Ownership of genetic materials, and benefits sharing (ATRIP, 4 August Session 3)

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. 5 hypothetical cases Robert Kneller ATRIP Session 3

3. 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. Robert Kneller ATRIP Session 3

4. 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. Robert Kneller ATRIP Session 3

5. 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. Robert Kneller ATRIP Session 3

6. 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. Robert Kneller ATRIP Session 3

7. 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. Robert Kneller ATRIP Session 3

8. 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. Robert Kneller ATRIP Session 3

9. 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? Robert Kneller ATRIP Session 3

10. 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. Robert Kneller ATRIP Session 3

11. 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. Robert Kneller ATRIP Session 3

12. 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. Robert Kneller ATRIP Session 3