Introduction - Dr Lisa Page, Partner

Welcome to the spring edition of BioBrief.
 
We start this edition with an article I wrote recently for OBN Connect magazine which covers the challenges faced by Biotech founders on spin-out and the career change it requires. This is something that I am familiar with as I changed my career from project manager of global clinical trials for IQVIA to being an IP lawyer.
 
Moving on from career changes, the thorny issue of whether Unitary SPCs will become a reality and the European Commission’s potential approach and what this will mean for SPC protection is considered in the next article. 
 
Regulatory issues are likely to be a regular feature in BioBrief as the MHRA carves its own way post Brexit. Our article by Rachel Bradley comparing the EU Clinical Trials Regulation and the MHRA consultation on clinical trials gives an insight into the MHRA proposals. The consultation closed on 14th March but as of this edition, there has been no further information released. We await that update. 
 
Data protection remains a recurring theme and raises issues given the international nature of biotechnology development. This next article provides practical guidance on what needs to be done for international data transfers now that final versions of the new standard form International Data Transfer Agreement (IDTA) and Addendum to the new EU Standard Contractual Clauses (SCC Addendum) came into force as of 21 March 2022.
 
We also provide an overview of a landmark case where, for the first time, a contract between a CRO and a client (IQVIA v Cardiorentis) is analysed in detail by the courts. The importance of clarity in the contractual terms in these contracts is highlighted and we provide some practical advice for negotiating these contracts.
 
Finally, in another first for BioBrief, our last topic is discussed in a video update by partner Duncan Curley and senior associate Amanda Easey who have recently joined the team adding Life Sciences IP litigation expertise to our offering. In this video update, they discuss the recent Apixaban case in the Patents Court that found the patent invalid for lack of plausibility, the first time this has been seen for a small molecule patent. It’s only a 10-minute listen and well worthwhile for its succinct review of this important case, that is likely to be the subject of an appeal. 
 
If you have any questions on any of the subject matter covered here, please do get in touch with any member of our growing team here and we will be happy to advise!