Hear from in-house counsel, the EPO, a leading judge and Europeana member Parliament of the 23rd Forum on Biotech & Business Information In A Global Context Pharma Patenting Legal, Tactical and Practical Strategies for Protecting and Leveraging Your Pharma & Biotech Portfolio

10 & 11 October 2012 | The Sheraton Park Lane Hotel | London, UK

PATENT OFFICES & ASSOCIATIONS: Attend this intensive two day conference to: European Patent Offi ce • Discover competitive patent fi ling strategies, tactics and implications of recent case law in Europe and the US on your business including: U.S. Patent and Trademark Offi ce - Brüstle v. Greenpeace European Patent Institute - HGS v Lilly EPLAW - Ranbaxy v AstraZeneca - Medeva AIPPI* • Avoid infringing anti-competition laws by tailoring your agreements and learning Asian Patent Information Services about the key factors the European Commission look for when conducting their Department, EPO investigations Member of Group of Experts Assisting • Develop patent strategies to optimise the lifecycles of your patents and extend EU Commission on the EU Patent Court your market dominance • Stay one step ahead of your competitors by discovering the latest trends and priorities MEMBER OF THE of the EPO and national patent offi ces EUROPEAN PARLIAMENT: • Avoid patent infringement when conducting clinical trials and how to use the Bolar Amedee Turner QC Exemption effectively Honorary Member of the European Parliament • Obtain Supplementary Protection Certifi cates (SPCs) to extend your patent lifecycle following IN-HOUSE REPRESENTATIVES: Eli Lilly (US and UK) NEW FOR 2012! Pfi zer (France) Interactive pre-conference workshops | Tuesday 9th October 2012 GlaxoSmithKline (UK) WORKSHOP A IP Due Diligence Procedure: Comprehensive Practical Guide to Best Practice H Lundbeck A/S (Denmark) WORKSHOP B Mylan (UK) Matters to Be Aware of When Reviewing Patent Settlement Agreements & Keygene N.V. (the Netherlands) Distribution Agreements to Minimise the Risk of Infringing Anti-Competition Laws Novartis (Switzerland) Emergent Biosolutions Inc (UK)

Up to 16.5 Media Partners: CPD

To register call +44 (0) 20 7878 6888 or register online at www.C5-Online.com/biotechpatenting NEW TECHNOLOGY, NEW CHALLENGES The protection and enforcement of a company’s intellectual property rights has never been more fundamental to a company’s success.

At C5’s 23rd Biotech & Pharma Patenting Forum, the distinguished faculty will share legal insights and practical strategies to respond to the critical challenges facing the industry, including: • A patent examiner from the EPO will provide a detailed insider guide on how to gain a competitive advantage by aligning your patent strategies with the latest EPO initiatives and priorities • Ann De Clerq, Chair of the Biotech Committee at the European Patent Institute (EPI) will give the EPI’s perspective on the patentability of stem cells and what is patentable in light of Brüstle • Wragge & Co LLP and Dr. Fiona Bor, Director of IP at Mylan will clarify the position regarding SPCs following recent decisions in this area. Take this information back to your offi ce to optimise your SPC strategy and ensure you utilise the paediatric extension, if applicable, to secure your market position • Dr. Rob Aerts, Principal Patent Attorney at Keygene N.V. and Pierre Véron from Véron & Associés will tell you how to take advantage of the proposed EU Patent Court and European patent reform to streamline your IP strategy • Lise Abildgaard-Ryberg, Head of Patenting at H Lundbeck A/S will guide you through reviewing your patent strategy to minimise the risk of falling foul of EU anti-competition laws in an era of heightened regulatory scrutiny from the European Commission • Pfi zer will discuss the implications of Prometheus on the patent eligibility of your gene patents • The USPTO will guide you through latest developments regarding the US Patent Reform • The Asian Patent Information Services Department at the EPO will join other leading practitioners and share their knowledge and tips for success when patenting in emerging markets • Eli Lilly will share the lessons learned from the signifi cant Eli Lilly v HGS decision regarding patenting and discuss the requirements of inventiveness and obviousness in Europe and the US • Amedee Turner QC, Honorary Member of the European Parliament and a key individual in the institution of patent insurance litigation schemes in the European Union will discuss the benefi ts of obtaining patent litigation insurance

