Myriad patents invalid
A US District Court judge has ruled against Myriad Genetics to invalidate patents relating to methods of detecting inherited breast cancer.
Judge Robert Sweet of the US District Court for the Southern District of New York has ruled against Myriad Genetics to invalidate patents relating to methods of detecting inherited breast cancer.
The ruling favours plaintiffs including the American Civil Liberties Union (ACLU). It disputes Myriad’s hold over the BRCA1 and BRCA2 breast cancer genes, labelling the patents incorrectly granted in terms of composition and method. As a rule, ‘products of nature’ cannot be patented.
The ACLU and Judge Sweet agree that genes should be restricted by such a rule. Sweet said: “The claimed invention, as a whole, [should be] sufficiently distinct in its fundamental characteristics from natural phenomena to possess the required ‘distinctive name, character, [and] use.’ None of Myriad’s arguments establish the distinctive nature of the claimed DNA.”
Myriad’s method claims involved the comparison and analysis of DNA strands to identify genetic mutations that increase the risk of breast cancer. The act of isolating and analysing the genetic material does not change the information carried by the material, nor does it represent a significant enough process to pass a ‘machine or transformation’ standard, the judge ruled.
The ACLU filed the suit on behalf of several plaintiffs, including the Association of Molecular Pathology and breast cancer sufferers, in May 2009. As well as Myriad, the US Patent and Trademark Office (USPTO) was named in the suit, because it granted the patents in question.
Judge Sweet dismissed claims by the plaintiff that the USPTO overreached its authority when granting Myriad its patents. Jim Greenwood, president and chief executive of the Biotechnology Industry Organization (BIO), said:
“BIO is pleased that the court dismissed the far-reaching claims regarding the constitutionality of patenting gene-based inventions. As explained in the ruling, the district court’s determination is only a preliminary step in the legal process that does not affect how the USPTO evaluates patent applications relating to DNA-based inventions.”
