Patenting of genetic material
Currently in New Zealand, genetic sequences may be patented if they meet the requirements for the granting of a patent prescribed in the Patents Act 1953, and many such patents have been granted in this area.
There has been increasing concern expressed in New Zealand, and internationally, that even where an invention involving human genetic sequences meets all the requirements for the grant of a patent, the resulting patent may still be overly broad. It is thought that patents directed to genetic sequences per se may have negative implications for research and innovation into diagnostic and treatment methods, health care costs and access to health care.
Concerns raised by the granting of patents over genetic material
Concerns that patents directed to genetic sequences per se are too broad include that, patents are being granted for genetic material even though no specific use for the gene has been identified, or that, having identified just one use, rights will be granted that cover all uses to which the genetic material might be put.
Such broad patents give rise to economic concerns, for example researchers may be deterred, as those who wish to use the patented genetic material for non-experimental use in order to identify further uses, must pay a licence fee to do so. This may discourage research, resulting in potentially valuable clinical applications of genetic material not being developed, or that such development of applications will be delayed until the patent expires.
Review of the Patents Act 1953
The Patents Act 1953 is currently under review. Although the issue of the grant of patents over genetic material was not specifically dealt with in the review, some of the proposed changes agreed to by Cabinet may assist in addressing some of the concerns surrounding the grant of patents over genetic material.
These proposed changes include:
- the introduction of examination for inventive step or "obviousness", in order to reduce the likelihood that patents will be granted over genetic material, or applications of genetic material that are no more than obvious variations on what is already known;
- a stricter utility requirement, which means that patents will not be granted unless the invention is shown to have a "substantial, credible and specific" use; and
- greater powers to refuse to grant a patent on a case-by-case basis if commercial exploitation of the invention would be "contrary to morality".
The proposed changes to the Patents Act 1953 will apply only to patent applications filed after the amended Act comes into force, they will not have retrospective effect over patents already applied for, or granted.
The Ministry of Economic Development’s discussion document
In light of the concerns, of which we have only highlighted a few, the government ministries found that the issues surrounding the granting of patents over genetic material should be examined further.
As a first step in this examination, it was recommend that a public discussion document be developed seeking input from stakeholders and the public. This discussion document will attempt to cover a range of issues relating to the granting of patent protection for genetic material and technologies including the moral, ethical, cultural, economic, legal, and technological issues, the implications for research and innovation in this field, and the implications for the health sector.
The document would include a range of options for addressing these issues, including the possibility of amendments to the Patents Act. Another option that may be explored is the role of government agencies, in managing the impact on the health sector of patents over genetic material.
The Government has released two Cabinet Papers on the subject of granting patents over genetic material – see:
- Implications of the Granting of Patents over Genetic Material; and
- Memorandum to Cabinet Policy Committee: Report Back with Recommendations and Options for Addressing Genetic Material Patents.
The content of these documents have been incorporated into an exposure draft for the new Patents Bill which was released on 20 December 2004 – see: Draft Patents Bill.
A summary of submissions on the exposure draft of the new Patents Bill was released on 1 July 2005 and may be viewed here.
Experimental use exception for New Zealand
In response to the submissions received and on the advice of the Ministry of Economic Development, the New Zealand Government has decided to insert an experimental use exception to infringement into the Patents Bill.
Although an experimental use exception exists at common law, no provision for such an exception is contained in the current legislation.
The wording of the exception will be based closely on the wording of the experimental use exception proposed for Australia by the Australian Advisory Council on Intellectual Property:
"The rights of a patentee are not infringed by acts done for experimental purposes relating to the subject matter of the invention that do not unreasonably conflict with the normal exploitation of a patent.
Acts done for experimental purposes relating to the subject matter of the invention include:
- determining how the invention works;
- determining the scope of the invention;
- determining the validity of the claims;
- seeking an improvement to the invention."
The four listed acts are not permitted acts as they are still subject to the requirement that they must not unreasonably conflict with the normal exploitation of the patent.
Likely changes to the above wording involve replacing the references to "invention" with "claimed invention" and specifying that "seeking an improvement to the invention" includes seeking new uses for or determining new properties of the invention. The second of these changes is intended to cover an act done to determine a new use or a new property of a patented gene.
Rachelle Beale - December 2007.
Postscript
The Patents Bill was introduced into Parliament on 9 July 2008 with an experimental use exception in clause 136 of the Bill based closely on the wording of the experimental use exception proposed for Australia. The clause specifies that seeking an improvement to the invention can be, for example, determining new properties, or new uses, of the invention. The select committee which reviewed the Bill has recommended that the words "if the act does not unreasonably conflict with the normal exploitation of the invention" be deleted from the clause.
