The genetic blueprint for human life is predicted to be fully charted by 2005. Gene-sequencing techniques are unravelling the complexities of DNA and identifying each building unit of the double helix.
As genes are increasingly found to have a significant, if not pivotal, role in many medical conditions, genetic therapy and tests represent a new frontier. Pharmaceutical and biotechnological companies are already investing heavily in gene research and the applications of genetic therapy/ testing. The logical consequence from their perspective is an ability to protect their work and applications by patenting.
So what's on today's EU Council of Ministers agenda when it comes to the patenting of human gene sequences? The answer: Article 5 of the directive on the legal protection of biotechnological inventions.
Article 5 (1) says: "The human body, at various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions."
All very well, but it is followed by an apparently contradictory 5 (2) clause. It says: "An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of the element is identical to that of a natural element."
The Council of Ministers looks set to adopt the directive. The Government believes it is required to "fill gaps in patent law, and does not purport to adjudicate on ethical or moral issues, such as cloning". It also believes it makes the necessary distinction between discovery and invention.
The Minister of State for Enterprise, Mr Tom Kitt, who is due to attend the meeting, has listened to the concerns of the Inherited Diseases Organisation but is set to approve the directive. A spokesman for the Minister said the directive would encourage research, improve economic competitiveness and help generate benefits and new health-care products and therapies.
