Seminar for Pharmaceutical – March 2013

INSTITUTE OF INTELLECTUAL PROPERTY RESEARCH & DEVELOPMENT
(IIPRD)

With The SUPPORT OF

SUGHRUE MION, PLLC, USA

And

CANTOR COLBURN, LLP, USA

And

BERDEHLE PAGENBERG, Europe

And

FUKAMI PATENT OFFICE, Japan

And

NAKAMURA & PARTNERS, Japan

And

KHURANA & KHURANA, IP ATTORNEYS, India

Presents

Three-Days International Symposium On
Strategies For Managing Pharmaceutical, Biotechnology & Chemical Patent Portfolios

for

R&D Scientists & IP Professionals

5’th – 7’th March 2013, at Chancellor- I, Hotel Hilton, (Andheri East) Mumbai

About the Symposium

With Patents becoming a core part of existing economic ecosystem, particularly for Pharmaceutical, Biotech, Chemical & Drug Industries, exploitation of Patent Portfolio has become an industry in itself; especially with the cost of development and protection of the portfolio being enormous. It is therefore crucial to understand important Patent issues, not only for IP team but even more importantly for R&D Scientists and Business Development Professionals, so as to minimize the efforts in Patent Development and to maximize the commercial gains. It is therefore important for Corporates and concerned stakeholders to understand the nitty-gritty's of patent portfolio creation, protection, management, and commercialization, without which there would always remain an open door for a serious blow either from an infringement threat or from a patent invalidation perspective or the portfolio would remain under commercialized. This is precisely why the number of major patent litigations are growing between competitors and contemporaries, besides the growing threat from international exploiters.

Exclusivity rights granted through patents can only be utilized if there is comprehensive knowledge of various patent related issues, more so when the National Patent Laws & Practices relating to prosecution practices, drafting practices, examination practices, enforcement practices and commercialization practices differ substantially across geographies, and therefore in the global business scenario, besides understanding of Patent Laws and Practices prevalent in India, we also need to understand the practices in economically and financially important geographies such as Europe, Japan and United States. It is in this direction that the International Symposiums is being organized to impart comprehensive knowledge to understand the nitty-gritty of Patent Regime.

How the Symposium is Unique and Why should the Delegates Attend

These Symposiums feature presentation of all important patent issues, as mentioned in the brochure, related to two different groups i.e. Business Development Professionals on one hand and R&D Scientists & IP Professionals on the other hand. Both these Symposiums for different groups would run concurrently in different Conference Halls with R&D Symposium taking place from 5 - 7'th March 2013 and Business Development Symposium taking place from 5-6 March 2013 at two different halls of Hotel Hilton. The speakers are a unique gathering of Patent Attorneys, Legal Counsels, and also include experts from the Commercial domain for Business Development Group, who have extensive years of experience in their professional fields. These Speakers will put across to the delegates a real insight of Patent Laws & Practices, and Commercial perspectives as prevalent and practiced in Europe, Japan, United States, and India. The Workshop will provide an opportunity to receive -hand information including recent judgments on various issues from the experts in the fields.

About the Organizers

About IIPRD

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 over twelve years of existence and is among the Indian IP Firms to have core focus on Commercialization, Technology Transfer, and Licensing for numerous Indian and Global 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.

About Cantor Colburn LLP

Cantor Colburn is one of the largest full service IP law firms in the U.S.A. providing exceptional counsel and representation to clients in litigation, patents, trademarks, and all areas of IP. Cantor Colburn LLP's Pharmaceutical Litigation Practice has successfully represented several generic drug companies in ANDA and Paragraph IV patent challenges. Experienced and highly skilled, Cantor Colburn helps its clients- including Fortune 100 companies, privately held companies, select high-tech start-ups, and universities- protect and defend their valuable IP.

About Bardehle Pagenberg

Bardehle Pagenberg is one of the largest IP firms in Europe representing clients in application proceedings and in litigation in all fields of intellectual property, including all procedures before the patent and trademark offices as well as litigation before the relevant courts through all appeal instances. Bardehle Pagenberg's patent attorneys and attorneys-at-law have long experience and expertise in protecting a wide variety of technical inventions.

