IP Australia has invalidated its acceptance of a patent application listing controversial South Korean researcher Hwang Woo-Suk as an inventor, in a move believed to be unprecedented and outside the express provisions of the Patents Act 1990.
The patent application claims a human embryonic stem cell line produced by somatic cell nuclear transfer, the cloning technique used to produce Dolly the Sheep, and subsequent isolation of cloned human embryonic stem cells from the resulting embryo. Such cloned human embryonic stem cells have enormous therapeutic potential for treating human diseases, as the cells have the ability to differentiate into any cell type, and further, are an exact genetic match of the human donor, meaning that the usual problems with immune-mediated rejection of transplanted cells may be avoided.
Hwang's "ground breaking" research was included in a patent application, in the name of Seoul National University Industry Foundation, and then published in Science. The Science articles were later retracted when, infamously, the research was found to have been faked. The patent application nonetheless proceeded in a number of jurisdictions, including Australia.
There is no express provision in the Patents Act that permits the Commissioner of Patents to reject a patent application during examination on the basis of falsification of data or lack of usefulness; although lack of usefulness is a ground for opposition, and both are grounds for revocation. Hwang's patent application was found to comply with the usual requirements during examination, such as novelty, inventiveness, full description, fair basis, etc. Accordingly, following examination, IP Australia formally accepted the patent application, advertising acceptance on 12 June 2008.
In a highly unusual move, the Commissioner of Patents later deferred sealing of the patent beyond the prescribed period, that is, six months from the date of advertisement of acceptance. In an explanatory media release, the Acting Commissioner of Patents, Mr David Johnson, asserted that "IP Australia considered that information relating to the falsification of research results... related to issues of utility and not matter that could be objected to in examination".
IP Australia has since taken the unprecedented step of advertising that acceptance of the patent application was invalid and, consequently, is a nullity. Intriguingly, there is no express provision that permits the Commissioner of Patents to invalidate or withdraw acceptance of a patent application in the Patents Act. IP Australia has therefore sought to rely on aspects of administrative law.
Further, in apparent contradiction to IP Australia's media release, the Commissioner of Patents has stated that "the application would have been rejected had the Examiner known, at the time, of the fabrication". IP Australia have now issued a further adverse Examiner's report which includes objections that the specification does not "fully describe the invention", and that the claims are not "fairly based" on the specification, due to the specification relying on fabricated data.
Additionally, since the permitted period of time for gaining acceptance of the application has now expired, the application is presently in a state of lapse. It may, however, be possible for the applicants to obtain an extension of time for meeting this normally strict deadline, and thereby re-instate the application, given the unusual circumstances involved in the case.
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