Innovation and Intellectual Property in the Biosciences

Intellectual Property Policies and Practices in the Life Sciences: International Aspects and Implications
Intellectual Property Policies and Practices in the U.S. Crop Biosciences

Intellectual Property Policies and Practices in the Life Sciences: International Aspects and Implications

Evolving intellectual property (IP) policies of governments and organizations are impacting biotechnology sectors and access to genetic materials for development of pharmaceuticals. The National Institutes of Health, through the Human Genome Project among others, specifically recognizes the need for policy options in the area of intellectual property to facilitate the widespread use of genetic and genomic information in both research and clinical settings. Unfortunately, the empirical evidence on the impact of IP on research and development in genetics and genome-related life sciences is thin and under-analyzed. Unanswered questions include:

• What specific biotechnologies are being protected, by whom, in which legal jurisdictions, and how have these patterns changed over time?

• Given the national nature of IP rights, is there a jurisdictional proliferation of IP generally or is it limited to specific, key inventions?

• How much IP in the United States is issued to foreigner inventors, and what is the extent of IP holdings by U.S. inventors in other parts of the world?

• What are the links between IP ownership and its use, and what are implications of policy and institutional designs for generating and accessing this intellectual property?

• Are there situations under which different types of licenses are more or less effective at disseminating different types of technologies?

• Can policy or market interventions such as compulsory licenses, clearinghouses, patent pools, or open source strategies improve, under real-world conditions, over the performance of status quo utility patenting and laizzez-faire licensing markets?

• Are there characteristic technologies for which patents are in fact not an optimal form of IP as an incentive to innovate or as a means for exchange of the resulting technology?

• How do non-patent forms of IP-such as trade secrets or open source contracts-interact with patented technologies?

• Finally, given what we learn in response to these questions, how might the global IP landscape change in the future as empirical patterns of R&D and innovation change and as national and international IP regimes change?

Building on substantial prior research, InSTePP is pursuing funding to analyze the evolving international biosciences IP landscape, emphasizing genetics and genomics and highlighting the changing structure and links among national IP markets. Complementing these empirical cum analytical efforts, the nature and scope of IP available in the United States and other countries will be appraised and contrasted with a view to the implications for generating and accessing key technologies. The analysis will not be limited to legal and policy aspects but will address actual patterns of ownership and exercise of rights, and their linkages with broader economic, technological and trade trends. Issues addressed include the implications of links between IP ownership and use, implications for generating and accessing key technologies, and the types of licenses that are more or less effective at disseminating different types of technologies. We assess policy or market mechanisms that might be preferable to patenting and laissez-faire licensing under certain circumstances, and examine the interactions of non-patent forms of IP-such as trade secrets or open source contracts-with patented technologies.

The outcomes will both inform and influence IP and R&D policies in national and international arenas; in addition, outcomes are expected to influence the development of specific institutional arrangements to facilitate the creation and exchange of genetics and genomics technologies internationally, and to establish effective mechanisms to promote innovation addressing neglected health and nutrition needs and other priorities.

Core Collaborating Individuals and Institutions

Brian Wright
University of California, Berkeley and InSTePP

Carol Nottenburg
Cougar Patent Law and InSTePP

Bonwoo Koo
University of Waterloo and InSTePP

Tony Taubman
World Intellectual Property Organization

Intellectual Property Policies and Practices in the U.S. Crop Biosciences

Providing environment to encourage the incentive for innovation is one of the main policy objectives in many countries, and various forms of intellectual property rights have been implemented for the protection of plant varieties. The United States has the most comprehensive system of protecting plant varieties: a breeder can resort to utility patent, plant patent, plant variety protection or trade secret. Asexually propagated varieties such as fruits, sugar cane and ornamentals can be protected under the 1930 Plant Patent Act, and sexually propagated varieties such as rice, wheat, and soybean are protected under the 1970 Plant Variety Protection Act (and its amendment in 1994). Since the 1980s, both types of varieties as well as their parts can be protected under utility patents, and trade secret was proved to be another means of protecting varieties, especially hybrid varieties, since the ruling of the Pioneer v. Holden seeds in 1994. In addition, recent ruling confirms that plant varieties can be protected both by utility patent and by plant variety protection or Plant Patent (J.E.M. Ag Supply v. Pioneer Hi-Bred International, 2001).

This complicated system creates confusion in choosing appropriate intellectual propriety policies and practices for breeders, scientists and researcher administrators alike and complicates a meaningful international comparison of plant breeders' rights. Building off prior research this research is developing several comprehensive data sets to facilitate a more formal analysis of the different types of protecting plant varieties in the United States, with special attention being paid to examining similarities and differences between the evolving structure of U.S. Plant Patents and Plant Variety Protection Certificates.

Core Collaborating Individuals and Institutions

Bonwoo Koo
University of Waterloo and InSTePP

Jennifer Drew
InSTePP Graduate Research Assistant