The patent landscape for RNAi 'gene silencing' - including CSIRO's hairpin RNAi technology - has been significantly clarified following the resolution of several opposition and re-examination cases in Australia.
RNAi-based gene silencing has been hailed as one of the most significant advances in biological and medical science in recent years.
Hairpin RNAi is used widely as a research tool to identify the function of genes in plants and animals and has huge scope for developing novel traits for use in agriculture, veterinary and medical science.
CSIRO has now been granted a patent for hairpin RNAi in Australia (No. 760041) after the completion of both an opposition process and a re-examination by the Australian Patent Office. This follows the granting of similar patents to CSIRO in China and New Zealand.
“Our patent application lodged in 1998 and based on CSIRO's early development of hairpin RNAi has been substantiated through this testing process. The granted patent covers use of the technology in plants, animals and humans,” says Dr Rob de Feyter, Intellectual Property Manager at CSIRO Plant Industry.
In a second case in Australia, CSIRO was successful in opposing a patent application (No. 747872) in the name of Syngenta Ltd, with broad claims to RNAi gene silencing. The opposition was recently resolved by withdrawal of Syngenta's application.
In a third case, two patents (Nos. 743316, 2001100608) co-owned by CSIRO and Benitec Australia Ltd, were maintained after re-examination.
These patents claim use of DNA-delivered RNAi in animal and human cells. Benitec has commercial rights for use in humans and related applications while CSIRO has exclusive rights for all other applications.
“Resolution of these patent cases provides greater clarity and confidence for users of RNAi. CSIRO will keep providing access to the technology through research and commercial licences,” says Dr de Feyter.
CSIRO has continued to develop and fine tune RNAi technology in more than 10 years of research, leading to a further nine patent families, and establishing CSIRO as a key player in this area of research.
This was confirmed by the recent grant of US Patent No. 6933146 to its 'Hellsgate' series of RNAi gene silencing vectors.
CSIRO is using hairpin RNAi for a range of research purposes including developing valuable new traits for plants and livestock animals.
Around the world others are using hairpin RNAi to identify the functions of genes in plants and animals and to develop technology to combat diseases in plants, animals and humans.