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Patent controversy: don’t let breast cancer gene genie out of the bottle

A test case is slated to challenge Myriad’s claim for breast cancer genetic mutations next February. TheAlieness GiselaGiardino²³/Flickr

The US Court of Appeals for the Federal Circuit has found Myriad Genetics is entitled to patents on two sets human genetic mutations used to predict if women have an increased risk of breast and ovarian cancer.

The case has been closely monitored here for two reasons:

1) The Australia Patent Amendment (Human Genes and Biological Materials) Bill 2011 is currently with the Senate and Community Affairs Legislation Committee, whose report on the Bill is due on August 25.

2) The Federal Court of Australia is slated to hear an Australian test case (discussed below) in February 2012.

Dr Luigi Palombi, who has previously written about the Patent Amendment (Human Genes and Biological Materials) Bill 2011 for The Conversation, gives his response about the implications of the decision for Australia:

The US decision is disappointing because it doesn’t provide a definitive resolution of the real question – should naturally occurring genes be patentable subject matter?

There were three judges hearing the case and effectively they’ve come to three different decisions.

While two of them held that isolated genomic DNA is patentable subject matter, one of the two only came to that view because she believed it was a matter for Congress, not judges, to change the policy first implemented by the US Patent Office allowing this kind of patenting.

What is puzzling is that all three judges invalidate Myriad’s patent claims to its BRCA genetic test.

Effectively, what the judges are saying is that the process of producing a genetic test result using patented DNA doesn’t result in an invention.

This is because the process of comparison involved in coming to a test result is merely a mental one that doesn’t transform anything physically.

As a mental abstraction, it’s not patentable subject matter.

That puts Myriad in the unusual situation of having a patent over the BRCA1 and BRCA2 genetic mutations linked to breast and ovarian cancers but not over their practical use in a genetic test.

Of course, having a patent monopoly of the genetic mutations means that anything anyone can usefully do with them is subordinate to Myriad’s gene patents, so it might be argued that the company has the BRCA test market cornered in any event.

Legal implications of the decision

The decision turns patent law on its head because it means that the prize is given for the discovery not for the invention (a new, tangible and practical use of the discovery).

The second problem is, Myriad’s scientists discovered and linked genetic mutations to breast and ovarian cancers, but that’s a long way off an invention.

If there was any invention by Myriad (assuming it was also novel and involved an inventive step), it was in the development of a diagnostic test.

So, the result is less than ideal.

The majority decision, in my opinion, is irrational, contrary to scientific fact and little more than a knee-jerk reaction to the fear mongering of the American biotechnology industry.

It claims that without gene patents it will not have any incentive to undertake necessary research. Of course, this is a lie.

The truth is that much of the research work that led to the discovery of the BRCA 1 gene was conducted by Professor Mary-Clare King over 16 years. And that research was publicly funded.

Indeed, this is the case for much of the research described in Myriad’s patents as an “invention”.

This work was undertaken by researchers at the University of Utah while receiving funding from the United States government, which is why the government is named as a co-patentee on some of the US patents.

And this is true even in Australia. For instance, in 2009 the Walter and Eliza Hall Institute received $55.2 million of its $74 million budget from Australian and US taxpayers. Only a meagre $1.6 million came from royalties it receives from gene patents.

It’s revealing that even though the US government is a co-patentee with Myriad, it argued in an amicus brief filed with the US Federal Circuit that the patent claims to the BRCA gene mutations were not patentable subject matter.

The US decision, unfortunately, raises more questions than it answers and what this means is that this case is on its way to the US Supreme Court.

The Australian test case

This US decision is not binding for the Australian courts, but obviously Myriad’s Australian lawyers will seek to rely on it as persuasive authority when the test case reaches trial in February 2012.

Cancer Voices Australia and Mrs D'Arcy, a woman who had breast cancer, are seeking to invalidate three of the 30 patent claims in one of Myriad’s four Australian patents over BRCA1 and BRCA2 mutations and their uses in genetic tests.

The case will determine the legality of patent claims to isolated BRCA1 and BRCA2 genetic mutations under Australian patent law.

Ironically, the US decision takes a backward step in the debate because leading Australian scientists like Professor Ian Frazer have argued that we should not be granting patents on isolated genomic DNA.

Professor Sir John Sulston, a Nobel prize winner, agrees.

Now, while the Australian test case is important, I believe that it’s more efficient if the Australian Parliament draws the discovery-invention line based on policy rather than basing it on what judges say.

I find myself concurring with Judge Moore, one of the majority judges in the US decision, not because her decision is permissive of the status quo, but because the policy underpinning this issue is better resolved through the parliamentary process than through the courts.

Read an alternative view of the US Court of Appeals decision.

Read Dr Palombi’s argument for Australia’s Patent Amendment (Human Genes and Biological Materials) Bill 2011

Read the argument against Australia’s Patent Amendment (Human Genes and Biological Materials) Bill 2011 by Douglas Hilton, Director and Julian Clarke, Business Development Manager of the Walter and Eliza Hall Institute (WEHI).

Leave your thoughts about gene patenting below.

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