VIAGRA IS A remarkable pharmaceutical object, and an even more remarkable social phenomenon. Its 1998 release was accompanied by media attention on a scale barely precedented for any medicine, let alone one that doesn't actually save lives. It swiftly became a global social phenomenon, turning an embarrassing and sometimes distressing personal condition into a recognized medical problem, susceptible to a pharmaceutical solution. “Erectile dysfunction” went from being a condition that people rarely talked about, to one that they couldn't stop talking about. In doing so, Viagra helped extend the boundaries of medicalization, accelerating the trend to label any deviation from supposedly normal human well being as a condition for which medical treatment, in some form or another, should be available.

What then is Viagra? It cannot be wholly defined by what it is made of, what it is for, by what it looks like, or by what it does when the human body absorbs it—essential features though these might be. But these aside, Viagra's identity, status, and value are determined by the regulatory regimes that control its use, and the intellectual property rights used to protect it. Although we can describe Viagra as a “sildenafilcontaining erectile dysfunction treatment in the form of a blue diamond-shaped tablet,” the drug is a kind-of legal construct created by intellectual property law, whose boundaries are defined by the scope of these rights, the freedoms of others, and the edges of the public domain.

Viagra is a highly specific product in pill form containing a single active ingredient and other substances called “excipients,” which protect the active ingredient on its journey through the body, control its rate of absorption, and enhance palatability. Scientifically, the active ingredient can be identified as l-[[3-(6,7-dihydro-lmethyl7- oxo-3 -propyl-1 H-pyrazolo [4,3 -d] pyrimidin-5-yl)4-ethoxyphenyl]sulphonyl]- 4-methylpiperazine or C22H30N6O4S; and it has the generic pharmaceutical name of “sildenafil citrate.”

To say that Viagra is sildenafil citrate is a simple statement of fact, but it obscures the ränge of ways in which Pfizer has used the intellectual property system to shape our understanding of Viagra. Sildenafil purposely disrupts a naturally occurring enzyme called phosphodiesterase type 5 (PDE5), and the drug was developed initially to deal with disorders like hypertension and angina.

Specific statutory educational use exception

Allows the publication for teaching or scientific purposes up to 1000 words (Emery 2008, sec. 8(2)(b), p. ARG-50).

Specific statutory educational use exception

Exceptions limited to theatrical and musical performances in educational contexts and reproduction of class notes (Pereira dos Santos 2008, sec. 8(2), p. BRA-62).

There has been increasing debate over the appropriateness of the intellectual property (IP) system for the promotion of pharmaceutical innovation and access to medicines. Some have argued that the reason poor countries have difficulty accessing medicines is not related to the IP system, but due to deficient health infrastructures and precarious local sanitation systems in the developing world (International Federation of Pharmaceuticals Manufacturers & Associations [IFPMA] 2004, p. 49). Others have qualified that a differentiation in local infrastructures does not detract from the fact that global structures, including the international IP system, actively shape those local variants and inequities. Among those who think that the IP system is flawed, whether in its design or implementation, there are increasing discussions about finding new and better models of innovation and medical progress. In a recent report by the International Expert Group on Biotechnology, Innovation and Intellectual Property entitled Toward a New Era of Intellectual Property: From Confrontation to Negotiation (‘IEGBIIP Report 2008’), a distinction is made between so-called ‘Old IP’ and an evolving ‘New IP’ era. The former refers to the way the IP system has been interpreted traditionally, mainly using principles of competition and profit-making as the basis for innovation. The core finding of the report is:

According to the IEGBIIP Report, the actors involved in research and development (R&D) need a shift in paradigm towards a ‘New IP’ model based on the concept of sharing knowledge rather than hoarding knowledge – a model where IP is viewed as a ‘servant to … values such as equity and fairness’ (ibid., p. 14). This emphasis that IP should be evaluated as a means towards attaining social justice and improving human well-being, rather than simply as an end in itself, echoes the human development paradigm discussed in Chapter 1 of this book. The ‘New IP’ model also reflects cultural factors in the innovation process, along with collective processes as a route towards equitable reforms. Innovation is seen as a social and communal phenomenon, a product of actors collaborating rather than working in isolation. The IEGBIIP Report offers numerous examples of this collaborative approach, including many public-private partnerships (PPPs). From the Public Interest Intellectual Property Advisors (PIIPA) literature review for this book, other examples of alternative, collaborative models for pharmaceutical innovation have been identified. Some models are briefly described here along with challenges or obstacles. Most of the models seek to direct funding to treatments for diseases where traditional market incentives have been insufficient, or explore different means of financing and rewarding research efforts.

The value of traditional medicinal knowledge (TMK) in meeting the primary health needs of populations around the world is well documented. Recognizing the widespread use of traditional medicine in various regions including Asia, Latin America and Africa (e.g. up to 80% of the population in Africa depends on traditional medicine for its health care needs), the World Health Organization (WHO) has pursued strategies and activities ‘to facilitate integration of traditional medicine into the national health care system[s] by assisting Member States to develop their own national policies on traditional medicine’. A 2003 resolution at the World Health Assembly urges WHO member states to:

A national sui generis law which deals specifically with the protection of traditional medicinal knowledge is the Act on Protection and Promotion of Traditional Thai Medicinal Intelligence (1999 [BE 2542]) [hereinafter ‘Thai Act’]. The Act distinguishes among different categories of ‘traditional formulations’: ‘national formulae’ are formulations which are crucial for human health and are held by the State; ‘private formulae’ can be freely used by the owner (third parties must obtain permission from the owner to use the formula); ‘general formulae’ may be used freely by anybody and comprise traditional formulae that have been widely used or whose intellectual property protection have expired (see Kuanpoth 2001). The Act stipulates that the Minister of Public Health has authority to decree a certain formula of traditional Thai medicine as a ‘national formula’ (section 17). To be eligible, the traditional formula must be of significant benefit or have special medical or public health value (section 17). After the announcement, the rights of such a formula belong to the State. The use of a national formula for R&D of drugs for commercial benefit is subject to permission from the authorities and the payment of fees (see section 19); criminal sanctions are provided for in the case of infringement (section 78; Kwanpoth 2001, pp. 6–7).

Introduction

Traditional knowledge (TK) and its relationship to the formal IPR system has emerged as a mainstream issue in international negotiations on the conservation of biological diversity, international trade, and intellectual property rights. In the past few years, high-level discussions on the subject have been taking place at the World Trade Organization (WTO), the Conference of the Parties to the Convention on Biological Diversity (CBD), and at the World Intellectual Property Organization (WIPO), which has established an Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC). Several developing country governments in these forums have adopted the view that TK needs to be protected legally, and they have criticised the formal IPR system in its present form for not only failing to provide adequate protection for TK, but also for legitimising its misappropriation.

Solutions to the protection of traditional knowledge under intellectual property law may be sought in the form of “positive protection” or “defensive protection.” Positive protection refers to the acquisition by the TK holders themselves of an IPR, such as a patent or an alternative right provided by a sui generis system. Defensive protection refers to provisions adopted in the law or by the regulatory authorities to prevent IPR claims to knowledge, to cultural expression, or to a given product being granted to unauthorised persons or organisations. The distinction is somewhat artificial in actual practice, but is nonetheless useful conceptually, and is adopted in this chapter.