The document advertises and provides information about the 7th annual IP Crys conference on patenting, litigation, and life cycle extension strategies for crystalline forms. The conference will be held October 25-26, 2011 in London and focus on maximizing patent wealth, understanding challenges in demonstrating innovation in crystalline forms, and implementing effective enforcement and protection strategies for polymorph patents. A pre-conference focus day on extending patent lifecycles through SPC/PTE applications will be held October 24.

1. Register and Pay by 29th July and save up to £350
presents the 7th annual
Leading international
practitioners share their
expertise:
Paul Fehlner, Global Head, Pharma
Intellectual Property, Novartis
Andre Bourgouin, Chief IP Officer, Ipsen
Creating effeCtive patenting, litigaton and lifeCyCle extension strategies Raymond Parker, Assistant General
to extend market exClusivity and maximise revenue streams Counsel, Vice President of Patents, Aptalis
Pharmaceuticals
www.IPcrys.com
main conference: 25th & 26th october 2011 Pre-conference focus day: 24th october 2011 Eric Ruhlmann, European Patent Attorney,
location: doubletree by Hilton, West end, london, uk Actelion
The only IP evenT In The world dedIcaTed To crysTallIne forms wIll helP you To: Bertrand Gellie, Director, European
Patent Office
Maximise your patent wealth by designing and drafting robust crystalline form patents with expert advice from Andrew Bartlett, Deputy Director,
the EPO and USPTO Intellectual Property Office
Save time and speed approval through successful models of patent prosecution highways in practice from the UK Chris Hayes, Senior Advisor, Intellectual
IPO Property Rights - Launched Products, Lundbeck
Understand and overcome the challenges of demonstrating true innovation in crystalline forms with Bo Hammer Janssen, Senior Patent Counsel,
best practice examples from Ipsen Novozymes
Implement effective strategies to enforce and protect your polymorph patent, gain unique insights from Merck Mandar Kodgule, Head Intellectual Property
and Novartis and Strategic Planning, Wockhardt
Analyse the latest patent strategies, case laws and judicial decisions to ensure a successful drafting and litigation James Horgan, Assistant Counsel, Merck
strategy with leading experts from Esteve, Aptalis, Wockhardt, Novozymes and more…
Nicolas Ruiz, Head of IP, Esteve
Richie Paul, Head of IP, Elan Drug
ToP 3 reasons To aTTend The only IP Technologies
forum focused on crysTallIne forms: DON’T MISS OUR
t
‘Extending Your Paten Dr Avajit Kelka, Director, Head IP
Management Cell, API and Generics, Dr
sful
1 your chance to ask global patent office Lifecycle With Succes Reddys Laboratories (UK)
representatives all of your crystalline form related ’
SPC/ PT E Applications
questions Alastair Wilson QC, Joint Head of
2. discuss the latest case laws and judicial decisions to FOCU S DAY Chambers, Hogarth Chambers
gain unique insights into the future of crystalline form Gain unique insights Professor Christian Lehmann, Head
m
patents sPonsor from representatives fro of Chemical Crystallography and Electron
3. Benchmark your patent protection strategies Lundbeck , Actelion, Mictroscopy, Max-Planck Institute
with leading experts in the field during our dedicated Dr Reddys and Hogarth Professor Sally Price, Professor of Physical
interactive networking and discussion sessions Chambers Chemistry, University College London
Ellen Setreus, European Patent Attorney,
Valea AB
+ 44 (0)20 7368 9300 enquire@iqpc.co.uk www.ipcrys.com

2. Pre-conference focus day - monday 24Th ocToBer 2011
exTendIng your PaTenT lIfecycle wITh successful sPc/PTe aPPlIcaTIons
10.15 Coffee and Registration
10.40 Welcome by Chairperson
10.45 Overview of Current Opportunities And Requirements For SPC/PTE Applications
• Update on the differences between SPCs and PTEs
• Determining what is and isn’t eligible for extended protection
• Where and when can you obtain more than one SPC/PTE per product?
