On Friday, 26 November 2010, the long-awaited report of the Senate Inquiry into gene patents was published.
The authors of the 190 page report make a number of comments and recommendations, many of which may have repercussions beyond gene patents.
The catalyst for the Senate Inquiry came when Genetic Technologies enforced its patent rights in Australia over the BRCA1 and BRCA2 genes. These genes are often referred to as the breast cancer genes, and if present in an individual, indicate an increased risk of developing breast cancer. The monopoly granted over these gene sequences in Australia is highly controversial.
Whilst the Committee did not recommend that the government expressly prohibit the patenting of gene sequences such as BRCA1 and BRCA2, it did make some interesting comments.
The Committee considered that “there is substantial doubt that IP Australia’s approach to the granting of patents over genes conforms with the general prohibition in law on the patenting of a discovery”. The Committee also rejected the reasoning that “genetic information that is ‘isolated’ from its naturally occurring state in the human body may be classed an an invention, and therefore properly be the subject of a patent…”
These comments are likely to well received by the legal team for Cancer Voices Australia and Ms Yvonne D’Arcy in the Australian breast cancer gene patent proceedings (which we have previously blogged about here and here).
In addition to its comments about the patenting of ‘mere discoveries’, the Committee also put forward potentially controversial recommendations aimed at improving patent quality and the operation of the patent system. These recommendations include various amendments to the Patents Act 1990, such as:
- an invention will be obvious if it was ‘obvious for the skilled person to try a suggested approach, alternative or method with a reasonable expectation of success’ (recommendation 6)
- common general knowledge not be limited to Australia (recommendation 7)
- removal of the requirement that prior art information be expected to be ascertained by the skilled person (recommendation 8)
- the introduction of descriptive support requirements, such that the whole scope of the claimed invention be enabled by the specification (recommendation 9)
- that an invention have a specific, substantial and credible use in order for it to satisfy the requirement of usefulness (recommendation 10)
Before these recommendations could be adopted, the implications for the patent system generally would need to be carefully considered.
