Summer course

 

International Patent Law and Genetic Resource Policy

 

(Elective course – 1 credit)

August 18 to 23, 2003

by

Shakeel T. Bhatti

 

 

 

Center for Intellectual Property Research and Advocacy

National Law School of India University

Bangalore,  India

 

 

Paper Assignments

 

 

Papers on Access Laws:

            -  Constitutive Elements for Comparative Tables

            -  Example of a Comparative Table:  Part 1 and Part 2

 

Papers on Literature Reviews:

reference lists will be uploaded in the course of the week; please begin with your own literature searches.

 

Length of papers:   7000 to 9000 words

 

Due dates:

Individual assignments:   Monday, September 15, 2003

Group assignments:   Monday, October 6, 2003

 

Format of papers:   A4 paper; 1 ½ spaced;  12 point font Times New Roman.

 

Questions:  please forward to CIPRA by the end of the day on Thursday, August 28, 2003.

 

Paper submissions:  to CIPRA in electronic form (MS Word format) by the due date.

 

 

 

Syllabus

 

Course Description

With the rise of modern biotechnologies, genetic resources have assumed increasing value and there have been growing interfaces between intellectual property law, genetic resource policy and the protection of associated traditional knowledge (TK).  The objective of this course is to give an introduction into the interfaces between patent law and genetic resource policy which are emerging at the international level.  The course will focus on plant genetic resources.  Time will also be spent on the intellectual property protection of traditional knowledge associated with such resources.  The course will include a review of recent international developments in these areas, as well as a comparative study of national and regional laws on patent protection, access to genetic resources and benefit-sharing, and TK protection.

 

 

Course Objectives

The objective of the course is to give a concise introduction into the specialized intellectual property issues arising in the context of the legal frameworks applicable to genetic resources and TK - and into the multilateral processes in which these intellectual property issues are being addressed at the international level. 

 

Evaluation

The evaluation of student performance in this course will be based on written assignments, which will be given to groups or to individuals.  Guidelines concerning due dates, length and structure of the written assignments will be specified during the course.

 

 

Course Sessions

 

Monday, August 17, 2003:

Course objectives, background, overview, conceptual framework, areas of focus

 

Topics covered:

Objectives of the course -  Conceptual Framework for the Course  -  Overview and structure of the Course  -  Background 1:  Importance of genetic resources (GR)  -  Background 2: Linkages between IPRs and GRs  -  Background 3:  Differentiating types of PGRs

 

 

Mandatory Reading

 

 

  1. WIPO/GRTKF/IC/1/3 - “Matters Concerning Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore”  (WIPO Intergovernmental Committee – first session)

click here

Paragraphs 1-22, Annexes 1, 2 and 3

  1. Barton, John H.  “Intellectual Property, Biotechnology, and International Trade”  World Trade Forum, Geneva, April 2000

 

click here

Entire text

  1. Chapter 3 on “Genetic Resources and Agriculture” of the Report of the Commission on Intellectual Property Rights (CIPR)

 

click here

Chapter 3 (“Genetic Resources and Agriculture”)

 

  1. Mali Case Study  -  WIPO/UNEP Study on the Role of IPRs in the Sharing of Benefits Arising from the Use of

click here 

Case Study 1, “Mali”

 

  1. US Patent on Gene Xa21 of Mali Rice

click here 

Claims; bibliographic information; description of the invention

 

 

Recommended Reading

 

 

  1. FAO.  State of the World’s Plant Genetic Resources for Food and Agriculture  (Long version)

 

click here

 

Introduction, Chapter 4, Chapter 5.

