This presentation examined the role of Material Transfer Agreements in bioprospecting relationships. Also covered were issues on benefits sharing under the Convention on Biological Diversity and the implementation of the CBD.

1. MTAs: A Key to the Bio-Prospecting Challenge Marcel D. MongeonIntellectual Property Coach

2. Outline MTAs and provisions The ‘model’ MTA Access and Benefit Sharing The reality of CBD Implementation

3. SomeIdeas Bio-Prospecting: the collection and screening of plant and other biological material for commercial purposes, such as the development of new drugs, seeds and cosmetics Ethical bio-prospecting accessing natural resources through legal means, securing prior informed consent from the custodians of the relevant natural resources, and promoting equitable benefit-sharing with the appropriate parties Unethical bio-prospecting, or Biopiracy: the uncompensated (and unauthorized) commercial use of biological resources and/or associated TK from developing countries, as well as the patenting by corporations of claimed inventions based on such resources or knowledge

4. Material Transfer Agreements Helps document ‘ethical’ bio-prospecting Scientific obligation on publications which applies even to companies is to make material “freely available” Provides transfer of material and then creates legal obligations

5. The Reality of MTAs Hundreds or thousands are signed Little (if any) auditing or follow-up What Kenyan resources exist to audit or track all outbound material transfers? Especially in Europe and North America? Would your foreign missions know what to look for?

6. MTAs: Terms and Conditions Definitions of Material Restrictions on Recipient’s use of the Material Provider’s rights to inventionsand research results Confidentiality Providers access/restriction on reports and publications Warranty disclaimer and indemnification

7. MTAs: Use WHO - distribution restrictions WHAT - Material and project THIRD PARTY funding - IP Options “Commercial Purposes”

8. MTAs: Intellectual Property Ownership or sharing of inventions Right of First Refusal vs ‘more favourable terms’ Normally under patent rules, provision of base material would not create ownership rights What happens if patents are filed in spite of MTA? What Kenyan resources exist to sue in foreign jurisdictions?

9. MTAs: Use of Research Data Obligations to submit a report Use of data and confidentiality Ownership of data Links to Confidentiality and IP Issues

10. The ‘Model’ MTA KEMRI MTA The uBMTA Company models University models

11. Access and Benefit Sharing Important concept in Convention on Biological Diversity But, what is commercial reality? Valuation of early stage research: 50% rule of thumb: At introduction of market-readyproduct 50% of risk remains. Earlier stages have even higher levels of risk Benefits are likely to be single digits at best

12. The Current Status of TK/IK WIPO was advancing issue as part of emerging economies agenda In part, TK/IK is used as a balance to developed economies ownership of patents/copyrights etc The discussions have broken down on TK/IK Inability to agree what it means

13. What is TK/IK? Under existing IP regimes, various implications Most have fixed terms of protection Challenge with TK/IK is infinite term is sought Then the law of unintended consequences Is there other TK/IK that people will claim rights to? i.e. the Alphabet?

14. My Approach to TK/IK Use existing rules: Patents Prior Art Projects to document Copyrights/TMs  Unauthorized Use Need to begin suits as appropriate

15. Best Benefit Sharing Approach Don’t let material out of Kenya! Do the work here Establish research base in the area Make the developments here in Kenya Then benefit sharing is a minor issue

16. Current Status of CBD Although US is signatory, not ratified Therefore, no legal effect in US Will be resistance to patent disclosure Reality is CBD is largely ignored by US patent system

17. National Rights Sometimes useful to explore history of IPRs In 1850s who was largest infringer of IPRs? In 1950s? In 1990s? Is it reasonable national policy to be an IP Infringer? Real issue is need to protect own IPRs As countries generate IP, they will protect

18. Your National Question If you want to abide by international IP rules it only works if you are generating IP Generation of IP requires government and corporate investments in scientific research

19. Marcel D. Mongeon +1 (905) 481 0133 UK: +44 (0) 1905 70 1818 marcel@mongeonconsulting.com Questions?