Historically, and certainly from a European or US perspective, Australia has been regarded as a comparatively “easy” jurisdiction in which to obtain patent claims of relatively broad scope. Two principle reasons accounted for this: the relatively low threshold for establishing non-obviousness and the applicant friendly disclosure (enablement) and support (“fair basis”) requirements.
However, following the introduction of the Intellectual Property Laws Amendment (Raising the Bar) Act changes made to the disclosure and support requirements have had a significant effect on allowable claim scope, particularly in the chemical and life sciences sector. Inconsistent examination practice and lack of judicial guidance has made it difficult to determine with any degree of certainty what claim scope may be allowable. Furthermore, comparison of recent examination practices between Australia, the US and Europe has revealed instances where disclosure and support objections were raised in Australia, but not for equivalent claims in Europe or the US.
The disclosure requirement imposes on applicants to teach the skilled reader how to put an invention into practice. Under “old” Australian law (prior to 15 April 2013) it was well established that there was no requirement for a claim to be enabled over its full scope. An applicant might therefore fulfill the disclosure requirement, and obtain relatively broad claims, by teaching the skilled person only one way of practicing an invention.
The support requirement dictates how broadly the applicant may claim an invention. Under the “old” law support was handled through the concept of “fair basis”. To fulfill this requirement it was generally enough for there to be consistency between the claims and the description.
The Intellectual Property Laws Amendment (Raising the Bar) Act introduced a number of changes to the Australian patent legislation with the intent of raising the standard required for grant of a patent and to bring Australia’s patent laws into line with those of its major trading partners. The Raising the Bar Act applies to all patent applications for which a request for examination was filed on or after 15 April 2013.
The Explanatory Memorandum for the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 notes:
“the difference in substantive law in different countries causes unnecessary complexity and uncertainty for applicants seeking protection in Australia and other jurisdictions………having such different standards in different countries imposes costs on global innovators, who must familiarize themselves with the varying requirements”.
The Raising the Bar Act introduced the requirement that the description “disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art” (Complete Description Requirement).
In addition, the requirement that the claims be “fairly based” on the description was replaced with a requirement that the claims be “supported by” the description (Support Requirement).
This requirement was intended to align the disclosure requirement with that applying in other jurisdictions with the effect that sufficient information must be provided to enable the whole width of the claimed invention to be performed by the skilled person without undue burden, or the need for further invention.
The Explanatory Memorandum notes:
“The item is intended to modify the wording of paragraph 40(2)(a) of the Act so as to require enablement across the full width of the claims, while adopting language that is consistent with that used in other jurisdictions. The wording in the amendment is similar to s 14(3) of the UK patents legislation, which has been interpreted as imposing this requirement. The wording is also similar to art 83 of the European Patent Convention, which has been interpreted with similar effect. The intention is that paragraph 40(2)(a) be given, as close as is practicable, the same effect as the corresponding provisions of UK legislation and the European Patent Convention”.
The Memorandum further notes that a specification that provides a single example of the invention may satisfy the requirements, but only where the skilled person can extend the teaching of the specification to produce the invention across the full width of the claims, without undue burden, or the need for further invention. However, the Memorandum indicates it would be more likely that, where the claims are broad, the specification will need to give a number of examples or describe alternative embodiments or variations extending over the full scope of the claims.
The Explanatory Memorandum notes:
“Overseas law generally requires there to be a relationship between the claims and the description, and between the claims and any document from which priority is being claimed. This is expressed by the requirement that a claim be ‘supported by’ or ‘fully supported by’ the description. Broadly speaking, the terms ‘support’ and ‘full support’ pick up two concepts:
Despite the underlying concept and policy between fair basis and support being similar, the different terminology has produced different substantive law in different countries”.
The Explanatory Memorandum further notes that this item is intended to align the Australian requirement with overseas jurisdictions’ requirements (such as the UK).
Based on the Explanatory Memorandum it would be expected that a more European approach to disclosure and support requirements would be adopted in Australia.
So, since Raising the Bar how have the new requirements been handled at the examination stage? Is it more difficult to obtain a patent with broad claims in Australia?
The answer is an unequivocal, yes. Objections for lack of support and complete description are now relatively commonplace in Australian examination reports, particularly in the chemical and life sciences. However, such objections are spuriously applied, to the extent that it is difficult to predict with any degree of certainty what constitutes an allowable claim scope.
Further, a review of recent Australian examination practice has revealed instances where claims have been found to lack support even where identical claims in the United States and Europe have suffered no such objection.
One area of particular concern is the handling of claims to Markush chemical structures and to therapeutic methods based on such structures. Severe limitations may be imposed to the scope of the claims particularly, for example, if disclosure is lacking as to nature of possible substituents or a narrow range of examples are included. This can have a significant effect on the scope of allowable claims.
It is a well recognized practice of Australian examiners to consult the publicly available prosecution histories of corresponding US and European applications and to apply findings therein to Australian applications. In the cases reviewed, such consultation had clearly occurred, yet objections for lack of support were raised by the Australian examiners.
While it is recognized that some degree of examiner subjectivity may be applied, it is curious that such disparity exists given the background drive to align the disclosure and support requirements with overseas jurisdictions’ requirements, so as to provide more certainty to applicants. Perhaps Australian examiners have become a little over zealous in their interpretation of the new law. However, current practice is unlikely to change until further guidance is available from Patent Office opposition decisions or Court decisions.
For European applicants filing into Australia it is likely that, for the most part, they should expect matters of sufficiency to be handled in a somewhat similar fashion to Europe. However, for US applicants there will be instances where even issued US claims will be found to lack support in Australia.
This is significant for those applicants perhaps contemplating GPPH applications based on an issued US patent. Such claims may be scrutinized by the Australian examiner in terms of support and may be objected to. However, in the first instance, we recommend arguing that claims are supported where there is at least some basis to do so and particularly where claims of similar scope have been allowed in Europe or the United States. In relation to Markush chemical structures we recommend including detailed disclosure as to preferred substituents and avoiding terms such as “optionally substituted” in the claims, where the options are not specifically defined in the description.
The clear tightening of the disclosure and support requirements for Australian patent grant comes at a time when the government is again reviewing the requirements for securing an Australian Patent. It seems that, at least, there ought to be some reasonable period of reflection where the Raising the Bar changes are given their chance to percolate through the system. This may take quite a number of years but that is the time scale that such evaluations require. Tinkering with the system every 2 or 3 years will simply create further confusion.
However, whatever the future holds, it has clearly become significantly more difficult to obtain a patent of broad scope in Australia and in some cases the allowable scope may be less than that allowed in Europe and, in particular, the US.
By Dr Grant Jacobsen
Contact Grant: email@example.com