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
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
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.
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The Ugg boots case revolves around who holds the trade mark rights to the word 'Ugg' in relation to sheepskin boots.
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