Conference Day One: 6th October 2010
08.45 Coffee and Registration
09.15 Co-Chair’s Opening Remarks
Giampiero De Luca
Senior Vice President,
Licensing & Intellectual Property, Merck Serono SA
(Switzerland)
Allen Norris
Vice President, Head Group IP,
UCB Pharma SA (Belgium)
09.30 Keynote Address: A Judicial View on Biotech
Patenting Litigation
The Rt Hon Lord Justice Jacob Court of Appeal
of England and Wales (UK)
10.00 “Raising the Bar”: Examining and Debating
the Impact of the EPO’s New Standards
and Rule Changes on Biotech Inventions
Panel Moderator:
Kristina Cornish, Partner, Kilburn & Strode (UK)
Panellists:
John Beatty
Patent Procedures Management,
European Patent Office (Germany)
Dr. Sjoerd Hoekstra, Director Biotechnology
Department, European Patent Office
(The Netherlands)
Tony Rollins, Managing Counsel European Patents,
Merck & Co. (UK)
Tobias Roeser, German and European Patent
Attorney, Sandoz AG (Germany)
Marion Rees, IP Director
Oxford Nanopore Technologies (UK)
- Raising the Bar: implications for biotech inventions?
- Examining the rule changes: divisional applications,
search procedure, responses to written opinions,
mandatory identification of amendments
- Changes to the filing of amendments
- RtB and inventive step
- What kind of comments has EPO received on the rule
changes and how does it measure their success?
- Experiences of attorneys and clients with the changes?
- Problems with unity in biotech applications and
how these might be resolved
- Strategies for dealing with the rule changes
- How to address your patent portfolio?
- Continuation of Raising the Bar - EPO’s research and
plans for future rule changes: what is the research doing?
what rules are taken into consideration?
- Extension of RtB to PCT
- Possible further changes - compact examination
procedure
11.30 Morning Refreshments
12.00 The EPO’s Perspective on Patenting
Biotechnological Inventions
Dr. Aliki Nichogiannopoulou, Director
Biotechnology, European Patent Office (Germany)
- Article 52(1) EPC: is biotechnology just another area
of technology?
- Analysing the impact of the Biotech Directive 98/44/EC
on the EPC system
- Differences between legislative systems within the
EU and the EPO member states
- Political and Economic consequences
- The EPO’s Enlarged Board of Appeal and exceptions to
patentability under Article 53 EPC: G2/06: stem cells;
G1/07: diagnostic methods; G2/08 dosage regimen; G2/07 and G1/08 essentially biological processes
- Outlook: what will the future bring?
01.00 Networking Lunch
02.15 An Overview of the Year’s Most Important Biotech
Cases and Other Landmark Decisions
EPO Cases
Leo Polz, German and European Patent Attorney,
Hoffmann Eitle (Germany)
Recent case law covering original disclosure, post-published
evidence, industrial applicability and inventive step: is a trend
developing which allows the applicant to distinguish between a
gamble or a calculated risk in the race to the patent office?
T 604/04, T1165/06, T 601/05, T 1172/06, T 433/05,
T 536/07, T 665/05, T 710/05, T 861/08
National Court Cases
Martin Chakraborty, Partner, Hogan Lovells (Germany)
Adam Cooke, Partner, Hogan Lovells (UK)
- Intervet UK Limited v Merial (2010) - construction of
claims, priority entitlement and obviousness in claims
to porcine circoviruses; lessons to be learned for drafting
- Actavis v Novartis (2010) - UK Court of Appeal:
the approach to obviousness
- Validity of selection patents under UK Law -
Dr Reddy’s v Eli Lilly (2009)
- Novelty - Federal Supreme Court Escitalopram
(Xa ZR 130/07), Sept. 10, 2009
- Exclusions from patentability
- BGH referral to ECJ (Xa 58/07): Prof. Bruestle ./.