About Fukami Patent Office p.c

Fukami Patent Office was founded by Mr. Hisao Fukami in 1969, is based in Osaka, Japan and also has its branch office in Tokyo. specialization in the electrical field, Fukami Patent Office has gradually expanded to cover all major technical areas and is truly a full-service IP firm. Clients of Fukami Patent Office include some of the largest and most prestigious clients in various business and technical fields. Currently, the office has a total of 239 staff members including 74 attorneys. By size, Fukami Patent Office ranks as the 6th largest in Japan.

About Nakamura & Partners

Nakamura & Partners is a leading international patent and law firm founded in 1914. Nakamura & Partners has approximately 180 staff members, including about 70 patent attorneys, about 20 attorneys-at-law and about 30 partners. Nakamura has been consistently awarded the 'Prosecution & Contentious IP Firm of the Year" by Managing IP including various others awards by Legal 500 and AsiaLaw IP Awards. Nakamura's aim is to provide the highest level of professional services in IP rights and legal matters relating thereto, to comply with the requests of clients and to construct an excellent and long-lasting trustworthy relation with their clients.

About Khurana & Khurana, Advocates and IP Attorneys

Khurana & Khurana is among the leading full service IP Law Firms in India and has, in a short period of 6 years since establishment, gained repute and acknowledgment for its IP Contentious and Non-Contentious practice. K&K is among the youngest Indian Firms to have been strongly ranked and recommended by Legal 500 and Managing IP and through its team of Patent and IP Attorneys, represents numerous Corporates ranging from Fortune 500 and Start-up Companies, which span across technology domains. K&K is based in Delhi (Noida) and Pune and is an active member of AIPPI, INTA, APAA, LES, among other such international bodies.

Schedule

Dates: 5'th - 7'th March '13
Venue: Chancellor- I, Hotel Hilton Mumbai (Andheri East)
(Earlier Known as Le Royal Meridian)

Who Should Attend

R&D and IP Group Programme: Research & Development Scientists, IP Managers, Patent Agents & Attorneys in the field of Practice, Patent Litigators, Professionals in Legal Domain related to Pharma, Biotech and Chemicals.

programme outline

DAY-1 US AND JAPAN SCENARIO

0915-1115:Strategies for R&D Scientists for conducting prior art searches and effective patent drafting in the chemical, drug delivery and formulation arts for the best protection globally.

1130-1310:Role of patent infringement in R&D; FTO analysis; Claim interpretation; Mechanics of drafting FTO opinions and types of FTO opinions; Integrating FTO landscape assessments into the product development process
1310-1400:Lunch

1400-1515:Recent Developments in Patentability standards at the USPTO in view of the recent case laws, Obviousness issues related to active pharmaceutical ingredients; impact of recent post KSR court decisions on obviousness issues of active ingredients, drug delivery and formulations

1530-1630:Strategies for successful disclosure of inventions in patent specifications in the US; determination of written description and enablement requirements; Strategies for efficiently obtaining patents; Strategies for handling a restriction or a lack of unity requirement

1630-1730:Patentability and Infringement Considerations in Japan; Invalidation of Japanese patent and Claim Interpretation, comparison between Japan and US patent law where applicable; FTO procedure and infringement analysis; amendments in Patent Act

DAY-2 EP AND JAPAN SCENARIO

0915-1115:Recent trends in pharmaceutical patent law and practice at the EPO; sufficiency of disclosure requirement; major differences between the EPO and USPTO patentability standards; how to effectively understand and respond to communications from EPO examiners

1130-1300:EPO Opposition and Appeal Procedure; best strategies for conducting freedom-to-operate for chemical synthetic processes; enforceability of patents; impact of the Eli Lily v HGS decision; Second medical use claims; Patenting Diagnostic methods in Europe
1300-1345:Lunch

1345-1500:Overview of European Generic Drug Approval Processes; Supplementary Protection Certificates (SPCs); Recent Decisions in SPC matters; Paediatric SPC extensions; SPC extensions for combination products; Data Exclusivity

1515-1730:Examination Guidelines in pharmaceutical fields in Japan; Japanese Patent trend in NDDS; Contributory and willful infringement, patent term extension in Japan, Japanese pharmaceutical R&D Best practices to get robust Patent

1400-1530:Update and Trends on Recent Paragraph IV disputes and litigation: Federal Court, PTO proceedings & ITC actions; Implications on Patent Prosecution and Litigation Strategies; which strategies have been successful?

