Lead Author: Mariano Genovesi
Organization: ALIFAR -Asociación Latinoamericana de Industrias Farmacéuticas
Country: Argentina
Abstract
The Automatic License System (ALS) can be positioned within the system of exceptions provided for in Article 30 of the TRIPS Agreement. Its main characteristics are:
1) Developing countries and less developed countries can establish an ALS for patents related to prescription drugs. Anyone who uses the patent will receive an automatic license to do so.
2) The patentees and licensees must negotiate a royalty. If they fail to reach an agreement, the licensees must pay a royalty that will be calculated using the following formula:
R = [(CR&D . MSC) / TP] . MSL where:
R represents the royalty;
CR&D represents the cost of investment in research and development for the patented invention;
MSC represents the country's participation in the world market for the drugs in question;
TP represents the remaining time of the patent protection in the country granting the automatic license;
MSL represents the market share of the licensee for the specific drug.
3) Failing agreement, the royalty shall be determined by an administrative or judicial authority.
4) The amount of the royalty may be doubled if the drug represents a significant therapeutic improvement.
5) The licensee shall pay a royalty until the expiry of the patent.
The ALS serves three important public policy objectives. First, it increases the accessibility and affordability of drugs in developing countries and less developed countries. Second, these countries collaborate in the financing of the R&D costs required for new drugs, but taking into account the taxpaying capacity of each country and its population. Third, the ALS can serve as an instrument for promoting the local production of drugs in developing countries and less developed countries, as well as encouraging technology transfer.
Submission
1. Introduction
ALIFAR (the Asociación Latinoamericana de Industrias Farmacéuticas) proposes the Automatic License System (ALS) to reduce the inconsistency between the rules governing the rights of inventors, human rights and the objectives of the public health authorities, in particular concerning access to drugs.
The ALS can be positioned in the general scheme of exceptions to patent law provided for under Article 30 of the TRIPS Agreement (hereinafter TRIPS). The ALS is intended solely to patent for products or procedures related to prescription drugs, i.e. excluding OTC or freely sold drugs, granted in developing countries and less developed countries. In essence, the ALS establishes a system of automatic licenses subject to the payment of a reasonable royalty.
2. Characteristics of the ALS.
The main characteristics of our proposal are as follows:
• Developing countries and less developed countries can establish an ALS for patents related to prescription drugs, excluding OTC drugs. Anyone who intends to use, manufacture, import or export a drug with such characteristics will receive an automatic license to do so.
2) The patentees and licensees must negotiate and mutually agree to a royalty. If they do not reach an agreement, the licensees shall be entitled to use the patent according to the ALS in exchange for a royalty that will be calculated using the following formula:
R = [(CR&D . MSC) / TP] . MSL where:
R represents the royalty;
CR&D represents the cost of investment in research and development for the patented invention;
MSC represents the country's participation in the world market for the drugs in question;
TP represents the remaining time of the patent protection in the country granting the automatic license;
MSL represents the market share of the licensee for the specific drug.
For example, if (i) the costs of R&D are USD 1,000 million; (ii) a specific developing country has a 0.5% share of the world market for the drug; (iii) 8 years of patent protection are remaining; and (iv) the licensee has a market share of 15% in that specific country; then the annual royalty should be USD 937,501.
• Failing agreement between the patentee and the licensee, the royalty shall be determined by an administrative or judicial authority.
• The amount of the royalty may be doubled if the drug represents a significant therapeutic improvement.
• The licensee shall pay the royalty until the expiry of the patent.
3. Objectives of the ALS.
The ALS serves three important public policy objectives.
First, it increases the accessibility and affordability of drugs in developing countries and less developed countries. In effect, the ALS facilitates competition in markets that would otherwise be monopolistic, thus allowing access to other offerors. Competition in the market will have a positive effect on the availability and price of the drugs.
Second, the developing countries and less developed countries collaborate in the financing of the research and development costs required to invent and develop new drugs2, but taking into account the taxpaying capacity of each country and its population. This contribution would be equivalent to the share of each country in the world market for the drug in question.3
Third, the ALS can serve as an instrument for promoting the local production of drugs in developing countries and less developed countries, as well as encouraging technology transfer. In effect, the patentees will have a strong incentive to negotiate and grant voluntary licenses to avoid being subject to the ALS.
