Precedents for the biotech and pharma industries: a book review

Reviewer: Trevor Cook (Bird & Bird. Email Trevor.cook@twobirds.com)

Citation: Journal of Intellectual Property Law & Practice, doi:10.1093/jiplp/jpp182

Book reviewed: Drafting Agreements in the Pharmaceutical and Biotechnology Industries, by Mark Anderson et al. (Eds)

Bibliographic details: Oxford University Press, 2009, ISBN: 978-0-19-953963-5, Loose leaf, pp. c. 1,200. Price: £395 (main work and first year's subscription). Web page here.

This is a book of precedents with two unique features. First, and uniquely at least for a European book (there are no doubt US ones), it focuses on a single industry sector, that of pharmaceuticals and biotechnology. Secondly, and probably uniquely for any book of precedents anywhere in the world, it bravely, and generally successfully, tries to adopt a multi-jurisdictional approach, with agreements primarily drafted and annotated from an English perspective, but with additional commentary also from a number of consultants giving German, French, Spanish, Dutch, and Swedish perspectives on them, and on some individual clauses. This latter feature, while, as the editor admits, not comprehensive, does at least provide a fascinating insight into certain aspects of these other legal systems, and if nothing else will be invaluable in explaining to those with a common law background the various sensitivities on the part of practitioners and contracting parties who are based in those other jurisdictions.

The 38 precedents that the book offers are divided into separate sections for preliminary agreements, collaborative R&D agreements, services agreements, clinical trial agreements, product manufacturing and supply agreements, distribution and marketing agreements, licence agreements and assignments—all types of agreement encountered in the pharmaceuticals and biotechnology sector, and many are very much tailored to the issues encountered in it—indeed many reflect relationships and business models, such as co-promotion, that are unique to the sector. The types of agreement tackled range from the simple to the downright ambitious. Precedents are introduced with general commentary, but commentary on specific clauses in the precedents is set out clearly and conveniently, on the opposite page to the clause the subject of comment. Despite the smaller type face of such commentary, this results, because of its thoroughness, in fewer expanses of blank space than one might fear—the only precedent to suffer from such blank space on the opposite pages is the NHS Clinical Trial Agreement and the accompanying guidance notes, these being standard documents prepared by third parties and which do not adopt the useful arrangement of the rest of the precedents and commentary. In addition to the precedents themselves and their commentary and introductions, there is some general commentary on a number of topics—regulations affecting R&D of pharmaceutical products, IP, competition law, contract law and practice, and tax and currency issues. There is also a small appendix of European Union competition law materials.

One can have every confidence in the drafting, edited as the book is by Mark Anderson, whose area of speciality this is, and who has already written a number of valuable books on technology licensing. My only criticism of the book is a minor one of presentation—some extra dividers to split up the chapters in the main section, which containing the precedents, would have been welcome. But this is a book that can thoroughly be recommended for anyone who is drafting or negotiating agreements in Europe in the pharmaceutical and biotechnology sectors.