Main Conference Day One: 9 May 2012
8.00 Coffee and Registration
8.30 Chair’s Opening Remarks
Raymond Mandra, Partner, Fitzpatrick, Cella, Harper & Scinto (USA)
8.40 Best Practice Approaches to Freedom to Operate
Patent Research
Aalt van de Kuilen, President of the CEPIUG (Confederacy
of European Patent Information User Groups) (Netherlands)
- Definition of a FTO search
- Clarifying the legal context of a FTO search
- Addressing guidelines for FTO searching
- Defining scope of a FTO search
- Introducing different types of FTO searches
- Best Practices: examining real life examples
- Common pitfalls and challenges and how to overcome them
9.15 Interpreting FTO Search Results and Patent Validity
to Reduce Risks and Maximise Your Revenue Potential
Sandra Pohlman, Partner, df. mp (Germany)
Michael Eder, Partner, df. mp (Germany)
1. Determining which products or processes require clearance
- Geographic considerations:
- identifying jurisdictions that provide the greatest exposure
- extraterritorial reach of certain claim types
- Temporal considerations:
- stratifying risk based on expected product launch date
- assessing likelihood of third party applications granting in
the intended market for intended use
- how to deal with uncertainty of earlier and/or expiring patents?
2. Challenging validity to overcome blocking patents
- Highlighting the EPO and National Patent Office approaches
to validity
- what are the differences between interpretations? How do
the different approaches affect invalidation approaches?
- which factors are most important when choosing the EPO
over National Patent Offices?
10.15 Morning Refreshments
10.45 Practical Advice for Conducting FTO Searches more
Time Efficiently and Cost Effectively
Gaye Ramazanoglu, Intellectual Property Specialist –
Patent and Trademark Attorney, Sanovel (Turkey)
Marco Nievo, PhD EPA, IP and Competitive Intelligence,
Siena Biotech SPA (Italy)
Lorenzo Polenzani, R&D Strategy Manager, Angelini (Italy)
Harry Kraft, Senior Patent Attorney, Ablynx (Belgium)
Ilian Iliev, CEO, Cambridge IP (UK)
- Conducting searches in-house v outsourcing
- when to try searching in-house and when is an external
search necessary
- building in-house expertise: establishing internal guidelines
and policies and how to monitor those
- how to fi nd the right search partner
- managing the risks of outsourcing the FTO search function
- Classifying and maintaining comprehensive search records
- how to organise and document search results
- identifying and categorising “relevant” data for the future
- Search strategies for different budgets and different sized projects
- how diligent do you have to be? When can you stop your search?
- how can search budgets be managed and allocated across
varying drugs?
- Exploring new tools and trends to ensure effective FTO
searches and analysis
- best practice on using search engines and databases
- comparing solutions available - how to decide which is
the most suitable one for your needs
- using translation machines effectively
- pros and cons to using crowd sourcing be used for FTO
- open innovation initiatives – what are the implications for FTO?
- moving beyond silos – using collaborative tools for patent
intelligence
- How to get the most out of your FTO searches with Data Mining
- what is data mining? How can it benefi t your fi rm?
- what data can be used at a later stage: reporting, storing
and retrieving data from searches?
12.30 Lunch
13.30 Impact of the Recent Court Decisions on Your FTO Strategy: Discussing the Pro and Cons of Lilly v HGS and Brustle v Greenpeace
Gareth Morgan, Partner, Winston & Strawn (UK)
Alex Denoon, Partner, Lawford Davis Denoon (UK)
Our experts will share their fi rst-hand insights and discuss the advantages and disadvantages these recent decisions will have for FTO practices; followed by an open discussion with the audience on the wider implications of both cases for FTO and patent strategies in Europe.
Eli Lilly v Human Genome Sciences
- Addressing the basis of the UK Supreme Court appeal
- UK Court of Appeal vs TBA
- How will “target” patents be assessed in Europe the future?
- Is the protection on offer commensurate with the innovation?
- Examining the impact on freedom to operate for drug
discovery/diagnostics companies
Brüstle v Greenpeace
- What did the Court of Justice decide?
