Pharma Patent Lifecycles

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9th Annual International Maximising Pharma Patent Lifecycles Business Information In A Global Context The Latest Legal and Regulatory Developments and Successful Strategies for Lifecycle Extension 23

1 9th Annual International Maximising Pharma Patent Lifecycles Business Information In A Global Context The Latest Legal and Regulatory Developments and Successful Strategies for Lifecycle Extension 23 and 24 June 2010 Sofitel London St James Hotel, London The an Patent Office, key industry players, top in-house counsel and leading lawyers will provide insights on: How to profit from the latest regulatory protections available to extend your patent lifecycles How to adjust your patent strategy to developments in key pharma patent cases in the UK and The scope of SPC protection and analysis of key definitions in SPC Regulation that have given rise to litigation How second medical use claims and dosage regimes can be used to extend your patent lifecycles: consequences of G2/08 an and US standards for biosimilars: where are we now? How to know when to file to maximize regulatory and patent protection with a critical update on the EPO rule changes How the Commission sector inquiries and follow-on investigations have changed the landscape for patent settlements? The practicalities of obtaining preliminary injunctions in pharma patent cases in the English Courts Media s Up to 11.5 CPD Get Essential Information from the Experts: an Patent Office Novartis (Switzerland) Astex Therapeutics (UK) Merck & Co., Inc. (US) Merck KGaA (Germany) Oxford Nanopore Technologies Ltd. (UK) Vertex (UK) Merial Limited (US) Covington & Burling (Belgium) Linklaters (UK) Hoffmann Eitle (Germany) Cabinet Plasseraud (France) Olswang (UK) Fried Frank (US) Vossius & (Germany) White & Case LLP (UK) Morrison & Foerster (US) Frommer Lawrence & Haug (US) Carpmaels & Ransford (UK) Patton Boggs (US) To register call +44 (0) or register online at

2 C5 s 9th Annual International Conference on Maximising Pharma Patent Lifecycles With the fearsome patent cliff year of 2011 approaching fast, pharmaceutical companies are working feverishly to replace the billions in revenue that could disappear overnight when big drugs go off patent. Maximising and prolonging the lifecycles of existing products is now a key priority. At the same time, the tried and tested commercial methods to extend patent lifecycles are being scrutinized on an unprecedented level following the EU Pharma Sector Inquiry. In these challenging times, as counsel to either a brand name pharmaceutical or generic, it is critical to have an in-depth and up-to-the-minute understanding of the latest legal and regulatory developments and the strategies to best protect and defend your company s position. Ground-breaking case law, legislative developments and evolving regulation mean that the rules of the game for effective patent lifecycle management and extension are constantly changing. Get the answers you need at C5 s 9th Annual International Conference on Maximising Pharmaceutical Patent Lifecycles. Bringing you an outstanding faculty from and the US including The an Patent Office, Novartis, Astex Therapeutics, Merck & Co Inc.(US), Merck KGaA (Germany), Oxford Nanopore Technologies Ltd. (UK) and Vertex (UK), this conference will provide you with the most up to date information on how to manage and extend the exclusivity of your patent protected product. Profit from our faculty s experience and get practical insights on: Raising the Bar : how the EPO s new standards and rule changes impact your lifecycle strategy The current state of play for patent settlements, product launch, and pricing issues under EU and US law The implications of the Regulation on Advanced Therapies for your company and product portfolio SPCs and the specific case of combination products in the recent case law The diverging views among the member states on negative or zero SPCs Be where your industry will be on 23 and 24 June 2010 in London, and don t miss out on this unique opportunity to hear from and network with your industry peers and experts. Don t delay, register today by calling +44 (0) , by faxing your registration form to +44(0) or by registering online at WHO SHOULD ATTEND? From Pharma, Biotech and Chemical Companies In-House Counsel and Legal Directors Heads of IP, IP Counsel and IP Managers Heads of Patents, Patent Counsel, Patent Directors and Managers Private Practice and In-house Lawyers and Patent attorneys specialising in Life Sciences/Pharma IP and Patents Conference Co-Chairs: Lyn Leaper IP Counsel, Astex Therapeutics (UK) John Todaro Managing Counsel, Intellectual Property Group, Merck & Co Inc. (US) Meet our Faculty Including: Dr. Peter R Roth Senior Patent Attorney, Oncology Novartis (Switzerland) Dr. Arno Hartmann Head of the Patent Department Pharmaceuticals Merck KGaA (Germany) Marion Rees IP Manager, Oxford Nanopore Technologies Ltd. (UK) Lisa Dixon Patent Attorney, Vertex (UK) Judy Jarecki-Black Esq. Head Intellectual Property Merial Limited (US) Roger Wyand Q.C. Deputy Judge England and Wales, Head of Chambers, Hogarth Chambers (UK) Huw Hallybone, Carpmaels & Ransford (UK) Maria Isabel Manley, Head of Regulatory Practice Ian Karet, Linklaters (UK) Leo Polz, Hoffmann Eitle (Germany) Geneviève Michaux Of Counsel, Covington & Burling (Belgium) Jürgen Meier, Vossius & (Germany) Thomas Kowalski, Frommer, Lawrence & Haug (US) Global Sponsorship Opportunities C5, along with our affiliate organisations in New York, American Conference Institute (ACI) and in Toronto, The Canadian Institute (CI), 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, Russia and the CIS, China, India, the US and Canada, C5, ACI and CI provide a diverse portfolio of first-class events tailored to the senior level executive. For more information about this program or our global portfolio, please contact: Brian Reffell on +44 (0) or B.Reffell@C5-Online.com

