On Friday the Guardian reported that a US company had applied for the first patent on a meningitis-causing bacterium, which could lead to royalties being paid on every treatment if a new vaccine emerges.
Many scientists, though supporters of patenting as an essential protection of their right to profit from inventions, are deeply worried about the willingness of the US government to grant patents on hundreds of thousands of genetic sequences - the likely key to cures for many diseases.
They are not true inventions in the patentable sense, they argue, in which natural products are enhanced for specific use through the application of human ingenuity and technique. They are rather discoveries of natural elements, no more patentable than water. Today the European Parliament attempts once again to grapple with the issue by voting on a controversial directive on patenting of biotechnological products. At stake is whether there is a fundamental difference between patenting living and non-living matter and processes, between, say, a light bulb and a new breed of cancer-susceptible mouse, the "oncomouse" developed in the US. And if not, where is the line to be drawn? MEPs will be asked to balance ethical concerns with industry claims that legal uncertainty and a proliferation of patent rules are making Europe uncompetitive. Proposals emerged first from the Commission in 1988 and were thrown out of the Parliament finally only in 1995 with all 15 Irish MEPs voting against. This followed a campaign by the Greens. There was considerable confusion, one Irish MEP telling this correspondent they should not be asked to vote on the issue as it was "too complicated". A new draft addressing most EP concerns wended its way back through the Council of Ministers for MEPs' approval last year. Following a massive campaign by the biotechnology industry backed by many patient groups, Irish MEPs (except the two Greens) joined the majority in backing the legislation.
It returns today for a second reading, having been again amended by ministers.
The new legislation, although allowing the patenting of some living matter, more explicitly prohibits that of human beings, parts of the human body, and gene sequences unless an industrial application is specified. "Germ-line therapy", which alters the genetic make-up of successive generations, is not patentable.
The directive rejects patentability where modifying genetic makeup of animals causes them suffering and processes which use human embryos for industrial/ commercial purposes. It also attempts to allay concerns about crop royalties. Ethical dilemmas will be referred to a special committee.
Opponents, who expect it to go through, say the draft fails to make restrictions sufficiently explicit. While companies have to specify what therapeutic use a gene sequence may be put to in order to acquire a patent, they are accused of making scientifically unsustainable catch-all claims in the hope of tying up royalties on possible future uses.
Ms Roberta Tweedy, of the UK Neurofirbromatosis Association - one of the patients' groups opposing the industry's position - believes "a gene sequence is only patentable in the context of a specific utility".
The US National Organisation for Rare Disorders has called for the legislation to "award patents for biotech medicines as well as process patents to protect manufacturing processes". It claims gene patenting can prevent or delay important research.
Third World NGOs and governments are opposed because of "biopiracy", the appropriation by multinationals of the genetic inheritance and knowledge of developing communities with no return to them. Oxfam says therapeutic techniques or new plant varieties developed by biotech companies are often based on old wisdom handed down through generations in a developing country. That knowledge is then privatised and sold back to the same community.
Industry lobbyists insist their work is about saving lives and feeding the hungry. Without patents there would be less research. Patents are the foundation on which the development of new products and industrial competitiveness depend, they say. Any weakening of the draft would shift the emphasis of biotechnology research further towards the US and Japan.
Biotechnology is one of the most rapidly developing technologies of the 1990s, with worldwide annual sales estimated to be in excess of $100 billion by 2000, and currently employing some 300,000 people in Europe. There is a lot at stake today.
