Allen Norris Vice President Head of Group IP UCB Pharma SA Belgium

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Solicitors Regulation Authority (SRA) and Bar Council CPD: Pre-conference workshop 4 hours Main conference 12 hours Particularly interesting content covering all hot topics (Delegate, Pfizer) Le

FORUM 2008 Advanced review and update of the major legal changes and developments in Europe and the US Chaired By: Allen Norris Vice President Head of Group IP UCB Pharma SA Belgium Attend to hear

1 Solicitors Regulation Authority (SRA) and Bar Council CPD: Pre-conference workshop 4 hours Main conference 12 hours Particularly interesting content covering all hot topics (Delegate, Pfizer) Le Méridien Munich, Germany Pre-conference afternoon workshop Monday 28 th January 2008 Two-day conference Tuesday 29 th & Wednesday 30 th January TH ANNUAL BIOTECH AND PHARMACEUTICAL PATENTING FORUM 2008 Advanced review and update of the major legal changes and developments in Europe and the US Chaired By: Allen Norris Vice President Head of Group IP UCB Pharma SA Belgium Attend to hear from senior pharma and biotech in-house counsel, leading lawyers and patenting experts: Keep up to date with the latest patent rules and practices in Europe and the US Embrace the scope and benefits of the EPC 2000 Examine cross-border patent protection issues Analyse supplementary patent certificates (SPC) Review best litigation strategies Assess the challenges surrounding parallel imports Drive your due diligence Compare the benefits and challenges of acquisition vs. academia Discuss key legal challenges of patent rights and learn how to improve your patent portfolio to maximise your ROI and commercial advantage. Pre-conference workshop Life Cycle Management of a Medicinal Product: A case study By using a simple case study, this interactive workshop will introduce you to the main areas and challenges of life cycle management and guide you through the various strategic decisions which you face. Expertly led by: OUR DISTINGUISHED SPEAKER FACULTY INCLUDES: Marc A. Markus, MD, LL.B, European Biology Patent Lead, Pfizer, France Stephen S. Yoder, Senior Director, Head of Licensing & Intellectual Property, MorphoSys AG, Germany Dr. Frank Burkert, European Patent Attorney, Bayer HealthCare AG, Germany Frank Landolt, IP and Legal Counsel, Dr. Christopher Heath, Member of the Boards of Appeal, European Patent Office, Germany Dr. Daniela Díez Schlereth, Administrator (Directorate Practice and Procedure), European Patent Office, Germany Sjoerd Hoekstra, Director Biotechnology, European Patent Office, The Netherlands Dr. Rob J. Aerts, M.A., European and Dutch Patent Attorney, Solvay Pharmaceuticals B.V., The Netherlands Dr. Andreas Emmendörffer, Managing Director, euroderm GmbH, Germany Dr. Andreas von Falck,, Lovells LLP, Germany Veronica Mullally,, Lovells LLP, USA Sarah Turner, Of Counsel, Lovells LLP, UK,, Dr. Jürgen Meier, European Patent Attorney, Vossius &, Germany George Pickering,, Reed Smith Richards Butler LLP, UK Dr. Philip Grubb, IP Consultant, Switzerland Dr. Rolf Witte, CFO, Neuraxo Biopharmaceuticals GmbH, fundamenta Life Sciences GmbH, Germany,, Sponsor: Media s: Book Online: Bookings Hotline: +44 (0) an informa business

