Fabienne Orsi

Establishing a new intellectual property rights regime in the United States: Origins, content and problems

Abstract Major changes have been made over the past 20 years in the US intellectual property rights regime. These include the fact that the regime has been opened up to software patents and to business models, on one hand, and to living entities on the other—all within a general environment marked by the relaxation of patentability criteria. They have resulted in major changes in the US system of innovation—more specifically in the increasing privatisation of knowledge domains and activities that were previously public. The changes result from the combined effects of a response to US perceptions of increased foreign competition, of the emergence of major new technological opportunities in biotechnology and ICT, and of a series of regulatory changes that have paved the way for the financial sector’s increased involvement, via direct investments in firms whose main activity is comprised of R&D. Contemporary doubts about the viability of these changes reflect, the harmful long-term economic effect of the privatisation of basic knowledge (especially in the biopharmaceutical sector) and the difficulties that the financial sector has faced in ensuring the sustainability of the necessary pre-conditions that allow for the development of innovation.

TRIPS post-2005 and access to new antiretroviral treatments in southern countries: issues and challenges.

Until 2005 some developing countries with pharmaceutical manufacturing capacities especially India used the transitional period allowing local manufacturers to produce and sell generic versions of first-generation ART drugs patented in industrialized countries and originally produced and sold at high prices by Western pharmaceutical companies. Thanks to international competition between generic manufacturers and these companies significant price reductions were achieved for the large majority of these drugs. This was a key factor in the implementation and strengthening of access to AIDS treatment in developing countries and a strategic element in the World Health Organization (WHO) 3by5 plan. However with the end of the extended deadline for TRIPS compliance the scenario is likely to change radically. Considering the end of the transitional period which effectively will prohibit the free manufacture of newer and innovative antiretroviral generations to mark a key episode in the history of the fight against AIDS in developing countries this review will provide an overview of the meaning and consequences of this turning point and to present some of the new challenges of the post-2005 period. (excerpt)

Soaring antiretroviral prices, TRIPS and TRIPS flexibilities: a burning issue for antiretroviral treatment scale-up in developing countries.

Purpose of reviewThe achievement of significant reductions in the price of antiretroviral drugs constitutes one of the main economic pillars of antiretroviral treatment scale-up in developing countries. Today this economic pillar is threatened. Recent findingsThe prohibitive prices of newer first-line and second-line regimens have created a watershed in relation to the prices of earlier first-line treatments. These price increases are closely related to the World Trade Organizations Agreement on the trade-related aspects of intellectual property rights (TRIPS) that imposes an important barrier to generic competition. Intellectual property flexibilities foreseen by the TRIPS agreement allow the manufacture and supply of affordable generic versions of new generations of antiretroviral under certain conditions. However, the capacity to supply a specified list of generics under such conditions is tight and the utilization of such flexibilities in their current form remains complex and unattractive. SummaryThe TRIPS agreement currently constitutes a significant barrier to providing access to new antiretroviral at affordable prices in developing countries. If the debate on initiatives for increased flexibility of intellectual property rights does not become more extensive or obtain the overwhelming support of the international community, serious consequences are to be expected in terms of the fight against AIDS in most of the developing countries.