The BRCA1 Gene Patent Ruling – An Australian Perspective

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By Dr Hilda High for oncologynews.com.au

Two weeks after Myriad Genetics’ BRCA1 patent expired, Yvonne D’Arcy and legal firm Maurice Blackburn won their case that “BRCA1 is a naturally occurring gene and not a patentable invention” in the Australian High Court.

This article explains the background of the patent and the effect of the ruling on BRCA testing in Australia.

Myriad Genetics

Myriad was founded in Utah in 1991 and set about finding the genetic cause of the very high risk of early onset breast and/or ovarian cancer in some families. Why Utah? Because there was a large Morman population who had the ideal combination of large families and generations of well-documented family trees.

Myriad had a good idea of where to look for the genes responsible for the increase in breast cancer risk as researchers such as Mary-Clare King had already used a technique called “linkage analysis” to narrow down the inherited problem to specific chromosomes (17 for BRCA1 and 13 for BRCA2).

Myriad, working closely with the local university, “discovered” the  BRCA1 and BRCA2 genes in 1994 and 1995 respectively.  It is not unusual for a not-for-profit university or hospital to have either its own private for-profit arm or to work with a private entity so that it can make money from its discoveries.

money ideas drug patent concept_oncology news australiaUS Constitution & Patent Laws

Patents form part of the US constitution.  The idea was to encourage people to spend time and money inventing and discovering useful things, safe in the knowledge that they would be able to benefit from their inventions.  To make sure that these discoveries would eventually benefit everyone, patents are granted for a limited time only.

Patents have to be for things that are novel, useful and non-obvious.  They can’t be for a law of nature, an abstract idea or a physical phenomenon.  So, while you can’t patent gold or the “process” of picking up a gold nugget from a river bed, you can patent a particular extraction process or tool to make the job easier / more efficient.  Similarly you can’t patent the laws of gravity or a sunset.

Patent law differs from country to country and usually an inventor or a company must apply for the patent in multiple countries.

Myriad was granted patents relating to BRCA1 and BRCA2 in 1997 and 1998 respectively.

BRCA1

Generally, you want a patent to be broad enough to make the most money and yet specific enough to be defended.  Also, you want to try to guess how your “invention” may be used and patent that, as well.  Myriads patents related to the gene, found in both normal and cancerous tissues and its use in diagnosis and treatment, including “isolated DNA coding for a BRCA1 gene” also known as cDNA.  (To read about the actual BRCA1 patent see http://www.google.com/patents/US6162897 as an example – you’ll see that the patent wasn’t as simple as “we own the BRCA1 gene”!)

Myriad allowed not-for-profit researchers to provide genetic testing but successfully sued Pennsylvanian University when they provided fee-for-service testing.  In this case, the US court ruled that when the DNA was removed from human cells, the ends were “chemically changed” and was therefore novel.

Over the years there have been multiple arguments to defend or attack the patents.  Supporters state that patents promote research by protecting the researchers’ investment while attackers state that patents hinder research and drive prices up.  Myriad was often criticised because, while they released the details of the pathogenic (disease causing) mutations found via germline genetic testing of patients, they did not share the information regarding changes of uncertain significance, called “variants” with the large databases (such as BIC) that had been set up to try to sort out which changes were pathogenic and which ones benign.  This led to a patient backlash: “How can someone own something that is part of me?”

Legal Challenges

The legal challenges in the US see-sawed between supporting and denying the patient:  the District court found that isolated DNA was not markedly different and therefore not patentable; the Federal Circuit then found that the chemical bonds were broken and therefore it was markedly different and patentable and lastly in June 2013, the Supreme Court, considering whether the steps to isolated DNA were conventional or routine and/or if isolated DNA was inventive decided that human genes are not patentable as naturally occurring DNA was a product of nature and not patentable but that that cDNA, which was created in the lab, was not a product of nature and could be patented.

The Australian Experience

In Australia, things were different. When Myriad decided to try to enforce its patents here in 2008, there was a big back-lash and legal action was threatened.  Perhaps fearing that if an Australian court decided that the patent was not valid that it could set a precedent for legal action in the US and elsewhere, Myriad “gifted” its patent to Australia (that is, it still kept it’s right to enforce the patent but agreed not to do so).  As a result, genetic testing in Australia was relatively inexpensive , <$2000 compared to <$5000 in the US or countries where the patent was enforced such as Malaysia, and cost around the same regardless of whether the test was done by Myriad’s Australian representative Genetic Technologies or a different lab.

Legal firm, Maurice Blackburn, decided to start a legal battle in 2010, together with patient advocacy group Cancer Voices Australia and Yvonne D’Arcy (who herself had had breast cancer) because they saw the commercialisation of human DNA as an example of social injustice.  The case was conducted pro-bono.

Australian judges also found interpreting just what could be patented when it comes to human DNA difficult.  In February 2013 Australia’s Federal Court ruled in favour of the patent and this ruling was upheld on appeal in September 2014, although for different reasons.

This week, on the 7th October, the battle culminated with a final win: the Australian High Court found that “an isolated nucleic acid, coding for the BRCA1 protein, with specified variations, is not a manner of manufacture” and thus the patent is not valid.

Access is the biggest barrier

So… what changes? Actually, not much as far as patients are concerned. With waiting times in some public familial cancer centres blowing out to over 3 years and no Medicare rebate for the test if the patient is seen by a private genetic oncologist or clinical geneticist, the biggest barrier to genetic testing in Australia remains one of access rather than cost per se.  Maybe this could be Maurice Blackburn’s next social justice case?

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About Author

Hilda High

Dr Hilda High is medical oncologist specialising in cancer genetics. She has worked with familial cancer services at the Prince of Wales Hospital, Westmead Hospital and Royal North Shore Hospitals and now works with Sydney Cancer Genetics through rooms at the SAN, in Ultimo in Sydney and via telehealth to rural and regional Australia.

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