Agenda

Day 1 - Tuesday, October 16, 2018

9:00

Focus of SPCs

SPC Update: Analyzing Key SPC Decisions and Assessing their Impact on the Pharmaceutical , Biotech and Medical Device Sectors

10:30

Networking Coffee & Drinks

11:00

European Patent Office Spotlight Sesson: Understanding the Impact and Effect of Board of Appeals Procedure Changes

11:45

The IP Fallout from Brexit: Assessing Consequences for New and Existing Patents

12:30

Networking Lunch

1:30

Breakout Session: Choose A or B

STREAM A – Pharma & Biotech Patents

1:30	Secondary Medical Use Part I: Analyzing the Consequences of Warner Lambert v. Generics (UK) Latest Updates
2:15	Secondary Medical Use Part II: Developing Strategies for Enforcement
3:00	Networking Coffee & Drinks
3:30	Antibody Updates: European Antibody Patent Claims
4:15	Examination into Epitope: Understanding the Latest Developments in the U.S. and Subsequent Effects in Europe

STREAM B – Medical Device Patents

1:30	The new EU medical device regulation (MDR) and the need for fresh view of IP strategies
2:00	Determining the True Value of Medical Device IP: Assessing Patent Strength and Commercial Viability
3:00	Networking Coffee & Drinks
3:30	Developing Strategies to Ensure Patent Protection of Medical Devices During Product Launches in Europe and the U.S.

5:00

Chair Closing Remarks & Recap of Day 1

5:15

Evening Networking Drinks

6:30

Speakers Dinner

Day 2 - Wednesday, October 17, 2018

9:00	Chair’s Opening Speech
9:10	Accounting for Inter Partes Review: Patent Application Strategies for Optimising Patent Success in the U.S. Market
10:00	Uncertainty in Biotech Patenting in Europe: Causes, Consequences and Possible Remedies
10:30	Networking Coffee & Drinks
11:00	Doctrine of Equivalence: Understanding How the Latest Decisions Will Impact Patenting Law in the UK, U.S., Germany, France and Netherlands
12:30	Networking Lunch
1:30	Us vs. Them: A Biologics Wargame Exercise
2:15	Focus on Brazil: Main Aspects of Patent Protection and Latest Updates Regarding Examination
3:00	Networking Refreshments
3:30	Patent Litigation Trends in Russia
4:15	Cross Border Litigation Case Analysis for Medical Device Patent Litigation: How to Enhance Strategic Decisions on Patent Portfolios
5:00	Chair Closing Remarks and Closing of Conference

Day 1 - Tuesday, October 16, 2018

9:00

Focus of SPCs

SPC Update: Analyzing Key SPC Decisions and Assessing their Impact on the Pharmaceutical , Biotech and Medical Device Sectors

Dr. Oliver Werner
Head of SPC Working Group
German Patent Trade Mark Office

Julia Florence
Assistant General Counsel (Patents)
GlaxoSmithKline

Dr. Joerg Dreyhsig
VP Associate General Counsel IP
Fresenius Medical Care AG & Co. KGaA

Frank Landolt
V.P IP
Ablynx N.V.

The supplementary protection certificate is a vital piece of patent protection to ensure pharmaceutical, biotech and medical device organisations can extend their product lifecycles. This session will provide invaluable information through two parts, the first a keynote address by the head of the German Patent and Trademark Office’s SPC Working Group, and the second, an interactive in-house panel discussion on how SPCs influence, not only IP, but business decisions as well. PART I: Keynote Address on Recent SPC Decisions from the European Court of Justice

Dr. Oliver Werner
Head of SPC Working Group
German Patent Trade Mark Office

This keynote session will address in detail the key takeaways and amendments following the most recent SPC decisions coming from the European Court of Justice.

The results of the SPC consultation and recent decisions
The scope of SPCs
Analysis of whether something that has been disclosed in a patent application can be used as basis for an SPC?
How to calculate SPCs: what is the duration from beginning to end?

PART II: In-House Counsel Perspectives on the IP and Business Implications of SPCs

Pharmaceutical

Julia Florence
Assistant General Counsel (Patents)
GlaxoSmithKline

Medical Device

Dr. Jorg Dreyhsig
VP Associate General Counsel IP
Fresenius Medical Care AG & Co. KGaA

Biotech

Frank Landolt
V.P IP
Ablynx N.V.

