In particular, I want to thank those who have always supported my choices, even when those choices took me away from home. I would especially like to thank Keir, my best friend and incredible companion on life's journey: your love, encouragement, courage and genuine passion for every single adventure big and small are fueling my life and I can't to be more grateful.
27 See Amendment of the Travel Agreement, December 2005, WTO General Council Decision Wt/L/641, available here: http://www.wto.org/english/tratop_e/trips_e/wtl641_e.htm, accessed 15 September 2014. The South -African patent system in particular does not undertake a substantive examination of the applications submitted by the petitioner.
The Constitutional aspects of the Human Right to Health 9
1444 provides a complete interpretation of the right to health, clarifying that it "is a fundamental human right indispensable for the exercise of other human rights" (section 1). In particular, section 27 of the Constitution of the Republic of South Africa states that "everyone has the right to access health services" and that.
The International Patents Regime under the TRIPS Agreement 14
- Origins 14
- Standards of protection: Patentability criteria 16
- The Flexibilities: 20
- Exclusion from patentability 21
- Limited exceptions 22
- Compulsory licensing 25
- Voluntary licensing 29
- Parallel Importation 30
Finally, Article 27 of the TRIPS Agreement requires that an invention be patentable, the third "industrial application" requirement. Notably, these mentioned exceptions were already in use in national laws before the implementation of the TRIPS Agreement.
Conclusion 32
Scope and overview 33
The WTO panel, emphasizing the limited nature of these exceptions, strictly interpreted the provision of Article 30 of the TRIPS Agreement. Correa, “Implications of the Doha Declaration on the TRIPS Agreement and Public Health”, World Health Organization, Health Economics and Drugs EDM Series No.
- Novelty 34
- Inventive step 38
- Industrial application 40
Despite the wording of the South African Patents Act, the TRIPS Agreement contains no provision requiring an interpretation of the novelty criteria in the manner adopted by Article 25(9). What was, at the priority date, the state of the art (as statutorily defined) relevant to that step.
Examination and opposition procedures 41
The patent registration procedure takes up to 6 months and provisional protection is granted for 12 months from the filing of the patent application. 146 For an example of the registration procedure before the EPO, see Guide for Applicants, Part 2: PCT Procedure before the EPO, Claim Fees available online at: http://www.epo.org/applying/international/guide-for-applications/html /e/ga_e_xi_3.html, accessed February 2015. For an example of the filing fee, see http://www.uspto.gov/about/offices /cfo/finance/fees.jsp, accessed February 2015.
In the case of the Indian Patent Office, it was only after much public pressure that the database provided the full text of published and granted patents and the status of applications."
The use of Flexibilities: 44
- Exclusion from patentability 44
- Limited exceptions 45
- Compulsory licensing 47
- Voluntary licensing 52
- Parallel importation 53
30 of the TRIPS Agreement gives WTO members a considerable level of autonomy to provide for various types of exceptions to the patentee's exclusive right. As previously discussed, Article 31 of the TRIPS Agreement allows, through the mechanism of compulsory licensing policies, the use of patented inventions without the express authorization of the patent holder. In this way, Section 4 imposes a further requirement on the process of granting a license for government use, which is expressly removed from Article 31(b) of the TRIPS Agreement.
As stated in chapter 2, the principle of international exhaustion of rights is recognized in Article 6 of the TRIPS Agreement.
Conclusion 56
Scope and overview 57
Therefore, an invention must involve an inventive step when it is not obvious to the person skilled in the art, taking into account any matter which is part of the state of the art.132. With regard to such a development or difference, would it be obvious to the skilled man to take the step?”. The court therefore dismissed the revocation of the patent because it accepted that it was sufficiently inventive.
According to section 25 (1) of the South African Patents Act, an invention is patentable if it is "capable of being used or used in commerce, industry or agriculture".
The implementation of the Trips flexibilities in the Indian Patent Law 57
- Origin and development of the current patent framework 58
- Patentability criteria in the Indian Patents Act 59
- Examination and opposition procedures 61
- Limited exceptions 63
- Compulsory licenses 64
- Parallel importation 66
- The Novartis judgment 67
Section 3(e), “a substance obtained by a mere mixture resulting solely in the combination of the properties of the components”; In this regard, Section 25 of the Indian Patent Act allows “any person” to initiate pre-grant opposition proceedings before the grant of the patent. 213 Several cases of civil society organizations in India launching opposition to pharmaceutical patent applications demonstrate the heavy use of Section 25(1) of the Indian Patent Act.
Section 2(1) of the amended Indian Patents Act; and (iii) involved an inventive step in terms of enhancement of efficiency under Section 3(d) of the Indian Patents Act.245.
The implementation of the TRIPS flexibilities in the Brazilian Patent Law 71
- Origin and development of the current patent system and its interaction with access
- Examination and opposition procedures 74
- Limited exceptions 75
- Compulsory licenses 76
- Parallel importation 78
- The WTO dispute settlement case: US v Brazil 79
In this regard, Article 43(II) and (VII) of the Industrial Property Law 280 expressly allows researchers to carry out activities of reverse engineering of the patented inventions. According to Article 68 of the Brazilian Industrial Property Law, a compulsory license can be issued if the title holder exercises the patent rights "in an abusive manner, or through it engages in abuse of economic power. Brazil has its compliance with the TRIPS Agreement defend and in particular declare that Article 68 of the Industrial Property Act is in accordance with Article 2.1 of the TRIPS Agreement.
