In the news

The US Patent Office has issued new guidelines on the patenting of gene-related inventions (see recent press release). The PTO rejected calls for genes and gene-based products to be removed from the scope of patent protection altogether, but the new guidelines tighten up the requirements for applications to demonstrate utility, stating that the utility must be "specific, substantial and credible". The guidelines also imply that the onus of proof of such utility rests with the applicant, and that patent examiners may reject applications if they consider that utility has not been clearly demonstrated. Some commentators in the biotechnology industry fear that the new rules will stifle research but others have welcomed them as a spur to companies to strive to find truly novel gene-based approaches to disease diagnosis and therapy. The full guidelines are available on the web site of the US Patent Office