INSTITUTE
OF INTELLECTUAL PROPERTY
RESEARCH & DEVELOPMENT
AND
SUGHRUE MION, PLLC, OF THE USA
Presents
THREE – DAYS INTERNATIONAL WORKSHOP
ON
STRATEGIES FOR MANAGING PHARMA/BIOTECH/CHEMICAL PATENT PORTFOLIO
With Focus on:
UNITED STATES, EUROPE, CHINA SCENARIO
ON
2'nd - 4'th September 2009
With Support of:
KHURANA & KHURANA, ADVOCATES AND IP ATTORNEYS
ABOUT THE SYMPOSIUM
In a business environment where competition in Pharma, Biotech and Chemical Industry is
becoming increasingly aggressive, there is an urgent need to understand the competitive
leverage that an efficient Intellectual Property Portfolio can provide. An understanding of
International Patent Laws and Practices for regulating and protecting one's business,
world over, becomes critical for the business growth and there is therefore an urgent need
to understand important issues relating to strategies for generic pharmaceutical
manufacturers, identification of invention, types of applicable claims, formulation of set of
claims, drafting issues, claim drafting, review of recent case laws impacting claim drafting,
amendments during prosecution, how to effectively understand and respond to
communications from EPO and USPTO examiners for avoiding prosecution, litigation
strategies, impact of major decisions on litigation strategies to extend product life when a
drug comes off patent. At the same time Patent Laws & Practices differ substantially
between Nations, in terms of their Grant, Scope, Protection and Enforcement mechanisms
and therefore need to be well understood and this symposium is organized only in this
direction. The symposium will also focus substantially on strategies for generic
pharmaceutical manufacturers who seek to enter the U.S. market, obviousness issues
relating to active pharmaceutical ingredients, evolving trends in declaratory judgment
actions, unique aspects of Orange book listing strategies, litigating ANDA and strategic use
of ANDA's infringement, patent trolls and patent portfolio structure for Pharma, Biotech
and Chemical Industry.
HOW THE WORKSHOP IS UNIQUE
This Symposium features the presentation of all important patent issues covering Pharma
Biotech and Chemicals products and processes. Composition of the panelists is a unique
gathering of Patent Attorneys and Litigators from USA, Europe, China and India who have
extensive years of experience in their professional fields and will put across to the
delegates the real insight of Patent Laws and Practices and first-hand information through
well coordinated and structured modules.
This is a one time opportunity when Seven Patent/ Litigation Experts would be interacting with limited delegates and would answer to any question that the delegates may have. Symposium would also provide to its participants an exclusive opportunity to interact and discuss personal patent issues with speakers, even on one to one basis and if required in confidentiality. Composition of the team and the coverage is so selected that R&D Scientists, Patent Attorneys, and Legal Corporate team at Pharma, Biotech and Chemical Industry will get to know the real insight and nitty gritty followed at USPTO, Europe and China Patent Office. The knowledge gained from the workshop will go a long way in formulating the right patent strategy and managing Patent Portfolio.
ABOUT THE ORGANIZERS
About IIPRD
Institute of Intellectual Property Research and Development is established to provide
Education, Industrial Training, Consultancy and related services in the field of Intellectual
Property Rights in an International scenario to the Indian business houses. In this direction,
the Institute has held scores of National and International Seminars as one of its focused
activities on its own and in collaboration with various Government and International
agencies such as CSIR, TIFAC (Ministry of Science and Technology), European Patent
Office among others. The Institute also conducts tailor-made IP educational programmes
for better known Corporates at their premises specific to their needs & is also successfully
running a 6-Months Distance-Learning course on 'Patent Portfolio Creation &
Management' for Scientists & IP Practitioners.
