INSTITUTE
OF INTELLECTUAL PROPERTY
RESEARCH & DEVELOPMENT
With the Support of
SUGHRUE MION, PLLC, OF THE USA
Presents
THREE – DAYS INTERNATIONAL WORKSHOP
ON
Resolving Principal Patent Issues Related to:
PHARMA, BIOTECH, & CHEMICALS
With Focus on:
United States & Japan Scenario
ON
21'st - 23'rd August 2008
ABOUT THE WORKSHOP
Foundation and Focus of business models has shifted from Physical Property to Intellectual
Property, wherein Patent issues are the core strength for corporates particularly for the Pharma,
Bio-Tech and Chemical Industry. At the same time, the concept of global economy and business
methods have fast expanded making business a 'Global Market Place', which has changed the
National Scenario to International Scenario of the Patent regime. Therefore, understanding of
International Patent Laws and Practices for regulating and protecting one's business, world
over, becomes critical for the business growth.
Patent Laws & Practices differ substantially between Nations, in terms of the Grant, Scope, Protection and Enforcement mechanisms. More importantly the standards for protection and enforcement as applied by the National Judiciary often vary widely, among countries. At the same time, the cost of development and protection of patents particularly in the Pharma, Biotech and Chemical domains is enormous. Therefore, there is a critical need to understand important issues such as strategies for generic pharmaceutical manufacturers as well as identification of invention, priority, types of claims, formulation of set of claims, and drafting, prosecution and Patent Litigation issues. This understanding can help us successfully evaluate and enforce patent rights and determine scope of protection so as to avoid suffering from the loss of patent due to infringement.
HOW THE WORKSHOP IS UNIQUE
This workshop features the presentation of all important patent issues broadly related to
Drafting of Patent Applications, Patent Prosecution, Enforcement and Litigation covering
Pharma, Biotech and Chemicals products and processes. Presentation will also focus
substantially on strategies for generic pharmaceutical manufacturers who seek to enter the
U.S. market, including ANDA litigation, actions to delist pharmaceutical patents from the FDA
Orange Book, advantages of different exclusivity provisions, and administrative challenges to
patents in the Patent and Trademark Office. Composition of the panelists is a unique gathering
of Patent Attorneys and Litigators who have extensive years of experience in their professional
fields, who are heading their respective departments from one large International IP Firm,
SUGHRUE MION, PLLC of USA from its Washington and Tokyo office who will put across to the
delegates the real insight of Patent Laws and Practices as prevalent in United States and
Japan. The Workshop will provide an opportunity to receive first-hand information from experts
from the single organization, in a well coordinated and scientifically structured module from
basic issues to latest developments affecting Patents, including recent Judgment on various
issues.
This is a one time opportunity when Five Patent Experts from one IP Firm of United States would be interacting with limited delegates and would answer to any question that the delegates may have. The speakers have thorough knowledge on the subject and have been practicing in the field for many decades. Composition of the team and the coverage is so selected that R& D scientist, Patent Attorneys and Legal Corporate team will get to know the real insight and nittygritty followed at USPTO and Japan Patent Office. The knowledge gained from the workshop will go a long way in formulating the right patent strategy and building Patent Portfolio.
Delegates will have ample opportunities to discuss personal patent issues on a confidential basis with all or any of the speakers, as the speakers and the residential delegates are accommodated in the same premises where the programme is being organised at The Stellar Gymkhana an excellent set up with wonderful ambiance at Greater Noida.
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 Indian business houses. In this direction, the
Institute has been regularly holding International Seminars as one of its focused activities on its
own and in collaboration with various Government and International agencies. The Institute has
held scores of National and International Programmes. The Institute also conducts tailored
made educational programmes for better known corporates at their premises specific to their
needs.
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 centre 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 duediligence in order to commercialise Intellectual Property and manage IPR-Risk. Further, the Institute provides route map and strategy to create trade mark and take them through brand building, IP protection, transfer of technology, licensing, remittance, accounting of damages for infringements, verification of royalties and license fee to foreign countries. The Institute has inhouse IP law firm which provides end-to-end support for creating managing Patent Portfolio and IP litigation and other statutory support. The Institute has a well established infrastructure and technical support. All these facilities are directed to create value addition and to commercialize intellectual property as a low investment growth mantra. 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: The Steller Gymkhana, Noida-Greater Noida Express Way,
Near EXPO MART,Greater Noida
Type: Residential/ Non Residential
Fees:
Non Residential:
For Indian Delegates: Rs. 13500/- per Delegate
For Foreign Delegates: US$ 350/- for Foreign Delegates
Residential:
Additional: At 'The Steller Gymkhana', Greater Noida
For single well furnished A/C accomodation Rs. 12500/- for Indian Delegate and US $ 350/- for Foreign Delegates
For Twin Sharing, well furnished A/C accomodation Rs. 9000/- for three days stay
At 'YMCA', Greater Noida
For single well furnished A/C accomodation Rs. 6500/- for Indian Delegate
For Twin Sharing, well furnished A/C accomodation Rs. 4500/- for three days stay
NOTE:
1) Charges include lodging, Boarding, Pickup and Drop Stay from 20'th to 23'rd, 08 before 1500 hrs. Delegates will be dropped back at the Airport/Railway Station by 1730 hrs on 23'rd Aug'08 and can plan their departure accordingly.
