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Life Sciences Intellectual Property Review is published by: Newton Media Limited 15-17 Newton Way


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Directors and publishers Nicholas Lipinski and John Eddington Editor


Peter Scott


Telephone: +44 203 301 8211 Email: pscott@newtonmedia.co.uk


Sub-editor Susan Gault


Journalist Mark Dugdale


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The views expressed in Life Sciences Intellectual Property Review are not necessarily those shared by the publisher, Newton Media Limited. Wishing to reflect the true nature of the market, we have included articles from a number of sources, and the views expressed are those of the individual contributors. No responsibility or liability is accepted by Newton Media Limited for any loss to any person, legal or physical, as a result of any statement, fact or figure contained in Life Sciences Intellectual Property Review.


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Life Sciences Intellectual Property Review: ISSN 1758-7528 (Print) Cover image:


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Te life sciences and biotech industry has a bright future. Indeed, it is likely to provide a large proportion of innovative medical solutions in this century. IP remains absolutely central to the success of that project. While it will certainly come under greater pressure from those who believe that companies should be obliged to share potentially life-saving innovations, and from those who see ethical and moral peril in the very notion of biotechnological research, IP, some international divergence in practice notwithstanding, has proven itself to be the best system we have. Why change a winning formula?


Peter Scott Editor


EDITORIAL PANEL


Stefan Abel, partner, Bardehle Pagenberg


Roberto Arochi, partner, Arochi Marroquín & Lindner SC


Roberto Barchiesi, president, International AntiCounterfeiting Coalition


Colin Davies, director, intellectual property law unit, University of Glamorgan


Michael Factor, partner, JMB Fa©tor & Co


Ronald Faggetter, managing partner, Smart & Biggar/ Fetherstonhaugh


Maurice Gonsalves, partner, Mallesons Stephen Jacques


Richard Gough partner, Baker & McKenzie


Chris McLeod, director of trademarks, Squire Sanders Hammonds


Jacqueline Needle, partner, Beck Greener


Sergio Olivares, partner, Olivares & Cia


John Pegram, senior principal, Fish and Richardson PC


Rebecca L. Roby, senior director of business affairs, Hard Rock International


Pier Luigi Roncaglia, partner, Studio Legale SIB


Mario Soerensen Garcia, founder and managing partner, Soerensen Garcia Advogados Associados


Paul J. Sutton, co-founding partner, Sutton Magidoff LLP


Stephen Yang, partner, Peksung Intellectual Property


EDITOR’S NOTE On the verge


In the biotech and life sciences industry, very little is clear-cut. Innovation ensures that the industry continues to grow, but also brings uncertainty, commercial and ethical, as companies push the boundaries of the possible. While it is not mainstream yet, there is a noisy body of opposition to many of the industry’s most exciting discoveries, while courts across the world are only slowly delivering decisions that will provide the necessary legal certainly to innovators.


And in the US, which remains the world’s leading innovator jurisdiction in biotech and life sciences, companies face a lack of clarity at every turn. Te implications of 2010’s healthcare reform are yet to be fully understood; whether there will be patent reform, and if so, how it will look, is another unknown. Add to this the looming spectre of the Myriad gene patent case, which is currently on appeal but could have disastrous implications for a host of innovative companies, and it is clear that the industry has much to ponder.


But it’s not all doom and gloom. As Jim Greenwood, president of the Biotechnology Industry Organization, tells us in an interview, investment is returning to the sector, though not yet at pre-recession levels. And in some of the non-traditional life sciences jurisdictions, business is good and growing.


We hear from India, where some have talked of a biotech ‘revolution’, and consider the leading life sciences jurisdictions in Europe. We look at the potential damage of counterfeit drugs and how best to tackle that menace—with manufacturers from Asia, imports to many countries across the world, and a burgeoning Internet trade (estimates suggest that 50 percent of drugs available on the Internet are fake) combining to leave brand owners facing threats from all sides. We look at some of the options for brand owners to effectively partner with law enforcement and other institutions to look aſter their assets.


Life Sciences Intellectual Property Review 2011


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