• Highlighting the places where you can apply for an SPC/PTE and those where you cannot
• Understanding where should you accelerate patent prosecution to maximise SPC/PTE duration
Dr Avajit Kelka, Director, Head IP Management Cell, API and Generics, Dr Reddys Laboratories (UK) “good
sPeakers wITh
11.30 SPCs At The Interface Between Patent And Pharmaceutical Law
• Examining the commercial importance of SPCs
vasT suBjecT
• Selecting the right patent basis for your SPC knowledge
• What protection is available to medicines? dr mandar kodgule,
• SPCs versus data protection: what are the pros and cons? WoCkHardt ltd
• SPCs and data protection as past of an IP strategy: what is the scope of protection and enforcement?
Chris Hayes, Senior Advisor Intellectual Property Rights - Launched Products, Lundbeck
12.15 Networking Lunch
13.00 Extending Patents Via Paediatric Exclusivity In Europe And The US
• EU regulation requirements: paediatric investigational plan, SPC and time limits
• Exploring European SPCs: case law update on paediatric exclusivity
• Federal Food, Drug and Cosmetic Act requirements
• US case law update concerning paediatric exclusivity
“excellenT,
Eric Ruhlmann, European Patent Attorney, Actelion really
13.45 SPC Judicial Case Law Update
valuaBle!”
• Current controversies in the employment of an SPC BHarati nadkarni,
• Ensuring your pharmaceutical SPC stands up to litigation sun pHarma
• What constitutes first marketing authorisation in the community?
• Analysis of recent judgements on SPCs including contradictory outcomes: how will these affect the future?
• Effective approaches to future enforcement
Alastair Wilson QC, Joint Head of Chambers, Hogarth Chambers
14.30 PANEL DISCUSSION
This session will bring together all of the speakers and delegates for an interactive discussion and debate to consolidate the
issues raised during the day.
Facilitated by all speakers
15.00 Closing Remarks
+ 44 (0)20 7368 9300 enquire@iqpc.co.uk www.ipcrys.com www.IPcrys.com

3. conference day one - Tuesday 25Th ocToBer 2011
08.15 Registration and Coffee
12.40 Networking Lunch
09.00 Pharma IQ’s Welcome and Opening Remarks from Chairperson
Chair: Eric Ruhlmann, European Patent Attorney, Actelion 13.40 Fast Tracking Your Application Using The Patent Prosecution Highways
And Accelerated Examination
DRAFTING YOUR PATENT APPLICATION TO MAXIMISE PATENT WEALTH: • Overview of current schemes in place to accelerate examination
as patent prosecution and protection for crystalline forms has matured, these sessions • Newly launched pilot projects
will go deeper into the strategies and techniques for drafting meaningful and robust PATENT • Successful examples of the patent prosecution highway in practice
OFFICE
crystalline form applications with expert input from patent office representatives and UPDATE • Strategies for using these procedures with crystalline form patent applications
industry professionals Andrew Bartlett, Deputy Director, Intellectual Property Office
09.10 Drafting And Designing A Robust And Meaningful Crystalline Form Patent: 14.20 Strategically Strengthening Your Patent Application
The EPO Perspective • Pre-patenting considerations to build a strong patent to withstand litigation
• Identifying and overcoming the common pitfalls in the application process • Choosing the right analytical tools
• Typical objections raised by the EPO • Single or multiple patent applications?
• Understanding the levels of data disclosure needed to avoid a lengthy examination process: ellen setreus, european patent attorney, valea aB
PATENT
OFFICE how much is enough?
