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CONTENTS 6 Life sciences in Europe: the key jurisdictions


The European life sciences industry has a long history. Many of the major players trace their roots to before the war, and often began as agricultural or chemical companies. LSIPR takes a look at the leading jurisdictions.


10 Covering all the bases: an interview with BIO president Jim Greenwood


The Biotechnology Industry Organization represents a broad constituency of biotechnology and life sciences companies. LSIPR talks to BIO president and CEO Jim Greenwood about patent reform, healthcare, court cases and plans for the future.


14 For better, for worse? How shifting IP laws change the global life sciences regulatory chessboard


With IP laws around the world subject to frequent and sometimes unpredictable changes, it can be diffi cult to keep abreast of everything you need to know. Richard Gough and Jane Woodhouse take a look.


18 It’s good to litigate a patent or two


Europe is home to many life sciences companies, so IP regimes throughout the continent’s jurisdictions need to provide cost-effective, speedy and certain litigation environments if patent disputes are to be satisfactorily settled. LSIPR talks to Thomas Friede and Johannes Heselberger about why Germany fi ts this mould.


22 Considerations for fi ling and prosecuting gene patents in Mexico


On the basis of scientifi c breakthroughs in the past 30 years in the fi eld of biotechnology, the number of patents has signifi cantly increased, particularly in relation to genetic materials. Fernando Rincón looks at the Mexican situation.


26 Building operative partnerships with law enforcement


There is a perfect storm brewing in the healthcare industry. Over the past few years, there has been an unprecedented rise in the trade of illicit healthcare products in the secondary market. Vaughn Volpi looks at how to address the problem.


30 Practice points in Israel patent prosecution: selection patents and treatment of earlier-fi led patent applications


Israel patent practice is distinct from US and European practice in a number of respects. Moshe Tritel describes a number of such areas with important practical ramifi cations for applicants seeking to maximise their patent protection in Israel.


34 Clinical trials in biopharma


A recent study revealed that biotechnology companies or universities discovered 42 percent of all innovative drugs approved by the US Food and Drug Administration (FDA) between 1998 and 2007. Biotechnology companies, however, are sometimes unprepared for the intellectual property considerations that arise as a promising drug (either their own or one licensed from a university) progresses through clinical trials. Eric Steffe explains.


38 Clinical trials and stratifi ed medicine— Maximising patent exclusivity


The traditional business model for a new drug relies on a substantial period of market exclusivity to recoup extensive research and development costs. It is important to understand the likelihood of obtaining the required degree of exclusivity, whether through strong patent protection, data exclusivity or orphan designation. Richard Korn and Stephanie Pilkington look at how patent exclusivity can be enhanced as development progresses.


4 Life Sciences Intellectual Property Review 2011 www.worldipreview.com


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