Category :
  1. Abstract / Resumo:

The present paper intends to study the international legislation on Compulsory License, specially arriving to article 31 bis of TRIPS Agreement and its legal effects. It will further be studied and compared legislations of India and Brasil, aiming to come to some conclusions regarding possible improvements in the Brazilian Legislation.

O presente artigo pretende analisar a legislação internacional em Licença Compulsória, com foco especial no artigo 31 bis do Acordo TRIPS e seus efeitos legais. Serão analisadas e comparadas posteriormente a legislação da Índia e do Brasil, objetivando-se chegar a algumas conclusões sobre possíveis melhorias na legislação brasileira.

Key Words: Doha Declaration, TRIPS 31 bis, Compulsory License, Generics, Anti-evergreening, Brazil

Palavras Chaves: Declaração de Doha, TRIPS 31 bis, Licença Compulsória, Genéricos, Anti Evergreening, Brasil.

  1. Table of Contents:

 

  1. Introduction
  2. International legislation on Compulsory License
  3. India’s legislation and experience
  4. Brazil’s Legislation and experience
  5. Which steps can Brasil take to benefit more from the actual situation through legislation change?
  6. Conclusion
  7. References

 

 

Introduction:

  1. The pharmaceutical market is going through impacting changes in the last decades. Not only because of new scientific discoveries, but also in view of legislation changes in the international, regional and domestic scenarios. In the past years, the generic industry grew strongly and in developing countries medicines are being better accessed by consumers that previously did not have access to some brand or patented medicines. These changes affected the profits of traditional pharmaceutical companies dealing with patented products.
  1. One legal tool that cooperates with said scenario is the Compulsory License, already provided for at the Paris Convention (PC), in article 5 A[1] and incorporated in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), articles 31 and more recently 31 bis, as well as in several regional and domestic laws, as the Indian and the Brazilian ones.
  1. Among the main industries for the generics, India is known as the Pharmacy of the developing world. Brazil is a big consumer and also manufactures, but mainly to the domestic market. India has rich experiences in this area, some brought by litigation with patented pharmaceutical producers due to market disputes. These experiences and comparisons may show better ways Brazil can follow, both to produce and export more medicines and to deliver efficiently to its nationals.
  1. Brazil is trying to adapt its legislation and important studies have been carried out on possible changes in its IP Law and examination procedures, together with Propositions for changing the Law. The discussion is on whether or not to increase the novelty and inventive step requirement level, anti-evergreening and facilitate compulsory license specially in healthy area.
  1. Studies from respectful institutions show the numbers and expectations for the pharmaceutical international and domestic markets. The present work will compare the specific Compulsory License, anti-evergreening and legislation of India that favors its situation as to try to identify possibilities for Brazil to better benefit from the field. It will be seeing if the Brazilian legislation and amendments propositions are well adapted and the study ends with suggestions by the writer.

International legislation on Compulsory License:

TRIPS – (negotiated at the Uruguay round of the GATT in 1994)

  1. Before the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), that came into force in January 01st, 1995, most developing countries did not have patent protection in their territories to pharmaceutical and food related products or had it partially, I.e. for their processes only, as it was the case in India[2]. Developed countries, together with their strong pharmaceutical and agricultural chemical companies, made strong lobby as to the creation of an agreement that would make developing and less developed countries include such protections in their legislations.
  1. With the economic power and influence of said producer countries into the WTO, the easier way to convince the developing countries to accept the inclusion of such subject matters in their legislations was through a WTO compliance treaty, as countries to be part of the WTO must accept all WTO treaties as a package. As well informed by Jodie Liu:

Although the TRIPS obligations clearly favored information-exporting developed countries, developing countries like India had no choice but to accept the terms of the agreement if they wanted to be welcome at the WTO.[3]

  1. The above influenced many developing countries that of course wanted to comply with the WTO to export their products, mainly agricultural, in some cases without the real notion of the results to come by the inclusion of pharmaceutical patent subject matter (food related products will not be the scope of the present paper).
  1. TRIPS is the “most comprehensive multilateral agreement on intellectual property[4]” and patents are treated in Section 5, from Article 27 to Article 34 of TRIPS, which also incorporated Paris Convention’s main provisions on the matter. Further to the now stronger possibility enforceability of IP rights, inclusively through taking disputes into the WTO’s Dispute Settlement Body, the so called “teeth” of the agreement, minimum standards were set out, such as 20 years minimum term for patent protection, sufficiently disclosure and inclusion of the said subject matter.
  1. For the scope of patentable subject matter, article 27 (1) provides that “(…) patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application (…)[5].”
  1. In article 30, TRIPs authorizes exceptions that may be conferred by members, under certain conditions, so called the three steps test, limiting the “exclusive rights conferred by a patent, provided that such exceptions (1) do not unreasonably conflict with a normal exploitation of the patent and (2) do not unreasonably prejudice the legitimate interests of the patent owner, (3) taking account of the legitimate interests of third parties”[6].
  1. TRIPS foresees exceptions and flexibilities in view of the necessity from certain member states, specially developing and less developed countries. An important limitation for the present paper, under its article 31, is on the expansion of the compulsory license’s rules previously brought by the Paris Convention, under certain conditions. “However, it does not limit the grounds upon which compulsory licenses may be granted, and it provides for a waiver of procedural prerequisites in cases of national emergency, extreme urgency or public non-commercial use.”[7]
  1. In a very short summary, the compulsory license is an act through which member states can allow a third party, without the attempted authorization from the right holder and following some rules, to the use of the patent without the owner’s authorization. Attempts of license must be made, denied and, under other certain conditions, a fair payment should be made by the licensee.

