This report examines the role played by IPRs in both upstream and downstream phases of the research, development and commercialization of biotechnology products and provides a review and analysis of the existing body of knowledge concerning the role of IPRs.
1) This report was commissioned by the Biotechnology Industry Organization (BIO).
2) This report examines the role played by IPRs in both upstream and downstream phases of the research, development and commercialization of biotechnology products and inventions in developed, emerging and developing economies.
3) The report provides a review and analysis of the existing body of knowledge concerning the role of IPRs more generally as well as specifically in biopharmaceutical and biotechnological innovation.
4) The key findings discussed in the literature include:
There is a growing body of evidence suggesting a positive link between economic development and growth, technology transfer, increased rates of innovation and the strengthening of IPRs. This is particularly strong in certain knowledge-intensive sectors such as biopharmaceuticals.
Much of the international debate on biopharmaceutical innovation focuses on downstream issues: whether IPRs stand in the way of commercialization and whether they enable or delay access to medicines in developing countries. This discussion is usually placed in the context of the "North-South" divide (i.e. developed vs. developing world) and the extent to which the use of IPRs benefits or damages developing countries.
The discussion on the use of IPRs in upstream innovation (or the relationship of IPRs and biotechnology innovation in the context of biotech SMEs and universities) is often theoretical in nature and only at times based on data and collected evidence. Some international debates on IPRs relating to the upstream R&D process also examine the issue of ownership of genetic innovations and biologic materials and so-called research exemptions.
Recent empirical studies and surveys seem to significantly ease ongoing concerns about the extent to which the patent system may be used in a manner that slows or hinders access to biotechnological research and innovation. Still, there is a relative paucity of direct evidence and data on the roles that IPRs play in stimulating biotech research and innovation.
5) Based on these findings, the report discusses and explains the impact of IPRs on biotechnological innovation in the upstream process. It provides an examination of existing and new evidence on how SMEs, universities, spin-offs and biopharmaceutical manufacturers are using IPRs (chiefly patents) in their day-to-day operations.
6) The report outlines how IPRs have encouraged collaboration between biotechnological entities and, as a result, enabled further research and development of new biotechnologies, specifically in emerging and developing economies. In particular, technology transfer mechanisms such as Bayh-Dole styled frameworks are discussed in the context of emerging and developing economies.
7) The key findings that have emerged from this report include:
IPRs, especially patents, are actively facilitating and contributing to upstream and downstream biotechnology activities in both developed and developing countries.
Today, not only mature economies but also major emerging economies are making growing use of the patent system to facilitate biotechnology research and commercialization.
Accordingly, biotechnology alliances for research and technology transfer have increased markedly since the early 1990s.
Case study analysis suggests that strengthening IPRs and introducing technology transfer frameworks based on IPRs in combination with other reforms can have a positive and sustained impact on innovation, economic development and growth, biopharmaceutical R&D and access to biotech products in emerging economies.
8) Based on these findings the report makes the following recommendations:
Focus the spotlight on upstream phases – Understanding the relationship and interaction between IPRs and the upstream phases of biotech R&D is as important as discussing the role of IPRs in the commercialization of these technologies and products. Therefore, attention should also be devoted to upstream processes, not least in international discussions.
A closer look at the nuts and bolts – In this context, we need to deepen our understanding of the mechanics and mechanisms by which IPRs can be used strategically in order to enhance the R&D process.
An enhanced architectural mindset – Policymakers should consider the architectural setting and how the use of IPRs during the upstream process can be optimized.
The needs of emerging economies – Given the growing positive impact of IPRs in emerging and developing economies, there is a real need to increase our awareness and body of knowledge about frameworks, best practices and specific experiences with the use of IPRs during the upstream phases of R&D.
An international observatory of best practices – It is worth creating an international observatory that maps both knowledge as well as instruments that could help galvanize entities around the world to make greater use of IPRs during the upstream phases of biotech R&D.