LSIPR Newsletter 12:14


Life Sciences IP Review is published by: Newton Media Limited Kingfisher House, 21-23 Elmfield Road Bromley, Greater London BR11LT, United Kingdom Telephone: +44 203 301 8201


Director Nicholas Lipinski


Group publisher Peter Scott


Group editor Ed Conlon


News editor Max Walters


Sub-editor Ros Bromwich


Editorial assistant David Brooke


Consultant John Haley


Production and design Fisherman Creative ©Newton Media Limited 2014 All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electrical, mechanical, photocopying, recording or otherwise without the prior written permission of the publisher. Te views expressed in LSIPR 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 LSIPR. Tis publication is not a substitute for advice on a specific transaction. Te publication of advertisements does not represent endorsement by the publisher. Life Sciences IP Review (LSIPR): ISSN 2049-2359 (Print)


Front cover image: Oleksiy Mark / Shutterstock.com EDITORIAL PANEL


MaryAnne Armstrong, partner, Birch, Stewart, Kolasch & Birch LLP


Victoria Beniac-Brooks, partner, Marks & Clerk LLP Wolfgang Bublak, partner, Bardehle Pagenberg


Trevor Cook, partner, Wilmer Cutler Pickering Hale and Dorr LLP Gabriel Di Blasi, partner, Di Blasi & Associates


Paul England, senior associate, Taylor Wessing LLP Janis Fraser, principal, Fish & Richardson PC


Gunars Gaikis, partner, Smart & Biggar/ Fetherstonhaugh Penny Gilbert, partner, Powell Gilbert


Andrew Jenner, director of IP innovation and trade, IFPMA Ashwin Julka, managing partner, Remfry & Sagar


Lars Kellberg, corporate vice president, corporate patents, Novo Nordisk A/S


Judith Kim, partner, Sterne, Kessler, Goldstein & Fox Simon Kremer, partner, Mewburn Ellis LLP Nathalie Moll, secretary general, EuropaBio


Matthew Nielsen, partner, Marshall Gerstein & Borun LLP


Caroline Pallard, partner, Nederlandsch Octrooibureau


Michael Pitzner-Bruun, partner, Kromann Reumert


Nabeela Rasheed, shareholder, McAndrews, Held & Malloy Ltd. Jason Rutt, head of patents, Rouse


José Trigueros, partner, Leyva Montenegro Trigueros Abogados SC Joachim Wachenfeld, partner, Vossius & Partner Jane Wainwright, partner, Potter Clarkson LLP


Gordon Wright, partner, Elkington & Fife LLP, on behalf of CIPA Franz-Josef Zimmer, patent attorney, Grünecker


Contents 4 News


8 Bulletproofing pharma patents


Maximising the strength of patent protection should be an important objective of any R&D pharma company. Janis Fraser and Christine Goddard of law firm Fish & Richardson offer their six top tips for success.


12 Repurposed drugs: Second time lucky


Bringing a ‘repurposed’ drug to market requires a clear patent strategy, but clarity is unfortunately lacking in this field, as Simon Kremer and Rachel Jones of law firm Mewburn Ellis outline.


16 Market authorisation: The right to challenge


A decision by the CJEU on a Latvian case should make it easier in the future to challenge an MA granted for a generic version of a reference product, as Trevor Cook of WilmerHale explains.


EDITOR’S LETTER/CONTENTS Bulletproof


Te battle between innovative pharma companies and generic drug rivals is a constant source of interest for readers of Life Sciences Intellectual Property Review. Although the nature of these disputes is typically identical, their commercial importance for both sides is extremely high. Tat means, from a practical viewpoint, our coverage of the age-old rows will continue to be useful.


With this is mind, we asked Janis Fraser and Christine Goddard, both principals at law firm Fish & Richardson, to provide their six top tips for keeping your patents bulletproof. One of the most interesting situations they describe (and one to avoid) is where an individual who does not assign a patent to a company, and has no obligation to do so, is later deemed by a court to be an inventor. If that individual licenses or assigns the rights to a competitor, the patent cannot be asserted against the latter. “It’s a nightmare scenario,” say Fraser and Goddard.


Teir advice is highly detailed although, as the authors admit, it highlights only a few of the many important factors to consider when building a strong pharma patent. Nonetheless, we hope the advice, which includes “knowing your enemy” and “embracing the narrow”, is both informative and helpful, and we would welcome any more suggestions for keeping a patent sturdy.


We hope you enjoy this and all the other content in what is the final issue of the LSIPR newsletter this year. Merry Christmas and have a prosperous New Year.


Ed Conlon, Group editor


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