3 Day One: 23rd June Coffee and Registration 8.45 Chair s Opening Remarks Lyn Leaper SVP IP Astex Therapeutics (UK) 9.00 Update on the Regulatory Protections Available to Extend Your Patent Lifecycles: Comparing and Contrasting and the US Geneviève Michaux Of Counsel Covington & Burling (Belgium) Kurt Karst Director Hyman, Phelps & McNamara (US) Using regulatory data protection to extend the product s lifecycle - determining what data falls into the protected categories of data - correctly filing with the competent authority What is a new active substance? Abridged applications: challenging a generic company seeking approval based on research data The an Court of Justice on data exclusivity Use of regulatory procedures by generic companies Patent linkage Is research in rare diseases adequately rewarded? Impact of the paediatric regulation on regulatory protections The current status of judicial reviews of EMA and NICE and how they can impact regulatory protection for your product US New chemical entity and new use non-patent market exclusivities - what is the scope of such exclusivities? - current issues ( old antibiotics; enantiomers) and litigation Paediatric and orphan drug non-patent market exclusivities Orange Book patent listings: what types of patents can be listed? Generic competition and Paragraph IV certifications - 30-month stay on approvals day generic drug exclusivity Patent Term Extensions: requirements and current issues Strategies adopted by innovator and generic companies Morning Refreshments Raising the Bar : How the EPO s New Standards and Rule Changes Impact Your Lifecycle Strategy Rationale for Raising the Bar (RtB) Amendments to the Implementing Regulations of the EPC in force since 1 April cut-off date for filing divisional - restriction of search - clarification before search - mandatory reply to EESR and WO-ISA Changes to the filing of amendments Extension of RtB to PCT RtB and inventive step Possible further changes - compact examination procedure Filing your Patents Strategically to Extend Patent Lifecycles Panel Moderator: Huw Hallybone Carpmaels & Ransford (UK) Panelists: Dr. Peter R Roth Senior Patent Attorney, Oncology Novartis (Switzerland) Dr. Arno Hartmann Head of the Patent Department Pharmaceuticals Merck KGaA (Germany) Marion Rees IP Manager Oxford Nanopore Technologies Ltd. (UK) Lisa Dixon Patent Attorney Vertex (UK) Toni-Junell Herbert Patton Boggs (US) Sufficiency - at what stage in your research do you want to file the patent application? - how much to put into it How to generate a patent portfolio around a product: how can you strategically file a compound so that you get the longest life? Opportunities during the lifecycle for secondary patenting Additional opportunities for complex products Identifying which patents have an effect on competitor entry Patent thickets Divisionals, the EU sector enquiry and the final report The EPO rule changes on divisional applications and the time frame for filing divisionals End of the patent term: - how to deal with anti-trust issues when dealing with generics? - how to make best use of regulatory means to extend the life of the product? Dieter A Tzschoppe Director Pure and Applied Organic Chemistry an Patent Office To register call +44 (0) or register online at

