Marcela Vieira, Working Group on Intellectual Property of the Brazilian Network for the Integration of the Peoples_A

Lead Author:  Marcela Vieira
Organization: Working Group on Intellectual Property of the Brazilian Network for the Integration of the Peoples
Additional Authors: Pedro Villardi, Felipe Carvalho, Carolinne Scopel, Oseias Cerqueira, Clara Alves, Marina Luna (GTPI/Rebrip - Brazil)
Country: Brazil

****GTPI is composed by the following organizations: (1) ABIA – Brazilian Interdisciplinary AIDS Association; Conectas Human Rights; RNP+/MA - Network of People Living with HIV/AIDS Maranhão; FENAFAR – National Federation of Pharmacists; GAPA/SP – Support Group for AIDS Prevention in São Paulo; GAPA/RS – Support Group for AIDS Prevention in Rio Grande do Sul; GESTOS – GESTOS - HIV+, Communication and Gender; GIV – Incentive to Life Group; Group for Life in São Paulo; Group for Life in Rio de Janeiro; GRAB – Resistance Group Asa Branca; IDEC – Brazilian Institute for Consumers Protection; UAEM – Universities Allied for Essential Medicines – Brazil. More information available at: http://www.deolhonaspatentes.org.br.

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Over the last decades, the protection of intellectual property (IP) has been the main mechanism adopted to promote research and development (R&D). However, the IP system has been inefficient to promote R&D to address the main health problems of world’s population. When products are developed, the IP system has created barriers to access to lifesaving health technologies. Barriers to access include high prices that are set by patent-holders during a period of time in which they have the exclusivity to explore the technology, allegedly as a mean to recoup their R&D investments. After two decades of WTO TRIPS Agreement, there is plenty of evidence showing that this exclusivity implies on the increase of medicines’ prices and the reduction of access to them. 

While it is necessary to adopt a R&D system on health that will not have the innovation and access problems existing in the IP system, there are also measures that can be adopted under the current system to reduce negative impacts of patents on access to medicines. Since 2001, Brazil has adopted a mechanism of joint analysis of patent applications in the pharmaceutical sector by the patent office and by the health agency, known as “Anvisa’s prior consent”. This has been an important measure to avoid unmerited patent monopolies that could hinder state’s capacity to fulfill the constitutional right to health. 

This contribution highlights the importance of the Anvisa’s prior consent in the fulfillment of the right to health in Brazil, by assuring a rigorous analysis of pharmaceutical patent applications. We call on the UN HLP to urge countries to adopt mechanisms to provide a stricter examination of patents applications in the health sector - such as Anvisa’s prior consent - and to stop questioning the application of such mechanisms by countries that adopt them.
 

Submission

Introduction – Statement of the problem

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), signed in 1994, set minimum common intellectual property protection standards to be adopted by the World Trade Organization (WTO) members. According to TRIPS, WTO members had to recognize patents for all technological fields, including pharmaceutical sector. The TRIPS Agreement, therefore, placed medicines and other health-related technologies in the trade arena. After 20 years, it has been shown that TRIPS generates great negative social impact, since high drug prices caused by patent monopolies excludes millions of people from access to health technologies in low, middle and even high-income countries. The monopoly created by pharmaceutical patents increases the price of medicines because only one company can manufacture the medicine. It increases public and private spending on purchasing medicines and hinders the sustainability of the countries’ health systems. This has been extensively demonstrated in many documents[1]. The UN system already recognized the concerns about intellectual property protection effects on prices[2].

In order to minimize those negative effects of patents on health, TRIPS have established that WTO members countries “shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice” (article 1) and can “adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development” (article 8), such as the health sector.

A key aspect of TRIPS implementation is how countries examine patents applications. Depending on how the examination guidelines are defined, more or less patents are granted or rejected. If more patents are granted, more monopolies are created, more technologies are taken away from the public domain and higher are the prices and lower the access. If less patents are granted, more technologies are on the public domain, more producers can manufacture the technologies, prices drop and access increases. In a public health perspective, patent examination should follow a strict standard in order to focus on genuine innovation and prevent monopolistic practices on products that are already known, hindering access by delaying the entry of generic drugs on the market [3].

