LAW, JUSTICE AND DEVELOPMENT WEEK 2011 INNOVATION AND EMPOWERMENT FOR DEVELOPMENT November 14-17, 2011 Washington DC LJD LAW JUSTICE and DEVELOPMENT

Intellectual Property: Facilitating Technology Transfer for Development Roy F. Waldron Senior Vice President & Chief IP Counsel Pfizer Inc. 2LJD WEEK 2011 INNOVATION AND EMPOWERMENT FOR DEVELOPMENT

3 Outline  The TRIPS Agreement: Creating the Right Framework for Technology Transfer?  What Factors are Conducive to Tech Transfer?  The Future: The Role of Pharmaceutical IP and Tech Transfer in an Evolving Landscape.  Q & A

4 TRIPS Articles 7 & 66.2 Explicitly Addresses Tech Transfer Article 7.  IP should contribute to: – the promotion of technological innovation; – to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge; in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

TRIPS contd LJD WEEK 2011 INNOVATION AND EMPOWERMENT FOR DEVELOPMENT5 Article 66.2 Developed country Members shall:  provide incentives to enterprises and institutions for the purpose of promoting and encouraging technology transfer to least-developed country Members. Article 66.2 Developed country Members shall:  provide incentives to enterprises and institutions for the purpose of promoting and encouraging technology transfer to least-developed country Members.

6 Rationale?  Assurance of a favorable environment for investing and transferring their technology.  A common baseline understanding of IP rights globally.  To provide its trading partners with protections and certainties to ensure fair competition through a regime of IP rights. IP creates a framework for rapid dissemination of ideas and efficient technology transfer

7 But why is IP critical for Tech Transfer?  Effective IP protection provides predictability and the ability to license and enter into contracts;  Such protection is critical for technology-intensive & high risk sectors such as the pharmaceutical industry;  Willingness to invest in value-added production and R&D facilities is directly linked to the strength and effectiveness of their intellectual property systems.  Effective IP protection provides predictability and the ability to license and enter into contracts;  Such protection is critical for technology-intensive & high risk sectors such as the pharmaceutical industry;  Willingness to invest in value-added production and R&D facilities is directly linked to the strength and effectiveness of their intellectual property systems.

8 Factors conducive to Pharmaceutical TT  Appropriate IP protection = Key  Stable business environment with predictable rights  Predictable regulatory standards and practices  Governments to committed to education and building a highly skilled workforce  Alignment with government’s economic development priorities

9 Does TT help Developing countries? The Economic Landscape is Evolving  The economies of developing countries growing fast– By World Bank estimates, GDP is projected to accelerate from 3.8 percent in 2010 to 4.6 percent in  Technology transfer has the potential to play a major role—including in the area of pharmaceuticals to help move LDCs to the next stage of development.

10 Potential Benefits of Pharmaceutical Tech Transfer in Developing Countries  Create strong alliances and collaborations  Strengthen local R&D  Robust IP lowers the barriers to the timely launch of innovative medicines  The more a local economy is able to attract foreign direct investment

11 Real-Life TT Examples from Industry  Licensing – Recently launched WIPO Re:Search Consortium for R &D for NTDs – ViiV (HIV joint venture between Pfizer and GSK) provides royalty free licenses on its innovative current and pipeline HIV medicines to generic companies.

Tech Transfer Examples contd  Innovative Partnerships: – Vaccine Development: GSK’s partnership with Brazil’s Oswaldo Cruz Foundation (Fiocruz) to develop and manufacture vaccines for pressing public health priorities in Brazil – Pfizer’s research partnership with DNDi - Scientists in institutes affiliated with DNDi will test at least 150,000 compounds in the Pfizer library against parasites that cause key neglected diseases. LJD WEEK 2011 INNOVATION AND EMPOWERMENT FOR DEVELOPMENT12

13 Examples Continued  Capacity Building – Pfizer and other companies participate in the WHO TDR Career Development Fellowship Program in partnership with the Gates Foundation to train researchers and public health professionals from disease-endemic countries. – Pfizer’s Global Health Fellows - More than 250 Pfizer colleagues have served in capacity building assignments with 30 international organizations since 2003.

14 Concluding Thoughts IP provides a critical framework for developing tech transfer and ought to be viewed as a tool that can aid in social and economic development—including: – building technological capacities – providing for early dissemination of information on innovative technologies – creating innovative ways to incentivize open models of collaboration – developing a strong platform for new types of positive partnerships; – Facilitating technology transfer arrangements to help move these countries to the next level of economic development

Thank you! LJD WEEK 2011 INNOVATION AND EMPOWERMENT FOR DEVELOPMENT15

16 Other TT examples in the Pharmaceutical Industry  Merck and China (private-public): Hepatitis B vaccine - agreement made with Shenzen Kantai Biological Products Co. in Shenzen, China  Lilly and China (Hisun), South Africa (Aspen), Russia (SIA) (private- public/private/private): transfer of technology for a Tuberculosis drug known as capreomycin  Merck and Shanghai Biochip (private-private): transfer of technology for the field of gene expression in profiling oncology  GSK and Jiangsu Walvex Biotechnology in China (private-private): formed a joint venture to develop pediatric medicines for use in China. The main drug being manufactured at Walvex will be Priorix. GSK is contributing almost $60 million to the collaboration.  Bristol-Myers Squibb and South Africa (Aspen) (private-private): transferred intellectual property and technical expertise to the manufacturing, testing, packaging, and handling of the active pharmaceutical ingredients for HIV products. Bristol-Myers Squibb has an official policy to wave its intellectual property on all HIV-related drugs in the Least Developed Countries (as defined by the UN).  Roche AIDS Technology Transfer Initiative (private-public): helps lower income nations in sub-Saharan and Southeast Asia manufacture second-line AIDS therapies  Gilead and Emcure, Hetero, Strides Arcolabs and JB Chemicals and Pharmaceuticals, Ltd. (private-private): production of generic equivalents for ninety-five low-income countries, including India.