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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 Find your reasons

speaker panel to attend

Jay Deshmukh, Ranbaxy, USA Successful Pharma & Biotech companies understand, that the
SVP Global IP IP and patenting practices are essential in facilitating enhanced
market exclusivity and revenue returns. Legal environment, in
Inma Estanol, European Patent Office, Germany
particular a patent and regulatory uncertainty, is becoming a
Senior Examiner Pharmacy
big challenge for operating globally. With problems with drug
Jurgen Hassa, UCB Group, Belgium registration in the new emerging markets and counterfeit drugs
Associate General Patent Attorney flooding the markets , the industry is doing all the possible legal
steps to protect their profits and good name. This event will
Thomas Bordner, Sanofi Pasteur, USA
bring together the experts to benchmark the best practices in
Director Intellectual Property
developing, implementing and improving IP, patent & litigation
Jean-Christophe Troussel, Bird & Bird, Belgium strategies. Understand, how the various patent offices throughout
Partner the world examine patent applications.

Andre Bourgouin, Ipsen, France

VP Intellectual Property Benchmark the winning patent & litigation strategies
Mary Catherine DiNunzio, H. Lundbeck A/S, Denmark
Reveal the impact of recent EU IP law & regulation on
Head of Global Patent Alliances and Patent Operations Pharma & Biotech industry
Martin Voet, Allergan, USA
Senior VP Chief IP Counsel Explore Patent Regulatory Frameworks in USA

Mark Rachlin, GSK, USA Listen to the case studies on IP situation in India and
Senior Patent Counsel for Litigation China

Sandeep K. Rathod, Matrix Laboratories Limited, India Understand the practices of Patent Offices when
Head of Corporate IP & Formulations Department examining the patent applications

Aleksandar Danilovski, Pliva, Croatia

Network with decision makers from leading
Senior Director and Head of Global API Research and pharmaceutical companies during coffee breaks and
Development cocktail reception
Marnix Moens, Biip, Belgium
And much more…
Managing Partner

Takashi Fujita, Hiraki & Associates, Japan

Patent Attorney, Head of Biotech group
Who must attend?
In a panel discussion: Heads of Legal Counsel, Intellectual Property, Business
Leighton Howard, Genericsweb, UK Development, Licensing, Partnering, Patent Attorneys, In-house
Managing Director Counsels, Directors of Patent Departments, Patent Managers, IP
Directors, Patent Agents, Patent Attorneys, IP Lawyers
Roman Lapka, Zentiva, Czech Republic
Director Intellectual Property

SilverMedia
Sponsor:
Partner: Media Partners:
Booking line: tel: + 420 257 218 505, fax: + 420 257 218 508

Day 1, February 21st, 2008 14:10 CASE STUDY Overview of the IP situation in
China
8:30 Registration and Coffee
• Protecting Pharmaceuticals in China
9:00 Opening remarks from the chair • Overview of Enforcement Issues

Jurgen Hassa, UCB Group

Benchmarking the winning patent & litigation European Patent Attorney
strategies
14:50 CASE STUDY Pre-grant oppositions under the
9:10 KEYNOTE PRESENTATION The Changing Indian Patent Law : Perspective from the
Landscape of European Patent Litigation Post pharmaceutical industry
the EU IP Enforcement Directive
• The law underlying pre-grant oppositions
• The present EU Systems /Germany, UK, France/
• Intricacies/ points worth considering in the present law
• The EU IP Enforcement Directive
• 2 case studies - one from a product / new chemical
• What impacts we have already seen entity segment and another from [possibly] a
formulation/ finished dose patent application
• Further potential impacts that we can expect to see
Jean-Christophe Troussel, Bird & Bird • Patent applications withdrawn by Innovator
Partner pharmaceutical companies from the Indian patent
office, in view of the Indian law
9:50 CASE STUDY Patent & Legal Issues Sandeep K. Rathod, Matrix Laboratories Limited
– Innovators vs Generics Head of Corporate IP & Formulations Department
• Recent patent issues for Generics for Biologics
15:30 Afternoon tea & networking
• Follow-on Biologics legislation currently pending in the
USA
16:00 Use of science for commercial advantage in the
• Contrasting to the EMEA framework for Biosimilars pharmaceutical minefield

