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E-DRUG: Guardian article on Meningitis Patent

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E-DRUG  Firm attempts to patent meningitis bacteria

The Guardian   Thursday May 7, 1998

An American company has applied to patent one of the bacteria that
causes meningitis. It could lead to royalties being paid on every
treatment if a new vaccine against the illness is found.

The application is one of three filed with the European Patent Office
by Human Genome Sciences (HGS), who are seeking to be the first to own
the whole genetic sequence of bacteria. If the application is granted,
as seems likely, it will open the door for commercial companies to
patent any lifeform from which they think they can make money -
including human gene sequences.

The prospect has appalled scientists in the field, who believe
discoveries should be shared for the common good and that the scramble
for patents for commercial gain will damage research.

There were 2,660 cases in England and Wales last year of the most
dangerous meningococcal form of meningitis, of which 243 were fatal.
Many of the victims of the largest outbreak for 50 years were young
children. The illness strikes quickly and is difficult to diagnose.

Julia Warren of the Meningitis Research Foundation said: "The idea
that someone should try to patent bacteria and then claim a royalty on
our research if we find a vaccine had never occurred to me. I am
stunned. It could make treating children prohibitively expensive. All
our money goes on research: we cannot afford royalties as well. Will
these companies accept responsibility if people die because we could
not afford to vaccinate them?"

The Wellcome Trust, which encourages the sharing of gene research,
also fears the consequences. Celia Caulcott said: "There is evidence
that commercial companies are doing research and then not publishing
it while they look for ways to exploit the knowledge they have gained.
Patenting the knowledge and so having the power to stop people
developing vaccines and other preventive medicines for killer diseases
would be an appalling result."

Until the American applications, scientists had restricted themselves
to patenting individual genes or microbiological processes for which
they had already isolated a commercial use. This new blanket patenting
of an entire gene sequence covers any future possible use of the data
for medical purposes.

Two of the three applications are for troublesome bacteria where
active research is under way to find treatments. The first is
Haemphilus inflenzae, which causes meningitis and is one of the few
strains for which an effective vaccine exists. However, most research
is directed towards finding a vaccine for meningococcal meningitis,
for which as yet no patent has been applied but is certain to follow
if this application succeeds.

Another patent has been applied for Mycoplasma genitalium which is
usually sexually transmitted and causes urethritus, a painful
inflammation. The Department of Health is investigating a screening
programme for this illness. The third bacteria causes no human
disease, but if a gene is extracted for any medical application
royalties would be due.

The applications, each the thickness of a telephone directory, have
been filed at the British Library in advance of a debate on patenting
in the European parliament on Tuesday. This is expected to agree a new
EU directive which backs the idea that all lifeforms can be patented
for profit.

Until now the idea that living organisms can be patented has not been
thought to be acceptable on legal grounds because a patent implies
both an invention and an industrial application. A gene sequence is
merely a discovery and was not previously thought possible to patent
one.

The applications are based on the work of Dr Craig Venter, who
pioneered large-scale gene sequencing. He originally tried to claim
patents on small fragments of genes but has since said he is opposed
to the idea.

However, his erstwhile partner, William Haseltine, who runs HGS, has
applied for 200 patents on individual human genes, and says it is
legitimate business. "We were the first to discover these genome
sequences and to describe practical medical benefits. We have broken
no new ground and acted within established patent rules."

He accepted that scientists had never before attempted to patent a
living organism.

Wendy Watson, of the Hereditary Breast Cancer Helpline, said: "Genes
are becoming a global currency and patents mean that currency will end
up in the hands of a select few. We may end up with monopolies we
cannot overrule. This will harm patients."



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