OECD sets guidelines for genetic invention licenses
On Feb. 23, the OECD Council adopted guidelines for the
licensing of genetic inventions. The guidelines present principles
and best practices for intellectual property licenses directed to
facilitating access to genetic inventions and increasing the
dissemination of genetic information derived from those
By Jeffrey A.
McKinney/Special to The National Law Journal|August 28, 2006 at 12:00 AM|Originally published on National Law Journal
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On Feb. 23, the Organization for Economic Co-operation and Development (OECD) Council adopted guidelines for the licensing of genetic inventions. See Guidelines for the Licensing of Genetic Inventions (OECD, Paris, 2006), www.oecd.org/sti/biotechnology/licensing . The guidelines present principles and best practices for intellectual property licenses directed to facilitating access to genetic inventions and increasing the dissemination of genetic information derived from those inventions. Policies informing the principles and best practices include a need to stimulate research through assurance of an adequate return on investment for biotechnology companies; a desire to encourage research by a broad range of scientists, especially those not involved in the conception of fundamental genetic inventions; and a hope that low-income countries will be able to utilize such inventions to further development of a health care system. The stated policies are well-intentioned, and each appears both reasonable and reachable when considered alone. It is the concurrent pursuit of all three that raises issues, which are discussed below. On Dec. 14, 1960, a Convention on the Organization for Economic Co-operation and Development was signed in Paris. See www.oecd.org . It came into force on Sept. 30, 1961, and delineated the mission of the OECD: “(a) to achieve the highest sustainable economic growth and employment and a rising standard of living in Member countries, while maintaining financial stability, and thus to contribute to the development of the world economy; (b) to contribute to sound economic expansion in Member as well as non-member countries in the process of economic development; and (c) to contribute to the expansion of world trade on a multilateral, non-discriminatory basis in accordance with international obligations.” OECD Convention, Art. I. There are currently 31 member states to the OECD Convention, and the organization has active relationships with 70 other countries. The OECD is well-known for its country surveys and reviews; it attempts to lay the groundwork for multilateral agreements through the production of internationally agreed-upon instruments, decisions and recommendations. The OECD’s governing body, the council, is made up of representatives from member states. The Guidelines for the Licensing of Genetic Inventions were an outgrowth of an earlier OECD initiative. The OECD held a workshop in January 2002 directed to whether patents granted for genetic inventions, and resulting licensing practices, were unduly affecting access to information, products and services for researchers, clinicians and patients. See Genetic Inventions, Intellectual Property Rights and Licensing Practices: Evidence and Policies (OECD, Paris 2002). Participants in the workshop found that IP systems were largely functioning as intended with respect to health care purposes. Innovation and the disclosure of information were being stimulated, and there was no evidence to suggest common licensing terms were undermining such objectives. A specific concern related to access to genetic-based, diagnostic tests, however, was identified. This concern served as a basis for the subject licensing guidelines. Prominent provisions In terms of principles and best practices, the guidelines are divided into five categories: “Licensing Generally,” “Healthcare and Genetic Inventions,” “Research Freedom,” “Commercial Development” and “Competition.” Under “Licensing Generally,” principles B.1.A and B.1.C stand out. Principle B.1.A provides: “Licensing practices should foster innovation in the development of new genetic inventions related to human healthcare and should ensure that therapeutics, diagnostics and other products and services employing genetic inventions are made readily available on a reasonable basis.” B.1.C provides: “Licensing practices should provide an opportunity for licensors and licensees to obtain returns from their investment with respect to genetic inventions.” The annotations provide further insight into the espoused principles and best practices. Annotation 1.14, for instance, states: “[T]he Principles encourage licensing practices that make available genetic inventions on a reasonable basis. In certain circumstances, such as in the cases of health crises or health emergencies, licensors or licensees may determine not to seek a financial return, thus determining to make the genetic invention available for free or at cost.” Two more notable principles and a best practice appear in the section on “Healthcare and Genetic Inventions.” B.2.A provides: “Licensing practices should seek to strike a balance between the delivery of new products and services, healthcare needs, and economic returns.” B.2.D states: “Licensing practices should encourage appropriate access to and use of genetic inventions to address unmet and urgent health needs in OECD member countries and non-member countries.” And B.2.1 provides: “Rights holders should broadly license genetic inventions for research and investigation purposes.”
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