  1. WIPO/GRTKF/IC/1/3 - “Matters Concerning Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore”  (WIPO Intergovernmental Committee – first session)

click here

Paragraphs 33-62

  1. Module 2 on “IPRs and Biotechnology” of the APEC Handbook on IP and Biotechnology

click here

Module2 (IP & Biotechnology)

  1. FAO website on plant genetic resources for food and agriculture

Click here

 

 

 

 

Tuesday, August 19, 2003:

International genetic resource policy #1:  

International instruments, fora and processes on genetic resources

 

Topics covered:

Interfaces between IPRs and general genetic resources instruments:

(1)   Overview of international genetic resources policy fora, processes and instruments (including CBD, FAO, UNESCO, WIPO, WTO)

(2)   Brief review of intellectual property instruments:  relevant provisions of the Paris Convention, TRIPS Agreement, Budapest Treaty, and Patent Cooperation Treaty (PCT);

Review of international instruments on genetic resources policy: 

(3)   CBD:  Introduction to CBD;  Bonn Guidelines;  outcomes of the WSSD and negotiations on an “international regime”;

(4)   FAO:  Commission on Genetic Resources for Food and Agriculture (CGRFA); 

(5)   WIPO:  Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore;

(6)   WTO:  TRIPS Council and Committee on Trade and Environment (CTE)

 

 

Reading:

 

Mandatory Reading

 

 

  1. Convention on Biological Diversity (CBD)

click here

Preamble, Art.1-4, 8, 15-19 and 22

 

  1. The Bonn Guidelines on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from  the Utilization

click here

full text, which is part of Decision VI/24 of the Conference of the Parties to the CBD

 

  1. “Plan of Implementation” of the World Summit on Sustainable Development (WSSD)

click here

paragraph 42, in particular 42(o)

 

  1. WTO document WT/CTE/W/125:  “The Relationship between the Convention on Biological Diversity (CBD) and the Agreement on TRIPS, with a Focus on Article 27.3(b)”

click here 

        

full text

 

 

 

Recommended Reading

 

 

  1. Laird, Sarah and Ten Kate, Kerry. The Commercial Use of Biodiversity.  Access to Genetic Resources and Benefit-sharing.  Earthscan, 2001.

Copies will be available during the course

Chapter 2 (p.13-33)

  1. Straus, Joseph. “The Biodiversity Convention and Intellectual Property.” IIC. 24

 

Pages 602-615.

  1. Glowka, Lyle.  A Guide to Designing Legal Frameworks to Determine Access to Genetic Resources. Gland: IUCN; 1998.

click here

Full text

  1. Marrie, Henrietta. The Convention on Biological Diversity, Intellectual Property Rights and the Protection of Traditional Ecological Knowledge. Macquarie University; 1998 Jul 20.

Unpublished dissertation on file with the author

 

 

 

 

Wednesday, August 20, 2003:

International genetic resources policy  #2:  

Plant Genetic Resources for Food and Agriculture (PGRFA)

 

Topics covered:

The International Undertaking on Plant Genetic Resources (1983) -  The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR) (2001):  negotiating history and main provisions  -  The Multilateral System of Access and Benefit-sharing to be established by the ITPGR  -  Farmers’ rights issues related to IPRs -  Intellectual property policy of the CGIAR -  IP policy and agrobiotechnological research in the public and private sectors;

 

Mandatory Reading

 

 

  1. The International Undertaking on Plant Genetic Resources (1983) (“IU”)

click here

Full text

  1. International Treaty on Plant Genetic Resources for Food and Agriculture (2001) (ITPGR)

click here

 

Preamble, Part I, Part III, Part IV, Annex I

  1. International Plant Genetic Resources Institute (IPGRI).  Farmers, Landraces and Property Rights.  World Trade Institute, 2003.

 

click here

Full text

  1. Hawtin, Geoffrey. Management of Plant Genetic Resources in the CGIAR:  Problems, Prospects and the Quest for Equity. 

text will be available during the course

Full text

 

 

 

Recommended Reading

 

 

  1. Barton and Siebeck.  Material Transfer Agreements in Genetic Resources Exchange. International Plant Genetic Resources Institute (IPGRI), 1994.

Click here

Full text

  1. Eberhardt, S. A.; Sands, H. L.; Collins, W., and Lower, R. L., eds. Intellectual Property Rights III:  Global Genetic Resources:  Access and Property Rights. Madison, USA: CSSA; 1998.

