Main Conference Day One: 14 March 2012
8.30 Coffee and Registration
9.00 Chair’s Opening Remarks
Jennifer Gordon, Partner, Baker Bott s (US)
9.10 Keynote Address
Recent Case Law Developments and Trends for Biotech Patents in Germany
Dr. Hubertus M. Zink
Patent Examiner
DMPA (German Patent and Trade Mark Office)
9.40 Determining How the G2/10 Decision will Change Biotech Disclaimer Practice Across Europe
Kristina Cornish, Partner, Kilburn and Strode (UK)
- Brief review of the background to the referral from T1068/07,
leading to G2/10
- Analysing the outcome in G2/10:
- under what conditions are “positive” disclaimers
permissible in claims?
- How will G2/10 change the way you structure your patent
application for Europe/the world?
- Using both “positive” and “negative” disclaimers (G2/10 or
G1/03) in European applications/patents
- What do the EPO Guidelines for Examination say about
the use of disclaimers?
- Examples of positive disclaimers in European applications/
patents, using the new test, as set out in G2/10
- Views of national offices and courts, within Europe, on G2/10
10.20 Examining the Patentability of Stem Cell Derived
Inventions in Europe
Ian Bryan, IP Counsel, GE Healthcare (UK)
The Patentability of inventions derived from human embryonic
stem cells
- Analysing the outcome of the CJEU Decision in Brüstle
- what aspects of the Advocate General’s opinion has the
Court followed?
- addressing the discrepancies between G2/06 and Brüstle
- impact on derivatives and other medical products derived
from human embryonic stem cells
- validity of existing European patents
- Assessing the current EPO approach to stem cell based
inventions
- the current stance on the destruction of embryos
for the purposes of an invention
- new standards for patentability: what will biotech companies
need to include in their applications to the EPO?
- Patentability of human embryonic stem cell based inventions
in other major jurisdictions
The patentability of inventions derived from induced pluripotent
stem cells
- What is the position for induced pluripotent stem cell lines in Europe and other major jurisdictions?
11.00 Refreshment Break
11.30 Recent Developments on Biotech Products
and Patent Considerations for Bio-Deposits
Jens Viktor Nørgaard, Partner, Hoiberg (Denmark)
Bart van den Hazel, Director Patent Counsel,
GlaxoSmithKline Biologicals (Belgium)
- Addressing recent EPO practice: what biotech claims are
permitted?
- Examining the latest Board of Appeal Case Law, including
decisions on
- the patentability of antibodies
- the patentability of biological processes for the production
of plants
- Discuss the latest developments relating to disclosure of
origin of genetic resources in patents
- Developments and clarity on bio-deposits: how are
bio-deposits dealt with in various countries?
- Examining patent considerations for bio-deposits
- pros and cons of making deposits
12.20 Managing Patents for Biosimilar Products and
Understanding the Bolar Provisions in Europe
Erik Scheuermann, Witt e, Weller & Partner (Germany)
- Addressing the scope of the Bolar provisions - impact on
market authorisation for generic companies
- How do you produce evidence that a biosimilar is similar enough to be a biological product that you have patented?
- To what extent will third parties producing generic drugs
be protected from patent infringement?
- Recent case law developments in Germany
- how will the Court interpret the Bolar provisions in the German Patent Act?
- Patent litigation strategies to combat recent case law developments: method patents vs. product patents
13.00 Lunch
14.00 Tackling Diagnostic Methods and Personalised Medicines
Harry Kraft , Senior Patent Att orney, Ablynx (Belgium)
- Discovering new approaches to diagnostic methods
- How do biotech companies successfully obtain patents
for protein biomarkers?
- Exploring new areas: epigenetic methods
- Assessing the challenges of research tool patents
- Personalised medicine at the EPO level
- exclusions of methods and medical treatments
14.30 Process Patens and New Technologies: Protection of the Immediate Product of the Process
Thomas Friede, Partner, Bardehle Pagenberg (Germany)
- Defining the immediate product of the process
- Manufacturing method v screening method
- UK High Court (2011) MedImmune v Novartis
- When is a product an immediate product of the process?
