The importance of the life sciences sector to the Irish economy cannot be over estimated. Ireland has in excess of 170 life sciences companies employing 35,000 people in the life sciences sector. In 2006, the Irish pharmaceutical sector exported products valued at over €40 billion. Sixteen of the world’s top twenty pharmaceutical companies have substantial operations in Ireland with many of these companies increasingly conducting significant research and development in Ireland. The last number of years has also seen a significant increase in the activities of indigenous Irish life sciences companies and an expansion in the technology transfer activities of Irish universities.

The life sciences umbrella covers the pharmaceutical, chemical, biopharmaceuticals, medical device and diagnostic sectors.

In addition to facing the same issues as companies operating in other sectors, companies operating in the Life Sciences sector face specific challenges given the highly regulated environment in which they operate. To this end, such companies must keep up to-date with ever changing regulation and developments in intellectual property law. In addition, strategic alliances in the Life Sciences sector tend to be both multi-faceted and complex given the fact that a successful collaboration is likely to last for a number of years. Furthermore, given the nature of the sector, most transactions have a significant international dimension.

In 2004 BCM Hanby Wallace made a significant investment in developing its Life Sciences practice by recruiting two lawyers with broad-based experience from Elan Corporation, plc (Colin Sainsbury and Alex Nesbitt). Since it was established in 2004, the Life Sciences practice has developed to become Ireland’s leading practice and in conjunction with the Firm’s other departments provides a proactive and added value service to its expanding number of clients.

The Firm has four lawyers working in its Life Sciences practice (Colin Sainsbury, Darren Daly, Fiona O’Neill and Alex Nesbitt).

Colin Sainsbury spent almost ten years with Elan and was General Counsel of Elan’s drug delivery business. Colin also held a senior corporate legal role in which he was the lawyer primarily responsible for the oversight and implementation of Elan’s Recovery Plan which entailed a $2bn Asset Disposal Programme comprising a broad-range of transactions including the sale of Abelcet to Enzon, Inc., and the sale of Elan’s Primary Care franchise (Sonata and Skelaxin) to King Pharmaceuticals, Inc. As General Counsel of Elan’s drug delivery business, Colin was involved both in structuring and negotiating transactions not only with many leading pharmaceutical companies, but also with many smaller biotech companies in Europe, the US and Japan. In addition to dealing with legal issues associated with the promotion and marketing of Elan developed products, Colin and Alex also played a significant part in the structuring and negotiation of a large number of transactions pursuant to which Elan acquired rights to products pursuant to licensing and distribution type agreements (for example, acquiring EU distribution rights for a number of US and Japanese companies).

The experience that Colin and Alex gained at Elan has been a significant added value driver in terms of their representation of a number of Irish and multi-national clients, including their ability to manage complex international transactions. With their specific sectoral experience, members of the department are able to provide proactive and added value support to clients both in relation to significant corporate transactions and other matters. In particular, our lawyers are able to propose to a range of options to the client and the other party of a transaction which greatly assists in finalising a transaction which can act as a solid foundation for a collaboration which may last many years. Hence, we have a broad range of sector specific experience which we can bring to bear on complex international transactions. We partner with our clients to successfully deliver these transactions in a commercially minded and solution driven manner.

Colin is also actively involved in the work of the American Chamber of Commerce Research and Development Committee (which has interacted with a number of State Agencies) and is also a member of the Laws Committee of the Licensing Executives Society.

As can be seen the examples of transactions listed below, the firm acts for a large number of Irish and foreign biotech, pharmaceutical and medical device companies. We provide broad based legal advice in relation to the negotiation and structuring of a variety of transactions in the Life Sciences/intellectual property sectors including product acquisitions and disposals and joint ventures, in-licensing, out-licensing, distribution and related structural issues. In addition we represent a number of research institutions and companies operating in the healthcare sector.

Members of the Life Sciences department have significant experience in representing clients in structuring and negotiating international transactions with companies in various parts of the world, including the United States and Japan. The Life Sciences department also advises clients in relation to regulatory matters. The Department also acts for a number of companies in the food sector who are increasingly becoming involved in companies intellectual property based transactions and related financings.