TRIPS article 31, Doha Declaration and Article 31 bis

  1. In the compulsory license system existing under TRIPs, many rules and procedures must be considered. Attention is therefore called to article 31 and article 31 bis, an important amendment brought by the DOHA Declaration, adopted on 14 November 2001.[8]
  1. While article 31 of TRIPs deals with Compulsory License, as other possible use without authorization of the right holder, its letter (f) rules that: “any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use”.[9]
  1. The condition brought by article 31(f) limited a lot the possibility to a country without a pharmaceutical industry capacity to obtain the benefits of the compulsory license, due to its lack of capacity to produce the medicine and with letter “f” it would not be able to import compulsory licensed medicines or generics made under that condition from another country. Said article is clear to state that the use shall be predominantly for the supply of the domestic market of the Member.
  1. As a response to address the above problem, developing countries united and influenced members to review TRIPs. As well taught by Professor Correa: “The adoption of the Doha Ministerial Declaration on TRIPS and Public Health was the outcome of carefully elaborated strategy by developing countries and a significant achievement for those nations”[10].
  1. From the many important outcomes of the DOHA declaration, it is here detached the one for the foresaid limitation, in its article 06, that states:

We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002[11].

  1. The offspring was the inclusion of article 31 bis at TRIPs, which now allows the importation of compulsory licensed medicines from another member state, as well as give other provisions and rules. For the moment, it is highlighted paragraph 1 of article 31 bis, that reads:

The obligations of an exporting Member under Article 31(f) shall not apply with respect to the grant by it of a compulsory licence to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s) in accordance with the terms set out in paragraph 2 of the Annex to this Agreement[12].

  1. In short, paragraph 1 of 31 bis retained all flexibilities under TRIPs but also allowed medicines under compulsory license to be exported to countries with lack of capacity to produce. The amendment is also built to avoid double remuneration to the patent holder, one interesting provision that allows one less developed country from a region of a trade agreement to negotiate and import not only to its market, but to the alike in same trade agreed region under similar circumstances, what provides a higher capacity to bargain prices against pharmaceutical companies and generics manufactures.
  1. Another annex to TRIPs was created by the amendment, setting out rules, definitions, commitments to develop needed countries possibilities, such as to develop a system to grant regional patents to members as in paragraph 3 of 31 bis, for such an end “developed country Members undertake to provide technical cooperation in accordance with Article 67 of this Agreement, including in conjunction with other relevant intergovernmental organizations” [13], as well as the promotion of technology transfer and capacity building for the pharmaceutical sector in said countries.
  1. Lastly, the amendment obliges the Council for TRIPS to review the accordance of the system as to ensure effectiveness and to annually report to the General Council.
  1. WTO members agreed on December 06, 2005 and the amendment application started on Jan.23.2017 to permanently incorporate the 2003 waiver that was subject to the acceptance of two-thirds of the members.
  1. The above described changes in the TRIPs agreement opened doors for the assistance of developed and less developed countries without the possibility to manufacture medicines. Further to this healthy issue, they have also opened market and economic possibilities to countries that are able to manufacture medicines.
  1. At the same time, Compulsory License united with possibilities foreseen in International Agreements and Treaties, together with domestic policies, are of extreme importance for the countries to create innovation and development, what is and should always be the main concern of the use of IP.
  1. Although the protection given through the patent system is to be respected, of course, aiming to keep the system working, states need to rely on the compulsory license for the cases where said system cannot reach fairness. The so called neutral Declaration on Patent Protection – Regulatory Sovereignty under TRIPs,[14] made by The Max Planck Institute for Innovation and Competition, in Munich, on April 15, 2014, bring important teachings that should be followed by every country, from which we highlight:

The discretion of states to make use of compulsory licences as regulatory instruments is ensured by the fact that neither Article 31 of the TRIPS Agreement nor Article 5A of the Paris Convention contains any restriction with regard to the grounds on which a compulsory licence may be issued.[15]

  1. It is pointed out that there are two kinds of Compulsory Licenses, the one that serves to allow improvement dependent patents to obtain the license from the main patent and, the other, focus of the present work, that serves to attend public interest.
  2. Although there are many compulsory licenses known and some scholars unite a considerable number, it is not easy to access the actual situation, as there is not yet a central registry where countries need to inform when this system is used. As explained by Ali Feroz:

One of the problems in the identification of compulsory licences is that there is no database under any of the international conventions where member countries need to record the issue of compulsory licences. This leads to an unclear record of the licences issued so far.[16]

  1. The present paper will use as examples experiences of India, for the obvious success, and the Brazilian one, since it will give the possibility to comparisons.

India’s legislation and experience

 

  1. India is a Common-Law country and its patent legislation is ruled by the Indian Patent Act (Act) of 1970. This Act was amended on 1999, 2002, and 2005, which incorporated the TRIPs Rules.
  1. India is a very interesting and important case to be considered, as its patent legislation is a result of a long-term concern with public health. There is a strong concern to make available medicines at a reasonable and affordable price. As explained by Viviana Munoz Tellez:

Since the 1970s, former government officials, parliamentarians, legal and political experts, trade unionists and social activists have organised in NGOs and worked in alliance with the national pharmaceutical industry to influence the process of reform of the Indian patent system.[17]

  1. It is so truth, that the Patent Act of 1970, with validity as from 1972, already aimed innovation specially directed to protect public interest and improve India’s industrial capacity. Always with these standards trying to be considered higher than Intellectual Property Rights, although causing dubious effects against patent holders. Before the 1970’s act, foreign Pharmaceutical companies represented 85% of medicines in India, with high prices and now it is a strong manufacturer country: “India has a growing pharmaceutical industry, exporting $13 billion worth of drugs last year [referring in 2013 to 2012]”[18], becoming a concern to many developed countries industries, like the US. As it is known, a generic market brings more competition among generics and forces price down of patented medicines.
  1. Very important characteristic of the original Patent Act is the existence in section 5 of pharmaceutical process patents, however, the patent for the product itself was not allowed. The obvious result was that the creativity of the Indian Industry made available through reverse engineering many important medicines, by simply applying a different process. This was not considered an infringement and companies could freely act on this objective, meanwhile increasing know-how and industrial capacity. Also in the 1970’s Act the validity of the process patent has been reduced from 14 to 7 years.
  1. To comply with TRIPs, among other changes, such as incorporation of patents in all fields of technology, India simply deleted section 5, including therefore pharmaceutical patent product in the legislation.
  1. On the other hand, TRIPs flexibilities were also brought to the Act in 2005, like the Compulsory License system with section 84. Also, with amendment of section 3(d), a strong anti-evergreening system was made available, not allowing new patents for medicines for a known substance. It is only granted a patent if there is a clear new and strong efficacy for same substance. As explained by Jodie Liu:

