March 2000 Background to the proposal for a European Parliament and Council Directive on the legal protection of biotechnological inventions

Patenting in Europe is governed by the European Patenting Convention, but different countries within the EEC may apply different criteria to patents. In 1988, the European Commission initiated a draft Directive on the Protection of Biotechnological Inventions, which would harmonise the protection granted to such biotechnology inventions. The first draft was rejected by the Parliament on 2 March 1995. The main points of contention were:

- the circumstances in which genetic material should be patentable;

- the provision of farmers' rights for animal as well as plant varieties.

In 1988, when the Directive was first put forward, there was a perceived need to clarify the position on patenting reproducible biological material, and the extension of patent rights of subsequent generations. However, since then the European Patent Office, and other major patent offices around the world, as well as the courts in many countries, have developed patent law and practice in the area of biological material.

The new proposal now being considered should, therefore, be seen in this context. If anything, rather than extending patenting rights, it would be more restrictive than current practice.

Why is there a need for patenting of DNA?

Biotechnological development, including the identification and isolation of genes of known function, has tremendous potential to relieve suffering and improve the quality of life of humankind. Patenting encourages disclosure of inventions by allowing inventors to enjoy a monopoly on the commercial exploitation of their research for a limited time in return for publication of the invention concerned. Patenting a gene does not grant ownership of genetic information, on the contrary, it actually encourages the publication and sharing of that information. It confers rights to the researcher to commercially exploit that information, in defined ways, for a limited period. If there were no protection of intellectual property rights, competitors could supply a beneficial product at a much lower price, as they do now on the expiry of patents. This would mean that industry would not invest in the research and development needed for new medicines and diagnostics. The development and testing of a new drug may cost several hundred million pounds spread over a period of several years.

The current position on patenting of genetic material

The UK is a signatory to the European Patent Convention. Inventions, not discoveries, are able to be patented, but the definition of invention is drawn extremely widely to include refined or extracted substances which occur in nature. However, the invention must be novel, not obvious to a person skilled in the art to which the patent refers, and it must also be industrially applicable. Under the EPC, inventions must also not be "contrary" to morality or "ordre-publique", designed to take into account the ethical dimension of technological inventions.

It should be noticed that the need for 'non-obviousness' means that the definition of what is patentable will change as technologies become more advanced. Patents granted when a technology is new are likely to be broader in their scope than those given later.

The techniques first used to isolate genes had novel value, but now these are routine. The isolation of genes now only requires the painstaking application of well known techniques. There is general agreement that fragments of genes, or genes of no known function, should not be patentable. The requirement for an invention to be novel would also mean that genes of known function isolated by commonly used techniques should also not be patentable, although there is a need to clarify this, and the EPC to be redrawn to allow patents to be challenged on the grounds that their claims go too wide. This now only currently available through the courts in individual countries once a patent has been granted.

It should be pointed out that public sector discoveries can be patented by the public sector and, if appropriate, licensed to others or can be rendered unpatentable simply by publishing details of the discovery. Patenting provides a means for companies to reveal the results of their research and, in the UK, research scientists and non-profit making research organisations may freely use patented inventions in their research without infringing the patent.

Science & Technology Select Committee Report on Human Genetics

The Committee (of which I was a member) made various recommendations to tighten up current practice, but these were rejected by the previous Government. In particular, we concluded that:-

only a combination of a gene and a known utility which is novel and not obvious should be patentable in the context of that utility


a combination of the same gene and a further novel utility should also be patentable

The effect of this would be to ensure that isolated genes are only patentable in the context of a particular utility and that the inventor of a different utility for the same gene would not be prevented from taking out a patent on that invention.

We made more recommendations, for example, relating to genetic testing and confidentiality, and the establishment of statutory regulation to maximise the benefits of advances in biotechnology and control possible harmful developments.

The European Directive should therefore not be opposed on the grounds that it loosens restrictions on patenting DNA. The exact opposite is the case. Instead, pressure should be put on the Government to accept the recommendations of the Select Committee, and to ensure that those recommendations are taken up on a European-wide basis.

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