Supreme Court's Genetic Patent Rule is Still a Win for Myriad

The high court rules against patenting naturally-occuring genomes, but for complementary DNA.

June 13, 2013

2 Min Read
Supreme Court's Genetic Patent Rule is Still a Win for Myriad

Even as the Supreme Court ruled against Myriad Genetics today, the genetics firm retained key protections on its patented work.

The Court’s opinion is that naturally-occurring human genomes may not be patented by companies. It was a rare unanimous decision by the high court, upholding the decision of a federal judge that a company could not control the patents on the BRCA1 and BRCA2 genes, which are known indicators of risk for breast and ovarian cancer.

“Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA,” the ruling, written by Justice Clarence Thomas, said. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes.”

It was believed that 40% of human genomes were patented up until the Supreme Court decision. The opinion said Myraid could not control the patents on the genes itself, since it simply found them and did not invent them.

“Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule,” the ruling said.

Myriad created a test based on its patents on the BRCA genes, which reached mainstream media prominence after actress Angelina Jolie announced going through the test and having a double mastectomy. During the coverage, the test, also known as the BRCAAnalysis, was criticized for its high price tag of $3,000 and being inaccessible to many women. This amount was due partially to Myriad’s patent on the specific genes.

However, the ruling does have a revision from the original federal decision. The ruling against patenting genes does not apply to synthetically-created human genomes. The decision on this complementary DNA, or cDNA, is very different, according to the ruling. “The lab technician unquestionably creates something new when cDNA is made,” the ruling said, adding that it is not a product of nature the way that BRCA1 and BRCA2 are.

The ruling acknowledges Myriad’s position in being the leader in applying applications regarding the BRCA1 and BRCA2 genes, as it is the “first party with knowledge.” This keeps a layer of protection on Myriad’s test, as it is still the only one currently available on the market, and the company still has over 500 claims in 24 different patents.

"We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward," Peter D. Meldrum, Myriad president and CEO, said in a statement. Accordingly, Myriad Genetics’ stock price was up by 10% in early trading to $36.65 at 1 pm eastern standard time, reaching a four-year high.

For analysis on the ruling, see Arundhati Parmar's take.

Reina V. Slutske is the assistant editor for MD+DI. 

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