9 OCTOBER 2012 | PRE-CONFERENCE WORKSHOPS

WORKSHOP A: 9.00 – 12.00 WORKSHOP B: 1.30 – 4.30 IP Due Diligence Procedure: Comprehensive Practical Matters to Be Aware of When Reviewing Patent Guide to Best Practice Settlement Agreements & Distribution Agreements to Minimise the Risk of Infringing Anti-Competition Laws This hands-on master class session will provide in-depth, critical As patent settlements between originator pharmaceutical companies insights into the often overlooked aspect of the procedure for and generic companies become more numerous, they are attracting conducting IP due diligence in M&A, joint venture and licensing increased scrutiny from anti-trust authorities in the EU and US. The transactions. The workshop leader will assist you to create and employ European Commission dropped several patent settlement cases lately new procedures and policies when approaching such negotiations (GSK; AstraZeneca) but still continue to scrutinize other cases (J&J v. to ensure more effi cient and cost-effective examination of the data Novartis; Cephalon v. Teva; Servier (Perindropil); Lundbeck). The US whilst ensuring accuracy of the results. and EU Competition Authorities will be keeping a close eye on these agreements so compliance is vital. The workshop leader will guide you through agreements and provide practical and strategic tips for drafting Reserve your place today by calling +44 (0) 20 7878 6888, and reviewing these agreements to ensure you do not fall foul of anti- faxing your registration form to +44 (0) 20 878 6885, competition laws in the US or the EU. This extremely complex and sending an email to [email protected] or highly topical workshop will provide you with a complete guide to take registering at www.C5-online.com/biotechpatenting. back to the offi ce and share with your team.

GLOBAL SPONSORSHIP OPPORTUNITIES C5 works closely with sponsors to create the perfect business development solution catered exclusively to the needs of any practice group, business line or corporation. With over 500 conferences held in Europe, Russia and the CIS, China, India, the US and Canada, C5, ACI and CI provide a diverse portfolio of fi rst-class events tailored to the senior level executive. For more information about this program or our global portfolio, please contact: Daria Arta on +44 (0)20 7878 6871 or email [email protected] PRE-CONFERENCE WORKSHOPS: TUESDAY 9 OCTOBER 2012

8.15 Registration and Coffee 1.00 Registration and Coffee

9.00 WORKSHOP A 1.30 WORKSHOP B IP Due Diligence Procedure: A Comprehensive Best Minimise the Risk of Infringing Anti-Competition Laws: Practices Guide to Ensure Cost Effective, Efficient Master Class on Drafting and Reviewing Patent & Accurate Due Diligence Examinations Settlement & Distribution Agreements

