The Advisory Council of Intellectual Property (ACIP), an independent body appointed by the Australian Government to advise the relevant Minister on IP issues, is currently conducting a review into Patentable Subject Matter. This is a topical issue at the moment in the area of biotechnology, for example, as it involves stem cell research and patenting of genetic material.
In Australia, the test to determine whether an invention constitutes patentable subject matter includes whether the invention is a ‘manner of manufacture’ and which is not ‘generally inconvenient’. In a 2004 review, the Australian Law Reform Commission (ALRC) “recognised the value of a flexible test for patentable subject matter, but found that the manner of manufacture test was ambiguous and obscure” particularly the meaning of the phrase ‘generally inconvenient’. The ALRC concluded their review by recommending that the ‘manner of manufacture’ test be reviewed.
On that basis, the Minister for Innovation, Industry, Science and Research requested that ACIP conduct a review of patentable subject matter, including the “appropriateness of the 'manner of manufacture' test as the threshold requirement for patentable subject matter and the historical requirement that an invention must not be 'generally inconvenient'”.
As a first step, ACIP has released an Issues Paper (which can be found as a link at the website below) to provoke discussion and invite submissions from interested parties. The Paper focuses on three main areas of the test, which are:
- its breadth and whether it allows patents in unsuitable subject matters;
- whether it is too flexible and unpredictable, and
- whether its structure and wording is confusing.
In the Paper, ACIP recognises that some in the community have a concern regarding the subject matter that can be patented. One perception was that “patents are being granted which hinder innovation, investment and public access to new technologies, rather than promote such activities”. ACIP noted that would have implications in various areas of technology, including software, business methods, medical treatments and biological and genetic materials.
With regard to medical treatments and biological materials, the Issues Paper notes that some see the patenting of such subject matter as restricting access to the best available medical care and states that “it has been argued that biological and genetic materials should not be patented because the power this gives patent owners is out of proportion with the contribution they provide to society, or that it is immoral for some to have a degree of ‘ownership’ over other life forms”.
From a historical perspective, the seminal Australian court case on what constitutes patentable subject matter was the 1959 High Court decision of National Research Development Corporation v Commissioner of Patents (NRDC). The Paper recognises NRDC as a landmark case which led to a complete rethinking of the historical categories of unpatentable subject matter and of pre-existing and newly emerging technologies. In the Paper, ACIP lists several examples of subject matter that the courts considered, post-NRDC, to be patentable, such as methods of treating humans, living organisms, and genetic material where the claimed matter had some use or commercial application.
The Paper further discusses patentable subject matter in the general context of “a manner of manufacture” and considers that a new product or process for which a practical, technical application has been identified is patentable subject matter. The Paper includes examples of how this principle is applied in practice. In the biotechnology area, such matter may include:
- a micro-organism, protein, enantiomer or antibiotic in its isolated form;
- a recombinant, isolated or purified gene;
- a gene per se, provided the claim does not include within its scope the native chromosome of which the gene forms part.
In light of the above, the Paper highlights subject matter (particularly as it relates to stem cell work) that is currently excluded from patenting in Australia, including:
- fertilised human ova and equivalents, zygotes, blastocysts, embryos, fetuses and totipotent human cells;
- methods of in vitro fertilisation, sperm injection, cloning, growing fertilised ova, introducing transgenes and donor genetic cytoplasmic material into fertilised ova, and methods of obtaining embryonic stem cells which include making an embryo.
Notably, the Australian Patents Act 1990 includes a general provision prohibiting patents for inventions that are “contrary to law” and explicitly states that human beings and biological processes for their generation are not patentable.
The Paper also provides some examples of subject matter that would be currently allowed in Australia including processes for:
- cryopreservation of gametes;
- preimplantation genetic analysis of gametes, and
- determining the developmental progress or viability of a fertilised ovum, blastocyst or embryo, by analysis of culture or incubation media.
ACIP is asking for written submissions from any interested parties by 19 September 2008 particularly in answer to specific questions posed in the Paper, including:
Question 1 – Economic objectives of limiting patentable subject matter
Can placing limits on inherently patentable subject matter be justified on economic grounds? Should the subject matter of each individual invention be assessed to determine whether a patent is necessary to encourage innovation, or should such an assessment be done for entire fields of technology?
Question 3 – Ethical reasons for limiting patentable subject matter
Can placing limits on inherently patentable subject matter be justified on ethical grounds? Is it appropriate for legislation to predetermine ethical limitations on patentable subject matter, or is it more appropriate for courts to determine such limitations on a case-by-case basis? Is patent law an appropriate avenue for dealing with ethical issues? If not, what is an appropriate avenue?
Question 4 – Ethical effect of inherent patentability test.
What would be the ethical consequences of imposing or removing limits on patentable subject matter? Are you aware of any examples of such consequences?
A complete copy of the Issues Paper can be accessed through the website below, which also includes details on making submissions to ACIP. After receipt of the written submissions, ACIP may engage interested parties through “round table” or one-on-one discussions later this year to assist in the preparation of the review.
We will report again when the review is released.
Source: http://www.acip.gov.au/reviews.html#subject
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