Day One – Wednesday 25th January 2012
8.15 Registration and Coffee
9.00 Chairman’s Opening Remarks
Immac J. Thampoe, Managing Counsel, Biologics
Merck & Co (US)
9.10 Regulatory Approval Standards and
Pharmacovigilance Criteria for Biosimilars
Armin Ritzhaupt, Manager, Global Regulatory Affairs
Boehringer Ingelheim (Germany)
Mohamed Oubihi, Senior Manager, International Regulatory
Affairs, Biogen Idec (UK)
Harvinder Popli, Director and Head of In-licensing
Ranbaxy Laboratories (India)
- Regulatory approval pathways for biosimilars
vs. pharmaceutical generics
– what are the basic criteria used to demonstrate similarity
of a compound compared with standard generics?
– glycosylation profi les as a key differentiator between
biosimilars and reference products
– recognising the need to evaluate biosimilar applications
on an individual basis
- Who has the power in biosimilar regulation?
– status of the FDA and EMA as regulatory overlords
– what is the chance of an international regulatory approval
package for biosimilars?
- Post-authorisation follow-up
– pharmacovigilance and immunogenicity testing
- The Japanese Regulatory Framework of biosimilars
and comparison to European and FDA regulatory pathways
- Overview of biosimilars operations in emerging markets
– key drivers and barriers for biosimilar uptake
in emerging markets
– which countries are most active in the biosimilars arena?
10.10 European Biosimilar Approval Guidelines:
Interpretation, Implementation and Evolution
Alexander Berghout, Medical and Scientifi c Advisor
Sandoz Biopharmaceuticals (Germany)
Lincoln Tsang, Partner, Arnold & Porter (UK)
Maria Manley, Partner, Head of the Regulatory Practice
Bristows (UK)
- Key features of the EMA guidelines
– what was the premise for EMA guidelines and how
were the application criteria decided?
– the EMA position on bioequivalence and comparative
pharmacodynamic studies
– significance of the Bolar provision for biosimilars
– establishment of the EMA taskforce for post-marketing
efficacy studies
- Guidelines for monoclonal antibodies
– reasons for the establishment of separate guidelines
for the approval of MAbs
– complexity issues associated with immunogenicity
assessment of MAbs
– opportunities and challenges for development of MAbs
as the new wave of biosimilars
11.00 Morning Refreshments
11.20 EMA vs. FDA: Comparing Biosimilar Approval
Pathways in Europe and the United States
Moderated by: George Schlich, Attorney, Schlich & Co (UK)
Hans Sauer, Associate General Counsel for Intellectual Property
Biotechnology Industry Organization (US)
Mohamed Oubihi, Senior Manager, International Regulatory
Affairs, Biogen Idec (UK)
Peter Embley, Associate Director,
PPD
- Why has legislation in the United States been so slow
to accommodate biosimilars?
- What drove the EMA to allow biosimilars on to the market
with such relative ease?
- The difference between Europe and US in terms of the order
of filing for patents of biosimilars and their development
- What universal strategies can innovators use to stave off
the threat of biosimilars?
- Which biosimilar products have the potential to gain
universal dominance?
- How intellectual property law works differently in the FDA
pathway and the EMA pathway
12.30 Networking Lunch
13.50 Navigating the US Information and Patent
Exchange Process for Biosimilars
Sanya Sukduang, Patent Attorney, Finnegan (US)
- Understanding the Intricacies of the Pre-Litigation Patent
Exchange Process
– pare for the patent
exchange process
– strategic points when drafting “detailed statements”
of infringement, non-infringement, and invalidity
– effectively negotiating the patents-in-suit
- Balancing the exchange of Information between biosimilar
applicants and innovators
– what are the rights of an biosimilar applicant in terms
of data exchange?
– what are the rights of an innovator in obtaining additional
information from the biosimilar applicant
– ensuring cooperation between the innovator
and the biosimilar maker through transparency
14.35 Patent Enforcement Issues Relating to Biosimilars
Moderated by: Jeffrey P. Kushan, Partner, Sidley Austin (US)
Bert Oosting, Partner, Hogan Lovells (Netherlands)
Anthony Tridico, Patent Attorney, Finnegan (US)
Hans Sauer, Associate General Counsel for Intellectual Property
Biotechnology Industry Organization (US)
- Planning for biosimilar litigation
– identifying the relevant patent estate
– managing relationships with third party patent owners
– licensing strategies
– pre-litigation steps to contest patents
– leveraging regulatory protections, patent protection
and patent term extensions
– patent linkage and patent litigation: differences between
EU and the US
- Patent litigation involving biosimilars
– scope of research exemptions and Bolar protection in Europe
– navigating the exchange of information
– leveraging the process and timeline of the patent dispute
resolution process
– strategies for conducting the litigation
– enforcement mechanisms in the US and Europe:
evidentiary seizures and preliminary injunctions
- Addressing challenges to data exclusivity from both sides
– the role of data protection in making up for shortcomings
in patent protection
– to what extent do the differences in a biosimilar product
affect the value of data?