Claire Baldock, Partner, Lise Abildgaard-Ryberg, Head of Patenting, Boult Wade Tennant* H Lundbeck A/S (Denmark)* The emphasis throughout the session will be on worked examples Patent settlement, licensing, & distribution agreements: and delegate participation including: • Drafting Tips: how to reduce the risk of infringing • An overview of the IP due diligence process from the anti-competition regulations memorandum of understanding/letter of intent through - which provisions are most problematic? to the transaction document - what provisions can you insert into your contracts? • Proven strategies for co-ordinating effectively across different - understanding the differences between the agreements jurisdictions and particular nuances that impact on drafting • Best practice for ensuring communication across internal • Reviewing the documentation: key considerations to bear departments and between different levels of management: in mind - the purpose of the task and defi ning its scope - critical terms and clauses to look out for - the documents to be reviewed - which provisions cannot be altered? - the expected contribution of each staff member and any • Examples of pro-competitive patent settlement, distribution training to be provided and licensing agreements - confi dentiality obligations • Lessons to be learned from the investigations by the - special IP-related data room procedures European Commission into anti-competitive behaviour: - the anticipated time scale - which provisions have the European Commission paid - the required method for publication of the results particular attention to? • The IP due diligence checklist: - how to minimise the risk of being investigated - level of detail of request - standard and customised requests 4.30 Workshop B Ends - co-ordination with the general/corporate request • Independent IP searches • IP due diligence results and report: DAY ONE | WEDNESDAY 10 OCTOBER 2012 - defi nition of rights - ownership 8.15 Registration and Coffee - third party rights - protection/registration - exploitation 8.45 Opening Remarks from the Chair - enforcement/disputes Ann De Clerq, Chair of Biotech Committee, • Allocating resources to the best advantage European Patent Institute (Belgium) • Practical steps to streamline the process • Clarifying the scope of the due diligence task to be undertaken 9.45 Examining What is Now Patentable in Light of Brüstle: • Working with external advisers: tips on briefi ng and liaising The Implications for Human Embryo Stem Cell Research • Critical steps and milestones to ensure the process stays on track and on time Aliki Nichogiannopoulou, Director, DG1, • Cost reduction strategies: tips for working effi ciently and European Patent Offi ce cost-effectively Ann De Clerq, Chair of Biotech Committee, • Strategies for analysing the data: key methods to use to ensure European Patent Institute (Belgium) accuracy of results • Reporting and presentation of the results • Human embryonic stem cells (hESCs): totipotent vs. pluripotent • The impact of the CJEU’s decision in Brüstle v. Greenpeace: 12.00 Workshop A Ends - likelihood of patents covering hESC being reissued - whether national courts in Europe are likely to implement 12.00 Networking Lunch the decision - potential confl ict between the EPO and the CJEU: - how likely is it that the EPO will respect this decision? - to what extent is the EPO likely to allow broad claims without the use of disclaimers to cut out any scope that might impinge on hESCs? - new technologies that could crop up as a result of the ban • Addressing the uncertainty left by the Brüstle v. Greenpeace decision: - what might constitute an invention susceptible of patent protection in stem cell research? - when is “the use of the human body” as a source material the “use of a human embryo” in the meaning of Article 6(2)(c)? - uncertainty regarding when the embryo stage ends To register call +44 (0) 20 7878 6888 OR fax +44 (0) 20 7878 6885 - what are the repercussions on the patentability of inventions - different fi ling strategies for an EU-wide patent making use of: or conventional European patent - early human development stages? - considering national fi lings to avoid having to engage - the human body at any stage of development? with the proposed scheme - the likely impact on stem cell research - issues arising when trying to ensure that litigation & legal advice privilege exists for patent attorneys/in-house lawyers 10.30 Morning Refreshments - the two draft EU regulations on the unitary patent 10.50 Optimising Your SPC Strategies & Utilising the Paediatric - the draft rules of procedure Extension: Prolonging Your Patent Life Cycles and - to what degree are all Member States in a position to ratify? Cementing Your Market Position 12.35 Paul Inman, Partner, Wragge & Co LLP (UK) Networking Lunch Dr Fiona Bor, Director of IP, Mylan (UK) 1.35 Avoiding Patent Infringements in Your Clinical Trials by • Recent case law in Europe – the contradictions and the Utilising the Bolar Exemption common ground Dr. Bernard McDonald, Global Intellectual Property Manager, - validity – the Medeva and Georgetown University judgements Emergent BioSolutions (C-322/10 and C-422/10) - scope of SPC protection – Novartis v Actavis (C-442/11) Liz Elmhirst, Patent Counsel, GlaxoSmithKline (UK) - zero and negative term SPCs – Merck Sharp & Dohme • Exemption for “experimental purposes” in the EU (C-125/10) • The German approach to clinical trial exemption and - Neurim Pharmaceuticals (C-130/11) “experimental use privilege” • What is left after the Medeva train of cases and the Novartis - an overview of the German, UK and Netherlands case law case? What still needs to be clarifi ed? • The BOLAR-type exemption in the EU - how will the case law be applied? - analysis of the disparity in implementing legislation across - to what extent will concerns be covered by the order issued EU member states by the court? - focus on implementing legislation in Germany, France, - what does this mean for the validity of the SPCs that have Italy, UK and Netherlands already been granted? - practical consequences of differences in implementation • Ensuring you meet the requirements for the grant of SPCs of the Directive across Europe • Strategies for effectively monitoring and managing your SPC • The UKIPO consultation portfolios - proposals to change the law in the UK in respect of the • Exclusivity extensions: tips and traps BOLAR-type exemption for clinical trials • The latest strategies regarding IP protection for your product • Agreement on a Unifi ed Patent Court • How to navigate patent offi ce variations across Europe - draft proposals to reset the scope of the BOLAR-type • Interaction between the SPC and the Paediatric Regulation exemption for clinical trials - how do paediatric extensions fi t in? - utilising the extension: insights from in house experts 2.20 The Implications of Prometheus on the Patent Eligibility - how to successfully defend a challenge to a paediatric of Your Gene Patents extension by a generic company • Successful litigation tactics Dr. Marc A. Markus, European Biology Patent Lead, Pfi zer (France) 11.50 Taking Advantage of the Proposed EU Patent Court & This session will address one of the most prevalent issues of the year: European Patent Reform to Streamline Your IP Strategy are the courts going to alter the intellectual property landscape for biomarkers and personalised medicine? The session will analyse the Dr. Rob J. Aerts, Principal Patent Attorney, leading cases on patent eligibility of diagnostic methods, in Europe Keygene N.V. (the Netherlands) and the US. The session will cover the implications of these cases for biotech patents and the future of biotech innovation, including Pierre Véron, Founding President of EPLAW, a member of personalised medicine. the group of experts assisting the EU Commission on the Unifi ed Patent Court System and Partner, • The trend towards personalised and precision medicine Véron & Associés (France) • The EPO’s approach to patent eligible subject matter in personalised medicine

