The Human Genetics Commission recently published a report on Intellectual Property and DNA Diagnostics which focused on the unlicensed use of patented DNA marker tests for diagnostics in publicly funded laboratories. Although the report focused on NHS laboratories the issues it raises will also apply to research laboratories in education institutions and the researchers working in them.

The report looks at the patenting of DNA sequences and DNA marker tests and the use of such patents by public sector laboratories in research and diagnostics. The current position is that laboratories often use these in breach of IP rights, but that the rights aren't enforced due to the cost of litigation and the low comparative value of marker tests.  However, as new DNA marker tests are patented for more common diseases this status quo is likely to change as R&D companies will want to exploit the fruits of their work. The US has already seen an increase in litigation to protect DNA patents and it is very likely that this trend will reach the UK.

It is easy for researchers to lose sight of what licences are required for research and the status quo has done nothing to help matters as researchers may not even be aware that there is a need for a licence.  Dr Hogarth of King's College is quoted as saying that the current system of "tacit approval" of infringement by the DoH and politicians cannot continue (The Telegraph). Some researchers will also get caught up in the academic debate about whether the patenting of DNA sequences or marker tests is inherently wrong or ethical, but it is important to understand that from a legal perspective this is irrelevant; if there is a patent which is enforceable in the UK they will require a licence to carry out research using the DNA sequence or marker tests. Institutions also need to be aware of this and should try to assist their researchers in reviewing whether licences are necessary and obtaining the relevant consent.