2 16 TH ANNUAL BIOTECH AND PHARMACEUTICAL PATENTING FORUM 2008 Keep up-to-date with current patent regulations and developments to unleash the power of your patents. Increasing pipeline pressures and the latest legal developments are significantly changing the landscape for pharmaceutical and biotech patenting in Europe and the US. Optimising regulatory procedures and enhancing patenting strategies have become crucial aspects in driving growth and innovation. As a private practice lawyer, or in-house counsel you need to stay abreast of the latest patenting developments and regulations in order to stay competitive and improve your patent portfolio. The 16th annual Biotech and Pharmaceutical Patenting Forum, by IBC Legal Conferences, provides you with a fantastic platform to discuss the most crucial recent legal developments and regulatory matters, bringing together international in-house counsel, private practice lawyers and patent experts. Meet and network with industry experts whose prime focus is the enhancement of patenting in Europe to drive innovation and profitability. WHO SHOULD ATTEND? Pharmaceutical, biotechnology & biopharmaceutical companies: In-house Counsel, Legal Directors and Company Solicitors/Attorneys IP Counsel, Heads of IP and IP Solicitors/Attorneys Patent Counsel, Heads of Patents and Patent Solicitors/Attorneys Officers & Directors for: o Business Development o Strategic Alliances o Licensing o Commercial Affairs o Inventions Private practice lawyers who have an interest in: Patents Litigation IP Life Sciences / Pharma Patent agents, consultants, examiners and governmental bodies Promotional Opportunities For details of the wide range of opportunities available, including insertion of promotional literature in the delegate pack, drinks reception or full conference sponsorship, please contact: Kelvin McManus on + 44 (0) , kelvin.mcmanus@informa.com HEAR FROM KEY REPRESENTATIVES FROM LEADING BIOTECH AND PHARMA COMPANIES INCLUDING: Pfizer the world's largest research-based biomedical and pharmaceutical company MorphoSys AG one of the world s leading biotechnology companies with a focus on fully human antibodies Bayer Health Care AG a subsidiary of Bayer AG - one of the world s leading companies in the healthcare and medical products industry Ablynx N.V. the only company in the world with US and European patents describing the composition of matter of Nanobodies Solvay Pharmaceuticals B.V. an international chemical and pharmaceutical group, employing some people in 50 countries UCB Pharma SA a leading global biopharma company with expertise in biology and chemistry BY ATTENDING THIS CONFERENCE YOU WILL: Keep up-to-date with the most topical patent regulations and case law Investigate best practice in patent protection Gain practical advice on how to enhance your patent portfolio Learn how to utilise patents for your commercial advantage Find out how to drive innovation and build up your pipeline. PLUS: The pre-conference interactive afternoon workshop Life Cycle Management of a Medicinal Product: A case study, expertly led by, at, and, at, will introduce you to the main areas and challenges of life cycle management and guide you through the various strategic decisions you face. CALL THE IBC BOOKINGS HOTLINE on +44 (0) BOOK ONLINE AT:

16 TH ANNUAL BIOTECH AND PHARMACEUTICAL PATENTING FORUM 2008 DAY 1 TUESDAY 29 TH JANUARY 2008 08.30 Registration and Coffee 09.00 Chairman s Opening Remarks 09.

patents in general Gene patents - the question of industrial applicability Recent case law and clarification of various issues. Dr. Rob J. Ae

3 16 TH ANNUAL BIOTECH AND PHARMACEUTICAL PATENTING FORUM 2008 DAY 1 TUESDAY 29 TH JANUARY Registration and Coffee Chairman s Opening Remarks The State of Gene Patenting in the Biotech and Pharmaceutical Industry in Europe Reviewing the challenges of the gene and protein patent landscape in Europe Assessing how gene patents differ from patents in general Gene patents - the question of industrial applicability Recent case law and clarification of various issues. Dr. Rob J. Aerts, M.A. European and Dutch Patent Attorney Solvay Pharmaceuticals B.V., The Netherlands Speed Networking and Focused Discussion Time EPC 2000 The latest developments and its impact on your patent portfolios Revision of the European Patent Convention: update on the latest patent regulations from initial filing to appeal Adopting the EPC2000: identifying and mastering challenges and understanding the new procedures Reviewing recent cases from the EPO and its impact on the biotech and pharmaceutical industry. Dr. Daniela Díez Schlereth Administrator (Directorate Practice and Procedure) European Patent Office, Germany Morning Coffee and Networking Break Improving Your Global Patent Litigation Strategy Update on the European and US patent litigation landscape Offensive and defensive strategies (including ITC proceedings). Examining practical, commercial and tactical issues for managing multijurisdictional litigation Enhancing the alignment between business plan and patent strategy Useful techniques in multi-jurisdictional actions (for example, obtaining and using evidence abroad, freedom of information requests etc) Dealing with counterfeits effectively. Veronica Mullally Lovells LLP, USA Sarah Turner Of Counsel Lovells LLP, UK Lunch Comparing European vs. US Patent Regulations and Practices Update on US patent regulations: coping with the new USPTO rules Exploring the impact of the recent change to US patent laws and patent office practice on primary and secondary pharmaceutical patents Discussing the key differences between US and European patent laws Assessing key challenges for global players adopting the most efficient patent strategy to maximise ROI. Dr. Frank Burkert European Patent Attorney Bayer HealthCare AG, Germany Exploiting the Potential of Patent Term Extensions in Europe, the US and Elsewhere - The types of PTE Comparing the types of PTE worldwide Assessing the importance of SPCs Understanding the requirements for filing SPCs Scope of protection given by SPCs Calculating SPC duration The Lichtenstein problem. Dr. Philip Grubb IP Consultant Switzerland INTERACTIVE PANEL DISCUSSION Will the New Regulatory Framework in Europe Really Meet the Expectations? How do new patent rules really affect the appeal practice in Europe? What are the grey areas and what is the impact of these grey areas? Can the EPO cope with the workload in biotechnology? What should you watch out for? European Patent Court - worth having? Facilitated by: And joined by: Dr. Christopher Heath Member of the Boards of Appeal European Patent Office, Germany Sjoerd Hoekstra Director Biotechnology European Patent Office, The Netherlands Dr. Jürgen Meier European Patent Attorney Vossius &, Germany Dr. Rob J. Aerts, M.A. European and Dutch Patent Attorney Solvay Pharmaceuticals B.V., The Netherlands GROUP DISCOUNTS AVAILABLE For group discounts or for any enquiries please contact John Mahjoubi by ing john.mahjoubi@informa.com or calling +44 (0)

