Bianca Phillips: Patent challenges

EARLIER this month, the High Court of Australia made a landmark ruling that isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide is not patentable.

 

The ruling brings Australia more into line with the US, where a 2013 Supreme Court ruling held that isolated BRCA1 and BRCA2 are not patentable.

 

In Australia, the federal government agency IP Australia administers intellectual property rights and legislation relating to patents. The patents filed by Myriad Genetics with IP Australia granted the company exclusive rights to test patients’ BRCA1 and BRCA2 sequences to provide predictive and carrier status testing. These rights arguably extended to research and experimentation. It was their claim over BRCA1 specifically that was the subject of the High Court case.

 

The acceptance of gene patents by regulators around the world has raised questions regarding ownership of human DNA. Arguments against gene patents frequently cite ethical and cost objections.

 

Although the High Court decision is certainly a win for those opposed to gene patents, the decision does not have any direct impact on the cost and competition for BRCA testing.

 

Myriad’s monopoly over BRCA1 expired in August this year, 2 months before the High Court ruling. This means that regardless of the High Court decision, all testing centres, subject to existing licensing agreements, are permitted to isolate the BRCA1 gene.

 

However, it is yet to be seen whether open competition will lead to lower costs for patients in Australia.

 

Myriad continues to hold a patent over isolated BRCA2 in Australia. This patent does not expire until December next year, meaning royalties must still be paid to Myriad for the isolation of BRCA2. Myriad holds one other patent in Australia over an isolated tumour suppressor gene on chromosome 10, mutations of which are associated with gliomas and other diseases.

 

Despite the ruling of the High Court that a mutated or polymorphic BRCA1 gene sequence is not an invention, there is another way to seek gene patents in Australia.

 

A patent can be filed for a new method or process for isolating genes and for diagnostic procedures, which may prevent testing centres from isolating specific genes.

 

In these circumstances, patent applicants would not be seeking rights over a genetic sequence, as contested in the High Court case, but rather for a method or process for extracting and/or using a gene. An example is the US patent for Myriad’s BREVAGenplus breast cancer risk assessment test, which combines an online questionnaire and cheek swab to assess a patient’s clinical risk of sporadic breast cancer.

 

Legislative intervention would be required for a blanket ban on the practice of gene patenting, as the High Court was only permitted to consider the arguments brought before it in relation to BRCA1 specifically. An attempt in Australia in 2010 to ban the patenting of gene sequences failed following the recommendation of the Senate Legal and Constitutional Affairs Legislation Committee.

 

Although the High Court did not rule more generally on the practice of gene patenting, its decision will impact on how IP Australia assesses future claims over isolated genes. The case also opens the door for litigation against gene patent holders to contest the validity of their patents.

 

The High Court case is certainly a landmark ruling on the interpretation of Australia’s Patents Act. However, gene patenting still remains a controversial area both ethically and legally.

 

For lawyers, ethicists, clinicians and patients, this field of medicine and the law is certain to continue evolving.