Preconference Workshop: Oct. 22,Afternoon

Taiwan and China Mainland Patent Linkage

  • 15:30

    Development and Challenges of Exploring Patent Linkage System in China Mainland

    Yongshun Cheng, Director, Beijing Intellectual Property Institute
  • 16:10

    Implementation of Taiwan’s Patent Linkage Laws and Rules

    Shuyin Zhu,Senior Consultant,Lee and Li Attorneys-at-Law
  • 17:00

    Round Table Discussion: Patent Linkage in China Mainland, Taiwan and US

    Yongshun Cheng, Director, Beijing Intellectual Property Institute
    Shuyin Zhu, Senior Consultant, Lee and Li Attorneys-at-Law
    Lijuan Wu, Deputy Director, Beijing Intellectual Property Institute
    Tony Chen,Partner,Jones Day
    Yongfeng Zheng,Legal Director and Vice President of Research Institute, Tasly Holding Group
    Yue Yang, Director, International Center for Food&Drug Policy and Law, Shenyang Pharmaceutical University
  • 18:00

    Tea Break and Networking

Day 1 Morning Oct. 23

Focus on China: Patent Law Amendment, IP Enforcement and Drug Regulatory Updates

  • 07:30

    Registration

    Morning Moderator: Tony Chen, Partner, Jones Day
  • 08:30

    Conference Chairman Opening Remarks

    Qingkui Zhang, Honorary Director, Pharma IP Right Research Committee
  • 08:40

    Examination of Invalidation Cases and Practice of Pharma Compound Patent Examination

    Hou Yao, Researcher of Chemistry Appeal DeptⅠ, Reexamination and Invalidation Department of the Patent Office, CNIPA
  • 09:20

    Pharma Patent Infringement Litigation Cases

    Chenglong Ma, Managing Partner Shanghai Office, HENGDU LAW FIRM
  • 09:55

    Measuring Pharmaceutical IP Index Values for Drugs in the Chinese Orange Book

    Tony Chen, Partner, Jones Day
  • 10:10

    Tea Break

  • 10:40

    Panel Discussion: Implication & Development of Patent Linkage, Patent Term Restoration and Regulatory Data Protection in China

    Moderator:
    Yongshun Cheng, Director, Beijing Intellectual Property Institute
    Panelist:
    Tony Chen, Partner, Jones Day
    Yang Xu, Patent Attorney, BeiGene, Ltd.
    Wenjun Geng, IP Director, CHIA TAI TIANQING PHARMACEUTICAL GROUP
    Lifang Sun, IP Vice President, Luye Pharma Group
  • 11:40

    Panel Discussion:Identification and Persuasion Strategy of Technical Facts in Pharma Patent Cases

    Moderator:
    Nick Qinghui Liu, Partner, Anjie Law Firm
    Panellist:
    Bo Xu, Counsel, LUNG TIN L AW FIRM
    Jun Yi, Head of Case-filing Division, Beijing Intellectual Property Court
    Feng Xu, IP Director for China and Asia, AstraZeneca
    Richard Liu, Partner, SAELINK LAW
  • 12:30

    Lunch

  • Day 1 Afternoon Oct. 23

    Focus on China: Patent Law Amendment, IP Enforcement and Drug Regulatory Updates

  • 14:00

    Data Supplementation for Chemical and Biotech Patents

    Wu Li, Partner, Anjie Law Firm
  • 14:40

    Drugs Innovators in China: IP Challenges and Strategies

    The Intellectual Property (IP) landscape in China as it relates to the pharmaceutical industry is undergoing dramatic changes. Along with the changes come challenges and opportunities. On the one hand, this y ear has witnessed an emerging trend of regulatory approvals of generic drug applications while the underlying patents protecting the active pharmaceutical ingredients (APIs) are still in force. This trend, coupled with the high rate of invalidating pharmaceutical patents and limited judicial remedies, presents new challenges to the innovative pharmaceutical companies. On the other hand, a more refined IP system is widely anticipated that promotes pharmaceutical innovation and balances varied industrial and public interests. It remains uncertain, as well as fascinating, to what extent such a system should or will ultimately be shaped, if at all, by certain time-proved components, notably patent linkage, patent term extension (P TE) and regulatory data protection (RDP). Furthermore, the rise of the Chinese pharmaceutical industry as whole, with increased international reach and R&D capabilities, represents a new, game-changing reality that international companies operating in China must respond to. How pharmaceutical companies choose to navigate the rapidly evolving IP landscape, manage the challenges and leverages the opportunities may eventually determine their survival or success in China.
    Feng Xu, IP Director for China and Asia, AstraZeneca
  • 15:20

