BA JFG BALS59 GD | Intellectual Property | Patent

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Pharma & Biotech IP & Litigation
Towards more effective protection of your IP
21st & 22nd February, 2008 Hotel Crowne Plaza Brussels

Your prestigious speaker panel
Jay deshmukh, ranbaxy, usa svP Global iP inma estanol, european patent office, germany senior examiner Pharmacy Jurgen hassa, uCB group, Belgium Associate General Patent Attorney thomas Bordner, sanofi pasteur, usa Director intellectual Property Jean-Christophe troussel, Bird & Bird, Belgium Partner andre Bourgouin, ipsen, France vP intellectual Property mary Catherine dinunzio, h. lundbeck a/s, denmark Head of Global Patent Alliances and Patent operations martin Voet, allergan, usa senior vP Chief iP Counsel mark rachlin, gsk, usa senior Patent Counsel for Litigation sandeep k. rathod, matrix laboratories limited, india Head of Corporate iP & Formulations Department aleksandar danilovski, pliva, Croatia senior Director and Head of Global APi research and Development marnix moens, Biip, Belgium Managing Partner takashi Fujita, hiraki & associates, Japan Patent Attorney, Head of biotech group

Find Your reasons to attend
successful Pharma & biotech companies understand, that the iP and patenting practices are essential in facilitating enhanced market exclusivity and revenue returns. Legal environment, in particular a patent and regulatory uncertainty, is becoming a big challenge for operating globally. with problems with drug registration in the new emerging markets and counterfeit drugs flooding the markets , the industry is doing all the possible legal steps to protect their profits and good name. this event will bring together the experts to benchmark the best practices in developing, implementing and improving iP, patent & litigation strategies. understand, how the various patent offices throughout the world examine patent applications. Benchmark the winning patent & litigation strategies reveal the impact of recent EU IP law & regulation on Pharma & Biotech industry explore Patent Regulatory Frameworks in USA listen to the case studies on IP situation in India and China understand the practices of Patent Offices when examining the patent applications network with decision makers from leading pharmaceutical companies during coffee breaks and cocktail reception And much more…

in a panel disCussion:
leighton howard, genericsweb, uk Managing Director roman lapka, Zentiva, Czech republic Director intellectual Property

Who must attend?
Heads of Legal Counsel, intellectual Property, business Development, Licensing, Partnering, Patent Attorneys, in-house Counsels, Directors of Patent Departments, Patent Managers, iP Directors, Patent Agents, Patent Attorneys, iP Lawyers

silver sponsor: Media Partner:

Media Partners:

Booking line: tel: + 420 257 218 505, fax: + 420 257 218 508

day 1, February 21st, 2008
8:30 registration and Coffee 9:00 opening remarks from the chair

14:10

CASE STUDY

overview of the ip situation in

China • Protecting Pharmaceuticals in China • overview of enforcement issues Jurgen hassa, uCB group european Patent Attorney 14:50
CASE STUDY pre-grant oppositions under the indian patent law : perspective from the pharmaceutical industry

Benchmarking the winning patent & litigation strategies
9:10 the Changing landscape of european patent litigation post the eu ip enforcement directive
• the present eu systems /Germany, uK, France/ • the eu iP enforcement Directive • what impacts we have already seen • Further potential impacts that we can expect to see
KEYNOTE PRESENTATION

• the law underlying pre-grant oppositions • intricacies/ points worth considering in the present law • 2 case studies - one from a product / new chemical entity segment and another from [possibly] a formulation/ finished dose patent application • Patent applications withdrawn by innovator pharmaceutical companies from the indian patent office, in view of the indian law sandeep k. rathod, matrix laboratories limited Head of Corporate iP & Formulations Department 15:30 afternoon tea & networking 16:00 use of science for commercial advantage in the pharmaceutical minefield • Pharmaceutical industry value Chain and trends • Life Cycle Management vs. Portfolio Management • iP assisted business Development • tactics used to attack and defend patents

Jean-Christophe troussel, Bird & Bird Partner 9:50
CASE STUDY patent & legal issues – innovators vs generics

• recent patent issues for Generics for biologics • Follow-on biologics legislation currently pending in the usA • Contrasting to the eMeA framework for biosimilars martin Voet, allergan senior vP Chief iP Counsel 10:30 morning coffee and networking 11:00 recent developments in us pharmaceutical patent litigation
CASE STUDY

