The Supreme Court is scheduled to rule some time this month on genes’ patent – a suit filed against Myriad Genetics for its patent on the BRCA1 and BRCA2 gene mutations, which raise the risk of breast, ovarian and certain other cancers.
The ruling by the nine justices, the first of its kind for the top U.S. court, buttressed important patent protections relied upon by biotechnology companies while making it clear that genes extracted from the human body cannot be patented.
Legal and medical experts believe the decision will have a lasting impact on genetic testing, likely making varieties more widely available and more affordable.
Opponents of patenting human DNA say a ruling in favor of Myriad will mean companies can own your genes, even though experts say it’s more complicated than that.
The patents set off a cascade of effects, opponents argue: it gives the company a monopoly on the test that can identify whether patients have the BRCA mutations so other companies can’t offer their own tests as a second opinion. There’s also no one to compete with the Myriad’s $3,000 price tag on the test, reports MSNBC.
Since Myriad owns the patent on breast cancer genes, it was the only company that could perform tests for potential abnormalities.
It says 1 million patients have benefited from its “BRAC Analysis” technology, and that about 250,000 such tests are performed yearly.
“Even if the patents are thrown out today, that doesn’t make the test available” since it would take time for other companies to develop a test, said John Conley, a law professor at the University of North Carolina who’s taken a special interest in the case.
“The patents are going to expire before any competitors could come into the field anyway. This case would have been a lot more important had it been decided 10 or 12 years ago,” he added. “A lot of things have happened in law and science since then.”
The court, in an opinion written by Justice Clarence Thomas, ruled that forms of DNA that have been manipulated in the lab in a way that alters their natural state can be patented.
Called cDNA – the “c” stands for “complementary” – it is essentially an edited form of a gene, with extraneous stretches excised. This DNA is patent eligible, the court said, because it is not naturally occurring, unlike isolated DNA simply extracted from a human body.
In the opinion, Thomas wrote that because cDNA is not naturally occurring, it can be patented under federal law.
A laboratory technician, he added, “unquestionably creates something new when cDNA is made.” Thomas noted that so-called method patents, which concern technical procedures for carrying out a certain process, are not affected by the ruling, reports Reuters.
Myriad, the University of Utah and the U.S. government’s National Institute of Environmental Health Sciences filed an application for the first patent on the BRCA gene mutations in 1994. The Patent and Trademark Office granted the patent on BRCA1 mutations in 1997. Another patent, on BRCA2, was granted in 1998.
Myriad’s work on cancer screening gained worldwide attention this year when actress Angelina Jolie announced she had a double mastectomy after undergoing a test and finding she had an extremely high risk of developing breast cancer.
The Supreme Court has long allowed patent protection for the creation of a new process or use for natural products. Whether “isolating” or “extracting” genes themselves qualifies for such protection became the central argument.
The justices took the position offered by the Obama administration — DNA itself is not patentable but so-called “cDNA” can be, writes CNN.
All sides agree the science of isolating the building blocks of life is no easy task. Myriad has said it has spent several years and hundreds of millions of dollars in its research. But the issue of patenting has divided the scientific and business communities.
Myriad said the decision left intact 24 different patents that relate to the BRACAnalysis test. Peter Meldrum, Myriad’s president and CEO, said the ruling ensures “strong intellectual property protection for our BRACAnalysis test moving forward.”