4 ALL YOU NEED TO KNOW IN BIOTECH AND PHARMA (CABINET PLASSERAUD) Afternoon Tea and Networking Break Examining the Issues Surrounding the Acts of Parallel Import and Clinical Trials in the EU Preserving patent rights for imported drugs: what can be done? Comparing national procedures - the latest situation in the enlarged EU Overview and interpretation of the EU "Bolar"Provision in the 9 main EU jurisdictions A practical look at what is permissible under the EU Bolarprovision Issues arising out of the lack of uniformity throughout the EU Conducting Patent Due Diligence Properly How to prepare for a due diligence process Efficiently integrating a due diligence into a negotiating process Reassessing contract negotiations, risk assessment and value protection Determining the appropriate scope, depth and budget of IP due diligence. Frank Landolt IP and Legal Counsel George Pickering Reed Smith Richards Butler LLP, UK & client PANEL DISCUSSION Discussing Key Patent Concerns in the Biotech and Pharmaceutical Industry Establishing a European Patent Court What should be done to speed up the harmonisation of the regulatory framework in Europe? How will new regulations affect the ability to obtain patents that cover all aspects of an invention? The future of patents as a viable defence strategy Facilitated by: And joined by: Dr. Frank Burkert European Patent Attorney Bayer HealthCare AG, Germany Plus other key speakers of the conference Chairman s Closing Remarks and End of Day One of the Conference Wine tasting sponsored by Lovells DAY 2 WEDNESDAY 30 TH JANUARY Registration and Coffee Chairman s opening remarks Allen Norris Vice President, Head of Group IP UCB Pharma SA, Belgium Driving Industrial Competition in the Field of Regenerative Medicine Reviewing the latest reforms and legal developments affecting competition in the industry Current available advanced therapies, medicinal products and emerging technologies Key strategies and benefits to promote competition Discussing key enforcement actions against anti-competitive business practices. Dr. Andreas Emmendörffer Managing Director, euroderm GmbH, Germany Morning Coffee and Networking Break Driving Biotech Innovation and Building Up Your Pipeline: Acquisition vs. academia Expanding biotech capabilities: assessing best strategies Analysing international innovation trends: who is really driving the innovation? Mastering an acquisition: identifying opportunities and dangers Examining priorities and interests of big pharmaceutical companies and academic institutions regarding biotech innovation. Dr. Rolf Witte CFO Neuraxo Biopharmaceuticals GmbH, fundamenta Life Sciences GmbH, Germany Lunch Improving Innovation and Revenue: Joint discovery, development and commercialisation Building collaborative relationships the drivers, challenges and benefits Evaluating patent portfolios Creating the most appropriate ownership, management and licence framework for programme intellectual property Ensuring effective patent management and protection Managing a cross-border and multi-product patent portfolio. George Pickering Reed Smith Richards Butler LLP, UK Frank Landolt IP and Legal Counsel Enhancing Patent Licensing Outlining common risks and challenges in licensing arrangements Legislating for co-development and co-promotion rights in a pragmatic way EU vs. US: does choice of law really matter? Analysing the impact of recent cases. Stephen S. Yoder Senior Director, Head of Licensing & Intellectual Property MorphoSys AG, Germany Afternoon Tea and Networking Break Using the Regulatory Tools to Protect Your IPR Worldwide Effectively The Hatch Waxman reform its initial intent, its impact, and its future

