Heart valve case by-passes experimental-use exemption

There is a dearth of UK case law on the application and scope of the experimental-use defence since the 1985 Monsanto v Stauffer decision. Many speculated that the UK court would, if asked to consider the issue, adopt a liberal approach to the construction of the exemption - akin to that adopted by the German Federal Supreme Court in the Clinical Trials I and II cases of the mid-1990s.

Read Wragge & Co's analysis on obiter comments made by Mr Peter Prescott QC (sitting as a deputy judge of the High court), in his 9 January 2009 judgment in CoreValve Inc. v Edwards Lifesciences. His comments suggest a more restrictive approach to the construction of the research exemption than predicted.