Can you Patent a Gene in Australia?

In Australia, the law prohibits the patenting of human DNA. This suggests that you cannot patent a gene. However, the Patents Act 1900 (Cth) (The Act) contains a potential loophole. This loophole may facilitate patenting ways to use DNA and other genetic material as inventions. The Act does not expressly forbid patenting genetic materials. Therefore, it would perhaps allow biological material that has been isolated from its natural environment to be patented. Arguably, the human skills necessary to extract the genetic material and the self-sufficiency of the genetic sequence would create a ‘manner of manufacture’ under the Act. This article explains the: 

• leading cases on patenting genetic material in Australia and abroad; and 
• broader implications for biotechnology. 

What is a Patent?

A patent is a legally enforceable right to exploit a substance, device, method or process that is new, useful and either innovative or inventive. A patent provides an exclusive legal right to commercially exploit an invention for the length of the patent. 

To be patentable, the invention must be:

• novel;
• inventive or innovative;
• useful (capable of commercial application);
• not secretly in use before the patent application; and
• a ‘manner of manufacture’.

The ‘manner of manufacture’ requirement dictates that you must make or apply a patentable invention industrially or commercially. As such, this requirement precludes: 

• discoveries;
• ideas or theories; and
• products of the ‘fine arts’.

Can I Patent a Body Part or DNA?

In Australia, patenting of biological material has been controversial and inconsistent. In October 2015, the High Court ruled that you could not patent an isolated gene sequence.

What is the Current State of the Law in Australia?

Before 2015, the Federal Court held that the isolated BRCA1 (a gene associated with increased susceptibility to breast cancer) fell within the definition of a ‘manner of manufacture’. Therefore, it was a gene you could patent. By focusing on the differences in the gene’s functions after isolation and human manipulation, the Federal Court found that the gene had been redesigned into an artificially created state of affairs that possessed economic utility.

However, this decision was overturned in 2015 when the High Court unanimously held that the isolated BRCA1 gene was not a manufactured creation. Even when artificially manipulated, information that was organically in the gene was an essential part of the alleged invention. Human ingenuity, therefore, could not create a genetic ‘invention’ that was identical to the gene in its natural state within the human body. Therefore, the gene could not be subject to a patent. 

Despite this, however, the law remains ambiguous. IP Australia has released a draft proposal in response to these developments indicating that it does not prohibit patents on all genetic sequences. 

What is the Law Internationally?

Patent law is unique to each country. There are, however, international instruments that regulate the content of these laws for purposes of free trade and competition. All member countries of the World Trade Organization (including Australia) are signatories to the TRIPS Agreement (the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights). The TRIPS Agreement requires all ratifying countries to provide non-discriminatory patent protection in all technology areas, as long as the product or process is new, inventive and capable of industrial application. This statement provides no express exclusion to genetic patenting. However, countries retain the discretion to refuse patents for inventions that would offend public policy if they were commercially exploited. The public policy exception, however, has a very low success and will only apply if there is evidence that patenting the subject matter would:

• seriously prejudice human life and morality; or
• undermine the structure of society.

In the United States, certain genetic sequences may be patented if they are isolated from the body. Historically, a case in 1980 spurred on the development of the biotechnology industry by ruling that a live, human-made microorganism was a patentable subject if it possessed markedly different characteristics to any natural phenomena. In the current leading case, the court held that if isolated genetic material is distinct from genetic material that exists within naturally occurring substances, the genetic material could be a patentable invention. 

Implications for Biotechnology 

On the one hand, patent law encourages self-interest and exclusive ownership of applied ideas. On the other hand, however, patent law also encourages the sharing of ideas for the common good. 

The law also balances the greater good of society, as patents are constrained by time before unrestrictedly released to the public. To benefit the public with new knowledge, we must incentivise creativity and invention by rewarding inventors and innovators with the prospect of self-interestedly profiting from their product.

Fundamentally, patent law is economically driven by cost-benefit considerations. Patents over commercially profitable inventions attract investment. In turn, the profits from patent exploitation can stimulate national industries and provide resources for further research. Patent law must balance the economic benefit with the benefits to the wider community, both through:

• knowledge sharing; and
• the provision of goods and services that cater to social needs.

Without the commercial incentive the patent system provides, many life-saving treatments might:

• go undeveloped; or
• rely solely on donations and public funding.

The protection that patents provide helps the medical industry to develop new medicines and treatments. Ultimately, patent law needs to strike a balance between providing commercial incentive to medical researchers and the public interest.

Key Takeaways 

Whether you can patent parts of the human body, including a gene, remains a contentious subject. This area of law inevitably raises legal and ethical questions. It also has far-reaching ramifications for the economy and society. Given the growing public awareness of genetic patenting, it is likely that the patenting debate will move to the Australian parliament. Law reform in the area of genetic patenting may be able to balance the competing ideas of economic pragmatism and ethical idealism.