But the TRIPS flexibility that has garnered even more international attention is the anti-evergreening provision section 3(d), explained in greater detail below, which excludes from patentable subject matter any new form of a known substance, if the new form does not feature an “efficacy” above and beyond that of the known substance.[19]

  1. As we can see, for Indian Policy there is not only the Compulsory License system to be used at said public interest, but also a tool to be used to avoid the evergreening and therefore avoiding the maintenance of monopolies for patents lacking novelty. This last tool was used in an important case Novartis AG Vs. Union of India and the Compulsory License in the Bayer Vs. Natco case.
  1. In summary, the most important sections to be highlighted in the Indian Law that relate to the promotion of healthy and access to medicines are:

Section 84: Compulsory licenses

(1) At any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory licence on patent on any of the following grounds, namely:

(a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or

(b) that the patented invention is not available to the public at a reasonably affordable price, or

(c) that the patented invention is not worked in the territory of India.[20]

(…)

  1. This section 84 was of extreme importance in the Bayer Vs. Natco case[21], as Nacto defended itself – after a Suite filed by Bayer regarding alleged copy of the medicine Nexavar – but, instead of claiming that the patent was not valid, or that the generic was not infringing, Natco filed a Compulsory License request before the Indian Controller General of Patents. This was the first Indian Compulsory license granted, on March 09, 2012, paying Bayer an initial 6% Royalty, then Revised by the Appellate Body to 7%.
  1. What is relevant on the above case is:

– The interpretation that should be given for section 84, for a compulsory license, that is always the satisfaction of public interest.

– The reasonably affordable price referred to in 84(1)(b) relates to the public, not the right holder, as Bayer tried to argue. The interpretation is that it doesn’t really matter how much the company spent on R&D if in the end the price does not reach consumers at a reasonably affordable price.

– Article 84(7) lists (not exhaustive) cases of non-satisfaction of the reasonable requirements of the public, and one in special, (d) “if the patented invention is not being worked in the territory of India on a commercial scale to an adequate extent or is not being so worked to the fullest extent that is reasonably practicable[22]” was not met, even though the medicine was being delivered to some people through a patients assistance program from Bayer, because there was no manufacture in India and the company was relying only in importation. “(…) the program’s imports had to be on a commercial scale to an adequate extent and be sold at a reasonably affordable price”[23].

– The Appellate Body decided that the meaning of “Working” in India is to be judged case by case, but importation of the product may not satisfy the requirement of worked on the Indian territory.

– Also, very important is that the Compulsory License began from a competition, or marketing issue, but the resolution considered public interest. It was not an exception measure ex oficio started by the government of India.

  1. Regarding the possibility of Compulsory License due to non-work of the patent in the territory, the decision of the Appellate Body seems to be correct, and it is never too much to remember the sayings of the Max Planch Institute on it:

Since the non-discrimination principle of Article 27 of the TRIPS Agreement – namely the prohibition to discriminate as to whether products are imported or locally produced – does not apply to Article 31 of the Agreement (see supra para. 8), states remain free to implement ‘local working requirements[24].

  1. According to Jodie Liu, the condition of reasonably affordable was the main point made strong on the above case:

The effect of Bayer is that the “reasonably affordable” condition in section 84(1)(b) now does essentially all of the work of the compulsory licensing scheme, as the other two conditions have been either defined away or made so ambiguous as to have little practical effect.[25]

(marked)

 

  1. Section 3(d) (Aid to the anti-evergreening system):
  1. What are not inventions. The following are not inventions within the meaning of this Act:

(…)

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant, is not patentable.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy[26].

  1. The above section had impact on the Novartis AG Vs. Union of India case[27], as the rejection of Novarti’s patent for Gleevec was kept by the Supreme Court of India with, in short, the compound “was indeed a new form of the known compound imatinib free base, but that Novartis did not present sufficient evidence of an enhancement in therapeutic efficacy in the imatinib mesylate beta crystalline as compared to imatinib free base”[28]. Therefore, efficacy of 3(d) should be read as therapeutic efficacy.
  1. It is important to point out, however, that the application of section 3(d) in a strong way may decrease the incremental innovations, what, unlike evergreening, are an important way for the development of health treatments. It is quite hard, however, to distinguish in a practical case what is evergreening and what is an incremental innovation.

Brazil’s legislation and experience

  1. Brazil is a Civil Law country and its IP Law number 9.279/1996 entered in force on Jan.1997 and adopted the changes to comply with the TRIPS Agreement at the time. In many aspects, the Law is similar to TRIPs complied legislations. Patents are also granted in all fields, under certain limits and they include process and product. The main articles that relate to Compulsory License are from Art. 68 to 74. Detached below are the relevant parts for the present work.

Compulsory Licenses

Article 68 – A patentee will be subject to have his patent licensed compulsorily if he exercises the rights resulting therefrom in an abusive manner or by means of it practices abuse of economic power that is proven under the terms of the law by an administrative or court decision.

