What is the object of patent law? Is it to promote technological innovation? To provide inventors with economic incentives to invent, by granting them a monopoly over that invention for a particular time? To let the public how a particular invention works, to promote further progress? Or a combination of all of the above?
In the complex area of gene patenting, these objects are interwoven with difficult questions of principle. Should a person be able to patent a human gene, or is that morally repugnant? On the other hand, are patents for genetic material necessary to provide sufficient incentives for important medical research?
These are two questions that have been asked and will be considered as part of the latest IP consultation, IP Australia’s “Consultation on an objects clause and an exclusion from patentability” (the consultation paper can be found here). The consultation specifically considers two out of a number of recommendations of the 2010 Advisory Council on Intellectual Property (ACIP) 2010 report, “Patentable subject matter” (see our previous posts here and here).
An object clause for the Patents Act
The first recommendation of ACIP that the consultation will consider is whether an “objects clause” should be introduced into the Patents Act.
IP Australia has proposed alternative wording to the ACIP proposal, which is intended to address the interests of patent applicants and the way in which the patent system promotes innovation and the dissemination of technology:
[T]he purpose of the patent system is to provide an environment that enhances the well-being of Australians by promoting innovation and the dissemination of technology and by balancing the competing interests of patent applicants and patent owners, the users of technology, and Australian society as a whole.
The objects clause could be used to assist interpretation of the Patents Act where there is ambiguity or uncertainty.
A patentability exclusion?
“Patentability” refers to whether or not a patent may be granted for an invention and usually refers to the conditions that a valid patent must meet (such as novelty, inventive step etc).
The second recommendation of ACIP that the consultation will consider is whether to replace s 50 of the Patents Act with an express exclusion from patentability. Section 50 currently excludes from patentability inventions that are contrary to law or relates to a substance that may be used as a food or medicine. The proposed exclusion is of “an invention the commercial exploitation of which would be wholly offensive to the ordinary reasonable and fully informed member of the public.”
Here, there is a threshold issue about whether patent examiners should be required to determine ethical considerations, something which has not technically formed part of their brief to date. Whether or not it is appropriate for examiners to decide whether or not a particular invention is offensive to the Australian public will form part of an interesting debate. In recommending that this exclusion be introduced, ACIP sought to deal with this issue by also proposing that the Commissioner of Patents be empowered to seek advice, as well as given the discretion to decide the most appropriate way to seek that advice.
The patentability of genes is currently a hot topic in patent law across the world. The consultation follows two important recent cases on gene patenting:
- The Cancer Voices case in Australia, in which Nicholas J found that isolated genetic material (DNA and RNA) was patentable (see our previous post here). An appeal from this decision will shortly be heard by the Full Federal Court (on 7 and 8 of August with a 5 judge panel).
- The US Supreme Court’s decision in Myriad Genetics that naturally occurring DNA is not patentable by virtue of being isolated (see our previous post here).
Submissions to IP Australia on these topics close on 27 September 2013.
We expect to hear a lot more in the gene patenting space this year.