The Institute provides End-to-End support to all business houses to create, promote, protect and commercialize their Intellectual Properties to maximize the economic gains. In this direction, the Institute has helped various business establishments in formulating the right IP strategy. The Institute has established a Valuation Center which undertakes valuation of Intellectual Property. The Institute has undertaken multiple brand and technology valuations, which have gone through International deals. The Institute has an IPR Audit cell which undertakes IP Due-Diligence in order to Commercialise Intellectual Property and manage IPR-Risk. Further, the Institute provides route map and strategy for IP protection, transfer of technology, licensing, remittance, accounting of damages for infringements, verification of royalties and license fee to foreign countries. The Institute has In-House full service IP law firm by the name Khurana & Khurana, Advocates and IP Attorneys which provides end-to-end support for creating, protecting and managing Patent Portfolio of Corporates from across technology domains. If you wish to know more about the Institute please log on to www.iiprd.com.
About SUGHRUE MION, PLLC, USA
Sughrue Mion is one of the world's leading intellectual property law firms managing
traditional and non-traditional intellectual property rights, for about five decades, with a
wide range of clients around the world. Sughrue's more than 100 lawyers protect ideas- all
ideas- and for nearly half a century have been helping their clients to develop, obtain,
protect and leverage their intellectual property rights in technology areas ranging from a
submicroscopic sequence of DNA to a vast constellation of satellites circling the globe.
Sughrue's Pharmaceuticals, Biotechnology, Chemical attorneys are trained in technical disciplines that include molecular and cellular biology, biophysics, pharmaceuticals, chemistry, immunology, virology, genetics and agriculture biotechnology. Their experts are particularly well versed in drafting claims to ensure the broadest possible coverage and have a long established expertise in handling patent interference proceedings that may be critical to determining basic patent rights in new areas of biotechnological and pharmaceutical industries. Their litigators who specialize in chemistry have tried cases relating to pharmaceuticals, biotechnology, industrial chemical processes, specialty chemicals, and nanotechnology.
Sughrue Mion handles a wide range of IP litigation matters for clients around the world, and when it comes to serving their clients, they go beyond traditional boundaries, advocating innovative theories and redefining the frontiers of law as they apply to creativity and invention. In nut shell, Sughrue provides complete Intellectual Property development, protection, management and exploitation strategy, effectively, as single point Corporate destination in US and abroad. If you wish to know more about Sughrue Mion please log on to www.sughrue.com.
SCHEDULE
Venue: Hotel Le Royal Meridian, Mumbai
Registration Fees:
For Indian Delegates: Rs. 13000/- + 1339 (Service Tax)
Rs. 14339/- Per Delegate
For Foreign Delegates: US$ 350/- + US$ 36 (Service Tax)
US$ 386/- for Foreign Delegates
Contact Person : Tarun Khurana 0-9810617992 (Ph: 0120-2342010/3104849)
(Fax: 2342011)
For any assistance write to: Vinod Khurana, Executive Director
iiprd@iiprd.com or vinod@iiprd.com
(Mob No: +91-9810281321)
WHO SHOULD ATTEND
Research & Development Scientists, IP Managers, Patent Agents & Attorneys in the field of
Practice, Patent Litigators and Managers in Generic Drug Companies, Professionals in Legal Domain
related to Pharma, Biotech and Chemicals.
ABOUT THE FACULTY
Mr. Kenneth J. Burchfiel:
Burchfiel is a senior partner with Sughrue Mion. Burchfiel has
expertise of 30 years in patent domain with focuses on Pharma, General
Organic Chemistry and Biotechnology. Burchfiel was the first American
patent lawyer admitted to practice in Japan under the reciprocal foreign
law practice statute. His practice includes litigation before the federal
courts, interferences and appeals. He also testifies as an expert witness
on patent law and US PTO practice and procedure. In addition to his
litigation and interference practice, Burchfiel counsels a variety of
international and domestic clients regarding U.S. intellectual property
law including providing clearance, enforceability, and validity opinions.
Burchfiel has numerous publications and teaching and has spoken on
various international symposium. He is also a visiting Scholar to Max-Planck among other
Universities/ Institutes.