Considering this relation, Brazilian authorities understood that pharmaceutical patents deserved a more careful analysis in order to reduce the negative impact on the fulfillment of the right to health and life and have adopted some measures to avoid granting of unmerited patents. In 2001, Brazil included in this national legislation the participation of health professionals in the process of examination of pharmaceutical patent applications, requiring the prior consent of Anvisa (Brazilian Health Surveillance Agency) for any patent to be granted (article 229-C, Law 9.279/96). Health professionals’ participation on the analysis of pharmaceutical patents is a measure that can be adopted by countries in order to protect public health, according to the TRIPS Agreement Article 8.

Since then, pharmaceutical patents can only be granted with the consent of Anvisa and the patent office (Intellectual Property National Institute - INPI) analysis - a double-step analysis. The rationale behind this mechanism is to give the as much accurate technical analyses as possible to patents filed in the pharmaceutical sector, by including the expertise and the interpretation of public health sector in the country. This way, the patent examination process reflects the understanding that patents are not just an industry and trade issue, but has also impacts on public health policies.

Anvisa’s role is to analyse the fulfillment of the patentability criteria as established by the Brazilian national law, in order to prevent granting of unmerited patents and also to improve the quality of the patents granted. The Anvisa’s prior consent is an important instrument that can be added to the analysis done by the patent office, making these two essential institutions work together in the pharmaceutical patents analysis.

Anvisa’s prior consent as a public health protective measure

The high prices of medicines and other health technologies are widely recognized as one of the main obstacles to the implementation of public health policies. In recognition of the foreseeable impact of monopolies on medicines prices and therefore in the sustainability of health public policies, TRIPS included a full range of permissible exceptions and protective measures, known in the literature as “safeguards”, “health protective measures” or “flexibilities”.

In 2001, the WTO member countries, including Brazil, approved by consensus in Doha, Qatar, the Declaration on TRIPS Agreement and Public Health, under which countries agreed that TRIPS does not and should not prevent members from taking measures to protect public health. In this sense, they reaffirm the right of WTO members to use, to the full, the provisions in the Agreement and to exercise its sovereignty, which include adding measures to assure the country's’ population access to medicines.

The UN Committee on Economic, Social and Cultural Rights has recognized that any intellectual property regime that makes it more difficult for a State party to comply with its core obligations in relation to health is inconsistent with the legally binding obligations of the State part [4]. Furthermore, the UN also recognized not only the right but also the duty of states to make full use of TRIPS safeguards to promote public health. The UN Human Rights Council, recognizing the need for states to create favorable conditions to ensure the full and effective enjoyment of the right to health, has urged states to make full use of the health-protective provisions of TRIPS, recognizing the concerns about intellectual property rights’ effects on prices [5].

Given the impact of patents in the public health system and access to medicine in Brazil, it is important that only products that really fulfill all the patentability requirements be protected. Therefore, the basis of Anvisa’s analysis lies on the fact that patents, when granted improperly, bring unjustifiable harm to public health, especially with to access to medicines policies, since it assigns an exclusive right to commercial exploitation of a product or process that did not attend the legal requirements for patentability, allowing the patent owner to charge high prices.

A close collaboration between health regulatory authorities and patent offices in the examination of pharmaceutical patent applications has been identified as a positive measure to enhance the examination of pharmaceutical patents from a public health perspective by several international institutions [6].

The World Health Organization (WHO) has identified it as positive since it helps to prevent concession of unmerited patents [7]. ANVISA's prior consent was considered at its creation as an innovative and exemplary practice in the public health protection.

Public health protective measures are not only those that ensures the generic competition to achieve more affordable prices during the patent term, such as compulsory license, but also the establishment of means to avoid the granting of undue patents, such as those filled solely to extend the monopoly over already known products or formulas - the so-called evergreening strategy. Many times, ANVISA's prior consent was crucial to detect and prevent evergreening methods by the patent's applicants (as in 'me too' drugs or 'patent clusters', ´markush formulas´, etc), which are especially harmful to access to health.

