Can a U.S. company own your genes? Patenting DNA is at the centre of US law controversy

TORONTO – Can a company own the rights to testing whether you carry mutated genes that increase your risk of breast cancer by 70 per cent?

The blood test that helped Angelina Jolie decide to have a double mastectomy is conducted by only one American company in the U.S. This is because the company claims to own a patent on the two genes that offer valuable insight into a woman’s risk of getting breast cancer.

The simple blood test costs $3,430 in the United States. Myriad Genetics is the only company in America handling the testing.

The company told Global News the patent extends into Canada and Europe.

Read more: Breast cancer and genetics: Angelina Jolie’s double mastectomy

On Tuesday, Oscar-winning actress Angelina Jolie turned breast cancer into a household conversation after she announced she had a double mastectomy, acting preemptively once she learned she had a “faulty” BRCA1 gene.

How does this patent affect Canadians?

For the most part, the patent hasn’t affected patients in Canada, according to Dr. Kelly Metcalfe, a University of Toronto professor and cancer prevention expert.

“We, in Canada, have provincial labs that are accredited to provide this testing in the clinical situation,” Metcalfe said.

“It’s important to recognize that this isn’t a test that any woman in Canada can get. You do have to meet the criteria,” Metcalfe said.

The gene is a rarity, but if women have the harmful BRCA mutations, it can increase the odds of breast cancer by five times.

In Canada, about one in 250 women carry the BRCA1 or BRCA2 mutation that puts them at an 80 per cent risk of breast cancer. The average woman has an 11 per cent risk of breast cancer, Metcalfe said.

Read more: Breast cancer and genetics: Angelina Jolie’s double mastectomy

The cost of genetic testing is covered in Canada – if the specific gene mutation is already confirmed in your family. If women meet the criteria for testing, it’s done for free and results are returned within three months.

If women don’t meet the requirements for testing, they are asked to head south of the border and pay the $3,430. Testing via Myriad Genetics takes about two weeks.

Myriad Genetics confirmed that the patent extends into Canada but did not respond to questions regarding how the patent is enforced in Canada.

In Canada, if you test positive for the gene and you chose a double mastectomy – the cost of that surgery is covered.

A controversy before the U.S.’ highest courts

Right now, Myriad Genetics is defending its patent to the U.S. Supreme Court after it was sued by a conglomerate of doctors, scientists and patients.

They accuse the Utah-based company of illegitimately patenting a product of nature that’s found in all men, women and children.

The company claims to own the rights to any testing of the presence of these two mutated genes: BCRA1 and BCRA2. Both dramatically increase risk of breast and ovarian cancer.

In enforcing this patent, the company has a monopoly over testing prices, Marguerite Ethier, an American- and Canadian-trained patent litigator, who practices in Toronto. She’s an expert in medical genetics.

The murky world of patenting human genes is hurting research and development, she said.

“There are very many companies that have sought and achieved patents on various targets that are important in biology and diagnostics,” Ethier said, pointing to patents on the HIV sequence and even hepatitis C, for example.

“It is a real barrier to the ability of companies to bring diagnostics to market, in my experience. It’s stood in the way of some very good therapies for patients.”

Kerry Bowman, a bioethicist at the University of Toronto, said the company’s patent lies in the gene sequence, not in the gene itself.

“You’re not patenting genes belonging to humans, but you’re simply patenting the sequence,” Bowman said.

The fate of Myriad Genetics’ patent lies in the hands of the U.S. Supreme Court, though.

Metcalfe said that the bottom line is consumers may be missing out on important testing that could save lives.

“I think the danger translates into a cost issue,” she told Global News.

“To say you can’t have that test because someone has a patent on it and as a result of having that patent, they’re charging a lot more than it actually costs … is concerning actually,” she said.

carmen.chai@globalnews.ca
Follow @Carmen_Chai