5 EXCELLENT CHOICE OF SPEAKERS (EPO) Assessing the changing regulatory framework for follow-on biologics Reviewing Hatch-Waxman infringement cases Enhancing biosimilars protection strategies: assessing the scope of the European legal pathway for the approval of biosimilars Discussing key challenges and national cases. Marc A. Markus, MD, LL.B European Biology Patent Lead Pfizer, France PANEL DISCUSSION Future outlook Key challenges and trends How will emerging realities affect your patent and business strategy? Prospects for future growth: how best to drive innovation and growth? How best to maintain the proper balance between innovative and generic drugs? Facilitated by: Allen Norris Head of IP UCB, Belgium And joined by: Dr. Andreas von Falck Lovells LLP, Germany Frank Landolt IP and Legal Counsel Chairman s Closing Remarks and End of the Conference By using a simple case study, this interactive workshop will introduce the participants to the main areas and challenges of life cycle management and guide the participants through the various strategic decisions which face a pharmaceutical company. An ideal complement to the conference for all those who need to enhance their knowledge on life cycle management, this workshop will provide an introduction to the following main areas: Parallel Trade: The specific mechanism Trade marks Copyright Stock management programmes Generics: Patent protection strategy Settlement agreements Own generic launch RDP Marketing exclusivity Genuine Competition: Advertising Patent protection Commercial dealing Counterfeit Products: IP protection Regulatory provisions Customs provisions You will take part in practical group exercises, discussions and debates. The workshop has a limited number of places to ensure you receive the maximum interaction. The workshop includes a 30 minute refreshment break. About the workshop leaders: is a partner at Bristows and head of the Regulatory Practice. She specialises in UK and European law, with a particular focus on regulatory matters and competition law. Pre-conference workshop - Life Cycle Management of a Medicinal Product: A case study Monday 28th January 2008 Led by: Liz is a senior associate in Bristows' Life Sciences Practice. Liz has extensive experience of representing pharmaceutical companies in both patent and healthcare regulatory issues before the UK Courts. Company profile Bristows is one of the UK's premier law firms. Its intellectual property practice is consistently ranked as one of the world's top IP practices. The firm has taken the lead on many complex and ground-breaking cases which have shaped today's intellectual property law. Previous Delegates at IBC s Biotech and Pharmaceutical Patenting Said: A hugely useful update on issues right across the sector (Simmons & Simmons) Excellent choice of speakers (EPO) Registration Very well organised conference with particularly interesting content covering all hot topics at present (Pfizer) Workshop begins All you need to know in biotech and pharma (Cabinet Plasseraud) Workshop concludes In order to maximise the market exclusivity of a medicinal product in the key markets, it is essential that a global strategy is put in place early on Conference Documentation is Available in the development stages. To be effective, this "life cycle management" If you are unable to attend, why not pass the brochure on to a colleague? must cover all areas of potential protection for the product, including Don t forget: you need not miss out, either the conference notes are patents, pharmaceutical regulatory legislation, competition law, brands available after the event for only 225 ( 240 outside the UK). and copyright. CALL THE IBC BOOKINGS HOTLINE on +44 (0)

