High Court rules breast cancer gene cannot be patented

Australia’s highest court has ruled a gene mutation linked to cancer cannot be patented, ending a long battle over whether companies can own the rights to genetic material.

The litigation is a win for 69-year-old Queensland breast cancer survivor Yvonne D'Arcy, who challenged Myriad Genetics' ownership of the BRCA1 gene mutation in Australia.

Myriad Genetics was granted a patent in 1995 for isolating hereditary mutations to the BRCA1 and BRCA2 genes, which increase the carrier’s risk of developing breast and ovarian cancer.

Some women carrying the gene, such as actress Angelina Jolie, have opted to have double mastectomies and their ovaries removed to reduce their risk of these cancers.

The High Court decision overturned a Federal Court ruling last year that allowed companies to patent genetic material in Australia.

D’Arcy had appealed the Federal Court decision to the High Court, arguing it was wrong to uphold the validity of three of the 30 claims Myriad Genetics held in patent law.

A “claim” defines the legal boundary of an “invention”, which it determines as being human DNA in an “isolated” form, outside from its naturally occurring state.

Patents over isolated genes can prevent others, such as doctors, from making use of genetic information for medical applications, such as in diagnostic tests used by clinicians.

They can also translate to exorbitant costs to patients carrying the gene.

Adjunct Professor at Murdoch University, Luigi Palombi, said the decision was a long time coming.

But he noted the ruling would not mean much for Australian women carrying the gene, in terms of the costs they may face, as the BRCA1 patent had expired in August.

He stressed this was more of a test case, effectively meaning clinicians could use genetic material for research purposes without the threat of legal action.

“It wasn’t just about BRCA,” Professor Palombi said, explaining that there were thousands of genes currently under patient.

“All genetic testing is now going to have the benefit of this decision. It means clinicians using a gene for say, epilepsy, will not have to worry about these sorts of claims.”

In considering the case in 2013, the Federal Court had focused on the chemical nature of the gene, saying its isolation from the DNA molecule in the natural environment was a significant enough structural modification for patent.

A parallel case in the United States saw the Supreme Court rule the informational content of the DNA was the same regardless of whether it was in its natural or isolated state.

Professor of Law at the University of Tasmania, Dianne Nicol said the High Court decision had broader implications, beyond analysing whether genetic material is patentable matter.

She noted the High Court also said that when patents were in new fields it was necessary to consider such matters as whether extending the patent monopoly could potentially have negative effects on innovation; whether there were important conflicts in public and private interests that needed to be considered; and whether it affected the coherence of patent law.

“And I think that’s really important. They say it’s not just about mechanically applying the traditional requirements for patentable subject matter, it’s about looking at broader policy considerations,” she said.

She said although this was an exciting decision, it wasn’t the end of the road for patents relating to genetic materials.

“There will be scope to work around the confines of the decision. There will still be the capacity to patent biotechnological inventions, but patent attorneys and lawyers will have to look closely at this and see what the consequences are.”

Maurice Blackburn Lawyers began the case pro bono in 2010 on behalf of D'Arcy.

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