• Addressing the challenges related to the current patent system & DNA Sequences - dosage regimens, diagnostics and second medical use claims - high costs for patent proprietors • The European perspective in view of cases decided at the - post-grant translation costs national level - national renewal fees - isolated DNA claims, dosage regimen and medical use claims - sub-optimal enforcement scheme • The US perspective after Mayo v Prometheus

- multiple litigation Therapeutic Treatments Diagnostic Tools, - method claims in the fi eld of medicine (Prometheus case) - diverging national decisions - isolated DNA claims (Myriad case) - legal uncertainty • Latest Commission Legality of a single EU patent court 3.05 Gain a Competitive Advantage by Aligning Your Patent - defi ning the roles of the CJEU and the EPO Strategies with the EPO’s Latest Initiatives & Priorities - the inclusion of Article 6 to 8 on infringement and the possibility of the CJEU being involved in patent decisions: Examiner - addressing concerns regarding the variable level of European Patent Offi ce patent expertise in the CJEU • The impact of the EPO’s recent initiatives - the risk of patent infringement cases being delayed • What are the EPO’s priorities for the next year? - practical and constitutional considerations: • Trilateral Patent Offi ce Harmonisation: an update - how would a single patent court be administered? • Patent fi ling tips and traps - addressing the technical issue of bifurcation: how can • Views of an EPO examiner on recent developments the impact of this be mitigated? An Insider Guide from the

