Developing IP Strategies for Crystalline Forms 2011 - Agenda

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Developing IP Strategies for Crystalline Forms 2011 - Agenda

  1. 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 Pharmaceuticalswww.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. 2. Pre-conference focus day - monday 24Th ocToBer 2011 exTendIng your PaTenT lIfecycle wITh successful sPc/PTe aPPlIcaTIons10.15 Coffee and Registration10.40 Welcome by Chairperson10.45 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 wITh11.30 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, Lundbeck12.15 Networking Lunch13.00 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 really13.45 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 Chambers14.30 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 speakers15.00 Closing Remarks + 44 (0)20 7368 9300 enquire@iqpc.co.uk www.ipcrys.com www.IPcrys.com
  3. 3. conference day one - Tuesday 25Th ocToBer 2011 08.15 Registration and Coffee 12.40 Networking Lunch09.00 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 application10.30 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. 4. conference day Two - wednesday 26Th ocToBer 2011 08.15 Registration and Coffee 12.10 Uncovering The Available Technologies To Differentiate Competitor08.50 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 Institute09.00 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. 5. sPonsors and exhIBITorssPonsor 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/Pharmaand long term commercial value to the client. Each individual client is provided with a personal contact • IP and Patentsat Valea, and we do our utmost to maintain close, long-term cooperation with our clients, based oncommitment and genuine insight into their business. Website: www.valea.se delegaTes who aTTended 2010maxImIse your InvolvemenT: sPonsorshIP VP/CEOand exhIBITIon oPPorTunITIes IN-HOUSE PATENT ATTORNEY/COUNSELthe pharma iQ ip strategies for Crystalline forms conference will be the perfect platform for lawfirms to meet senior-level in house pharmaceutical patent counsel in search of external expertise to help protect and litigate their patent portfolio. PATENT AGENT/MANAGERContact pharma iQ to discuss how to position your company in front of your participants who are ip managerkeen 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 sCientistsponsorship@iqpc.co.uk or phone +44 (0) 207 368 9300aBouT Pharma IQ “very valuaBle” dr miCHael BeCker, solvias agWeb: http://www.pharma-iq.com/Phone: 1-646-454-4559 medIa ParTnersBecome 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 hasbeen 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. 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 My registration code is: PDFW Online: www.ipcrys.com Email: enquire@iqpc.co.uk Please contact our database manager on +44(0) 207 368 9300 or at database@iqpc.co.uk quoting the registration Payment Method code above to inform us of any changes or to remove your details. Total price for your Organisation: (Add total of all individuals attending): Card Number: VISA 6 M/C 6 AMEX 6 4 Register and Pay Register and Pay by Register and Pay by Standard Price by 29th July* 9th September* 30th September* 6666666666666666 Exp. Date: 6 6 6 6 Sec: 6 6 6 6 Conference + £1998 + VAT £2098 + VAT £2198 + VAT £2348 + VAT Name On Card: Signature: Focus day save £350 save £250 save £150 Billing Address (if different from below): City/County/Postcode Conference Only £1299 + VAT £1399 + VAT £1499 + VAT £1499 + VAT Cheque enclosed for: £ (Made payable to IQPC Ltd.) save £200 save £100 (Please quote 11549.005 with remittance advice) IQPC Bank Details: Account No: 51304143 IBAN Code: GB59 MIDL 4038 1851 3041 43 Focus Day Only £849 + VAT Sort Code: 40 38 18 Swift Code: MIDLGB2112V Account name: International Quality & Productivity Centre Ltd. Bank: HSBC Bank Plc, 67 George Street, Richmond, Surrey TW9 1HG, United Kingdom. * To qualify for discounts, payments must be received by the early bird registration deadline. Early booking discounts are not valid in conjunction with any other offer. UK VAT is charged at 20%% VAT Registration #: GB799225967 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 6 Mr 6 Mrs 6 Miss 6 Ms 6 Dr 6 Other at the best possible rates.The map displays live availability and allows you to book directly with each hotel: www.HotelMap.com/M55L4 Alternatively, if you would like to book your accommodation by 6 Please send me conference materials indicated above. First Name Family Name