IN A decision that may have far-reaching consequences for the
biotechnology industry, the US government has decided that it will grant patents
for tiny fragments of synthetic DNA that may correspond to commercially valuable
genes鈥攔egardless of whether a link to any particular gene has been
established.
The DNA segments, known as expressed sequence tags (ESTs), are cheap to make,
so the decision by the US Patent and Trademark Office, announced on 14 February
at the AAAS meeting, will encourage companies to try and stake claims to
expanses of the human genome by mass producing ESTs and patenting them.
ESTs are produced from messenger RNA, which normally tells cells how to
manufacture proteins and is made by DNA. ESTs are made by reversing that process
and using fragments of messenger RNA to replicate a segment of the original
DNA.
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Companies that have been filing for patents on ESTs claim that they are
useful鈥攁 prerequisite for a patent鈥攂ecause they can be used as
probes to find genes in the human genome. But they also hope that the EST
patents will guarantee a share of the profits from genes that may allow
researchers to develop lucrative new drugs. Lawrence Goffney, deputy
commissioner of patents and trademarks, said in Seattle that it was the probe
argument that convinced the patent office. 鈥淓STs are useful鈥攙ery low use,
but they are useful.鈥� A patentable invention need not be enormously useful, he
argued: the patent office will award a patent for a screwdriver that boasts only
a minor modification, for example.
But many molecular biologists reject this reasoning. Leroy Hood of the
University of Washington in Seattle complains that ESTs are merely listings of
the chemical sequence of a gene. 鈥淓STs are the ultimate in non-thinking,鈥� he
says. A gene should be patentable only in conjunction with an identified
biological function, Hood argues. If a second researcher finds another function
of a gene, that should also be patentable.
Alan Williamson, vice-president of research strategy for Merck Research
Laboratories in Rahway, New Jersey, fears that EST patents will hinder research.
Biologists may have to pay royalties to the labs that have patented the ESTs if
they wish to use them in their work, he says. Although it is possible to patent
a screwdriver, 鈥渨e don鈥檛 think you should have to pay royalties on everything
you build with that screwdriver鈥�, he argues.
But Robert Benson, a patent attorney with Human Genome Sciences of Rockville,
Maryland, the company that has led the way in patenting ESTs, points out that
restriction enzymes鈥攁 key tool in molecular biology used to cut
DNA鈥攁re already covered by patents. 鈥淪omehow the biotech industry has
managed to cope with that,鈥� he says.