MAIN CONFERENCE DAY ONE • 21st June 2011
8.30 Coffee and Registration
9.00 Chair’s Opening Remarks
Dr. David Cottam
Senior IP Counsel, TEVA Europe Patent Department (UK)
KEYNOTE ADDRESS
9.10 A Plethora of References: Medeva and Its Sequels
The Hon. Mr. Justice Arnold
Chancery Division of the High Court of Justice
An analysis of the cases referred to and pending in the European Court of Justice relating to the interpretation of Articles 3A and 3B of the SPC regulations and whether an SPC can be successfully obtained for combination products.
- Medeva
- Georgetown University
- Sankyo Daiichi
- Yeda; and
- University of Queensland CFL
9.55 Recent Cases on SPCs in Europe – the Originator Perspective
Jürgen Dressel
Head Patent Litigations (ex USA)
Novartis Pharma AG (Switzerland)
- Combination SPCs: infringement vs. disclosure tests
- Scope of SPCs: coverage of combination products
- SPC enforcement and EU case law update
- The different SPC treatments in Europe: zero and negative term SPCs
− what have been the contradictory outcomes in the patent offices?
10.40 Refreshment Break
11.00 Adopting Strategies to Overcome Challenges Based on Recent Industry Trends
Sarah Boxall
IP Manager, Boxall IPM (UK)
Clare Dunne
Manager, IMS Health (UK)
- How to address increasing diffi culties of extending patent lifecycles
− identifying the most valuable drugs, patents and countries
− following the status of the patent: withdrawal, grant, opposition, amendment, refusal
- How to calculate patent expiry dates by country to ensure maximum protection
- Overcoming depleting industry pipelines
− what internal processes can be adopted to plan for the future?
- Combating generic competition
− how early in the lifecycle of a medicinal product are innovator companies losing exclusivity?
− how to overcome the increasingly earlier challenges to exclusivity
− what happens once exclusivity is lost?
− lifecycle strategies to combat the rapid erosion of sales
- What is the likelihood of rule changes to improve the effectiveness of lifecycle management strategies?
11.45 The German Patent and Trade Mark Office (DPMA) Perspective on Tackling Biotech Patents
Dr. Roman Maksymiw
Head of Division, German Patent and Trade Mark Offi ce, DPMA
- Position of the DPMA as a National Patent Offi ce in the European patent landscape
− German Patent Act – Directive 98/44 EC
− Patentability criteria for “biological” Inventions
− Extension of patent lifecycles through SPCs
- Treatment of stem cells
− the EPOs WARF decision
− the stance of the German Federal Supreme Court (Bundesgerichtshof, BGH) on neural progenitor cells
- The DPMAs current approach to plant varieties and product-byprocess claims
− the EPOs “Broccoli” decision (G2/07)
− the EPOs “Tomato” decision (G1/08)
- Absolute compound protection and the pragmatic ECJ decision
− Monsanto v Cefetra
- Evaluating the extent of SPC protection
− the pending decisions of Medeva/Georgetown/Queensland
- Approach to negative term SPCs
− Merck (Sitagliptin)
- The ECJs approach to third party SPCs
− Biogen v SmithKline
- What approval is required for marketing authorisation?
− reviewing the confl icting decisions in the German Federal Patent Court
12.25 Combating Practical Challenges for the Grant of SPCs
André Bourgouin
Vice-President Corporate IP, Ipsen Pharma (UK)
- What experimental basis is required by the regulations to support an SPC application?
− how much evidence is required to satisfy the test?
− can you get an SPC for a different formulation?
- Does an approval for SPC purposes need to comply with Directive 65/65/EEC?
− what approval is required?
− what standard of compliance would be suffi cient to prevent a later applicant obtaining an SPC with an approval that was Directive 65/65/EEC compliant?
- Overcoming the problems and pitfalls to successfully obtain an SPC
- Establishing the scope of SPCs: mono-therapies and combination therapies
− what SPCs can be obtained for different therapies?
- The Losartan and Valsartan decisions on combination therapies
− distinguishing the confl icting decisions in France and Belgium
13.10 Lunch
14.20 Examining Potential Anti-competitive Practices and Recent Patent Settlement Agreements
Bernardine Adkins
Partner, Wragge & Co. (UK)
- What is the impact of the Astrazeneca decision on:
− drafting applications?
− interacting with the national patent offi ces?
− the operating procedures and internal processes for pharma companies?
− best practice methods?
- Avoiding allegations of gaining unjust exclusivity
− what are the limits of extending exclusivity?
- Addressing the confl icting anti-competitive laws and patent laws
- What is the impact of blocking trade on generic medicines?
