The IP landscape in China

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The IP landscape in China Tom Carver External Expert China IPR SME Helpdesk 12 May 2016, Dublin, Ireland 1

Today s Speaker Name: Tom Carver Firm: J A Kemp Location: London, UK Tom Carver is a partner at J A Kemp who specialises in intellectual property and has substantial experience in multiple-jurisdiction patent and design right litigation in the UK and in China. Tom is now based in London, having previously spent three years living in China, and advises clients on the enforcement of intellectual property rights in China as well as other Chinarelated issues, including commercial law. Tom also advises Chinese companies on UK law. He is a regular speaker on the topic of IPR in China and has published several articles on this subject. 12 May 2016 2

Agenda 1. Lessons learnt from the latest pharmaceutical patent infringement cases in China 2. What evidence can you bring before the Chinese courts? 3. Main procedural aspects you must be aware of when initiating proceedings in China 12 May 2016

Main Procedural Aspects Patent linkage Timeline of an action In-suit applications Evidence Preservation Orders Asset Preservation Orders Customs seizures 12 May 2016

Procedural Aspects: Patent Linkage Drug Registration Regulations Articles 18 and 19: the applicant shall provide information on patents and a statement of non-infringement and the SFDA shall issue drug approval after the expiry date of the patent. But Incomplete patent/drug database. SFDA does not have the resources to police effectively. 12 May 2016

Procedural Aspects: Timeline Authorisation documents Patent, company certificate, certificate of authorisation, passport, power of attorney. Collect evidence Witnessed, from the factory, with a chop. 2 July 2015 6

Procedural Aspects: Timeline File at Case Acceptance Division Jurisdiction challenge plus appeal Evidence Exchange Trial Settlement discussions Appeal 2 July 2015 7

Evidence Preservation Order Court (or IPO) will visit premises and seal evidence Not guaranteed success Not permitted access Not shown crucial evidence 2 July 2015 8

Asset Preservation Order Preserve assets to pay damages Not guaranteed success No assets Other creditors 2 July 2015 9

Customs Seizures Inform officers Seize container Bond Counter-bond Civil Litigation 2 July 2015 10

What Evidence Can You Use? Sale/manufacture Notary public (or EPO) is essential Judge has little/no discretion Recent Guidance on burden of proof Expert evidence Approved institutions only but no weight 2 July 2015 11

What Evidence Can You Use? Foreign evidence? Foreign import documents? FDA approval/licence? For damages? Reverse burden of proof? 2 July 2015 12

Recent Lessons Learnt Interim injunctions are possible Novartis re Glivec Eli Lilly re trade secrets 2 July 2015 13

Interim Injunctions? Must prove Infringement Irreparable harm New guidelines circulated in draft Stable patent Not irreparable if damages are relatively easy to calculate 2 July 2015 14

Conclusions Remains a challenging jurisdiction Specialist IP courts started 2014 Fundamentals have not changed No rule of law Courts have very little power 2 July 2015 15

China and South-East Asia IPR SME Helpdesks Enquiry Helplines Websites & Blog Training Workshops & Live Webinars E-learning & Business Tools IP Guides & Newsletters 12 May 2016 16

Enquiry Helpline IPR one-to-one consultations: E-mail, telephone, face-to-face First-line advice on China countries IPR matters Confidential Delivered by China IPR specialists Available for EU SMEs and SME intermediaries question@china-iprhelpdesk.eu +86 (10) 64620892 12 May 2016 17

Information & Materials Library of publications: IP specific guides, incl. patents & trade marks Industry specific guides, incl. textiles, machinery, creative industries Business guides, incl. technology transfer Hong Kong and Macao Factsheets Quarterly Helpdesk newsletters Article placement Topical blog posts 12 May 2016 18

Training workshops & webinars Workshops across Europe and China Addressing general IPR and industry specific IPR matters Trainings delivered in several languages Free one-to-one consultations Webinars: Save time by joining these interactive training sessions from your own office or watch recordings online 12 May 2016 19

Online portal Practical IPR guides E-learning modules Case study catalogue FAQs Helpdesk newsletters Event information Latest blog posts Helpdesk videos www.china-iprhelpdesk.eu 12 May 2016 20

The China IPR SME Helpdesk provides free, confidential, business-focused advice to European Small and Medium Enterprises (SMEs) relating to IPR in China Helpdesk Enquiry Service / Training & Events: question@chinaiprhelpdesk.eu Materials Online Services -www.china-iprhelpdesk.eu For more information about our services and how the China IPR SME : Telephone/Hotline: +86 (10) 6462 0892 12 May 2016 21

Feedback Questions Discussion 12 May 2016 22