Should the New Zealand Parliament Allow the Intellectual Property Office of New Zealand to Continue to Grant Patents for Isolated Human Genes?

Abstract

"The good patent gives the world something it did not truly have before, whereas the bad patent has the effect of trying to take away from the world something which it effectively already had." In each cell of each human body, and in the cells of almost all other living things on Earth, we find deoxyribonucleic acid, or DNA. DNA is a large molecule consisting of two strands of covalently bonded nucleotides, held together in a double helix structure by the weaker hydrogen bonds between the strands. Each nucleotide contains a nucleobase, and every three nucleobases code for an amino acid. A string of amino acids make up a protein, and proteins make up the human body. A sequence of amino acids that codes for a particular characteristic of the human body is called a gene. Scientists can isolate a gene from the rest of a person’s DNA, so it exists as a single strand of nucleotides, with its covalent bonds broken at either end. Gene isolation was originally a complex procedure, but today is mostly automated and can be done quickly. The Intellectual Property Office of New Zealand (IPONZ) has granted patents for isolated human genes. However, IPONZ has not released any guidelines on how it approaches patent claims for any kind of genetic material, and there has been no case law on the question of whether IPONZ should be granting these patents or not. We in New Zealand are in a unique position to decide whether or not we want to allow patents over isolated human genes, as our current patent system does not fully examine patents before granting them, making all patents conditional on later decisions.9 The United States biotechnology sector is much more advanced than ours, and the US patent system has proved destructive that sector, driving up the cost of diagnosis and inhibiting research. We need to learn from their example and establish a law of gene patenting that encourages innovation, ensures access to healthcare, and is consistent with our patenting law as a whole. In this paper I aim to determine the approach New Zealand intellectual property law should take to the patenting of isolated human genes. I will first analyse the New Zealand law on patentable subject matter, and then the tests US courts have used to determine the patentability of isolated genes, as there is no New Zealand case law on this specific issue. I will then determine which test is best for New Zealand and how it would apply to isolated human genes. I will then examine further legal issues in this field: the impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and the Patent Act 1953’s morality exemptions, as well as the related exemption from patentability for methods of medical treatment and diagnosis practiced on humans. Having examined the legal issues, I will then consider policy. Does patenting in the field of biotechnology inhibit or encourage research? Do gene patents drive up the costs of genetic tests? I will also attempt an overview of Māori objections to gene patents as voiced in the Wai 262 report, bearing in mind that Māori objections to intellectual property law are much broader than the scope of this paper.