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.
Why so?
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.
