munich

A long-standing question at the European Patent Office (EPO) about whether it is legally entitled to grant patents on transgenic animals and plants could soon be resolved, following last week's approval by the European Parliament of revised rules on the legal protection of biotechnological inventions.

The EPO has almost 2,000 such applications in abeyance, following a decision two years ago that the exclusion of plant and animal varieties from patentability by the European Patent Convention of 1973 is sufficient to reject a patent on a plant or animal that has been genetically modified.

But the draft European directive explicitly allows patenting of life, including human genes, provided that a truly inventive step and industrial use can be proved, and provided that the procedures involved are within defined ethical limits.

It also requires the European Commission to set up a bioethics committee, which would report annually to the parliament on issues concerning the patenting of biotechnological inventions (see panel).

The directive must be approved by the European Council of Ministers in November, before returning to parliament for its second reading, expected early next year. But the council's support for the initial draft, the modifications to which have been generally accepted by the commission, means that a successful conclusion seems virtually guaranteed.

The pharmaceutical industry has welcomed the parliamentary vote, saying that it will help Europe's biotechnology sector to catch up with the United States and Japan. But it has been criticized by environmentalists, who continue to oppose patents on novel life-forms.

The first draft of the directive was unexpectedly rejected by the parliament in 1995 because of ethical concern about patenting of life and human genes, as well as concern that it could impinge on farmers' privilege to breed or propagate stock (see Nature 374, 103 103; 1995).

The commission, which drafts all European Union directives, was more careful with the text in its second attempt. It consulted industry, pressure groups and other stakeholders before putting pen to paper (see Nature 379, 197 197; 1996), and included additional clauses to safeguard ethical standards.

But members of the parliament still tabled hundreds of amendments, reflecting a controversy that cuts across political party lines. And, in a unique move, the parliamentary Committee on Research, Technological Development and Energy declined to give an opinion of the directive before its first reading because of disagreements about which amendments to recommend.

As now approved by the parliament, the draft directive excludes patents on procedures for human reproductive cloning and germline therapy, and methods using human embryos. But many opponents of the directive remain upset that patenting of any form of life should be allowed. “This is a sad day for human respect for life,” said a spokesman for Greenpeace after the vote.

Peter Stevenson, political and legal director of the British pressure group Compassion in World Farming (CIWF), says he is “deeply disappointed” that parliament has voted to allow animals to be patented. But he welcomes a clause that excludes patents on processes for modifying the genetic identity of animals “which are likely to cause them suffering or physical handicaps without any substantial medical benefit to man or animal”.

The addition of the word ‘medical’ by the parliament means that benefits to agriculture alone will not necessarily outweigh any proven suffering to an animal genetically engineered, for example, to overproduce growth hormone, as grounds for rejecting a patent.

Stevenson says that CIWF has filed an opposition to a patent issued to the Australian company Bresagen on a method for producing transgenic pigs with extra growth hormone genes, claiming that such animals suffer joint disease, gastric ulcers and diabetes.

A spokesman for the EPO says the exclusion clause is likely to cause problems for patent lawyers because of the difficulty of legally interpreting what constitutes a physical handicap. In principle, the EPO is not formally bound by EU directives, as it is not an EU body. It was established by a separate convention with its own rules on what may be considered patentable. But in practice the directive would have a profound effect on EPO policy.

Eighteen months ago, opponents of patents on life, who had never managed successfully to oppose a patent on ethical grounds, exploited a loophole in the EPO's convention and put an abrupt stop to issuing of any new patents on transgenic plants and animals.

The convention, which was drawn up in the early 1970s, allows animals and plants to be patented in principle, but excludes animal and plant varieties from patentability, to allow breeders to claim their traditional non-patent rights to new varieties.

In 1995 an EPO board of appeals ruled against a patent issued to the Belgian company Plant Genetics Systems (PGS) on a procedure for producing plants containing a new gene conferring resistance to herbicides based on glutamine synthase inhibitors, which also covered their progeny. The patent office accepted opponents' arguments that a transgenic plant can also be considered a plant variety, and is therefore not patentable.

Until this precedent is overturned by a further decision by an appeals board, the EPO cannot legally issue further patents on transgenics. A backlog of around 1,200 patent applications for plants, and 500 or 600 on animals, has since built up.

The next case to be brought to the EPO board of appeals, scheduled for October, will consider an appeal from the Swiss company Novartis against the rejection — following the PGS case — of its patent application for a process for creating transgenic plants containing genes conferring pathogen resistance, and again covering their progeny.

The board will refer to the draft directive to help it to interpret the ambiguity in the EPO's rules created by the advent of genetic engineering. The draft states unambiguously that “inventions which concern plants or animals may be patented if the practicability of the invention is not technically confined to a particular plant or animal variety”.

In the unlikely event that the board of appeals rejects this interpretation and upholds the ruling in the PGS case — that animals and plants are not legally distinguishable from their varieties — it would cause a major conflict, as EU member states, which form the core of EPO members, will be required to incorporate the directive in national legislation.