Widespread infringement of DNA patents by public sector laboratories in Europe is making the EU an “unattractive market” for diagnostics companies and holding back the development of personalised medicine.
There is now a “profound divergence” between the commercial diagnostics sector, intent on exploiting the financial value of biomarker patents, and a public sector laboratory community that “routinely infringes” such IP rights, according to a report by the UK’s Human Genetics Commission.
The problem is compounded by the influence of academics and public sector technology transfer offices, which are patenting publicly-funded biomarker discoveries in hope of capturing their commercial value, says the report on ‘Intellectual Property and DNA Diagnostics’, published earlier this month.
The report also reveals a growing divide between the US and Europe in terms of attitudes to gene patents, with commercial testing labs in the US more likely to take out licenses than public testing laboratories in Europe, where there is open hostility to such patents.
To date, most genetic testing involves the diagnosis of monogenetic inherited diseases. Now, the move to develop biomarkers for testing responses to drugs in clinical trials and as companion diagnostics to show if patients will respond to specific marketed drugs, demands a higher investment in validating each biomarker.
There is a need to create better incentives for the development and validation of biomarkers through strong intellectual property (IP) protection, according to one contributor to the report, M J Finley Austin, of the Swiss pharma and diagnostics company Roche. Strong IP protection has been a cornerstone of the pharmaceutical industry’s business model and is needed to preserve incentives for R&D investment.
High cost of validating biomarkers
Whilst it is relatively easy to discover potentially useful drug response biomarkers, the cost of validating them and demonstrating cost-effectiveness is very high, Austin said. Biomarkers will fail in clinical trials, just as many drug fail.
Another contributor to the report, Berwyn Clarke, founder and chief scientific officer of the UK diagnostics company Lab21, agreed, saying IP protection of biomarkers is essential, since it creates a unique selling point and a barrier to entry for competitors. IP is a core part of the business plan of any diagnostics company seeking funding and companies that have IP are more likely to invest in getting full regulatory approval for their tests, Clarke believes.
For Clarke, infringement of IP in the UK is a problem. Lab21 is the UK holder of the license for the infamous Myriad Genetics’ BRCA breast cancer genes, which Clarke suggested, “wasn’t worth the paper it was written on,” because National Health Service (NHS) genetics testing labs are infringing patents on these and other genes.
The advance of personalised medicine requires that there is respect and recognition of IP, to support investment and encourage the development of high quality diagnostics that will underpin it.
Gail Norbury, a senior NHS clinical geneticist and Commissioning and Governance Director of the Genetics Laboratory at Guy’s Hospital in London acknowledged NHS labs have often ignored gene patents, but said the rapid advances in the field mean it is a challenge to stay up to date with IP rights that are relevant to different genetic tests. In one example, the rights for detecting foetal DNA in maternal blood have been licensed to a series of companies, causing confusion about who to approach to discuss use of the technology.
Responsibility for IP issues
The uncertainty created by not being able to access details on licensing fees has implications for costing on grant applications and planning for service contracts, Norbury added. The picture is further complicated because it is not clear who is responsible for dealing with IP issues within the NHS in the UK.
The report concludes that the extent of the impact of biomarker IP on innovations in diagnostics is not clear, nor is the impact of IP on the cost and quality of tests. Balancing the need to support commercial innovation - whilst ensuring patients access and improved tests - will require attention to a slew of interacting factors.
It is recommended that public sector funders review their policy on licensing of patents taken out by the academics they fund. The report also calls for an IP monitoring function to be set up within the Department of Health, to gather evidence on the impact of current policies on the incentives for public sector and private sector biomarker-based innovation in diagnostics; to encourage private sector IP biomarker holders to contribute genetic data arising from diagnostic tests to public databases with the aim of developing libraries of the relevant DNA sequences which are as comprehensive as possible, whilst ensure confidentiality of individual data; and to develop guidelines for out-licensing and in-licensing of IP by public sector funded staff.
The report, based on a workshop organised by the Human Genetics Commission in October 2010, was published earlier this month. Last week, Alistair Kent, chair of the IP Monitoring Group at the Commission submitted the report to a review of innovation in the UK National Health Service, which is taking place currently.
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