• impact of recent us supreme Court Decisions on Hatch waxman and other pharma patent decisions • Case trends in Hatch - waxman Litigation • Comparison of major recent us Decisions with Decisions from other Jurisdictions mark rachlin, gsk, usa senior Patent Counsel for Litigation

aleksandar danilovski, pliVa senior Director and Head of Global APi research and Developmen 16:40 roundtable discussions Cee iP discussion moderated by: leighton howard, genericsweb Managing Director suggested topics: • status of Patent systems in Cee countries • eu Accession and its impact on iP protection • Patent filing trends in Cee countries roman lapka, Zentiva Director intellectual Property 17:20 Close of day 1 followed by

strenghtening protection of ip worldwide
11:40
CASE STUDY

eu-wide litigation - the ranbaxy

experience • uK and ireland • Netherlands and the file wrapper estoppel doctrine • spain and italy Jay deshmukh, ranbaxy svP Global iP 12:20 interactive Q & a session featuring speakers from the morning session 12:40 luncheon

Speakers and delegates are cordially invited to attend a

networking Cocktail reception

email: pharmaip@jacobfleming.com, www.jacobfleming.com

day 2, February 22nd, 2008
8:30 registration and Coffee 9:00 opening remarks from the chair

12:20 interactive Q & a session featuring speakers from the morning session 12:40 luncheon 14:10
CASE STUDY prosecuting Bio&pharma application before the Japanese patent office

patent regulatory Frameworks
9:10 recent decisions by the european Boards of appeals in the field of biotech patents
KEYNOTE PRESENTATION

• Latest developments • example of cases: High court decisions • Medicinal invention and Pharmacological test • Data submission after filing takashi Fujita, hiraki & assoCiates Patent Attorney, Head of biotech group 14:50
CASE STUDY the impact of pediatric eu regulation on supplementary protection Certificates • the importance of sPC’s for Pharma industry

• insights into the european biotech Patent Directives • Discussing a couple of decisions like: t 562/04 decided Feb. 2006 t 937/02 decided oct. 2006 t 1155/05 decided Feb. 2007 t 192/06 decided March 2007 • Case study examples andre Bourgouin, ipsen vP intellectual Property 9:50 recent updates and changes in usa law on ip rights
CASE STUDY

• Practices to protect drugs in compliance with the Pediatric eu regulation (speaker from a law firm to be confirmed) 15:30 interactive panel discussion suggested topics: • triPs applicability and defending the patent validity • recent developments in pending litigations • Avoiding the inefficiency of litigation 16:10 Closing remarks from the chair 16:20 Farewell Coffee and networking i would like to thank everyone who has helped with the research and organization of this event, especially the speakers for their support and commitment. dasa laslopova, Conference Producer dasa.laslopova@jacobfleming.com

• Pharma industry experience – examples of patenting in usA • the recent updates and expected changes in usA law • Future outlook – how can Pharma industry be prepared for the changes thomas Bordner, sanofi pasteur Director of intellectual Property 10:30 morning Coffee and networking

patent offices practice
11:00
CASE STUDY

examining the patent applications

• Pitfalls to obtaining a patent • Key principles for obtaining a patent • benchmarking the main differences in various markets mary Catherine dinunzio, h. lundbeck a/s, denmark Head of Global Patent Alliances and 11:40 post-grant procedures at the epo • Latest developments in view of the ePC 2000 • Limitation or revocation of the european patent • opposition procedure ePC 2000 and Medical use Claims inma estanol, european patent office, germany senior examiner Pharmacy

Booking line: tel: + 420 257 218 505, fax: + 420 257 218 508

meet our Comprehensive speaker panel
andre Bourgouin, ipsen, France vice President, Corporate intellectual Property
Andre is the Vice-President of Intellectual Property of SCRAS, the holding company of IPSEN which he joined in 1996. Before this, he began his career in the Patent department of ROUSSEL UCLAF in 1974 where he finally became Deputy Head of Department. In 1993 he joined PASTEUR MERIEUX CONNAUGHT (now SANOFI PASTEUR) where he held the position of Director, Corporate intellectual property. Andre holds a Doctorate degree in Organic Chemistry and studied law at the University of Paris (Licence en droit and DESS degrees). He graduated from the CEIPI and is a registered French and European patent attorney and a European Trade mark attorney.

where he was responsible for meeting the patent information needs for the company’s global generic development portfolio. Leighton has obtained an Honours degree in Chemistry from Loughborough University (UK) and an Executive MBA with the Australian Graduate School of Management (AGSM). He is a member of the Royal Society of Chemistry and a member of the Chartered Institute of Library and Information Professionals.

martin Voet, allergan, usa svP Chief iP Counsel
Martin Voet is Senior Vice President, Chief Intellectual Property Counsel and Assistant Secretary for Allergan with over 20 years of experience in the pharmaceutical intellectual property field. He graduated from the University of California at Berkeley with a degree in Chemistry; received his Juris Doctorate degree with Honors from the George Washington University National Law Center and an MBA from Pepperdine University School of Business and Management. Mr. Voet is a member of the State Bar of California, the American Intellectual Property Law Association, the Licensing Executives Society and an Editorial Board member and contributing writer to “Managing Intellectual Property.” He recently published a book on pharmaceutical life cycle management entitled “The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management.”

