Human genes cannot be patented – what does it mean?

On Thursday, June 13, the Supreme Court unanimously made the landmark decision to not allow individual human genes to be patented or held for profit, and the entire cancer and general e-patient community took a tentative sigh of relief. But what does it mean?

Patents are the legal protection that gives inventors the right to prevent others from making, using or selling a novel device, process or application. What might surprise you is that the United States Patent and Trademark Office has been awarding patents on human genes for almost 30 years.

There has been a lot in the news about the cost of the BRCA1 and BRCA2 tests following Angelina Jolie’s decision to come forward about her preventative double mastectomy. Without insurance (which is difficult enough to convince to cover), the test costs more than $2000 because the gene is “owned” by Myriad Genetics, the company at the center of the Supreme Court case. They hold the monopoly on testing. Lack of competition breeds higher costs and stifles medical innovation and research, which in turn makes it a financial strain that prevents families from getting testing to make sure they make empowered medical decisions for themselves.

“Myriad did not create anything,” Justice Clarence Thomas wrote for in arguments. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.” This interpretation left DNA molecules engineered by man – including so-called “cDNAs” – eligible for patents.

The medical community, including the American Medical Association, is in support of the ruling. And it seems that competitors are gearing up to begin producing genetic testing at affordable rates. Hopefully we will see an influx in research and competition between biotech companies that will positively impact a whole range of disease research and testing.

The focus on money-making for biotech companies now comes not from discovering and patenting a gene first, but by gaining a competitive advantage by using it best. The door is open for innovation. According to Wired.com : “Thursday’s ruling should make it easier for companies, researchers and special-interest groups to share genetic data and build open databases of genomes to improve and develop new applications in fields like health care and agriculture without fear of getting slapped with a patent-infringement lawsuit.”

From my perfect vantage point in Boston, one of the strongest biotech markets in the country, I’m excited to see where this decision takes us.

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