− the result of WTO complaints fi led in the EU by India and Brazil
- The significance of the Mylan v Pfizer patent settlement agreement
- Current US approach to patent settlements and anti-trust practices
− In re Ciprofloxacin Hydrochloride Antitrust Litigation
15:05 The Impact of US Developments on Pharma Lifecycle Extensions
Jim Nelson
Partner, Schwegman, Lundberg Woessner (US)
Thomas J. Kowalski
Patent Attorney, Vedder Price (US)
- Implications of KSR and Ariad on pharma lifecycle extension patents in the US
− inclusion of formulation, crystal form, polymorphs, combinations, extended/sustained release
- Why have lifecycle extensions?
− new chemical entity patents
− extending exclusivity of the drug
- What is the impact of KSR and Ariad on pharma lifecycle extensions?
- Do KSR and Ariad make pharma lifecycle extensions more difficult to obtain and enforce?
- Flip side: do KSR and Ariad make lifecycle extensions easier to challenge in court?
− what do the U.S. PTO statistics and litigation cases indicate?
- What steps can be taken to assure valid lifecycle extensions in light of KSR and Ariad?
− practical aspects for prep and pros
− dealing with the U.S. PTO
- Practical aspects for litigation
− who challenges?
− what is argued?
16.15 Refreshment Break
16.30 Structuring Successful Applications for Selection Patents and Analysing the Various Approaches in Europe
Dr. David Cottam
Senior IP Counsel, TEVA Europe Patent Department (UK)
- What is the likelihood of obtaining a selection patent for a narrower class of compounds?
- The significance of Dr Reddy’s v Eli Lily for obtaining selection patents
- What are the criteria to satisfy when drafting a selection patent application?
− the evidentiary requirements:
- how much data is required for the fi rst application in order to obtain broad protection?
- how much and what further data is required for the selection patent application?
− what factors will be considered when determining whether the selection invention is valid or not?
− what are the timing considerations?
- How has the law on selection patents changed in the UK?
− how will the new laws affect the way patent attorneys advise clients about the potential patentability of new compounds?
- What is the treatment of selection patents in other European countries?
17.10 Maximising Exclusivity for New Medicinal Products In Light of Regulatory and Case Law Developments
Peter Bogaert
Partner, Covington & Burling LLP (Belgium)
- Examining the prospective impact of the pending Sepracor Case T-27509
- What is a new medicinal product?
− HMPv case
- What is the standard to get the “+1” extension?
− what needs to be shown in addition to being “clinically signifi cant”?
- What are the common obstacles to gain access to the market for:
− traditional chemical molecules?
− biosimilar molecules?
- Obtaining data exclusivity for combination products
− can you get data exclusivity on a novel combination with known components?
− what is the level of difficulty for generics to design around regulatory data protection?
− the implications of losing exclusivity
- The interaction between the patent laws and the data exclusivity regulations
− what is the impact of the regulations on the patent structure?
- Case law update: market exclusivity and orphan products
− CSL Behring v Commission EMA, Case T-26407
− NowPharma v Commission T-7408
17.40 Chairman’s Closing Remarks and End of Day One
MAIN CONFERENCE DAY TWO- 22nd June 2011
9:00 Chair’s Welcome
John Miles
Partner, Potter Clarkson LLP (UK)
KEYNOTE ADDRESS
9.05 Guidance from the European Commission on Lifecycle Extensions
Lavinia Teodorescu
Antitrust: Pharma and Health Services, DG Competition
European Commission
- What has actually changed in practice following the EC Sector Inquiry?
− what problems have been experienced?
− what solutions have been successfully implemented to overcome the challenges?
- What is the Commission’s latest stance on anti-competitive practices and patent settlement agreements?
− what is the impact on both R&D and generic companies?
− policy considerations
- The “EU community patent”
− how will a harmonised European patent enforcement system operate?
9.50 Developing Strategies to Successfully Monitor and Manage SPCs on Patent Portfolios
John Miles
Partner, Potter Clarkson LLP (UK)
JKate Privett
Consultant to GlaxoSmithKline
- What strategies can be deployed in the drafting stage to optimise SPC protection for combination products?
- How can pharma companies maximise and extend composition of matter patents?
- What is the likelihood of successfully obtaining an SPC for an old product that has been re-formulated and a new authorisation obtained?
− what are the ramifications?
- What do pharma patent attorneys need to consider when developing SPC strategies?
- What will be the impact of SPC strategies on the way patent attorneys advise their clients?