- How does this affect existing patents (including patents relating to
stem cells broadly rather than just human embryonic stem cells)?
- How might this affect companies’ patenting activities?
- Practical ramifications given the regulatory hurdles to generics
of cell-based therapies
- Will this lead to an increased reliance on trade secrets?
- Analysing the impact on freedom to operate
- Wrap up: Is the impact on investor confi dence greater than the
patenting issues given the commercial hurdles to developing
these products?
14.20 Understanding the Effects of Patent Extensions on
FTO: How SPCs and Regulatory Data Protection Could Threaten your Patent Strategy
Gertjan Kuipers, Partner, De Brauw Blackstone Westbroek
(Netherlands)
- Interpreting the latest SPC developments and trends
- Analysing the latest ECJ decisions regarding SPCs for
combination products and what they mean for the‘infringement test’ and further FTO considerations:
- Medeva (C-322/10)
- Georgetown University (C422/10)
- Addressing cross-border challenges – how are SPCs dealt with
by national courts?
- Extend your SPC protection or extend your data exclusivity
protection?
- determining which exclusivity right is more beneficial
- Reviewing recent case law on data exclusivity
14.55 FTO and Paediatric Exclusivity – What the Patent
Practitioner Should Know
Eric Ruhlmann, European Patent Attorney, Director, Senior
Patent Counsel, Actelion Pharmaceuticals (Switzerland)
- EC regulations and access to paediatric exclusivity in Europe
- what are the rewards?
- what are the requirements (Paediatric Investigation Plan (PIP), SPCs, timelines...)?
- main pitfalls
- European case law update
- E I du Pont Nemours & Co v. UKIPO
- C 125/10 (Merck & Co Inc. v. Deutsches Patent- und Markenamt - “Negative Term SPCs”)
- FDA regulations and access to paediatric exclusivity in the US
- what are the rewards?
- what are the requirements (written request from the FDA, timelines...)?
- US case law update
- In re Omeprazole Patent Litigation
- the Norvasc case – Pfizer v. Apotex and related decisions
15:30 Refreshment Break
16.00 Finding the Right Balance When Reporting Your FTO Strategy: Privilege and Confidentiality
Jeroen den Hartog, PhD, Partner, European and Dutch
Patent Attorney, Hoyng Monegier (Netherlands)
- Assessing how to report in a clear way while dealing with
uncertainty and later potential discovery
- Best practice strategies for ensuring confi dentiality of information
- Understanding privilege issues and overcoming challenges for
in-house counsel
- examining the impact of e-discovery
- how to keep communication with R&D private?
- what information in an FTO assessment remains confi dential?
- handling privilege issues during incoming due diligence
- Latest update on privilege for in-house attorneys and
the potential impact on any US proceedings of reported assessments of your FTO reports
16.40 Stratifying and Quantifying FTO Risks – How Do You Advise on and Deal With Grey Areas?
Michelle Jones, PhD, EPA CPA, Associate Director IP,
Astex Pharmaceuticals (UK)
Giampiero De Luca, VP Intellectual Property, Merck Serono
(Switzerland)
Daniel Becker, Partner, Dechert (USA)
- Quantifying the risk of third party patents
- Assessing the likelihood of preliminary injunction
- Addressing damage claims – discussing the latest case law and
its implication for FTO considerations
- Using licensing as a tool to circumvent FTO roadblocks:
- when should licensing become a consideration?
- evaluating your licensing options
- Reporting FTO risks – what does the upper management need
to know?
17.20 Conference Adjourns
18.00 Networking Event –
Apple Wine Tasting Evening
Relax after a long day of conferencing as you sample traditional Frankfurter apple wine (cider) with your new industry contacts and fellow Freedom to Operate experts.