    IP Challenges and Coping Strategies of Generic Drug Company in China

    Yuanxia Liu, Senior Partner, Beijing Origintelligence Intellectual Property Law Firm
  • 15:55

    Tea Break

  • 16:25

    Patent Protection of Biological Sequences

    With the development of China's economy in recent years, the patent applications in the biotechnology field have shown a significant growth trend, and biological sequences are one of the important parts, involving DNA sequences, RNA sequences, protein sequences (including antibodies, enzymes, etc.). Correspondingly, disputes in the biotechnology field have gradually become heated. In particular, the expiration of major pharmaceutical variants of foreign original pharmaceutical companies such as “Humira” will usher in a flash point of relevant surrounding patents invalidation and litigation. Therefore, the patent protection in the biotechnology field will increasingly become a concern. This keynote speech will combine five invalid cases of the “ glucoamylase” series represented by the speaker (one of which is the 2018 Patent Reexamination Board 's top ten cases), to discuss some of the hot issues in patent protection for biological sequences, such as supportive and creative issues.
    Jiwei Yin, Partner / Deputy General Manager, Beijing Sino-Creativity Intellectual Property Law Firm
  • 17:10

    Panel Discussion: Evaluation of Inventive Step of Pharmaceutical Compound Inventions

    In the context of China's biomedical inno vation, intellectual property protection is a top priority. Among them, the compound patents are the basis of pharmaceutical patent pr otection, but the eff ectiveness of pharmaceutical compound patents are often challenged in practice. How to grasp the inventiveness of pharmaceutical compound in ventions, including the Markush claims and specific compound claims, is of paramount importance. The rules f or inventiveness judgment of pharmaceutical compound in ventions are being formed in patent in validation and administrative litigation cases. The panel discussion will discuss v arious aspects of pharmaceutical compound patents in conjunction with specific cases, such as the thr ee-step approach and unintended technical effects considerations, technical effects and technical issues identifications, whether changes to the existing Markush-style ring structure and fixed parts are obvious, whether jumping out of the definition scopes of the existing Markush-type variables will mean that it is ob vious, the identification of supplementary experimental data in diff erent stages of the trial, and so on.
    Moderator:
    Wenping Chen, Partner, King & Wood Mallesons
    Panelist:
    Peter Storm, Senior Patent Attorney, AstraZeneca
    Yang Xu, Patent Attorney, BeiGene, Ltd.
    Jun Yi, Head of Case-filing Division, Beijing Intellectual Property Court
    Tina Tai, Partner, King & Wood Mallesons
  • 18:00

    Cocktail & Networking

Day 2 Morning Oct.24

Focus on US: Patent Layout, Generic Drug Launches and IP Protection Strategy in US

  • 08:30

    Morning Moderator Opening Remarks

    Yehudah Livneh,Former VP Corporate IP and Legislative Affairs, Teva Pharmaceuticals
  • 08:40

    Latest Developments of IPR and Recent Patent Invalidation Cases

    • Patenting in US
    • Introduction of US Post-Grant Review (IPR,PGR,CBM,EPR) and Latest Developments
    • Rules and Principles in IPR Procedures
    • IPR Cases Study
    Michael Wise, Partner, Perkins Coie LLP
  • 09:20

    The Strategy of ANDA Filers to Challenge Patents Under a PIV Certification and Recent ANDA Litigation Cases Study

    Shashank Upadhye, Founding Partner, Upadhye Cwik LLP
  • 09:55

    Identifying the Loss of Exclusivity (LoE) of a U.S. Pharmaceutical Patent Portfolio

    • The LoE date • Factors that can increase term: PTA and PTE • Factors that can reduce term: obviousness-type double patenting and terminal disclaimers • Interplay with FDA regulatory exclusivities • Assessing LoE in a complex pharmaceutical patent portfolio
    Carl A. Morales, Partner, Dechert LLP
    Gang Wang, Associate, Dechert LLP
  • 10:40

