Seminar for Pharmaceutical – Sep 2010







Two-Day International Symposium On
Effective Strategies For Managing Pharma & Biotech Patent Portfolio

With Focus On:

ANDA Litigation, Strategies for Generics as Innovators, Biosimilar Legislation and its impacts & Latest Pharma Prosecution Practices

15’th-16’th September 2010, at Hotel Le Royal Meridian, Mumbai

17’th-18’th September 2010, at Hotel Crowne Plaza, New Delhi

About the Symposium

In a business environment where opportunities and the competition in Pharma and Biotech Industry, particularly in USA, is becoming increasingly aggressive, there is an urgent need to understand the competitive leverage that an efficient Patent Portfolio can provide. At the same time an understanding of US Patent Laws and Practices for regulating, protecting and leveraging Pharma Business in USA is becoming critical for business growth in new emerging opportunities. There is therefore an urgent need to understand important issues relating to strategies for generic pharmaceutical manufacturers, as well as new inventors in view of new laws on Bio-Similar products for formulating Business and Litigation Strategies and understanding impact of major decisions emerging from Litigations. At the same time new patent laws and practices on Biosimilars in terms of their Grant, Scope, Protection and Enforcement mechanisms have undergone substantial changes in the recent past 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, evolving trends in declaratory judgment actions, unique aspects of Orange book listing strategies, litigating ANDAand strategic use of ANDA's infringement, and patent portfolio structure for Pharma and Biotech Industry.

How is the Symposium Unique

This Symposium features presentation of all important patent issues covering Pharma and Biotech products and processes. Composition of the speakers is a unique gathering of Patent Attorneys and Litigators from the single IP Law Firm from USAwho have extensive years of experience in their professional fields and will put across to the delegates a real insight of Patent Laws and Practices and first-hand information through well coordinated and structured modules.

This is a one time opportunity when Six Patent/ Litigation Experts from a single firm Sughrue Mion, PLLC of the USA 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 and Biotech industry will get to know the real insight and nittygritty followed at USPTO and in Federal Courts. The knowledge gained from the workshop will go a long way in formulating the right patent strategy and managing Patent Portfolio.

About the Organizers


IIPRD is a premier IP Consulting and Licensing Firm with a diversified business practice providing services in the domain of Commercialization, Valuation, Licensing, Transfer of Technology and Due-Diligence of Intellectual Property Assets along with providing complete IP and Patent Analytics and Litigation Support Services to Indian and International Corporates and Global Law Houses.

IIPRD has been established precisely to assist the business houses in strategizing their growth by leveraging their IPR's through effective Creation, Promotion, Protection, and Commercialization of IP. IIPRD has a legacy of ten years of existence and is among the first Indian IP Firms to have core focus on Commercialization, Technology Transfer, and Licensing for numerous Indian and Global Corporates. IIPRD has been a part of large number of Out-Licensing deals for technology companies in Pharmaceutical and Hi-Technology domains such as NCE's, Formulations, and Proceess Patents in Pharma domain and Telecommunication/Network and Green Technologies. IIPRD along with sister concern and leading full service IP Law Firm Khurana & Khurana, Advocates and IP Attorneys focusing on representing over 600 Indian and International Clients becomes a single point destination for all IP needs, a diffrentiator very core to both the firms. IIPRD also takes pride in its strong associate base in US, EP, Singapore, Israel, and Australia which assists IIPRD in Out-Licensing Technologies and have advanced level of negotiations with leading In-Licensing firms and Corporates.

About Sughrue Mion

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 the last 50 years have been helping their clients to develop, obtain, protect and leverage their intellectual property rights in technology areas ranging from a submicroscopic sequence of DNAto 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

About Khurana & Khurana, Advocates and IP Attorneys

Dates: 15'th - 16'th Sep'10
Venue: Hotel Le Royal Meridian, Mumbai
Dates: 17'th - 18'th Sep'10
Venue: Hotel Crowne Plaza, New Delhi
Registration Fees: Rs. 9927/- (Rs. 9000/- + Rs. 927/- Service Tax)

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.

programme outline



0930-1130:Update on Recent Pharmaceutical Federal Circuit Case laws; Implications on Patent Prosecution and Litigation Strategies

1130-1300:Resolving ANDALitigation; Key Learning from Top Ten US Litigation cases in popular ANDA jurisdictions such as Delaware and New Jersey; Settlement Strategies; Early Market Access Agreements.

1345-1500:10 important steps in Pre-Litigation Due Diligence in ANDAcases; Preparation & Strategies for ANDA Challenge; Declaratory Judgment Jurisdiction.

