Genetic land-grab or reward for ingenuity? Australian court to rule on gene patents

What the court decides in this case could potentially change the genetic research landscape for ever. David/Flickr

IDEAS AND OWNERSHIP: The concept of protecting ideas and innovation by legal means dates back to antiquity. But in the age of the internet and multinational business models, many of the existing laws are under strain, their suitability and ultimate purpose called into question.

Here, Dianne Nicol examines a court case that will decide whether human genes are patentable subject matter in Australia.

The Federal Court of Australia will soon rule on a case with significant implications for the multitude of gene patents granted in Australia. In a hearing that ended on February 24, the court was, for the first time, given the opportunity to decide whether genes are patentable subject matter in Australia.

Patient advocacy organisation Cancer Voices Australia has challenged the validity of a patent owned by the US biotechnology company, Myriad Genetics, Inc. Myriad claims exclusive rights to exploit the so-called BRCA1 gene, which is linked to increased susceptibility to breast and ovarian cancer.

Myriad Genetics has been exposed to negative publicity in many countries because of its patent claims to BRCA1 and BRCA2 (another gene linked with breast and ovarian cancer), and its method of detecting mutations in these genes associated with increased breast cancer risk. But there’s nothing out of the ordinary about Myriad making claims to both the sequences and their diagnostic tests.

The criticism is largely because of the way the company has chosen to use its patent rights. Myriad requires all BRCA testing to be done in its own laboratories. The biotech has been particularly vigilant in enforcing its patent rights in the United States (where it is facing the possibility of a Supreme Court challenge to the patents), but has been less successful in Europe and Canada.

In Australia, Myriad’s patents are exclusively licensed to Melbourne-based biotech company, Genetic Technologies, Ltd (GTG). And there are concerns in some quarters that GTG could take the same approach as Myriad in enforcing the BRCA patents in Australia.

Challenges elsewhere

The validity of Myriad’s patents was challenged in the United States in 2010 by the Association for Molecular Pathology and a number of other organisations and individuals. The patents were initially found to be invalid.

In a successful appeal by Myriad, a majority of judges decided the company’s claims to the BRCA gene sequences were valid, but claims relating to methods of detecting mutations (diagnostic tests that show if people have the gene mutation) were invalid.

The United States Supreme Court will soon decide if it will hear an appeal on the question of whether or not the gene sequence claims are valid.

Here and there

The US case and the Cancer Voices litigation in Australia are the first time in both countries that courts are being asked to decide on the fundamental question of whether isolated genes can be patented.

For many readers the answer may seem obvious, but in the eyes of the law, the judgement is far from clear.

The test for patentable subject matter in Australia is cast in curious legal language – proof of “manner of manufacture”. This phrase comes from the English Statute of Monopolies of 1623, and various law reform inquiries have considered whether the wording is appropriate in modern Australian patent law.

The most recent inquiry by the Advisory Council on Intellectual Property has recommended the language be modernised but amendments have not yet been made.

The best explanation of the manner of manufacture requirement comes from a case in 1959, which says the condition is satisfied if the subject matter is:

  • an artificially created state of affairs

  • in the useful rather than the fine arts

  • a material advantage

  • in a field of economic endeavour.

It was easy for such requirements to be satisfied by inventions such as steam engines, electric cars, velcro, and the like. Everyone would probably agree that these are the very types of inventions that the patent system was designed to cover.

But things get more complicated for methods of medical treatment, computer software, business methods, living organisms and other material coming from the natural world, such as gene sequences.

In the Cancer Voices case, the court will doubtless seek assistance from decisions in other jurisdictions (such as the United States), but it must ultimately decide based on the peculiarities of the Australian “manner of manufacture” requirement.

While it’s difficult to predict the outcome, it’s worth noting that courts have tended to take an expansive view of what constitutes patentable subject matter, suggesting that the validity of this patent may be upheld.

Some will be disappointed by a decision not invalidating the Myriad patent; some will be concerned about the viability of the biotechnology industry if the decision goes the other way. But what’s more important is that we have a well-reasoned decision on this crucial aspect of patent law, based on sound legal authority.

It’ll be some months before we’ll have a decision on whether or not genes are patentable subject matter in Australia. And given the importance and impact of this issue, we can expect appeals. All we know with certainty is that what the court decides could potentially change the landscape for ever.

This is part seven of Ideas and Ownership. To read the other instalments, click on the links below:

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