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The Life Sciences Lawyer Sciences the Life Asia Leads the Annual • Innovation Race …But Its Full Potential Remains Untapped LSL front cover_v7:Layout 1 17/1/20 08:56 Page 1 The Issue 1 2020 LifeGLOBAL REACH, LOCAL KNOWLEDGE Sciences www.lslawmag.com Lawyer Patents are not the way to fix drug pricing issues Bob Stoll of Drinker Biddle & Reath LLP explains why drug pricing bills may not be the answer to public concern over pharmaceutical costs CTC Legal Media • Singapore’s patent-linkage scheme and generic drugs • European plant patents • Pharma and bio-pharma inventions in India • Patenting chemical compounds in Russia Editor’s welcome_print:Layout 1 22/1/20 08:19 Page 3 Editor’s EDITOR’S WELCOME welcome elcome to the first issue of our new publication,The Life Sciences Lawyer. The field of life sciences is a fast-moving and heavily regulated sector. WIt covers a wide range of subject areas, some of them highly controversial, and many of which will prove to be of critical importance to the human race as a whole, no less, as we move into what can feel like a strange and uncertain future. The possibilities and opportunities offered by, to give but a few examples, CRISPR gene editing, genetically-modified crops, personalized medicine, and therapeutic CBD, are far-reaching, but so too are the ethical debates that these topics provoke. It’s no surprise, then, that the life sciences continue to present jurisdictions across THE LIFE SCIENCES the globe with uniquely complex legal and regulatory challenges. Almost any discussion of life sciences in a legal context involves a consideration LAWYER of intellectual property. To that end, The Life Sciences Lawyer is written and advised Issue 1 2020 by a panel of international life science and intellectual property experts and guest Editor writers, who will ensure that we provide up-to-date information on the most Matt Seex important international developments. [email protected] For this, our inaugural issue, the topic at the forefront of our minds is Publishing Director pharmaceuticals. Bob Stoll of Drinker Biddle tells us why patents are not the way to Chris Dooley fix drug pricing issues. MacKenna Roberts GC asks whether the door is opening or [email protected] closing on market abuse litigation for the pharmaceutical industry. And James Advertising Enquiries Kinnaird and Tim Headley of Marks & Clerk Singapore look at the impact of Naz Hassan – [email protected] Singapore’s patent linkage scheme on generic drug approval. Katie Kerr (Publishing Executive) Elsewhere, we have an update on CBD regulation in Europe, plant patent [email protected] protection in Mexico, and the protection of inventions in India. Dael Carter (Publishing Executive) All this and much, much more can be found in this debut issue of The Life Sciences [email protected] Lawyer. We sincerely hope you enjoy our first issue and look forward to receiving your Subscription Enquiries feedback. [email protected] Accounts Enquiries [email protected] Matt Seex Editor Published by: Front co y CTC Legal Media Ltd, /19 15:41 Page 1 The The 23 Hedgers Way, Kingsnorth, PatentGLOBAL REACH, LOCAL KNOWLEDGE LawyerAsian Patent Annual 2020 www.patentlawyermagazine.com GLOBAL REACH, LOCAL KNOWLEDGE Lawyer Trademarkyermagazine.com Annual Ashford, Kent TN23 3GN www.trademarklaw Lawyer2020 Tel: +44 (0)20 7112 8862 ’s Annual Bentley Clothing v The impact Supplement to The Patent Lawyer Magazine Fax: +44 (0)20 7084 0365 Bentley Motors of AI on IP Asia leads the An Exclusive Interview innovation race The latest IP Trend M onitor with Bentley Clothing stud Design and Repro by: y looks at where Artificial co-founder and …but its full potential Intelligence might have an Editorial Board impact on Intellectual Property Design and Printing Solutions Ltd member Chris Lees remains untapped Yifeng Song, M explains why managing Director, Asia Pacific, CPA Global Asia, Unit 45C, Joseph Wilson Industrial aximizing long-term value from Estate, Whitstable, Kent CT5 3PS IP assets is vital ow will AI transform Annual Survey 2019: H tellectual Property? the management of In Printed by: CTC Legal Media PLUS s battles over ceedings in Turkey, plu PLUS emark in opposition pro Proving use of a trad s and threats CTC Legal Media Geerings Print Ltd, witzerland – opportunitie Neural networks: rethinking IP in the auto industry, plus Canadian patent emarking in S “Halloumi”, and trad law – adjusting to new practice, and are partial designs protected in China? • Your trademark policy for Generation Z Includes our updated A “Queer” decision by the UKIPO? Not my jurisdiction – or is it? • The new certification marks in Mexico • Developing a successful licensing program patent ranking pages Cobbs Wood House, Chart Road, • An overview of the current M• • Not every COCO is Chanel • exican patent system • Swedish SMEs CTC Legal M Ashford, Kent TN23 1EP edia Whilst every effort has been made to ensure that the For information on our sister publications please visit www.patentlawyermagazine.com information contained in this