An important study developed by ANVISA [8] analyzes the decisions taken in the context of prior consent from 2001 to 2009 and brings some evidence to be observed. It is important to remind that ANVISA’s analysis at the time occured only after the patent application was already analyzed by INPI and was ready for approval. These numbers demonstrate the importance of ANVISA’s prior consent in the process of granting patents, once it avoided improper granting of patents. In that period, ANVISA analyzed 1,346 patent applications, out of which 988 were given prior consent, 119 were not given prior consent, 90 were denied by INPI after ANVISA’s participation in the process and 149 were in other situations (such as waiting for ANVISA’s analyzes or waiting for the applicant to answer requirements made by the agency). The main reasons for ANVISA’s denial of prior consent are shown in the table below:

Main reason for denial of ANVISA’s prior consent n. %
Lack of novelty (total or partial) 57 47.9%
Lack of inventive step 27 22.7%
Lack of sufficient description 19 16%
Product of nature 7 5.9%
Object not defined 6 5%
Late modifications on the application 2 1.7%
Application file outside the time limit 1 0.8%
Total 119 100%

Moreover, it is important to highlight that out of the 988 applications that received ANVISA’s prior consent, about 40% only received ANVISA’s approval after fulfilling some requests made by the agency. According to the study, most of these demands reduced the scope of claims, since part of the application lacked novelty, inventive step or were related to non patentable matter. In other cases, the demands were to clarify the object of protection or to enhance disclosure. This reduction in the scope of claims, from a public health perspective, is key since avoids health technologies from being taken out of public domain.

In other cases, ANVISA’s participation in the process led INPI to change its view regarding the granting of the patent application, which would have been granted if it was not for ANVISA’s participation. That happened in 90 cases. An emblematic case that shows how ANVISA’s collaboration with INPI in the analyzes of pharmaceutical patent applications can protect public health is the case of docetaxel, an anti-mitotic chemotherapy medication used mainly for the treatment of breast, ovarian, and non-small cell lung cancer. INPI had first issued a decision for the granting of the patent filled by Aventis Pharma S/A (PI9508789-3), but ANVISA denied its prior consent based on the lack of inventive step. After ANVISA’s decision, INPI changed its previous exam and denied the patent. The granting of this patent could have caused a great harm to the public programs of distribution of the medicine and to consumers in general, since the patent could be used to stifle competition in the supply of this product.

As shown, ANVISA’s participation on the analysis of pharmaceutical patent applications, in addition to prevent the granting of undeserved patents, also corrects inaccuracies in applications that in INPI’s view would be ready for approval, reducing or clarifying the scope of the object protected by the patent. Given the essentiality of medicines, as well as the impact of patents in access to medicines, ANVISA’s prior consent is a legitimate measure adopted by the Brazilian legislation to protect the right to health.

The monopoly created by a patent should last for 20 years, but if the patent-holder gets new patents for the same product, it may, in practice, extend its monopoly for an indefinite period of time, a strategy to "evergreen" patents (known as evergreening). Guidelines for the examination of patents that prevent the granting of such secondary patents are essential. To get an idea of excessive number of patent applications in Brazil: 18 patent applications for the drug lopinavir/ritonavir, 14 for darunavir, 10 for abacavir and 7 for tipranavir, all used to treat HIV/AIDS [9]. The mere existence of these applications can block competition and, in the case they are granted, the monopoly can be extended, delaying price reductions and access to these medicines.

One of the objectives of the patent system is to promote the development of new inventions. However, currently there is a decrease in the development of new pharmaceutical entities, but there is an increase in the number of patent applications. This dichotomy exists because most patent applications focus on minor changes to existing products (strategy known as evergreening). These are called secondary innovations, which often offer no therapeutic benefit and are of "low quality" in relation to the patentability requirements of novelty and inventive step. Examples are salts, ethers, polymorphs of a product (new forms) and different doses and therapeutic indications (new uses). Despite the "low quality" of such patents, they may have a high impact on health policies, blocking the use of generic medicines and allowing the company to obtain more profit from a product that could be in the public domain if there were no secondary patents. Therefore, it is necessary that countries have public health driven mechanisms to avoid the granting of this sort of patents. As shown, in Brazil, Anvisa’s prior consent mechanism has the potential to reject unmerited patents.
Anvisa’s prior consent is repeatedly applauded by human rights defenders around the world, but also has the displeasure of some sectors, specially transnational pharmaceutical companies that feel aggrieved, since they are not interested in rigorous analysis of patent applications. In some cases, pharmaceutical companies filled judicial actions over specific rejected patent requests that would question, additionally, the legitimacy of Anvisa’s prior consent. In other cases, the companies filled judicial actions questioning directly Anvisa’s participation in the patent granting process.

