Patent for BRCA1 ‘breast cancer gene’

Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 saw the Court consider whether claims to composition comprising naturally occurring DNA and RNA that has been isolated are for a manner of manufacture for purposes of s 18(1)(a) of Patents Act 1990 (Cth). Until now, there had been no Australian court decisions on the patentability of isolated DNA or RNA sequences.

The Court said that a composition of matter may be patentable if it consists of an artificial state of affairs, with some discernible effect, of economic utility and the result of some human intervention. Ultimately the Court decided that there was the necessary artificial state of affairs, explaining:

  • Earlier cases binding on the Court regarding similar issues had used expansive language.
  • In the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and isolated nucleic acid does not exist inside the cell.
  • It would lead to very odd results if a person whose skill and effort culminated in the isolation of an DNA sequence could not be independently rewarded by the grant of a patent

CNN reported the decision, noting that that the same gene along with BRCA2, is at the centre of a high-profile lawsuit set to be heard by the United States Supreme Court in April 2013.

A more detailed summary of this decision has been published by ‘The Conversation‘.

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