The NHS may be at risk of being sued over patent infringement, says a new report published by the Human Genetics Commission (HGC), the UK Government's genetics advisory body.
At a meeting held to launch the report on DNA patents, experts warned that public sector health workers who regularly use diagnostic genetic tests protected by patents developed in the private sector may be ignoring intellectual property (IP) rights.
The report highlights a 'profound tension between the industry's desire to exploit the financial value of biomarker patents and the routine infringement of such IP in NHS laboratories'. It urges policymakers to begin to address the issue.
The granting of these patents is seen as controversial and unjustifiable by some within the NHS. Gail Norbury, commissioning and governance director of the Genetics Labs at Guy's Hospital, London, said: 'The view from the NHS is that, for diagnostics, gene patents are unacceptable, unenforceable and detrimental to the delivery of patient services'.
Alastair Kent, the chairman of the HGC's IP monitoring group and director of Genetic Alliance UK, said that it was unlikely that companies would sue hospital laboratories that occasionally use a test that infringed a patent. 'I think there would be a very strong patient and public kick back against any company that was seen to be demanding excessive royalties for providing the opportunity for patients with severe and life threatening diseases getting a diagnosis', he said.
Unlike the USA, where more patents are filed and enforced, the UK has so far avoided seeing large-scale litigation in this area. But companies that have invested heavily in the development of patented techniques may soon be looking for a return.
'The fact that they have not been enforced in the UK so far is that generally the amounts of money have been small and many companies shy away from suing hospitals', said Dr Michael Hopkins of the Science Policy Research Unit, University of Sussex. 'But as the sums of money increase it's more likely companies will assert their intellectual property rights'.
Indeed some believe the UK's approach to patent enforcement may push biotechnology companies towards jurisdictions where patents are more readily enforced. Chief scientist of Cambridge-based Lab21 Dr Berwyn Clarke said: 'The UK should be one of the best countries in the world to operate but at the moment it is one of the worst'.
The HGC made several recommendations including a review of licensing guidelines and government monitoring of the use of IP-sensitive genetic tests and their impact on healthcare diagnosis.