Part Two: Reforms to the Patents Act 1953
Philosophy of the Patents Act
Patents represent a bargain between the Crown and the inventor. The community, including Maori, is taken to benefit from new ideas and research, such as the development of new products and technology. In return for an inventor putting time, creative thinking and money into research for new inventions, and making full details of the invention public, the Crown grants a period of monopoly protection to the inventor to allow them to recoup their investment and benefit from their invention.
The Patents Act allows the Crown to grant a set of exclusive commercial rights to inventors to benefit from their inventions for a period of 20 years.
What are "Life Form" Inventions?
As well as engineering and other industrial inventions, patents can be issued over living things that have been changed or modified by humans in some way from their natural state. Humans, animals and plants are all considered to be "biological materials" or "genetic material" which can be used to develop products from life forms, for example vaccines, or to create new life forms.
What "Life Forms" can be patented under the Patents Act?
Patents can be issued for life form inventions. Decisions about whether to grant patents are made by the Commissioner of Patents according to the interpretation of the Patents Act.
Any living thing apart from a human being can be considered for grant of a patent. However, only life forms that qualify as 'inventions' under the Patents Act may be granted patents. An invention must be new, industrially applicable and involve an inventive step, that is, a step which produces a result that would not be obvious to anyone skilled in that area.
What is required to obtain a patent for a Life Form?
The grant of a patent for a life form invention requires that the invention:
- is new
- is industrially applicable
- involves an inventive step, that is a step which is not obvious to someone skilled in that area; and
- there must also be a true and first inventor.
Can native plants and animals be patented?
Patents cannot be granted for substances or life forms "when found in nature". However, the "active ingredients" or parts of native plants and animals, such as enzymes and genes or the processes for isolating those inventions, may be granted patents. Exclusive rights for hybrids of native plants maybe granted under the Plant Variety Rights Act 1987.
Traditional Maori Values and Customs about Life and Life Forms
Maori have customs and traditions that regulate the relationships between life forms and all other things. Iwi have different tribal perspectives on these matters. The following section reflects a general summary of views expressed by some Focus Group members from their own perspectives. It is not in any way a definitive discussion.
In the Maori conception all life forms - animate and inanimate - have divine origins as all have a genealogy back to the gods; the source of their life and being. Each life form, including each person, is therefore imbued with its own Mauri and each makes a substantial contribution to the Cosmos and all things that live within. This Mauri and the life forms are linked together, including humanity, by whakapapa, through mutual descent. As the Mauri of all living things is connected by these kinship ties, acts that change or degrade the essence of one life form have an impact on the integrity of all other life.
In addition to the interconnection between all things, whakapapa defines ancestral rights as between people. Rights flowing from whakapapa include rank and status in society, mana to belong to a specific or a number of hapu or whanau kinship groups, and authority to exercise rangatiratanga or chieftanship.
Maori refer to genes by the use of phrases such as:
- "...kei roto i nga toto..." ("...it is in the blood...")
- "...nga toto o ana tipuna..." ("...it is in the blood of his/her ancestors...")
Genes are a part of the whakapapa relationship as animal or plant life. For Maori, a gene has Mauri that continues to exist ex-situ (when taken from its original place). The same perspective is carried over to issues of replication, trans-genetic engineering and cloning. Hence to alter the "genes" or genetic material is to alter the blood of the ancestors, altering the whakapapa relationship by changing or introducing "new blood" that may impact on the other rights that are passed down, rights of authority, status and control.
Some Questions for Maori on Patenting of Life Forms
Should Life Forms be "tampered" with or changed at all?
Maori possess an indigenous body of knowledge that seeks to define the origins of the universe and the place of humans within it. This knowledge connects humans, plants, animals, gods and all animate and inanimate objects. There is no distinction or break between the origin of the universe to the present day in terms of the use and evolution of that body of knowledge.
This knowledge regulates the relationship between humans, plants and animals. These 'regulations' employ concepts such as kaitiaki, rahui, rongoa and matauranga Maori. The practice of these 'regulations' varies from area to area and is often tribally specific.
Maori traditions and cultural values prescribe the types of life forms that could or could not be changed. Specific life forms may only be changed in certain ways.
How should Life Forms be owned? What types of rights should be granted for Life Forms?
A patent grants exclusive monopoly rights to the inventor, their assignee or personal representative, to use an invention.
The grant of exclusive monopoly rights to life forms explicitly ignores Maori traditions and cultural values and denies input from Maori regarding rights of ownership, use and control of life forms.