UPDATE
• Recent EPO case law relating to solid state chemistry and polymorphs 15.00 Understanding The Value And Reasons For Patenting Crystalline Forms
Bertrand Gellie, Director, European Patent Office • Life cycle management of new chemical entities
• Establishing your generic IP position
09.50 USPTO: Your Guide To Examination Of Crystalline Forms In The US And The CASE
STUDY
• Obtaining patent protection for publically available products
Impact Of These On Your Patent Application nicolas ruiz, Head of ip, esteve
• What questions are US patent examiner’s asking during prosecution of crystalline form
patents?. 15.40 Networking Refreshment Break
PATENT • Examining recent decisions of the USPTO board of appeals
OFFICE • Update on latest US case law: how might this affect future applications for polymorphs, DEMONSTRATING INNOVATION: as computer technology becomes more
UPDATE
cocrystals, and crystalline salts? sophisticated and proving novelty becomes increasingly difficult, these sessions will highlight
James smith, Chief of Board of patent appeals and interferences, uspto the advances in polymorph screening and examine the optimal methods to differentiate from
(subject to final confirmation) prior art in order to build a robust patent application
10.30 Extended Networking and Refreshment Break 16.10 Differentiating Your Polymorph From Prior Art: How Do You
Bring plenty of business cards to exchange with your fellow attendees during our extended Demonstrate True Innovation And Prove Novelty And Iinventive Step?
networking session • Techniques to prove your polymorph is truly innovative
CASE
• Data requirements needed to differentiate from prior art and rebut inherent anticipation
11.20 Are Crystalline Forms Patentable In India? Understanding What Is And LAW • Optimal timing of disclosure: in the application or during examination
What Isn’t Eligible For Submission And Approval • Understanding recent UK High Court rulings on entitlement to priority: what is the impact
• Ensuring you get the correct submission criteria: similarities and differences to EU and US on patenting polymorph forms?
requirements Andre Bourgouin, Chief IP Officer, Ipsen
• Best practice strategies for proving increased bio efficacy of novel crystalline forms
• Interpreting Section 3(d) of the Indian patent act: how do you quantify therapeutic efficacy 16.50 Computational Prediction Of Crystal Structures
• Lessons from the Novartis Glivac case • Reliability of current methods of computational screening for polymorphs, as revealed by
• Evidence needed to grant IP rights blind tests
• Patentability aspects of certain polymorph patents : practical examples and case studies • Why do we over predict polymorphs?
• Analysing the patentability vs. non-infringement options • Scope for multi component forms: co-crystals, salts, solvates etc
• Practical examples and certain critical issues in addressing technical solutions and possible options professor sally price, professor of physical Chemistry, university College london
Alpesh Pathak, Head API Patent Cell, Alembic
17.30 Closing Remarks from Chairperson and End of Day One
12.00 INTERNATIONAL PANEL DISCUSSION: Your chance to ask specific
questions and get the answers you need to ensure successful global
crystalline form patent applications
Contributors: Betrand Gellie, EPO
andrew Bartlett, uk ipo
James smith uspto
+ 44 (0)20 7368 9300 enquire@iqpc.co.uk www.ipcrys.com www.IPcrys.com

4. conference day Two - wednesday 26Th ocToBer 2011
08.15 Registration and Coffee
12.10 Uncovering The Available Technologies To Differentiate Competitor
08.50 Pharma IQ’s Welcome and Opening Remarks from Chairperson Samples From Reference Samples: Beyond X-ray Diffraction
Chair: Bo Hammer Jensen, Senior Patent Attorney, Novozymes • Overview of analytical techniques used to characterise crystalline forms in final drug products
• Benefits of using terahertz pulsed spectroscopy
PATENT PROTECTION, ENFORCEMENT AND LITIGATION STRATEGIES: • Using the analytical results to mount a successful litigation campaign
these sessions will outline the currents techniques in use to guarantee that you polymorph professor Christian lehmann, Head of Chemical Crystallography and electron mictroscopy,
patent stands up to challenge enabling you to capitalise on your market exclusivity Max-Planck Institute
09.00 Enforcing And Protecting Your Polymorph Patent 12.50 Networking Lunch
• How to overcome early challenges to exclusivity
• Preparing for litigation: due diligence and risk analysis 13.50 European Judicial Update
• How to prove infringement of polymorph patents • Analysis of recent judgements that impact crystalline form patents: how will these affect the future?