Martin Voet, Allergan • Pharmaceutical Industry Value Chain and Trends

Senior VP Chief IP Counsel • Life Cycle Management vs. Portfolio Management

10:30 Morning coffee and networking • IP assisted Business Development

• Tactics used to attack and defend patents
11:00 CASE STUDY Recent Developments in US
Aleksandar Danilovski, PLIVA
Pharmaceutical Patent Litigation
Senior Director and Head of Global API Research and
• Impact of Recent US Supreme Court Decisions on Hatch Developmen
Waxman and other pharma patent decisions
16:40 Roundtable discussions
• Case Trends in Hatch - Waxman Litigation
CEE IP discussion
• Comparison of major recent US Decisions with Decisions
from Other Jurisdictions Moderated by:
Mark Rachlin, GSK, USA Leighton Howard, Genericsweb
Managing Director
Senior Patent Counsel for Litigation
Suggested topics:
Strenghtening protection of IP worldwide
• Status of Patent systems in CEE countries
11:40 CASE STUDY EU-wide litigation - the Ranbaxy • EU Accession and its impact on IP protection
experience
• Patent filing trends in CEE countries
• UK and Ireland
Roman Lapka, Zentiva
• Netherlands and the file wrapper estoppel doctrine Director Intellectual Property
• Spain and Italy
17:20 Close of Day 1 followed by
Jay Deshmukh, Ranbaxy
SVP Global IP Speakers and delegates are cordially invited to
attend a
12:20 Interactive Q & A session
featuring speakers from the morning session Networking Cocktail reception
12:40 Luncheon
email: pharmaip@jacobfleming.com, www.jacobfleming.com

Day 2, February 22nd, 2008 12:20 Interactive Q & A session

featuring speakers from the morning session
8:30 Registration and Coffee

12:40 Luncheon
9:00 Opening remarks from the chair

14:10 CASE STUDY Prosecuting Bio&Pharma

Patent Regulatory Frameworks application before the Japanese Patent Office
• Latest developments
9:10 KEYNOTE PRESENTATION Recent decisions by
the European Boards of appeals in the field of • Example of cases: High court decisions
biotech patents
• Medicinal Invention and Pharmacological Test
• Insights into the European Biotech Patent Directives
• Data submission after filing
• Discussing a couple of decisions like:
Takashi Fujita, HIRAKI & ASSOCIATES
T 562/04 decided Feb. 2006 Patent Attorney, Head of Biotech group
T 937/02 decided Oct. 2006 14:50 CASE STUDY The impact of Pediatric EU
Regulation on Supplementary Protection
T 1155/05 decided Feb. 2007
Certificates
T 192/06 decided March 2007 • The importance of SPC’s for Pharma Industry
• Case study examples • Practices to protect drugs in compliance with the
Pediatric EU Regulation
Andre Bourgouin, Ipsen
VP Intellectual Property (Speaker from a law firm to be confirmed)

15:30 Interactive Panel Discussion

9:50 CASE STUDY Recent updates and changes in USA
Suggested topics:
law on IP rights
• TRIPS applicability and defending the patent validity
• Pharma Industry experience – examples of patenting in
USA • Recent developments in pending litigations

• The recent updates and expected changes in USA law • Avoiding the inefficiency of litigation

• Future Outlook – how can Pharma Industry be prepared

16:10 Closing remarks from the chair
for the changes

Thomas Bordner, Sanofi Pasteur

16:20 Farewell Coffee and Networking
Director of Intellectual Property
I would like to thank everyone who has helped with the
10:30 Morning Coffee and Networking research and organization of this event, especially the
speakers for their support and commitment.
Patent Offices Practice Dasa Laslopova, Conference Producer
dasa.laslopova@jacobfleming.com
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.
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.
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.
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.
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 full-
time 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.
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)
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.”
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].
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.
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.
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
 Pharma & Biotech IP & Litigation
Towards more effective protection of your IP
21st & 22nd February, 2008, Brussels
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