Medical Research in UK Law

Lo 1, and the other Patents, are subject to a Pooled Patents Agreement dated 2 December 2014 between Illumina and Sequenom ("the PPA"), which concerns intellectual property relating to NIPD. Illumina alleged that an exclusive licence under the Lo 1 Patent was granted by Sequenom to Illumina under Section 2.3 of the PPA.

The Paediatric Regulation was to encourage specific research – and dissemination of knowledge about its results —into already known medicines as to their applicability for children. Prior to the Regulation there was no specific incentive for such research. You could then get an SPC if there was delay in getting an MA.

In my judgment, therefore, this is not a case where the Claimant can show that a novel duty of care would be but an incremental development from some well established duty. It would, on the contrary, be a radical departure to impose liability in circumstances such as these.

But, like all guidance on construction, Lord Wilberforce's remarks are more appropriate to some cases than others. This is not a case in which one starts with the presumption that Parliament's intention was directed to the state of affairs existing at the time of the Act. It obviously intended to regulate research and treatment which were not possible at the time. The word "suitable" is an empty vessel which is filled with meaning by context and background.

Common law liability would be measured against those standards, with the relevant professional practice and guidance very much to the fore. Indeed it seems to me evident, given the difficulty of such decisions, that the Courts would allow considerable latitude to clinicians faced with such a dilemma.

Mr Mylonas protests that the emphasis on the ‘interests of justice’ by the judge does not justify an unprincipled extension to the jurisdiction. In my judgment, that submission fails properly to take into account the focus of the judge's finding in relation to the interests of justice. The judge's emphasis was on the prospect of a court trying to make a finding on a matter as important as parentage (and therefore the identity of the Respondent) on incomplete oral and written evidence.