DAY-3 US SCENARIO-ANDA

0930-1030:Primer on patent and regulatory backdrop for the clear in-depth understanding of the Hatch Waxman litigation; understanding the interplay of the USPTO and FDA in the patenting of drugs; Exclusivities; Bioequivalence; Orange Book Listings; ANDA approval process; etc.

1030-1130:Best Strategies for Generic product development lifecycle management from the perspective of R&D group; patenting of bioequivalence characteristics; extended-release drug products; formulation development

1345-1300:UEvaluating new trends in validity challenges including extended and delayed release formulations; obviousness-type double patenting and litigation strategies based on prior art obviousness analysis; Understanding the significance of Novo Nordisk v. Caraco

1400-1545:An update on recent Para-IV disputes; Strategies used for litigating different types of listed claims, such as claims to compounds, formulations, methods of treatment etc.; Reassessing Paragraph IV Strategies for Method of Treatment Patents in View of Recent Decisions Regarding Inducement and Divided Infringement;

1600-1730:Key provisions of the America Invents Act (AIA); influence of AIA on Orange Book listings; Assessing the impact of AIA on Paragraph IV Litigation

About the Faculty
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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 counselling in a variety of technologies with focus on chemical and pharmaceutical. Chid has prepared and prosecuted over 100 applications for a leading research laboratory.

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Mr. Steven M. Coyle Steve Coyle is a Partner and trial lawyer at Cantor Colburn with nearly 20 years of experience in litigating and trying complex disputed matters, and has specialized in patent and all varieties of IP litigation for the past 15 years. Steve's areas of focus include ANDA and Hatch- Waxman litigation, and is the Group Leader of Cantor Colburn's Pharmaceutical Litigation Practice. Steve has represented clients in a variety of other patent and IP matters, as both plaintiffs and defendants, in courts as well as in alternative dispute resolution proceedings such as arbitrations and mediations.

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Mr. Jeffery Arnold Partner at Cantor Colburn LLP, is an IP attorney with more than 20 years' experience and has a M.S. in biochemistry. Jeff concentrates his practice on generic pharmaceuticals, to include litigation and validity, infringement, and freedom-to-operate opinions in support of ANDAs and launch-at-risk evaluations/opinions. Further, Jeff counsels his clients on strategies for managing and protecting patent portfolios; prepares validity, infringement, freedom-to-operate, and patentability opinions; represents clients in all aspects of patent prosecution; and supports numerous litigation matters in addition to his generic pharma practice.

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Mr. Tarun Khurana Mr. Khurana focuses on Patent Preparation, Prosecution, Litigation, and Valuation related issues and represents IP portfolio of over 750 Indian and Global Corporates. Tarun brings a practice of over 9 years in the IP domain and has helped numerous US and European Patent Attorneys in providing Patent Support Services including Patentability Searches, Invalidation Searches, FTO, Infringement Analysis, Patent Preparation and Responding to Office Actions. Tarun represents a number of Fortune 500 Corporates and is involved in significant infringement and nullity proceedings. Tarun has a Bachelors in Engineering from Pune University, Masters in Software Systems from BITS Pilani, Bachelors in Law, and MBAfrom IIM Lucknow. Tarun is a member of AIPPI, APAA, INTA, TIE, and LES.

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Ms. Leslie-Anne Maxwell, Ph.D. 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 preinterference matters, such as provoking or avoiding interference proceedings, copying claims, and evaluating inventorship disputes. Prior to joining Sughrue Mion, Ms. Kokabi also served at the U.S. Patent and Trademark Office as an Examiner.

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Mr. David E. Rodrigues, Ph.D. Dave Rodrigues, Partner at Cantor Colburn LLP, has 11 years' experience with increasing responsibility in patent preparation and prosecution, due diligence, opinion work, including noninfringement, invalidity, and right-to-practice. Prior to becoming a patent attorney, he worked as a Plant Chemist for Armstrong World Industries and as a Pilot Plant Manager for General Electric Silicones and the General Electric Global Research Center. He is the lead partner for the technology transfer office of a major research university and for other clients with sophisticated technology and IP portfolios.

