Women with a mutated BRCA-1 or BRCA-2 gene have a higher risk of developing breast cancer and ovarian cancer.
Myriad Genetics Inc had isolated the BRCA-1 gene with certain mutations and claimed a patent which would give it a monopoly over the right to manufacture the resulting product for cancer treatment. It could control all testing in relation to the mutations, including the price of such testing.
In a decision with major implications, the High Court has ruled Myriad's patent invalid.
The major factor in the case was whether the 'invention' constituted a 'manner of manufacture', a key requirement for patentability.
The best way to think about ‘manner of manufacture’ is that an invention must be tangible. It can’t be a theory, or an idea. The Court said that it is something that needs to be made; something which is brought about by human action. It can’t be something which already exists in nature.
Essentially, the Court found that the BRCA-1 gene mutations were not patentable because, although the discovery was the product of human action, the gene and its mutations themselves are naturally occurring phenomena, which had been discerned rather than “made” by human action.
In coming to this finding the Court also expressed concerns about patenting gene mutations, as it would have the likely effect of preventing others from doing similar research in respect of the BRCA-1 gene.
What does it mean?
Companies like Myriad pile in loads of money and resources to make these discoveries, with the reward in sight that they will be able to exclusively exploit them for the life of the patent.
Some argue that the decision will discourage research, discovery and initiative, which can only be bad for the advancement of medicine and treatment of disease.
That may be right, to some extent at least. Drug companies are in business to make a profit; curing disease is not their driving purpose. They won't prioritise research in fields where they can't make money, and patents provide the pay-day. However, does it make sense that they should be able to gain a legal monopoly over a part of the human body, because otherwise they won't bother discovering it? Doesn’t make sense to us nor, we're happy to say, the High Court.
It's also important to remember that identifying the gene mutation is just the discovery part. The real scientific effort, and the potential for genuinely valid patents, lies in working out how to use that discovery to treat or cure the disease. The drive for that outcome is unaffected by this court case.