The High Court in October 2015 unanimously confirmed that you cannot patent genetic material in Australia. Below, we step you through the leading cases on patenting genetic material in Australia and abroad as well as the broader implications for the Biotechnology community. 

Cancer Voices Australia v Myriad Genetics (Inc) [2013] FCA 65

The leading case on gene patenting is against Myriad Genetics. Myriad Genetics (Myriad) successfully isolated BRCA1 gene from its naturally occurring environment, a human cell.  Mutation in the BRCA1 gene is responsible for 80% of familial breast cancers and ovarian cancers.

Justice Nicholas granted the patent to Myriad due to an artificial state of affairs, providing a new and useful effect that is of economic significance and met the subject matter requirements under section 18(1)(a) of the Patents Act 1990.  

Justice Nicholas’s initial decision applied Commissioner of Patents v National Research Development Corporation (NRDC). NRDC held that isolated human genetic mutations were, in fact, an “artificially created state of affairs” for “economic endeavour”.

The patent initially granted to Myriad for the isolation of BRCA1 would allow for screening the mutation in Australia. The patent granted Myriad exclusive commercial rights to the technique and testing of BRCA1. Many disagreed with the decision, arguing that it was unethical to prevent other companies from providing accessible testing for the BRCA1 gene. Breast cancer clinicians and their patients, in particular, were concerned about the potential to monopolise testing and set market rates. This decision was always going to attract controversy due to the high-profile nature of Breast Cancer.

Cancer Voices Australia commenced action against Myriad, as like many other organisations, they felt that genes were not inventions. That even when genes are in “artificial state of affairs”, they are identical to what is naturally occurring.

The Court initially decided that isolated DNA was eligible for a patent based on the “artificial state of affairs”, as some human intervention was required to extract and purify the nucleic acids. The decision continued to aggravate people who felt that Myriad and other companies who successfully isolated genes would have a monopoly on medical innovation, and that this would stifle competition. 

D’Arcy v Myriad Genetics Inc [2015] HCA 35

As Cancer Voices no longer decided to pursue litigation, Yvonne D’Arcy brought their case against Myriad. D’Arcy, a cancer sufferer herself, understood the implications of a potential monopoly on the technology isolating BRCA1 and BRCA2.

The High Court of Australia in October 2015 rejected Justice Nicholas’s decision. Gene patents or patents over isolated genetic materials are no longer possible in Australia. Unfortunately, at the time of the decision Myriad’s patent had expired. Effectively Myriad held a patent for 20 years over an unpatentable subject matter.

USA Position

Australia’s position, for the most part, didn’t reflect the United States’ Supreme Court  (U.S.S.C) ruling on patenting genes. The U.S.S.C held in a similar matter, Association for Molecular Pathology v Myriad, which patents over BRCA1 and BRCA2 mutations when isolated from the body were not inventions.

Europe Position

The European Patent Office (EPO) granted the Myriad gene a patent in 2001, which was subsequently revoked in 2004 and reinstated in 2008. After the EPO had reinstated the patent, they clarified that the patent applies only to the testing for BRCA gene mutations. The BRCA gene itself is excluded from the patent scope.

Germany, however, uniquely deals with gene patenting and its regulatory scheme is more restrictive than that of the European Patent Convention. Germany has decided that patent protection is not available for human gene sequences.

The TRIPS Agreement: Can a Failure to Patent Violate the Agreement? 

Australia is a signatory to the TRIPS agreement (the World Trade Organisation Agreement on Trade-Related Aspects of Intellectual Property Rights). The TRIPS Agreement requires Australia and ratifying countries to provide patent protection in all technology areas. From this position, we can understand why Australia hasn’t outlawed the patent protection of biological materials as this would potentially contravene the Act. 

The TRIPS Agreement provides two exceptions to patentability, namely that countries can refuse patents for inventions where commercial exploitation would offend ordre public or morality.  This is inclusive of patents that could involve “human, animal or plant life or health”.

Key Takeaways

Applying the above clause allows a government to withhold patents over inventions that through commercialisation could endanger public health. Section 53 of the EPO also excludes from patentability commercial exploitation that is considered contrary to the ordre public or morality.

What do you think? Tag us on Twitter @legalvision_au and let us know.

Sophie Glover

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