Patenting Genes

Patents exist to protect inventors (and their investors) from those who would steal their idea for, say, a new cell phone charger and manufacture a cheap knock-off. But what happens when companies patent genes?

The question of whether companies should be allowed to patent something that exists in nature and can grow, mutate, and replicate on its own is far from resolved. A case before the U.S. Supreme Court this year will set an important precedent for what can and cannot be patented that will impact agribusiness, biotechnology firms, and consumers for decades to come.

Pro: Patents Encourage Innovation and Protect Investment

CNN reports that last week an Australian federal judge upheld a U.S. biotech company’s patent on the BRCA1 gene, which signals an increased risk of breast and ovarian cancer.

Myriad Genetics, the company in question, says that about seven percent of breast cancer cases and 15 percent of ovarian cancer cases are caused by mutations on the BRCA1 or BRCA2 gene (Myriad also owns a patent on BRCA2).

According to Myriad, patients with BRCA mutations have "risks of up to 87 percent for breast cancer and up to 44 percent for ovarian cancer by age 70." Women, especially of Ashkenazi Jewish descent, whose close relatives were diagnosed with breast or ovarian cancer before age 50 are often urged to undergo genetic testing for these mutations.

The Australian judge said that because the process of isolating the gene for testing requires human ingenuity, the resulting isolated gene could be patented.

Proponents of gene patenting say that private companies like Myriad are doing a vital public service through their medical research, and that they should be allowed to protect the product of techniques they’ve invested millions of dollars to develop.

Con: Don’t Monopolize Life-saving Science

The Association for Molecular Pathology, the American Civil Liberties Union (ACLU), and patient advocacy groups who brought the lawsuit against Myriad say that by giving a single company the exclusive right to test for mutations on the BRCA1 gene, the test could be made prohibitively expensive.

In 2011, the New York Times reported that Myriad’s test cost $3,340, with a $700 supplemental test to achieve more accurate results.

By restricting who can and cannot test for BRCA mutations, patient advocates worry that women who need it will not receive the test, or the personalized preventative care they may require. Patenting will also discourage other companies and research labs from developing a fast, cheaper, and more sensitive test for breast cancer gene mutations.

According to a news release from the ACLU, “The U.S. Patent and Trademark Office (PTO) has granted thousands of patents on human genes—in fact, about 20 percent of our genes are patented. A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene. As a result, scientific research and genetic testing has been delayed, limited or even shut down due to concerns about gene patents.”

Opponents of gene patenting add that patenting a naturally occurring piece of human DNA is a slippery slope, as companies rush to patent (and price) genes for everything from eye color to cholesterol, and so restrict the ability of scientists to study them.

For now, Myriad Genetics is not enforcing their patent protections on BRCA1 and 2, but the U.S. Supreme Court will hear arguments from both sides on April 15.

The Big Question

Should companies be able to patent the very genes that make us human? Should the results of vital healthcare research—even research financed by the private sector—be part of the public domain?

Talk Back

Tell us what you think. Email hross@healthline.com and include your first name and hometown.  We’ll publish the top reader comments next week.

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