Mr. Chid Iyer:
Chid received a B. Tech in Chemical Engineering from IIT, Bombay in 1984,
an MS in Chemical Engineering from University of Akron and an MS in
Computer Science from the University of Tennessee Space Institute. He
received his JD from Georgetown University in 1997. Chid is a partner of
International Law Firm of Sughrue Mion and is involved in all aspects of
patent practice including litigation, prosecution and client counseling in a
variety of technologies with focus on chemical and pharmaceutical. Chid
has prepared and prosecuted over fifty applications for a leading
research laboratory. Chid has conducted and presented in various
workshops and seminars on patent practice at various locations in U.S,
Korea, Japan, and India. He is currently chairing the AIPLA
subcommittee on IP practice in India.
Mr. Michael R. Dzwonczyk:
Michael has over 15 years experience successfully
representing multinational companies in patent litigation, including trials
and appeals of patent cases. His experience has encompassed
technical areas that include pharmaceuticals, recombinantly produced
hormones, protein synthesis and expression products, fibers, and
medical devices. His interference practice has included topics in
chemistry and biotechnology including hormone and gene therapeutics,
as well as anticholesterics. Michael also counsels clients on intellectual
property issues, including validity and infringement of intellectual
property rights, licensing and contract matters and Hatch-Waxman
issues. He has lectured on numerous topics including strategies for
drafting pre-litigation opinions, pharmaceutical litigation strategies, and Patent Law
Reform.
Dr. William Simmons:
Simmons is an associate at Sughrue Mion and
works out of the Washington office. He did his masters in Biological
Sciences in 1995. Simmons practice focuses on worldwide
procurement, defense and enforcement of patents in the biotechnology
and chemical industries. Simmons works in all areas of patent law,
including interferences, reexaminations, oppositions and prosecution.
Simmons prepares opinions regarding patentability and infringement
and conducts freedom-to-operate analysis. He did his Post-doctoral
Fellow from National Institute of Health at New York University.
Vinod has been in the field of IP Commercialisation, Litigation and Invetigation for the last 35 years. Vinod started his practice in Intellectual Property in late nineties, with focus on Protection and Commercialization of Intellectual Properties with emphasis on IP Valuation, Due Diligence, Transfer of Technology, Licensing, and resolving IP disputes. Vinod has also been researching and educating on fighting thefts and frauds of Intellectual Properties and white-collar crimes to protect corporate properties. Vinod has represented numerous corporates for devising their investigation, Prosecution and Litigation Strategies such as Indian Oil Corporation, ITC, Bharti Tele venture among many others. Vinod is the Founder Director of the Institute of Intellectual Property Research & Development and is also the President of the Institute of Forensic Accounting and Investigative Audit. He is also the Senior Partner of Khurana & Khurana Advocates & IP Attorneys. His professional qualification includes B.Com, PGDFA, MBA, FICWA, CFA, and LLB among other specialized qualifications in Investigation.
Mr. Samson G Yu:
Samson obtained his Bachelor of Science degree, and Electrical Engineering from Dalian Marine University in 1982, and his International MBA from Hong Kong University of Science & Technology. Samson began his IP career in 1984 as a patent attorney with the CCPIT Patent and Trademark Law Office, eventually serving as deputy director of its German office. In 1990, he joined a U.S. IP firm in Silicon Valley as a patent agent. He returned to Beijing in 1995 and joined Kangxin Partners, P.C. in 1998 and was promoted to managing partner in 2001. He has successfully litigated numerous IP disputes involving patent infringement and unfair competition. Samson has been named as Asialaw Leading Lawyer by Asia Law & Practice four times since 2006 and the Leading Patent Attorney by the Beijing Intellectual Property Office in 2006, 2008 and 2009.
Dr. Adrian Brasnett:
Adrian Brasnett is a partner in the firm of Mewburn Ellis LLP, one of the largest firm of European Patent and Trade Mark Attorneys. Adrian received his primary education at Hyderabad Public School in Andhra Pradesh, where his father was British Council representative, Adrian did his first degree in Genetics at University College, London. His PhD was awarded by Imperial College, London for research in Molecular Biology based in the London laboratories of the Imperial Cancer Research Fund (now Cancer Research UK), where he investigated interferon-induced gene regulation. Adrian's patent work has covered many areas of life sciences, from small molecule chemistry in the pharmaceutical and herbicidal fields, through to recombinant DNA technology in the human, microbiological and plant sectors. Adrian has 20 years experience in patent prosecution, post-grant proceedings and litigation in the UK, Germany and Holland and in US interference proceedings.