Maori traditions and cultural values prescribe ways in which the rights in life forms are to be held. Some areas recognise collective as opposed to individual ownership of specific life forms. This "collective ownership" may include both individual and groups of whanau, hapu and iwi. Likewise, a prohibition on the sale, purchase or trade of the rights in certain species may also be considered.
How can the Patents Act respond to Maori knowledge, processes and products?
Maori knowledge, processes and products often do not qualify under the criteria in the Patents Act to be granted a patent. The Patents Act does not generally allow Maori knowledge, processes and products to be patented because these things are considered to be a part of an existing body of knowledge and practice and therefore not "new" in terms of the novelty criteria of the Patents Act. In addition, Maori values and customs are not included in the things which can be considered in decisions on granting or revoking a patent.
Maori could benefit, if they so wished, from patenting improvements or new elements of traditional products and practices, where these improvements would satisfy the criteria in the Patents Act. To do so they would need to agree to that information becoming known to the general public on the granting of the patent, and freely available to be used by anyone on the expiry of the 20 years.
Maori may wish to have a monitoring role to determine Maori interests in life forms which may be the subject of a patent and provide input on dealing with the application for the benefit of the applicant and the Commissioner of Patents.
This will require legislative change to the Patents Act. The Commissioner of Patents, may suggest applicants take up these issues, but as there is no legal requirement to do so, the applicant may refuse. There is no legal requirement in the Patents Act to restrict or prevent the grant of a patent on a life form invention for lack of Maori cultural values and traditions.
Stages in the Process of Creating a Life Form Invention and Obtaining a Patent
Inventions for which a patent may be sought are developed in three main stages, each stage raising specific issues for Maori. These stages are the Research stage, the Process stage and the Product stage.
The Research Stage
This stage involves selection of the original or existing material from which the inventor hopes to derive the new genetic components, compounds or life forms.
An inventor needs to secure access to the rights to use the original life form for research. In the case of species, this may involve obtaining a permit from the Crown who took legal ownership to all wildlife under the Wildlife Act 1953 on behalf of the general public. Where human material is used, this genetic material must be gained from the individual people.
As well as securing access, scientists gain funding from public good or private sources who may or may not have certain ethical rules governing what is appropriate research.
Maori issues in the research stage include:
- Rangatiratanga: Exercising rights and responsibilities to decide on use of taonga species according to Maori values, customs and traditions.
- Access: Controlling access to these resources and their availability as material for research.
- Appropriateness and Morality: Determining what uses and associations are acceptable relative to the taonga status of the life form and Maori conceptions about their relationship to natural resources.
- Informed Consent: (a) Ensuring that iwi with kaitiaki responsibilities for particular species make fully informed decisions about their use; and (b) Ensuring that indigenous people whose genetic material is sought for research are fully informed about the intentions of the researchers and consent to their genetic material being used for those purposes.
- Acknowledgement: Recognition of the origin of the life forms, the status of iwi holding rangatiratanga over them, and the contribution of indigenous people to their long-term care and preservation.
The Process Stage
Once access to the original material has been secured, a variety of technological processes might be applied to alter, extract or manipulate that material to produce the new life form. Biotechnology refers to techniques that use living organisms or parts of organisms to make new life forms or modify existing life forms. Genetic engineering is a biotechnological technique where scientists transfer genes from one organism to another to make or modify existing life forms. The process chosen depends on the outcome sought from the research. Biotechnological processes can themselves be patented.
Maori issues with respect to the Process stage include:
- Appropriateness and Morality: Determining whether the intended process is appropriate according to Maori values and preferences when applied to the original life form in question.
- Whakapapa: (a) Maintaining the integrity of the kinship relationship between people and other living things; and (b) Maintaining the integrity of ancestral authority rights which pass down to descendants according to whakapapa.
- Maori Traditional Knowledge and Processes: Protecting Maori intellectual property in traditional processes for using natural resources, for example, rongoa or traditional Maori medicine preparation.
The Product Stage
At the end of the research and application of technological processes, a product is obtained for which a patent may be granted. These products might include genetically engineered new life forms, or genetic components of life forms such as tissues and cells, genes and enzymes. It is the newly discovered or invented life form or life form component which is patented, not the original naturally occurring life form from which the product is derived. Maori issues with respect to genetically engineered life forms of invented or discovered genetic components include:
- Acknowledgement: Recognition, where appropriate, of the origin of the natural life forms from which the new or modified life form product is derived, the status of iwi holding rangatiratanga over them, and the contribution of indigenous people to their long-term care and preservation.
