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The Green group in the European Parliament has appealed against the
granting of a patent for a human gene. Last year the European Patent Office
in Munich awarded the Howard Florey Institute at the University of Melbourne,
Australia, a patent on the gene for a human hormone, relaxin. The Greens
have lodged a formal protest with the EPO in the hope that the case will
arouse public pressure for a European ban on patenting human genes.

Relaxin, a hormone that causes the muscles of the birth canal to relax,
is produced by the ovaries during labour. Relaxin from pigs has been used
to assist women in labour. Genentech, the US-based biotechnology firm, has
taken out a licence for relaxin with a view to marketing the human version
as an obstetric drug.

Genentech will have to wait for patent protection in Europe, however.
The legal procedure started by the Greens last week takes time. An appeal
against the first European patent on a genetically modified plant, granted
in 1989, could finally be heard by the appeal board of the EPO later this
year.

The Greens have launched the case in order to delay the licence, says
their legal counsel, Rolf Wilhelms. They hope public pressure against patenting
human genes will be brought to bear on the EPO while the appeal is pending.
They also want to force changes to the directive on patents for biological
inventions, to be decided by the European Community this year (‘Europe debates
the ownership of life’, New Å®ÉúСÊÓƵ, 4 January).

The EPO has granted patents on several human genes, starting with the
insulin gene in the mid-1980s. The European directive, as it stands, would
permit other human genes to be patented. The Greens say genes should not
be patentable, because they are discoveries, not inventions.

Rainer Osterwalder of the EPO says genes are regarded as ‘chemical compounds
that can be used to provide technical solutions to precisely defined problems’.
It is the production and application of the cloned gene that is regarded
as the patentable invention, he says, not the discovery.

The patenting of human material is causing increasing strife in Europe.
The Baylor College of Medicine in Texas applied to the EPO in 1988 to patent
a method for expressing specific genes in the mammary glands of mammals.
They also applied to patent any mammal with the implanted gene in its germ
line. The application asked separately for a patent on ‘mammals’ and ‘nonhuman
mammals’. The EPO says Baylor wanted to patent a human with the implanted
gene, and rejected the application. Baylor is appealing. Paul Braendli,
head of the EPO, says ‘human beings are not patentable’.

But patenting humans is not explicitly prohibited in European law. Braendli
bases his assertion on his interpretation of an article of the European
Patent Convention stating that patents must not contravene ‘public order’.
This moral concept has so far been a matter for interpretation by the patent
examiners.

The Greens want the European directive on biological patents to make
morality explicit. They want to stir up public pressure to ensure that Community
industry ministers ban patenting of human genes specifically, when they
make the final decision on the directive.