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The Royal Commission on Genetic Modification - submissionsThe New Zealand Institute of Patent AttorneysINTERNATIONAL OBLIGATIONS — SECTIONS A(2)Submission The NZIPA outlined in detail the international obligations that impact on legislation and practices relating to genetic modification, genetically modified organisms and products. These are as follows:
The Paris Convention This convention established basic standards for intellectual property protection. Under article 1(3) innovations in all fields of technology, including biotechnology, can be patented. Through the Paris Convention New Zealand is committed to provision of a patent system offering international equivalence in basic rights, protections and scope of coverage. In addition, states that are parties to the Paris Convention must grant the same level of intellectual property protections to the nationals of other states that are available to their own nationals. In a 1999 submission to the then Ministry of Commerce the NZIPA observed that this limits the potential grant of special rights to groups within New Zealand, for example Maori, without granting those same rights to nationals of other countries.
Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) The TRIPS agreement sets minimum standards of intellectual property protection which must be met within the national laws of WTO member countries. Under article 27 of TRIPS, New Zealand is obliged to provide for patents in biotechnology, including genetic modification, when patent eligibility criteria are met. Exceptions to this rule are allowed under articles 27.2 and 27.3 of TRIPS. The NZIPA submits that except for the need for a human exclusion, all exclusions to patentability should be removed from patent law, as anti-competitive anti-innovation and better dealt with in other legislation controlling use of the invention. Article 39(3) of TRIPS outlines protections for undisclosed information acquired for regulatory purposes by agencies involved in the market approval of pharmaceutical or agricultural chemicals.
Budapest Treaty The Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for the Purposes of Patent Procedure is a registration treaty that allows one international filing of an organism to have effect in all signatory states. The Budapest Treaty protects the public interest in disclosure of patented inventions by ensuring that samples of microorganisms for which patents have been filed are accessible under internationally agreed conditions from recognised permanent depositories. New Zealand has not yet acceded to this Treaty despite recommendations do to so from the Industrial Property Advisory Committee (IPAC). This means that patents that include references to the depository remain theoretically open to challenge on the basis of insufficient description under the Patents Act 1953. The NZIPA stated that it adopts the IPAC recommendations in respect to changes to the Patents Act 1953.
Protection of Plant Variety Rights New Zealand became a member of the International Union for the Protection of New Varieties of plants (UPOV) and acceded to the 1978 Act of the UPOV Convention in November 1981. The Plant Variety Rights Act 1987 established the New Zealand plant variety rights framework. In 1991 a further UPOV Convention extended plant variety protection. Article 14(5) introduced the concept of essential derivation which is further described in sections The NZIPA highlighted that eight years later New Zealand has still not updated its laws to accede to the 1991 version of the Treaty. In the opinion of the NZIPA, the absence of 1991 UPOV protections for essentially derived plant varieties disadvantages New Zealand growers and research institutes.
Convention on Biological Diversity New Zealand is a party to the 1992 United Nations Convention on Biological Diversity (CBD). Article 3 of this Convention is a key statement of principle that recognises the sovereignty of states over their own genetic resources. Article 8(j) of the CBD also directs states to respect, preserve and maintain the knowledge, innovations and practises of indigenous and local communities in respect to conservation and sustainable use of biological diversity. It also directs states to promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practises and encourages the equitable sharing of benefits arising form the utilisation of such knowledge, innovations and practises. Implementation of Article 8 (j) would require national action in three main areas:
The best international means of addressing the complex indigenous intellectual property issue is still a matter of debate. Consequently, the NZIPA urges support for development of a sui generis system of indigenous intellectual property protection governed by an international treaty. The NZIPA strongly recommends that New Zealand take an active role in future WIPO deliberations on intellectual property and indigenous peoples.