journal is correct, neither and www.trademarklawyermagazine.com the editor, contributors or CTC Legal Media can accept any responsibility for any errors or omissions or for any consequences resulting therefrom. © CTC Legal Media 2020, and contributors. The contents of this journal are protected under the Mission statement copyright law of the United Kingdom, the Berne Convention and the Universal Copyright Convention. The Life Sciences Lawyer educates and informs professionals working in the Any unauthorised copying of the journal may be in industry by disseminating and expanding knowledge globally. It features breach of both civil and criminal law. Infringers will be prosecuted. articles written by people at the top of their fields of expertise, which contain not just the facts but analysis and opinion. Important judgments are examined CTC Legal Media in case studies and topical issues are reviewed in longer feature articles. CTC Legal Media THE LIFE SCIENCES LAWYER 3 Contents:Layout 1 16/1/20 10:49 Page 4 Contents:Layout 1 20/1/20 10:18 Page 5 CONTENTS ContentsIssue 1 2020 6 Meet the editorial board 17 The CBD regulatory Meet our Editorial Board members who help landscape in Portugal determine the direction of this magazine. and in the EU Ricardo Costa Macedo and Diana Mâncio da 7 News Costa of Caiado Guerreiro look at Portugal’s Challenge to HIV drug patent extension, approach to CBD. Shanks v Unilever, "pay-for-delay", and more. 32 21 Singapore’s patent-linkage scheme and its effects on 38 Protection of plant 50 A case analysis of patent 10 COVER STORY Patents are marketing approval for inventions in Mexico invalidation of Ticagrelor not the way to fix drug generic drugs Janett Lumbreras, Senior Associate, Uhthoff, in China pricing issues James Kinnaird, Partner, and Tim Headley, Gomez Vega & Uhthoff S.C, looks in detail at Xiaofeng Tang, Managing Partner and Bob Stoll of Drinker Biddle & Reath LLP Associate, Marks & Clerk Singapore, discuss an increasingly important area of IP protection. Patent Attorney at Beijing Geach Intellectual explains why drug pricing bills may not be the aims and operation of Singapore’s Property Law Office, looks at a recent the answer to public concern over patent-linkage scheme. 42 Doing justice to chemical invalidation case in China concerning pharmaceutical costs. a blood-thinning medication. 24 Understanding the patents inventive step for pharma Vladimir Biriulin, Partner and Head of Legal 54 Announcing the birth of 14 Life sciences meets Practice at Gorodissky & Partners, discusses competition law and bio-pharma inventions the application of term extensions to SMAS INTELLECTUAL patented chemical compounds. MacKenna Roberts, General Counsel and in India PROPERTY’s sister DPO to Choice Telemed Ltd, asks whether Rajeev Kumar and Pankaj Musyuni of company “BAIANAT courts will become an accepted forum to LexOrbis discuss the importance of the 46 Functionally-claimed INTELLECTUAL challenge exploitative drug pricing practices inventive step and the ways of establishing it. antibody patent – the in the pharmaceutical industry, and explains PROPERTY” why it matters. 28 Understanding the state of Amgen v Sanofi case Shadya Ahmed Awad of SMAS-IP details uncertainty of life sciences Osamu Yamamoto, patent attorney and some recent developments at her firm, patents partner at Yuasa and Hara, examines recent and highlights the challenges posed by an Japanese drug patent litigation. ever-changing IP landscape. 10 David G. Rosenbaum, founder and chairman of Rosenbaum IP, discusses the difficulties and uncertainty facing those who wish to register patents in the life science sector. 42 32 Plant protection in Europe: seeds of discord? Dr Penny Gilbert, Partner, and Dr William Hillson, Associate, Powell Gilbert LLP look at the tensions and controversies caused by the thorny issue of European plant patents. 35 Precision medicine in Taiwan Mr. Yu-Li Tsai and Mr. Lu-Fa Tsai of Deep & Far Taiwan look at a recent memorandum of understanding between the Taiwanese National Health Research Institutes and Swiss healthcare giant Roche. 4 THE LIFE SCIENCES LAWYER CTC Legal Media CTC Legal Media THE LIFE SCIENCES LAWYER 5 Editorial board:Layout 1 20/1/20 10:23 Page 6 LSL news:Layout 1 16/1/20 10:09 Page 7 MEET THE EDITORIAL BOARD NEWS MacKenna Roberts - General Counsel and DPO, Bob Stoll - Partner, Choice Telemed Ltd Drinker Biddle & Reath LLP MacKenna is a life sciences litigation and regulatory Bob is a partner at Drinker Biddle & Reath LLP lawyer who has worked in private practice, and Co-Chair of the Intellectual Property Group. academia and in-house as General Counsel and In October of 2013, he was appointed to a three- DPO to Choice Telemed Ltd. MacKenna is an year term on the CAFC Advisory Council, was experienced strategic adviser assisting clients in reappointed for another three-year term in 2016, the commercialization of medical innovation at the and reappointed in 2019 for an additional three- News frontiers of medicine, specializing in cell and gene year term.
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