In addition to facilitating the structuring and negotiation of complex transactions, members of the Life Sciences group regularly advise clients in relation to life science and pharmaceutical law regulatory related matters, including the conduct of clinical trials and EU Medicine Law. The Life Sciences department also provides sectoral specific advice in relation to competition law issues that arise in relation to the research and development, licensing and marketing of technologies and pharmaceutical products.

The following are some examples of clients and/or transactions that we are in a position to disclose:

• Members of the department regularly advise Elan Corporation, plc in relation to a broad-range of matters including transaction with Amarin, a strategic manufacturing alliance with Lilly, and licensing transactions with Abbott Laboratories (single dose Tricor®/Crestor® combination) and Entremed (2ME2).
• Acquisition by Azur Pharmaceuticals of the US rights to Gastrocrom from UCB Pharma, Pharmelle and most recently the acquisition of FazaClo.
• Alimentary Health Limited (a Cork-based biotech company with probiotic technology) including transactions with Mead Johnson (part of the BMS Group) and Procter & Gamble.
• Merrion Pharmaceuticals in relation to the licensing of its technologies and its proposed listing on NASDAQ and IEX.
• Newport Pharmaceuticals Limited in relation to a strategic alliance with Amilar Pharmaceuticals (a subsidiary of Bioaccelerate) in relation to Isoprinosine.
• Bank of Scotland (Ireland) in relation to financing an acquisition by Alltracel Pharmaceuticals.
• A number of medical device companies in relation to distribution and licensing agreements with a number of US partners.
• A US biotech company in relation to a pan-European strategic licensing transaction.
• A number of European biotech and speciality pharmaceutical companies in relation to strategic alliances and other transactions.
• A number of spin-out companies in relation to strategic licensing transactions with US biotech companies, including a worldwide licensing agreement between Diabetica Limited and Amylin Pharmaceuticals in relation to Diabetica’s Intellectual Property for the development of GIP Agonists.
• A number of individuals in relation to the establishment of ventures, pharmaceutical investment and acquiring pharmaceutical technologies and products.
• A number of Irish food companies in relation to joint venture and licensing agreements
• Advised a number of research institutions, university spin-outs and companies in relation to the conclusion of research and development agreements in which management of intellectual property and utilisation of funding have been core issues.
• Acting for National University of Ireland Galway in relation to a number of joint venture and licensing transactions including the recently announced transaction with Eirzyme.
• Acted for Forfas in relation to the review of the ICSTI National Code of Practice for Managing and Commercialising Intellectual Property from Public-Private Collaborative Research.

As a full service law firm, members of other departments are actively involved in providing pro-active legal support to companies operating in the Life Sciences sector including members of the firm’s Healthcare department with whom there is significant interaction in advising on a range of regulatory and ethical issues.

The firm’s Corporate Commercial department have significant experience in advising both venture capital funds and companies in relation to all aspects of fundraising (including Merrion Pharmaceuticals on its proposed NASDAQ and IEX listings and Azur Pharma on a number of acquisitions) and advising on corporate restructurings.

Members of the department regularly speak at conferences. The firm is a sponsor of Bio-Connect. Colin Sainsbury is a member of the Laws Committee of the Licensing Executives Society, the R&D Committee of the American Chamber of Commerce as well as being a member of the Business Law Committee. For example, Colin is the author of a chapter on Life Sciences in a book to be published by the Law Society of Ireland and is also writing a series of articles for Life Sciences review.

Colin is recommended by a number of publications, including PLC ‘Which Lawyer’ as a Leading Lawyer in the Life Sciences sector.

Colin Sainsbury (Head of the Life Sciences practice area) is ranked as one of only two Leading individuals in Ireland in the Life Sciences Corporate Commercial category as follows:

“Formerly general counsel at Elan's drug delivery unit, his forté is on the commercial side of the transactional spectrum, especially on strategic alliance issues.”

“Colin Sainsbury has 'impressive technical knowledge', and extensive experience in the life sciences and technology sectors. The group provides 'valuable support' to in-house legal teams.”

Colin Sainsbury remains the firm’s principal draw in this sector. His in-house experience at Elan and technology and IP expertise makes him a popular choice for a number of players in Ireland’s pharmaceuticals and life sciences industry. “I can’t recommend him highly enough,” said one client. He is “diligent, competent and extremely helpful,” according to sources.

Partners

• Darren Daly
• Colin Sainsbury