ABOUT THE WORKSHOP

The Indian Pharmaceutical and Drug Industry has gone through substantial changes during the last about ten year and is at the threshold to take on new challenges in the expanding globalization, which are making India the R & D hub Centre. To grow the Industry is fully aware that they need to have in-depth and insight understanding of Patent Laws and Practices prevalent not only in India but also across the world, particularly at United States of America, being the world largest market in financial terms in Pharmaceutical Industry. It is in this direction that the Six Days Workshop is organized to impart in-depth knowledge to Pharmaceutical and Chemical Industry to understand the nitty-gritty of Patent regime at United States as enforced and practiced by USPTO.

The workshop is organized to fulfill the resounding expectations generated during the recent Six-Days workshop, held by the Institute during Oct’ 04, 2004 on European Patent Laws & Practices, The recently held workshop was a great success and had lived up to the expectations of all the delegates in all respects, which was attended primarily by all well established Pharmaceutical Industry and large number of Patent attorneys from India and abroad.
How The Workshop is Unique

Protection and exploitation of Intellectual Property is an expensive strategy The monopoly rights granted through patent can only be utilized, if there is comprehensive knowledge of various related issues, more so in Pharmaceutical and Chemical Industry. To provide comprehensive knowledge on United State Patent Laws and Practices at USPTO and to address all the queries that the delegates will have the best of the team from United State is invited on a single platform. The team consists of Mr. John Richards, Patent Attorney, who is managing Partner in Ladas & Parry PLLC, based in New York. Dr. Thomas Paul, Patent Attorney and managing Partner of Fulbright & Jaworski, LLP. with Head Office in Washington, Mr. John T. Callahan, Patent Attorney and Managing Partner of Sughrue Mion.LLP. with Head Office in Washington and Mr. Cliff Mass Patent Attorney and Partner in Ladas & Parry. Their detailed profile is mentioned separately. The Composition of the team is so selected that the R & D scientist, Patent Attorney and Legal Team at Corporate will get to know the real insight and nilty-gritty followed at USPTO. The knowledge gained from the workshop will go a longway in formulating patent strategy at pharmaceutical & Chemical Industry.

This is a one time opportunity when four patent experts from United States would be interacting with a limited delegates for Six-Days and would also answer to any query that the delegates may have the experts may also take different positions during deliberations and would express their personal views on Controversial issues and aspects. Delegates will have ample opportunity to discuss personal Patent problem on a confidential basis with all or any one of the speakers. If the delegates have any practical problem or any issue that they want to clarify and elaborate in detail, they may write to the Institute in advance and the issue will be deliberated during the workshop.

The Institute has well stocked library with more than 3000 books on various issues related to Intellectual Property, including patent and patent drafting. The library would remain open till late hours for the delegates to make use of the facility after workshop hours.

ABOUT THE ORGANIZERS
About the Institute

The Institute of Intellectual Property Research and Practice was registered as a society in 1995, primarily to provide industrial training and education in the field of intellectual property rights, their practices and legal enforcement in an international scenario. Intellectual property being intangible in nature is more fragile and needs international protection and commercialization in a global economy. In order to protect and commercialize intellectual property, the knowledge and update of International Scenario of intellectual property is critical. The institute has been regularly holding international seminars as one of its focused activities to educate and sensitize Indian industry with international happenings in intellectual property. The Institute organizes these seminars on its own and in collaboration with various Government and international agencies.

The Institute also provides a platform and medium to exploit intellectual assets to maximize and hone intellectual skills in the field of IPR in India. In this direction the Institute has established a Valuation Center which undertakes valuation of intellectual capital with focus on Brand valuation and an IPR Audit Cell, in order to make IPR as low investment growth mantra and to manage IPR-Risk. The Institute also provides assistance in transfer of technology, licensing, remittance, accounting of damages for infringements, verification of royalties and license fee to foreign countries and many more cognate and allied subjects. The Institute has a centrally air-conditioned and well laid out premises. It has well furnished and equipped library holding more than 3000 books on intellectual property itself and all facilities are directed towards the goal of learning the benefits of intellectual property research and practice.