An important example of the second type of judicial case is the lawsuit filed by Associação da Indústria Farmacêutica de Pesquisa (Interfarma). INTERFARMA is an association of 52 pharmaceutical companies, mostly transnational, responsible for the majority of branded drugs sales in Brazil. In the case the lawsuit is judged in favor of INTERFARMA’s request, it would be the end of Anvisa’s prior consent and a great setback in the guarantee of the right to health in Brazil.

Anvisa’s prior consent mechanism has also been listed in the United States Trade Representative Special 301 list, as a mean to put pressure on Brazil to stop to apply the mechanism. This is an illegitimate and illegal mean of challenging Brazil’s sovereignty, right and duty to adopt TRIPS-compliant measures to fulfil the right to health.

Impact on remedying policy incoherence

UN human rights officials and bodies have repeatedly found that the globalization of intellectual property rights can only be squared with human rights if countries are allowed and encouraged to use the full scope of intellectual property protective measures provided in the TRIPS Agreement to protect public health and promote access to medicines [10]. The involvement of Anvisa in the analysis can contribute to verify compliance with patentability requirements, to prevent the granting of unmerited patents, to improve the quality of patents granted and to prevent barriers to access, since it brings the public health perspective to the analysis.

Impact on public health and human rights

With a stricter analysis of patentability criteria, less patents are granted and the ones granted have clearer scope of protection, reducing obstacles to production of generic versions of medicines, which can lead to more accessible prices. Lower prices increases the capacity both of the public health system and patients to purchase the needed medicines. Therefore, more people would be able to have access to lifesaving and health-increasing technologies.

The impact in the public health policy can also be economical, since it can lead to savings of financial resources. The high prices of medicines can be a burden on public health budget, putting at risk the sustainability of public policies on access to medicines. The savings allowed by Anvisa’s mechanism may be used in other areas of the health system. Areas such as prevention, health promotion and access to medicines to a larger part of the population may have more resources available if unmerited patents are not granted.

A economic study showed that the Brazilian government spent an estimated U$420 to U$519 million more for five ARVs protect by undeserved patents between 2001 and 2007 than would have spent had purchased their generic versions [11].

Brazil is the only country in the world with more than 200 million population and with a universal, free-of-charge public health system. Anyone can have access to all levels of care - from vaccines to transplants - including access to medicines. However, with a limited and short budget, the Brazilian State capacity to fulfill its population health needs can be in jeopardy if medicines - a key aspect of the right to health - are overpriced due to patent monopolies.

Implementation

While it is necessary to adopt a new R&D system on health, the negative impact of patents in access to medicines is certain to remain a global challenge over the next years. Therefore, it is necessary to increase the use of health protective measures already existing in the IP system, in order to increase as soon as possible access to needed medicines. An system of automatic compulsory licenses for already granted patents should be put in place. An for patent applications that are still pending analysis, a stricter mechanism of analysing the fulfillment of the patent criteria should be implement. This could be done by adopting mechanisms such as Anvisa’s prior consent, which is nothing more than having professionals linked to the health sector, and only to the industrial sector, analysing the patent applications for health-related technologies.

However, health protective measures still face many political barriers. Transnational pharmaceutical companies, with the support of the governments of the countries where they are based, have challenged the implementation of these measures and treating countries not to use them. This must stop immediately.

Bibliography and References

[1] Several studies show that there is a drastic reduction in the price of drugs once patents expire, due to competition from generic products that become available in the market (see, among others, "Integrating Intellectual Property Rights and Developing policy", Report of the Commission on Intellectual Property Rights, London, 2002, especially pages 29-56). In addition, a comprehensive study by the U.S. government found that on average the price of generic drugs is 43% of the branded medicine price practiced during the term of the patent (Generic drug industry dynamics. U.S. Federal Trade Commission Working Paper 248, 2002, www.ftc.gov/be/workpapers/industrydynamicsreiffenwp.pdf).

[2] UNITED NATIONS. A/HRC/RES/12/24. Paragraph 5. (2009).

