1. Ownership of genetic materials, and benefits sharing (ATRIP, 4 August Session 3) Robert Kneller, J.D., M.D. Professor, Department of Intellectual Property Research Center for Advanced Science and Technology (RCAST) University of Tokyo kneller@ip.rcast.u-tokyo.ac.jp

2. 4 August 2003Robert Kneller ATRIP Session 32 5 hypothetical cases

3. 4 August 2003Robert Kneller ATRIP Session 33 Case 1 A UK woman with family history of leukemia is asked to take part in large scale epidemiology survey: Her blood is collected for genetic and other studies. Family history and lifestyle data are also collected. It is unlikely that a commercially valuable gene, protein, etc. will be discovered.

4. 4 August 2003Robert Kneller ATRIP Session 34 Case 2 A US patient with rare form of leukemia, seeks surgical care: Surgeons think that the patient’s tissues will be useful for discovering new drugs. Some of the patient’s cancerous cells are removed and analyzed in the course of standard surgical treatment.

5. 4 August 2003Robert Kneller ATRIP Session 35 Case 3 Same situation as (1), except that the donor is a member of a small tribe in a developing country, and blood samples are collected under a collaborative project involving a Japanese university. The blood samples are to be analyzed in the Japanese university.

6. 4 August 2003Robert Kneller ATRIP Session 36 Case 4 Same situation as (2) except that the patient is a member of a small tribe in a developing country, and the analysis of his cancer cells will be done in a Japanese university under a cooperative research agreement.

7. 4 August 2003Robert Kneller ATRIP Session 37 Case 5 Same situation as (3), but this is a small collaborative study focusing on this tribe. Information from tribal members is valuable for determining the hereditary pattern and other information related to the disease. These factors make this tribe a unique and valuable focus of research.

8. 4 August 2003Robert Kneller ATRIP Session 38 Suppose: The researchers in the UK, US or Japan discover a receptor on one of the donor’s cells that may be the basis for a way to diagnose and treat this type of lymphoma. They apply for a patent on the receptor. Eventually (and unexpectedly) a drug is developed that is effective against this and other types of lymphomas.

9. 4 August 2003Robert Kneller ATRIP Session 39 Questions for all 5 cases According to current laws, who probably owns the patent on the cell-surface- receptor? Who ought to own the patent? What would be a practical and fair way to allocate rights and benefits?

10. 4 August 2003Robert Kneller ATRIP Session 310 Importance of ownership for the researchers who collect the blood: Allows them freedom to do important research. Allows them to sell or license the patent rights to a company that will develop a drug based upon the receptor. Without exclusive patent rights, it is unlikely the company will obtain the private investment needed for its development work.

11. 4 August 2003Robert Kneller ATRIP Session 311 Importance of ownership for the blood donor: Control over use of what was once part of his/her body (autonomy). Confidentiality (especially, protection of privacy and prevention of discrimination). Maybe control can increase access to medical care or medical information. Right to share in commercial benefits.

12. 4 August 2003Robert Kneller ATRIP Session 312 Main points: Donors probably have no ownership rights. But access to medical care, medical information, and commercial benefits may be more important. Bargaining and contractual agreements probably are the best hope for donors of tissue samples. Technology transfer to LDCs is called for under the Doha Declaration Developing country governments are enacting laws to ensure governmental organizations share in benefits. Some developed country organizations are promoting benefits sharing.