Supreme Court Hears Arguments On Gene Tests And Research

News, U.S. News

This week the Supreme Court is hearing arguments on whether human genes can be patented. The court seems skeptical on whether it should be allowed. This decision, however, could have an impact on private scientific research. Patent law is complex and with the added complexities of biochemistry it’s no surprise that some justices are expressing anxiety about the case.

The justices’ trepidation is because the decision will have an impact on the future of medical and genetic research (effecting pharmaceuticals and GMO’s). The reason for the hearing is to consider whether or not a challenge should be made on Myriad Genetics. The company wants to be granted a patent for isolating human genes strongly linked to breast and ovarian cancer. This would mean that doctors and their patients must used Myriad’s gene testing technique. Furthermore, researchers would be prohibited from investigating that area.

Opponents of the patent claim that genes are a product of nature and cannot be patented. The DNA found in each of us should not be trademarked even though the US patent office has issued similar patents for decades. The lawyer representing the opposition argued that Myriad did not deserve a patent since it didn’t invent anything. He further argued that while Myriad deserves credit for unlocking the secret to the genes linking to breast and ovarian cancer, they do not deserve a patent for it.

The Supreme Court does not disagree with opponents. Instead, the court is worried about the consequences for not rewarding companies that invest millions in genetic discoveries. While taxpayer money and natural curiosity will continue, Justice Kennedy doesn’t think that will be enough. It’s not responsible to just assume that the money will come from somewhere.

A representative for the government said on Monday that it mostly agrees with the challengers. However, the manipulation of the gene, like where to begin the DNA sequence and where to end it to produce results, would be patentable.

While the concern seems to be on how research companies can benefit, the ruling on gene patents will have effects on patients. For example, some are worried gene patents will limit access to genetic testing. If patients must use Myriad’s methods for testing and it is not covered by their insurance, then it would be too costly for some women to have access.

Myriad’s patents in essence give them a monopoly on genetic testing for those specific genes. They will be able to charge high prices for testing without competing markets. Right now myriad charges patients $3,000 for testing when it actually costs the company about $200 dollars. Myriad defends the price hike as a way to earn back the money already spent on research and developing the tests for these genes.

Another barrier to patient care is receiving a second opinion. Myriad’s patents have in the past prevented patients from second guessing their test results. Although, Myriad has since created tests to look for mutations in the genes they discovered, the patents prevent other researchers for improving on their genetic test. If a patient receives a false positive she may have no way to ask for an independent confirmatory test.

Patients may be at a disadvantage, but companies like Myriad are opening a door of opportunities for others who want to make a profit from patented genes. For example, a future where companies develop designer synthetic genes won’t be far off. There are thousands of genetic markers that distinguish us from others. It would still be difficult to do so since it’s very difficult to determine which genes are responsible for specific characteristics. But with a patent as an incentive, who knows where biotech companies could go.

The Supreme Court has a tough decision on its hands. It seems that they don’t want to lean too far on either side of the argument. The challenge is figuring out a way to maintain companies investing in research and balancing genetic testing as it pertains to patient care.

 

 

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