COMPANIES do not have the right to a patent over human gene sequences and genetic mutations because such biological material is a product of nature, a court has been told.

The patient advocacy group Cancer Voices has launched landmark legal action against two biotechnology companies that hold patents over a genetic mutation linked to breast and ovarian cancer, known as BRCA1.

The Federal Court has been asked for the first time to decide if patents granted over segments of human DNA are valid.

The US biotech company Myriad Genetics and the exclusive Australian licensee, Genetic Technologies, have a monopoly right to control the use of the BRCA1 mutation for research and development as well as diagnostic testing.

It was granted on the basis that the process of isolating the gene from the human body in a laboratory constituted an “invention”.

In 2008, Genetic Technologies threatened to invoke its patent by ordering all other laboratories to stop performing BRCA1 diagnostic testing but withdrew after a public backlash. The patent is enforced in the US.

Rebecca Gilsenan, from Maurice Blackburn lawyers, which is running the case pro bono, said isolating a gene from the human body cannot amount to a patentable invention, as it is merely a ”discovery”.

Under Australian law, patents can only be granted over “inventions” which constitute a “manner of manufacture” or “manner of new manufacture”.

The court will have to decide whether a naturally occurring biological material when isolated from its natural environment is a ”manner of manufacture”.

Ms Gilsenan said the plaintiffs would argue there were no material structural or functional differences between a BRCA1 gene that is inside the body and a BRCA1 gene that has been isolated from the body.

However, David Shavin, QC, for Myriad, told the court that when removed from the body and used to predict a person’s predisposition to breast or ovarian cancer, the isolated nucleic acid is, in fact, different to that which exists in the cell.

”We are not seeking to patent the BRACA1 gene,” he said. ”The thing that has been created and isolated … is an artificially constructed state of affairs.”

Cancer Voices says allowing genetic mutations linked to specific diseases to be patented could restrict access to life-saving diagnostic procedures and actively discourage scientific research.

”More and more research is leading to the genetic diagnosis of cancer,” the group’s executive director, John Stubbs, said outside court. ”They are our genes, we want to make sure they and the diagnostic tests that go along with them are protected.”

The second applicant, breast cancer survivor Yvonne D’Arcy, said she has taken legal action as she believes biological material should not be used for profit.

”If you’re really sick and its a genetic form of cancer, then everyone female down the line should be able to get the testing done at a price they can afford and if its patented, it won’t be,” she said.

In 2010, a US District Court ruled the same patent was invalid, but the decision was overturned on appeal last year. The American Council for Civil Liberties has petitioned the US Supreme Court to review the decision.

The hearing before Justice John Nicholas is expected to last up to eight days.

Sourced & published by Henry Sapiecha

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