Pharma & Biotech Patent Litigation

February 26 - 27, 2019 Radisson Blu Hotel, Amsterdam

At a Glance

Day 1 - Feb 26

Day 2 - Feb 27

Day 1 - Tuesday, February 26, 2019

8:00	Registration & Networking Morning Refreshments
9:00	Chair’s Opening Remarks
9:10	STAKEHOLDER THINK TANK The Unitary Patent Court and Brexit – Devising Patent Strategies Which Adapt to the Variables of the Unknown
10:00	Latest Updates: Arrow Declaration from UK
10:45	Networking Break
11:15	FOCUS GROUP The Economics of Cross Border Patent Litigation Strategies: Effectively Utilizing Different Patent Systems to Protect IP and Ensure Product Value
12:00	Networking Lunch
1:00	FOCUS ON SPCs Analysing Recent SPC Decisions Which Will Shape the Future of IP Protection
2:00	Analysing the Influence of The Trade Secret Directive (EU Directive (2016/43) on Future Patent Strategies
3:00	Networking Break
3:30	DEBATE Warner-Lambert vs. Generics: an Examination of the Proper Utilization of Secondary Medical Use Patents for Innovators and Generics
4:30	Chair’s Closing Remarks & Introduction to Day 2

Day 2 - Wednesday, February 27, 2019

8:00	Registration & Networking Morning Refreshments
9:00	Chair Opening Remarks
9:10	Patent Legalities and Practicalities in the U.S.: Takeaways from the Latest U.S. District Court and Patent Trial and Appeals Board Decisions
10:00	The Doctrine Of Equivalence: Where are we now?
10:45	Networking Break
11:30	Digital Concerns for the Quality of Patents
12:30	Networking Lunch
1:30	European Patent Convention: Exploring Questions of Claim Construction and Burdens of Proof
2:30	CRISPR and Broad Institute vs. University of California: Contrasting Current Developments in U.S. and Their Opposition from the EPO
3:30	Networking Break
4:00	Review of the latest developments in English law
4:30	Chair’s Closing Remarks & End of Conference

Day 1 - Tuesday, February 26, 2019

8:00	Registration & Networking Morning Refreshments
9:00	Chair’s Opening Remarks Judith Krens Partner Taylor Wessing
9:10	STAKEHOLDER THINK TANK The Unitary Patent Court and Brexit – Devising Patent Strategies Which Adapt to the Variables of the Unknown Francesco Macchetta Director Intellectual Property Bracco Group Paul Inman Partner Gowling WLG Pierre Veron Honorary President EPLAW Member, Drafting Committee of the Rules of Procedure of the Unified Patent Court Member, Expert Panel group Dean Thomas Head of Intellectual Property Glenmark Pharmaceuticals The Unitary Patent Court (UPC) which will cover 25 countries is expected to come into full force in Spring 2019. This unified system will streamline the patent approval process through the use of both legal and technical experts and as such will likely provide cost savings in the long-term for Pharmaceutical and Biotech firms. The UK ratified the UPC system prior to its announcement that it would leave the EU, so it is anyone’s guess as to what will happen to the UPC. Determining whether the UK can still participate in the UPC after its exit from EU What are the expected outcomes of Brexit to the UPC and how will this impact pharma and biotech organisations? Assessing the impact of Brexit on the European Court of Justice How will IP case law develop as a result of Brexit?
10:00	Latest Updates: Arrow Declaration from UK Paul Inman Partner Gowling WLG
10:45	Networking Break
11:15	FOCUS GROUP The Economics of Cross Border Patent Litigation Strategies: Effectively Utilizing Different Patent Systems to Protect IP and Ensure Product Value Arvid van Oorschot Partner Vondst Dr. Claudia Milbradt Partner Clifford Chance Brian Cordery Partner Bristows This session will provide a detailed analysis of landmark Pharmaceutical and Biotech patent cases that will help improve your understanding of the enforceability and value of of patent rights across significant jurisdictions. UK: How will Brexit affect cross boarder patent litigation strategies? Spain: Being outside of the UPC, how will this impact decisions and implementation of patent litigation? Germany: What are the current scenarios and developments for the future?
12:00	Networking Lunch
1:00	FOCUS ON SPCs Analysing Recent SPC Decisions Which Will Shape the Future of IP Protection Adrian Spillmann Head of Corporate IP Valneva Ricardo Dijkstra Advocaat Vondst Marco Blei Counsel Portolano Cavallo SPCs are a vital tool for innovator companies to extend the product lifecycle. Recently, there has been conflict between the legal and technical interpretation of SPC regulation and the application of decisions from European Court of Justice to ensure that the timeline of an SPC is fully satisfied by both innovators and generics. This panel will examine this conflict and its repercussions. Examining the most recent SPC decisions and how they are applicable to innovators vs. generics Considering advances in technology in pharmaceutical and biotechnology: Which areas can the courts improve to ensure the pragmatic nature of SPC decisions What are the new proposals for SPC regulations? In light of Brexit, should SPC applications apply under existing EU laws or be held in abeyance until new UK laws are enforced?
2:00	Analysing the Influence of The Trade Secret Directive (EU Directive (2016/43) on Future Patent Strategies Dr. Sven Bostyn Associate Professor of Biomedical Innovation Law University of Copenhagen Benjamin May Partner ARAMIS Société d'Avocats Analysing the most recent implementation of UK Trade Secrets Regulation 2018 into the European directive on unlawful acquisition, use and disclosure of know-how, and business information How do pharmaceutical companies put the changes in the EU directive into effect? Will the trade secret directive amendments create a new and separate IP right? How to find evidence relating to the Trade Secret Directive?
3:00	Networking Break
3:30	DEBATE Warner-Lambert vs. Generics: an Examination of the Proper Utilization of Secondary Medical Use Patents for Innovators and Generics Judith Krens Partner Taylor Wessing Dr. Lorenz Kallenbach Corporate Patent Counsel Merck Group Hubert Witte Head of Patents Basel Roche Professor Dr. Maximilian Haedicke, LL.M. Professor of Intellectual Property Law Freiburg University (Former Judge at Higher Regional Court of Duesseldorf) Evaluating how the latest Secondary Medical Use cases are impacting innovators and generics What are the immediate and long-term effects of Warner-Lambert vs. Generics (UK) on Secondary Medical Use patents Discovering best timing strategy for Secondary Medical Use enforcement? Cost/benefit analysis for the originator’s position to litigate weaker patents in the portfolio following expired product patents. Consideration for generics/biosimilars manufacturers who have already attempted to launch products with specific labelling strategies
4:30	Chair’s Closing Remarks & Introduction to Day 2