LAW & LEGISLATION — SECTIONS B(f)Submission Patents in New Zealand In New Zealand, in order for a gene or gene sequence to be patentable, it must meet the requirements of novelty, inventiveness, sufficient and fair description and be a manner of new manufacture. A patent eligibility criterion, which is common to all jurisdictions, is that a mere discovery must be combined with an industrial application to be patentable. In New Zealand that principle is applied through an analysis of whether an alleged invention is a manner of new manufacture. A naturally occurring substance is not an invention
However, the discovery of a product of nature, and the industrial application of that discovery is an invention. For example, water from the hot pool in Rotorua was not an invention, but the microorganism was when isolated in an artificial environment where it produced proteins. Similarly, a gene sequence in an organism where it occurs in nature is not an invention. However, the isolated gene sequence, or an organism modified by the insertion or deletion of that sequence, or an organism manipulated in a controlled way by having knowledge of the sequence, can each be a "manner of new manufacture".
Plant variety rights The NZIPA stated that the Plant Variety Rights Act 1987 was inadequate to protect intellectual property rights in New Zealand. They submitted that it is essential that the New Zealand Plant Variety Rights Act be upgraded to incorporate all of the changes in. the UPOV 1991 Convention particularly to introduce the concept of essential derivation to protect New Zealand’s classically bred varieties. This is because under section 18 the rights of the owner of a protected variety do not extend to the use of that protected variety to produce a new variety. This has the potential for patentees with patents for genetic modification to use protected varieties bred in New Zealand for genetic modification to the disadvantage of New Zealand breeders. Because of the breeders’ exemption the patentees would have exclusive rights in the modified varieties. They would not require the permission of the New Zealand breeder of the unmodified variety they had genetically modified. Genetic modifiers could potentially free ride on years of research in breeding the unmodified varieties.
Confidentiality of registered data The NZIPA has a concern with the confidentiality of data provided for the purposes of approval under the Hazardous Substances and New Organisms (HSNO) Act and the Agricultural Compounds and Veterinary Medicines (ACVM) Act (see also Monsanto submission). Data provided to support applications for such approvals is expensive to generate and will usually be maintained as a trade secret. It is to the commercial disadvantage of the applicant if data are disclosed to competitors.
NZIPA especially objected to ERMA’s ability to release information under section 57 of the HSNO Act. Under this section the applicant is provided 10 working days from receipt of the notice to respond to a request for information. In the absence of a response, ERMA may release that information to a third party without further reference to that person. In the opinion of the NZIPA it is absurd that a trade secret potentially worth millions of dollars could be released and its value lost because of such a provision. Suppose a bank had such a policy. Suppose a stranger came in and asked for access to a customer’s account. The bank would then notify the customer and ask if the customer had any objection to the stranger getting access to the account. Suppose the customer is on holiday and not able to be contacted. Would the public regard that policy as sensible, if the customer in the circumstances returned after 20 days to find the stranger had emptied the account. But this is the potential effect of Section 57 of the HSNO Act.
The NZIPA submitted that section 55 of the HSNO Act should be simplified so that it gives protection to all confidential supporting information. Section 73 of the ACVM Act provides an appropriate model. Section 57 of the HSNO Act should be repealed for all the reasons stated above. Similarly, Section 12 of the ACVM Act (which is modelled on section 57 of HSNO) should be repealed for the same reasons..
Owning life A common public concern about gene modification relates to the legitimacy of "owning life". Various groups have objected to the concept of private ownership of genetic material or of activities associated with it. As outlined above, however, natural products and naturally occurring DNA sequences cannot be patented in their natural source or environment because they are not new or inventive. In addition, a gene sequence is not "life". It is the chemical code for a sequence of DNA. Genes used in genetic modification are synthesised constructs based on this code. However once genes are inserted into an organism such as a plant or animal, this new lifeform may also be patented and the patentee has the right to defend the invention from unauthorised commercial exploitation by others.
Moral objections Furthermore, there is provision in both TRIPS (Article 27(2)) and the New Zealand Patents Act (section 17) for consideration of moral issues in granting a patent. However, ideas of morality differ between individuals, and between cultural and religious group. It is the opinion of the NZIPA that the Commissioner of Patents ought not to be placed in a position where he/she has to decide whether an invention is patentable or not on an issue of morality. Rather, the NZIPA considers that these aspects should be addressed by another legislative framework, which provides one or more specially appointed and qualified committees.