Brazil emphasized that Article 5(A)(4) of the Paris Convention referred to local work and also.
The implementation of the TRIPS flexibilities in the Argentinian patent law 81
302 Polymorph is "an inherent property of the solid state of drugs used in the pharmaceutical industry (active substances and excipients). Consequently, “procedures for obtaining pseudopolymorphs are routine experimentation in drug preparation and are not patentable” (Review Guidelines No. 1)(ii)). Thus, they "cannot be patented independently of the active ingredient from which they are derived, although they may have safety and efficacy profiles that differ from those of the parent molecule".
Indeed, from a public health perspective, the strict application of patentability criteria achieved through specific review guidelines can be used to address the public health issues associated with this increasingly widespread phenomenon.
Conclusion 84
Scope and overview 86
As mentioned earlier, monopoly abuses can be prevented through the use of a compulsory licensing mechanism. Filed an application to export tablets to Nepal using the Compulsory Licensing Policy tool. Auxiliadora, editor, Intellectual Property in the Context of the WTO TRIPS Agreement: Public Health Challenges, Rio de Janeiro: Escola Nacional de Sau de Publica (2004).
This provision obliges Member States to comply "with Articles 1 to 12 […] of the Paris Convention".
- The Draft National Policy on Intellectual Property (IP) of South Africa 87
- Patentability criteria: novelty, inventive step and industrial application 88
- Recommendation 91
- Examination and Opposition Procedures 91
- Exclusion from patentability 97
- Limited exceptions 97
- Recommendation 99
- Compulsory licensing 100
- Recommendation 103
- Parallel importation 104
- Recommendation 106
335 See Chapter IV, paragraph 4) "Application of TRIPS flexibilities in Argentine patent law" of this study. Limited exemptions as such are authorized by the TRIPS Agreement as part of the TRIPS flexibilities. 378 See paragraph 5(c) of the Declaration on the TRIPS Agreement and Public Health, 20 November 2001, WTO Doha Ministerial Declaration 2001 (supra note) and Article 31 of the TRIPS Agreement.
Regarding section 4 of the South African Patents Act, it is recommended that South Africa remove the obligation of prior negotiations with the patent holder.
Implications for access to medicines of the new South African Patents Policy 106
Moreover, South Africa can take Kenyan IP legislation (especially Section 58.2 of the Industrial Property Act 2001) as a suitable example of appropriate use of the flexibility of parallel importation. As already seen, in July 2005, after long negotiations between the pharmaceutical company Abbott and the government of Brazil on the granting of a compulsory license for the drug Kaletra, 406 agreed to lower the price of the drug from US$1, 17 down to US$. 0.63 (unit price per Kaletra capsule).407. The above are only a few examples of the results achieved by low-income countries, which have successfully reduced medicine prices, due to a better use of the flexibilities granted by the TRIPS agreement.
Consequently, the positive implications arising from the implementation of the TRIPS flexibilities, as experienced by the discussed emerging economies, can succeed through an effective strategy of full use of the flexibilities available in the TRIPS, and especially not to introduce new TRIPS plus entering into FTAs. 414.
Competing interests: the Human Right to Health versus Intellectual Property Rights –
- Pro-Reform: The NGOs, Generic Drugs companies’ and Scholars’ perspective 110
The submission makes "key recommendations" regarding critical aspects of the IP systems in South Africa. In this regard, Pharma Dynamics highlighted the importance of the draft national policy to increase access to medicine and healthcare in South Africa. Regarding parallel imports and compulsory licensing, IPASA pointed out that the reference to the 2001 Doha Declaration in the draft national policy, although correct, needs to be revised in the context of the time the Doha Declaration was issued: "2001.
IPASA stated that the need for compulsory licensing should be seen in the context of the health crisis affecting South Africa and other developing countries at the time the Doha Declaration was issued.
Conclusion 119
Therefore, the aim of this study was: (i) first, to critically analyze the current South African patent systems, as defined by the South African Patents Act, which, it has been argued, does not fully facilitate access in affordable medicine, in part because it greatly expands patentability beyond the minimum required by the TRIPS Agreement; (ii) secondly, to define and explain internationally recognized public health methods, particularly TRIPS flexibilities, necessary for South Africa to achieve the policy objective of facilitating access to essential medicines in the country; (iii) thirdly, to critically examine, in relation to patents and only access to medicines, South Africa's new Intellectual Property (IP) Policy as currently formulated in Draft National IP Policy470; (iv) fourth, assess, with the help of a comparative analysis in terms of the implementation of TRIPS flexibilities in similar developing economies (in particular, India, Brazil and Argentina), the positive impact of the new rules of the future reform patent legislation could potentially have on IPRs and access to medicines; (v) finally, formulate practical recommendations for reforming the South African patent system in order to positively improve access to medicines. 472 See Government of the Republic of South Africa and others v. Grootboom and others, (supra note). Correa C., “Implications of the Doha Declaration on the TRIPS Agreement and Public Health”, World Health Organization, Health Economics and Drugs Series EDM No.
Office of the United States Trade Representative (USTR), USTR publishes Annual Special Report 301 on Intellectual Property Rights.
