Broadly defined, intellectual property refers to the legal rights that result from intellectual innovation in the industrial, scientific, literary and artistic fields. These exclusive rights are meant to ensure that the creators of original works receive some economic benefits for their work. In the field of human genetics, researchers can be rewarded by intellectual property rights such as copyrights, patents and database rights.

Currently, there is no international consensus on a common definition of human genetic materials. In its 2005 Report, Human Genetic Materials: Making Canada’s IP Regime Work for the Health of Canadians, the Expert Working Party established by the Canadian Biotechnology Advisory Committee defined human genetic materials as: “nucleotide sequences (including sequences of entire genes or parts thereof and non-coding sequences) that exist in humans, as well as the products (e.g., proteins) expressed by those sequences or parts thereof.”

It is not possible to obtain intellectual property rights, such as a patent, over human genetic material in its natural state, within a person’s body. However, if genetic material or data is isolated from the human body and reproduced within a laboratory and are included in an invention that meets certain legal criteria, there is the possibility that this material could be patented. A well known example of such patent is the one given to Myriad Genetics for predictive genetic tests for hereditary breast cancer relating to BRCA 1 and 2 genes.

The patenting of human genetic material is a controversial topic that has attracted attention from policymakers at the international level. Presently, there is a vast corpus of normative documents on this topic. Moreover, renowned international organisations such as the United Nations Educational, Scientific and Cultural Organization (UNESCO), the Human Genome Organization (HUGO), the Organisation for Economic Co-operation and Development (OECD) and the World Health Organization (WHO) have also taken positions and produced recommendations, guidelines or other normative documents pertaining to this topic. These documents deal with the variety of issues associated with the use of certain intellectual property rights such as research tool patents, patents on genetic diagnostic tests and the exclusive licensing of these patents. They also address the question of the patentability of living and higher life forms.

Examples of such international documents are:
- The Organisation for Economic Co-operation and Development (OECD), in its guidelines on biobanks and databases (Guidelines for Human Biobanks and Genetic Research Databases (2009)), make recommendations at the management level in order to balance the researchers’ needs and the rights of the individuals whose genetic information is stored in a biobank.
- The Organisation for Economic Co-operation and Development (OECD), also published guidelines on the patenting and licensing of genetic inventions in 2006, Guidelines for the Licensing of Genetic Inventions. The objectives of these guidelines are to propose a balance between three potentially conflictual concepts raised by the process of granting licenses on genetic inventions. These concepts are the sharing of knowledge in genomics, the increasing of the population’s access to treatments and genetic diagnostics, and the profitability of investments in genetics.
- The World Health Organization (WHO), in its report Genetics, Genomics and the Patenting of DNA: Review of Potential Implications for Health in Developing Countries (2005), studies how intellectual property legislations could have an impact on the use of genomics by developing countries.
- The Intellectual Property Committee of the Human Genome Organization (HUGO) have adopted a declaration entitled Statement on the Scope of Gene Patents, Research Exemption and Licensing of Patented Gene Sequences for Diagnostics (2003). In this declaration, the Committee promotes the use of stricter patenting criteria. The Committee also encourages the exclusion of genomic research as an activity that could violate the protection provided by a patent; all this with the goal of stimulating research in this field.
- The World Health Organization (WHO), in its report Genomics and World Health (2002) exposes the challenges of accessibility to genetic inventions in developing countries. In its recommendations, the WHO promotes the improvement of intellectual property legislations in an effort to make genetic technologies more accessible in these countries.
- UNESCO, more specifically the International Bioethics Committee (IBC), issued a report in 2002, Report of the IBC on Ethics, Intellectual Property and Genomics. In this document, the Committee promotes the concept of profit-sharing between developed and developing countries. They also suggest the inclusion, within the different international normative frameworks, of the principle that holds that the human genome cannot be patented.
- The Intellectual Property Committee of the Human Genome Organization (HUGO) also published a report entitled Statement on Patenting Issues Related to Early Release of Sequence Data (1997). In the document, the Committee advocates in favor of a quick release of all known information on the human genome. To achieve this goal, the Committee proposes several options, for example the granting of grace periods for obtaining patents after the release of data, which normally prevents a patent from being granted because the invention is no longer considered “new”.

The Tri-Council Policy Statement does not say much concerning the question of intellectual property within the research context.

The Canadian Biotechnology Advisory Committee (CBAC) has released two reports on the topic:
- In their 2006 report Human Genetic Materials, Intellectual Property and the Health Sector, the Committee promotes the reinforcement of patenting criteria and the restriction of patent rights on human genetic material.
- In their 2002 report, Patenting of Higher Lifeforms and Related Issues, the Committee supports the patenting of higher lifeforms but they emphasize the exceptions that must be considered in such cases. Among the positions taken by the Committee, some are in favour of excluding research as an activity that could violate the protection provided by a patent and the protection that goes against the patenting of the human body.

In 2002, the Ministry of Health and Long-Term Care of Ontario published a report to the Prime Minister entitled Genetics, Testing & Gene Patenting: Charting New Territory in Healthcare. After acknowledging the importance of patents in the development of the biotechnology industry, this report promotes the reinforcement of the criteria for granting patents that are linked to biology, for mandatory granting of licenses by the Commissioner of Patents and for the rejection of patents that do not conform to the morals and values of Canada.

More recently, in 2008, an independent non-profit consultancy organisation, The Innovation Partnership has released a report entitled Toward a New Era of Intellectual Property – From Confrontation to Negotiation. This group of experts made a recommendation to encourage the decision-makers to create genomic services in developing countries to increase the access to scientific knowledge in this field.

There is no specific normative framework governing intellectual property and human genetic material in Quebec. The federal framework applies.

Most countries have provisions within their national laws or constitution that would prohibit the patenting of a transgenic human. The situation is different when it comes to transgenic plants or animals. Canada’s position, however, runs contrary to the international tendency. This position arose from a controversial Canadian legal decision, which prevents a definite answer to the question pertaining to transgenic plants and animals, at the federal level. In the majority of jurisdictions (e.g., United States, France, Japan, and the United Kingdom), patents on inventions relating to transgenic plants and animals are allowed.

Several ethical and moral arguments have been used by those who oppose the patenting of human genes, among which we might find arguments of a religious nature. The ontological view of man goes against the granting of intellectual property rights on human genes.

Other arguments are based on the consequences of granting property rights on human genes. Some worry about the pernicious effects of the economy and the commercialization of the human body.

The effect of patenting human genes on genetic research are still unknown.

The genetic research process of finding solutions to human health problems via genetics  is long, costly and requires many steps. Furthermore, according to some, patents on human genetic material might impose an additional constraint, from the start, on research to find new treatments. In fact, the development of new treatments could necessitate the use of multiple patents, making research much more difficult for both economic and administrative reasons.

The effect of patenting the human genome on the access to research results remains unknown.

Some hints lead us to believe that it might decrease the population’s access to genetic analyses. On the other hand, there is nothing to prove that the benefits for investments aimed at the adjustment of products did not indirectly increase the population’s access to genetic analyses and knowledge.