  • 1 – The following may also result in a compulsory license:

I – the non-exploitation of the subject matter of the patent in the territory of Brazil, by lack of manufacture or incomplete manufacture of the product or, furthermore, by lack of complete use of a patented process, except in the case of non-exploitation due to economic inviability, when importation will be admitted; or

(…)

  1. Article 68 deals with abusive use of rights. In paragraph 1st it is brought cases that are of special interest for the present. Item I is broad and is well written. When compared to India’s Law and TRIPS, it brings the notion of “work in the territory”. In the Brazilian case, it is foreseen incomplete manufacture of product or patented process. There is an exception due to “non-exploitation due to economic inviability”, when importation will be allowed. This economic inviability, nevertheless, brings space to different interpretations and may be used as excuse to a possible creation of economic viability.

II – commercialization that does not meet the needs of the market.

  1. The above possibility of Compulsory License is important, nevertheless, it is limited by the word “market”. Although we will see further provision of public interest, it should be, as in the Indian case, included the word “public interest”, since it should be the major interest by the State and another company would be able to bring a discussion to compulsory license even claiming public interest in a common law suit as in the Indian Bayer Vs. Natco case (referring to Section 84 of the Indian Patent Act).
  • 2 – The license can only be requested by a party with legitimate interest and that has the technical and economic capacity to carry out the efficient exploitation of the subject matter of the patent, that should be destined predominantly for the internal market, suppressing, in this case, the exception provided for in item I of the previous paragraph.
  1. The above provision is not in compliance with article 31 bis of TRIPs, as the restriction of the exploitation “predominantly for the internal market forbids an importation of generics medicines from another member state. The importation, however and as we will see below, happened on the Compulsory License by an act of the Brazilian Federal Executive Authorities on the “efavirenz” drug case, due to public interest, as per article 71 of Brazilian Law.
  • 3 – In the case that a compulsory license is granted due to abuse of economic power, a period of time, limited to that provided for in article 74, will be guaranteed to the licensee proposing to manufacture locally, to proceed with the importation of the subject matter of the license, provided it has been placed on the market directly by the patentee or with his consent.
  • 4 – In the case of importation for exploitation of a patent and in the case of importation provided for in the previous paragraph, the importation by third parties of a product manufactured according to a process or product patent will equally be allowed, provided it has been placed on the market directly by the patentee or with his consent.
  • 5 – A compulsory license, to which § 1 relates, may only be requested after 3 (three) years from grant of the patent.

Article 69 – (exceptions to the granting of a CP, as non-use due to legitimate reasons, prove of preparation, legal obstacles).

Article 70 – (deals with dependent patent)

Article 71 – In cases of national emergency or public interest, declared in an act of the Federal Executive Authorities, insofar as the patentee or his licensee does not meet such necessity, a temporary ex officio non-exclusive compulsory license for the exploitation of the patent may be granted, without prejudice to the rights of the respective patentee.

Sole Paragraph – The act of grant of the license will establish its term of validity and the possibility of extension.[29]

  1. The above provision in article 71 is of extreme importance for Brazil, as it is an emergency and flexible tool that can be used for the granting of a Compulsory license, always respecting the Brazilian Law and international treaties, however with the strong power of an executive act (Presidential act), what gives a power of bargain to Brazil, as a tool of threaten in case of non-compliance of public interest by the patent owner.
  1. As an Executive Act, however, and an exception, article 71 cannot be used in normal disputes from companies in market cases, as the ones exemplified above in India, the public interest is mainly used as a Policy from the Brazilian Government (Executive/Presidential act), and it results in less people deciding for what are public concerns.
  1. A second effect is that, first, Administrative and Court (Art. 68: ´ by an administrative or court decision´) decisions will be more turned into Market or competition interests (article 68, paragraph 1, II) not necessarily due to public interest even when started by an interested company, third, these decisions may not be TRIPS 31 bis compliant, as Brazilian legislation foresee the limitation of the use to the domestic market (article 68, paragraph 2).
  1. Brazil had some CL (compulsory license) cases previous to the Law 9.279/96, They referred to patent PI 76.767, of a viral culture process patent for a vaccine against aftosa fever, from the National Research Development Corporation, and another for patent 7.107.076, licensed to Nortox Agro-Química S/A from Monsanto Company.[30]
  1. After that, in 2001, Brazil could reduce prices for HIV/AIDS medicines in about 40 to 70%[31] only through bargains, threatening to provide Compulsory licenses for medicines nelfinavir and efavirenz.
  1. The United States have filed a complaint at WTO, in 2001 (WT/DS199/3), informing the non-compliance to TRIPS on Brazilian law’s authorization to compulsory licenses if objects were not worked, however, this case ended with a bilateral agreement and, now, if Brazil intends to grant a Compulsory License against the US, although it seems that Brazil is right in its interpretation (inclusively as informed at the Max Planck position above), it has first to try a bilateral agreement with the US. As further explained by Professor Correa:

This agreement does not prevent Brazil from granting a CL based on Article 68 but only requires it to enter into bilateral discussions; Brazil may subsequently decide to grant a CL. It may be speculated that the USA withdrew the complaint against Brazil because of fears that an adverse ruling in the WTO could set a negative precedent—from the US perspective—on the interpretation of Articles 27.1 and 31 of the TRIPS Agreement. The fact is that the TRIPS compatibility of CL provisions for non-working has never been raised again under the DSU, despite the fact that several national laws contain provisions allowing for compulsory licences in such cases[32].

  1. As it is noticed, although the Max Planck Institution’s opinion, there is not a decision in international level on what would be the precise limitations for the “Work” in the territory requirement.
  1. Since Brazilian Law changed to be TRIPs, (Law 9.279/ of 1996,) the case that called attention is the one related to efavirenz, the anti-HIV drug, compulsorily licensed from Merck & Co. Inc. to the Brazilian Health Ministry (Presidential Decree No. 6.108, of May 4, 2007. In this case, importation from India was made by the Brazilian Government after attempts to negotiate with Merck.
  1. Excepting therefore the limitation rule existing in Brazilian article 68 paragraph 2, the decision itself on the above CL was compliant to TRIPs article 31bis., however in an indirect way of the exception through Executive act provided by such Brazilian article.
  1. Also interesting on the above CL was the use of Patent writing techniques that did not allow the complete disclosure of the patent. As again explained by Prof. Correa:

Due to the lack of sufficient technical information in the patent specifications, Farmanguinhos had to perform its own research activities in order to reverse engineer the product and to import small quantities of efavirenz from India; a preliminary injunction filed by Merck to stop the importation was rejected by the Brazilian courts.33 The CL allowed the Ministry of Health to save around 58 % (US$103.5 million) of the resources otherwise needed for the period 2007–2012[33].