    Tea Break

  • 11:00

    U.S. Biosimilar Patent Litigation: Strategies and Trends

    Keith A. Orso, Partner, Irell & Manella LLP
    Ian Washburn, Partner, Irell & Manella LLP
  • 11:40

    Panel Discussion: IP Considerations & Strategies for Pharma Companies When Entering the U.S. Market

    • Developing Your IP Portfolio to Maximize Value
    • U.S. Specific Issues – Don’t let them trip you up!
    • Ownership and Inventorship
    • CROs, Foreign filing licenses, and the On-Sale Bar
    • Partnering and Due Diligence – Best Practices
    Moderator:
    Wu Li, Partner, Anjie Law Firm
    Panelist:
    Teresa Lavoie, Principal, Fish & Richardson P.C.
    Caihui Li, Senior IP Director, 3SBio Group
    Andy Zhang, Senior Corporate Counsel, Intellectual Property, Sunovion Pharmaceutical
    Bharati Nadkarni, Vice President Portfolio Planning and IP litigation, Sun Pharmaceutical
  • 12:30

    Lunch

  • Day 2 Afternoon Oct.24

    Challenges Under Brexit &Unitary Patent System & Global Antibodies, Biosimilars IP Issues

  • 14:00

    Afternoon Moderator Remarks

    Markus Engelhard, Partner, Boehmert & Boehmert
  • 14:00

    UPC and UPS - Why does it Make Sense for Europe and What Could be the Impact of Brexit?

    • Why – if at all – is Brexit a problem for the UPC/UPS.
    • Determining whether the UK can still participate in the UPC after its exit from EU?
    • How does this affect pharma companies seeking patent protection in the U.K?
    • How will this impact patent prosecution strategies for pharmaceutical companies looking to obtain Unitary Patents?
    • How are we targeting the new Courts – how will Bayer use it?
    • Why is Bayer in favour of the new system?
    Dr. Joerg Thomaier, Head of IP, Bayer Group
  • 14:40

    Recent European Regulatory Developments on Supplementary Protection Certificates (SPCs)

    • The potential impact of Brexit on SPCs
    • Regulatory data protection rules in the UK
    Chris Goddard, Partner, Dehns Patent and Trade Mark Attorneys
  • 15:20

    How to Build a Successful Licensing Program and Other Strategies for IP Monetization

    • Developing a systematic approach to successful patent Licensing
    • Portfolio evaluation & management.
    • How do you value IP?
    • Enforcement & monetization
    • Creating a strategic licensing plan
    Peter L. Dolan, Strategy and Business Development Senior Director, Sanofi
  • 16:00

    Tea Break

  • 16:30

    Panel Discussion: Global Patent Issues of Therapeutic Antibodies

    • PD-1/PD-L1 patent landscape in the U.S., Europe and China – what are the main freedom-to-operate risks?
    • Challenges of obtaining global patent protection over antibody inventions – what are the common issues?
    • Enhancing the value of antibody inventions – what are the successful claim strategies in different jurisdictions?
    • Life cycle management of therapeutic antibody products – how to protect later arising inventions?
    Moderator:
    Wanli Tang, Associate, Jones Day
    Panelist:
    Markus Engelhard, Partner, Boehmert & Boehmert
    Lareina Chen, IP Manager, Shanghai Junshi Biosciences
    Qiujuan Ma, Director of Pharmaceutical Division, Patent Examination Cooperation Center (Beijing)
    John Lu, Partner, Milbank
  • 17:30

    Panel Discussion: Biosimilars in US, EU and China: Where Are We Now and Where Are We Going?

    • Regulatory pathways for biosimilars in China,EU and US
    • Regulatory data exclusivity – will it be available for biologics and would it matter?
    • Biosimilars vs. me-toos and biobetters – what is the trend?
    • What is the future of a crowded market for me-toos – is there enough space for biosimilars?
    • Domestic and global players – (when) will global biosimilar players enter China?
    • Will domestic me-too/biosimilars players go global? and Competitive advantage of domestic biosimilars
    Moderator:
    Dr. Christof Bull, Associate General Patent Counsel, UCB Biopharma
    Panelist:
    Daisy Wu, IP Director, Shanghai Henlius Biotech,Inc.
    Caihui Li, Senior IP Director, 3SBio Group
    Dr. Alexander Jamnišek, Senior Patent Attorney, Sandoz
    Christopher T. Griffith, Founding Partner, Green, Griffith & Borg-Breen LLP
  • 18:30