Main Conference Day Two: 10 May 2012
8.00 Coffee and Registration
8:30 Chair’s Welcome
Raymond Mandra, Partner, Fitzpatrick, Cella, Harper & Scinto (USA)
8.35 How are EPO Divisional Applications and the America Invents Act Impacting FTO Strategies?
Bernd Hutter, Director, Head of Intellectual Property,
European Patent Attorney, MorphoSys AG (Germany)
Eric Ruhlmann, European Patent Attorney, Director, Senior
Patent Counsel, Actelion Pharmaceuticals (Switzerland)
Dr. Klaus-Peter Döpfer, European Patent Office
- Latest Insight from the EPO
- update and feedback regarding divisional applications
- strategies and perception of patents not granted yet
- what is the impact of the new rules on FTO? How the EPO is making processes more efficient and user-friendly
- Implications for the America Invents Act on FTO
- US ex parte and inter partes re-examination
- US post grant and inter pates reviews
- declaratory judgement actions
- Industry Response: What is the downstream effect of the
legal changes?
- how are divisional applications impacting the FTO strategies: what are people doing? Filing divisional? What are your options when you are concerned someone will file a divisional?
- what strategies are available for overcoming delays by the EPO and USPTO (e.g. fi ling a third party application in the meantime)
- overcoming validity when you have a pending application
- discussing ways to circumvent the law to get your divisional filed
FTO IN EMERGING MARKETS
9.20 Latest Developments in the Indian Patent Landscape and Their Impact on FTO
Dr. Malathi Lakshmikumaran, Head (Life Sciences),
Lakshmi Kumaran & Sridharan (India)
- How are the processes and procedures to gain FTO in India
different?
- Understanding the requirements for obtaining a valid patent
- what data records should be maintained?
- Overcoming the challenges of obtaining reliable search data
- National Patent Office (NPO) assistance vs. using search databases
- safeguarding confidential information
- Protecting your products from infringement in India
- identifying the key examiners, regulators and Courts
- Discussing latest case law update
10.00 Latest IP Trends and Regulatory Changes in China
and the FTO Implications
Dr. Qinghong Xu, Partner, Lung Tin International
Intellectual Property Agent Ltd. (China)
- Developing and executing an effective FTO search in China
- Overcoming challenges of acquiring reliable data for FTO searches
- Conducting an efficient infringement analysis
- Dealing with infringement in courts: hear an update on latest
case law developments
- Challenging validity of blocking pharmaceutical or biotech patents
10.40 Morning Refreshments
11.10 Patent Filing and Litigation in Brazil – Optimise your
Chances of Success
Otto Licks, Partner, Leonardos & Licks Advogados (Brazil)
- Examining criteria adopted by the Brazilian PTO
- Overcoming challenges of acquiring reliable data for FTO
searches
- Clarifying the requirements for obtaining a valid patent –
what data records should be maintained?
- Gain practical insights in enforcement: how strong are
pharmaceutical and biotech patents
- Analyse the latest case law developments
- Understanding the new rules issued by Brazil’s Regulatory
agency regarding biosimilars
11:50 The Impact of US Developments on European FTO
Analysis
Raymond Mandra, Partner, Fitzpatrick, Cella, Harper & Scinto (USA)
- Addressing the America Invents Act and its impact on FTO
strategies
- is the expanded Prior Use Defense applicable?
- priority examination - does it create a potential minefield?
- considering Interpartes Review and Post Grant Review –
are they in play or could they be useful?
- Examining recent case law developments on (in)validity
and infringement
- how does the obviousness analysis after KSR continue
to be refined by the Federal Circuit?
- when are method claims requiring the acts of multiple
parties infringed?
- Analysing case law developments on claim construction
- do reexam arguments create intrinsic evidence for claim construction?
- Considering Biosimilars
- will the legislation survive Supreme Court review?
- will US data exclusivity under the biosimilars legislation remain unchanged?
12.35 Adapting your Patent Tactics for Biosimilars:
Keeping Abreast with Regulatory Changes while Staying Competitive
Dr. Manja Epping, Partner, Taylor Wessing (Germany)
- Analysing the regulatory risks for biosimilars
- Comparing the EU biosimilars legislation and Hatch-
Waxman Act procedures in the US
- Antibody claims – exploring breadth of claims in the biosimilars era
- Pricing and reimbursement issues and their impact on your
patent strategy
- Examine patent strategies for biosimilars
- Patent thickets as delaying tactic
- Follow-on patents
13.15 Chair’s Closing Remarks and End of Conference
13.15 Lunch (for Workshop Attendees)
Conference Details