Introduction

Welcome to the first edition of Bio Brief for 2018. As usual across the life sciences sector there is a lot of activity reflecting the breadth and dynamism of the sector. We aim to support your business by providing you with a variety of articles reflecting both recent case law and major legal changes on the horizon which will have implications for your business.

Mid-December saw a further court ruling in the ongoing litigation between Glaxo and Sandoz on the use of the colour purple in Sandoz’s generic version of Seretide, which is Glaxo’s combination therapy for asthma. This was the sixth court ruling in litigation that is being watched with interest by both Active Pharmaceutical Ingredients (API) rights holders and generic manufacturers owing to its possible implications for market entry by generic competitors.

The key corporate shareholding percentages are often believed to be either 50% or 75%. These shareholdings are perceived to dictate ‘control’ within a company, with the Companies Act stipulating this level of votes as being necessary for ordinary or special resolutions. However, focusing on share ownership of 50% or 75% can be a ‘red herring’. Several other key percentages may have an equally if not more important impact on a company’s operations.

The demand for commercial property for start-up companies is growing rapidly in many areas of the UK. The need for laboratory spaces and offices in science parks and incubators is increasing and can be costly. Companies need to be alive to potentially hidden pitfalls if they envisage sharing such spaces with collaborators and service providers. This article sets out some strategies to avoid the most common problem that arises in this context.

A new regime for clinical trials in Europe is set to come into force in 2019. However, there are currently uncertainties about what clinical trials legislation will apply in the UK once it leaves the EU. This article is a brief summary of the changes that will come into force for businesses based in Europe or for global businesses running clinical trials in Europe, and the potential impact of Brexit.

This time last year the expectation was that Europe’s new Unified Patent Court (UPC) would be open for business in December 2017. That deadline has now passed and it is currently unclear when the UPC will open. Although progress was made last year, with only the UK and Germany now required to ratify the UPC Agreement for the UPC to open, delays have arisen due to the UK general election called in June 2017 and a private challenge to the UPC system before the German Constitutional Court.