NHS labs may be ill-prepared to deal with patents on genetic tests

BioNews reporting from the British Society for Human Genetics (BSHG) annual conference in Warwick:

NHS genetic testing laboratories may lack the funds and legal expertise necessary to cope with the increasing number of patented genetic tests coming on to the market, according to Dr Michael Hopkins, researcher in science and technology policy at the University of Sussex. The licensing fees demanded by patent owners will inevitably drive up the cost of genetic tests and the government must be prepared to foot the bill for this and provide support to labs facing legal challenges over patents, he told delegates at the annual meeting of the British Society for Human Genetics, held in Warwick last week.

Dr Hopkins says that more needs to be done to provide labs with the support they need to deal with patent-related issues. He said: 'Many labs don't realise they are infringing patents. They develop their own in-house 'home brew' tests, often without checking for patents first and there's going to be legal implications for that at some stage. The government needs to accept this as a reality and start providing labs with the necessary support to deal with legal challenges if it wants to continue to promote patenting as a means of driving innovation in genetics.'

While many see patents as necessary to ensure that companies secure a return on investment for their inventions, patents can prove problematic in the field of genetics where many feel the identification of a gene sequence should be viewed as a discovery, not an invention. In recognition of this the European Patent Convention has strict rules in place which ensure that companies can't patent genes directly, but the law does allow a monopoly over technical applications arising from the identification of a gene sequence of interest, warns Dr Gerry Kamstra, biotech expert in patent law at Bird and Bird.

Also speaking at the BSHG meeting, Dr Kamstra said: 'Companies can't patent gene sequences per se, but they are allowed to patent the chemical tools which allowed them to sequence those genes in the first place, as well as technical applications of their inventive effort such as isolated gene sequences or probes. Some companies decide to exploit their monopoly over such technical applications by restricting use of the patented technology to themselves, rather than by allowing others to access it by paying a licence fee or royalty. In some cases they may have good reasons for doing this, such as a guarantee of technical quality, speed and ready availability of their products and services. I think it's definitely an area that warrants further investigation.'