  1. Although the disappointment from the United States and threatens received by Brazil in the commercial sphere, no commercial sanctions were made.
  1. On what regards to Anti-evergreen, Brazil’s Law 9.279/96 has yet not a clear rule as India has in its Section 3 (d), above informed. It has the general TRIPs understands on what regards inventive activity, as below indicated:

Article 8 – To be patentable an invention must meet the requirements of novelty, inventive activity and industrial application.

Article 13 – An invention shall be taken to involve inventive activity when, for a person skilled in the art, it does not derive in an evident or obvious manner from the state of the art.

  1. Nevertheless, Brazilian Patent and Trademark Office has created guidelines (not a Law) as to examiners to consider the inventive step, as follows:

Brazil: Recently new guidelines were drafted by the Brazilian Patent Office to restrict the patentability of new forms of already known compounds (polymorphs) or new property or new use of a known process which makes exactly similar sense as that Section 3(d)[34].

  1. As we will see further, however, there is a new guideline in force regarding the Chemical patents examination procedure, being a strong anti-evergreening tool in Brazil regarding that kind of patent, including pharmaceuticals.
  1. Concerning Doha, as to the present moment Brazil did not make amendments in its national Law to Comply with TRIPS 31 Bis (Doha’s declaration paragraph 6), as it can also be noticed in the WTO’s web page[35].
  1. However, Brazilian Government has a Centre for Studies and Strategic Debates, made by its Chamber of Deputies, and it has discussed and concluded for a Proposition of an amendment in the Brazilian IP Law. Among many other information brought by a study made by that Centre, it is highlighted:

India has amended its patent law in 2005, following a transitional period of 10 years granted by the Agreement on Trade-Related Intellectual Property Organization (TRIPs) World Trade Organization (WTO) for the adoption of pharmaceutical patents in countries where such patents were not authorized at the time when the WTO was Unfortunately, Brazil did not take advantage of this transition period, which could have been used to assist in the formation of our national industry.

The Novartis case before the Indian Supreme Court, decided early in 2013, is emblematic for having rejected the grant of a patent for a new form of known substance (polymorphs), and highlights the importance of implementing the safeguards of the TRIPs Agreement. India has adopted this safeguard and has become the international supplier of affordable generic medicines to the general world public – as well as empowered its truly national industry.[36]

  1. The above study, approved unanimously by the Chamber of Deputies in 2011 shows that Brazilian Government was well informed and updated on the economic effects and uses that can be made by the IP system. This study generated the proposal for the amendment of Brazilian IP Law number 5.402/, year 2013 (not voted nor in force yet).
  1. The amendment proposal foresees changes in Brazilian IP Law that consider, within the TRIPs agreements, an adaptation in the Brazilian IP Law to better serve the countries public interests and access to medicines.
  1. Among all proposed changes, we number here five that are more related to the present work. One, to Public Use of the patent, is cited at the proposal as to increase the possibilities of forced license.
  1. The second one that relates to the possibility of an opposition procedure before or after the granting by any interested party, considering that nowadays it is only made through the sending of information that may be against or in favor of the granting.
  1. The third and fourth ones are: the intention to prohibit the patent of second use and to prohibit patents of polymorphic forms, as already done by India. Fifth, a highest level for the inventive step requirement when judging a patent application.
  1. These last three proposals can be understood to relate to an anti-evergreening system.
  1. The proposition has deep concerns and considers very up to date studies, including the considerations from Polymorphs and second use, what in fact are the incremental changes that wanted to be avoided, as an anti-evergreening system. It also considers the Markush claims, public interest and many others.
  1. Calls attention in the Amendment proposition the studies made at many other Laws, like the Indian Law referred previously in this work.
  1. Brazil is not the only country in South America worried about the balance of public interest and the patent monopoly / accessibility at the pharmaceutical area. Argentina, Brazil, Chile Paraguay and Uruguay Healthy Ministers signed an agreement called “Criteria for Patentability, Access to Medicines and Public Health” that includes:

Compliance and application of the patentability criteria in our region raises concern because of the proliferation of patent applications on matters that do not constitute an invention or are marginal developments. That these difficulties were highlighted in several studies that point out the negative effects on access to medicines and public health in the granting of patents for medicines [based on this type of claims].[37]

  1. Professor Correa’s 2007 “Guidelines for the examination of pharmaceutical patents: developing a public health perspective” is used as a strong reference and has influenced the way Mercosul’s countries are considering the examinations.
  1. All the studies for the Proposition above cited take a lot into consideration the Public Interest and conveys, among other important conclusions, that incremental patent protection causes an effect that is demotivating the actual important and big steps inventions. Therefore, protecting the public interest should be motivating Brazilian entities to deeper studies and bigger steps of protection.
  1. It will be highlighted below the parts of the amendment proposition that relate more to the compulsory license and anti-evergreening system, as they are the core of the present work, nevertheless, changes proposed are many.
  1. The proposal of change in article 10 of the Brazilian IP Law Nb. 9.279/96 in fact implements an anti-evergreening system similar to the Indian Law. In the proposition to change that article there are items X and XI that read:

Art. 10. It is not considered an invention or utility model:

(…)

X – any new property or new use of a known substance, or the mere use of a substance known process unless this known process results in a new product;

XI – new forms of known substances which do not result in improved efficacy substance.