2) Residential Registration is assured if the nomination is received by 09 Aug'08.
Contact Person : Tarun Khurana 0-9810617992 (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 Litigator and Managers in generic drugs, 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. Mr. 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. Prior to joining Sughrue, Chid worked as an Engineer in chemical and software industry
for a decade.
Mr. Michael R. Dzwonczyk:
Michael has over 15 years experience
successfully representing multinational companies in patent litigation,
including trials and appeals of patent cases and Section 337 cases at the
International Trade Commission. 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,
experimental and exempt uses after Merck, and Patent Law Reform.
Mr.Miku Mehta:
Mehta did his Masters in System Engineering in 1993 from
University of Virginia, US and J D from George Mason University School of Law, US, in
1998. He presently is an Associate with Sughrue Mion, PLLC of the USA. He currently
Practices at District of Columbia and at US PTO and his area of focus includes
technology fields such as computer software and hardware, networks, Internet-related
applications, optics, electronics, mechanical engineering, business processes and
medical devices. His area of legal focus is the preparation of new patent applications,
the prosecution of patent applications before the U.S. PTO, and Appeals to the U.S.
Board of Patent Appeals and Interferences. He has also prepared opinions in the areas
of patentability, infringement and product clearance. Mr. Mehta is also a Foreign Law Advisor to Japan
Office. Mehta has published scores of articles and teaching and has spoken on various Patent issues in
United States and abroad.
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.
Mehta did his Masters in System Engineering in 1993 from University of Virginia, US and JD from George Mason University School of Law, US, in 1998. He is an Associate with Sughrue Mion. PLLC of the USA and looks after Japan office. He currently Practices at Japan patent office and his area of focus includes technology fields such as business processes and medical devices, His area of legal focus is the preparation of new patent applications, the prosecution of patent applications before the Japan Patent Office. He has also prepared opinions in the areas of patentability, infringement and product clearance. Mr. Mehta is also a Foreign Law Advisor to Japan Office. Mehta has published scores of articles and teaching and has spoken on various Patent issues in United States and abroad including India.
PROGRAMME
DAY-1
0900-0930: Registration
0930-1330: 10 Pitfalls of Indian Pharma/Biotech/Chemical filers in US & Japan and strategies for overcoming obviousness rejections & prosecuting around.
1330-1400: Lunch
1430-1600: Patent Application Drafting; Analysis of Invention Disclosure, Specification, Claim Drafting and other relevant issues which help the Inventor at all stages.
1620-1800: Application Drafting Workshop - Review of Problem, Drafting & Analysis of Claims
DAY-2
0915-1115: KSR and Post-KSR Pharma cases in the federal circuit focusing on
strategies
covering prosecution and litigation including
i) Stereoisomer obviousness;
ii) Motivation provided by FDA requirements for data on related
compounds or compositions;
iii) Product/Composition/Method double patenting and anticipation;
iv) The degree of unexpectedness required to rebut Prima Facie
obviousness; and
v) Proof of obviousness by expert testimony and opinion litigation
1130-1330: Overview of ANDA litigation and the strategic use of ANDA's Infringement and Remedies under 271(e)(2) AND 271
1330-1430: Lunch
1430-1600: Action for patent certainty under S.355(j)(5)(c) and broadened declaratory judgment jurisdiction after MEDIMMUNE
1620-1720: Actions to delist pharmaceutical patents from the FDA Orange Book
1730-1900: Open house with all speakers for deliberation on Leveraging Patent Exclusivities
1930-2200: Dinner
DAY-3
0830-1030: Administrative alternatives to litigation
i. Interference as opposition
ii. Interference to force a license
iii. Strengthened reexamination; Third Party vs. Inter Parties
iv. Has PTO Favoritism to patentees diminished ?
1045- 1145: Status of proposed legislations and rule changes and its prospects
1200-1300: Communication between In-House IP Manager and US Counsel and effective coordination of strategy in entering the US Pharma and Biotech with US counsel
1300-1430: Procedural Highlights & Updates on Japanese Patent Practice
Note: The Programme on the last day will start at 0830 hrs and lunch would be hosted at 1430 hrs after the closing session, the delegates would be dropped at Airport / Railway station by 1730 hrs
REGISTRATION FORM
Please register the following participant:
Name: ____________________________________________
Designation:________________________________________
Organisation:_______________________________________
Address___________________________________________
E-mail:____________________________________________
Tel. _____________________Fax.______________________
Registration Type Residential------
Non-Residential------
If Residential: Gymkhana------
YMCA------
If Residential: Single------
Twin Sharing------
Registration Fees Non Residential:
Additional charges for Residential Nomination
At 'The Stellar Gymkhana', Gr. Noida
Single Basis: Rs. 12500/-
Twin Sharing Basis: Rs.9000/-
At 'YMCA', Greater Noida
Single Basis: Rs. 6500/-
Twin Sharing Basis: Rs.4500/-
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@sify.com or khuranavinod@yahoo.com
For any query please contact:
Tarun Khurana
Phone: +91-120-2342010/ 11, 2340556
Mb: 0-9810617992