This article first appeared in the St. Louis Beacon: Medical researchers in St. Louis believe the U.S. Supreme Court has strengthened the area’s biotechnology industry in its ruling Thursday that companies can patent synthetically produced genetic material but not isolated human genes.
While local scientists say the ruling could bolster the growth of biotechnology research and make certain testing more accessible and less costly, one national biotech industry group argued that the ruling could stifle innovation.
The case before the court involved a biotech firm in Utah, Myriad Genetics, which held patents on the so-called BRCA1 and BRCA2 genes linked to ovarian and breast cancers. Because it held the patents, the company had been the only firm offering the relatively expensive genetic tests, which can determine who is at higher than normal risk for these cancers.
On the day the court handed down the ruling, Richard Wilson, head of the Genome Institute at Washington University, was at the Smithsonian Institution in Washington, D.C. He was among scientists taking part in a new exhibition marking the 10th anniversary of the first complete human genome sequence. While Wilson was unavailable for comment on the ruling, he is one of the many scientists who have been critical of the idea of patenting actual genes or DNA sequences.
Others at Washington University and Saint Louis University said the ruling means more researchers and companies will now enter the marketplace for offering tests and treatment.
Their views were in contrast to those of the Biotechnology Industry Organization, BIO, which said in a statement that the ruling is likely to stifle biotech inventions. Among those taking issue with that argument was Dr. Ramaswamy Govindan, a professor at Washington University School of Medicine.
“People are talking about that, but that’s a bit of overreaction,” Govindan says. “There are many ways we can come up with valuable service, and there are many opportunities for people to offer the same testing. No single company can do testing for every human being on this planet.”
He also called the ruling a case of capitalism at work, saying it’s “an opportunity to lower the price that’s favorable to consumers. This doesn’t limit opportunity; it allows multiple companies to work in the same space.”
The price of the tests became a public issue recently after actress Angelina Jolie, who had a family history of cancer, disclosed that she had the BRAC1 gene, which put her at greater risk of breast cancer. She responded by undergoing a double mastectomy.
The tests run about $3,800, putting them out of the reach of many people, says Suzanne Mahon, a genetics expert at Saint Louis University Cancer Center.
She says the ruling is welcome by those who teach genetics because the decision should bring down the price of the tests.
“If the cost comes down, the tests should be more accessible to a larger group of patients. And if it’s used correctly, the testing should help us develop good preventive care for cancer for individuals and families.”
What doesn’t change with the ruling, she says, is whether the test should be ordered only by genetics professionals. A long-standing concern, she says, is that primary-care providers “and people not trained in genetics have been encouraged by some of the testing companies to just go ahead and order this (testing).”
She says genetics professionals need to be in control because the issue goes well beyond a patient. “Once I identify a mutation in one family member, there are siblings, offspring, cousins and a lot of other people who are potentially at risk. A genetics professional is going to figure out who all these people are and help the patient inform them.”
She says Jolie’s decision was an example of helping people understand that the issue “isn’t just about BRCA1.” The actress’s “lifetime risk of breast cancer was over 90 percent, so she made a good decision. And she raised awareness.”
Calls to SLU’s Cancer Center quadrupled after Jolie went public with her story. “It helped a lot of people who maybe had thought about it to take the next step. We were happy that we were able to provide that kind of counseling and education to families.”