- Mixture or modification of the immediate product in the infringing embodiment
- ECJ (2010) Monsanto v Cefetra
- Considering time and location for carrying out the process
- carrying out the process before the grant of the patent
- carrying out the process abroad with subsequent importation
- OLG Düsseldorf decision “Prepaid telephone cards”
15.10 Refreshment Break
15.30 Strategies for successful Cross-Border Litigation
Richard Ebbink, Partner, Brinkhof (Netherlands)
- Addressing the legal basis for cross-border injunctions
- Examining recent EUCJ case law
- GAT v LuK
- Solvay v Honeywell
- Learning from recent provisional cross-border injunctions granted by the Dutch Courts:
- Yellow v Yell
- Apple v Samsung
- What is the exposure for generic companies across Europe?
- Developing strategies for obtaining pan-European relief
16.10 Th inking Ahead: How Will your Strategies Need to Change in Light of the New Initiatives and Reforms of EU and US Patent Laws
Javier Vera, Deputy Director of Patent Department,
Oficina Española de Patentes y Marcas (the Spanish Patents and Trademarks Office)
Francesco Macchett a, Director IP, Bracco Group (Italy)
Dr. Frank Burkert, European Patent Attorney,
Bayer Healthcare (Germany)
Prof. Dr. Li Westerlund, Vice President, Global IP,
Bavarian Nordic Group (US)
- Latest discussion on an “EU patent” and “unitary court system”
- Evaluating the potential impact of an EU patent system on
the internal practices of biotech companies
- Distinguishing the two systems: European Patent Convention
and EU Law
- Update on the new US Patent Reform
- Key developments of the America Invests Act: transition to “first-investor-to –file”, post-grant review proceedings and
its impact on U.S. litigation
- What impact will it have for the biotech industry? How will the industry deal with increased work load and costs?
17.20 Chairman’s Closing Remarks and End of Day One
Main Conference Day Two: 15 March 2012
9.00 Chair’s Opening Remarks
Allen Norris, Vice President, Head Group IP,
UCB Pharma (Belgium)
9.05 Patentability of Gene Sequence Patents in Europe
and the US
Tim Powell, Partner, Powell Gilbert LLP (UK)
European Developments
- Outcome of Lilly v HGS in the UK Supreme Court and EPO
- Relationship between enablement, industrial applicability
and obviousness
- Examining underlying policy concerns
- Addressing the enforceability of gene sequence patents
- implications of the CJEU decision in Monsanto v Cefetra
US Developments
Jennifer Gordon, Ph.D., Partner, Baker Bott s (US)
The United States Court of Appeals for the Federal Circuit has recently rendered decisions in the Myriad, Prometheus and Classen cases that impact the patent eligibility of DNA sequences (and other biomarkers). These decisions further impact the patent eligibility of diagnostic and therapeutic methodologies that are based on a correlation between a biomarker and an important piece of medical information. This session will explore:
- The standards set by the Federal Circuit and the U. S. Supreme Court under 35 USC 101
- for patenting biological compositions of matter
- for patenting processes or methods that involve a law of nature, a physical phenomenon or an abstract idea
- Whether the U. S. Supreme Court will agree with the Federal Circuit’s analysis in Prometheus, which was based on the transformation prong of the “machine or transformation test” articulated in Bilski
- Whether the U. S. Supreme Court will likely hear an appeal in the Myriad case and what the likely outcome may be
- What the impact on the U. S. biotechnology and pharmaceutical industries may be, particularly with respect to the area of personalized medicine, if biomarkers and/or
methods based thereon are deemed unpatentable by the U. S. Supreme Court
- Whether the controversies in this area of law ultimately boil down to claim language and claim interpretation, and how best to draft claims that will pass the patent eligibility hurdle of 35 USC 101 and stand up in litigation
10.10 Examining Case Law Developments in Double Patenting
EU Perspective:
Dr. Christoph Rehfuess, European Patent Att orney,
Director Intellectual Property, MagForce (Germany)
- Addressing double patenting at the EPO
- Clarifying the legal framework for fi ling divisional applications
- Analysing recent case law of the Enlarged Board of Appeals relating to double patenting (G 1/05 and G 1/06)
- Implementation by the Technical Boards starting from T 307/03 and T 1423/07
- Procedural consequences for the practice and open questions
US Perspective:
- Marian Flattery, Of Counsel, Finnegan (US)
- Clarifying double patenting and obviousness following
the the refusal of grant certiorari in Eli Lilly & Co. v. Sun
Pharmaceutical Industries Ltd.