3. Implementation
Our proposal can be implemented at two levels: On the one hand, at the international level, by incorporating the ALS into international treaties. On the one hand, at the international level, by incorporating the ALS into international treaties.
The first possibility is an amendment to TRIPS to regulate the exception specifically. In this regard, ALIFAR proposed the incorporation of the exception as Article 31b of TRIPS in a call for tenders organized by Médecins sans Frontières in 201124.
Article 31b of TRIPS as we propose it would read as follows:
"Article 31b
Automatic Licenses for Prescription Drugs
1. Developing countries and less developed countries can provide automatic licenses for patents for products and procedures related to prescription drugs.
2. The licensee shall require a voluntary license from the patentee. The patentee and the licensee must negotiate and mutually agree on a royalty within 30 days of receipt of the notification of the licensee. If no agreement is reached within said period of 30 days, the licensee shall be automatically authorized to use the patented product or procedure. In this case, each member shall determine the administrative or judicial authority that will fix the royalty.
3. The royalty shall be fixed according to the following formula:
R = [(CR&D . MSC) / TP] . MSL where:
R represents the royalty;
CR&D represents the cost of investment in research and development for the patented invention;
MSC represents the country's participation in the world market for the drugs in question;
TP represents the remaining time of the patent protection in the country granting the automatic license;
MSL represents the market share of the licensee for the specific drug.
4. The judicial or administrative authority shall be authorized to double the amount of the royalty if the prescription drug constitutes a significant therapeutic improvement."
Notwithstanding its incorporation into TRIPS, nothing prevents this proposal from being subject to regulation in other multilateral, regional or bilateral treaties. For example, in Latin America, the proposal may be subject to codification by a Decision of the Andean Community or a Protocol in the field of Mercosur.
The second option consists of its implementation in the national patent laws. The recognition of the exception in an international treaty gives the ALS greater legal certainty, but we emphasize that the fact that no treaty provides for the ALS cannot be an obstacle to its implementation in national laws.
In effect, as analyzed above, the ALS can be placed within the general scheme of exceptions provided for in Article 30 of TRIPS Agreement and, consequently, the Members of the WTO could develop the ALS under the scope of that standard.
5. Compatibility of the ALS with TRIPS.
TRIPS allows the members of the WTO to structure intellectual property rights and adapt them to their economic, political, social and developmental needs through the use of so-called "flexibilities".
The Doha Declaration4 pioneered the recognition of the seriousness of the public health problems affecting many developing and less developed countries. The Doha Declaration reaffirmed the right of the Members to make maximum use of TRIPS flexibilities to protect public health. The Declaration also reaffirmed that TRIPS – and in particular, its flexibilities – should be interpreted and applied in a way that supports the right of the Members of the WTO to protect public health and promote access to drugs for all.
One of the TRIPS flexibilities is that provided for in Article 30 on exceptions to the rights conferred by patents.
Article 30 of TRIPS does not contain a numerus clausus or catalog of exceptions to the rights conferred by a patent. On the contrary, its Article 30 establishes a numerus appertus for exceptions, insofar as all those ex exceptions are admissible that meet three requirements: (i) they should be limited, (ii) they and should not conflict unreasonably with the normal use of the patent, and (iii) they should not prejudice unreasonably the legitimate interests of the patentee, taking into account the legitimate interests of third parties. Any exception legislated by the Members of the World Trade Organization (WTO) should, therefore, be consistent with the requirements of Article 30, known as the "three-step test".
Thus, the Members of the WTO chose to draft a comprehensive text that is not limited to any particular circumstances, is not subject to a particular end or purpose, is not limited to a specific type of exception, and is not limited by a numerus clausus list.
The Patent Law Committee of the WIPO has paid special attention to the exceptions to patent law over the last ten years. Among other initiatives, it has commissioned a significant number of studies on the matter by internationally recognized experts5.
One of these studies states that "it is appropriate to carefully consider making wider use of exceptions," for which reason it is advised, regarding exceptions, "to ensure that international standards do not impede the use of this very important means for properly adjusting the national patent policy."6 This openness regarding the use of exceptions is responsible for the fact that the same exceptions help to ensure that "an appropriate compromise is reached within the patent system"7, and have been set up as a kind of "dimmer switch" which allows reduce the intensity to be reduced, without, however, turning off the light8.