Greenpeace eV, November 12, 2009
- SPCs: Term “Product” – German Federal Supreme Court
Doxorubicin-Sulfate (X ZB 4 / 08), October 14,2008
- Federal Supreme Court Escitalopram (Xa ZR 130/07),
Sept. 10, 2009
- Federal Patent Court Indivina (14 W (pat) 42/06),
June 4, 2009
- SPCs: Deviation MA – Basic Patent
- German Federal Supreme Court Anti-Helicobacter
Drug (X ZB 1/08), July 8, 2008
- Paediatric Extension - Regulation EC 1901/2006;
German PTO in Sitagliptin (Merck & Co); on appeal
German Patent Court referred case to ECJ on January
28, 2010 (15 W pat (36/08))
03.30 Afternoon Refreshments
03.45 HGS v Eli Lilly: Satisfying the Requirements
for Industrial Applicability
Tim Powell, Partner, Powell Gilbert (UK)
- What is the threshold that needs to be crossed for
establishing industrial application for patents in the
genomics field relating to newly identified gene sequences?
- The decision by the EPO Technical Board of Appeal
- Decision of the Court of Appeal on HGS v Eli Lilly
- Further appeals to the Supreme Court of the UK
- Interaction between the Technical Board of Appeal’s
decision and the UK Court of Appeal’s decision
04.30 The Scope of Second Medical Use Claims after G2/08
Paul Commander, Patent Counsel,
Eli Lilly and Company Limited (UK)
Dr. Luke Kempton, LL.M, Partner, Wragge & Co. (UK)
- The scope of second medical use claims after G2/08:
what you can or cannot claim
- The future of Swiss-type claims
- The history of second medical use claims: how did
we get to where we are today?
- Drafting of second medical use claims after G2/08:
capturing what your competitors or infringers are likely
to be doing while ensuring your patent’s validity
- Status of first and second medical uses in national
jurisdictions
- Second medical use claims in litigation
05.30 Chair’s Closing Remarks & Conference Adjourns
Conference Day Two: 7th October 2010
08.45 Chair’s Welcome
Brigitte Stephensen,
Senior Vice President
IPR & Legal,
Genmab (Denmark)
09.00 Supplementary Protection Certificates (SPCs):
Where Do We Stand and What Does the Future Hold?
Lawrence Cullen, Deputy Director
(Biotechnology & Pharmaceuticals), UKIPO (UK)
Sandra Pohlman, Partner, df-mp (Germany)
- Analysing the scope of the SPC protection and the
relevant EU and UK jurisprudence
- What is meant by
- “product” within the meaning of the SPC Regulation?
- “first authorization to place a product on the market”?
- ECJ clarification of entitlement of multiple patent
owners to SPCs
- The specific case of “combination products”
- Paediatric SPC extension: can applicants obtain a
negative or zero SPC (diverging views among the
Member States)?
- What does the future hold?
09.45 Biosimilars and Biologics: Comparing and
Contrasting European and US Standards
John Carlin, Partner, Fitzpatrick Cella (US)
Fiona Bor, Senior Patent Counsel Patent Department,
Teva Europe (UK)
- The Biologics Price Competition and Innovation Act
- Data exclusivity of a follow-on biologic and similarity
standards
- Preparing for the “Patent Information Exchange”
- Practical tips for preparing your patent portfolio
- Patent litigation: How the Biologics Act differs from
the Hatch-Waxman Act
Biosimilar medicines in Europe
- Definitions and context
- The EU regulatory regime
- Application of the EMEA guidelines
- Current biosimilar product approvals
- The future of biosimilars and possible biosimilar
monoclonal antibodies
10.45 Morning Refreshments
11.00 Patent Strategies for Therapeutic RNAi
Mark Einerhand, Partner, Vereenigde (Netherlands)
- How patentability requirements apply to RNAi
technology
- Areas of patent coverage that a company will need to
acquire if it is to be successful in the RNAi field
- Strengths and weaknesses of an RNAi patent estate: lessons
learned from mature technologies, such as monoclonal
antibodies, gene therapy, and antisense technology
- The next step: delivering your RNAiDeveloping a well planned and executed patent strategy
- Wording your RNAi claim
11.30 G1/08 and G2/07: Patentability of Plant Breeding
Methods in Relation to “Essentially Biological
Processes”
Joachim Wachenfeld, Partner, Vossius & Partner
(Germany)
- Patentability of plant breeding methods: G2/07
and G1/08Patent exemption under Art 53(b) EPC and the EPO’s
interpretation of ‘essentially biological processes’
- when does a non-microbiological process for the
production of plants, consisting of steps of crossing
and selecting plants, fall under the exclusion of
Article 53(b) EPC?
