Patent necessity: intellectual property dilemmas in the biotech domain & treatment equity for developing countries.

• Author: Spectar, J.M.

1. INTRODUCTION

   The dearth of access to affordable AIDS therapies in developing countries is increasingly blamed on the intellectual property norms of the North and their operationalization in global free trade regimes. This article examines key issues, interests, orientations and preferences in the North-South debate on intellectual property rights (IPRs) and the prospects for treatment equity for HIV/AIDS patients in developing countries. The article argues that the North-South logjam over the nature, purpose and extent of IPRs, as illustrated by the polemics over the patentability of plant genetic resources and their ensuing pharmaceutical products, constitutes a significant stumbling block to achieving treatment equity for developing countries. The article further argues that to achieve much needed treatment equity for HIV/AIDS, the international community must examine and adopt new approaches that transcend the strictures of the North-South conflict over intellectual property. The article concludes with recommendations designed to improve the prospects for treatment equity for developing countries within the context of a global pandemic without undermining the basic framework of intellectual property protection.

   First, the article reviews the differences between North and South on intellectual property rights, especially with regard to the patentability of plants that often provide the compounds for commercial pharmaceutical products. Then, focusing on the illustrative case of plant genetic resources, the article discusses the differing North-South postures, preferences and priorities that have often colluded to create an impasse in negotiations on IPR protection. In the main, the article argues that the inability of the North and South to satisfactorily resolve key questions about the nature, purpose and extent of intellectual property protection in the previous negotiations sowed the seeds of future conflicts over issues such as compulsory licensing and sovereign rights. In Part II, the article examines the HIV/AIDS treatment gap between North and South and the efforts to close this chasm by achieving treatment equity. Here, the article will examine the perceived impact of the interaction between intellectual property norms and international trade rules, particularly TRIPS, on the affordability of AIDS therapies. Specifically, the article will focus on how the simmering unresolved issues in the North-South schism on the matter of intellectual property rights culminated in conflict over compulsory licensing for HIV/AIDS therapies. Against the backdrop of the North-South treatment gap, the article examines the illustrative conflict between the United States and South Africa over IPR protections, specifically over the matter of compulsory licensing for AIDS therapies and the application of trade policy. In Part III, the article argues that to achieve much needed treatment equity for HIV/AIDS, the international community must examine and adopt new approaches that break the North-South logjam over protection of intellectual property. The article makes several recommendations designed to increase the prospects for achieving treatment equity in the context of the AIDS pandemic without undermining global intellectual property and trade regimes.

2. NORTH-SOUTH DEBATE OVER INTELLECTUAL PROPERTY RIGHTS

   Below, the article examines North-South perspectives on intellectual property rights, focusing on the divergence in views on the nature, purpose and extent of IPRs in the biotech domain. The failure of both North and South to satisfactorily resolve key differences about intellectual property protection continues to fan the flames in the fracas over access and affordability.

   1. Introduction to Biotechnology

      The growth of biotechnology has been spurred by advances in biodiversity prospecting, (1) a practice that many believe will someday lead to a cure for several ailments, including HIV/AIDS. (2) The practice of "biodiversity prospecting" or "natural products drug discovery" involves the quest for "bioactive compounds contained in natural sources such as plants, fungi, insects, microbes, and marine organisms." (3) These complex bioactive molecules cannot be produced in labs. (4) Because the major "centers of genetic diversity," or the "centers of origin of the world's economically important crops," (5) are located mostly in the tropics or subtropics, (6) biodiversity prospectors must venture into the tropical forests or other natural habitat in order to locate them. (7) These regions are endowed with rich, biodiverse resources largely because tropical areas were able to preserve their genetic diversity during the Ice Age while the vegetative assets of the temperate zones were interred in a deep freeze. (8) It is estimated that about fifty percent of all species are in the tropical forests, including nearly half of the 250,000 species of the higher plants found on earth. (9)

      Although most of the "lucrative" "centers of genetic diversity" are in the tropical areas of the Third World, (10) the plant breeders, patent holders, and marketers of engineered plant genetic resource (PGR) products are located in the North, (11) particularly the United States. (12) The Northern biotechnology firms use the germplasm from the tropical forests of the South and elsewhere to create new varieties of plants, animals, and microorganisms, as well as pharmaceuticals. (13) To determine potential "usefulness and commercial viability," (14) scientists screen plant material gathered from a source country. (15) Thus, after a Northern company "discovers" a compound with "therapeutic value in traditional medical practices," it refines its chemistry, and obtains a patent for the refined product "giving it the opportunity to reap monopoly profits." (16) It is estimated that about twenty-five percent of all pharmaceuticals sold in the United States are derived from or originated from plants, (17) and sales of biotechnological pharmaceutical products are expected to exceed billions of dollars annually. (18)

   2. Intellectual Property & Multilateral Trade Regimes

      The developed countries (DCs) of the North are generally very protective of intellectual property rights, going to great lengths to assure that international agreements do not derogate from vested patent rights. (19) At the end of the nineteenth century, biological inventions, including new plant varieties, were generally considered unsuitable for patent protection. (20) By the early part of the twentieth century, the difficulties associated with obtaining patents for the cultivation of plants and the increasing realization that new plant varieties had tremendous commercial potential led many DCs to pass laws for the protection of new plant varieties. (21) While DCs do not generally allow the patenting of naturally occurring substances, when material that was "previously unknown in its purified and isolated form" is refined into a distinguishable product which demonstrates "unexpected properties," it may be patented. (22)

      The United States has extended significant intellectual property rights to plant breeders. (23) For example, the U.S. Plant Patent Act of 1930 (24) created exceptions in patent laws to provide patent protection for some plants--giving breeders who created new cultivars the right to exclusively propagate the patented plant by asexual reproduction for seventeen years. (25) In addition, the 1970 Plant Variety Protection Act (26) widens the scope of protection to include cultivars that are reproduced sexually. (27)

      The 1961 International Convention for the Protection of New Varieties of Plants (UPOV Convention) (28) established a new global type of intellectual property protection for new plant varieties, thereby creating the so-called "plant breeder's rights." (29) To qualify for patent protection, the new plant variety was required to be clearly distinguishable by at least one important characteristic from all the others. (30) Under the UPOV convention, breeder's rights are protected regardless of the origin--"artificial or natural"--of the initial variation from which the new plant variety was developed. (31)

      In the view of the Northern defenders of the patent system and the opponents of compulsory licensing, IPRs reward industry, innovation and ingenuity. (32) The North also maintains that the disclosure requirements of the patent system foster research because they provide security to sponsors. (33) In addition, the North claims that by increasing the commercial value of plant genetic resources, biotechnology patents help spread the technological gains obtained from biodiversity. (34)

      It is also argued that the least developed countries (LDCs) have the most to gain from strengthening their IP systems, particularly because they lack the technological ability to engage in successful piracy. (35) For example, while piracy may provide a developing country with cheaper copies of some drugs, it is difficult to replicate new drugs since advanced innovative technology is often required. (36) In addition, the LDCs require large capital investments to develop a technological base. (37) Furthermore, a country's refusal to comply with the prevailing IP regime may also endanger its citizens to the extent that drug makers (who spend as much as $359 million developing a single drug) may refuse to sell their products in countries lacking an effective patent system. (38) Finally (and ironically), prohibitions on compulsory licensing help promote scientific research and development of industries in developing nations. (39) These arguments suggest that by modifying their IP systems and transforming their economies into market-based economies with free trade systems the LDCs will encourage foreign capital necessary for development. (40)

      Several judicial decisions, treaties and multilateral agreements have accelerated the pace of biotechnology patents. (41) As a result of the...