Patent examiners in the US have made it tougher for gene researchers to obtain patents on genes.
From now on, the US Patent and Trademark Office will turn down patents unless applicants state at least one 鈥渟pecific, credible and substantial鈥� use for the gene.
The word 鈥渟ubstantial鈥� has been newly added to the guidelines that were originally issued for consultation in December 1999. The tougher wording will force applicants to spell out at least one genuine application for newly discovered genes, or fragments of genes.
Advertisement
A key objective is to deter applicants who sequence thousands of genes or gene fragments, then assign functions by guesswork. 鈥淧eople can鈥檛 now get away with 鈥榯hrowaway鈥� utility,鈥� says Brigid Quinn, a spokeswoman for the PTO.
鈥淭he guidelines are seen as raising the bar on the utility an applicant needs to show,鈥� says Quinn. 鈥淎ddition of the word 鈥榮ubstantial鈥� means that it must now have a real-world application,鈥� she says.
All proteins made by genes could be listed as potential additives for dog food or shampoo, for example, but this would not now qualify as a bonafide, 鈥渟ubstantial鈥� application, she says.
Fixed framework
The guidelines have been welcomed by the biotechnology industry. 鈥淲e think the PTO has done a great job,鈥� says Lila Feisee, director of intellectual property at the Biotechnology Industry Organization in Washington DC. 鈥淭hey鈥檝e given us a framework in which to work, so we know how to file for specific applications and when to put a little bit more information in.鈥� Beforehand, says Feisee, it was possible to obtain a patent simply by saying that a newly sequenced gene could be used as a molecular probe for detecting that same gene in humans. But now, the applicant would have to say why finding the gene would be important, linking its presence with a disease, for example.
Opponents who oppose patenting of genes criticised the new guidelines, however. 鈥淭hey鈥檙e fiddling with technical details when I believe a gene should not be patented because it鈥檚 part of nature,鈥� says David King of the London-based Campaign Against Human Genetic Engineering lobby group. 鈥淭hey鈥檙e not inventions and shouldn鈥檛 be patentable,鈥� he says.
鈥淚f we allow a small number of companies to patent thousands of genes, the future of medicine will be hostage to those companies,鈥� says King.
Tough in Europe
The PTO has dismissed these concerns, listing detailed responses on its . It says that genes qualify as inventions provided they are manufactured and used outside nature.
This same argument is used to defend gene patenting in Europe by the European Patent Office. A spokesman for the EPO said that Europe has tougher rules on gene patenting anyway, and that the new guidelines simply bring the US into line.
鈥淓uropean rules have been considered tougher than the US ones, and the function of the gene must be described,鈥� says the spokesman.