phone, you can call Daniel Spinner, our dedicated London concierge, on 020 7292 2335 (if outside 6 I have filled out credit card details below UK +44 20 7292 2335) quoting Special Reference Code M55L4. He will be happy to help you with Job Title Tel No. For further information your hotel booking and provide assistance organising your time in London. Email Please call: 0207 368 9300 or email: 6 Yes I would like to receive information about products and services via email Free Online Resources knowledgebank@iqpc.co.uk. To search IQPC’s archived conference documentation Organisation To claim a variety of articles, podcasts and other free resources please visit visit: www.iqpcknowledgebank.com Nature of business www.ipcrys.com Address Terms and ConditionsCONFERENCE CODE: 11549.005 Postcode Country Telephone Please read the information listed below as each booking is subject to IQPC Ltd standard terms and conditions. agreed with IQPC, which must occur within one year from the date of postponement. Fax Approving Manager Payment Terms: Upon completion and return of the registration form full payment is required no later than 5 business days Except as specified above, no credits will be issued for cancellations. There are no refunds given under any circumstances. from the date of invoice. Payment of invoices by means other than by credit card, or purchase order (UK Plc and UK government IQPC is not responsible for any loss or damage as a result of a substitution, alteration or cancellation/postponement of an Name of person completing form if different from delegate: bodies only) will be subject to a £49 (plus VAT) per delegate processing fee. Payment must be received prior to the conference event. IQPC shall assume no liability whatsoever in the event this conference is cancelled, rescheduled or postponed due date. We reserve the right to refuse admission to the conference if payment has not been received. to a fortuitous event, Act of God, unforeseen occurrence or any other event that renders performance of this conference IQPC Cancellation, Postponement and Substitution Policy: You may substitute delegates at any time by impracticable, illegal or impossible. For purposes of this clause, a fortuitous event shall include, but not be limited to: war, fire, providing reasonable advance notice to IQPC. labour strike, extreme weather or other emergency. Signature For any cancellations received in writing not less than eight (8) days prior to the conference, you will receive a 90% credit to be Please note that while speakers and topics were confirmed at the time of publishing, circumstances beyond the control of the used at another IQPC conference which must occur within one year from the date of issuance of such credit. An administration organizers may necessitate substitutions, alterations or cancellations of the speakers and/or topics. As such, IQPC reserves I agree to IQPC’s cancellation, substitution and payment terms fee of 10% of the contract fee will be retained by IQPC for all permitted cancellations. No credit will be issued for any the right to alter or modify the advertised speakers and/or topics if necessary without any liability to you whatsoever. Any Special dietary requirements: 6 Vegetarian 6 Non-dairy 6 Other (please specify) cancellations occurring within seven (7) days (inclusive) of the conference. substitutions or alterations will be updated on our web page as soon as possible. In the event that IQPC cancels an event for any reason, you will receive a credit for 100% of the contract fee paid. You may Discounts: All ‘Early Bird’ Discounts require payment at time of registration and before the cut-off date in order to receive Please indicate if you have already registered by Phone 6 Fax 6 Email 6 Web 6 use this credit for another IQPC event to be mutually agreed with IQPC, which must occur within one year from the date of any discount. Any discounts offered whether by IQPC (including team discounts) must also require payment at the time of Please note: if you have not received an acknowledgement before the conference, please call us to confirm your booking. cancellation. registration. All discount offers cannot be combined with any other offer In the event that IQPC postpones an event for any reason and the delegate is unable or unwilling to attend in on the rescheduled date, you will receive a credit for 100% of the contract fee paid. You may use this credit for another IQPC event to be mutually 6 Please do not pass my information to any third party

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