Following concerns that the strict patent infringement tests applied by the Courts in the UK are driving lucrative clinical trials overseas, the UK government has now concluded a review of the statute that would allow for a broader ‘Bolar’ exemption to enter UK law.
For several years the UK position has differed from that in, say, Germany where a more liberal approach has existed to exempting research studies and trials from patent infringement if the research is directed at obtaining regulatory approval for an innovative drug. In its staunch defence of one of the few manufacturing industries left in the UK, the government has listened to the big pharma and CRO lobbies and decided that we need more home-based clinical trials. The proposal is not limited to exemption from infringement for trials directed solely at obtaining regulatory approval in the UK or EU, but is broad enough to cover submissions to other countries too. The Chancellor of the Exchequer is clearly expecting that legions of drugged up students desperately hoping to pay their university fees will be a major driver for growth in the floundering UK economy.
The conclusion of the Government’s consultation reads:
The Government … accepts that section 60(5) of the Patents Act 1977 should be changed to include an exemption from infringement, for activities involved in preparing or running clinical or field trials involving innovative drugs for the purpose of gaining regulatory approval in any country. This exemption should also cover activities involved in health technology assessment (HTA). The change should be brought about using a legislative reform order. [emphasis added]
The revision is likely to occur in the next twelve months and is seen more as a realignment of policy to bring the UK into line with other European nations rather than as a major shift in the balance of power in the pharma industry. Of course the actual cost of running clinical trials in the UK is more likely to determine whether Britain becomes a willing population guinea pigs than any change in the statute. However, the pharma industry of all sizes will likely welcome this legislative tweak.