About the TIFAC

Technology Information Forecasting & Assessment Council (TIFAC) is an autonomous body registered under the Department of Science and Technology of the Government of India. It is a unique institution covering a lot of ground on technology development, by promoting innovative technologies at one end and providing technology support services like information and assessment on the other.

In 1995, a patent Facilitating Centre (PFC) was created at TIFAC for creating patent and IPR awareness in the country and providing a single window system for protecting the inventive works of Indian scientists through patents and other forms of IPR. The centre has so far conducted 180 IPR awareness workshops across the country, sensitizing more than 20,000 scientists and technologists.

PCF has taken a number of concerted and consistent steps for capacity building in the area of IPR at different levels of creativity and inventive spirit by way of organising training programmes, facilitating IP protection and also developing facilities to conduct patent searches, etc. In the coming days, PFC plans to launch scholarships for educated women having good science/engineering/medical qualifications under the Women Scientists’ Scheme for unleashing dormant scientific force. PFC has many firsts to its credit and has brought out a number of IPR reports and IPR products, viz. “Patenting of Microorganism” “Ekaswa” Cds on Indian Patents “Patents Made Easy” video, to name a few.
About the Faculty

Mr. John Richards:- Mr. John Richards after obtaining his post graduate degree in National Science with specialization in Chemistry from Cambridge University and Law Degree from University of London, started his carrier in the Patent Department in the year 1966 with Albright & Wilson Ltd. London as Patent Attorney. Mr. Richards joined the International Law Firm Ladas and Parry at its new your office in the year 1973 and became a partner in the firm in the year 1982. He is a member of the New York Bar Association, American Bar Association, American Group of AIPPI, Chartered Institute of Patent Agents (U.K.), American Association for the advancement of Science among others. Mr. Richards is also European Patent Attorney and has written for various publication including Patent world. He is the author of book entitled “Legal aspects of Introducing Products to United State Market” and is Adjunct Associate Professor of Law with Fordham University School of Law.

Dr. Thomas D-Paul:- Mr. Paul received Graduation in Biology in 1970 from Carroll College, an M.S. in 1975 and a Ph.D. in Medical genetics in 1977 from Indiana University and a J. D., cum Laude, in 1987 from the University of Houston. Dr. Paul serviced as a assistant Professor at State University of New York at Buffalo from 1977 to 1984 and completed research, teaching and publication on genetics and biochemistry. Dr. Paul joined Fulbright & Jaworski L.L.P. in the year 1986 and is a partner in the firm. He is registered to practice as Patent Attorney in Supreme Court of Texas in 1987 and before U.S. Patent and Trademark Office in 1988. His practice involves Patent prosecution, Litigation and Licensing with focus on biochemistry, drugs and clinical tests and assays. Dr. Paul is board certified by the Diplomat of American Board of Medical Genetics Sub specially Clinical Biochemical Genetics.
Mr. John T. Callahan:- Mr. Callahan received his Masters in Chemistry in the year 1985 from calhotic University of America and J.D. from University of Berltimore School of Law in 1990. Mr. John Callahan is a managing Partner of International Law Firm Sughrue Mion and is looking after Washington D.C. Office. His areas of Practice includes Patent Drafting, reissue and reexamination proceeding and World Wide Prosecution with focus on Chemical, Pharmaceuticals and biotechnology. Mr. Callahan counsels a variety of International clients providing clearance, enforceability, validity opinions and licensing matters.

Mr. Callahan has lectured widely on U.S. Intellectual Property Laws. He has lectured for Practicing Law Institutes the U.S., Korea, Japan among other countries on topics including opinion writing, and on generic drug litigations.

