Researchers will be the big winners if changes to the Patents Act successfully pass through both houses of Parliament.
Arguably, the most significant changes proposed by the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (Bill) relate to the Patents Act. The Explanatory Memorandum to this Bill states that the changes have been proposed in order to raise the quality of granted patents and provide free access to patented inventions for research and regulatory activities.
The proposed changes have grown from criticism that:
- the thresholds set for the grant of a patent in Australia are too low, thereby suppressing competition and discouraging follow on innovation
- there is currently no statutory provision clarifying a researcher's freedom to conduct experiments and there is uncertainty about the scope of any existing common law protection.
The Bill amends the Patents Act to address four key areas of patentability.
First, the Bill removes restrictions on the information and background knowledge taken into account when assessing whether an application is sufficiently inventive to justify a patent. In particular, some of the amendments proposed include:
- Currently, common general knowledge for inventive step is restricted to what is known in Australia. The Bill removes that restriction.
- The Bill also removes the requirement that prior art for the purposes of assessing the inventive step of an invention is restricted to only that information that would be 'ascertained, understood and regarded as relevant' by a skilled person in the art. Under the Bill, inventive step will be assessed against all information available to the public at the priority date of the patent.
Secondly, the amendments bolster the requirement that the patented invention be useful. This addresses the concern that in some fields the uses claimed are often speculative and that the current definition does not effectively prevent claiming such speculative inventions. To this end, the Bill amends the definition of useful to require that the specification discloses a 'specific, substantial and credible' use for the claimed invention. This definition accords more closely with the meaning of 'useful' in US patent law.
Thirdly, the Bill raises the standards for disclosure of an invention. The amendments address circumstances where the information disclosed in a patent specification, although sufficient to make one thing within the scope of each claim, is not sufficient to make the invention across the full scope of each claim. The changes ensure that granted patents are no broader than the invention that has been disclosed. In particular, some of the amendments proposed include:
- The Bill requires that a provisional specification discloses the invention in a manner that is clear and complete enough for the invention to be performed by a person skilled in the relevant art. Currently, a provisional application needs only to describe the invention generally in its rough state, and does not need to enter into all the minute details as to the manner in which the invention is to be carried out.
- Currently, the requirement to fully describe an invention pursuant to section 40(2)(a) of the Patents Act is met if the applicant discloses enough to enable the person reading the specification to produce something within each claim. This is despite the fact that multiple examples or embodiments of the invention may be claimed. The Bill amends the Patent Act to require enablement across the full scope of the claim. In this respect, the wording of the Bill reflects UK patent legislation and the European Patents Convention.
Fourthly, the Bill increases certainty in the validity of granted patents by expanding the grounds that the Commissioner can consider when deciding whether to grant a patent. Under the Bill, the circumstances in which the Commissioner can refuse to grant a patent are the same as those grounds on which a Court can subsequently find a patent invalid.
As currently proposed, the new provisions that relate to inventive step, usefulness and disclosure in complete specifications will apply to applications and patents where the Commissioner has not yet reported on whether the application meets the substantive requirements of the Patents Act. Somewhat controversially, this means that applications filed under the existing Act, and even applications upon which an examination request has been filed, will be subject to the new provisions unless an examination report has issued by commencement of the new Act.
In relation to changes to the disclosure requirement of a provisional application, this new provision will apply to provisional applications filed on or after the day of commencement.
The Bill amends the Patents Act to distinguish between research and commercial activities, leaving researchers free to conduct experiments without worrying about whether they are infringing a patent. Further, the Bill also expands the existing exemption for activities undertaken solely for the purposes of gaining regulatory approval to market or manufacture, which is currently limited to pharmaceuticals inventions, to all technologies.
These new provisions will apply to any acts done after the date of commencement of the Bill.
Where to from here?
It is clear that the big winners under the proposed amendments are researchers.
However, what is less clear is the effect the proposed amendments will have in relation to patentability. This is particularly so given that patents filed by life sciences companies are often drafted in the global context and therefore often conform to the highest standards of patentability, whether that be pursuant to UK or US legislation.
What is clear, however, is that there is a general trend for patents to be litigated in the last few years of the patent term. In light of this trend and the transitional provisions that apply to patentability, it may be some time before the real effects of these amendments become clear.
We will continue to keep you updated in relation to any progress with this Bill.
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