Carriers of the BRCA1 mutation, in which the BRCA stands for BReast CAncer susceptibility, have a much higher risk of developing breast and ovarian cancer than those women without it.
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Myriad Genetics however ensured patents that innovation could be commercialized for everyone’s benefit. “It also opens up the conversation a bit more”, said Stacey Miller, a genetic counselor at the Ellis Fischel Cancer Center. Since the Statute of Monopolies is an English statute dating back to 1623, Australian courts have had to stretch the meaning of this phrase to keep up with technological developments.
“The High Court’s decision comes at a critical time when we’re entering the golden era of personalised medicine”, they continued.
The court decision in Australia is yet another setback for Myriad in its efforts to patent the gene. “But the court here is saying neither would be patentable”.
The concern about the potential “chilling effect” on research activities is surprising given that the Australian Parliament recently introduced a statutory defence to infringement for experimental research. Indeed, this was a point made by the special five member appeal bench of the Federal Court. The BRCA genes occur naturally in the human body and are responsible for creating proteins which help fix DNA. Holding [judgment summary, PDF] that allowing the gene to be patented would “involve an extension of the concept of a manner of manufacture”, the court said that this question was not “appropriate for judicial determination”.
“The testing will be a lot cheaper and it will be more available to them by more geneticists, rather than using only Myriad’s agents at a price that nobody really can afford, except for Angelina Jolie”, said D’Arcy. By patenting BRCA1, the company said it was insuring that research into the gene would be commercialised.
Another beneficiary of the screening, Mrs Godwin Ikechukwu, said: “I advise Nigerians both men and women to come out for the free training and get screened, she went further to say that she was glad to come and brought her children along”.
But the High Court unanimously decided today that the gene didn’t classify as having been “manufactured” – one of the requirements for patent law in Australia.
The judges also were concerned about the breadth of Myriad’s claims.
THOMAS ORITI: But why was it in Myriad’s interests to defend the patent?
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Experts stated the Australian choice might impression entry to genetic testing, medical analysis and coverings within the nation.
