Gene patents may sound scary but soon they may no longer matter

Challenges to the patents for BRCA mutation tests in Australia and the United States resulted in opposing conclusions. Christiana Care/Flickr, CC BY-NC-SA

Recent cases in Australia and the United States and a new case in Canada show how controversial the subject of gene patents is. But technological advances and the cost of patenting may soon mean gene patents no longer matter.

On February 13, 2015, the High Court of Australia granted special leave to hear an appeal against the Federal Court decision in D'Arcy v Myriad Genetics Inc. The case centred on whether the BRCA gene, certain mutations of which predispose women to breast cancer, could be patented. The full Federal Court had decided late last year that patent claims for the isolated genes were valid.

The special leave means the High Court has agreed to review the decision; we can expect its judgment towards the end of this year, or possibly next year.

Different jurisdictions

The Australian case is indicative of global concern about gene patenting.

In June 2013, the United States Supreme Court found patents for isolated genes were not valid, also based on a challenge to the BRCA patents. The relevant legal test in the United States is whether the invention is “markedly different” from what occurs in nature. The Supreme Court focused on the information content of the isolated gene, finding it was not sufficiently different.

The relevant test in Australia is whether an invention constitutes an “artificially created state of affairs”. On this point, the Federal Court found the term “isolated” as used in the patent had a specific meaning – that the genetic material had been removed from its native environment and undergone a series of chemical alterations.

The Federal Court accepted that genetic material claimed in the patent may well have the same informational content as that found in nature. What made it artificial was that it differed chemically, structurally and functionally. The court drew attention to the fact that the material would not function properly if re-inserted into human cells.

In Canada, the Children’s Hospital of Eastern Ontario is also challenging the patentability of isolated genes. While the Australian and US cases were directed to a gene associated with breast cancer, this case concerns long QT syndrome, a rare disease that can lead to heart arrhythmia and sudden death.

Onset of the disease has been linked with mutations in a number of genes. And every one of these genes has to be tested to ensure they perform their job properly. The owner of the Canadian patents is trying to prevent hospitals from doing some tests.

The Canadian case will also ask whether isolated genes are valid subject matter for a patent. But other important questions – including whether methods of analysing genes are patentable, whether aspects of the inventions were so obvious that patents should not have been granted, and whether the Canadian diagnostic organisation is actually infringing any patent claims – are also being raised by the case.

Answers to all these questions are vital to modern genetic diagnostic testing. But the infringement question is particularly interesting because diagnostic technology is constantly changing.

There are good arguments that new types of diagnostic testing and whole genome sequencing may not actually infringe patents claiming isolated genetic material because genes do not have to be chemically and structurally “isolated” to carry out the test.

It is possible for the Australian High Court to reach a different conclusion from both the Canadian and US courts on the patentability of genes. By itself, this does not mean that any one country’s laws are better than any other. What should and should not be patentable is a complex ongoing debate without a clear answer.

Australian law and practise

In light of this, there are three particular aspects of Australian patent law and practice that we would like to clarify to encourage informed discussion.

First, no patent can directly claim elements of any naturally occurring organism. Although some patents claim similar subject matter to that in nature, it must still be different. This means there are no valid patent claims to things as they exist in nature.

A patent provides the right to stop others from using the invention that it claims, but it does not provide ownership of tangible things. It’s the stuff of fiction that “corporations own your genes” and can exercise rights to them in your body.

Second, Australian patent law explicitly allows experiments on inventions claimed in patents aimed at improving or modifying them. Any concerns that patents significantly and negatively affect basic research in Australia are exaggerated or represent a misunderstanding of our patent laws.

Third, patents often lead to higher prices because they provide a period of exclusivity in the market. The system is specifically designed this way to encourage research and development. Despite this, our recent survey shows that, aside from the cost of materials and reagents, there is no evidence of Australian public testing facilities paying a fee or royalty to provide BRCA genetic tests - or any other genetic test. And anyway, the BRCA patent in question expires on August 11, 2015.

That’s not to say the patent holder, Myriad Genetics, hasn’t pursued royalties or asked companies to stop testing for BRCA mutations around the world – it has. The company’s Australian licensee, Genetic Technologies, has also considered having all tests run through them but decided against it. Currently, any accredited testing organisation can perform the test for BRCA mutations in Australia.

Whatever the High Court ultimately decides in the D’Arcy case, it’s unlikely there will be a surge in gene patent applications. A recent government-sponsored investigation has found such applications have been significantly decreasing in number, following a global trend. The reason is not entirely clear, but commentators have suggested that because patents have annual fees and many are not profitable or useful in other ways, they are now being discarded.