C. The Legal Conflict: The WTO's TRIPS Agreement and South Africa's Medicines Act International intellectual property protection generally, and patents of pharmaceutical products specifically, are dependent on the particular national laws of each country within which protection is sought.36 This creates a "problem with regard to international trade of intellectual property.., that products put into the international market lose the patent protection provided by the original granting nation. This forces the patentee to seek protection from those nations to which the products are being sold., 37 This problem is significant because the substance and scope of protection offered by the patent laws of various countries vary greatly from country to country, with some countries providing only minimal legal protection and with others providing very stringent protection. This extreme variability in intellectual property protection is seen in the way in which different nations treat the patentability of pharmaceutical products.39 A number of countries have refused to grant any patent protection for new pharmaceutical products. 40 Other countries have chosen to grant only very limited forms of patent protection to pharmaceutical products, with compulsory licensing provisions being a common form of limitation on patent protection.4 ' In addition to the laws of individual countries, a number of international treaties and agreements regarding intellectual property protection have served to create some uniformity between the intellectual property laws of participating nations.42 There are two major international agreements that provide the basic framework for the international treatment of intellectual property. The first of these is the Paris Convention for the Protection of Industrial Property.43 The Paris Convention provides limited international regulation of intellectual property with its major requirement being merely that member nations provide the same intellectual property protections to foreign patent holders that they provide to domestic patent holders.44 Such a requirement does not require the provision of any particular level of intellectual property protection, only equal protection. Under the Paris Convention, a member nation may well choose not to allow the patenting of pharmaceuticals products, as long as those laws meet the minimum requirement of equal treatment.46 Although placing no requirements on member nations as to which classes of inventions must be protected by patent law, the Paris Convention does place some limited restrictions on the abilities of member nations to impose compulsory licensing on inventions to which they have granted patent protection.47 The Paris Convention allows member nations to impose compulsory licensing on patented products, but only after the passage of three years from the grant of the patent or four years from the application for the patent, thus guaranteeing some minimum period of exclusive rights to patent holders.48 Some consider the protections offered under the Paris Convention to be inadequate.49 In 1989 this concern led to the consideration of intellectual property protection in the Uruguay round of General Agreement on Tariffs & Trade ("GAT'") negotiation, a round of negotiation in which the Trade Related Aspects of Intellectual Property Rights ("TRIPS")" agreement was adopted as part of the World Trade Organization ("WTO") and GATT. Surpassing the protections mandated under the Paris Convention, the TRIPS agreement provided more substantial minimum standards for international intellectual property protection, as well as dispute settlement mechanisms and enforcement procedures.52 The TRIPS agreement, like the Paris Convention, allows compulsory licensing but only under a restricted set of conditions.53 TRIPS allows WTO member nations to compulsorily license a patented product or process in only two situations: (i) in national emergency or some other extreme urgency or for public non-commercial use, (ii) in other cases, if the proposed user has made efforts to get authorization from the owner on reasonable commercial terms and conditions and not been able to get the authorization within a reasonable period of time.54 In situations in which the WTO would allow a member nation to compulsorily license a patented product or process, several requirements must be observed: (i) the owner will be paid adequate remuneration, (ii) the authorization of such use will be mainly for the supply to the domestic market, (iii) the scope and duration of such use will be limited to the purpose for which it is used.55 The TRIPS agreement limitations on compulsory licensing are at the heart of the United States and PhRMA challenge to the South African Medicines and Related Substances Control Amendment Act.56 The law was challenged as violating the TRIPS agreement on the grounds that it was overly broad in the powers granted to the South African Minister of Health to provide compuls
C. The Legal Conflict: The WTO's TRIPS Agreement and South Africa's Medicines Act International intellectual property protection generally, and patents of pharmaceutical products specifically, are dependent on the particular national laws of each country within which protection is sought.36 This creates a "problem with regard to international trade of intellectual property.., that products put into the international market lose the patent protection provided by the original granting nation. This forces the patentee to seek protection from those nations to which the products are being sold., 37 This problem is significant because the substance and scope of protection offered by the patent laws of various countries vary greatly from country to country, with some countries providing only minimal legal protection and with others providing very stringent protection. This extreme variability in intellectual property protection is seen in the way in which different nations treat the patentability of pharmaceutical products.39 A number of countries have refused to grant any patent protection for new pharmaceutical products. 40 Other countries have chosen to grant only very limited forms of patent protection to pharmaceutical products, with compulsory licensing provisions being a common form of limitation on patent protection.4 ' In addition to the laws of individual countries, a number of international treaties and agreements regarding intellectual property protection have served to create some uniformity between the intellectual property laws of participating nations.42 There are two major international agreements that provide the basic framework for the international treatment of intellectual property. The first of these is the Paris Convention for the Protection of Industrial Property.43 The Paris Convention provides limited international regulation of intellectual property with its major requirement being merely that member nations provide the same intellectual property protections to foreign patent holders that they provide to domestic patent holders.44 Such a requirement does not require the provision of any particular level of intellectual property protection, only equal protection. Under the Paris Convention, a member nation may well choose not to allow the patenting of pharmaceuticals products, as long as those laws meet the minimum requirement of equal treatment.46 Although placing no requirements on member nations as to which classes of inventions must be protected by patent law, the Paris Convention does place some limited restrictions on the abilities of member nations to impose compulsory licensing on inventions to which they have granted patent protection.47 The Paris Convention allows member nations to impose compulsory licensing on patented products, but only after the passage of three years from the grant of the patent or four years from the application for the patent, thus guaranteeing some minimum period of exclusive rights to patent holders.48 Some consider the protections offered under the Paris Convention to be inadequate.49 In 1989 this concern led to the consideration of intellectual property protection in the Uruguay round of General Agreement on Tariffs & Trade ("GAT'") negotiation, a round of negotiation in which the Trade Related Aspects of Intellectual Property Rights ("TRIPS")" agreement was adopted as part of the World Trade Organization ("WTO") and GATT. Surpassing the protections mandated under the Paris Convention, the TRIPS agreement provided more substantial minimum standards for international intellectual property protection, as well as dispute settlement mechanisms and enforcement procedures.52 The TRIPS agreement, like the Paris Convention, allows compulsory licensing but only under a restricted set of conditions.53 TRIPS allows WTO member nations to compulsorily license a patented product or process in only two situations: (i) in national emergency or some other extreme urgency or for public non-commercial use, (ii) in other cases, if the proposed user has made efforts to get authorization from the owner on reasonable commercial terms and conditions and not been able to get the authorization within a reasonable period of time.54 In situations in which the WTO would allow a member nation to compulsorily license a patented product or process, several requirements must be observed: (i) the owner will be paid adequate remuneration, (ii) the authorization of such use will be mainly for the supply to the domestic market, (iii) the scope and duration of such use will be limited to the purpose for which it is used.55 The TRIPS agreement limitations on compulsory licensing are at the heart of the United States and PhRMA challenge to the South African Medicines and Related Substances Control Amendment Act.56 The law was challenged as violating the TRIPS agreement on the grounds that it was overly broad in the powers granted to the South African Minister of Health to provide compuls
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