James Ryan, associate, Morrison & Foerster
14 January 2010
29 April 2013
8 February 2013
23 April 2013
23 September 2013
16 September 2013
The life sciences sector is the business sector concerned with the development, manufacture and commercialisation of pharmaceuticals and medical devices.
What’s it all about?
The life sciences sector is concerned with the development, manufacture and commercialisation of pharmaceuticals and medical devices. A specialist life sciences lawyer’s work in general encompasses advising clients on a diverse range of topics, but the categories of advice clients in this sector are generally looking for can be broken down into three key groups: (i) intellectual property protection and enforcement advice, (ii) regulatory advice, including competition and anti-trust advice, and (iii) corporate and commercial advice.
What is the working culture like in a life sciences team?
Our team is small, friendly and supportive owing to the open door policy which exists here. The team itself is comprised of lawyers from our commercial or “technology transactions” group and our corporate group. The work we do is very client-focused and, as we tend to advise the same clients on all their corporate and commercial transactions rather than one-off, infrequent transactions, we have developed a good understanding not only of the drugs and products which they offer but the commercial drivers which underpin their businesses.
What is the typical makeup of a life sciences lawyer’s client base?
Life sciences work in general encompasses a number of different companies from small biotech businesses focused on identifying and developing new drugs and technologies, to generic drug manufacturers through to large multi-national pharmaceutical companies. Our client base is predominantly comprised of specialist biotechnology and medical device companies, which are focused on developing novel products as well as some larger pharma companies. We also advise investors in the sector including banks and venture capitalists.
Which other practice areas do you work most closely with?
Given the multi-disciplinary nature of the work we do we work closely with a myriad of different departments including our tax and litigation departments, the competition and anti-trust lawyers in Brussels and Washington D.C. our patent attorneys in San Diego and Palo Alto. Many of our projects are cross-border, so we regularly work with teams from our other offices in the US and Asia.
Which skills make a good life sciences lawyer?
Given the nature of the industry, a background in science is very useful but is by no means a complete prerequisite. Above all, a real interest in the work done by clients, in terms of the products and drugs they make is essential as there is often a lot of background reading into a particular drug or scientific development. Good drafting skills are essential given the contractual nature of the work we do. Finally, it is important to address not only the immediate legal concerns of a client but to address the wider commercial implications raised by work and to have a good awareness of the client’s wider business model and activities.
What impact has the recession had on your practice area?
Our clients provide medical products and services and these are still needed in spite of any recession. However, as is common across the board, at present, we have seen a slow down in some areas of work, e.g. equity capital markets. But other types of work are still keeping the sector busy.
What recent key life sciences work has your firm been involved in?
Two recent representative transactions have been advising Singapore-based S*BIO Pte Ltd on a $550 million Development Collaboration, and Option & License Agreement with Onyx Pharmaceuticals, Inc. to develop and commercialise some of S*BIO’s most novel and important drugs which are used in the treatment of cancer and auto-immune diseases; and advising German-based QIAGEN N.V. on its $130 million acquisition of DxS Ltd, a privately held UK developer and manufacturer of diagnostic products.
What do you think will be the future shape of life science departments?
Life science work encompasses many different types of legal work and for this reason departments are likely to become more multi-practice. Instead of tasking another department with a specific aspect of work because it is, for example, corporate in nature, that life science department is likely to have a dedicated lawyer specialising in corporate work who can address those client needs.
Which phrase is a life science lawyer most likely to use and what does it mean?
There is a huge amount of technical jargon used in the life sciences sector. Most of this is driven by the huge amount of legislation which governs drug development and it does take a while to get to grips with.
The most confusing thing is that the same regulatory approvals can have different names in different countries (even though they all do the same thing). For example, in order to conduct a clinical trial in the UK you need to hold a CTA (or Clinical Trial Authorisation) issued by the MHRA (Medicines and Healthcare products Regulatory Agency). By contrast, in order to conduct a clinical trial in the USA you need to have an IND (Investigational New Drug application) approved by the FDA (US Food and Drug Administration).