Supreme Court Invalidates Myriad's BRCA Gene Patents, Allows for cDNA Patents

Theral Timpson

The Myriad gene patent case reached its final point today when the U.S. Supreme Court handed down a decision that will resonate throughout the life science industry for years to come.

In a rare unanimous ruling, the high court ruled that Myriad's BRCA gene patents are invalid.

Justice Clarence Thomas wrote for the court: “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring . . . Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad’s patents” and are not at issue in this case, the decision went on. “Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes.”

However, the court left the door open for patenting cDNA.

“cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a 'product of nature' and is patent eligible,” continued the decision.

At issue for the life science industry, particularly the booming area of diagnostics is whether without patent protection, diagnostics companies such as Myriad are less likely to develop innovative tests.  Where would the drug industry be, for example, without patents for such therapeutics as Viagra and Lipitor?

The decision will be greeted with different responses around the industry.  Those in academic research positions are generally against gene patents, while those in industry such as today's guest, Mark Trusheim, hoping for IP protection for their innovation.

This morning on Twitter scientists were attempting to parse the decision and determine just where the justices had drawn the line.

Ewan Birney, leader of the ENCODE project appeared confident that the court struck a good balance. "Plenty of real estate each side of the boundary - both public goods side and private innovation," he tweeted.

Scientist Leonid Kruglyac was less enthusiastic about the cDNA part of the decision. He tweeted: "Thomas: "lab technician unquestionably creates something new when cDNA is made.” // So do I when I make a sandwich."

The Wall Street Journal article this morning asserts that "the court in recent years has sought to constrict the scope of patent protections, concerned that patents were being issued too easily and so broadly as to squelch competition and impede innovation. Justice Elena Kagan at one point alluded to such concerns, describing the Patent and Trademark Office as "patent-happy.""

Over at GEN, an article points out that in a blog response, Myriad is seeking to "shift focus away from the patentability of the genes. Myriad noted that under the Affordable Care Act, the BRCAnalysis test is considered preventative, and insurance is required to cover 100% of the cost “for many women. We offer financial assistance to uninsured patients with the greatest need.”"

The results of today's decision will be far reaching and hotly debated for some time to come.   

"Perhaps there's a silver lining to the ruling, as this will free the industry up to develop broader, algorithmic based tests," says Charles Matthews of Boston Healthcare in an upcoming program.  

We'll be following the decision and its fallout closely.