Sole Paragraph. For the purposes of this Article, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance should be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

  1. It is important to point out that the proposed changes above are very close, in fact basically the same, of the Indian Patent Act previously studied, in Section 3(d):

Indian Patent Act:

Section 3(d) (Aid to the anti-evergreening system):

  1. What are not inventions. The following are not inventions within the meaning of this Act:

(…)

(d) the mere discovery of a new form of a known substance (A)

which does not result in the enhancement of the known efficacy of that substance (B)

or the mere discovery of any new property (C)

or new use (D)

for a known substance (A)

or of the mere use of a known process (E),

machine or apparatus (no equivalent)

unless such known process results in a new product (F)

or employs at least one new reactant, is not patentable. (no equivalent)

Brazilian amendment proposition:

X – any new property (C) or new use (D) of a known substance (A), or the mere use of a substance known process (E) unless this known process results in a new product (F);

XI – new forms of known substances (A) which do not result in improved efficacy substance (B).

Indian (cont.):

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy .

Brazilian Proposition (cont.):

Sole paragraph. For the purposes of this Article, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

  1. It is not necessary to say that the Brazilian Amendment Proposition in what regards to the above clauses are practically identical to the Indian Law. It is considered, when thinking at the public/social interest, that the above proposed changes are indeed attending it.
  1. Further, proposed article 31 includes an opposition system, while in the actual Law it is only allowed the sending to the Brazilian PTO of documents that my aid the extensive examination and a cancelation procedure after the granting. The opposition system obliges the examiner to responding technically to the basis of opposition and to inform why rejects or accepts each one, justifying its position.
  1. New art. 43-A. would implement very strong Governmental Public noncommercial use system. The starting of this article states:
  1. 43-A:

The Public Power, through an Ordinance of the Minister of State concerned, may make use of non-commercial public domain of the subject matter of patents or patent applications, without the consent or authorization of the patent owner or of the patent application, either directly or through hiring or authorization to third parties for purposes of public interest, including those of national defense and Social Interest.

  1. Attention is called to the fact that, further to implementing a public use, it includes as basis on public interest and it can be issued from the act of a State Minister with no previous negotiations. Therefore, this Government direct use would be easier issued. Paragraph 2nd says that the State through the Public Power simply will inform the patent owner of the noncommercial public use of the patent. Therefore, the proposed system requires much less bureaucracy.
  1. Paragraph 4th rules that the payment for the Public Use will be set by the Public Power according to each case’s particulars, taking into consideration a percentage of what would be paid in a regular voluntary licens The public use will not be suspended or stopped in reason of a judicial appeal regarding the amount to be paid.
  1. Proposed Public Use system in Brazil will not exclude the actual Compulsory License system under article 68. This would be a new procedure, much more simple and direct interference. Of course, the owner will be able yet to continue with the exploitation of the patent, however, having to stand the government use at same time under Governments discretion. This is a very strong change.
  1. The above proposed Public Use follows tendencies in other countries, such as the United States of America (Section 28, US Code, paragraph 1.498) and Australia, Ireland, Italy, Germany, New Zealand, Philippines, Malaysia, Singapore, among many others[38].
  1. The main discussion here would be that this direct use with no discussion or defense possibility (with exception to the amount paid) generates a Right insecurity to patent owners, out of the actual Compulsory system in Brazil that gives more chances to discussion or is highly decided when by the President act.
  1. While the amendments proposition is waiting to be judged by the Plenary, as anticipated, the Brazilian PTO has issued an administrative Directive (Resolution Rule Number 208/2017, published and in force from December 2017) that changes the examination procedures regarding chemical patents, including examinations for biotech and pharmaceutical applications. There was a public consultation prior to the acceptance of the Resolution.
  1. The new Directive takes into deep consideration same aspects that were taken into the Proposition to amend the Brazilian IP Law. There is a strong anti-evergreening system, increase of the novelty and inventive steps requirements, Markush claims considerations, polymorphs, Stereoisomers, solvates, clathrates, co-crystals, analogs processes and new use (and new medical use) restrictions, only related to a considerable improvement.
  1. A chemical composition, for instance, should be claimed by the description of its chemical structure, and not through the process to obtain, unless in strict exceptions when such description is not possible. Also, salts, n-oxides, esters and ethers when generically anticipated by the state of art, cannot be specifically claimed. And, among others, the directive brings restrictive interpretation to pro-drugs, intermediate reaction compounds (as main part of the invention or not).
  1. Also, chemical compositions found in nature, of course, are not patentable, therefore the patenting of chemical compositions selection has strict requirements too.
  1. Technical aspects are not the focus of the present paper and will not be dealt in deep. What is important to realize is that through a direct system, using examination procedures, Brazilian Government has found a shortcut to implement a strong anti-evergreening based on international studies and considerations.
  1. It appears, however, that there is still a missing part in the Brazilian IP Law that should authorize interested competitors and others to go to Court due to decisions related to public interest, not only to market interest (Art. 68, paragraph 1, Item II of Brazilian IP Law).

Which steps can Brazil take to benefit more from the actual situation through legislation change?

