An Australian Court has, for the first time, had the opportunity to consider whether human genetic information (in the form of nucleic acids, ie DNA and RNA) can be patented under Australian law.
The Court confirmed that:
- isolated nucleic acids (ie, extracted from the human body and purified) can be patented; and
- naturally occurring nucleic acids cannot be patented.
The Court was asked to consider the validity of a patent owned by Myriad Genetics Inc. Myriad Genetics’ patent claims isolated nucleic acid sequences coding for the BRCA1 gene. BRCA1 has been linked to breast and ovarian cancer.
The patent was challenged by Cancer Voices Australia, an advocacy network for people affected by cancer, and Ms Yvonne D’Arcy who has a history of breast cancer.Cancer Voices Australia and Ms D’Arcy contended that the patent was not valid as it claimed isolated nucleic acid that is not materially different from nucleic acid that occurs in nature.
The key aspect of the Australian test for patentable subject matter considered by the Court was whether an isolated nucleic acid is an “artificial state of affairs”. It was accepted that the isolated nucleic acid sequences claimed have the same chemical composition and structure as the nucleic acids present in a human. The Court concluded that an isolated nucleic acid is an “artificial state of affairs” as;
- human intervention is required to extract and purify ‘isolated’ nucleic acid;
- potentially immense research and intellectual effort is required to isolate nucleic acids; and
- Australian law has taken an expansive approach to patentable subject matter.
US Myriad litigation
The patent subject to the Australian proceedings is related to the gene patent currently under challenge by the Association for Molecular Pathology in the United States Supreme Court in the Myriad Genetics Inc litigation.
In those proceedings, the United States Court of Appeals for the Federal Circuit (by majority) held that isolated DNA could be patented. That decision is on appeal to the United Stated Supreme Court, with oral arguments to be heard on 15 April 2013.
The decision confirms and supports the Australian Patent Office’s longstanding practice of granting patents claiming isolated nucleic acid sequences. This confirms that patents protecting isolated nucleic acid sequences will be granted, subject of course to satisfying other legal requirements such as novelty. This provides comfort to owners of gene patents who may otherwise face revocation of their patents, and investors in gene research who wish to protect their investment by obtaining patents protecting identified genetic sequences.Conversely, many groups and individuals opposed to gene patents have already expressed concern at the outcome of the case. An appeal from the decision is likely. Any appeal could take at least a year to be resolved.