1500-1600:Defense strategies for use in Para 4 Notifications for reducing costs; Distinguishing from other defendants for an early successful resolution.

1615-1715:Successfully exploiting market & patent exclusivities and avoiding forfeitures

1715-1830:Substantive Legal issues in ANDA Litigation for different type of Claims including New Chemical Entities, Method of Treatment especially new indications, New Dosage Forms& Formulations; Strategies for generics as innovators

1900 Onwards:Cocktail-Dinner


0915-1115:Discussion on latest US Biosimilar Legislation; Standards for determining Biosimilarity and Interchangeability

1130-1315:Strategically taking advantage of the new legislation; Patent notices and prelitigation disclosure provisions including confidentiality provisions; Determining which Patents will be litigated; Limits on staying FOB Approval

1400-1530:Various exclusivities for Biosimilars; Issues and Limits on Biosimilar approvals; Comparisons with Hatch-Waxman

1545-1700:Current trends in Pharma and Biotech Prosecution Practices; Recently set Obviousness Standards in view of recent case laws

1700-1730:Questions & Answers on any Patent Matter not deliberated during the conference

About the Faculty
Mr. Chid Iyer

Chid received a B. Tech in Chemical Engineering from IIT, Bombay in 1984, MS in Chemical Engineering from University of Akron and 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 100 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 AIPLAsubcommittee on IP practice in India.

Mr. Mark Boland

Boland has successfully represented a variety of companies in the U.S., Asia and Europe as lead counsel in numerous patent litigations before federal district courts; such as lMerck v. Ranbaxy, Civil Action No. 07-229 (D. Del.) - lead counsel for Ranbaxy in pending ANDA litigation lMars vs. Natraceutical, S.A., Civil Action No. 02:07-CV-01574 (D. NJ) - lead counsel lForest Labs. vs. Wockhardt et al, Civil Action No. 08-021 (D. Del) - trial counsel for Wockhardt defendants in pending ANDA litigation involving use of memantine hydrochloride in the treatment of Alzheimer's disease. lOrtho McNeil Pharmaceutical, Inc. and Daiichi Phamaceutical Co., Ltd. v. Lupin Ltd., et al., Civil Action No. 3:06-cv-4999 (D. NJ) among many others. He has also successfully represented clients in patent interferences before the U.S.P.T.O., and district court US 146 interference appeals and is also regularly engages in patent infringement and validity opinion practice and counseling, freedom-to-operate, due diligence and product clearance work, licensing and contract matters including joint ventures and co-development situations, patent application preparation and prosecution, and counseling clients in devising global intellectual property strategies. Boland is a partner and member of the firm's Management Committee. Boland did his Post-graduation in 1982 in Biology and JD from Catholic University of America. He has spoken on Paten Litigation in Japan, Belgium, Munich, India among other countries.

Mr. Michael R. Dzwonczyk

Michael has over 17 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.

Ms. Azy S. Kokabi

Azy S. Kokabi practice focuses on worldwide procurement, defense and enforcement of patents in the biotechnology and pharmaceutical industries, with focus on prosecution, interference, and litigation motions practice. Kokabi did her post graduation in Biology and JD from George Mason University School of Law . Kokabi has served as counsel in interference proceedings and related matters, before the Board of Patent Appeals and Interferences and the Court of Appeals for the Federal Circuit. Kokabi counsels clients about pre-interference matters, such as provoking or avoiding interference proceedings, copying claims, and evaluating inventorship disputes. Kokabi also prosecuted patent applications covering biotechnology subject matter, and assisting in the drafting of license agreements relating to intellectual property. She also assisted in various aspects of litigation, including researching and preparing legal memoranda for pharmaceutical and biotechnology litigations. Prior to joining Sughrue Mion, Ms. Kokabi also served at the U.S. Patent and Trademark Office as an Examiner.

Registration Fees

Indian Delegates : Rs. 9927/- (Rs. 9000/- + Rs. 927/- Service Tax) Service Tax: AABFI6363FSD001

Nomination Form

Name, Organization, Designation, Address and Contact Details along with the payment drawn in favor of "Institute of Intellectual Property Research & Development" and mail it to IIPRD at : Mr. Tarun Khurana IIPRD, IFAIA Centre, S/20-22, Greater Noida Shopping Plaza, UPSIDC Site-IV, Kasna Road, Greater Noida-201308, UP, India.

for any query contact

Contact Person: Mr. Tarun Khurana Mobile: +91-9810617992 Email:, Ph : +91-120-2342010, 3104849, Fax: +91-120-2342011