Day 2 - Wednesday, February 27, 2019

8:00	Registration & Networking Morning Refreshments
9:00	Chair Opening Remarks Paul Inman Partner Gowling WLG
9:10	Patent Legalities and Practicalities in the U.S.: Takeaways from the Latest U.S. District Court and Patent Trial and Appeals Board Decisions Jon Singer Principal Fish & Richardson Understanding the different proceedings at the U.S. District Courts and PTAB Discovering the constantly evolving political and economic factors associated with filing for patents in the U.S. Developing the best practice strategy for filing patents in the U.S. and mitigating the cost of litigation
10:00	The Doctrine Of Equivalence: Where are we now? Paul Reeskamp Partner DLA Piper A little history: what was the idea behind part 2 Protocol? Protection of equivalence and legal certainty Actavis v Lilly; Neuberger’s Kirin-Amgen revenge? Recent developments in case law
10:45	Networking Break
11:30	Digital Concerns for the Quality of Patents Dominic Adair Partner Bristows The digital era has brought a considerable amount of data to the field of patenting. This poses a real concern to innovators as how to best protect their products. Join us for a fireside chat with distinguished outside and in-house counsel as they discuss: How the digital age is affecting the quality of patent More data: can this create different types of claim? Whether an increase data can provide better claims? Creating insights for new ways in producing different results What are the consequences with access to more data.
12:30	Networking Lunch
1:30	European Patent Convention: Exploring Questions of Claim Construction and Burdens of Proof Dr. Stephan Kutik European Patent Attorney Chiesi Farmaceutici S.P.A Rene Wagner Examiner JC Biotechnology European Patent Office Daan de Lange Partner Brinkhof Through progressive technological advances in the areas of anti-bodies and therapeutics, function claims are being reexplored and questioned. This panel will explore these controversies How does the EPO assess patentability of broad claims? Exploration of recent EPO decision cases What legal provisions are infringed? Is there a lack of inventive step? (Art 56 EPC) or is there a lack of sufficiency disclosure? (Art 83 EPC) What can be considered as different standard of proof? What type of evidences are available and correct? What are the plausibility of national courts regarding establishing their own standard?
2:30	CRISPR and Broad Institute vs. University of California: Contrasting Current Developments in U.S. and Their Opposition from the EPO Brian Coggio Of Counsel Fish & Richardson Dean Thomas Head of Intellectual Property Glenmark Pharmaceuticals Discovering patentability requirements in the U.S. for natural sequencing to ensure a valid and correct patent application via Broad Institute vs. University of California What are the procedures and requirements to make a claim a priority? How does the recent decision from the EPO impact the future of CRISPR technology- influenced patents in Europe?
3:30	Networking Break
4:00	Review of the latest developments in English law Jane Lambert Barrister 4-5 Gray’s Inn Square Anna Lopez Head of IP Esteve How far did Eli Lily v Actavis really change the law? A review of the cases in which the Supreme Court’s judgment has been considered and applied such as Icescape Ltd v Ice-World International BV and Regen Lab v Estar; Clinical commissioning and licensing: the Administrative Court’s decision in Bayer Plc v NHS Darlington CCG and others; The Implementation of the Trade Secrets Directive in the UK; Proposals for supplementary protection certificates after Brexit
4:30	Chair’s Closing Remarks & End of Conference

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