Executive Summary
2. In October 2003 officials from the Ministry of Health and MED, in consultation with MAF, MoRST, MFAT and Te Puni KÅkiri were directed to report back to POL with recommendations on the issues and options for addressing genetic material patents (POL Min (03) 26/5).
3. A previous Cabinet paper (POL Min (03) 26/5) noted that the Patents Act 1953 is currently under review and that the issue of patents over genetic material had not been specifically addressed to date in that review. The paper also noted the increasing concern both in New Zealand and internationally that patents over genetic material may be overly broad, and that this may have negative implications for research and innovation, health care costs and access to health care. Furthermore, it was noted that many people have moral and cultural objections to the patenting of genetic material.
4. This paper outlines a number of options for addressing the concerns expressed regarding genetic material patents. Any changes to New Zealand's policy on the patenting of genetic material would need to consider impacts on the research environment and other fields of technology. The changes would also need to be consistent with New Zealand's international obligations in particular the World Trade Organization (WTO) Agreement on Trade Related Intellectual Property Rights (TRIPS).
5. While there are a number of concerns raised by patents on genetic material we do not recommend the exclusion of genetic material from patentability because of:
- the difficulties in defining types of genetic material (given the rapid advancements in the field of biotechnology);
- the large amount of genetic material already patented; and
- because it may be inconsistent with New Zealand's international or TRIPS obligations.
6. We consider that focus should not be on the type of material being patented but rather on limiting the breadth of some patents such as those on genetic material. It may be the case that strict application of the new criteria (as agreed by Cabinet (CAB Min (03) 25/4 refers)) will go some way to addressing our concerns. In this regard the way in which the Intellectual Property Office of New Zealand (IPONZ) applies the new criteria on applications involving biological material will be crucial in determining the breadth of patents on genetic material.
7. However, we are concerned that even with strict application of the patenting criteria there may be still be issues with the breadth of patents on new and rapidly advancing technologies. We would therefore recommend a review take place three years after the amended Patents Act comes into force. This review would examine how the criteria of the Act have been implemented and how the new criteria have been applied. MED will undertake further work to determine the scope and resources required for this review.
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