- to what extent is there likely to be forum shopping? European Patent Office (EPO) To register call +44 (0) 20 7878 6888 OR fax +44 (0) 20 7878 6885 • EPO’s tips on best practice through their “Raising the Bar” 4.45 Surmounting the Problems Arising from Inconsistent project: Provisions in Brazil’s Paradoxical Patent Law to - how has this project worked out? Successfully Protect Your IP Assets - how much is it likely to develop? - what are the procedural changes? Rana Gosain, Partner, Daniel Advogados (Brazil) • Update on the Danube Patent Institute initiative As an emerging economy, Brazil is becoming one of the most • How is the EPO precluding Swiss type claims? important economies in the world. It has brought its IP legislation • EPO’s approach to patenting human genomes after the into sync with international standards, however, inconsistencies in its decision on the patentability of genes and DNA derived patent provisions are causing concerns. information. How would the EPO protect patents? • What type of patent protection can be obtained? 3.45 Afternoon Refreshments - weighing the value of biotech patents in Brazil - the role of the PTO and ANVISA (the National Health Surveillance Agency) Emerging Markets Focus Afternoon: Successfully Overcoming - what are the patentability requirements? Hurdles to the Protection & Management of IP Assets in - how does ANVISA apply the requirements? Emerging Markets - type of claim formats: product or use claims: the impact on your fi ling and prosecution strategies These sessions will provide an overview of the challenges and opportunities involved in protecting pharma and innovations in emerging markets. - to what extent is there patent linkage? • To what extent is the current IP law TRIPS compliant? Discover cost effective strategies for the enforcement of IP in these countries. - what are the implications for businesses Find out how the recent changes in the IP landscape of emerging markets are • Enforceability of patent rights: expected to impact industry growth so that you are ahead of the curve and gain a competitive advantage over your peers. - how much is your patent worth if you need to litigate it? - what do you need to do to get an injunction? - how easy is it to enforce your IP rights? what conditions 4.00 Overcoming Regulatory & Strategic Hurdles need to be satisfi ed? to Enforcement of Your Patents in Asia - complementary provisions which can be used • How often are compulsory licences issued? Christine Kämmer, Asian Patent Information Services, • What must you do to manufacture in Brazil? Product Distribution & Spec. Services, European Patent Offi ce • What is the process regarding the conduct of clinical trials? Dr. Benjamin Bai, Partner, Head of IP Practice China, • How much action do the competent authorities take to Allen & Overy LLP (China) protect data against disclosure and unfair commercial use during the established periods of exclusivity? A practical analysis of notable IP law developments and best practices • What measures are being taken to deal with the backlog for IP protection and enforcement in Asia. Discuss emerging IP in patent applications? challenges and the latest solutions for multinational companies. You will have the chance to learn directly from the industry on Asia’s IP - what measures can be taken if there is a delay? landscape, opportunities and challenges. Come prepared with your - update on the Brazilian Courts’ position regarding pharma questions and get the best solution for your company by discussing patent extensions with Asian IP practitioners. • Understanding the provisions within the Bolar exemption and the implications of the mandatory review of pharma • Regulatory climate for biotech and pharmaceutical companies patent applications by ANVISA • Latest developments to the patent systems and the impact on • Evaluating the recent decision undertaken by Brazilian Courts this industry sector to re-evaluate the status of data protection for human drugs - implications of the Third Revision to the Patent Law in China • To what extent do courts and authorities comply with 5.30 Tips, Traps and Techniques for Successfully Obtaining the rules? & Protecting Your Patents in India & the Implications • What steps are being taken to address anti-corruption? of the First Compulsory Licence Issued in India • Recent case law developments and their potential impact Suja Subramaniam, Managing Partner, • How to successfully protect and enforce your patents in Asia Idee IP Consultants LLP (India) • What aspects of EU & US patentability criteria are followed? - suffi ciency of disclosure Liz Elmhirst, Patent Counsel, GlaxoSmithKline (UK) - novelty considerations • Implications of the fi rst compulsory licence issued in India: • Defending patent infringements in Asia - the signifi cance of the interpretation of the third condition • What is the approach to patent extensions? for granting the licence: • Obtaining R&D related tax incentives in high and new - ramifi cations for drugs manufactured outside India? technology enterprises status, advanced technology service - how can this be reconciled with Article 27 of TRIPS? enterprises status and China’s new fi ve-year plan - how likely is this to be the start of a trend • IP Ownership in Government Funding Research Projects - to what extent has TRIPS achieved what the industry • Preventing trade secret theft & gathering evidence for claims wanted in getting India to protect patents? • Successfully convincing the police departments to initiate • Recent case law developments and their potential impact anti-counterfeiting raids • The role of the Indian Patent Offi ce • Compliance and royalties issues when conducting IP licensing • What is the situation in India regarding forced licences? deals in Asia - what do you need to prove to keep your licence? • Litigation: • What type of patent protection can be obtained? - patent litigation strategies from both plaintiff and • Weighing the value of biotech patents in India defendant perspectives • What are the patentability requirements? - impact of the establishment of the new Beijing High - how are these requirements applied People’s Court for Patent Infringement on your litigation strategy in China • Type of claim formats: product or use claims: - why can you not get usage claims in India? - how should you alter your fi ling and prosecution strategies?

