Tokyo

The Japanese Patent Office (JPO) has released guidelines on human gene patents. These outline its view of the patentability of expressed sequenced tags (ESTs), single nucleotide polymorphisms (SNPs) and full-length complementary DNA (cDNA) clones.

Although the office reached a general agreement with the US Patent and Trademark Office and the European Patent Office over EST patents in July — namely that such partial DNA sequences cannot be patented without demonstrated utility — its position on other genetic patents had remained unclear.

The new guidelines, unveiled on 5 October, are a response to a call for guidance from Japanese researchers and industry, particularly in the wake of the government's decision to increase support for biotechnology (see Nature 400 389; 1999).

This initiative includes a planned database of SNPs in the Japanese population, which is hoped to lead to novel drugs and diagnostic techniques, and a project aimed at creating a central repository of cDNA clones for medical and research applications.

The introduction of a technology-transfer bill, based on the US Bayh–Dole legislation, which grants private patents on government-funded research, is also hoped to encourage patent applications from industry–university collaborations. JPO officials predict that such projects will lead to a large increase in the number of patent applications on human genes, including SNPs and cDNA clones. In fact, the Helix Research Institute, a genomics company, has already filed patent applications on more than 6,000 full-length human cDNA clones (see Nature 401, 3 & 520; 1999).

Helix, a joint venture between the Ministry of International Trade and Industry and ten private companies, plans to create a portfolio of intellectual property that can be shared by a planned consortium of 20 biotech companies and research institutes.

But many argue that Helix's patent applications, which largely consist of cDNA clones with unknown functions, are not valid, as they do not demonstrate the invention's utility.

JPO's guidelines on patenting human genes state that the gene must be sequenced and demonstrate utility, such as in diagnosis or treatment. They also specify conditions for patenting a sequence linked to a disease (that is, mutations such as SNPs), which can be used as a probe.

“We may not be successful with obtaining the patents, but the importance lies in the precedent that we have set for patent applications on full-length cDNA clones,” says a spokesman for Helix.