– paediatric data exclusivity extensions and other barriers
to applicants
15.30 Afternoon Refreshments
15.45 Analysing the SPC Regulatory Landscape
for Biosimilars
Moderated by: Gerry Kamstra, Partner, Bird & Bird (UK)
Frank Landolt, VP Intellectual Property and Legal
Ablynx (Belgium)
Frank Burkert, European Patent Attorney, Bayer (Germany)
André Bourgouin, Vice President, Corporate Intellectual
Property, Ipsen (France)
- What do patent attorneys need to consider when advising
clients on SPCs for biologics?
- What are the marked differences in relation SPC approval
compared with conventional pharma products
- The scope of SPC approval for combination products
- First authorisation, negative term SPCs and paediatric
extensions
- Differences between SPC regulation in Europe and Patent
Term Extension in US
- Paediatric-use marketing authorisations (PUMAs)
- sharing biosimilar applications with third-party owners
- What would a biosimilar mean for an orphan drug
in terms of market exclusivity?
- Paediatric extensions and their impact on biosimilar approval
16.50 Case Studies and National Perspectives on SPCs
and US Patent Dispute Provisions
Reiner Spieker, Patent Examiner, German Patent and Trademark
Office (DPMA) (Germany)
Courtenay Brinckerhoff, Partner, Foley & Lardner (US)
- SPC applications for Biologics compared to those for standard
pharmaceutical drugs
- SPC case studies on “the process is the product”: Phage display
and cell lines used for expression
- Interpreting “product protected by a basic patent”: Claim test,
Disclosure test, Infringement test
- SPC cases for combination products of Biologics referred
to the CJEU
- Bordetella vaccine: Medeva (C-322/10), HPV vaccine:
Georgetown University (C-422/10) and University of
Queensland (C-630/10), Antibody: Yeda (C-518/10)
- Case study on the Paediatric Extension of SPCs for Biologics
- Negative Term SPCs, Merck vs. DPMA (C-125/10)
- Lessons about SPCs for Biologics learned and future challenges
- Patent Dispute Procedures under the US Biosimilars Act
of 2009
- Strategies relating to information and patent list exchange
- Comparing US Biosimilar vs. Hatch/Waxman ANDA
(Generic)
– Market Exclusivity Periods
– Patent Lists vs. Orange Book
– Method of Manufacture Claims
– 30-Month Stay of FDA Approval vs. Preliminary Injunction
17.30 Conference Adjourns
Day Two – Thursday 26th January 2012
8.15 Re-registration and Coffee
9.00 Chairman’s Opening Remarks
Gerry Kamstra, Partner, Bird & Bird (UK)
9.10 Clinical Standards for the Approval of Biosimilars
Bernd Liedert, Head of Immunopharmacology, Merck Serono
(Germany)
Alex Kudrin, Medical Director, Takeda (UK)
- The importance of carrying out clinical trials on the most
vulnerable market
- Using comparison of trials as the basis for approval over
bioequivalence
- How much can clinical trials be abbreviated and what
are the criteria used to decide?
- Guidelines for risk assessment analysis in biosimilar
development including immunogenicity testing
- Impact of differences in glycosylation patterns and
manufacturing process
- Why are arbitrary standards not appropriate for the evaluation
of biosimilar applications?
- The use of post-authorisation effi cacy studies to supplement
applications to other regulators
- Regulatory requirements on extrapolation of clinical
indications for biosimilar MABs
- Proposed study designs in development of biosimilar MABs
- Points to consider in pharmacovigilance of biosimilar MABs:
pre- and post-marketing data
9.50 Biosimilars in Merger, Licensing and Collaboration
Agreements
Bruce S. Manheim and Anita Varma
Partners, Ropes & Gray (US)
John Quisel, Vice President and General Counsel
Acceleron (US)
- How do innovators and biosimilar manufacturers protect
their rights in untested waters?
