Possible Options for Reform
Any reform options for the Patents Act will be required to balance the following factors:
- Ethical and environmental concerns about the patenting of biotechnological inventions.
- Growth and innovation in the biotechnology sector, particularly in the area of life saving medical and disease treatment, for which patents are likely to be wanted.
- The inherent limitations of the Patents Act in addressing the wider ethical and environmental issues in relation to the development and use of biotechnological inventions.
- The need for any legislative reforms to be sufficiently flexible to meet potential future developments.
Some general options for the reform of the Patents Act are listed below.
TO RETAIN THE EXCEPTION RELATING TO 'INVENTIONS WHICH ARE CONTRARY TO MORALITY' CURRENTLY IN PLACE IN THE PATENTS ACT
As discussed previously, the TRIPS Agreement, to which New Zealand is a signatory, does permit exceptions for inventions which are thought to be contrary to morality. It would not therefore be inconsistent with TRIPS to retain this provision.
The contrary to morality exception is one which, has been relatively untested in New Zealand, with no instances of its application in respect to the patenting of life forms. Essentially this means that despite the limited judicial guidance available in this area, there is nothing about the provision that can be pointed to as being problematic.
TO REMOVE THE EXCEPTION RELATING TO 'INVENTIONS WHICH ARE CONTRARY TO MORALITY' CURRENTLY IN PLACE IN THE PATENTS ACT
Based on past use of this provision, it is likely that its application to general ethical and environmental concerns would be limited. Additionally, with the possible exception of concerns about the patentability of human beings, it seems unlikely that this provision could be effectively used to meet Maori concerns.
As discussed previously, there are questions as to whether it is appropriate that the Commissioner of Patents should be required to make decisions about whether or not an invention is 'contrary to morality', and there are suggestions that determining such ethical questions essentially falls outside this role.
For these reasons it may be appropriate not to retain this exception to the Patents Act.
TO ENACT A SPECIFIC EXCEPTION TO PATENTABILITY FOR HUMAN BEINGS IN THE PATENTS ACT
Presently the Intellectual Property Office has a practice of excluding human beings from patentability on the basis that human beings cannot be regarded as a "manner of manufacture" and therefore do not fall within the definition of invention contained in the Patents Act.
In 1992, the Ministry of Commerce proposed to remove the definition of invention from the Patents Act. If the exception for inventions contrary to morality is also removed from the Patents Act, there will no longer be any provision granting statutory authority for the Intellectual Property Office to refuse patents for human beings.
In this case it would seem desirable to enact a specific exception to patentability for human beings, possibly similar to the one operating in the Australian Patents Act.
Such an exception prohibiting the patenting of human beings, could also be enacted in addition to the existing contrary to morality exception. A definition of what constitutes a "human being" may need to be included to clarify the situations in which inventions will be considered to be for a "human being".
Issues that might need to be addressed by such a definition may include the stage of development, i.e. conception, pre-embryonic, or embryonic at which a human being is considered to exist and whether parts of human bodies are patentable. This could give rise to other considerations, including what should be defined as a part of a human body (for example, whether it includes organs, but not cells and cells lines).
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