It should be noted that the ALS is consistent with the objectives, principles and provisions of the TRIPS Agreement. In particular, the ALS is a measure to protect public health and promote technological development in the pharmaceutical sector in developing and less developed countries9. In this context, we can state that the ALS complies with the three-step test of Article 30 of TRIPS.
First, it is a limited exception. The Declaration on Patent Protection sponsored by the Max Planck Institute states that, to be considered "limited", an exception does not need to have limited effects, as noted by the panel on the matter Canada-Generics10. On the contrary, it is understood that it constitutes a limited exception if the scope thereof is provided in accordance with its objective and purpose. Therefore, the exception must pursue a legitimate objective, be appropriate to achieve this objective and not exceed what is necessary and sufficient to achieve such an objective11.
In this interpretive context, the ALS can be considered a limited exception. First, because the object of the ALS can only be patents related to prescription drugs that are patented in developing and less developed countries. Second, the exception has several legitimate objectives that are recognized in Article 7 of TRIPS, such as social and economic welfare and technology transfer and dissemination.
Third, the ALS does not exceed what is necessary and sufficient to achieve such objectives.
Further, it could not be claimed that the ALS constitutes unlawful discrimination. Treating different cases differently does not constitute discrimination. On the contrary, the principle of nondiscrimination requires differentiating between different situations, providing a specific solution and a rule suited to each case12.
Second, the ALS does not conflict unreasonably with the normal use of the patent.
According to the Special Panel Canada - Generics, the determination of whether an exception conflicts with the normal use of a patent is a matter that relates to the economic impact of the exception13. The Special Panel noted that the protection of all practices of normal use is a key element of the policy reflected in all patent legislation. On this panel, the parties agreed that the "use" of the patent involves the extraction of its commercial value through three forms of "exploitation": (i) selling the product in a market from which competitors are excluded; (ii) granting to others the license to do so; and (iii) directly transferring the rights granted by the patent14.
Further, according to the Declaration, an exception conflicts unreasonably with the normal use of the patent if it harms the efficiency of the patent as a mechanism for regulating prices15. Applying these principles, it can reasonably be argued that the ALS does not affect the "normal use" of the patent, because it does not unduly restrict the rewards that the market provides for innovation16.
On the one hand, the patentee can continue its use by obtaining an economic profit from the commercialization of patented drugs. In addition, it will also obtain an economic profit as a consequence of the royalty that the ALS provides. It should be noted that the legal monopoly granted by patents is not a objective in itself17. The legal monopoly granted by patents constitutes an economic incentive for innovators to make a profit for their efforts. If such a profit is granted by an equivalent economic incentive, the interests of the patentee are not harmed18.
Third, the ALS does not unreasonably harm the legitimate interests of the patentee, taking into account the legitimate interests of third parties.
According to the Special Panel Canada - Generics, it is not enough to argue that it affects the rights to exclude provided for in Article 28.1 of TRIPS to configure the involvement of the "legitimate interests" of the patentee. To this end, a legitimate interest should be identified, protected by a standard policy widely recognized among the Members of the WTO, the burden of proof of which rests with the party that invokes its existence19. We could not identify any legitimate interest affected by the ALS that is policy widely recognized by the Members of the WTO.
Moreover, even if, by way of hypothesis, the ALS did affect the "legitimate interests" of the patentee, the decisive question is to determine the degree or level of "harm" that may be considered "unreasonable", given that, in accordance with the third condition, it could be considered that a certain "harm" is "not unreasonable".
The TRIPS structure serves the purpose of achieving a balance between competing interests and ensuring that claims against patent rights do not prevent the achievement of other social objectives. As stated in the first paragraph of the preamble and in the objectives set out in Article 7, TRIPS is not intended to promote patent rights at the expense of social and economic welfare and the rights of third parties. It is in this context that, in order to achieve the balance sought with the reference to "third parties" in Article 30, the interests of such third parties are recognized.
The "legitimate interests" of third parties also underlie the principles recognized in Article 8 of the TRIPS Agreement, insofar as it empowers the Members, in implementing the obligations arising from the Agreement, to adopt the measures necessary to protect public health and the nutrition of the population, or to promote the public interest in sectors of vital importance to their socioeconomic and technological development.
