceriani found a grant to cover the cost of the test, and a second, $700 one to look for rare mutations. The first test came back negative, but the second found she had one of the rare genetic glitches that gave her an 80 percent likelihood of developing ovarian cancer. She had her ovaries removed two years ago to prevent that possibility.

“I’d probably not be talking to you right now if I hadn’t done this test,” she said.

Patenting genes prevents people from fully understanding their bodies and taking care of themselves, according to Judy Norsigian, executive director of Our Bodies Ourselves, the women’s health group that publishes a book by the same name.

“People shouldn’t be losing this kind of control over their own genetic information.”

“These broad patents are a barrier to any woman’s ability to know about her body and health history,” Norsigian said. “People shouldn’t be losing this kind of control over their own genetic information.”

There is 100 years of case law finding that companies can’t patent the products of nature. The government allowed gene patents initially, according to ACLU attorney Sandra Park, because the companies were isolating specific genes  – a task that is not part of nature.

Patenting single genes also raises the question of what will happen in a few years when, as expected, scans of the whole genome will become common. Will doctors have to give patients only 70-80 percent of their results, requiring other tests for the remaining genes? No one knows.

At Boston University, the Center for Human Genetics was forced  by another gene patent holder to desist from offering certain genetic screens.

“You can’t patent gold you can’t patent diamonds, how on earth can you patent genes?” the center’s director, Aubrey Milunsky, asks.

He’s cautiously optimistic that the Supreme Court will come to the same conclusion he has.

“We’re headed, I hope for a Supreme Court that has the wisdom to understand the complexities of the subject and see to it that patients are not deprived of the remarkable advances in human genetics,” he said.

Last Friday, the court discussed the ACLU-Myriad case, but didn’t make any public comments about it.  Park said the court will make its next public statement on Monday; an answer could come then, or not for months, she said.

Karen Weintraub, a Cambridge-based Health/Science journalist, is a frequent contributor to CommonHealth.

Correction: An earlier version of the story noted that Ceriani’s insurance company did not cover the test. She says it was Myriad who declined to accept her insurance, rather than the other way around.

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  • Reasonable?

    I spoke to a Harvard researcher about this a couple of years back.
    He said universities and companies are literally sitting on patent applications and following the court cases on this time.  He said that literally, the moment that a decision allowing patents for human genes occurs, there will be a flood of applications that have been lying in wait.

  • Trenalg

    Wanting to patent life-saving or life-enhancing discoveries is evil.  Wanting to do this reveals that the “scientist” has only the motive of self-promotion, not the motive of probing our universe as a helpful member of the human community. 

  • Nobody

    Imagine Euclid patented geometry, Einstein patented relativity, Columbus patented America and Steve Jobs patented… oh yes he did!

  • Nobody

    It’s called capitalism, stupid!

  • The Beautiful Truth

    This is the virtually the same battle which is ensuing culturally with Monsanto who has patented variations of plant DNA, and pollinator DNA in an effort to control our food chain and prevent others from studying the results of their food science on human beings and the natural world. The first living patent happened in the early 1980′s with a strain of bacteria known to produce antibiotics. When this living matter cannot be patented, because of the requirements and control laws around the U.S. patent, food, medicine and science will be open territory where the “best” science will win the dollars and corporate backing. The ethics of corporate science need to be first and foremost about healing human kind, not making the most dollars. The courts will need to be the one to uphold this principle first and foremost. When our courts fail, our ethical and moral rooting as a culture will be forgotten. 

  • Kristen

    I work with cancer patient everyday and find this patent morally wrong. While I see Myraid’s point about needing to get some reimbursement for their research, this owning of the test is onerous and limits some patient’s ability to get the testing done, as this article points out. I don’t have much hope for this lawsuit with the leaning of the Supreme Court towards  business as people mindset. I just can’t get my head around how it is okay to profit off of others illnesses. Yes, research costs money but why can’t our government take just a fraction of what we spend on the military and fund research?  

    There is a fascinating book on the subject of early genetic research I would recommend. “The Immortal Life of Henrietta Lacks” by Skloot. There are some precedences on judicial rulings talked about in this book which I hope will not make the court lean towards Myraid. I am just glad to see this case being brought for the millions of woman and their daughters who need this test and cannot afford it.  

  • Scott Moe

    Just because it costs money, discovery does not turn in to invention. There is tremendous evil being done by people who believe they own basic knowledge of life on earth. Facts and ideas are not the stuff of property, trying to treat them as property and assert control is a horrific thing to witness.