Fax order form to +44 (0) 20 7878 6885 or register online at www.C5-Online.com/biotechpatenting • To what extent is there patent linkage? What are the • Written description post-Centocor v Abbott implications? - is it possible to obtain broad antibody claims? • Enforcement of patents in India - tips for providing written descriptions • Measures preventing certain items being imported into • Gene patenting: what is eligible subject matter? India by possible competitors • Tips on drafting claims to cover personalised medicine products - specifi c use and other effective claim types 6.15 Conference Adjourns • The different approaches to overbroad claiming by innovators by the EPO and different national courts: - factors that courts consider in France, Denmark, Germany DAY TWO: THURSDAY 11 OCTOBER 2012 - addressing concerns regarding the paradox where the EPO is willing to give very broad claims but also in some circumstances very narrow claims 8.15 Registration and Coffee • How the EPO’s treatment of antibody patent claims compares with that of small molecules 8.45 Opening remarks from the Chair - strategies for overcoming the higher standard of proving inventive step in relation to novel : Paul Inman, Partner, Wragge & Co LLP - tips on what to mention in the specifi cation - to what extent is there a role for chemical structure in 9.00 The Impact of the US Patent Reform on European Biotech considering the inventive step of a novel antibody? and Pharma Companies: Updating and Strengthening • Case law that has come out of the EPO in this respect Your Global Patent Strategies • Tips on overcoming challenges with inventiveness with biotic drugs in the US Jasemine C. Chambers, Deputy Administrator for Policy - proceeding in the aftermath of KSR v. Telefl ex in the US and External Affairs, U.S. Patent and Trademark Offi ce, - comparison with the EPO’s informal approach U.S. Department of Commerce (US)* • Analysis of key provisions of the patent reform in 10.30 Morning Refreshments The Leahy-Smith America Invents Act (AIA) - the impact of the reform on overseas pharma companies - examining the new “First-to-File” System and “Grace 10.50 Obtaining Injunctive Relief: Provisional Enforcement Period” and its impact on this sector of Rights before Trial - opportunities and risks in post-grant review proceedings Ewan Nettleton, Senior Patent Counsel, • Anticipated changes to the enforcement landscape Novartis Pharma AG (Switzerland) • What new risks and opportunities might arise? • Comparison of the new US system with the EU patent system Robert Burrows, Partner, Bristows (UK) - differences between US and European oppositions • Analysis of the implementation of the IP Enforcement - how does the US “fi rst-inventor-to-fi le” or “fi rst-to-disclose” Directive in EU member states system differ from the European fi rst-to-fi le system? • Update on developments regarding the ability to obtain - differences in time limits preliminary injunctions - how to deal with the extra workload and costs when faced - recent decisions of note from key EU jurisdictions with a succession of individual US oppositions in the US - cross border injunctions - US Privilege and Work Product concerns • Accurately assessing preliminary injunction requirements - assessing the pros and cons of the US patent system in the UK, France, Germany and the Netherlands as part • Potential technical and practical challenges facing owners of your IP strategy of IP in the life sciences sector • The impact of recent launch strategies by generic companies - to what extent is the AIA law likely to lead to more on preliminary injunctions homogenous international patent strategies? 11.50 Gain a Competitive Edge by Understanding How the New 9.45 Eli Lilly Case Study: Antibody Patenting: How to Satisfy Biosimilar Regulatory Guidelines in Europe & the US Will the Requirements of Inventive Step and Obviousness in Affect Your Patent Strategy Europe and the US Frank Landolt, Vice President Intellectual Property Mark Stewart, Senior Director / Assistant General Patent and Legal, Ablynx N.V. (Belgium)* Counsel, Eli Lilly (US) Simon Cohen, Partner, Taylor Wessing (UK) Andrew Smith, European Patent Counsel, Eli Lilly (UK) • The regulatory framework regarding obtaining marketing • Developments in how national courts are addressing permission for pharma companies: obviousness and inventive step in the US and Europe - how will the guidelines affect your patent strategy? • Lessons that Eli Lilly learned from the Eli Lilly v HGS • Follow-on patent protection decision: an insider perspective • Examining preliminary injunctions for biosimilars - what is suffi cient to be considered an inventive step? • Opportunities and challenges in the biosimilars market - the way in which the requirement of industrial applicability • Consultation at the EMA for general guidelines of Articles 52 & 57 of the EPC extends to a patent for • How to get the balance right in terms of claims scope to keep biological material biosimilar molecules off the market - consequences for scientifi c research & the biotech industry • How a biosimilar manufacturer can take advantage of the - what does this mean for Article 57 of the EPC? data package of the innovator but still be different enough - if the primary innovation is precluded from patentability is to get outside the patent claim there still a possibility for patenting downstream inventions? • How much documentation do you have to provide to the - at what stage in the research process should you fi le your authorities to get marketing approval patents? - test for industrial application in biotech patent cases 12.50 Networking Lunch

