Biotechnology / Life Sciences Ensuring Access Christina Sampogna July 2005 CASRIP – University of Washington, Seattle *Views expressed are those of the author and not necessarily of the OECD Copyright OECD, 2005 BIOTECHNOLOGYDIVISION

Some Policy Challenges Development of internationally recognised and mutually compatible best practice policies for quality assurance for genetic testing Exploration of broader implications of developments in pharmacogenetics Guidance on the structure and governance of human genetic research databases, particularly with respect to issues of privacy and security Examination of possible impacts of restrictive licensing practices BIOTECHNOLOGYDIVISION

Trends in biotechnology patents: total & main regions BIOTECHNOLOGYDIVISION

Draft Guidelines for the Licensing of Genetic Inventions Origins –widespread debate over the efficacy of patents covering genetic inventions and over the licensing practices employed with respect to these inventions –concern/debate over whether patents and licensing practices were effectively fostering innovation – or stifling it? BIOTECHNOLOGYDIVISION Version of Draft dated March 2005

Draft Guidelines for the Licensing of Genetic Inventions Objectives Guidelines establish a set of principles and best practices intended to assist the private and public sector, such as universities, research labs, etc., –in the consideration of whether or not to license; and –in the negotiation of licensing agreements or material transfer agreements with the intent to promote the divers interests in a balanced manner. BIOTECHNOLOGYDIVISION Scope Guidelines intended to apply to the licensing of intellectual property rights that relate to ‘genetic inventions’ used for the purpose of human health care. Definition of “Genetic Inventions” Version of Draft dated March 2005

Draft Guidelines: General Licensing Practices (LP) LP should foster innovation in the development of new genetic inventions related to human health care and should ensure that therapeutics, diagnostics and other products and services employing genetic inventions are made readily available on a reasonable basis. LP should encourage the rapid dissemination of information concerning genetic inventions. LP should provide an opportunity for licensors and licensees to obtain returns from their investment with respect to genetic inventions. Licensees and licensors should have reasonable certainty over their rights and the limitations to those rights in relation to genetic inventions. BIOTECHNOLOGYDIVISION Version of Draft dated March 2005

Draft Guidelines: Health Care and Genetic Inventions Licensing practices (LP) should seek to strike a balance between the delivery of new products and services, health care needs, and economic returns. LP should ensure that patients benefit from the highest applicable standards with respect to privacy, safety and good laboratory method available pursuant to the laws of their jurisdiction or those of the jurisdiction of the service provider. LP should not be used to restrict the choice of other products or services available to patients and their health care providers. Licensees and licensors should encourage appropriate access to and use of genetic inventions to address unmet and urgent health needs in developing and developed countries. BIOTECHNOLOGYDIVISION Version of Draft dated March 2005

Draft Guidelines: Research Freedom Commercial considerations in public research activities should not unduly hinder the academic freedom of researchers. Commercial considerations in public research activities and, in particular, the need to preserve the opportunity to seek patent protection on inventions arising from these activities, should not unduly limit the ability to publish in a timely manner the results of research. Commercial considerations in public research activities should not unduly limit the educational training of students. BIOTECHNOLOGYDIVISION Licensing practices should increase access to genetic inventions for research purposes. Version of Draft dated March 2005

Draft Guidelines Commercial Development Foundational genetic inventions should be broadly licensed. Licensing practices should be used as an effective means to create value for licensors and licensees through the development of new products and services from genetic inventions. Licensing practices should strive to overcome co-ordination problems resulting from the need to access multiple genetic inventions. BIOTECHNOLOGYDIVISION Version of Draft dated March 2005

Draft Guidelines: Competition Licensing practices pertaining to genetic inventions should foster economic growth through innovation and substantive competition, while complying with the applicable competition laws. Licensing practices should not be used to expand the breadth of exclusive rights beyond the scope of the relevant intellectual property rights. BIOTECHNOLOGYDIVISION Version of Draft dated March 2005

Conclusion & Future Work Draft Guidelines –Conclusion & Next Steps seek to foster the development, delivery and access to the products and services based on genetic inventions, such as therapeutics and diagnostics, in order to more effectively and efficiently address health care and research needs in both OECD member and non-OECD countries. Future Work BIOTECHNOLOGYDIVISION

THANK YOU! Christina Sampogna Biotechnology Division (DSTI) OECD 16, rue Andre Pascal 75016, Paris, France – Tel: Website: BIOTECHNOLOGYDIVISION