Rush to Patent Genes is Hampering Medical Research

RUSH TO PATENT GENES STALLS CURES FOR DISEASE

Gene patents hit research
The Guardian (UK)

Julian Borger in Washington
Wednesday December 15, 1999

Vital medical research aimed at developing screening methods and cures for
congenital diseases is being stifled by the rush to patent human genes and
the corporate use of those patents to maximise profits. A poll of American
laboratory directors found that a quarter of them had received letters from
lawyers acting for biotechnology companies ordering them to stop carrying
out clinical tests designed to spot early warning signs for Alzheimer's
disease, breast cancer and an array of other disorders.

Although the sharpest impact on scientific research has been witnessed in
the US, under World Trade Organisation rules many of the patents are
applicable worldwide. They could inhibit ground-breaking studies in Britain
and other scientific centres.

So great is the perceived threat to medical research that a group of
American doctors and scientists have issued a protest saying: "The use of
patents or exorbitant licensing fees to prevent physicians and clinical
laboratories from performing genetic tests limits access to medical care,
jeopardises the quality of medical care, and unreasonably raises its cost."

According to the survey, carried out by researchers in California and
Pennsylvania, half the laboratories questioned said they had stopped work
on developing screening because they knew a patent had been licensed or was
pending.

Some of the research scientists who pioneered work on isolating and
identifying genetic deformities linked to serious diseases are now saying
the pace of research and the spread of ideas has been stultified by the
fear of being sued by patent licence holders.

"I've been at conferences where we have been addressed by patent lawyers
and told to stop showing our colleagues our notebooks, or think twice about
submitting an abstract at a meeting," said Jonathan King, a genetic
researcher at the Massachusetts Institute of Technology. "It's a common
experience at scientific meetings for people to withhold information
because they have a patent pending. Progress is being slowed down."

The patenting of genes dates from a supreme court ruling in 1980 that
permitted patenting of some organisms found in nature. But the granting of
such patents has only taken off in recent years after a series of
breakthroughs in deciphering genetic codes.

The survey of US laboratory directors, which has yet to be published,
offers the strongest evidence so far that the "gene rush" to take out
patents on the human genetic code is beginning to inhibit research designed
to turn the explosive growth in genetic knowledge into practical ways of
identifying inherited disorders and finding cures.

It emerges at a time when the ethics of patenting living genetic material
is coming under increasing scrutiny. A race is under way to decode the
human genome - the entire biological blueprint that makes up DNA.

One of the authors of the new survey, Mildred Cho, director of the Stanford
University centre for biomedical ethics, said she was surprised by the hold
the patent lawyers had on genetic testing.

"It will diminish access to testing," she said. "It will affect quality
because laboratories normally cross-check their samples for quality
control. You can't do that if one laboratory is doing all the testing."

Laboratories have received letters from a Massachusetts corporation called
Athena Diagnostics informing them that it has "acquired exclusive rights to
certain tests in the diagnosis of late-onset Alzheimer's disease. These
tests are covered under US patent number 5,508,167, a copy of which is
enclosed," the letters said. Testing anywhere else would infringe that
patent, but Athena would be pleased to perform the tests itself for the
published price of $195 per specimen. That is more than twice the price
previously being charged by some university medical laboratories.

The cost put the test way beyond the researchers operating on government
grants, who need to examine hundreds of samples in the search for new
mutations and possible therapies.

Another biotech company, Myriad Genetics, has secured exclusive licences
based on patents for the BRCA 1 and BRCA 2 genes, mutations in which are
linked to breast and ovarian cancer. Like Athena it dispatched letters
ordering laboratories to stop screening women for the mutations.

Arupa Ganguly, a researcher at the University of Pennsylvania who received
one of the letters, said: "In reality this lab has been stopped from
testing for BRCA 1 and BRCA 2."

Tom Frank, medical director at Myriad, defended the company. It still
allowed testing for purely research purposes, he said, adding that the
company's tests were far more thorough than those carried out by other
laboratories. "It's a little bit disconcerting to license a lab which might
be missing mutations. The tests they were offering were inferior," he said.

Ms Ganguly, however, said the university tests were accurate and much cheaper.

Barbara Weber, a genetics specialist who resigned as a Myriad consultant
earlier this year because of the company's patent policies, said yesterday:
"I felt their interest in making money had completely subsumed their
willingness to be reasonable and collegial."