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Date:

August 12, 2000

Subject:

How can the developing world protect itself from biotech

 

How can the developing world protect itself from biotech patent-holders?

Nature 406, 455 (2000) Macmillan Publishers Ltd.

Sir Biotechnology offers great potential for improving health and food
production in the developing world, and achieving both will require
significant cooperation between the public and the private sectors.

Such cooperation is being made more difficult by the accumulation of
intellectual property rights (IPRs). These include in particular patents
on genomic information, and on the basic tools of agricultural
biotechnology such as important genes, promoters, and transformation
methods. Patent considerations have already had to be taken into account
in arranging dissemination of the new vitamin A-enriched rice (see
discussions at http://www.agbioworld.org; archive message 503 gives the
details). Not surprisingly, IPRs in biotechnology are highly
controversial. Yet there is a dearth of knowledge about their impact, and
about appropriate responses.

A concerned group of scientific, legal and economic experts in both
agriculture and medicine, from the developed and developing worlds, met at
the Rockefeller Foundation's centre at Bellagio in Italy earlier this year
to discuss this matter. A number of priorities emerged: the first is to
discover whether there really is a problem. Systematic study is needed,
for example, of the 'platform' and enabling technologies that are most
likely to be valuable to developing nations, to find out whether current
IP practices present a barrier to access.

Allegations of direct infringement, such as those made in recent claims
lodged by the University of Rochester against pharmaceutical firms
marketing Cox-2 inhibitor drugs1, are not the only concern. We need to
know whether the increasing emphasis on IPRs has led researchers to focus
on areas likely to maximize royalty income, rather than address
developing-world needs.

Information is also needed on whether research institutions, concerned
about their relations with donors, are avoiding technologies that they are
legally free to use in a limited context. Will international agricultural
research institutes, for example, distribute crop varieties containing a
Bt gene that is unpatented in developing countries, but patented in donor
countries?

If there is a problem, the second need is to explore the potential to
fine-tune IPR systems. Adjusting standards for granting patents might
limit the scope for restricting access to basic or enabling technologies.
We need to examine concepts such as 'experimental use' and 'dependency
licences', which permit use for certain experimental purposes and for
develop follow-on inventions. These could avert problems such as those
faced by the US National Institutes of Health in gaining access to Cre-lox
technology2. The evaluation will include an economic analysis and the
implications for health care and agriculture. Important lessons may be
learnt from examining past changes in national IP systems.

Other changes also deserve attention. There is an urgent need to examine
the legal remedies available to developing countries that find their
access to important technologies and products restricted by IPRs
highlighted, for example, by the recent debate over HIV/AIDS drugs in
South Africa. Compulsory licences are frequently mentioned in this
context. But other approaches exist, such as the public funding of
licences, technology exchanges, anti-monopoly mechanisms, and creative use
of the leverage available to major donors.

Better understanding of how to manage and license intellectual property in
the public sector is also required. When should inventions be licensed
exclusively and when non-exclusively? When should inventions originating
in the public sector be put in the public domain without legal protection?
Some major research organizations such as the International Maize and
Wheat Improvement Centre are trying to keep their resources freely
available by patenting them before private companies can seize the chance
to do so3.

The adoption of the Trade-Related Aspects of Intellectual Property
agreement (TRIPs) means the roles of international institutions in area of
trade and intellectual property are changing significantly.

The development of international policy needs to be closely studied. This
research is likely to lead to proposals for strengthening the
participation of developing nations, and modifying procedures for
negotiation and resolving disputes.

John H. Barton
George E. Osborne Professor of Law, Stanford University, Stanford,
California 94305, USA

Joseph Strauss
Max Planck Institute for Foreign and International Patent, Copyright and
Competition Law, Marstallplatz 1, D-80539 Munich, Germany


References
Malakoff, D. Science 288, 410-411 (2000).
Marshall, E. Science 281, 1261 (1998).
Dalton, R. Nature 404, 534 (2000).