Myriad Genetics: landmark ruling for gene patenting

In the latest instalment of a highly contested case, the US Federal Circuit Court of Appeals in Washington DC upheld Myriad Genetics' right to patent two genes, BRCA1 and BRCA2, which are associated with the  risk of breast and ovariancancer.

The case was sent back to the Court of Appeals by the US Supreme Court for re-examination earlier this year, as reported in BioNews 651. The lawsuit was filed against Myriad Genetics by the American Civil Liberties Union (ACLU) and the Public Patent Foundation who argued that patents on human genes, which are a 'product of nature', violate the First Amendment and patent law.

Myriad Genetics in response argued that isolating the DNA from the human body alters its chemical structure to something that does not occur naturally. Judge Alan Lourie agreed.

'Everything and everyone comes from nature, following its laws, but the compositions here are not natural products. They are the product of man, albeit following, as all materials do, laws of nature', he said,  writing for the majority.

However, the Court did prevent the company from patenting methods for comparing or analysing DNA sequences.

Commenting on the decision, Professor James Watson, co-discoverer of the double helix structure of DNA, said that he feared the Court had failed to appreciate the unique nature of human genes.

'It is a chemical entity, but DNA's importance flows from its ability to encode and transmit the instructions for creating humans. Life's instructions ought not be controlled by legal monopolies created at the whim of Congress or the courts', Professor Watson said.

One of the dissenting judges, Judge William Bryce, said the decision will 'likely have broad consequences, such as preempting methods for whole genome sequencing'.

Chris Hansen, a lawyer for the ACLU said that the decision was 'extremely disappointing' and that it 'prevents doctors and scientists from exchanging their ideas and research freely'. He added: 'Human DNA is a natural entity like air or water. It does not belong to any one company'.

Peter Meldrum, President and CEO of Myriad Genetics said: 'We are very pleased with the favourable decision the court rendered today. Importantly, the Court agreed that isolated DNA is a new chemical matter with important utilities, which can only exist as the product of human ingenuity'.

Biotech patent lawyer Tim Worral of law firm Dorsey & Whitney commented that much of the value of DNA based inventions is based on the notion that genes are patentable.

The Court accepted Myriad's argument that not allowing patents could stifle innovation, with Judge Lourie writing that, 'Patents encourage innovation and even encourage inventing around; we must be careful not to rope off far reaching areas of patent eligibility'.

Sandra Park, a lawyer also for the ACLU, said that the patents allow Myriad to maintain a monopoly on BRCA testing in the United States' and added that the test does not look for all the causes of hereditary breast cancer.

The US-based National Comprehensive Cancer Network, which represents non-for-profit cancer centers, now advises in its guidelines on BRCA testing that all women should also be tested for large rearrangements on the genes.

A positive result from Myriad's BRACAnalysis gene test signals an 82 percent increased risk of breast and a 44 percent increased risk of ovarian cancer over the patient's lifetime.

The case is Association of Molecular Pathology et al vs.US Patent and Trademark office et al, US Federal Circuit Court of Appeals, number 2010-1046.