The balance between the "legitimate interests of the patentee" and the "legitimate interests of third parties" must be achieved by applying the test of proportionality20, the result of which is in favor of the exception:
i) the ALS is an effective means for protecting the legitimate interests of protection of health and access to drugs, economic, social and technological development of competitors of the patentees, and society as a whole;
(ii) the exception is ideal for achieving compliance with these objectives, since it enables the development of investments; scientific and technological research, job creation; objectives which, in the absence of the exception, competitors could not even attempt to achieve.
Notwithstanding what has been developed so far, it should be noted that, even if one considered that the conditions of Article 30 of TRIPS are cumulative and that the ALS does not meet the third requirement (because it causes unreasonable harm to the legitimate interests of the patentee, taking into account the interests of third parties), the payment of the royalty provided for in the ALS serves as a control variable to rebalance the exception and consider it compatible with said Article 30.
This means of attenuating or mitigating "unfair harm" was provided for in Article 9 (2) of the Bern Convention. This standard, which was introduced at the 1967 Stockholm Conference, is the source of Article 30 of TRIPS21.
In the Report on the Work of the Main Committee I (substantive provisions of the Bern Convention:
Articles 1 to 20), in explaining the scope and meaning of Article 9(b), it is stated that an exception may not cause unreasonable harm to the legitimate interests of the author, provided that, according to national legislation, an equitable remuneration is paid22.
This principle can be extended, mutatis mutandis, to Article 30 of TRIPS23. If an exception exceeds the conditions of being "limited" and not interfering with the normal use of the patent, but does not meet the third condition of not causing unreasonable harm to the legitimate interests of the patentee, taking into account the legitimate interests of third parties, then the payment of an equitable remuneration could reduce the negative impact of the unreasonable harm. As has already been pointed out, the ALS provides for the payment of an equitable remuneration to the patentee by limiting its right.
In summary, the ALS is perfectly compatible with Article 30 of TRIPS.
Bibliography and References
1 USD 93.750 = [(USD 1,000 million 0.5% MSC) / 8 remaining years of the patent. 15% MSL ]
2 The United States, Europe and Japan account for approximately 84.7% of the global pharmaceutical market. See IMS Health, MIDAS, 2009. Consequently, the ALS would only affect 15.3% of the global pharmaceutical market.
3 An alternative could be that the contribution is calculated taking into account the ratio between the gross domestic product (GDP) of the country concerned compared to the gross world product.
4 World Trade Organization, Ministerial Conference, Declaration on the TRIPS Agreement and Public Health, WT/MIN(01)/DEC/2, 20 November 2001.
5 Vid. World Intellectual Property Organization, Standing Committee on Patent Law, Exclusions from patentable subject matter and exceptions and limitations to the rights granted by patents, Geneva, 23 to 27 March 2009, SCP/13/3; Expert study on exclusions from patentable subject matter and exceptions and limitations to the rights granted by patents, Fifteenth Session, Geneva, 11 to 15 October 2010, SCP/15/3; Overview of the replies to the Questionnaire on exceptions and limitations to the rights granted by patents, Geneva, 21 to 25 May 2012, SCP/18/3; Exceptions and limitations to the rights granted by patents: private and noncommercial use, Geneva, 27 to 31 January 2014, SCP/20/3; Exceptions and limitations to the rights granted by patents: Use for experimental purposes or scientific research, Geneva, 27 to 31 January 2014, SCP/20/4; Exceptions and limitations to the rights granted by patents: extemporaneous preparation of drugs, Geneva, 27 to 31 January 2014, SCP/20/5; Exceptions and limitations to the rights granted by patents: prior use, Geneva, 27 to 31 January 2014, SCP/20/6; and Exceptions and limitations to the rights granted by patents: use of articles in ships, aircraft and foreign land vehicles, Geneva, 27 to 31 January 2014, SCP/20/7.
6 Standing Committee on Patent Law, L. Bentley. Expert study on exclusions from patentable subject matter and exceptions and limitations to the rights granted by patents, Fifteenth Session, Geneva, 11 to 15 October 2010, SCP/15/3, Annex I, 2 September 2010, p. 4.
7 L. Bentley, ibid., p. 63.
8 Ibid.
9 See Article 8 of the TRIPS Agreement.
10 World Trade Organization, Special Panel Report, CANADA - PATENT PROTECTION OF PHARMACEUTICAL PRODUCTS - Complaint by the European Communities and their Member States, 17 March 2000, WT/DS114/R.