[3] Reports have suggested practices of big pharmaceutical companies to block competition through the file of several patent applications for the same product. See, among others: the European Commission DG. Pharmaceutical Sector Inquiry: preliminary report, July, 2009. Available at: http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/communication_en.pdf.

[4] UNITED NATIONS. SUBSTANTIVE ISSUES ARISING IN THE IMPLEMENTATION OF THE INTERNATIONAL COVENANT ON ECONOMIC, SOCIAL AND CULTURAL RIGHTS. Follow-up to the day of general discussion on article 15.1 (c), November 2001. Human rights and intellectual property. Statement by the Committee on Economic Social and Cultural Rights. E/C.12/2001/15. Paragraph 12. 2001.

[5] UNITED NATIONS. HUMAN RIGHTS COUNCIL. Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, Anand Grover. A/HRC/11/12. 2009.

[6] “[I]t would be desirable to develop a close cooperation between, on the one hand, the ministries of health and health regulatory authorities and, on the other, the patent offices, for the examination of pharmaceutical patent applications. Moreover, the intervention of authorities competent in the area of public health can be envisaged. For instance, in Brazil, a provisional measure by the President (December 14, 1999) subsequently converted into Federal Law 10.196 of February 14, 2001, introduced into the Industrial Property Code a requirement of “prior consent” by the National Sanitary Supervision Agency (ANVISA) for the granting of pharmaceutical patents”. Guidelines for the examination of pharmaceutical patents: Developing a public health perspective, WHO-ICTSD UNCTAD, by Carlos Correa, Professor, University of Buenos Aires, January 2007, page 25. Available at:
http://www.ictsd.org/sites/default/files/research/2008/06/correa_patentability20guidelines.pdf.

[7] “A fundamental practical issue is that at the time of patenting, very little may be known about efficacy or other characteristics, particularly incremental, relative to the parent drug. Moreover, given the variability of the current skills set of patent examiners, it is difficult to rely on consistent and appropriate decisions on efficacy claims, particularly when patent applications routinely precede clinical trials, which would, inter alia, determine efficacy and other product characteristics. There is a case for patent authorities to consult health authorities in the examination process, to help determine whether patentability criteria are met”. Final Report of the WHO Commission on Intellectual Property Rights, Innovation and Public Health, CIPIH/2006/1, p. 134. Available at:
http://www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf.

[8] Coordenação de Propriedade Intelectual – COOPI/GGMED/ANVISA. NOTA TÉCNICA PROBLEMAS EM PEDIDOS DE PATENTE FARMACÊUTICOS. 2010. apud GTPI. INDIVIDUAL COMPLAINT AGAINST BRAZILIAN STATE. URGENT APPEAL TO UNITED NATIONS SPECIAL RAPPORTEUR ON THE RIGHT OF EVERYONE TO THE ENJOYMENT OF THE HIGHEST ATTAINABLE STANDARD OF PHYSICAL AND MENTAL HEALTH. ANVISA`S PRIOR CONSENT MECHANISM. 2011. Available at: http://www.deolhonaspatentes.org.br/media/file/Urgent%20appeal%20against%20Brazil%20-%20by%20GTPI%20(with%20annexes).pdf

[9] Villardi, Pedro. Status patentário e registro sanitário dos ARVs no Brasil: implicações para o complexo industrial de saúde. ABIA, Rio de Janeiro, 2012. Available at: http://deolhonaspatentes.org.br/media/file/Publica%C3%A7%C3%B5es/Publica%C3%A7%C3%A3o%20Pedro_Final_23OUT.pdf.

[10] See, for example, Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, A/HRC/11/12, Paragraph 27, (2009); Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, A/63/263, Paragraph 63, (2008); Human Rights and Intellectual Property, Committee on Economic, Social and Cultural Rights [CESCR], E/C.12/2001/15, Paragraph 12, (2001); Report of the High Commissioner, The Impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights on Human Rights, E/CN.4/Sub.2/2001/13, Paragraphs 27 and 28, (2001).

[11] HASENCLEVER, Lia et al. Pipeline patents and access to drugs: economic and legal aspects deleterious to health economy . Journal of Health Law, Brasil, v. 11, n. 2, p. 164-188, oct. 2010.. Available at: <http://www.revistas.usp.br/rdisan/article/view/13212>.