4 1.00 Networking Lunch 2.15 Adjusting Your Patent Strategy to Developments in Pharmaceutical Patent Protection: Key Cases in the UK and Ian Karet Linklaters (UK) Leo Polz Hoffmann Eitle (Germany) Cyra Nargolwalla Cabinet Plasseraud (France) UK Claim construction: determining infringement risk and assessing validity - Virgin v Premium Aircraft Edwards Lifesciences v Cook Biotech: entitlement to priority Clarifying inventive step: - Dr. Reddy v Eli Lilly - Generics v Lundbeck - Actavis v Novartis Eli Lilly v HGS: sufficiency and industrial application German Federal Supreme Court, X ZR 89/07: clarifying the German concept of disclosure Appeals Court of Düsseldorf, I-2 W 47/07: preliminary injunction granted despite patent found invalid in first instance District Court of Düsseldorf, 4b O 172/08: omission in the German translation of an EP German Federal Supreme Court, Xa ZR 130/07: novelty of an enantiomer The Lundbeck case in the Netherlands and in France Strategy for SPC s on vaccines in different an countries Update on relevant case law in France: - preliminary injunctions - sufficiency of disclosure 3.30 Afternoon Refreshments 3.45 Second Medical Use Claims and Dosing Regimes: Consequences of G2/08 Jürgen Meier Vossius & (Germany) G2/08: the patentability of dosage regimes in the EPO Consequences of G2/08: novelty and inventive step of dosage regimes as the only delimiting feature The end of Swiss-type claims: are we expecting an impact on infringements in the future? Status of first and second medical uses in national jurisdictions Day Two : 24th June Chair s Opening Remarks John Todaro Managing Counsel, Intellectual Property Group Merck & Co., Inc. (US) 9.15 Supplementary Protection Certificates (SPCs): Where Do We Stand and What Does the Future Hold? Maria Isabel Manley, Head of Regulatory Practice Analysing the scope of the SPC protection and the relevant EU and UK jurisprudence; in particular - Yamanouchi Case - Farmitalia Case - Generics (UK) Limited v Daiichi Pharmaceutical Co Ltd What is meant by product within the meaning of the SPC Regulation? What is meant by the first authorization to place a product on the market? - Hassle Case - Swiss /Liechtenstein case - Synthon v Merz Case - Generic (UK) v Synaptech case ECJ clarification of entitlement of multiple patent owners to SPCs The specific case of combination products in the recent UK jurisprudence - Generics (UK) Limited v Daiichi Pharmaceutical Co Ltd - Gilead Case - Astellas Case - Medeva Case Paediatric SPC extension: - can applicants obtain a negative or zero SPC (diverging views among the MS)? - the Merck Case What does the future hold? Patent Settlements, Product Launches, and Pricing Issues under EU and US Law: What is the Current State of Play? James Killick White & Case (UK) Sean Gates Morrison & Foerster (US) To what extent did the Commission sector inquiries and follow-on investigations change the landscape? Are there some patenting practices that have to be revisited in the light of the Commission sector inquiry or can the industry continue as before? 4.30 Chairs Closing Remarks & Conference Adjourns Fax order form to +44 (0) or register online at

5 US Antitrust Issues in Pharmaceutical Product Launch and Pricing US antitrust perspective on product migration strategies to extend product life - introducing new products for the same indication as a company s existing products - introducing new dosage forms for existing products US antitrust issues involving product pricing bundled discounts - pricing of drugs used as a complement for competitors drugs How do US and EU practices on settlement agreements compare? Morning Refreshments US Major Case Law and Policy Developments John Todaro Managing Counsel, Intellectual Property Group Merck & Co., Inc. (US) Thomas Kowalski Frommer, Lawrence & Haug (US) Judy Jarecki-Black Esq. Head Intellectual Property Merial Limited (US) The need for regulatory and patent coordination - patent marking: the new field of trolls Patent reform Congress v the judiciary: are US courts boldly going where no Congress has gone before? - the status of patent reform in the US Congress - the features of recent US court decisions implementing patent reform in areas of insufficiency, inequitable conduct, obviousness, and damages - implications of this judicial patent reform for patent enforcement and infringement defense strategies New procedures and directions at the USPTO: is the USPTO really more business friendly? - streamlining procedures such as the patent prosecution highway - dropping its litigation to implement the harsh new rules - other aspects of obtaining patent protection that have become more difficult - the PTO s substantive rule-making authority and limits on continuation applications: looking forward from Tafas v Kappos - extending your patent for PTO delay in light of Wyeth v Kappos Update on FDA patent matters: - a perspective on the impact of the Hatch-Waxman Act - the status of Hatch-Waxman type protection for biologicals - an update on proposals to limit settlements in Hatch-Waxman Litigation 2.00 Biosimilars Where Are We Now: Comparing and Contrasting an and US Standards Stephen Reese Olswang (UK) Stephen Rabinowitz Fried Frank (US) How biosimilars fall into patent and regulatory law? The implications of the Regulation on Advanced Therapies How will the SPC regime apply to biosimilars? Where are we on the international non-proprietary names regime for biosimilars? Notable updates on biosimilar decisions: products that have been approved under the an system US Understanding the Biologics Price Competition and Innovation Act The standard for biosimilarity contrasted with interchangeability - how can you prepare your patent portfolio? Will biosimilars have the same official name as the reference product, or unique names? Data exclusivity and the effect of the Patent Information Exchange Comparison with the Hatch-Waxman regime for small molecule pharmaceuticals 3.00 Afternoon Refreshments 3.15 Mechanisms for Dispute Resolution: Mediation, Arbitration or Litigation? Roger Wyand Q.C. Deputy Judge England and Wales, Head of Chambers, Hogarth Chambers (UK) Identifying your objects and aims When is mediation appropriate? What is the down side to mediation? What type of mediation is suitable? Combining mediation and arbitration Extending protection through litigation 4.00 Obtaining Preliminary Injunctions and Calculating their Worth in Pharma Patent Cases in the English Courts Liz Cohen Obtaining an interim injunction in pharma cases: how easy is it? The cross-undertaking in damages: how broad is it and what are the implications for the patentee? Considerations for the recovery of damages following a wrongly granted interim injunction Practical tips for obtaining an interim injunction and minimising the impact of the cross-undertaking Networking Lunch 4.45 Chairman s Closing Remarks and End of Conference To register call +44 (0) or register online at C5, 2010

