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An Alliance for Science SEPTEMBER 2014 NEWSLETTER NEWS AND INTELLIGENCE FROM LIFE SCIENCES INTELLECTUAL PROPERTY REVIEW HIGHLIGHTS THIS ISSUE: 4 EPIRUS, RANBAXY WIN An alliance INDIAN APPROVAL FOR for science ARTHRITIS DRUG Biotech in the Bay Page 10 6 PHARMACEUTICAL IP “UNDER THREAT FROM MALWARE” 12 US BIO/PHARMA PATENTS UNDER ATTACK 14 LSIPR ROUNDTABLE Founding Sponsor: OTHER CONTENTS >> 102217 LSIPR Advert:Layout 1 09/04/2014 16:21 Page 1 Translating Innovation Expert intellectual property services for the life science industry www.potterclarkson.com LSIPR Newsletter 09:14 EDITOR’S LETTER/CONTENTS 3 Life Sciences IP Review is published by: Newton Media Limited Kingfisher House, 21-23 Elmfield Road Our first roundtable Bromley, Greater London BR11LT, United Kingdom Having driven up the coast from San Diego to San Francisco after the BIO International Telephone: +44 203 301 8201 Convention in June, I was fascinated to learn from our latest “cluster focus” that the Bay Area of Director Nicholas Lipinski California has one of the greatest concentrations of life sciences companies in the world. Publisher Yet apparently, even though there are law firms in the area to support the technology industry, Peter Garner Telephone: +44 203 301 8217 there’s a shortage of life sciences IP lawyers there. Of course, some lawyers will be able to apply their Email: [email protected] high-tech experience to the life sciences industry but it still seems too good an opportunity to miss: Managing editor Martin Essex to set up in the warm, sunny Bay Area to serve companies urgently looking for your expertise. Telephone: +44 203 301 8211 Email: [email protected] Back home, it was time to chair the first LSIPR roundtable discussion, which took place in a Deputy editor hotel with superb views of the Tower of London, Tower Bridge and the River Thames. There were Ed Conlon six invited guests—including both patent attorneys and patent litigators—and the discussion News editor Max Walters began, inevitably, with the USPTO’s guidelines on patent-eligible subject matter in the wake of Editorial assistant the Myriad and Mayo court decisions. David Brooke Sub-editor That had been a focus of attention in the IP stream at BIO—at times it seemed the only focus—and Ros Bromwich the debate in London was lively and animated. There were plenty of other topics discussed in a session Consultant John Haley that lasted for several hours, and we’ll be bringing you those in a special report to be published shortly. Production and design However, in this issue of the LSIPR Newsletter, we’ve included as an hors d’oeuvre some of the Fisherman Creative ©Newton Media Limited 2014 debate on the USPTO guidelines, which readers will know have been roundly criticised by all and All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any sundry. Key questions debated included whether they will be changed and what the implications form or by any means, electrical, mechanical, photocopying, are this side of the pond. recording or otherwise without the prior written permission of the publisher. The views expressed in LSIPR are not necessarily Next time, it’s been suggested, a good topic would be the Unified Patent Court and its implications those shared by the publisher, Newton Media Limited. Wishing to reflect the true nature of the market, we have included articles for pharma but if you think we should include something else then just let me know. from a number of sources, and the views expressed are those of the individual contributors. No responsibility or liability is Martin Essex, Managing editor 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. This publication is not a substitute for advice on a specific transaction. The publication of advertisements does not represent endorsement by the publisher. Life Sciences IP Review (LSIPR): ISSN 2049-2359 (Print) 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, Taylor Wessing LLP Janis Fraser, principal, Fish & Richardson PC Contents Penny Gilbert, partner, Powell Gilbert Andrew Jenner, director of IP innovation and trade, 4 News IFPMA Ashwin Julka, managing partner, Remfry & Sagar 4 Cipla agrees rifaximin licensing deal Lars Kellberg, corporate vice president, corporate 4 Epirus, Ranbaxy win Indian approval for arthritis drug patents, Novo Nordisk A/S 5 Gilead announces Sovaldi generic deal Judith Kim, partner, Sterne, Kessler, Goldstein & Fox Simon Kremer, partner, Mewburn Ellis LLP 6 Pharmaceutical IP “under threat from malware” Nathalie Moll, secretary general, EuropaBio 6 Bristol-Myers Squibb hits Merck with cancer patent lawsuit Matthew Nielsen, partner, Marshall Gerstein & Borun LLP 8 Australia suggests uprooting plant rights Caroline Pallard, partner, Nederlandsch Octrooibureau 8 Myriad cancer patent upheld in Australia Michael Pitzner-Bruun, partner, Kromann Reumert Nabeela Rasheed, shareholder, McAndrews, Held & 10 Cluster Focus Malloy Ltd. Jason Rutt, head of patents, Rouse An alliance for science: Biotech in the Bay Area of California José Trigueros, partner, Leyva Montenegro Trigueros Abogados SC 12 Expert comment Joachim Wachenfeld, partner, Vossius & Partner US bio/pharma patents under attack Jane Wainwright, partner, Potter Clarkson LLP Gordon Wright, partner, Elkington & Fife LLP, on 14 Expert comment behalf of CIPA Franz-Josef Zimmer, patent attorney, Grünecker The firstLSIPR roundtable discussion www.lifesciencesipreview.com 4 NEWS LSIPR Newsletter 09:14 Cipla agrees rifaximin licensing deal MUMBAI, INDIA Subhanu Saxena, global CEO at Cipla, said: “As we look to go live with our own front-end Indian drug maker Cipla has signed a deal presence in North America, we are happy that with Salix Pharmaceuticals allowing the through this association we can demonstrate US-based company exclusive rights relating to the wider industry that we are open to to the ‘Rifaximin Complexes’ patent family. global partnerships for the development and The agreement excludes Asia, other than commercialisation of complex products.” Japan, and Africa. Salix is required to make an up-front payment Rifaximin is used for the treatment of as well as additional regulatory milestone travellers’ diarrhoea caused by non-invasive payments. It will also pay royalties on net sales strains of Escherichia coli. of products covered by the patents. According to Cipla, the agreement is an Cipla, along with several other Indian expansion of a 2009 exclusive licence drug makers, has also reached a licensing agreement in which Cipla granted Salix agreement with Gilead, enabling it to sell exclusive rights in the US, Canada and a generic version of the hepatitis C drug n Mexico. / SHUTTERSTOCK.COM WAVEBREAKMEDIA Sovaldi (sofosbuvir). See next page Epirus, Ranbaxy win Indian approval for arthritis drug BOSTON, US drug controller general of India has approved disease, psoriasis and other inflammatory the similar version of Remicade (infliximab) conditions. Biopharmaceutical company Epirus has said and that it will be sold by Epirus’s Indian In India, it sells at about 70,000 rupees ($1,145) that India’s drug regulator has approved a partner, Ranbaxy Laboratories, early next year. per month. biosimilar application to produce a version of Remicade, produced by pharmaceutical a popular arthritis treatment drug. Boston-based Epirus, which focuses on companies Johnson & Johnson and Merck, developing biosimilar drugs for sale, said it Epirus announced on September 15 that the is used to treat rheumatoid arthritis, Crohn’s would launch the Remicade biosimilar in India under the name Infimab before the first quarter of next year. “With these final clearances, we are now able to deliver a high-quality product to patients who may not be able to afford current treatment options,” Amit Munshi, president of Epirus, said in a statement. “We also intend to leverage this clinical data package to support additional regulatory filings in targeted global markets.” Ranbaxy and Epirus signed a licensing agreement for the Remicade biosimilar in January 2014. Under the terms of the agreement, Epirus will develop and supply the drug and Ranbaxy will register and commercialise it in India. In July, LSIPR reported that the US Food and Drug Administration (FDA) accepted what was thought to be the first successful biosimilar application in the US since a law was passed introducing them in 2010. The application was related to Amgen’s Neupogen (filgrastim) drug, used to treat MELODIA PLUS PHOTOS / SHUTTERSTOCK.COM patients with insufficient white blood cells. n www.lifesciencesipreview.com LSIPR Newsletter 09:14 NEWS 5 Gilead announces Sovaldi generic deal FOSTER CITY, US working to make its medicines “accessible to as many patients, in as many places”, as quickly US biotechnology company Gilead has agreed as possible. a licensing deal with seven Indian drug makers that will enable them to sell a generic version “In developing countries, large-volume generic of a drug used to treat hepatitis C. manufacturing and distribution is widely regarded as a key component in expanding Gilead will license its Sovaldi (sofosbuvir) access to medicines. These agreements drug to generic manufacturers Cipla, Ranbaxy are essential to advancing the goals of our Laboratories, Cadila Healthcare, Sequent humanitarian programme in these countries,” Scientific, Strides Arcolab, Hetero Drugs and Alton said. Mylan Laboratories, which will in turn market it to more than 90 developing countries. According to Reuters, Sovaldi is normally The companies will set their own rates for the given to patients for either three or six months sale of the drug but will pay a royalty fee to and costs $84,000 for a 12-week course in the Gilead. US. Gilead said it would launch the drug in India at a price of $300 a month.
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