In a recent media release IP Australia announced the official lapse of Australian patent application 2004309300. The application relates to a human embryonic stem cell line generated by the process of somatic cell nuclear transfer, and the applicant is Seoul National University Industry Foundation.
This is not the first time that this application has been the subject of a media release by IP Australia. In late 2008 IP Australia announced that, despite the application having met the examination requirements, which resulted in the application being accepted, and despite no oppositions being filed in the prescribed opposition period, a 'bar to sealing' had been placed on the application until further notice. In other words, despite the application meeting the requirements for grant of a patent, the patent office was preventing its progress to this end. Why?
The application has a controversial history. One of the named inventors notoriously falsified a number of experimental results and this false information appears in the patent specification. Consequently, there are grounds for considering that the patent specification does not disclose information which would bring about a workable result or teach a skilled person how to reproduce the claimed invention practically.
It is interesting to compare how other patent offices have dealt with the same issue.
The equivalent application in Europe (published as EP1711599) is undergoing examination. The European examiner objected to the majority of the claims as lacking sufficiency (Article 83 of the European Patent Convention). In other words, due to the reported issues concerning the false results, the patent specification would be insufficient to enable a skilled person to reproduce or carry out the invention as claimed. Hence, the European Patent Office has been able to utilise its examinable criterion of sufficiency to deal with the issue. Interestingly, the examiner has indicated that certain claims did not fall foul of the sufficiency issue and would be considered allowable for grant of a European patent, in the absence of any other objection being raised.
The equivalent application in the United States (published as US2007/243610) is also currently undergoing examination. Similarly to the European case, the US examiner relied upon a lack of enablement, as an examinable criterion, to object to the majority of the claims. Again, however, the examiner did not raise lack of enablement against all the claims; although obviousness objections have been raised against the other claims.
In terms of the validity of the Australian application, this raises the question of whether the application lacks utility (ie, there is no disclosure of a useful or workable teaching) or whether there has been fraudulent conduct before the patent office. Australian patent law does not provide an express enablement criterion. However, as a rule of thumb, claims lacking enablement can be marked as having a lack of utility.
The problem faced by IP Australia is that these particular issues of invalidity are beyond the considerations required for examination. Although utility was introduced as a ground of opposition following the adoption of the Australia-US Free Trade Agreement, it is unclear how it can be brought to bear on an application in the absence of an opposition.
Clearly, the official granting and sealing of a patent having real invalidity issues could be an embarrassment for IP Australia.
According to the latest media release, IP Australia revoked the official acceptance, re-opened examination and issued an adverse examination report. Given that the legislated timeframe for bringing an application into acceptance had passed, this allowed the patent office to lapse the application officially.
However, under what legislated powers was IP Australia able to revoke the acceptance and what examinable grounds were used to issue an adverse examination report?
Such powers do not appear to come from any express wording used in the Patents Act. Perhaps the powers derive not from the wording, but from the intent of the act. Does IP Australia have some purposive right to maintain the integrity of the patent register? If so, were the actions undertaken just for meeting such a purpose?
The prosecution histories of the European and US cases suggest that not all the claims lack enablement or sufficiency. In fact, the European examiner went so far as to indicate that certain claims may be patentable. In view of this, perhaps the application should not be so readily dismissed. Surely a patent applicant should not be denied or unfairly hindered from viably amending and claiming patentable rights.
While the media release highlighted that the applicant may have the available option of requesting an extension of time to attempt to deal with the adverse report, to do so effectively would incur cost and place an onus upon the applicant to justify the extension. Is this a fair hindrance?
Unless IP Australia’s actions are challenged by the applicant we may never know whether IP Australia controversially exceeded its powers or acted unjustly. Whatever the right answer, it is hard to deny that there is a public expectation that IP Australia should be empowered to deny the grant of patent rights to a claimed invention that is clearly invalid. It is perceived that the test for utility is an impractical one to apply to the patent specification in isolation. The test requires exposure to the practical implementations of the invention as described, or regard to evidence of the actual working of the claimed invention. Ordinarily, patent examiners would have no access to the relevant information to consider the test properly. However, the present case has exposed an exception.
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This article first appeared in IAM magazine. For further information please visit www.iam-magazine.com