- what are the relevant criteria for distinguishing
excluded non-microbiological plant production
processes from non-excluded ones?
- Questions of technicality of features in biotech
inventions, in particular in the field of plant breeding
12.00 Networking Lunch
ECJ Referrals/ Biotech Directive
01.15 The Biotech Directive: Highlighting the Challenges
with Europe’s Two Legal Systems
Rob J. Aerts, Principal Patent Attorney, Abbott
Healthcare Products B.V. (The Netherlands)
- Are the different legal systems governing biotech
patenting in Europe compatible in practice?
- Where does the current legal uncertainty in biotech
patenting stem from?
- What are the consequences of mixing EU Law
and EPC Law through the implementation of the
Biotech Directive?
- Should you be prepared for a shift to more influence
of EU law on biotech patenting?
- Will this bring the necessary legal certainty?
- Which decisions in the biotech patenting area will
ultimately be your guideline in biotech patenting?
- What is the role of the European Court of Justice?
- Status of negotiations of the European Patent Court
- The future of biotech patenting in Europe
01.45 Stem Cells - The Latest Controversies
Jürgen Meier, Partner, Vossius & Partner (Germany)
- Patentability of stem cells, developments since G2/06
- what is ethical and what is not?
- ethical constraints on stem cell or embryonic therapy
- The German referral to the ECJ on stem cells
- Constraints on the patenting of human stem cells in
different European jurisdictions: reviewing the enormous
variations in how these issues are viewed across Europe
- European stem cell patent drafting and filing strategies
02.30 Gene Patents to Be Limited to Function?
The Monsanto Case (C 428/08)
Dr. Philip Weber, Partner, Dehns
- What does “performs its function” mean?
- Is it right that Article 9 of the Biotech Directive should
over-ride national protection for genes as products?
- Is the EPO likely to interpret the Article in the same way?
- Likely impact on European biotech industry?
03.00 Afternoon Refreshments
03.15 Major Case Law and Policy Developments in the US
Anthony Tridico, Partner, Finnegan (US/Belgium)
Dr. Rouget Henschel, Partner, Foley & Lardner (US)
- A critical analysis of the Myriad case
- Developments in Bilski and KSR
- Eli Lilly v Ariad: written description requirement
- Strategies for dealing with obviousness, in view of KSR
- Procedural and legal strategies for dealing with the
lower allowance rate at the patent office incl KSR:
- ways to interview examiners
- how to use the different procedures that are in place
- effective use/best strategies for re-examination procedures
- The use of re-examination in the biotech area
- Patent reform legislation: opposition procedure; first to file
04.30 Developments In Patent Litigation Procedure and
Cross-Jurisdictional Litigation Management Strategies
Ian Hiscock, Head, Group IP Litigation EU & OUS,
Novartis International AG (Switzerland)
Duncan Curley, Head of Patents, Innovate Legal (UK)
- Recent developments in biotech litigation procedures
- What are the implications of different national courts
reaching different decisions on the same patent?
- Managing complications arising when parallel
proceedings take place at the EPO and national courts
- Availability of injunctions and the risks involved
- Use of opposition proceedings vs litigation: a more cost
effective alternative?
05.15 Chair’s Closing Remarks and End of Conference
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