The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 constitutes the most extensive change to Australian patent law and procedure in the last 20 years. This new law, which came into full effect on April 15 2013, has far reaching consequences. It effectively establishes a class of “new law” patents to which higher validity standards apply, while the relatively lower validity pre-amendment standards will continue to apply to the “old law” class of patents.
There are now also important consequences regarding exemption from infringement with the codification of experimental use exemptions and a broadening of previous exemptions to cover acts connected with getting required regulatory approval. Many of these changes are intended to bring Australia’s patent system in line with global practices.
The new law increases the requirements for a valid patent specification by introducing new written description and enablement standards. The patent specification must “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”.
This language comes directly from the corresponding United Kingdom law. It is clear that the intention is to align disclosure requirements with those in the UK and other jurisdictions. To meet this requirement, the disclosure in the specification should enable the claimed invention to be performed across the full scope of each claim.
On the other hand, the requirement for an applicant to disclose the best method of performing the invention remains unchanged. Under the new law, a similar enablement requirement also applies to provisional specifications. However, there remains no need to describe the best method of performing the invention in a provisional specification.
Another important change is the limitation of amendments. Applicants are no longer allowed to amend the specification so as to add new matter that goes beyond the disclosure contained in the specification at its filing date, except to correct a clerical error or obvious mistake. Applications under the new law will be assessed on grounds that have not yet been tested in Australian courts. Although it is intended that the new grounds will be applied in the same manner as in the UK, it will take some time for disputes under the new law to reach the courts to clarify how these provisions will be interpreted.
That said, given the tendency of Australian patent examiners to follow the prosecution of foreign counterpart applications in the US and Europe, it is likely that practice before the Australian Patent Office should be more certain: if there is a problem in Europe on enablement for a given claim, one should reasonably expect the same problem in Australia.
Tougher obviousness standards
The new law also increases the requirements for a patentable invention by expanding the prior art base and the common general knowledge relevant to testing obviousness. Like the other changes regarding validity, this will bring Australia’s obviousness requirements in line with other patent systems. Consequently, Australian claims will likely bear greater resemblance to the scope of the claims of foreign counterparts.
For patents filed under the new law, there are two important changes with regard to obviousness. First, the new law removes the limitation that the prior art be “ascertained, understood and regarded as relevant” by the person skilled in the art. A skilled person will be deemed to be aware of all publicly available prior art information. However, we expect that the courts will continue to assess the weight to be attributed to prior art information depending on the degree to which the skilled person would appreciate the relevance of the prior art to the problem being addressed. Second, the new law removes the geographical restriction on common general knowledge (CGK) to what was known in Australia. Under the old law, the lower local CGK standard may have led to a granted patent in Australia where protection was not available in other jurisdictions due to lack of inventiveness. That geographical limitation also tended to limit the parties to evidence from Australian experts, which could be problematic in some cases.
On its face, the “whether in or out of” Australia wording of the new law on CGK raises a number of interesting questions:
- Is it acceptable to rely on the CGK of a person skilled in the art outside Australia if that CGK is not also the CGK of an Australian skilled person?
- If non-Australian CGK is acceptable, must the knowledge be common to persons skilled in the art in just one, some, or all jurisdictions outside Australia?
- Must the CGK be common to all persons skilled in the art, regardless of geographical location?
The intention behind this expansion reflected in the external legislative materials appears to answer the last of the above questions in the affirmative. Practically, as with many aspects of patent law, where there is a contest on the evidence as to the appropriate CGK, the Patent Office or a court is likely to resolve the contest by weighing the evidence.
It seems reasonable to expect that Australian applicants will find obviousness more challenging. That said, the Patent Office’s practice of relying on the prosecution history of corresponding US and European patent applications may result in there being limited real change in this regard. The real impact of the new law is likely to be felt more in opposition and revocation proceedings.
Raising the Bar increases the usefulness requirements for a patentable invention, though this should only have application to patent claims that define inventions that are speculative with regard to possible use. According to the new law, an invention is to be taken not to be useful unless a specific, substantial and credible use for the claimed invention is disclosed in the complete specification. This can take the form of an explicit disclosure or, if the skilled person could appreciate the use with their background knowledge in the art and without undue burden, then the disclosure need not be explicit.