To register call +44 (0) 20 7878 6888 OR fax +44 (0) 20 7878 6885 2.00 Practical Steps to Take to Protect Your Patent Portfolio 3.50 Alternative Models for Protecting Your Knowhow & Following Occluder Intellectual Assets: Lessons to Be Learned From Other Dr. H. Ulrich Dörries, Partner, DF-MP (Germany) Technology Sectors • Developments in analysis of the Occluder decision and follow Dr. Clemens-August Heusch, Head of European Litigation, on cases: Nokia GmbH (Germany) - in what circumstances does the minor difference in produce Koenraad Wuyts, Head of the IP Group, KPN (Netherlands) lead out of the literal scope of protection? - how should you deal with the trend towards a very narrow John Mulgrew, Associate General Counsel, Microsoft (US) scope of protection? • Alternative models for commercialisation - how likely is it that Germany will adopt legislation similar • What synergies are there between sectors? to the File Wrapper Estoppel used in the US? what are the - the food and beverage industry has not used patents: implications? how have they achieved that? what are they relying on? - what strategies companies need to use to protect • Reverse engineering formulas: how easy would it be for themselves when: someone to reverse engineer? - drafting the claims - what implications does this have for patenting? - drafting the specifi cations part of the patent application - in what circumstances can you use other strategies such - conducting the prosecution as confi dentiality agreements? What are the advantages - impact of differences in the US and EU regarding output 2.45 Minimise the Risk of Your Patent Strategy Falling Foul - the US obligation to disclose the best method of Anti-Competition Laws in the US and the EU in an Era • What can we learn from other sectors? of Heightened Regulatory Scrutiny - what would it take to apply these models to the pharma and biotech sector? Lise Abildgaard-Ryberg, Head of Patenting, - what are the savings that can be made? H Lundbeck A/S (Denmark)* • How can we learn from other sectors in terms of streamlining Kristoff Roox, Partner, Crowell & Moring (Belgium) processes such as crops and manufacturing processes? • Marketing, advertising and promotion through different Patent settlement agreements in the EU: channels to market: methods that other sectors use • Commission’s fi ndings from the sector inquiry: - insights from the cosmetics industry on: - defensive patent strategies - how to deal with the restrictions on selling from - patent clusters supplier to consumer - patent settlements - compliance with regulatory requirements: products - patent litigation strategies that have therapeutic in addition to cosmetic qualities • Commission’s investigations following the sector inquiry • Learning from how the various sectors deal with: • National competition authorities’ investigations - DNA issues • Industry-wide patent settlement monitoring - overbroad claiming • Reviewing the Commission’s second monitoring report - divisional applications • Update on the review of Servier by the Commission - reaching a fair balance • Assessing the long term impact on patent strategies: action - litigation strategies and challenges you should take now • The trend of biotech and pharma companies moving into • Analysis of investigations by the Commission: the food and beverage sector and the medtech sector how to minimise the risk of being investigated • Utilising the experience of those in other sectors Patent settlement agreements in the US: • The use of patent settlement agreements in the US: 4.35 Minimising the Cost of Potential Litigation through - details of the fi rst reverse payment in the US Alternative Methods of Funding • The stance taken by the courts and the FTC Amedee Turner QC • An overview of legislative initiatives of the US government Honorary Member of the European Parliament • The outlook regarding future regulation of patent settlement agreements in the US Ian Lewis, Director, Samian Underwriting (UK) • Distinguishing the US approach with EU developments • A guide to patent litigation insurance • Important pending US anti-trust cases - what does the insurance policy typically cover? what is - Federal Trade Commission v Cephalon, Inc. excluded? - FTC v Boehringer Ingelheim Pharmaceuticals Inc. - enforcement cover - In re K-Dur Antitrust Litigation - cover for risks arising as a result of contractual indemnities - Johnson’s Village Pharmacy Inc et al. v King Pharmaceuticals Inc. - how do insurers calculate it? - AFL-AGC Building Trade Welfare Plan et al. v Pfi zer Inc. et al. - what are the requirements to obtain cover? - In re Cipro Cases I & II, in the Supreme Court of the State - countries which has an insurance scheme in place and of California their experiences - the advantages for SMEs of obtaining insurance 3.30 Afternoon Refreshments • The rules, regulations and ethical considerations of third party funding - examination of the criteria that funders use to assess the merits of cases - assessment of the risks and the potential rewards of such funding