11 Declaration on Patent Protection, Regulatory Sovereignty under TRIPS, op. cit., point 23, p. 8. http://www.ip.mpg.de/fileadmin/IP/pdf3/Declaration_2015-10-07_Espanol.pdf.
12 Dinwoodie, Graeme B., “One Size Fits All. Consolidation and Difference in Intellectual Property Law”, ATRIP Congress, Munich, 21 July 2008, available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1601225. In the context of our proposal, it is clear that public health in developing countries and less developed countries requires different solutions to those applied in developed countries.
13 World Trade Organization, Special Panel Report, CANADA - PATENT PROTECTION OF PHARMACEUTICAL PRODUCTS - Complaint by the European Communities and their Member States, 17 March 2000, WT/DS114/R., § 7.49.
14 Ibid., § 7.51.
15 Declaration on Patent Protection, Regulatory Sovereignty under TRIPS, op. cit., point 24, p. 8.
16 Ibid.
17 See Declaration of the International Association of Economic Law (IAEL), "Intellectual Property and Technology. El Acuerdo ADPIC diez años después: visiones europea y latinoamericana”, Buenos Aires, La Ley, 2006. [The TRIPS Agreement ten years later: European and Latin American visions.]
18 Challú, Pablo M., “Un método alternativo de compensación a las empresas innovadoras que minimiza los costos asociados a la exclusividad de la patente de producto”, Revista del Derecho Industrial, Depalma, Separata, No. 42, September/December 1992; and “The consequences of pharmaceutical product patenting”, World Competition, Vol. 15, no. 2, 1992. Penrose, Edith, “La Economía del sistema internacional de patentes” [The economics of the international patent system], 1st Ed., Siglo Veintiuno Editores, Mexico, 1974; Correa, Carlos M. “The Role of Intellectual Property Rights in Global Economic Governance”, The Initiative for Policy Dialogue at Columbia University, The United Nations Development Program, Paper Series: Development Dimensions of Global Economic Governance, First draft March 2009, revised April 2011), available at http://policydialogue.org/files/publications/Correa_IPRs1.pdf; MSF (Médecins Sans Frontières), HAI (Health Action International) and CPT (Consumer Project on Technology), “Open letter to the WTO members countries on TRIPS an access to health care technologies”, Geneva, 12 November 1999, available at http://www.twnside.org.sg/title/twr120d.htm; Reis, Renata – Viegas Neves da Silva, Francisco, “Licencias obligatorias: ¿cómo acceder a tecnología patentada?”, Temas de Derecho Industrial y de la Competencia Nº 9 – Patentes de Invención e Interés Público, Ciudad Argentina, Buenos Aires, 2010, p. 169-178, inter alia.
19 World Trade Organization, Special Panel Report, CANADA - PATENT PROTECTION OF PHARMACEUTICAL PRODUCTS - Complaint by the European Communities and their Member States, 17 March 2000, WT/DS114/R., § 7.60.
20 Declaration on Patent Protection, Regulatory Sovereignty under TRIPS, op. cit., points 25 and 26, pp. 8 – 9. Regarding the principle of proportionality in Community Law, see, inter alia, the judgment of the Court of Justice of the European Union on the cases Internationale Handelsgesellschaft mbH v. Einfuhr- und Vorratsstelle für Getreide und Futtermittel v. Einfuhr- und Vora, case 11/70, [1970] ECR 1161.
21 P. Roffe, C. Spennemann, Resource Book on TRIPS and Development, op. cit., p. 431.
22 World Intellectual Property Organization, Records of the Intellectual Property Conference of Stockholm, Geneva, Vol. II, 1971, p. 1146. The Special Panel Canada - Generics recognized that the interpretation of TRIPS can also be based on the preparatory work of international intellectual property instruments incorporated into the Agreement.
23 The context for interpreting TRIPS is not limited to its text, preamble and annexes, but also to the provisions of the international instruments incorporated into TRIPS. See the case Canada - Generics, paragraphs 7.14 and 7.15. Article 9(b) of the Bern Convention is incorporated by reference under the provisions of Article 2.1.
24 ALIFAR, “Automatic License System For Pharmaceutical Patents In Developing And Least-Developed Countries Revising Trips For Public Health: An Ideas Contest From MSF”, http://www.msfaccess.org/sites/default/files/MSF_assets/Access/Docs/Access_Contest_AutomaticLicenseSystem_Abete_Eng_2011.pdf.
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