HIV researchers were first surprised, then baffled, and finally outraged.
Human Genome Sciences (HGS), a company based in Rockville, Maryland, issued a
press release proudly proclaiming that it had been granted a patent 鈥渇or a human
gene that produces what is believed to be the critical entry point for the AIDS
惫颈谤耻蝉鈥�.
But experts knew that the company wasn鈥檛 responsible for showing that the
product of this gene, CCR5, helps the AIDS virus to enter cells. In fact, HGS
applied for the patent in 1995鈥攁 year before several other groups
published pivotal experiments showing that HIV depends on CCR5.
HGS has been able to obtain a patent based simply on sequence information
that the Human Genome Project had made public. A computer program analysed the
sequence and found that it looked similar to genes for a family of known cell
receptors.
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The DNA sequence itself occurs in nature and can鈥檛 be patented, but the
company had enough information from the computer analysis and laboratory tests
to speculate on ways that the gene could serve as a drug target. It was this
informed speculation on the gene鈥檚 function that turned a 鈥渄iscovery鈥� into a
patentable 鈥渋nvention鈥�. 鈥淲e even went on to guess that it might be a virus
receptor in that patent,鈥� says William Haseltine, chief executive officer of
HGS.
It turned out to be an extremely profitable prediction. Perhaps that鈥檚 why
the CCR5 patent, awarded two months ago, has been singled out for such
opprobrium. Craig Venter, president of Celera Genomics in Rockville, Maryland,
and hardly a stranger to controversy himself in the field of genomics, charges
that the combination of free DNA sequences and liberal patent requirements has
enabled lots of companies to file a patent 鈥渨ithout doing any work鈥�.
But Lee Bendekgey, a lawyer for gene patenter Incyte, says: 鈥淗ow you got the
information is irrelevant as long as the information is reliable and
肠辞谤谤别肠迟.鈥�
Companies such as HGS and Incyte Genomics in Palo Alto, California, have
filed thousands of applications based on little more than DNA sequence
similarity and speculation. Hundreds of such patents have already been awarded
(see Table).
Chuck Ludlam, vice-president for government affairs at the Biotechnology
Industry Organization in Washington DC, predicts that a flood of gene patents
will be granted in the coming months. There are already 20 000 applications
pending at the US patent office. Europe is some way behind with just a few
thousand applications based on gene sequences, according to the European Patent
Office in Munich.
But will these patents strangle research or turbocharge drug development?
Critics like Jon Merz at the University of Pennsylvania鈥檚 Center for Bioethics
in Philadelphia worry that granting broad patents primarily based on sequence
information could prove a disincentive for scientists who don鈥檛 hold the patent.
鈥淭heir research would be immediately taxed if it was ever fruitful. That鈥檚 the
problem with CCR5. I do have a lot of concerns about being able to tie
up the development of therapeutics based on the gene.鈥� Incyte and HGS retort
that patents are already responsible for attracting drugs company
investment.
It has been widely assumed that purely academic or non-profit research will
be immune from patent squabbles. But the evidence suggests otherwise鈥攁s
Andrew Read, a geneticist at St Mary鈥檚 Hospital in Manchester, already knows.
Read runs tests for patented cystic fibrosis and breast cancer genes, and has
already had a demand for royalties from one company. He predicts that in Britain
this will become an increasing problem for the National Health Service. In the
US, Myriad Genetics of Salt Lake City, Utah, has already cracked down on labs
testing for the breast cancer gene BRCA1 without paying licensing fees.
These examples highlight the problems where a gene patent gives a company a
monopoly on a single gene.
But in the case of CCR5, other patents may still be granted if
distinct biological functions for the gene can be demonstrated鈥攂ut this
raises the spectre of a quagmire of litigation if the differences in such
functions are disputed.
As yet, it鈥檚 not clear how many of these gene patents will even hold up in a
court of law. Law firms are no doubt licking their lips in anticipation of a
feast of protracted patent infringement actions. 鈥淧eople are rushing to
conclusions prematurely,鈥� Ludlam says. 鈥淭he last word on this is not the Patent
and Trademark Office, but the courts.鈥