The Japanese Patent Office (JPO; Tokyo) has released its first directives on human gene patents, outlining the patentability of expressed sequence tags (ESTs), full-length cDNA clones, and single-nucleotide polymorphisms. The directives specify that partial DNA sequences and genes cannot be patented without demonstrated utility, and are in line with the position taken by the US Patent and Trademark Office (Washington, DC) and the European Patent Office (Munich) on human gene patents.

The new directives could be bad news for Helix Research Institute (Chiba Prefecture), which filed patent applications on more than 6,000 full-length human cDNA clones in July. Helix, a genomics company jointly funded by the Ministry of International Trade and Industry (MITI; Tokyo) and 10 Japanese pharmaceutical companies, applied for three patents—two for cDNA clones (sets of 200 and 850) believed to correspond to genes that express membrane and secretory proteins, and one for about 5,000 cDNA clones of unknown function. Critics say Helix's patent applications are unlikely to be approved as the utility of the invention is not clear.