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Gene patents

The ability to take out a patent on the results of gene research is a highly controversial and difficult question. The first time a gene was patented was in the US in 1980, something that brought a tidal wave of patent applications for genes. Critics asserted that the requirements for application were entirely too low. Nearly a fifth of all known human genes have been patented in the US by the end of 2005, the majority by private companies, a study has revealed.

Background

Through its Food and Agriculture Organization's Resolution in 1983, the UN established that heredity is humankind's common legacy (a more recent UN Code of Conduct for Plant Biotechnology can be found here). This action, however, hardly solved the problem. In the beginning of the 1990s, when two experts representing Forskningsrådsnämnden (the Swedish Council for Planning and Coordination of Research, now Vetenskapsrådet, the Swedish Research Council) were assigned with elucidating the issue, one said "yes" and one "no" to the possibility of a gene patent. The patent law's §1 states that patents are not granted for plant varieties or animal breeds or essential biological processes for the production of plants or animals; a patent can, however, be granted for microbiological processes or products of such processes. The motive for the latter part was a protection of discoveries of microorganisms' ability to create new substances, such as antibiotics - that organisms themselves should be able to be patented was not the intent. Thus, a possible "no". Others maintained that living organisms meet all the requirements placed on an invention and that the wording "microbiological processes or products of such processes" can also be extended to apply to plant varieties and animal breeds, thereby answering the question with a "yes". In 1999 in the US, the Patent and Trademark Office made the requirements more stringent. The Supreme Court ruled in 2013 that human genes are "products of nature" and therefore cannot be patented as such.

The EU Directive

For the European Union, in 1998 the Parliament and Council issued a directive that is also enforceable in Sweden, Directive 98/44/EG from 6 July 1998 on the legal protection of biotechnical inventions, which explains how the European Patent Convention should be interpreted. Among other things, the directive rests on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), which established that all types of technology must be guaranteed patent protection. The EU's directive states that discovery of a bodily function such as a gene sequence in itself cannot be patented, but on the other hand an invention based on such a discovery can be. Inventions can also be patented if they concern a product consisting of or containing biological material ("biological material: material that contains genetic information and that can reproduce itself or be reproduced in a biological system") or a process in which such biological material is produced, worked with or used. This also applies to the biological material found in nature. However, inventions cannot be patented if their commercial exploitation is in conflict with general order and morals (explicitly, operating on human gametes and cloning of humans). The directive also excluded from patent right the use of the human embryo for industrial or commercial purposes. The European Patent Office's president, Alain Pompidou, said in the summer of 2005 that the EPO will not patent any embryonic stem-cell technology for the time being, because "there are too many ethical aspects that have not been resolved at the political level". Then followed Development and implications of patent law in the field of biotechnology and genetic engineering (Report from the Commission to the Council and the European Parliament) and the EU Parliament's Resolution on patents for biotechnological inventions, before the European Court of Justice ruled in 2011 that all patents that would require the process of destroying a human embryo at and after the blastocyst stage for stem cell research are banned in the EU. An EU researcher might of course seek patent rights in other parts of the world.

As regards animals, the Directive establishes that a patent cannot be obtained for processes that cause suffering in animals and that do not have "substantial medical benefit in terms of research, prevention, diagnosis or therapy to man or animal".

In connection with the directive discussed above, in the proposition "Gränser för genpatent m.m." (Boundaries for gene patenting, etc.) the Swedish government suggested that boundaries for patents be clearer and that changes in the patent law and the act relating to the rights of plant breeders be implemented beginning 1 May 2004. Now implemented, this suggestion establishes that the human body, or a part of it such as a gene, cannot be patented in its natural state. The boundary between discovery and invention has thereby become clearer in legislation. The government's standpoint is that a balanced and sufficiently restrictive patent practice is needed so that negative effects can be avoided. Among other things, the use of the human embryo for industrial or commercial purposes is forbidden. These changes also mean new regulations regarding agricultural exemptions and compulsory licensing. Through the directive 2005:002, Uppföljning av patentskyddet för biotekniska uppfinningar [Follow up on patents for biotechnology inventions], a committee was called to follow up the developments of biotech patents in healtcare and research. The committee shall especially follow gene patents. A final report has been published (SOU 2008:20) that suggests that every application of a gene should be possible to patent.

Other standards

If the biological material cannot be described so that the invention, on the basis of the patent application, can be replicated by a specialist, the material is to be deposited with the authority in accordance with the regulations set forth in the international Budapest Treaty from 1977.

The OECD held a workshop in 2002 to investigate the impact on access to information, products and services for researchers, clinicians and patients resulting from an increase in patent applications filed and patents granted for genetic inventions used in human health care as well as the associated licensing practices for such inventions. Expert meetings were held to develop the Guidelines for the Licensing of Genetic Inventions. These Guidelines offer principles and best practices for the licensing of genetic inventions used for the purpose of human health care. They seek to foster the objectives of stimulating genetic research and innovation while maintaining appropriate access to health products and services. More recentlyu, the Standing Committee of European Doctors issued a Statement on Ethical and Fair Patents.

The Human Genome Organisation has published "statements" on the Patenting of DNA Sequences, Patenting Issues Related to Early Release of Raw Sequence Data, and the Scope of Gene Patents, Research Exemption and Licensing of Patented Gene Sequences for Diagnostics. The International Bioethics Committee (UNESCO) has published Advice of the IBC on the Patentability of the Human Genome. Recommendations on Patenting and licensing in genetic testing: ethical, legal and social issues have been made by the European Society of Human Genetics.

New plant varieties

There is an international convention for new plant varieties: the 1991 UPOV convention for the Protection of New Varieties of Plants, which serves as the basis for the Swedish växtförädlarrättslagen (law on plant breeders' rights) from 1997. New in the Swedish law was that, concerning the rights of plant breeders, the validity period for all plants was extended to 25 years except for potatoes, trees and wine, the protection time of which was extended to 30 years. For the European Union the Council has decided about the approval of the accession of the European Community to the International Plant Protection Convention and also approved the accession of the European Community to the International Convention for the Protection of New Varieties of Plants. In 1992, the EU wrote more in the Convention on Biological Diversity, which is relevant in these questions, and which was later followed up with many conferences at which complementary decisions were made. See also Regulation No 2100/94 of 27 July 1994 on Community plant variety rights.

A much discussed question is the rights of countries to their traditional knowledge and how benefits gained should be shared with them. See for example the Nagoya Protocol. Developments are reported on here.

Last updated: 2013-06-18

Rules & guidelines

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CODEX, Centre for Research Ethics & Bioethics, BMC, Husarg. 3, Uppsala | Webmaster | About the web site