- Royalties: Equitable sharing of the benefits and proceeds from commercial marketing of the new product in acknowledgement of (a) the derivation of the commercial product from the naturally occurring taonga owned and cared for by the iwi; and/or (b) the use of traditional Maori knowledge in the identification of the potential of the original life form source, or in its processing.
- Displacement of original species significant to Maori by genetically modified ones through release, deliberate cultivation or habitat competition.
- Disruption to traditional knowledge about the characteristics, for example healing properties of traditional plants or animals by genetic modification or cross-pollination. That is, Maori knowledge of those traditional properties for medicinal purposes may be undermined by the introduction of genetic counterparts which have different properties from the original species from which they are derived.
- Derogation from existing iwi rights to use original taonga species. For example, exclusive rights to harvest the young of titi (muttonbirds) may be denied with respect to a genetically modified counterpart.
Ways in Which the Patents System Could Respond to Some of the Concerns Raised at Each Stage
Can the Patents Act be used to address the problems in all three stages?
Many of these concerns highlighted above, such as issues of access, acknowledgement and appropriateness cannot be addressed in the Patents Act because that Act deals only with the granting of rights over the "end result" of research and development. Some of these concerns are best considered elsewhere. For example, ethics committees within research organisations assess research proposals at the outset of the research stage to determine whether the proposals, and the "end result" which the research is aiming to achieve, is appropriate given the ethics of the day.
What about research which does occur?
One of the advantages of the "vetting" that occurs at the very early stages of research and development is that many proposals, the "end result" of which has the potential to be of benefit to a large part of the population, animal health or assisting agricultural potential, can be developed so that a patentable product is reached. For example, recently in the news you may have heard about the vaccine developed and soon to be trialed in New Zealand to help combat cancer. This is just one of the developments made by the biotechnology industry. Another helpful development is research currently in progress which is addressing the possibility of whether small molecules could prevent the start of tumours in women who may be genetically disposed to breast cancer.
On average it takes 12 years to bring medicines from a point where a patent is granted to when the patented product, for example, medicine is approved for marketing. Most of this time is taken up with the clinical safety evaluation of products and also further technical development of products. As such, the time and costs of research and development are significant. Patents ensure that there is an incentive to continue to advance knowledge. This knowledge can save lives and make advances for humanity.
What steps can be taken within the "Patents System"?
Having said this, there are still concerns regarding the wider issues related to the patenting of life form inventions. By way of background to the discussion on the issue of patenting of life form inventions, it is worth noting that section 17 of the Patents Act provides a general exclusion from patentability for inventions the use of which are contrary to morality. The Commissioner of Patents may refuse patents under this exception. The Commissioner's decision is subject to review in court.
The contrary to morality exception is, in practice, of limited use and has not been the subject of any court decisions in relation to biotechnology patents. This exception is hard to use because there are no guidelines as to what is the correct interpretation of "morality". However, options for addressing concerns in the patents system include clearly defining what can be considered to be "contrary to morality". This and other possible options for addressing the patenting of life form inventions issue are outlined below.
- The patents system could include changes which:Inform applicants for patents on life form inventions about Maori concerns, particularly concerns about the lack of respect for the Maori relationship with plants and animals. This could be done initially by outlining the concerns in the Intellectual Property Office information booklet on patents;
- Request that applicants indicate that they have satisfied ethics criteria in developing the invention, if applicable (this may not be applicable, for example, for mechanical/engineering or chemical inventions) - although it may not be legally binding, it is an effective way of ensuring that applicants give some thought to the research that they have developed. Additionally, it may highlight for the Commissioner where an invention is contrary to morality;
- Establish guidelines in the patents legislation of what contrary to morality means, these could include inventions (a) where informed consent for research on human beings or gathering of human genetic material had not been obtained from the person from whom the genetic material was taken, or if deceased, from that person's whanau and (b) where Maori spiritual values had been transgressed in the development of inventions relating to indigenous species with which Maori have an affinity;
- Encourage Maori to institute revocation proceedings where there is a strong case to be made for "prior use", for example of a plant remedy, or prior knowledge of a plant remedy;
- Specify that the definition of "any person interested", for the purposes of opposition and revocation, includes Maori and/or iwi;
- Enact a specific exemption to human beings being patented and specify a definition of what "human being" means; and
- Provide that third parties could inform the Intellectual Property Office of any concerns which they have and which they consider that the Office should take into account in deciding whether an invention is contrary to morality.
Attached as Appendix A to this paper is a diagram of the patenting process.
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