Humans and human related matter The morality question also arises when considering whether patents should be granted for humans and human related matter. The morality section (section 17) of the Patents Act 1953 is the basis for IPONZ policy to refuse patents for humans. Also sections 2 and 10(7) prevent the patenting of a substance found in nature. Taken together, these patent criteria mean that a patent cannot be given to either a human, a human body part, or a human gene in its natural host, a human. Consequently any public perception that "people are being patented" is related to misconceptions of patent law, and has no foundation in reality.
The NZIPA does not believe that parts of humans should be excluded from patentability, other than the "parts" referred to in the previous paragraphs. Many valuable inventions in the medical field have to do with DNA sequences, cell lines and replacement body parts. This medical research should be encouraged by providing the incentive of an exclusivity period in which to offset the large developmental costs associated in developing these technologies. The NZIPA considers that New Zealand should follow the approach of Section 18(2) of the Australian Patents Act 1990 (Annex 8) in which there is a specific statement that human beings per se and biological processes for their generation are not patentable.
Biodiversity The existence of biodiversity is clearly a matter of importance in the healthy functioning of the world’s ecosystems. The effect of the whole range of human activities on the survival of other species, on the diversity of genetic types within species, and on the diversity of ecosystems in the world is a matter which requires serious consideration by governments. This is not, however, a matter which is unique to genetic manipulation. Nor is it established that genetic manipulation will have a major adverse impact on genetic diversity"
Indigenous resources Most of the traditionally and culturally important matters which Maori might want to have exclusive ownership of or control over are not matters that can be covered by the Patents Act. If special rights are to be given in respect of such matters, in addition to or substitution for any rights given by current law, then it should be by way of separate legislation. The World Intellectual Property Organisation has been mandated by the UN to analyse the intellectual property aspects of traditional knowledge and folklore over the period 2000-2001. The aim is to engage in dialogue with indigenous interests and cooperatively develop and test possibilities for traditional knowledge protection. This area of indigenous intellectual property rights is complex and is being addressed in New Zealand by the Treaty of Waitangi claim WAI 262. The NZIPA considers the Waitangi Tribunal the more appropriate forum to consider this difficult issue which is more wide ranging than the impact of genetic modification alone.
Biopiracy An example which critics of the patent system often cite in relation to biodiversity and alleged biopiracy is the European neem tree oil patent. This patent (EP 436257) - copies available free from www.european-patent-office.org - did not describe or claim any genetic modification. It claimed a neem oil extract and the use of that extract for controlling insects. The Opposition Division of the European Patent Office found the patent was invalid because of prior use of the invention in India. They found that there had not been the necessary consideration from the patentee (the claimed invention was not new) and the patent has been revoked. In conclusion the NZIPA believes stated that patents in biotechnology are adequately handled within the existing Patents Act. Concerns about possible misuses of inventions and patents are governed by other laws. There is nothing in the technology of genetic. modification that indicates any need for any fundamental changes to the Patents Act 1953.
Research Lockdown One of the objections to biotechnology patents is that they might lock-up knowledge. However, a necessary consequence of seeking exclusive rights is a full disclosure of the invention. While a patentee can stop commercial use of a patented invention, mere experimental use of that invention without the consent of the patent owner is permitted. For instance, although the sequences to the breast cancer genes BRCA have been patented, a recent Medline search shows several hundred papers have been published discussing these genes.
Furthermore, the New Zealand Patents Act 1953 also guards to a degree against a patentee not making an invention available in New Zealand. Section 46 provides for an application to the High Court to issue a compulsory license to a third party if a market for the invention covered by a patent is not being supplied on reasonable terms in New Zealand. This provision helps ensure that the patentee is not draconian about issuing licences or locking down the invention. The compulsory licence provisions of the Patents Act are as applicable to biotechnological inventions as to other inventions. |