 

  1. Brazil could make legislative changes to take more advantage of the pharmaceutical scenario. It should, firstly and as soon as possible, amend its legislation to be compliant to TRIPs article 31 bis, therefore changing its article 68, paragraph 2, of Brazilian IP Law, excluding the obligation to be predominantly to the domestic market. Also, 68, paragraph 1, II, should read “public interest”, further to “market”: “Public interest and market interests”.
  1. By doing so, discussions would be initialized also by practical competitor disputes based on Public Interest, not only on market requirements, as recites the Law. As to the present moment, decisions to import generic drugs have only been made by a Presidential Act (Executive act) as exceptions and as a matter of direct policy to public interest, therefore not in the hands of more people, as it could be observed if Courts could also judge when existing the rule of public interest in the Law itself.
  1. Brazil, as an example of India, has included in its legislation, through the new directive 208/2017, independently of the acceptance of the IP Law Amendment Proposition, a competent and updated anti-evergreening measure, which can avoid the perpetual renewal of rights. Also, the current legislation and said directive tries to avoid basic incremental patents granting. The aim is to motivate domestic companies to try for higher steps innovations and to increase the development of the country.
  1. The IP Law Amendment Proposition, on the other hand, appears to be a very strong way which may frighten investors to apply in and invest Brazil, since this system can generate juridical insecurity to patent holders or applicants.
  1. A system where there is more chances to a defense (Brazilian Constitution Article 5th, letter LV provides the right of defense) and discussion on the necessity of a compulsory license would result in more stability and investments, being always possible to use Government interference through a Presidential act, as it is nowadays.
  1. At the same time, formal pharmaceutical market shows a decrease due to the higher commercialization of the generics. Big pharmas, however, are also entering into the generic market, which shows yet good possibilities for developing countries.
  1. As demonstrated by a relevant study proposed by Price Waterhouse Coopers, “most of the projected increase in pharmaceutical sales over the next decade is expected to come from generics rather than patented products”[39]:
  2. Referring to the Brazilian Market: “From 2007 to 2011, the medicines retail sales registered an accumulated growth of 82,2%, jumping from R$ 23,6 billions to R$ 43 billions, according to a report from Interfarma based on IMS Health data”.[40]
  1. Brazil could take advantage not only by exploring better the generic market, but also investing in public pharmaceuticals production and in private Brazilian companies.
  1. When analyzing the text written by Joseph E. Stiglitz, named “Knowledge as a Global Public Good”[41], Abbot, Cottier and Gurry point out:

(…) patents are not the only mechanism by which governments can and do promote inventive activity. The principal alternative to the patent is the government “subsidy”, that is, payment (direct or indirect) by the government to a person to support research.[42]

  1. Another important way Brazil can profit from the pharmaceutical industry is not looking at it directly, but as part of the health system. In this system, other sub areas also act and can bring results. One of these related areas is the software and mobile applications one. It is getting more and more popular the use of phone/mobile apps to help in the treatment of diseases.
  1. Mobile apps can be used to unite pharmaceutical industries, doctors, public (patients) and government, making treatments more effective. An app used by a pharmaceutical company to monitor the use of medicines by their consumers and their development on the treatment would bring to this companies an immediate response and the possibility to make better treatments. Using apps consumers would save on the medicines because they should use it in a more effective way, avoiding for instance to forget the dosages and ingestions. Accessing the apps and checking the usage and results, doctors also would be able to better the treatment doses or their ways of application.
  1. Software and mobile applications can therefore help in the health area and, when compared with the development of new drugs, for instance, they could be far cheaper, bringing important results. Looking from the IP side, it is also possible to obtain software and related IP protection rights for the apps and have security. As it is known copyright related rights do not need international filings as patent rights.

 

Conclusions

 

  1. It becomes clear, from the above considerations, concerning anti-evergreening, that Brazil´s situation is up to date, complying with public and social interest policy.

 

  1. When compared with Brazil, India’s legislation is more permissible to the granting of compulsory licenses, even considering that Brazilian IP Law Amendment Proposition 5.402. Besides, has an important anti-evergreening system, further to an intrinsic public interest concern.
  1. On the other hand, Brazilian anti-evergreening system, as anticipated, has gained strength through the Brazilian PTO’s new cited Directive.
  1. The compulsory license system in Brazil lacks a stronger public interest basis to aid in a market discussion at the Courts. This could be changed by inserting the Public Interest possibility into Article 68, Paragraph 1, Item II of the Brazilian IP Law 9.279/96.
  1. In summary, the lack of the (i) adoption of the TRIPs 31 bis and (ii) the preference gave to the market in the federal IP Law, together with the (iii) possibility to authorize a Compulsory License importation only through a Presidential Act, put Brazil in a situation by which the market legal disputes are weak to bring more benefits to Brazil concerning compulsory licenses.
  1. On the other hand, if Amendment Proposition number 5.402 is accepted, the public use of patents and/or patent applications would bring Brazil into a situation that could decrease the interest in the market by investors, both domestic and foreign ones, as the juridical instability and uncertainty would be higher. It brings to decisions by the government that do not leave good opportunities of discussion from the right holders. Or else, the Proposition is not so democratic.
  1. The actual lack of compliance with TRIPS 31 bis does not facilitate Brazilian manufactures to produce and export medicines/drugs to less developing countries.
  1. Proposed changes in the Brazilian IP Law (9.279/96) should finally include:
  1. Amendment in article 68, paragraph 2, excluding the obligation to be predominantly to the domestic market, as to comply with TRIPs 31 bis.
  1. Same article 68, in paragraph 1, II, should read “public interest”, further to “market”.
  1. The above changes would permit Brazil to include in its judiciary system decisions related to compulsory license in a better way, instead of leaving the allowance of Importation of compulsorily licensed drugs to the Presidential Act only. Decisions by the Judges would come from the market disputes rather than only from Government Policy.
  1. Further, although the patented medicines market is going down, numbers demonstrate that the Generics market is growing and there are opportunities for developing countries to either manufacture more generics for their internal markets and/or, especially in the Brazilian case that has a possibility for manufacture, to export to other developing or less developed countries.
  1. The informed changes in the Brazilian legislation would therefore favor Brazil to increase its commercial position in the international scenario and, more important, increase access to medicines in its territory as well as in other countries.