Impact of recent case law
What potential effect will these decisions have on my future business strategy?
Implementing the most recent European Commission updates into practical IP and litigation strategies
How will these decisions impact the future of SPC medical device applications?

10:30

Networking Coffee & Drinks

11:00

European Patent Office Spotlight Sesson: Understanding the Impact and Effect of Board of Appeals Procedure Changes

Overview of important elements to the procedure changes and what to look out for
Analyzing the impact of Article 10 – consolidation and acceleration of appeal proceedings.
- How this will affect:
  - The timeline for deadlines
  - Filing for additional arguments for patents
Understanding how the Article 12 basis of appeal proceedings will affect the overall procedures for an Appeal

11:45

The IP Fallout from Brexit: Assessing Consequences for New and Existing Patents

Julia Florence
Assistant General Counsel (Patents)
GlaxoSmithKline

With less than one year to go until UK formally withdraws from the European Union, this session raises the important IP questions that will affect all life science companies and provides answers for how better to prepare for this imminent major change.

The Unitary Patent Court – how will this be affected after Britain leaves?
What are the consequences of Brexit on IP? How does it affect SPCs and the UPC?
Understanding whether SPCs granted under existing law can still be utilised after Brexit

12:30

Networking Lunch

1:30

Breakout Session: Choose A or B

STREAM A – Pharma & Biotech Patents

1:30	Secondary Medical Use Part I: Analyzing the Consequences of Warner Lambert v. Generics (UK) Latest Updates Corinna Sundermann Senior Vice President IP Management Fresenius Kabi Deutschland GmbH Guido Pontremoli Corporate IP Patent Director Chiesi Farmaceutici Nicolas Ruiz Head of IP Esteve Dr Dieter Tzschoppe Director,Healthcare, Biotechnology and Chemistry European Patent Office
2:15	Secondary Medical Use Part II: Developing Strategies for Enforcement Guido Pontremoli Corporate IP Patent Director Chiesi Farmaceutici Dr Philipp Cepl Partner DLA Piper Nicolas Ruiz Head of IP Esteve Arvid van Oorschot Partner Vondst Advocaten N.V.
3:00	Networking Coffee & Drinks
3:30	Antibody Updates: European Antibody Patent Claims Fredrik Fredh European Patent Attorney Novartis Pharma AG Karine Crepin Global Head of Biologics Patents Sanofi Global IP Department
4:15	Examination into Epitope: Understanding the Latest Developments in the U.S. and Subsequent Effects in Europe Karine Crepin Global Head of Biologics Patents Sanofi Global IP Department James Velema Partner Lathrop Gage LLP Emilie Frugier Patent Manager NBE Therapeutics AG Dr. Ulrich Storz Senior Partner Michalski Hüttermann & Partner Patentanwälte mbB

STREAM B – Medical Device Patents

1:30	The new EU medical device regulation (MDR) and the need for fresh view of IP strategies Azadeh Mehrabi Strategic Intellectual Property Manager Biotronik
2:00	Determining the True Value of Medical Device IP: Assessing Patent Strength and Commercial Viability Robin Ellis Head of IP Product Development & Strategy Sandoz
3:00	Networking Coffee & Drinks
3:30	Developing Strategies to Ensure Patent Protection of Medical Devices During Product Launches in Europe and the U.S. Sascha Roeder IP Manager PARI Pharma GmbH Frank Landolt V.P IP Ablynx N.V.

