Myriad of claims imperilled following US ruling on breast cancer gene patent

A US district judge has ruled that patents directed to the detection of inheritable breast cancer are invalid, on the basis that the invention was directed towards a law of nature.  The patents were in the name of Myriad Genetics, Inc and were challenged by the American Civil Liberties Union and other advocacy groups. We blogged on the case earlier this year.

The patents covered a genetic testing procedure to identify mutations which can lead to the development of breast cancer, including claims to isolated gene sequences and claims to a method of comparing the gene sequences to detect mutations.  Both sets of claims were found to be invalid. In the case of the claims to gene sequences, Justice Sweet found that isolated DNA did not acquire any special characteristics due to its isolation.  Rather, it remained a product of nature and hence inherently not patentable under US law.  The process claims were struck out as they referred to analysing or comparing gene sequences in order to identify mutations.  The judge found that was in fact claimed were only ‘mental processes independent of any physical transformations’.

The decision will have a financial impact on Myriad, which has been charging approximately US $3,000 per test.  It should be kept in mind, however, that the decision was from a judge of the District Court, and commentators believe it is likely to be appealed.

Impact on Australia

In Australia, patents cannot be obtained for mere discoveries.  However, the pure and isolated form of a substance found in nature, including a genetic sequence, can be patented, provided the other criteria for validity are met.  Whether this policy is correct has been the subject of much discussion, and has led to the ongoing Inquiry into Gene Patents by the Senate Community Affairs Committee. In its submission to the Inquiry, the Australian Law Reform Commission made the following statement:

we are faced with the hard and inconvenient fact that since the 1980s — in Australia and internationally — many tens of thousands of patents have been granted on genetic sequences, provided they have been isolated from their natural state and otherwise satisfy the statutory requirements for patentability…  [F]aced with the practicalities of the contemporary situation, the ALRC concluded in 2004 that if there had been a time to recommend that gene sequences should not be patentable, that time had long since passed.

Clearly, if the decision of Justice Sweet is upheld in the US, this will feed into the debate in Australia on the policy underlying gene patents.

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