Intellectual Property Rights and Pharmaceuticals

(Following Up the ‘Novartis case’ )

Background note prepared for PHM Vic Internet Workshop

Next hearing is on 26th March in Madras High Court while final ruling is expected after a month

Can legislature specify and comment on derivative for which patent application was made? Or should it decide on facilitating Controller of Drugs to use his discretion either to grant or reject patent application?

Is availability of generic version a solution?

What order a Court should pass provided a given provision of Patent law is found to be TRIPS-violative?

Can an individual/company challenge a national legislation on the basis that it is anti- TRIPS, while member countries have provision to take such issues to a specific board (dispute resolution) of WTO?

30% enhancement in efficacy, which might be sufficient for anti-cancer drug, can not be laid down as criterion for all patent seeking products uniformly.

Summary of Recommendations by

Report of the Commission on Intellectual Property Rights,

Innovation and Public Health

that can serve as guiding points to think about what action

should we frame

Public health research institutes/Universities in developed world should,

-focus on issues/areas that are of concern to developing world -tie up with research institutes /Universities /private sector organizations in developing country -adopt policies that make it easier to transfer its R&D outcomes to developing world (technology transfer)

Increased funding, political will and policies to upgrade research infrastructure in developing countries and to promote research around public health issues of concern in a way that innovations fit into socio economic context of developing world.

Support from developed country government and NGOs and other donors in strengthening clinical trials and regulatory infrastructures and standards in developing countries

Effective pricing policies to make health care products available at consistently low and affordable prices (equitable pricing) in developing countries

Efficient health system research, improvement in health delivery infrastructure and Incentives to retain health workers in employment in developing countries

Patent offices should have detailed information on traditional medical knowledge and should involve traditional knowledge holders in deciding how to use it for innovative purpose

WHO, WIPO and other international orgs should create a pool of patents and available information and should work towards creating sustainable funding to facilitate research around relatively neglected issues of developing world.

Health ministry should play crucial role in negotiating any bilateral agreements and such agreements should avoid Trips Plus measures that can impede access to drugs

Developing countries should make use of public health measures (flexibilities in TRIPS agreement) in light of their own circumstances to assure access to affordable medicines {pro competitive measures, parallel import, provision to facilitate generic entry on patent expiry (early working exception), avoidance of data exclusivity etc.}

CGIAR (Consultative group on International Agricultural Research) includes OECD governments, World Bank, International Orgs and developing country governments (with majority of fund coming from OECD nations) which acts as a central funding agency to fund research around issues of concern in developing countries and also act as a body to facilitate priority setting, monitoring and evaluating as well as advocacy work. Many organizations and previous reports have made suggestion to develop similar body for public health research.