The US Court of Appeals for the Federal Circuit has upheld the validity of the human gene patents held by the company Myriad Genetics.
The three judge panel ruled in a 2-1 decision that “each of the claimed molecules represents a non-naturally occurring composition of matter”. The court also upheld Myriad’s patent on a technique for identifying potential cancer therapies by monitoring effects on cell growth, but denied their claim on assessing cancer risk by comparing DNA sequences because the method is based on “abstract, mental steps” of logic that are not “transformative”.
Myriad holds patents on variants of the genes BRCA1 and BRCA2 that are linked to inherited breast and ovarian cancer, giving them exclusive rights to diagnostic tests on the genes. Myriad’s patents were upheld last year, but this March the Supreme Court instructed the Court of Appeals to reconsider the case following a ruling against the (unrelated) diagnostics company Prometheus Laboratories whose patent on a test to determine drug dosage was found to have ‘tied up’ the laws of nature (see previous news).
The legal argument hinges on whether artificially isolated DNA is the same as natural DNA; ‘natural law’ cannot be covered by patent in the US. The court’s judgement regards the patents as based on ‘non-natural’ DNA fragments, as opposed to the ‘natural’ DNA found in the nucleus of cells.
Yesterday’s decision will have largely pleased biotech and drug companies, but disappointed many researchers, patients and medical organisations. James Watson, co-discoverer of the structure of the DNA molecule, was amongst those gave evidence to the court arguing that “Life's instructions ought not be controlled by legal monopolies created at the whim of Congress or the courts”.
The attorney for the American Civil Liberties Union, who coordinated the case against Myriad, said “This ruling prevents doctors and scientists from exchanging their ideas and research freely”.
A ruling against Myriad could potentially have rendered thousands of similar gene patents invalid. It would have left many biotech companies in an uncertain and vulnerable position, since investors would be reluctant to become involved with enterprises lacking the security of patent protection.