Mr. Clifford Mass:-Mr. Mass did his masters in Chemistry from University of Pennsylvania during 1972 and J.D. from Emory University in 1977. He was admitted to Bar during 1977 and was registered to practice before US Patent and Trademark Office during 1988. Mr. Mass has represented his patent clients in various courts and has sucessfully represented the applicants in large number of Patent Appeal wherein the Board of Patent Appeals and Interferences reversed an Examinar’s decision. Mr. Mass is a Senior Partner in Ladas & Parry, which has played an important role in World Intellectual Property Practices for over 90 years.

SCHEDULE

Duration : Six Day

Dates : 11th to 16th April, 2005

Fees : Rs. 25000/-
Per Participant (Non- Residential for Indian Delegates)

US $ 700 per participant
(Non-Residential for foreign delegates)

For Residential Stay - Additional:
Rs. 10000/- Per Participant for Residential-stay for Indian delegates(Lodging & boarding, stay from 10th April to 16th April before noon, with Independent A/C Room)

US $ 300 Per Participant for foreign delegate(Lodging &
boarding. Stay from 11th April to 16th April before noon, with Independent A/C room)

Venue : Institute of Intellectual Property Research and Practice
Plot No. B-28, Sec- 32, Institutional Area, Gurgaon.
and Hotel Bristol-Gurgaon as required, transportation arrangement would be made by the Institute as required.

For any query : Mr. Vinod Khurana, Secretary General
write to : at iiprp@sify.com or khuranavinod@yahoo.com
Mobile No. 9810281321

Note : Residential accommodation is assured only for delegates whose confirmation is received by 6th April, 2005.

Who Should Attend

Representatives from Chemical and Pharmaceutical Industry in the field of Research and Developement, Patent Professional and Counsultants. Patent Attorneys in the Law Firms and in the field of Practice.

PROGRAMME
Day 1.
1. General Introduction;
The U.S. legal system; constitutional requirements - separation of powers: functions of executive, legislative and judicial branches; the role of government agencies; state and federal law - federal preemption
Bonito Boats v Thundercraft; Purpose of the Patent System
Differences from other types of intellectual property protection; the role of the state; the nature of the patent document; the importance of defining the scope of protection; chronology,

2. Patentable Subject Matter and Utility
The basic nature of what is patentable; biological inventions, medical methods, and plant patents. The PTO requirements for credible, substantial and specific utility. 35 USC 101
Diamond v. Chakrabarty, State Street v. Signature, (Fed Cir),, Brenner v. Manson,. University of Rochester v. G.D. Searle

3 Written Description/Enablement/Best Mode;
Different purposes of specification (description) and claims (definition).
Description must be sufficient to enable the invention described to be utilized without "undue experimentation"; the requirement for a "written description" of the invention is separate from the enabling disclosure requirement; what is the "best mode"? Drafting an application to avoid future problems. 35 USC 112 paragraph 1

in re Fisher, in re Wands, in re Wallach; Gennentech v. Novo Nordisk; ; Eli Lilly and Co. v. Barr Laboratories Inc.

4. Start of Running Problem

Assume that a client advises that it has found that a single nucleotide polymorphism in a gene is associated with psychiatric disorders. The gene is one that codes for an enzyme involved in serotonin production and the polymorph produces an inactive protein. What is potentially patentable? What lines of research should the client pursue to establish a basis for the strongest patent protection? What searching should be done to assist in designing development plan? .
Day 2

1. Novelty and Statutory Bars I
Difference between novelty (first to invent) and statutory bars denying patentability even if one is first to invent 35 USC 102(a) and (b). Publication, public use and the "on sale" bar; the experimental use exception.
Titanium Metals v. Banner, in re Klopfenstein; Allied Colloids v. American Cyanamid; In re Cruciferous Sprout Litigation. Abbott Laboratories v. Geneva Pharmaceuticals.