• What scientific evidence you will need and how to present it • Effective approaches to future enforcement
James Horgan, Assistant Counsel, Merck CASE • Choice of country or countries in which to litigate crystalline form patents: are some
LAW
better than others?
09.40 Understanding The Orangebook Requirements To Avoid Litigation alastair Wilson QC, Joint Head of Chambers, Hogarth Chambers
• Identifying which patents can and cannot be included
• Improper listing of patents 14.30 Update On The Community/EU Patent And Unified Litigation System
CASE • Creating a patent portfolio impervious to attack • How is the work for a EU patent progressing – what are the present proposals?
STUDY • Case examples • Bundle patents or community patent? What could be the advantages and disadvantages of
Raymond Parker, Assistant General Counsel, Vice President of Patents, Aptalis Pharmaceuticals CASE the system?
LAW • The unified litigation system – what is the Commission doing after the decision of the
10.20 Networking Coffee Break European Court of Justice ruling?
• Would this satisfy the ECJ?
10.50 Maximising Your Patent Lifecycle To Extend Market Exclusivity • What are the main issues for the users?
• Effectively analysing when to file your primary patent Bo Hammer Jensen, senior patent Counsel, novozymes
• Time of secondary patent filings
• Maximising the revenue from and the lifetime of your patent portfolio 15.10 Networking Refreshment Break
• Where do patent applications to crystalline forms fit?
richie paul, Head of ip, elan drug technologies
15.50 Unravelling Multinational Approaches to Avoid Exploitation: Strategies
11.30 BREAKOUT ROUNDTABLE DISCUSSIONS: Participants will be For Obtaining A Preliminary Injunction
able to choose one of the roundtables outlines an spend 40 minutes • Exploring the conditions needed to start proceedings
discussing the points below: • Time to get a PI vs time to generic launch
• Requirements for a positive PI decision
A) Supplementary Protection Certificates • Update on the situation in key countries: UK, NL, FR and DE
delegates will have the opportunity to discuss challenges and solutions for maximising • Highlighting the possible outcomes and effects
patent lifecycles via the application of spCs. • Key learnings and practical tips
Topics discussed will include: where, when and how to apply for an SPC, relevance of paul fehlner, global Head, pharma intellectual property, novartis
zero and negative term spCs, recent judgements and case law.
Chris Hayes, Senior Advisor Intellectual Property Rights - Launched Products, Lundbeck 16.30 Identifying And Exploiting Vulnerable Patents: The Generics Perspective
• How to recognise the weak spots of patent enforceability and validity
B) Designing And Drafting A Robust Patent Application • Strategic techniques used to circumvent existing patents
this session with explore the techniques for drafting meaningful and robust crystalline CASE • Successful case study examples for API’s and crystalline forms
form applications. STUDY
Mandar Kodgule, Head Intellectual Property and Strategic Planning, Wockhardt
Topics discussed will include: differences in patent office requirements, recent
judgements and case law and strategies for ensuring a speedy examination and approval. 17.10 Closing Remarks from Chairperson and End of Conference
To be confirmed
C) Preparing For Litigation
during this session current litigation strategies will be highlighted.
Topics discussed will include: proving infringement, patent enforceability in a changing
legal landscape, risk analysis and litigating stratgies in different countries
Mandar Kodgule, Head Intellectual Property and Strategic Planning, Wockhardt
+ 44 (0)20 7368 9300 enquire@iqpc.co.uk www.ipcrys.com www.IPcrys.com

5. sPonsors and exhIBITors
sPonsor who wIll aTTend?
Valea AB is one of Europe´s leading consulting agencies within the field
From Pharmaceutical and Generic Companies:
of intellectual property law, and can trace it’s roots since the end of
19th century. Our current staff of approximately 90 employees consists • In-House Counsel and Legal Directors
of authorised European patent attorneys, trademark attorneys, design • Heads of IP, IP Counsel and IP Managers
attorneys and lawyers. We have offices in Gothenburg, Linköping, Lund, • Heads of Patents, Patent Counsel, Patent Directors and Managers
Malmö and Stockholm.
