Welcome to the (very full) Summer 2020 edition of Inside Life Sciences.
Although it may seem surprising, I do not intend to dedicate much time to the impact and consequences of the COVID-19 pandemic on the Life Sciences industry. So much has happened that it would be difficult to know where to start. Also, while there has been significant disruption to normal working - most notably the impact on clinical trial programmes, much of the Life Sciences industry continues as before and we wish to reflect this. Suffice it to say that at Mishcon we have been privileged to be involved in some of the efforts of the industry to combat the virus, from involvement in one of the vaccine projects and other antiviral therapies to the supply of PPE. We can only say that the level of effort and collaboration has, to our direct knowledge, been awe-inspiring and I make particular mention of the regulatory bodies and their speed and flexibility in dealing with this unprecedented situation.
As I say, life goes on elsewhere, and with Brexit now looming the likelihood is that the UK will reach the end of the year without a formal trade deal in place. The impact will be significant. By way of example only, in this edition we discuss the impact of Brexit on clinical trials and the application of the SPC manufacturing waiver. Also, and perhaps more significantly, is the letter dated 3 August from the Department of Health and Social Care to suppliers of medicines and medicinal products relating to the new border procedures that will apply. It does not make encouraging reading; the emphasis on re-routing supplies away from the usual entry points to avoid congestion and the suggestion to create buffer stocks and warehouse space is not a statement of unalloyed confidence in the border procedures that will apply.
In other areas, the recent Supreme Court decision to transgenic mice patents is discussed in this edition, and does require a brief mention of Professor Phil Leder, who in the 1980's invented and patented the first transgenic mouse - the oncomouse as it was termed – and who passed away earlier this year.
Also particularly noteworthy is the decision of the CJEU to reject the application of SPC's for second medical uses, overturning its own previous decision.
Finally, the regulatory environment around cannabidiol, or CBD, continues to develop at a pace, and the articles in this newsletter summarise these developments and the recent decision by the FDA to require a large scale safety study into the effects of CBD.
I hope you enjoy this edition and, of course, stay safe.