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Photograph (omitted)

This time next year the single European market will be born. As midwife,
preparing for the happy event, the European Commission has been pressing
hard to make the laws governing business consistent across the Community.
Arguably the most contentious of these measures is the attempt to ensure
that the 12 member states have the same law on patenting the products of
biotechnology.

First put forward in 1988, the proposal is presently blocked in the
European Parliament, where debate over the ownership of genetically engineered
plants and animals has generated a furore rare even in Brussels. The notion
of these ‘life patents’ has opened up a hornet’s nest of moral, legal, social
and scientific concerns. Industry ministers are expected to discuss the
proposal in the coming months and, while the Parliament’s protests have
no legal force, the storm is one that elected ministers are unlikely to
ignore.

On one side of the argument is the chemicals industry, which insists
that without rigid patent protection for virtually everything its members
wish to market, the US and Japan will obliterate European biotechnology.
Britain’s BioIndustry Association says ‘uncertainty’ over future patent
protection for biotechnology ‘is already hampering investment in the industry’.
While the Community debates the issue, ‘the entire future of European biotechnology
is hanging in the balance,’ says Louis Da Gama, the association’s director.

On the other side of the argument is an alliance of religious groups
and Greens, who insist that patenting a living thing is immoral. In the
middle are lawyers, scientists, plant breeders and environmentalists who
are worried by many of the implications of widespread life patents.

Commission officials say the issue is clear. The products of biotechnology
will have a market worth $40 billion in 2000. Those profits will go to
the companies that hold patents on these products. The Commission wants
those companies to be European.

Within Europe, companies can acquire both national patents and European
patents, awarded by the European Patent Office (EPO) in Munich. The Commission
can change only national laws on patents. It has no jurisdiction over the
EPO, but aims to influence its application of the European Patent Convention,
by clarifying what can be patented.

In the 1960s, when the convention was being drawn up, there were concerns
that companies could use patents to control sectors of vital public interest.
As a result, the convention prohibits patenting of food, surgical and other
therapeutic procedures, plant and animal varieties (but not microorganisms),
and ‘essentially biological’ ways of producing plants and animals. Patents
on anything contrary to ‘public order’ or ‘morality’ are also banned under
the convention.

The problem has been applying this list to biotechnology. In 1989 EPO
examiners rejected a European patent for the Harvard ‘onco-mouse’ on the
grounds that it was an animal ‘variety’. The mouse, which has a cancer-causing
gene or ‘oncogene’ inserted into it, develops tumours within a few months
of birth. This makes the creature a boon to medical researchers, and it
has already been patented in the US.

The European examiners were overruled in 1990 by the EPO appeals board.
When the convention was written, ‘variety’ could only have described animals
produced by a breeding programme; genetic engineering did not exist. Certainly,
said the appeals board, the term was not meant to exclude all animals from
patenting. Once this was decided, the important issue was morality, it said.
The examiners were told to decide whether the mouse’s suffering outweighed
its potential benefit to medical research.

Last October, the EPO decided in favour of cancer research, and the
onco-mouse could be patented (This Week, 19 October 1991). But at the same
time it ruled against a French creature – a mouse given various genes for
hair and wool, making it a model system for research into hair growth. This
creature’s raison d’etre was judged to be too trivial to be morally justifiable.

The patent examiners in Munich admit that they are not the best people
to decide questions of public morality. Marie-Angel Hermitte of the French
national research agency, CNRS, who addressed the European Parliament on
the issue, calls it ‘a scabrous accounting between the interests of humanity
and the interests of the animal’. She says the process leaves ethical choices,
‘not to society as a whole by means of law . . . but once more to interest
²µ°ù´Ç³Ü±è²õ’.

According to Hermitte the ethical choices should be laid down in law,
by the European patent directive. But, so far, the proposed directive does
not seem to reflect ‘society as a whole’.

The original proposals allowed nearly anything to be patented, even
the plant and animal varieties excluded by the European Patent Convention.
Church groups protested that even human beings were not excluded. In a revision,
last year, the Commission duly excluded humans. But Hermitte notes that
in Britain embryos up to two weeks old could still be patented because,
under the Human Fertilisation and Embryology Act 1990, they are not legally
human. The national ethics committees of France and Luxembourg have called
for a ban on any patents for human organs, cells or genes (This Week, 14
December 1991), but, so far, such patents are permitted in the proposed
directive.

The loudest protests in Brussels are reserved for patents on animals
and humans. But it is plant patents that are expected to have the most immediate
impact. Plant patents are already permitted by the EPO, but have only been
used extensively for three years in Europe and the US. Pat Mooney of the
Rural Advancement Foundation in Canada, which opposes patents, says it is
too early to see the effects of these patents. But their effects will be
hard to avoid, he says.

For example, ordinary patents applying to a product are ‘exhausted’
once it has been sold. The manufacturer will have negotiated a licence to
use the patent and will have agreed to pay royalties for the privilege.
The product can then be resold without attracting further royalty payments.
But under the proposed directive, living things would continue to be covered
by patents after their sale. Their offspring would also be patented. Britain’s
BioIndustry Association points out that were this not so, competitors could
make patented microorganisms patent-free by simply leaving them in a culture
dish for a generation.

This would mean, for example, farmers having to pay royalties on seed
they save from patented crops. At present, no such duties must be paid.
Storing seed saves farmers $80 million a year in Britain, and more in other
Community countries. American farmers save $500 million per year by setting
aside seed from wheat, soya bean and cotton alone, according to studies
at Cornell University. Being denied these savings would particularly hurt
small farms.