    Cocktail & Networking

Day 3 Morning Oct.25

Focus on Japan, India,Korea and Brazil: IP Protection and Practical Experiences

  • 08:40

    Morning Moderator Opening Remarks

    Mahendra B. Thakre, Senior General Manager, Mylan Laboratories
  • 08:50

    Patent System and Practice of Medical Fields and Patent Term Extension in Japan

    • Introduction of Japanese patent examination guidelines on medical field, focused on “patent subject matter eligibility of medical invention” and “novelty and inventive step of medical invention” with case examples.
    • Patent term extension system in Japan
    • Recent IP issues in JPO
    Toru Matsuoka, Deputy Director, Examination Standards Office, JPO
  • 09:30

    The Emergence of India’s Pharmaceutical Industry as the Major US Generic Player

    How Indian pharm industry evolved, refined strategy and re-oriented business model to embrace new challenges and stay ahead of the game.
    Poonam Raghuvanshi, Vice President & Head of IP, Dr. Reddy's Laboratories Ltd.
  • 10:00

    Patent System for Pharmaceutical Invention in South Korea

    • Tips for obtaining a pharmaceutical patent in Korea
    • Patent term extension in Korea since 1987
    • Patent-approval linkage system in Korea since 2015
    • Recent key decisions rendered by the Korean Supreme Court
    Ilseok Alban Kang, Patent Attorney, FirstLaw P. C.
  • 10:30

    Tea Break

  • 11:00

    Life Sciences: IP and Regulatory Environment in Brazil and Selected Latin American Jurisdictions

    Gustavo Morais, Partner, IP Agent, Dannemann Siemsen
    Ana Carneiro, Partner, IP Agent, Dannemann Siemsen
  • 11:35

    Panel Discussion: Best Practices for IP Litigation

    • Preparations prior to beginning litigation.
    • Assembling a team both in house and outside counsel - key considerations and best practices.
    • Best practices for managing outside counsel teams - the in-house perspective.
    • Coordination of IP litigation with the business - Strategies for collaboration of business and legal teams.
    • Global strategies for managing worldwide patent disputes - best practices for developing and executing a unified strategy.
    Moderator:
    Yehudah Livneh, Former General Patent Counsel, Teva Pharmaceuticals
    Panelist:
    Mahendra B. Thakre, Senior General Manager, Mylan Laboratories
    Bharati Nadkarni, Vice President Portfolio Planning and IP litigation, Sun Pharmaceutical
    Joerg Thomaier, Head of IP, Bayer Group
  • 12:20

    Lunch

  • Day 3 Afternoon Oct.25

    Focus on Traditional Chinese Medicine:IP Protection and Challenges of Going out

  • 13:40

    Afternoon Moderator Remarks

    Xiaoting Song, Professor, Shanghai International School of Intellectual Property of Tongji University
  • 13:45

    Patenting Situation of TCM and Studies from Invalidation Cases

    • Status of patent applications of Traditional Chinese Medicine
    • The problem of low quality of patent application documents
    • Novelty,Inventiveness and Practical applicability issues
    • Studies from invalidation cases
    • Practical advises for patent applicant
    Jiangming Wu, Deputy Director, Patent Examination Cooperation Jiangsu Center of The Patent Office
  • 14:25

    Rethinking of Patent Creative Evaluation for Traditional Chinese Medicine

    Yongfeng Zheng, Legal Director and Vice President of Research Institute, Tasly Holding Group
  • 15:10

    Tea Break

  • 15:30

    Protect the Technologies from Traditional Chinese Medicine: Challenges and Opportunities

    Xiaoting Song, Professor, Shanghai International School of Intellectual Property of Tongji University
  • 16:10

    Panel Discussion: IP Challenges and Strategy for Traditional Chinese Medicine ‘Going Out’

    Moderator:
    Xiaoting Song, Professor, Shanghai International School of Intellectual Property of Tongji University
    Panelist:
    Jincai Hou, Research Institute President, China Shineway Pharmaceutical Group
    Xiangjun Li, Vice President, SHIJIAZHUANG YILING PHARMACEUTICAL
    Yongfeng Zheng, Legal Director, Tasly Holding Group
    Xiarui Dou, IP and Legal Director, Yabao Pharmaceutical Group
  • 17:10

    Conference Ending


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