mary Catherine dinunzio, h. lundbeck a/s, denmark Head of Global Patent Alliances and Patent operations
Mary Catherine is responsible for managing Lundbeck’s patent portfolio pertaining to specific drug development projects. Her duties include assessing and augmenting, when necessary, the scope of international patent protection needed for each project, conducting freedom to operate inquiries, and assessing licensing/business opportunites related to the projects. Mary Catherine is also responsible for developing and implementing intellectual property strategies relating to the extent of patent protection needed for various assets at different stages during the drug discovery and development process. She received a university degree in chemistry from Mississippi State University in 1990 and a law degree from The George Washington University National Law Center in 1995. Mary Catherine was a patent examiner at the United States Patent and Trademark Office from 1990 until 1992. She is a member of the state bars of New York and New Jersey and is registered to practice before the US Patent and Trademark Office.

sandeep k. rathod, matrix laboratories limited, india Head of Corporate iP & Formulations Department
Sandeep is an experienced IP professional, specialising in patents & pharmaceutical IPR; presently heading Matrix Laboratories Limited’ Corporate and Formulations IP department (Part of Mylan, World’s 3rd largest generic pharmaceutical company). He obtained his LL.M. in IP & Corporate laws, LL.B. from the Government Law College, Mumbai. He presented several papers/articles: e.g. Support-researcher for Intellectual Property and taxation published by LexisNexis Butterworths [March 2007], invited by Medicine Sans Frontiers to conduct workshop on “prior art search for Patent Oppositions” [2006] and “Intellectual Property licensing & Indirect Taxation” published in Excise Law Times, India’s premier indirect tax monthly, Invited by C.S.I.R. to present a paper on Licensing IPR [2003]. Sandeep received JPO- AOTS full fellowship for advanced training in Patents at Tokyo [2005]. He completed WIPO, Geneva scholarship for pursuing two years advanced Intellectual Property Rights specialization program [2004-5].

mark rachlin, gsk, usa senior Patent Counsel
Mark is a Senior Patent Counsel for Litigation at GlaxoSmithKline. He manages all phases of pharmaceutical patent litigation with an emphasis on Hatch-Waxman Act matters. Before joining GSK, Mark was senior counsel with both The Dow Chemical Company and Union Carbide Corp. Mark was also associated with Sidley Austin in the firm’s Washington and New York offices. Before entering private practice, Mark clerked for Hon. Jane A. Restani of the U.S. Court of International Trade and then was a Trial Attorney in the U.S. Department of Justice Civil Division under the Attorney General’s Honors Program. Mark graduated from New York Law School, magna cum laude in 1984. He is admitted to the bars of Pennsylvania, New Jersey, New York, and D.C. and is registered to practice before the USPTO.

takashi Fujita, hiraki & associates, Japan Patent Attorney, Head of biotech group
Takashi obtained a master’s degree in biophysics from the Graduate School of Science at Kyoto University in 1985. He joined the Japan Patent Office (JPO) as Assistant Examiner in 1985. In 1989, Takashi became an Examiner of the Food Technology Division in the Fourth Examination Department. From 1994 to 1997, he served in the Japanese Consulate at Munich. In 1997, he was assigned as Deputy Director of the Examination Standards Office in the Japan Patent Office. Thereafter, he became Appeal Examiner in the 22nd Board of Appeals. In 2001, he left the JPO to become a patent attorney at Hiraki & Associates.

Jurgen hassa, uCB group, Belgium european Patent Attorney
Juergen received his Masters Degree in Chemie from the University of Erlangen in Nurnberg, Germany in 1990 and his PhD in Organic Chemistry in 1993. He currently holds a position of Associate General Patent Counsel in Corporate IP Department. His responsibilities includes: protection of UCB’s IP interests in the field of CNS research & development, Protection of UCB’s Keppra® franchise, and IPD Internal – Collaboration Templates, Professional Association, Epoline, Review of policies. Prior to this position, Juergen was working as a Director, Corporate IP Department at Serono International from 1999 to 2005. Between 1994 and 1999, he was working in a Patent Department of E. Blum & Co. Patentanwälte VSP, focusing on chemistry related inventions.

inma estanol, european patent office, germany senior examiner Pharmacy
Inma currently holds a position of Substantive Examiner in the field of Pharmaceuticals in the General Direction for Substantive Examination and Opposition (GD2) at the European Patent Office. Between 1994 and 1998, she has been working as Project Leader in cooperation programmes in the field of industrial property with Latin American countries, in the International Affairs Directorate. Since 1994, she has been a Patent Expert in different missions organised by the United Nation Organisation WIPO and the EPO in Latin American countries. Since 2006, she is a member of the Assessment Committee for the project “Innovation Awards in health and food” organised by Merck Sharp & Dohme, Mexico. Inma received her BSc in Pharmacy from the University of Barcelona and as well PhD in Microbiology at this university. She holds as well Msc in Diary products from the University of Nancy, France. Inma has studied European Patent Law in the International Section of CEIPI – Centre d’ Etudes Internationales de la Propiete Industrielle, Germany/France.

