Picture this scenario: you are suffering from breast cancer, and a multinational biotechnology company approaches you to use a genetic mutation in your cell line as part of their medical research. They obtain patent rights over your cell line and not only are you excluded from all subsequent information and profit that your genetic material produces, but you also don’t legally own something that was once inside your body. The issue of patenting genetic materials remains a legal, ethical and moral quagmire. This article unpacks the current law both in Australia and overseas to reveal the legal considerations that affect medical research and biotechnology today.

What is a Patent?

A patent is a government-granted legally enforceable monopoly right to exploit a substance, device, method or process that is new, useful, innovative and inventive. When granted a patent, you are granted an exclusive legal right to exploit commercially (that is, make, hire, sell or otherwise dispose of) your invention for the length of the patent. In Australia, standard patent protection lasts for 20 years.

For a patent over an invention to be granted, the invention must be:

  • New (novelty requirement);
  • Inventive (not obvious);
  • Useful (capable of commercial application);
  • Not secretly used before the patent application; and
  • A ‘manner of manufacture’.

It is the ‘manner of manufacture’ requirement that is generally the most difficult to understand and to satisfy. Essentially, this requirement dictates that a patentable invention must be something that can be made or applied industrially or commercially. As such, this requirement precludes things like discoveries, ideas or theories, as well as products of the ‘fine arts’.

It is important to bear in mind that the purpose of the patent system is to give people an incentive to create new, useful products (inventions). Granting a patent represents a type of exchange between society and the patent owner: in exchange for monopoly rights to the invention for a limited period, the patent owner must tell the world exactly how to make the invention. Through this system, the body of public knowledge is increased, and the patent owner has an opportunity to profit from their invention. This bargain system applies across the full spectrum of inventions, from small-time devices for personal or domestic use to software for commercial use, right through to the developments of medical treatments.

Can I Patent a Body Part or Genetic DNA?

In Australia, the law prohibits the patenting of human beings and their DNA. The Patents Act 1900 (Cth) (The Act) however, contains a potential loophole that may facilitate the patenting of DNA and other genetic material as inventions. The Act does not include an express exclusion for patenting genetic materials and would perhaps allow biological material that has been isolated from its natural environment to be patentable. Arguably the human skills used to extract the genetic material and the self-sufficiency of the genetic sequence would create an artificial state of affairs that would be deemed a “manner of manufacture” under the Act.

Patenting of biological material, and in particular gene sequences has been mired in controversy and inconsistency. In October 2015 however, the High Court in the landmark case of D’Arcy v Myriad Genetics Inc. ruled that an isolated gene sequence could not be patented.

What is the Current State of the Law in Australia?

Before Myriad Genetics, the leading case in Australia had been Cancer Voices Australia v Myriad Genetics Inc. In Cancer Voices, 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’ and thus the scope of patentability. 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 and was, therefore, patentable.

Cancer Voices was overturned last year in D’Arcy, where the High Court unanimously held that the isolated BRCA1 gene was not a manufactured creation. Even when artificially manipulated, it was the existence of information that was organically in the gene that 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.

While the case of D’Arcy was a triumph for cancer survivor Yvonne D’Arcy, the law remains ambiguous. IP Australia released a controversial draft proposal in response to D’Arcy’s case that appeared to concede to only the bare minimum of changes. Rather than prohibiting patents on all genetic sequences, the draft still permitted patents to be granted to a range of naturally occurring DNA, a move that angered the Cancer Council of Australia. The law in Australia currently remains uncertain.

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. While this statement provides no express exclusion to genetic patenting, countries are given 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 rate (only two cases in the European Union) 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, the 1980 case of Diamond v Chakrabarty spurred on the development of the biotechnology industry as it ruled that a live, human-made micro-organism was a patentable subject if it possessed markedly different characteristics to any natural phenomena. The current leading case is Association for Molecular Pathology v Myriad Genetics where it was 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

Reconciling the Aims of Patent Law With Restrictions on Gene Patenting

Patent law attempts to coalesce contradictory principles. On the one hand, it encourages self-interest and exclusive ownership of applied ideas, and on the other, the sharing of ideas for the common good. Patent law itself reveals the tension between these conflicting ideas, rewarding invention and innovation with the monopoly right to exploit an invention exclusively. The law also balances the greater good of society as the monopoly right is constrained by time before unrestrictedly released to the public. Patent law is an uneasy truce. 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, and the profit reaped from patent exploitation can then stimulate national industries and provide resources for further research. The economic benefit is balanced by 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 would go undeveloped, or rely solely on donations and public funding. Modern medicine relies on the protection that patents provide in order to develop new medicines and treatments.

On the other hand, restricting access to lifesaving treatments does present a difficult moral conundrum. Ultimately, patent law needs to strike a balance between providing commercial incentive to medical researchers and the public interest.

Conclusion

The uncertain boundaries of what can and cannot be patented in Australia, and in international jurisdictions, reveal that patenting subjects within the human body remain a contentious subject. This area of law inevitably raises legal and ethical questions and appears to be a subject that will be constantly scrutinised, due to its far-reaching ramifications for the economy and society alike. Given the magnitude the D’Arcy case and growing public awareness of genetic patenting, it is likely that the patenting debate will traverse into the Australian Parliament. It is hopeful (yet perhaps impossible) that law reform in the area of genetic patenting will balance the competing ideas of economic pragmatism and ethical idealism.

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

Daniel Smith

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