The purpose of this dissertation is to assess the efficacy of intellectual property legislation in South Africa and its impact on access to medicines. The purpose of this dissertation is to assess the efficacy of intellectual property legislation in South Africa and its impact on access to essential medicines.
Socio-economic Obligations Contained in the International Covenant on Economic,
Access to Essential Medicines and the Right to Health
Access to essential medicines is included in the UNCRC as a significant aspect of the right to health contained in Article 12.47, which recognizes that everyone has the right to enjoy the highest attainable standard of physical and mental health and guides that these rights should be realized progressively. This provision suggests that there is an obligation for states parties to supply essential medicines.48 Implementation of the UNCRC is overseen by the Committee on Economic, Social and Cultural Rights (CESCR) which often issues general interpretive and authoritative comments which are not binding. . in nature.49 In 2000, the CESCR further defined the right to health in General Comment 14,50 which interpreted the obligation under article 12.2 (d) of the Covenant to include the provision of essential medicines.51.
Duty to Provide Essential Medicines as a Core Obligation
India was one of the signatories of the TRIPS Agreement in the Uruguay Round in 1995. One of the most important factors affecting access to essential medicines is cost.
Duties Imposed upon States
Domestic Obligation
Socio-Economic Obligations under the 1996 Constitution
110 P Thorpe "Study on the Implementation of the TRIPS Agreement by the Commission on Intellectual Property Rights of Developing Countries" 18, available. Adelman MJ and S. Baldia “Possibilities and Limitations of the Patent Provision in the TRIPS Agreement: The Case of India Vand.
What are State Duties
Justification for Patents
The need for patent protection is important as it gives the inventor a monopoly to recover research and development (R&D) costs. However, from a theoretical perspective, it is uncertain whether the intellectual property patent system is effective as an incentive to invent especially in the context of developing countries.101 India, a developing country, was able to establish its own pharmaceutical industry. in the absence of a patent, the protection of pharmaceutical products. 102.
The TRIPS Flexibilities
- Patentability Criteria
- Exceptions to Patent Rights
- Compulsory Licenses
- Parallel Importation
- Anti-Competitive Practices
- The Waiver for Least Developing Countries until 2016
- The Doha Declaration
243 MJ Adelman and S. Baldia “Possibilities and Limitations of the Patent Provision in the TRIPS Agreement: The Case of India Vand. Although South Africa is a signatory to the TRIPS Agreement, it has not taken advantage of the large number of flexibilities contained in the agreement.
Patent Act 57 of 1978
Introduction
164 Y Daya and N Vink "Protecting traditional ethno-botanical knowledge in South Africa through the intellectual property regime Aggrekon 319, 326. 167 D Kaplan "Intellectual property rights and innovation in South Africa: An Economic Framework of Intellectual Property " (2009) in South Africa 1, 3 available at http://www.wipo.int/ip-.
Patentability Standards
What was, on the priority date, the latest knowledge (as statutorily defined) relevant to this step. In what respect does the step go beyond, or differ from, this state of the art.
Exclusions from Patentability
Once it is determined that the invention is sufficiently different from the prior art with respect to both the new and inventive requirements, the final prerequisite is that the invention's function be implemented. For the invention to be patentable, it must be able to be used or applied in commerce or industry or agriculture.
Exceptions to Patentability
The Act also provides specific exclusions by distinguishing between inventions that may not be patentable and therefore not considered inventions in terms of the Act:. 45 is infringed by the use of a patented invention on board a convention vessel, if the vessel enters territorial waters of the Republic, temporarily or accidentally, and the invention is used exclusively for the actual needs of the vessel.
Compulsory Licensing
46 (c) the use authorized in relation to the previous patent cannot be assigned except by the grant of the dependent patent.‖. This case is also significant as Plewman J referred to the essential quid pro quo theory of intellectual property law, recognizing that patent protection is granted in exchange for inventors disclosing their inventions for the public good.192.
Government Use
Parallel Importation
Disclosure
In addition, a complete specification must include a summary; the invention must be sufficiently described, verified and, where necessary, illustrated or illustrated and the manner in which it is to be carried out, so that the invention can be practiced by a person skilled in the art of such invention; and it must end with a claim(s) defining the invention for which protection is claimed (section 32(3)). Although the law provides for disclosure requirements, it is argued that this provision has become redundant in light of the non-existent patent examination system in South Africa.
Opposition procedures and Examination System
Love JP "Recent examples of the use of compulsory licenses on patents" (2007) KEI Research Note 2 1, 15 available at http://www.keionline.org/misc-. Intellectual Property Working Group ‗Private interests and state complicity: the case of pharmaceutical patents and the role of ANVISA available at.
Revocation of Patents
Medicines and Related Substances Control Act 101 of 1965
Parallel Importation
The Minister may prescribe conditions for the supply of more affordable medicines in certain circumstances to protect the health of the public, and may in particular: a) notwithstanding anything to the contrary contained in the Patents Act 1978, provides that the rights in respect of any medicine granted under a patent shall not extend to acts in respect of such medicine which are performed by the owner of the medicine on the market is not placed. , or with his or her consent;. Section 15(C)(a) has caused confusion as it is unclear which "acts" are excluded from patent protection, as the provision only addresses medicines that are "placed on the market".209 On a broad interpretation, the law can deny patent protection for patented medicines that have been commercially exploited, once patent holders start selling their medicines.210 Essentially, once a patented medicine has been sold, pharmaceutical companies have placed their patented medicine "on the market", and the Minister of Health can then parallel import the of the patented product authorized.211.