Jay deshmukh, ranbaxy, usa svP intellectual Property
After receiving his Master of Science degree in Chemical Engineering at Cleveland State University, Mr. Deshmukh received his law degree from Case Western University in 1992, while working fulltime as a patent agent. Mr. Deshmukh was registered to practice before the United States Patent and Trade¬mark Office in 1990 and admitted to practice in Ohio in 1992. He is also admitted to practice in the Southern District of Ohio, 6th Circuit, and the Federal Circuit courts. After successful associations as a Patent Attorney with the firms of Frost & Jacobs (1992-1994) and Dinsmore & Shohl, LLP (1994-1998), Mr. Deshmukh assumed the position of Director of Worldwide Intellectual Property for Ranbaxy Pharmaceuticals Inc. in Princeton, New Jersey. While making the transition from law firm to corporate practice, he also sat for and successfully passed the European Qualifying Examination to practice before the European Patent Office. Since joining Ran¬baxy, Mr. Deshmukh has been admitted to the bars of New Jersey and NNew York in 1999. He now maintains the position as a corporate Senior Vice President, and directs the global Intellectual Property department of Ranbaxy Laboratories Limited from Ranbaxy’s Princeton, New Jersey office. Ranbaxy’s global Intellectual Property group consists of: (U.S.) three attorneys, two Technical Specialists, five paralegals/support staff; and (India) approximately 44 patent scientists/liaisons. Mr. Deshmukh’s daily responsibilities include overseeing Ranbaxy’s worldwide patent litigation and patent prosecution and U.S. trademark prosecution and FDA legal matters. He heads a team of in-house and law firm patent litigation attorneys which has successfully litigated various patent lawsuits for Ranbaxy. These wins include successfully defending a $200 million (US$) patent infringement drug case brought by GlaxoSmithKline; winning a patent infringement action brought to facilitate the launch of generic amoxicillin clavulanate; and winning in lower court and on appeal to prevent delisting of challenged patents, thereby restoring Ranbaxy’s 6 month exclusivity in regards to simvastatin. Currently, Mr. Deshmukh is leading the company’s litigation efforts on numerous ANDAs in the U.S. and other patent litigation matters in Canada, Europe, Latin America, Australia, Africa, and Asia.

aleksandar danilovski, pliva, Croatia senior Director and Head of Global APi research and Development
Dr. Aleksandar Danilovski is the Senior Director and Head of Global API Research and Development at PLIVA, subsidiary of Barr Pharmaceuticals, Inc. He is responsible for the research and development of numerous active pharmaceutical ingredients (APIs or drug substances). His leadership role includes overseeing various aspects of organic and inorganic synthetic chemistry and analytics, scale-up and process development, solid-state chemistry and analytics (polymorphism related phenomena), morphological and surface studies (particle size and shape) up to the final goal of developing vertically integrated formulation (drug product). Dr. Danilovski received (with honors) his Ph.D. in Chemistry and Crystallography from University of Cambridge, United Kingdom and University of Zagreb, Croatia. He has around fifteen years of experience in the pharmaceutical industry, and quite a number of papers in peer-reviewed scientific journals, poster and oral contributions at various international conferences, as well as a high number of granted patents and patent applications.

Jean-Christophe troussel, Bird & Bird, Belgium Partner

leighton howard, genericsweb, uk Managing Director
Leighton Howard is the founder and managing director of GenericsWeb, a provider of Generic Pharmaceutical Intelligence to government institutions, legal practices and industry firms in over 30 countries. He also acts as a consultant in the development of generic pharmaceuticals, specialising in patent strategy. Leighton has extensive experience of patent searching and information management, based on his past employment at professional patent searching firm RWS. This knowledge was integrated into the generic pharmaceutical industry at IVAX Pharmaceuticals (UK)

pharma & Biotech ip & litigation
towards more effective protection of your ip 21st & 22nd February, 2008, Brussels
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Who must attend?
Heads of Legal Counsel, intellectual Property, business Development, Licensing, Partnering, Patent Attorneys, in-house Counsels, Directors of Patent Departments, Patent Managers, iP Directors, Patent Agents, Patent Attorneys, iP Lawyers
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