We can offer our clients the complete range of IP services. Valea’s staff comprises consultants specializing
Private Practice and In-house Lawyers and Patent attorneys specialising in:
in patents and law. Their knowledge is combined with a good business understanding of the short term • Life Sciences/Pharma
and long term commercial value to the client. Each individual client is provided with a personal contact • IP and Patents
at Valea, and we do our utmost to maintain close, long-term cooperation with our clients, based on
commitment and genuine insight into their business. Website: www.valea.se
delegaTes who aTTended 2010
maxImIse your InvolvemenT: sPonsorshIP VP/CEO
and exhIBITIon oPPorTunITIes
IN-HOUSE PATENT ATTORNEY/COUNSEL
the pharma iQ ip strategies for Crystalline forms conference will be the perfect platform for law
firms to meet senior-level in house pharmaceutical patent counsel in search of external expertise
to help protect and litigate their patent portfolio. PATENT AGENT/MANAGER
Contact pharma iQ to discuss how to position your company in front of your participants who are
ip manager
keen to learn more about your services and expertise including Ipsen, Novartis, Elan, Lundbeck,
Merck and many more.
For more information on available sponsorship opportunities please email sCientist
sponsorship@iqpc.co.uk or phone +44 (0) 207 368 9300
aBouT Pharma IQ “very valuaBle” dr miCHael BeCker, solvias ag
Web: http://www.pharma-iq.com/
Phone: 1-646-454-4559
medIa ParTners
Become a member of Pharma IQ and receive complimentary access to resources that will keep you
at the forefront of industry change. You will receive access to our growing library of multi-media
presentations from industry leaders, an emailnewsletter updating you on new content that has
been added, free aggregated news feed from over 1000 global news sources tracking your industry
and special member only discounts on events.
Become a member here: http://www.pharma-iq.com//IQLogin.aspx?IQ=pharma
+ 44 (0)20 7368 9300 enquire@iqpc.co.uk www.ipcrys.com www.IPcrys.com

6. 5 WAYS TO REGISTER
Freephone: 0800 652 2363 or +44 (0)20 7368 9300
main conference: 25th & 26th october 2011 Pre-conference focus day: 24th october 2010 Fax: +44 (0)20 7368 9301
location: doubletree by Hilton, West end, london, uk
To speed registration, please provide the priority code located on the mailing label or in the box below.
Post: your booking form to IQPC Ltd. 129 Wilton Road, London SW1V 1JZ
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Team Discounts* Digital Conference On CD-ROM
IQPC recognises the value of learning in teams. Groups of 3 or more booking at the A digital version of the conference proceedings, including
same time from the same company receive a 10% discount. 5 or more receive a 15% all presentations, is available to buy.
SPECIAL OFFER: discount. 7 receive a 20% discount. Only one discount available per person.
First 10 General Counsel; Head of IP; Patent Counsel or Head of Legal Registrations 6 I cannot attend the event, please send me the CD Rom
will receive a 50% discount. Offer applies to Pharmaceutical or Biotech in-house employees only Venue & Accommodation priced at £599 plus VAT
VENUE: DoubleTree by Hilton West End, 92 Southampton Row, London WC1B 4BH
Tel: +44-207-2422828 Fax: +44-207-8319170 Recent digital conferences available - £599 plus VAT each
6 Developing IP Strategies for Crystalline Forms,
Delegate Details ACCOMMODATION: We look forward to welcoming you to Developing IP Strategies for Crystalline
Forms at the DoubleTree by Hilton West End. To help you get the perfect accommodation and the best
December 2010
6 Global Patent Congress September 2011
Please photocopy for each additional delegate special offers we have put together a unique HotelMap that shows the nearby accommodation options 6 Nordic IPR March 2011
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