9th Annual International Maximising Pharma Patent Lifecycles The Latest Legal and Regulatory Developments and Successful Strategies for Lifecycle Extension Business Information In A Global Context

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6 9th Annual International Maximising Pharma Patent Lifecycles The Latest Legal and Regulatory Developments and Successful Strategies for Lifecycle Extension Business Information In A Global Context Priority Service Code 518L10.WEB SELECT PACKAGE REGISTER BEFORE 31 MARCH 2010 REGISTER AFTER 31 MARCH 2010 o Conference 1,299 + VAT 1,399 + VAT 5 Easy ways to register : ' 8 Ê * Website: REGISTRATIons & enquiries registrations@c5-online.com Fax: Please return to C5, Customer Service 6th Floor, Trans-World House, 100 City Road London EC1Y 2BP, UK call for Group discounts Book 4+ places and save s. Call +44 (0) Delegate Details TITLE SURNAME APPROVING MANAGER COMPANY/FIRM ADDRESS CITY POSTCODE PHONE INTL. CODE Payment Details BY CREDIT CARD Please charge my AMEX VISA MasterCard Card Number Exp. DATE Holder s Name FIRST NAME POSITION COUNTRY PHONE TYPE OF BUSINESS FAX For multiple delegate bookings please copy this form Valid From BY CHEQUE I have enclosed a cheque for made payable to C5 BY BANK TRANSFER C5 Communications Limited Account Name: C5 Communications Limited Bank Name: HSBC BANK Plc Bank Address: 31 Chequer Street, St Albans Herts AL1 3YN, UK Bank Branch: St Albans Branch BIC ( Bank Identifier Code ): MIDLGB22 GBP Account (VAT num: ) IBAN: GB41 MID L Sort Code: If you wish to pay in Euros or USD$ please contact Customer Service Event Code: 518L10-LON Administrative details Date: June 2010 Time: 8:45 am to 4:45 pm Venue: Sofitel St James Hotel Address: 6 Waterloo Place, London, SW1Y 4AN, UK Telephone: +44 (0) An allocation of bedrooms is being held for delegates at a negotiated rate until 27 April To book your accommodation please call Venue Search on tel: +44 (0) or beds@venuesearch.co.uk. Please note, lower rates maybe available when booking via the internet or direct with the hotel, but different cancellation policies will apply. DOCUMENTATION IS PROVIDED BY CD The documentation provided at the event will be available on CD only. If you are not able to attend, you can purchase a CD 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 information please call +44 (0) or enquiries@c5-online.com. CONTINUING EDUCATION 11.5 hours towards Continuing Professional Developments hours (Solicitors Regulation Authority). Please contact C5 for further information on claiming your CPD points. payment policy Payment policy is due in full upon registering. Your entry to the event will not be guaranteed until payment has been recieved. All discounts will be applied to 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 individuals employed by the same organisation. TERMS AND CONDITIONS You must notify us by at least 48 hours in advance if you wish to send a substitute participant. Delegates may not share a pass between multiple attendees without prior authorization. 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 against any other C5 conference. If you prefer, you may request a refund of fees paid less a 25% service charge. No credits or refunds will be given for cancellations received after 10 days prior to the conference date. C5 reserves the right to cancel any conference for any reason and will not be responsible for airfare, hotel or any other costs incurred by attendees. No liability is assumed by C5 for changes in program date, content, speakers or venue. INCORRECT MAILING INFORMATION If you receive a duplicate mailing of this brochure or would like us to change any of your details, please data@c5-online.com or fax the label on this brochure to +44 (0) To view our privacy policy go to If you do not wish to receive mailings from other companies indicate here Please delete me from your mailing list

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