2. Novelty and Statutory Bars II
Patentability destroyed by abandonment of one's invention, grant of patent to another on basis of prior filing or prior filing by oneself abroad giving rise to patent before U.S. filing date if foreign patent application filed more than one year before U.S. filing date, treatment of interfering applications by different persons each relating to the same invention; 35 USC 102 (c), (d), (e). (f) and (g).

in re Kathawala, in re Hilmer,Singh v. Burke, Fiers v. Revel

3. Double Patenting
Day 3
1. Obviousness
Patent not granted for what is obvious over prior knowledge, use etc. Tested by what is obvious to person having ordinary skill in the art. Distinction between "prima facie" obviousness and final determination of obviousness. Role of "secondary considerations" in final determination of obviousness. Motivation. Issues of structure v. function in the chemical and biochemical arts. "Obvious to try" - requirement for reasonable expectation of success. Obviousness over work of co-workers

Graham v. Deere, U.S. v. Adams, inre O’Farrell, In re Vaeck, Yamanouchi Pharm. Co. v. Danbury Pharmacal, In re Dillon, In re Deuel, In re Baird

2. Claims;
Types of claims: role of transition language in defining scope of claim; use of functional language in claims. 35 USC 112 paragraph 2
Orthokinetics v. Safety Travel Chairs, Standard Oil v. American Cyanamid, Unique Concepts v Brown,

3. Inventorship and ownership
Need for care in determining true inventors; rights of inventors. 35 USC 116 -118, 256 -262
Preparation of claim for discussion in class.
Burroughs Wellcome v. Barr; U.S. Surgical v. Ethicon, Stark v. Advanced Magnetics Inc
4. Running Problem II

Drafting claims based on the conceptual possible inventions identified on day 1 in the light of results of "prior art search"

Day 4

1. Patent Office Procedure

Formal requirements of a patent application; restriction requirements and division; final rejections and use of continuation or continuing prosecution applications; appeals; use of declarations to establish prior invention to overcome prior art, outline of interference practice.

2. Patent Term and Possible Extension

3. Review of File Wrappers of two US patents
4. Overcoming Rejections
Especially those based on written description and obviousness issues.

5. PCT and TRIPs

6 Running Problem III : Responding to objections raised to claims drafted

Day 5

1 Infringement
Literal infringement; doctrine of equivalents, limitations of the application of the doctrine of equivalents; indirect infringement; specific statutory provisions relating to infringement; willful infringement. 35 USC 271, 295

Warner-Jenkinson v. Hilton Davis; Graver Tank v. Linde Air Products; Wilson Sporting Goods v. David Jefferey; Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co (Fed. Cir and Sup Ct).; Dawson Chemical v. Rohm & Haas,;

2 Remedies; Defenses;
Implied licenses, repair v. reconstruction, inequitable conduct, means of amending claims or correcting errors in granted patents by re-examination or reissue, requirements for reissue. 35 USC 281 - 289, 251-252, 302 - 318

Orr v Littlefield; Panduit Corp v. Stahlin; Rite-Hite v. Kelley;

3. Reissues, Re-examination and Correction
Quantum v Rodime; Hewlett-Packard v. Bausch & Lomb

4 Patent Litigation
Federal Court System, Pleadings, Discovery, Markman Hearings, Trials, Appeals, Federal Rules of Civil Procedure, Federal Rules of Evidence
Markman v. Westview, Daubert v. Merrill Dow Pharmaceuticals

5. Consideration of a potential infringement issue with respect to the Running Problem.

Day 6

1. Licensing and Patent/Antitrust Issues
Overview of Sherman and Clayton Acts as they apply to patent law and in particular to patent licensing; consideration of issues that arise in patent licensing
DOJ/FTC Antitrust Guidelines for Licensing Intellectual Property
Continental TV v. GTE Sylvania; Morton Salt v. Suppinger; Brulotte v Thys, Aronson v. Quick Point; Nobelpharma v. Implant Inovations; Lear v. Adkins; Mallinckrodt v Medipart

2. Consideration of a potential licensing issue with respect to the Running Problem.

3. Landmark Cases in relating to Pharmaceutical Inventions

4. Sharing of Delegates Experiences and lessons learned.

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