6 16 TH ANNUAL BIOTECH AND PHARMACEUTICAL PATENTING FORUM 2008 Pre-conference afternoon workshop Monday 28th January 2008 Two-day conference Tuesday 29th & Wednesday 30th January EASY WAYS TO REGISTER Contact Customer Services on Tel: +44 (0) Fax: +44 (0) ProfessionalCustServ@informa.com Would you like to receive updates from us in the future? Yes Web: Conference Venue: Le Méridien Munich Bayerstrasse 41, Munich, 80335, Germany Tel: +49 (89) Fax: +49 (89) Customer Number Brochure Number Event Code LY1343 ARE WE MAILING YOU CORRECTLY? To update your contact details on our database please visit Mail: The Bookings Department Informa PO Box 406 West Byfleet KT14 6WL United Kingdom Terms and Conditions FEE: Cost of Pre-conference Workshop - 28th January 2008 Only: - Book by 5th December: % MWSt - Book by 9th January: % MWSt - Book after 9th January: % MWSt Cost of 2-day Main Conference - 29th & 30th January 2008 Only: - Book by 5th December: % MWSt - Book by 9th January: % MWSt - Book after 9th January: % MWSt Discount for attending both the Pre-conference Workshop and 2-day Main Conference - 28th-30th January 2008: - Book by 5th December: % MWSt - Book by 9th January: % MWSt - Book after 9th January: % MWSt DISCOUNTS: Group discounts and 10% discount for IP Institute members available on application, contact John Mahjoubi by ing john.mahjoubi@informa.com or calling +44 (0) MWSt: Under German regulations delegates from all countries are required to pay MWSt on any event taking place in Germany. Delegates will be sent information on how to claim back MWSt. ACCREDITATION: This course has been accredited with Law Society CPD of xxx Hours (Ref EV/LSSL). Level: introductory/intermediate. For all enquiries regarding CPD please quote registered company name: Informa UK Limited. Accredited with Bar Council CPD: Law Society xxx hours CPD Hours Bar Society xxx Hours CANCELLATIONS: Must be received in writing to daniel.browne@informa.com at least 3 weeks before the event and will be subject to an administrative charge of It is regretted that no refunds will be made or invoices cancelled after and the full registration fee will be payable. Substitutions may be made at any time. Fee includes lunch, refreshments and supporting documentation. Telephone calls may be recorded for quality purposes. It may be necessary for reasons beyond the control of the organisers to alter the content and timing of the programme or the identity of the speakers. This contract is subject to English Law. ARE YOU REGISTERED?: You will always receive an acknowledgement of your booking. If you do not receive anything please call us on +44 (0) to make sure we have received your booking CALL MONITORING: Telephone calls to Informa UK Limited may be recorded or monitored in order to check the quality of the service being provided. DATA PROTECTION: The personal information shown and/or provided by you, will be held on a database and may be shared with companies in the Informa Group in the UK and internationally. Sometimes your details may be obtained from, or made available to, external companies for marketing purposes. If you do not wish your details to be used for this purpose, please contact the Database Manager at Informa UK Ltd, Informa House, Mortimer Street, London, W1W 7RE, UK. Tel +44 (0) , fax: +44 (0) or by ing database@informa.com. Sometimes your details may be obtained from or made available to external companies for marketing purposes. If you do not wish your details to be used for this purpose, please write to: The Database Manager, Informa UK Ltd, PO Box 406,West Byfleet KT14 6WL.. REDUCED RATE HOTEL ACCOMMODATION The cost of the accommodation is not included in the event fee. Reduced rate accommodation can be arranged for you as a free service to Informa delegates by contacting Zibrant, call +44 (0) ; informa@zibrant.co.uk or visit Please book early to avoid disappointment some destinations fill up very quickly. DELEGATE DETAILS (FOR EASE, ATTACH YOUR BUSINESS CARD) PLEASE PHOTOCOPY FORM FOR MULTIPLE BOOKINGS! (Mr/Mrs/Ms/Miss/Dr) Family Name Fax Forename Tel Job Title APPROVING MANAGER DETAILS (Mr/Mrs/Ms/Miss/Dr) Family Name Forename Tel COMPANY DETAILS Name of Company Department Address City Postcode Country VAT Reg no Nature of Company Business PRICES Cost of Pre-conference Workshop - 28th January 2008 Only: - Book by 5th December: % MWSt - Book by 9th January: % MWSt - Book after 9th January: % MWSt Cost of 2-day Main Conference - 29th & 30th January 2008 Only: - Book by 5th December: % MWSt - Book by 9th January: % MWSt - Book after 9th January: % MWSt Discount for attending both the Pre-conference Workshop and 2-day Main Conference - 28th-30th January 2008: - Book by 5th December: % MWSt - Book by 9th January: % MWSt - Book after 9th January: % MWSt Group discounts and 10% discount for IP Institute members available on application, contact John Mahjoubi by ing john.mahjoubi@informa.com or calling +44 (0) TOTAL I am unable to attend this event but please reserve me _ set(s) of conference notes at 225 ( 240 outside of UK) Proof of Payment Delegates who do not pay with their booking are requested to provide a copy of bank transfer/credit card/cheque details to help payment allocation. Staff at the event will request a credit card guarantee for delegates without proof of payment. IBC Legal Conferences is part of Informa Professional. Informa Professional is a trading name of Informa UK Limited. Registered in England under no Registered Office: Mortimer House, Mortimer Street, London W1T 3JH PAYMENT INFORMATION Bank transfer: Please quote the event code LY1343 and the delegates surname in the transfer instructions. Transfers should be made to: Natwest Bank, Colchester, Essex, UK Account Name: Informa UK Ltd Account Number: Sort COde: SWIFT code: NWBKGB2L. Please fax a copy of your transfer to Joanne Blore, fax +44 (0) Cheque: All cheques should be sent together with your booking form, and made payable to Informa UK Ltd, and posted to, The Booking Department, Informa, PO Box 406, West Byfleet, KT14 6WL Credit Card: Please charge my credit card; Visa Diners Mastercard American Express Expiry Date: / Card No: Security No: Cardholders Name: Signature: Contact Telephone Number: Date: / / Yes I agree to the Terms and Cancellation Conditions as stated on this form

Change the Game, SMEs! Leverage on your IP

Change the Game, SMEs! Leverage on your IP WHY YOU SHOULD ATTEND The World IP Day, held on 26 April annually, is an international event established by the World Intellectual Property Organisation to celebrate IP's role in encouraging innovation