Collaboration in a Public Private Partnership in R & D for Public good

1. Collaboration in a Public Private Partnership in R & D for Public good Conference on Dispute Resolution in International Science and Technology Collaboration WIPO, Geneva 25 April 2005 P V Venugopal Director (International Operations) Medicines for Malaria Venture (MMV) Web: www.mmv.org

2. MMV’s mission “Medicines for Malaria Venture is a not-for-profit foundation dedicated to reducing the burden of malaria in disease endemic countries by discovering, developing and delivering new affordable antimalarials through effective public-private partnerships.”

3. Long road to a new medicine Registration Clinical Data Analysis Full Development Studies in 100-300 Patients (Phase II) Candidate Medicine Tested in 3-10,000 Patients (Phase III) Large Amounts of Candidate Medicine Synthesized Extensive Safety Studies Candidate Studies in Healthy Volunteers Phase I Formulations Developed Exploratory Development Early Safety Studies Project Team and Plans Synthesis of Compounds Screening Discovery

4. MMV’s global network of R&D partnership

5. GSK at Tres CantosCollaboration Partners in R & D Courtesy: GSK Tres Cantos

6. A Public-Private Partnership for the Discovery and Development of Anti Malarial Drugs Public • MMV Input • $$$ • Drug Profile • Background IPR • Link to WHO/Policy • Malaria Expertise • MMV Gets • Rights in DEC • IPR in ‘Field’ • Drug Supply • Return on non DEC Sales Joint R&D • Pharma • Chemistry IPR • Toxicology • Know How • Assets in Kind • Technology • Pharma/Bio Gets • Rights in non DEC • IPR outside ‘Field’ • PR Benefit • HR Benefit • Validation of • Technology Private

7. Project team: University of Nebraska Swiss Tropical Institute Monash University Roche/Basilea Ranbaxy Laboratories + Outsourced Support Cideim St George’s Hospital Medical School Quintiles Pharmalytics Inveresk Unimark RCC Fulcrum Basilea Cerb Cerep Maccine MDS ICGEB MMV Synthetic Peroxide Project - an example of International Partnership

8. Pharma Companies University / Public Research Institution Scientists Public Private Partnerships Government Profit* Recognition, more research scientists, creation of facilities Fame, money, ability to add research students to team Public Health, Public good Political gains / Recognition Priorities are not the same for different partners *MMV had to drop a Project because of the Pharma partner’s insistence on profit

9. ‘Ideal Agreements?’‘Prevention better than cure’ – It is better to go into all details before finalizing the Agreement of Collaboration, in order to avoid disputes later** • Create better understanding among all the partners and clarify all aspects before the commencement of collaboration • Specify in the Agreement the mode of action in respect of all points of possible causes of dispute: e.g. use ‘outside field’ of a Pharma NCE under development, ownership of IPR created during collaboration etc. • Give due credit to the Scientists (generally in Universities / Academic Institutions) whose original idea is being ‘commercialized’ • Ensure that both the individual scientist (s) and the University / Institution benefits from the collaboration. • Respect the ‘sensibilities’ of all partners in respect of multiparty Agreements ** There are examples of Agreements which have taken over a year in negotiation. It is actually worth disputes are avoided later.

10. Thank you