- utilizing obvious-type double patenting claims as a
litigation tool
- investigating the policy implications of patents whose terms are extended well-past twenty years and are vulnerable to invalidation by a double patenting finding
- what are the issues that may infl uence an obviousness rejection?
- Discussing double patenting standards
- understanding the implications of disclosures in the specification for double patenting
- considering the public policy implications of double patenting following Amgen v. Roche
- dissecting the dichotomy between strict statutory interpretation and policy considerations following Lilly v. Sun
11.10 Refreshment Break
11.30 To Divide, or Not to Divide, Th at is the Question.
Unity of Invention and Divisional Applications
Dr. Miranda van Heusden, Examiner in Biotechnology,
European Patent Office
- Examining recent practice on the evaluation of unity of invention
in biotechnology
- Addressing implications for applications covering more than one invention
- Filing of divisional applications:
- recent rule changes and their practical implications for the practitioners
- time frames for filing divisional applications
- the issue of double patenting and the use of disclaimers
12.10 SPC Application Requirements in Europe: Update on Recent Case Law
Dr. Thierry, Calame, Partner, Head of Intellectual Property,
Lenz & Staehelin (Switzerland)
- Recent SPC cases referred to the CJEU and opinions by
the Advocate General
- Medeva BV
- Georgetown University
- Yeda Research and Development Company Ltd
- Neurim Pharmaceuticals (1991) Ltd
- Merck Sharp & Dohme Corp.
- Overview of current requirements for SPC applications
- Devising effective SPC filing strategies to overcome challenges based on recent case law
12.50 Lunch
13.40 Dosage Regimes: A Th erapeutic Method?
Dr. Marc Markus, Head of Patents Biotherapeutics East,
Pfizer (France)
- Addressing the exception of patentability of therapeutic
methods in Europe
- Examining current EPO and EP national case law on dosage
regimens
- Comparing approaches to dosage regimes in the national Courts
- To what degree have EU national courts achieved a common
interpretation of the provisions in the EU Patent Convention
on dosage regimes?
- Discussing dosage regimen claims in the context of personalized
medicine & biomarkers
14.20 Understanding the “Person Skilled in the Art”
Concept when Litigating Patents
Isabelle Romet, Partner, Vėron& Associės (France)
- General criteria for determining the “person skilled in the art”
- what are the deviations in approaches taken by the various
EU national courts?
- Applying the judgment by Kitchen J in Astrazeneca
(Esomeprazole)
- How can you present the skilled person into evidence?
- Where you are permitted to have a “person skilled in the art”
to give expert evidence, what are the requirements?
- requirements in UK proceedings
- approach by other EU national Courts
- How can you use the same expert in more than one jurisdiction?
15.00 Reviewing Recent Case Law Developments
Regarding Reverse Payment Sett lements
Andrzej Kmiecik, Partner, Van Bael and Bellis (Belgium)
- Review of the recent 2nd monitoring report by the European
Commission
- Update on the review of Servier by the European Commission
- Recent US case law developments on reverse payment
settlement agreements
- Distinguishing the US approach with developments in Europe
15.40 Refreshment Break
16.00 Th e Current Stance on Nanotechnology for Medical
Devices in Europe
Thomas Adocker, Partner,
Schwarz Schönherr Rechtsanwälte (Austria)
Andreas Wildhack, Partner, Wildhack & Jellinek (Austria)
- Introduction to legal problems of nanotechnology and medical
devices
- protection
- regulation
- liability
- Using nanotechnology for medical devices
- What are the approaches to nanotechnology in the various
EU national patent offices?
- review of the recent decisions
- EPO approach to patent applications for nanotechnology
16.50 Latest Biotech Patenting Regulatory Changes
and Developments in India
Hari Subramaniam, Patent & Trademarks Attorney,
Subramaniam, Nataraj & Associates (India)
- Recent case law developments and their potential impact
on other jurisdictions
- How to protect and enforce your patents in India
- what aspects of the EU and US patentability criteria
are followed?
- Sufficiency of disclosure
- Novelty considerations
- Defending patent infringements in India
17.30 Chairman’s Closing Remarks and End of Conference
Conference Details