Myriad – June 2013

The Supreme Court of the United States has just partially reversed, in its decision of June 13, 2013, the proceeding decision of the United States Court of Appeals for the Federal Circuit dated on August 16, 2012.

It is to be reminded that Myriad is the owner of a number of patents relating to an isolated DNA from BRCA1 or BRCA2 genes, mutations of which can dramatically increase an individual’s risk of developing breast and ovarian cancer.

Contrary to the opinion of the United States Court of Appeals for the Federal Circuit, who considered that isolated DNA as cDNA was patent-eligible, the Supreme Court of the United States holds that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”.
According to the Supreme Court, identifying and separating a gene from its surrounding genetic material is not an act of invention.

In fact, the Supreme Court considers that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. Nor did Myriad create or alter the genetic structure of DNA.

However, the Supreme Court affirms that cDNA is patent eligible because it is not naturally occurring.

By the way, relating to Myriad’s argues based on PTO’s practice, the position of the Supreme Court is that: PTO’s practice was not “a sufficient reason to hold that isolated DNA is patent-eligible.”

What would be the consequence of this decision?
Other than the loss of monopoly for Myriad in the Unites States, this decision partially leads to medical and research public domain restoration while reaffirming the patent-eligibility of laboratory genetic constructions.

What will happen in other country, especially in Europe?
The article 5.2 of Directive 98/44 on the legal protection of biotechnological inventions and corresponding articles in national law (L611.18 in France) or European law (R29(2)EPC) will always be applicable?

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