Regulatory Challenges to Life Science IP's
8:00 - 8:50 Morning Coffee, Registration, and IQPC Welcome
8:50 - 9:00 CHAIRMAN’S REMARKS & OPENING OF DAY ONERob J. Aerts - Director of Intellectual Property, Tigenix
9:00 - 9:30 KEYNOTE - Patent Innovation: Patient Value FirstStephane Drouin - Chief IP Counsel, UCB
Aaron Smethurst - Director, Intellectual Property Policy, UCB
Address public perception of companies’ patenting strategies and their impact on competition, Combined more recently with that of overpriced medicines, is putting tremendous pressure for change on our industry,
Need to be proactive to show core value of patents for policymakers who see weakening IP as a boon to patients and payer budgets.
UCB will show how to put this belief into practice by optimizing patent portfolio to only file and retain those patents that demonstrate clear value
Stephane DrouinChief IP Counsel
Aaron SmethurstDirector, Intellectual Property Policy
9:30 - 10:15 Dual Discussion - Patent Protection and Infringement ProceedingsDr Matthias Zigann - Presiding Judge, Munich Regional Court
The Honourable Sir Richard Arnold - Judge, UK High Court of Justice Chancery Division
Covering topics relating to Rules 26-28 EPC:
Genetic inventions vs essentially biological (breeding) processes
Disclaimers within patent claims
Problems that may arise within infringement proceedings
Dr Matthias ZigannPresiding Judge
Munich Regional Court
The Honourable Sir Richard ArnoldJudge
UK High Court of Justice Chancery Division
10:15 - 10:45 Doctrine of Equivalents – What is the Right Balance Between Innovators and Generic Pharma?Rachel Fetches - Partner, HGF London
Details of the Presentation:
Where are we now with the DoE?
Advising on scope of protection & validity
File wrapper estoppel
10:45 - 11:15 MORNING BREAK & NETWORKING
11:15 - 11:45 UPC and Brexit – An Update of Current DevelopmentsKevin Mooney - Chairman of the Rules and Procedure Committee, UPC
A generalised update on current processes of the UPC/What has changed since 2017?
With UK Ratification in April 2018, and German/Hungarian ratification still unclear, what would this entail for filing post-March 2019
Kevin MooneyChairman of the Rules and Procedure Committee
11:45 - 12:15 Case Study - Secondary Patents for Further Medical UsesDr Nicolas Ruiz - Intellectual Property Head, European Patent Attorney, Esteve
In a multi-jurisdictional context, secure patent protection for further medical use arising from a new clinical development is challenging, depending on the background of the product and on the legal framework.
Are those “second medical use” claims enforceable, and are injunctions easily granted? What are the remedies to be expected?
Distortion coming from regulatory authorities and legal framework may be an additional barrier for a valuable protection of those further medical uses.
Dr Nicolas RuizIntellectual Property Head, European Patent Attorney
12:15 - 13:15 NETWORKING LUNCH
13:15 - 14:00 Plausibility – An Ancillary or Independent Patentability RequirementDr Jürgen Dressel - Former Head of Global Patent Litigation, Novartis
Dr Sven Bostyn Lic.Jur., LLM, PhD - Associate Professor of Biomedical Innovation Law, Law Center for Advanced studies in Biomedical Innovation Law
This session will cover the following topics:
Sufficiency vs. Inventive Step
European Case Law examples
UK Supreme Court battles (Warner-Lambert vs. Actavis/Pregabalin)
Fairness and Practicality
Dr Jürgen DresselFormer Head of Global Patent Litigation
Dr Sven Bostyn Lic.Jur., LLM, PhDAssociate Professor of Biomedical Innovation Law
Law Center for Advanced studies in Biomedical Innovation Law
14:45 - 15:15 The Unpredictable Nature of the Interaction Between EU and EPC lawRob J. Aerts - Director of Intellectual Property, Tigenix
How do the EU and EPC law systems establish patentability in the field of biotechnology in Europe?
Due to their different legal status, the systems do not always tend to align
In practice much depends on which system takes the lead
How does this work
15:15 - 15:45 AFTERNOON BREAK & NETWORKING
15:45 - 17:00 Interactive Roundtable Sessions
New for 2018, this series of interactive roundtable discussions will be designed by you, for you. Whilst we appreciate that presentations are a great source of information, we understand the value of discussion-based problem solving. With this in mind, you will select a key topic where you will join your peers to discuss challenges, develop a strategy and share your feedback with the audience.
Each person will have the opportunity to select and discuss two of the below topics for 30 minutes each, before people will be invited to share their thoughts collectively in the wrap-up summary session. Please note all attendees will be asked to provide their preferences prior to the conference to help manage numbers onsite and to avoid disappointment on the day!
TableOne: Effective Strategies for IP Monetisation/Management
TableTwo: UPC, Brexit and the European Regulatory Framework
TableThree: AI and the Convergence of Technology and IP
Table Four: Manufacturing Waivers and the new SPC Reality