5.15 Conference Ends

©C5, 2012 Fax order form to +44 (0) 20 7878 6885 or register online at www.C5-Online.com/biotechpatenting 23rd Forum on Biotech & Pharma Patenting Legal, Tactical and Practical Strategies for Protecting and Leveraging Your Pharma & Biotech Portfolio Business Information Business Information 10th & 11th October 2012 | The Sheraton Park Lane Hotel | London, UK In InA GlobalA Global Context Context

Priority Service Code EASY WAYS TO REGISTER 521L13.W 5 WEBSITE: www.C5-Online.com/biotechpatenting REGISTRATIONS & ENQUIRIES  +44 20 7878 6888  EMAIL: [email protected]  FAX: +44 20 7878 6885 PLEASE RETURN TO FEE PER DELEGATE Register & Pay by 12 September, 2012 Register & Pay after 12 Septmeber, 2012  C5, Customer Service  ELITEPASS*: Conference & Both Workshops £2395 £2495 6th Floor, Trans-World House, 100 City Road  Conference & Workshop A B £1995 £2095 London EC1Y 2BP, UK  Conference Only £1495 £1595 TEAM DISCOUNTS: Booking 3 or more delegates? Call +44 (0) 20 7878 6888 for details. ADMINISTRATIVE DETAILS

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APPROVING MANAGER POSITION An allocation of bedrooms is being held for delegates at a negotiated rate until 28 August 2012. To book your accommodation please call Venue Search on tel: +44 (0)208 541 5656 or e-mail [email protected]. Please note, ORGANISATION lower rates may be available when booking via the internet or direct with the hotel, but different cancellation policies will apply. ADDRESS

DOCUMENTATION IS PROVIDED BY WEBLINK The documentation provided at the event will be available on weblink only. If you CITY are not able to attend, you can purchase an electronic copy of the presentations provided to delegates on the day of the event. Please send us this completed booking form together with payment of £350 per copy requested. For further POSTCODE COUNTRY information please call +44 (0) 207 878 6888 or email [email protected].

PHONE FAX CONTINUING EDUCATION EMAIL 16.5 hours (conference only) plus 3 hours per master class towards Continuing Professional Developments hours (Solicitors Regulation Authority). Please contact TYPE OF BUSINESS C5 for further information on claiming your CPD points. FOR MULTIPLE DELEGATE BOOKINGS PLEASE COPY THIS FORM PAYMENT POLICY PAYMENT DETAILS Event Code: 521L13-LON Payment is due in full upon your registration. Full payment must be received prior to the event otherwise entry will be denied. All discounts will be applied to BY CREDIT CARD the Main Conference Only fee (excluding add-ons), cannot be combined with any other offer, and must be paid in full at time of order. Group discounts available to Please charge my ○ AMEX ○ VISA ○ MasterCard ○ Discover Card individuals employed by the same organisation. NUMBER EXP. DATE CARDHOLDER TERMS AND CONDITIONS You must notify us by email at least 48 hours in advance if you wish to send BY CHEQUE a substitute participant. Delegates may not “share” a pass between multiple I have enclosed a cheque for £ ______made payable to C5 attendees without prior authorisation. If you are unable to find a substitute, please notify C5 in writing no later than 10 days prior to the conference date and a credit voucher will be issued to you for the full amount paid, redeemable BY BANK TRANSFER against any other C5 conference. If you prefer, you may request a refund of C5 Communications Limited fees paid less a 25% service charge. No credits or refunds will be given for Account Name: C5 Communications Limited cancellations received after 10 days prior to the conference date. C5 reserves Bank Name: HSBC BANK Plc the right to cancel any conference for any reason and will not be responsible for Bank Address: 31 Chequer Street, St Albans Herts AL1 3YN, UK airfare, hotel or any other costs incurred by attendees. No liability is assumed by for changes in programme date, content, speakers or venue. Bank Branch: St Albans Branch C5 BIC ( Bank Identifier Code ): MIDLGB22 GBP Account (VAT num: 913 0992 30) INCORRECT MAILING INFORMATION IBAN: GB41 MID L 4040 0182 1816 22 If you receive a duplicate mailing of this brochure or would like us to change Sort Code: 40-40-01 any of your details, please email [email protected] or fax the label on this brochure to +44 (0) 20 7878 6887. To view our privacy policy go to www.C5-Online.com/privacy_policy_statement. If you wish to pay in Euros€ or USD$ please contact Customer Service