- What types of legal issues involving biosimilars are likely
to arise in transactions?
- How should counsel for large pharma approach acquisition
of a biotech company?
- What issues will counsel for biosimilar companies need
to consider in licensing arrangements?
- How will parties reach some understanding of the valuation
of a product?
- What timelines and milestones should be considered
in deals involving biosimilars?
- What types of IP questions should be addressed in deal
diligence?
- How will regulatory issues and agency positions shape
transactions and licensing deals?
- What types of provisions should address potential IP
litigation issues?
- What about pharmacovigilance issues and the terms
of any transaction?
10.30 Morning Refreshments
11.00 Biosimilars vs. Biobetters
Moderated by: Marjan Noor, Partner
Simmons & Simmons (UK)
Frank Landolt, VP Intellectual Property and Legal
Ablynx (Belgium)
Dan Hartley, Senior Vice President, Associate General Counsel
Shire (UK)
Vineet Kohli, Patent Counsel, Lundbeck (US)
- Measuring the potential clinical and commercial value
of a biobetter
– evaluating the commercial and clinical signifi cance of
demonstrating novelty in relation to originator product
– balancing the benefits of obtaining patent protection
and premium pricing with the need for extended
clinical development
– how much clinical development is satisfactory to allay
immunogenicity and safety fears?
- Navigating the patentability requirements of biobetters
– examples of adequate written support for novel
biobetters and recent case law in the US
– achieving compliance with the enablement requirement
including the type of data required to satisfy criteria
– non- obviousness considerations of biobetters vs. other
known biologics for same target – types of evidence
required in US vs. Europe
- Claim scope strategies for novel biobetters
– distinguishing a biobetter for a novel antigen vs. a known
antigen and impact on claim scope
– differences in claim scope: US vs. EP perspective
– types of methods for use claims: (i) biomarkers (ii) scoring
(iii) methods of treatment claims (iv) diagnostic claims
- Production and manufacturing issues affecting biosimilars
– impact of broad patents on purifi cation and production
royalty obligations
12.20 Networking Lunch
13.50 Market Access and the Commercial Landscape
of Biosimilars
Gillian Cannon, Vice President, Commercial Operations
Merck Bioventures (US)
Hartwig Gajek, Medical Director, Europe, Baxter Innovations
(Austria)
- Pricing and market share analysis
– what is the estimated share of the market for biosimilars
now and in the future?
– potential for developing markets around biosimilars
in the EU and emerging markets
– orphan drugs as targets for biosimilars and biobetters
– carrying out risk-benefi t analysis
- Health economics of biosimilars
– using price as the key differentiator between a biosimilar
and the originator drug
– price controls for biosimilars?
- Options for a strategic response to the threat of biosimilars
– to what extent can an innovator infl uence the approval
path of biosimilars without resorting to legal course?
– scope for a shift in regulation now and in the future
- Post-approval Risk Management Strategies for Biologics
– The ‘5th hurdle’: continued benefi t-risk assessment
– The cost of maintaining your product in the market
14.40 Interchangeability and Substitution
of Biosimilars and Reference Products
Gareth Morgan, Partner, Winston & Strawn (UK)
Peter Feldschreiber, Barrister and Physician, 4 New Square (UK)
- Justifying substitution of reference products with biosimilars
– demonstrating comparability with the reference product
to the point where it can be considered a viable substitute
– divergence between biosimilars and reference products
- Nomenclature
– using non-proprietary names for biosimilars
– can a pharmacy distribute a biosimilar under the same
name as a substitution if active substance is simple
and interchangeable?
- Impact of the WHO Informal Consultation on International
Non-proprietary Names (INN) on biosimilars
- Product liability issues for biosimilars as substitutes
– what rights does a patient have if they react badly
to a substitute
– responsibility of the prescriber
15.50 Standards for Inequitable Conduct in Patent Cases
Thomas F. Gillespie III, IP Transactional Counsel
Emergent BioSolutions (US)
- Examples of engaging in inequitable conduct as a means
of hindering the pathway to approval of biosimilars
- Assessing misrepresentation on behalf of the patent holder
by identifying disclosure of false information
- To what extent is providing irrelevant information
inequitable conduct?
- What impact can it have on the applicant’s development
process?
- The need for reform of the inequitable conduct doctrine
- What is the European position on inequitable conduct
for biosimilars?
16.35 Afternoon Refreshments and Close of Conference
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