Another casualty of the widespread use of plant patenting could be plant
breeding organisations and companies. In most of Europe, breeders’ rights
are protected by a 1961 convention on plant varieties known as UPOV. This
gives breeders exclusive rights to sell varieties that they produce, but
allows other breeders to use those varieties for further breeding. These
rights resemble copyright in that a breeder owns a particular ‘arrangement’
of genetic information, but not the genes themselves.

With widespread patents, however, breeders will have to check any strains
they wish to use for breeding to see if they contain any patented traits,
or if any patented technique was used to create them. They will then have
to pay royalties on any such strains that they use. At a recent conference
at the European Parliament, plant breeders predicted that these extra costs
would bankrupt most small seed firms.

Henk Hobbelink of the pressure group Genetic Resources Action International
(GRAIN), which is lobbying against the directive, says patents will also
lead to increased genetic uniformity on farms – a move which could increase
the risks to crops from pests and disease. Breeders will be limited to genes
they can afford and that patent holders are willing to license to them.
Companies would be more likely to promote patented varieties, which would
not necessarily be the most desirable varieties. Hobbelink says this will
reduce diversity, while royalty costs to farmers will be passed on to consumers.

Biotechnology firms want the Commission to give them exclusive patents.
This means they would be able to decide who gets a licence and how much
they should pay. Such a move would allow the companies to ‘play the market’,
says Mooney, with multinationals agreeing to sell each other, say, rights
to a patented corn variety here in return for rights to a hybrid production
process there. He says such market leverage means more to companies than
royalty payments.

To prevent a patent owner simply refusing to issue licences, the Commission
called originally for compulsory licensing of patented plants or animals
to breeders (on payment of a ‘reasonable’ royalty), three years after a
patent is granted. Willy Rothley, a Socialist member of the European Parliament,
wants the three-year requirement scrapped, to help breeders. But in recent
revisions, the Commission has instead increased the waiting period to 10
years. Britain’s BioIndustry Association says compulsory licensing ‘is potentially
a very serious disincentive’, because patent holders could no longer choose
who to grant licences to.

According to EPO records, a third of all the plant patent applications
made to the EPO before 1990 came from three companies: Lubrizol, Monsanto
and Ciba-Geigy. Hobbelink says three-quarters of the applications were made
by transnational corporations, or companies on contract to them. He predicts
that small breeders will be wiped out and that small biotechnology firms
will be bought up by multinationals. This trend will concentrate patents
for crop plants in the hands of companies that already produce most of the
world’s agricultural chemicals and control much of the food processing business.
Power over food production would then be in the hands of a few big companies.

Critics charge the Commission with talking only to big business when
drafting the directive. They point to provisions stipulating that if a company
patents a process to make something that can already be manufactured by
other means, it is up to everyone else who makes that product to prove they
do not use the patented process. This reverses the usual burden of proof
under patent law.

Inge Govaere, a legal expert at the University of Ghent, envisages a
situation in which a farmer who buys a patented animal would owe royalties
on every one of its descendants. Under the proposed directive, the farmer
would have to prove that any animal born on the farm was not descended from
the patented beast. ‘Farmers would spend more time in court than on their
farms,’ she says.

These fears raise the question of what patents are for. Commission officials
take the classic view: if companies invest to create a product, they should
be given a period of exclusive marketing rights to recoup their investments.
Mooney disagrees. He points to the spate of applications for plant patents
three years ago, when they were first permitted. The research for those
products had already been done. He cites the economist Milton Friedman,
who called patents an unfair distortion of the free market by governments.

Some patent lawyers in Brussels, who are familiar with the proposed
directive, privately doubt whether its real aim is to promote innovation.
Electronics firms, they note, often patent processes and designs with the
specific aim of preventing their competitors from exploiting them.

Just such a pre-emptive strike may have been made by the National Institutes
of Health in the US. NIH officials last year filed patents for a number
of sequenced human genes for which functions have not yet been identified.
This should ensure that the NIH will have a claim on any commercial use
found for the genes. The move may also discourage others from doing research
on the genes. Such patents would be permitted by the proposed European directive.

The Commission says patents are essential for scientific openness. Without
protection, it says, companies would keep data secret. But some scientists
in pharmaceuticals companies say privately that patents do not lead to openness.
Results must be kept secret while the lawyers apply for patents, preventing
scientists from sending results to journals. Even data that may conceivably
lead to something patentable must stay secret.

Another form of openness which could be put at risk by the Commission’s
proposals is the exchange of seeds, crops and wild plants that now underpins
the world’s crop breeding system. At a meeting in 1990, scientists from
the IARCS – publicly-funded international agricultural research centres
that develop crops chiefly for developing countries – said lack of patent
protection for their discoveries made it difficult for them to share data
with researchers at private biotechnology firms.

Developing countries are already responding to the prospect of IARCS
and private firms claiming exclusive marketing rights to genes collected
free from their territories. In December, Costa Rica sold exclusive rights
to its native crop varieties to the US company Merck, barring others from
free access to the country’s gene pool.

The European Patent Convention states that patents were meant for inventions,
not discoveries. Until scientists can create an original gene–which they
cannot yet do – it is questionable to what extent any biological entity
can be patented. There is an increasing feeling among European politicians,
agricultural experts and concerned citizens, that Europe should come up
with a more imaginative and appropriate means of rewarding its biological
innovators.