5:00

Chair Closing Remarks & Recap of Day 1

5:15

Evening Networking Drinks

6:30

Speakers Dinner

Day 2 - Wednesday, October 17, 2018

9:00	Chair’s Opening Speech Paul Inman Partner Gowling WLG
9:10	Accounting for Inter Partes Review: Patent Application Strategies for Optimising Patent Success in the U.S. Market Jon Singer Principle Fish & Richardson Martina Hufnal Principle Fish & Richardson John D. Murnane Partner Fitzpatrick, Cella, Harper & Scinto Examining the inter partes review process and its applications Survey and summary of results from the U.S. PTO’s Patent Trial and Appeal Board and the Appellate Court (U.S. Court of Appeals for the Federal Circuit) Analysying the impact of these decisions on the pharma, biotech and medical device sectors Examining successful IPR strategies and potential footfalls from recent cases How to effectively incorporate IPR findings into the patent drafting process to ensure legitimacy in the U.S. courts? Examining successful strategies and potential footfalls from recent case studies.
10:00	Uncertainty in Biotech Patenting in Europe: Causes, Consequences and Possible Remedies Rob Aerts IP Director Tigenix SAU Which regulatory body or bodies in Europe determines what is a patentable subject-matter and what is not? Examining the role of both EU law and EPC law Understanding why the systems sometimes collaborate and sometimes go in different directions How to take measures in regard to safeguard rights?
10:30	Networking Coffee & Drinks
11:00	Doctrine of Equivalence: Understanding How the Latest Decisions Will Impact Patenting Law in the UK, U.S., Germany, France and Netherlands Simon Llewellyn Senior Associate Carpmaels & Ransford Christoph Rehfuess Head of IP Sotio Brian Coggio Of Counsel Fish & Richardson Otto Swens Partner Vondst Advocaten N.V. Mathilde Rauline European Patent Attorney August-Debouzy Analysing the latest judgements from both the UK Court of Appeal and the Netherlands Supreme Court Understanding how to extend the scope of protection for a patent Assessing whether there are similarities between each jurisdiction and whether this relief can be adapted in other jurisdictions Is this still similar in each jurisdiction if the test or wording of the test to determine the scope of protection is somewhat different? Case Study: Actavis vs Eli Lilly [2017] UKSC 48 A UK Supreme Court decision in 2017 gave guidance on the new approach for the UK patenting process. Now, the UK Supreme Court has adopted a doctrine of equivalence standard whereby elements falling outside the scope of claims can also be considered as infringement. One year on, this panel will discuss its subsequent effect in multiple jurisdictions: U.S., Germany, Netherlands and UK. What are the practical results following the decision? Determining whether the result of this case has created a knock-on effect on the validity of patents Industry best practices on how to construe patents: If a product now falls within the scope of patent claim, can it still infringe due to immaterial variation. Patents being invalid from novelty claims Sufficiency attacks
12:30	Networking Lunch
1:30	Us vs. Them: A Biologics Wargame Exercise Ha Kung Wong Partner Fitzpatrick, Cella, Harper & Scinto Scott Reed Partner Fitzpatrick, Cella, Harper & Scinto Richie Paul Vice President, Intellectual Property Operations Alkermes Pharma Ireland Limited up-to-date FDA guidances and initiatives regarding biologics, biosimilars and interchangeables conducting pre-suit investigations for biologics matters the trends and potential impact of PGRs on pharmaceutical manufacturers, including biologics (including insight gained from past IPRs) Practical takeaway include: How to plan for and protect resource investment in for both BLAs and aBLA Considerations for determining what type of biologic to pursue based on recent FDA actions The current impact of IPRs and PGRs on the pharmaceutical industry and how to plan for the potential of bringing or defending against PGRs in the pharmaceutical industry
2:15	Focus on Brazil: Main Aspects of Patent Protection and Latest Updates Regarding Examination Ms Kene Gallois Head of Life Science Daniel Legal & IP Strategy The current scenario in Brazil: Brazilian PTO x ANVISA’s roles Current controversies: filing of amendments and divisional applications How to obtain patent protection for second medical use and antibody How to expedite the examination?
3:00	Networking Refreshments
3:30	Patent Litigation Trends in Russia Vladislav Ugryumov Partner Gowling WLG Exploring the patent litigation system in Russia Examining concepts of patent Infringement Identifying available remedies: Preliminary injunction Permanent injunction Collection of damages Cancellation of MA for infringing product Update on recent decisions in pharmaceutical area
4:15	Cross Border Litigation Case Analysis for Medical Device Patent Litigation: How to Enhance Strategic Decisions on Patent Portfolios This session will provide a detailed analysis of landmark medical device patent cases which will help improve understanding and enforceability of patent rights. Understanding The European Court of Justice’s Interpretation of Medical Device Patents Whether there is a broad or narrow interpretation Whether the scope of protection is similar to pharmaceutical companies Whether it is an easier or more difficult process to gain patent protection Whether an injunction against a third party is available
5:00	Chair Closing Remarks and Closing of Conference