 

 

  1. IPR policy pages of the CGIAR website

Click here

 

 

 

 

 

Thursday, August 21, 2003:

Genetic resources and the Scope of Patentable Subject Matter under the TRIPS Agreement

 

Topics covered:

Background and negotiating history of the TRIPS Agreement  -  Art.27.1, TRIPS – Practices of major patent-granting authorities regarding the requirements of patent protection in respect of genetic resource based inventions  -  Art.27.2  -  Art.27.3(b)  -  Optional exclusions and mandatory inclusions of certain genetic resources within the scope of patentable subject matter - 

 

 

Mandatory Reading

          

 

1.      Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS Agreement)

click here

Preamble, Art.1-4, 7, 8, 27-30, 33, 34, 70.8, 70.9

2.      Flitner, Michael and Dan Leskien. Intellectual Property Rights and Plant Genetic Resources: Options for a Sui Generis System. Rome: International Plant Genetic Resources Institute (IPGRI), 1997 (Issues in Plant Genetic Resources; v. 6)

click here

Entire text

 

3.      Adcock, Mike and Llewelyn, Margaret. TRIPs and the Patentability of Micro-Organism. Bio-Science Law Review. 2000; 4(3)

Click here 

Pages 91-101

 

4.      Reichman, J. H. The TRIPS Agreement Comes of Age:  Conflict or Cooperation with the Developing Countries?  Eds. Cottier, Thomas and Mavroidis, Petros. Berne: World Trade Institute, 2000.

click here

Entire text

 

  

Recommended Reading

 

 

  1. Gervais, Daniel. The TRIPS Agreement: Drafting History and Analysis. London: Sweet & Maxwell; 1998

Library

Sections on Art.27 – 31, TRIPS

  1. Otten, Adrian (Intellectual Property Division, WTO). Implementing and Enforcing Trips Obligations.  Cottier, Thomas and Mavroidis, Petros; Berne, World Trade Institute, 2000.

 

Full text

12.    Reichman, Jerome.  Of Green Tulips and Legal Kudzu: Repackaging Rights in Subpatentable Innovations.  2003

Click here

Full text

 

 

 

 

Friday, August 22, 2003:

Linking Patent Law and Genetic Resource Policy:  Emerging Legal and Policy Interfaces 

 

Topics covered:

 

Linkages between patent law and legal frameworks for access to genetic resources and benefit-sharing:  (a) deriviatives and progeny,  (b) genetic parts and components, (c) disclosure requirements in patent applications  -  Comparative analysis of CBD implementation through national and regional access laws  -  Comparative analysis of Art.27 implementation through national patent laws

 

Mandatory Reading

 

 

WIPO/GRTKF/IC/1/6 – Information Provided by Member States on the Legal Protection of Biotechnological Inventions

click here

Annex 1

 

Eberhardt, S. A.; Sands, H. L.; Collins, W., and Lower, R. L., eds. Intellectual Property Rights III:  Global Genetic Resources:  Access and Property Rights. Madison, USA: CSSA; 1998.

click here 

To be announced

 

 

  

 

 

Saturday, August 23, 2003:

Consolidation and Conclusion 

 

Topics covered:

Review and summary of course contents – clarification of pending questions  - assignments and student evaluation – course evaluation.

 

 

 

 

 

 

 

Access and Benefit-sharing Laws for Student Assignments

 

 

Country/Regional Integration Organization

Copy

 

AFRICAN UNION  -

 

 

ANDEAN PACT - 

 

 

ASEAN -

 

 

AUSTRALIAQueensland:

-         Biodiscovery Bill 2003 & Explanatory Notes

-         see also the Voumard Report

 

 

BRAZIL -

 

 

COSTA RICA -

 

 

Cook Islands

NEW!

GAMBIA -

 

INDIA -

 

MALAYSIA -  Sarawak

-         Sarawak Biodiversity Regulation 1998

-         Sarawak SBC Ordinance

-         Export Application Form

-         Sarawak Acc & Coll

-         Research Application Form

-         Sample Research Agreement

-         Sarawak Ethnobiology

 

PHILIPPINES  - Executive Order and Implementing Regulations

 

PORTUGAL -