10.35 Refreshment Break
11.00 Extending and Protecting Patent Lifecycles in the BRIC Countries
Rana Gosain
Partner, Daniel Advogados (Brazil)
Denis Khabarov
Partner, Baker & McKenzie – CIS Limited (Russia)
Nilam Gadani
Patent Attorney, H K Acharya and Company, Advocates
Patent and Trademarks Attorneys (India)
Zhaohui (Zoe) Wang
Partner, Jun He Law Offices (China)
- The key features of patent laws in the BRIC countries
− what are the requirements for inventions in order to obtain patents?
− what are the rules for divisional applications filed in the BRIC countries?
− what is the ability to obtain patent extensions?
- Clinical trials data
− how should pharma companies instruct scientists in BRIC countries to produce clinical data for use before the EMA and FDA?
− what data is required to be produced to the regulatory authorities?
- Requirements of the patent offices in the BRIC countries
− where to file?
− when to file?
− what to file?
- What types of patents can be extended in the BRIC countries?
− how are the patent extension terms calculated?
- When pharma companies enter BRIC countries with innovative patented molecules, will they:
− risk having their IP rights stolen or disregarded?
− end up in situations where they have to compulsorily licence the product to a local manufacturer?
− be forced to sell the drug at a much lower price than what they would want to sell it at?
- Combating the infringement of IP rights
− what can pharma companies do when their IP rights are infringed?
- Regulatory data protection and data exclusivity provisions
− what are the common pitfalls for obtaining exclusivity in the BRIC countries?
− how to overcome the problems of technology transfer out of the BRIC countries
- The grant of market approval in the BRIC countries
− what are the requirements for fi ling a statement of the working of the patented invention in India?
− Bayer Corporation v. Union of India
− the Draft National Pharmaceutical Policy 2002 in India
12.30 Preparing for the Expiration of Transitional Provisions on Paediatric Extensions
Deeba Hussain
Senior Patent Attorney, Merck Sharp & Dohme Ltd. (UK)
James Horgan
Assistant Counsel, European Patents
Merck Sharp & Dohme Ltd. (UK)
- How can pharma companies prepare for the expiry of the transitional provisions?
− what will become the new deadlines for fi ling paediatric extension applications?
− what will be the impact of the changes on SPC applications?
− how to monitor lifecycle management processes in order to file applications for extensions on time
- How to successfully obtain your paediatric extension term
− the procedure and requirements in Losartan Du Pont
− the significance of the pending Nycomed case
− what is the current process to obtain agreement and acceptance for paediatric studies?
− overcoming recent problems with the requirements of the EMA
- What are the rewards if:
− you do not have an SPC for the product?
− you satisfy the criteria for an ‘orphan product’?
- Case law update on the grant of paediatric extensions
13.15 Lunch
14:30 Successfully Obtaining Preliminary Injunctions to Block Exploitation from Generic Drugs
Paul Fehlner
Global Head, Pharma IP, Novartis Pharma AG (Switzerland)
- The likelihood of successfully obtaining a preliminary injunction
− assessing the different approaches across Europe
- What is the impact of changes on clearing the way for generic companies?
- Assessing conflicting European approaches
− UK approach: Cephalon v. Orchid
− Dutch approach: Mundipharma v. Sandoz
− French approach: Mundipharma and Grünenthal v. Mylan
− German approach: Eli Lily
15.15 Classifying Biosimilars and Follow-on Biologics in Europe and the US
Dr. Kati Hudson
Senior Manager, Intellectual Property, Oxford BioMedica (UK)
Rouget F. (Ric) Henschel
Partner, Foley & Lardner LLP (US)
EU-specific
- How will regulators examine abbreviated applications for the approval of biosimilars?
− how will biosimilar products be classifi ed?
− what will be the impact on complex biological products, such as viral vectors?
- Assessing the ease or diffi culty for generic pharma companies to enter the market
- How similar does the manufacturing process on the biological need to be in order to be able to “piggy back” on the clinical data produced by the innovator?
- Determining whether the antibody is suffi ciently similar to be captured by the data exclusivity
− what are the ramifi cations for protecting more than just the specific molecule that has previously been authorised?
US Developments
- Highlighting the FDA guidance to date
- Determining status as “biosimilar” or “interchangeable”
- 4-year data exclusivity and 12-year market exclusivity periods
- The exclusivity period for fi rst “interchangeable” biosimilar
- Mandatory information exchange between biosimilar applicant and innovator
− the patent litigation framework
- Strategic considerations
16.15 Monitoring the Approval and Grant Processes of Third Party SPC Applications
Ian Karet
Partner, Linklaters LLP (UK)
- What are the new regulations for making third party SPC applications?
- What are the time limits to make an application?
- The pending case of Protein Design Labs
- What applications have recently been granted in Europe?
17.00 Chairman’s Closing Remarks and End of Conference
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