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Mr. Toshio Nakamura Toshio is a Japanese patent attorney in Fukami Patent Office, p.c. He has over 20 years of experience in patent prosecution and litigation covering general chemistry, pharmaceuticals, biotechnology, patent term extension, etc. He obtained his PhD in chemistry from Tokyo University in 1985. Before joining Fukami Patent Office in 2010, he worked for Sumitomo Pharmaceuticals, Co., Ltd. and Mitsubishi Tanabe Pharma Corporation.

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Ms. Satsuki Ichikawa Satsui is a Partner and Patent Attorney in Chemical Section of Nakamura & Partners. Her main practices include Patent Infringement, Nullity Actions, Patent Clearance Searches including opinions regarding patentability and infringement. She has specialization in chemistry, pharmaceutics, industrial polymer compounds, foods, fibers, and medical devices. She holds a degree of Ph.D from Keio University, Department of Applied Chemistry. She joined Nakamura & Partners in 1995.

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Mr. Thomas Friede Thomas is a Partner, European Patent Attorney and German Patent Attorney at Bardehle Pagenberg in Munich, Germany. He holds a Ph.D in Biochemistry and concentrates on Life Sciences and pharmaceutical inventions. His practice encompasses patent prosecution before the EPO and patent litigation before the District Courts and the Federal Patent Court. He has particular litigation experience with drug-eluting stents, diagnostic assays, cosmetics, vaccines and antibodies. Thomas is recommended for patent prosecution and patent nullity matters by Intellectual Asset Management (IAM).

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Mr. Wolfgang Bublak Wolfgang is a partner at Bardehle Pagenberg, his practice covers prosecution and litigation of patents and utility models including opposition proceedings and national patent revocation actions, infringement litigation and licensing. His technical expertise encompasses organic and inorganic chemistry as well as biochemistry. Wolfgang represents major European and international corporations in patent opposition and invalidation proceedings and as lead patent attorney in complex patent infringement litigation.

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Mr. Vinod Khurana Vinod has been in the field of commercial legal finance for the last 39 years. Vinod started his own practice in Intellectual Property and Investigative Audit in the late Nineties. Vinod is Executive Director at the IIPRD. He is also the President of the Institute of Forensic Accounting and Investigative Audit and is Senior Partner at an IP Law Firm, Khurana & Khurana Advocates & IP Attorneys and Litigates Fraud/ Infringement related matters. Vinod has been speaking on various Intellectual Property and Fraud Investigation matters at more than 150 National & International forums in India and Abroad.

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Mr. Michael R. Dzwonczyk Michael is a partner at Sughrue Mion and has about 20 years of experience in 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. Michael also counsels clients on intellectual property issues, including validity and infringement of intellectual property rights, licensing and contract matters and Hatch-Waxman issues.

Registration Fees

Indian Delegates : INR 15,000/- Per Delegate (If 4 or more delegates are nominated, the delegate fees would be Rs. 12000/-)
Foreign Delegates : USD 300/- Per Delegate

Nomination Form

Please Forward the Delegate Fees with the following details:
Name, Organization, Designation, Address and Contact Details along with the cheque drawn in favour of " M/S IIPRD " to Mr. Tarun Khurana
IIPRD, E-13, UPSIDC Site-IV, Kasna Road, Greater Noida-201308, UP, India

or

Transfer Funds at our Bank; details are as Follow:
Bank Name: UCO Bank Branch, Branch Name: Greater Noida
Bank Account Number: 19620210002476
Bank Address: G.N. Shopping Plaza, Plot No.-S-7/1, Site-IV, Kasna Road,
Greater Noida MICR Code: 110028055 IFSC Code: UCBA 0001962
Name of the Account Holder: M/S IIPRD

for any query contact

Contact Person:
Ms. Meenakshi Khurana
Mobile: +91-9910307992
Email: Meenakshi@iiprd.com
Mr. Tarun Khurana,
+91-9810617992, +91-9810281321,
Email: tarun@iiprd.com, iiprd@iiprd.com
Ph : +91-120-2342010/4296878, Fax: +91-120-2342011