PROGRAMME
DAY-1
0900-0930: Registration
0930-1130: Developments in global biosimilars and prospects for legislation in major jurisdictions
1130-1345: Current trends in pharmaceutical, biotechnology & chemicals patent law and practice in the United States.
1300-1345: Lunch
1345-1515: How to draft a robust pharma, biotech & chemical patent, analyzing invention disclosure and capturing them in a sophisticated set of patent claims; comparing the different approaches of EPO and USPTO.
1530-1645: Obviousness issues related to active pharmaceutical ingredients; overcoming a case of prima facie obviousness; impact of recent post KSR court decisions on obviousness issues of active ingredients.
1645-1800: Using alternate USPTO procedures like Reexaminations and Interferences strategically in a preemptive manner to attain business goals.
DAY-2
0915-1115: NDA and ANDA products: salts, polymorphs, cocrystals solvates and enantiomers, combination products; bracketing the IP space around NDA products, impurities, manufacturing processes, finished dosage forms and exportation to the US.
1130-1315: Recent developments in the law every pharmaceutical company should know: old antibiotics, enantiomers, patent law reform, In Re Bilski, and selected court provisions.
1315-1400: Lunch
1400-1600: Preparing for the legal challenge; Orange Book patents, the opinion of counsel, the Paragraph 4 certification, offer of confidential access, jurisdiction and litigation strategy.
1615-1730: Single and multi-defendant litigation; managing e-discovery; the Markman hearing; working with a litigation budget; the effective use of experts; preparing for trial.
1730-1900: Resolving the ANDA litigation: settlement strategies; early market access agreements; authorized generics; FTC review; shared and unshared exclusivity, forfeiture, and citizens petitions.
1930-2130: Dinner
DAY-3
0915-1115: Current trends in pharmacutical and biotechnology patent law and practice in the European Patent Office and how to effectively understand and respond to communications from EPO examiners for avoiding prosecution pitfalls.
1130- 1300: Patent Litigation; Patent trolls, patent portfolio structure, scientific risk analysis to initiate patent litigation.
1300-1345: Lunch
1345-1530: Chinese Patent Laws for Pharma and Biotech Industry and best practices for protection and enforcement, with focus on third reform of the Chinese patent Law.
1545-1730: To deliberate all issues, raised by the delegates and emerged during the conference, but were not adequately replied in the respective session due to paucity of time and deliberation on any new patent application aspect brought out by delegates.
REGISTRATION FORM
Please register the following participant:
Name: ____________________________________________
Designation:________________________________________
Organisation:_______________________________________
Address___________________________________________
E-mail:____________________________________________
Tel. _____________________Fax.______________________
Registration Fees:
For Indian Delegates: Rs. 13000/- + 1339 (Service Tax)
Rs. 14339/- Per Delegate
For Foreign Delegates: US$ 350/- + US$ 36 (Service Tax)
US$ 386/- for Foreign Delegates
Enclosed is Cheque/draft in favor of “Institute
of Intellectual Property Research & Development”.
Payable at New Delhi
Draft/Cheque No.__________________Dated____________
Drawn on ________________________
Amount Rs.________________________
(Signature)
Use photocopy for more participants, if required.Please mail the complete form for Registration along with your payment in favor of "Institute of Intellectual Property Research and Development" to:
Vinod Khurana
Executive Director
Institute of Intellectual Property Research and Development ,
IFAIA Centre, S-20-22,
Greater Noida Shopping Plaza,
UPSIDC, Site-IV, Plot No: S-7/2, Kasna Road,
Greater Noida-201308, UP, India
Emails: iiprd@iiprd.com or tarun@iiprd.com
For any query please contact:
Tarun Khurana
Phone: +91-120-2342010/ 11, 2340556
Mb: 0-9810617992