This week, more than six years after the European Commission first thought of it, a directive on the patenting of human, animal and plant life finally comes to a vote in the European Parliament. Although designed to clarify and harmonise the law in member states, the directive is unlikely to do any such thing.
For a start, it may get thrown out, as a coalition of green groups is urging. Even if it is passed, three member states - Germany, Austria and Italy - have indicated that they disagree with a key section. And last week, a ruling from the appeals board of the European Patent Office (not an EU body) appeared to conflict with another section of the directive.
Confused? You are not alone. The EPO decision was greeted as a victory by both Greenpeace, who had challenged the granting of a patent to plants containing a gene that confers pesticide resistance, and the companies granted the patent. And nobody is very happy with the directive, which Dr Nick Scott-Ram, of British Biotechnology, calls "a fudged compromise" and Anna Brindley, of Greenpeace, "a mess".
As it stands, the directive will allow patents on human genes, proteins, and cell-lines, while transgenic animals will also be patentable. Patents on entire genetically-engineered crops will be allowed, in spite of the EPO ruling last week limiting protection to the altered plant cells.
The issue raises strong views, with opponents arguing that it is morally wrong to "own" a stretch of human DNA, and the industry arguing that without such ownership to guarantee a return on investment, a lot of worthwhile research will never be done. So far, most of the decisions have been going the way of the industry.
The EPO, for example, threw out an attempt by MEPs to disallow a patent covering the gene for H2-relaxin, the protein that relaxes connective tissue to allow a woman's pelvic girdle to widen during pregnancy and childbirth. The patent was granted in April 1991 to the Howard Florey Institute of Experimental Physiology and Medicine, in Melbourne.
The appeal board in this case dismissed all the arguments, moral and practical, against the patent. "DNA is not life," it declared. "Even if every gene in the human body were cloned, it would be impossible to reconstitute a human being."
Last week's ruling on the genetically-engineered plants seemed to offer the objectors something, by narrowing the scope of the patent to the cells, not the entire plant. But Plant Genetic Systems, one of the patentees, was unconcerned.
"We're very happy with the decision," said a spokesman for the company, based in Belgium. "This patent offers the same level of protection as before." The only effect of the ruling, he believed, would be to influence the way the patent claims are drafted in future, not their effect.
The next key decision will be the EPO board's verdict on the "oncomouse" a transgenic mouse bred to die young from cancer. The patent, granted in May 1992, has been challenged by animal welfare groups and will be heard later this year.