International Response to Section 15(C)
Domestically, the drug companies argued that the provisions of the 1997 Medicines Act violated their property rights and were therefore unconstitutional. 215 The Pharmaceutical Manufacturers' Association and Others v The President of the Republic of South Africa and Others.
Competition Act 98 of 1998
Background and Relevant Provisions
Competition law can be used to penalize companies involved in monopolization and forms of anti-competitive practices that have resulted in excessive prices or restricted the availability of essential medicines.231. The TRIPS Agreement recognizes and grants Member States flexibility when dealing with anti-competitive practices.
Hazel Tau v GlazoSmithKline and BoehringerIngelheim
A fine of 10% of the annual turnover of GSK's and BI's ARVs in South Africa for each year they are found to have breached the Act.239. Before the case could be heard by the Competition Court, the companies agreed to voluntarily license the contested patents to generic manufacturers for both private and public markets at a royalty not exceeding 5% of the selling price of the generic versions.
India
Historical Background
60 been commercially exploited by the patentee or available to the public in India at a reasonable price.248 Under this section, an application to the Registrar for a compulsory license will be made by any person three years after sealing, limiting the patent protection to only three years. A potential infringer of a process patent for food, medicine or pharmaceuticals can thus obtain a rights license after the patent holder's three years of protection had expired.
Steps Taken by India to Comply with the TRIPS Agreement
298 Intellectual Property Working Group “Private Interests and State Consent: The Case of Pharmaceutical Patents and the Role of ANVISA” available at. Hogerzeil HV et al “Access to essential medicines as part of realizing the right to health: Is it enforceable through the courts, available at http://www.who.int/medicines/news/Lancet_EssMedHumanRight.pdf, accessed 25 July 2012.
Novartis AG v Union of India and Others
- Constitutional validity of section 3(d) by Madras High Court (2007)
- Appeal on merits rejected on the ground of section 3(d) (2009)
- Proceedings before the Supreme Court (2011)
Thailand
- Thailand‘s Patent Laws
- Compulsory Licenses
- Government Use Licences in Thailand
- Bristol-Myers Squibb taken to court
- Exceptions to patent rights
- Opposition
- Revocation
One of the key questions before the court was whether individuals have the right to challenge a patent. According to Article 54 of the 1999 Act, the invalidity of a patent can be challenged by anyone.
Brazil
Furthermore, it can be granted when the patented product is not exploited in Brazil or when the sale of the protected product does not meet the needs of the market (the "lack of work" requirement). In Brazil, the threat of compulsory licenses was a major strategy used to pressure pharmaceutical companies in price negotiations for essential medicines.300 For example, in 2001, the Brazilian Minister of Health proclaimed that the government would issue a compulsory license for the manufacture of the ARV nelfinavir to a Brazilian pharmaceutical manufacturer. 301 On August 28, the Brazilian Minister of Health and Roche resumed negotiations and agreed that the drug would be sold at a further 40% discount and that Brazil would not issue the license.302 In 2007, Brazil granted its first compulsory license to import efavirenz, a patented drug in Brazil.303.
Lessons that can be learnt from India, Thailand and Brazil
India
The Indian experience has shown us that opposition to the granting of patent applications, particularly secondary patent applications, can help curb the number of such applications being granted. South Africa allows the granting of compulsory licenses to prevent abuse of a patent, but does not explicitly allow them as a way to protect public health.
Thailand
Politics of Medicine available at http://www.politicsofmedicines.org/articles/access- to-essential-medicines-as-a-human-right, accessed 3 August 2012. Musungu S ‗Intellectual Property and Access to Medicines' ( 2011 ) Management Sciences for Health , 3 available at http://www.msh.org/resource-centre/publications/upload/MDS3-FrontMatter-Nov2011.pdf , accessed 16 July 2012 .
Brazil
Standards of patentability
As for the practice of "evergreening", pharmaceutical companies are always willing to file patent applications for slight modifications of known substances, thereby extending the term of patent protection to another 20 years. India has been exemplary in combating this practice by introducing Section 3(d) of the Indian Patents Amendment Act of 2005, which excludes new forms, new uses and new formulations of existing drugs that do not enhance therapeutic efficacy from patenting.
Patent examination
With regard to the patentability criteria under the TRIPS Agreement, South Africa has the flexibility to determine its own criteria for assessing patentability, and therefore has the freedom to set stricter patentability standards than is currently the case (such as in the case of India). . Applying stricter criteria would have a direct impact on the number of patent applications currently granted.
Compulsory licenses
79 Large numbers of patents are applied for on a local scale.305 Another consequence of a weak examination system is the granting of patents with a broad scope.306 According to Vawda, the lack of an examination system leads to a large number of 'weak' patents. granted and 'closes the possibility of opposition proceedings before and after the grant'.
Prior Consent by Health Authorities
A proper examination system will ensure that frivolous patents are not granted, thereby reducing the number of patents granted.
Pre and post grant opposition
Voluntary Licenses
Third World Network Briefing Paper (2001) available at http://www.twnside.org.sg/title/drugs2.htm, accessed 15 August 2012. Saha R ‗Management of Intellectual Property Rights in India available at http:// www.pfc.org.in/workshop/workshop.pdf, accessed 25 September 2012.