Furthermore, the disclosure in the complete specification must be sufficient for that specific, substantial and credible use to be appreciated by a person skilled in the relevant art. The relevant external legislative materials consider the following interpretations given by the US courts as appropriate:
- “Specific” means a use specific to the subject matter claimed and can provide a well-defined and particular benefit to the public.
- “Substantial” means the claimed invention does not require further research to identify or reasonably confirm a real world use. According to the materials: “An application must show that an invention is useful to the public as disclosed in its current form, not that it prove useful at some future date after further research”.
- An asserted use will be credible “unless there is evidence that the invention is inoperative (does not operate to produce the results claimed by the patent application) or there is reason to doubt the objective truth of the statements in the specification”.
It is expected that this new law will not have a significant impact on the majority of patent applications and how they are drafted. The amendments will show their usefulness by eradicating the claiming of speculative inventions, thereby strengthening the requirement that patented inventions are useful.
While the new law does not apply to old law patents, it is important to remember that both new and old law patents are subject to the requirement that they have utility - that the claims actually achieve what is promised by the patentee in the specification. The Australian courts have been quite clear that where a single claimed embodiment does not meet this requirement, the relevant claim is likely invalid.
The Act also introduces a number of exceptions to infringement related to seeking regulatory approval and experimental use. Unlike the bulk of the Act which came into force this year, both of these exceptions came into effect on April 15 2012.
Obtaining regulatory approval
Under the new law, acts done solely for purposes connected with obtaining regulatory approval of a relevant product are now exempted from patent infringement. The exemption applies to acts done in relation to agrochemicals, veterinarian medicines, medical devices, diagnostics and any other non-pharmaceutical subject matter for which there is a legally established regulatory approval regime. This amendment significantly broadens the previous narrow exemption that applied only to acts connected with obtaining regulatory approval of a pharmaceutical.
Prior to the enactment of the new law, Australian manufacturers were at a disadvantage to their competitors with operations in other countries that allow springboarding (undertaking infringing acts required for regulatory approval of a non-pharmaceutical product before patent expiry). Now, acts done solely for purposes connected with obtaining regulatory approval can take advantage of this new exemption.
The new law is not prescriptive of what acts would be exempted, although it is clear that the acts done must be solely for purposes connected with obtaining a regulatory approval required by law. The exemption then is unlikely to extend to acts undertaken for one or more purposes in addition to regulatory approval, even if those other purposes are ancillary to a core purpose of regulatory approval.
Experimental use exemption
Under the new law, acts done for experimental purposes relating to the subject matter of the invention are exempted from infringement. Experimental purposes relating to the subject matter of an invention include:
- determining the properties of the invention;
- determining the scope of a claim of the patent;
- improving or modifying the invention;
- determining the validity of the patent or of a claim; and
- determining whether the patent would be, or has been, infringed by the doing of an act.
There is no need for the experimenter to have knowledge of the patent to use the exemption, so there is no requirement to conduct patent searches before starting an experiment.
Under the old law there was no legislative provision that exempted acts done for experimental purposes relating to the subject matter of a claimed invention, and the common law that applied was uncertain. In this context, the exemption is perhaps a welcome introduction into Australian patent law and provides some certainty to researchers.
Interestingly, unlike the regulatory approval exemption, the research exemption is not limited to acts undertaken solely for experimental purposes. The intention is that the research exemption will apply where acts are undertaken for the predominant purpose of gaining new knowledge. This reflects the reality that research is frequently undertaken for mixed purposes.
However, research undertaken for predominantly commercial purposes, for example market research to test commercial demand for a product, does not fall within this exemption. The exemption is also not intended to apply to experimentation using patented research tools, that is, a tool used to facilitate an experiment rather than being the subject matter of the experiment.
A new era
Raising the Bar ushers in a new era in patent law and practice in Australia. The procedural changes are already being felt with new shorter deadlines coming into play for applications and oppositions. However, it will take around four years for the last of the old law applications to be accepted by the patent office (or finally lapse). Until then, applicants and practitioners prosecuting patent applications will have to operate under both sets of laws.
It will likely be some years beyond this before the Australian courts will have an opportunity to determine how high the bar has been raised by interpreting the substantive law changes, particularly those in relation to validity. In the meantime, prosecuting patent applications and advising on the validity and infringement of new law cases will be fraught with uncertainty.