Bibliography / References:

  1. Paris Convention for the Protection of Industrial Property, available at: http://www.wipo.int/wipolex/en/treaties/text.jsp?file_id=287556
  1. Indian Patent Act of 1970, amendment and updated versions, available at: http://www.ipindia.nic.in/acts-patents.htm
  1. Liu, Jodie, Compulsory Licensing and Anti-Evergreening: Interpreting the TRIPS Flexibilities in Sections 84 and 3(d) of the Indian Patents Act, 56 Harv. Int’l L.J. 207, 228 (2015).
  1. WTO, TRIPS : A MORE DETAILED OVERVIEW OF THE TRIPS AGREEMENT, accessed on Dec.01st.17 at: https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm
  1. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments—Results of the Uruguay Round, 33 I.L.M. 1125, 1197 (1994) [hereinafter TRIPs Agreement].
  1. Abbot, F.M., Cottier, Thomas, Gurry, Francis, International Intellectual Property in an Integrated Economy, CCH Incorporated, Wolters Klumer, 2015.
  1. Declaration on the TRIPS agreement and public health, DOHA WTO MINISTERIAL 2001: TRIPS, WT/MIN(01)/DEC/2, 20 November 2001. [hereinafter Doha Declaration]
  1. TRIPS Agreement (AGREEMENT ON TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS), available at: https://www.wto.org/english/docs_e/legal_e/27-trips.pdf
  1. CORREA, Carlos M. and World Health Organization, Implications of the Doha Declaration on the TRIPS Agreement and public health. 2002.
  1. Max Planck Institute for Innovation and Competition, Declaration on Patent Protection – Regulatory Sovereignty under TRIPs, Munich, 2014, accessed on Dec.10.2017, available at: http://www.ip.mpg.de/fileadmin/ipmpg/content/forschung_aktuell/04_declaration_on_patent/patent_declaration_en.pdf
  1. Feroz, Ali, Nexavar: The First Market-Initiated Compulsory Licence, 9 NUJS L. Rev. 229, 258 (2016).
  1. Tellez, Viviana Munoz, Patent Reform in India: The campaign to protect public health.
  1. Casey Jr., Robert P, Advances by Pharmaceutical Companies Have Saved Lives, Create Jobs And Boosted PA’s Economy but Intellectual Property Violations from India Are a Threat, BOB CASEY, June 7, 2013, accessed on Dec.08.2017 at: https://www.casey.senate.gov/newsroom/releases/casey-200-000-pa-jobs-40-billion-industry-is-threatened-by-intellectual-property-violations-in-india
  1. Bayer Corp. v. Natco Pharma. Ltd., Order No. 45/2013, para. 50 (Intellectual Property Appellate Board, Chennai, 2013).
  1. Novartis AG v. Union of India, 2007 A.I.R. 24759 (2013)
  1. Brazilian Industrial Property Law – Law 9.297/96, accessed on Dec. 12, 2017, available at http://www.planalto.gov.br/ccivil_03/leis/L9279.htm
  1. VIANNA, Joao Luis D’OREY FACCO, MORO, Maitê Cecilia FABBRI, The impact of public health issues on exclusive patent rights, AIPPI Committee nb. Q 202.
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  1. Arun, Kumar and Arun, Nanda, Ever-greening in Pharmaceuticals: Strategies, Consequences and Provisions for Prevention in USA, EU, India and Other Countries , in: Pharmaceutical Regulatory Affairs: Open Access, Page 6. Accessed on Dec. 11, 2017, available at: https://www.omicsonline.org/open-access/evergreening-in-pharmaceuticals-strategies-consequences-and-provisions-for-prevention-in-usa-eu-india-and-other-countries-2167-7689-1000185.pdf.
  1. WTO: https://www.wto.org/english/tratop_e/trips_e/par6laws_e.htm
  1. PWC – Price Waterhouse Coopers, From vision to decision Pharma 2020, page 20, available on Dec. 01st, 2017, Accessible at: pwc.com/pharma2020
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  1. BRAZIL, Brazilian Chamber of Deputies, A Revisão da Lei de Patentes inovação em prol da competitividade nacional, available on Jan.01st, 2018, at: http://www2.camara.leg.br/a-camara/estruturaadm/altosestudos/temas/seminarios/lancamento-patentes-9-10-13/a-revisao-da-lei-de-patentes, page 18.
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  1. BRAZIL, Amendment to Law Proposition Nb. PL 5402/2013, Deputies Chamber, available on Feb. 5th, 2018, at: http://www.camara.gov.br/proposicoesWeb/prop_mostrarintegra;jsessionid=54BD46B2FF62941069C9754815069A62.proposicoesWebExterno2?codteor=1078755&filename=PL+5402/2013, page 30.

[1] Paris Convention article 5 A:

(1) Importation by the patentee into the country where the patent has been granted of articles manufactured in any of the countries of the Union shall not entail forfeiture of the patent.

(2) Each country of the Union shall have the right to take legislative measures providing for the grant of compulsory licenses to prevent the abuses which might result from the exercise of the exclusive rights conferred by the patent, for example, failure to work.

(3) Forfeiture of the patent shall not be provided for except in cases where the grant of compulsory licenses would not have been sufficient to prevent the said abuses. No proceedings for the forfeiture or revocation of a patent may be instituted before the expiration of two years from the grant of the first compulsory license.

(4) A compulsory license may not be applied for on the ground of failure to work or insufficient working before the expiration of a period of four years from the date of filing of the patent application or three years from the date of the grant of the patent, whichever period expires last; it shall be refused if the patentee justifies his inaction by legitimate reasons. Such a compulsory license shall be non-exclusive and shall not be transferable, even in the form of the grant of a sub-license, except with that part of the enterprise or goodwill which exploits such license.

(5) The foregoing provisions shall be applicable, mutatis mutandis, to utility models.

[2] India’s Patent Act of 1970, INDIA CODE, Section 5, are excluded patents on “substances intended for use, or capable of being used, as food or as medicine or drug.”

[3] Liu, Jodie, Compulsory Licensing and Anti-Evergreening: Interpreting the TRIPS Flexibilities in Sections 84 and 3(d) of the Indian Patents Act, 56 Harv. Int’l L.J. 207, 228 (2015). Page: 211

[4] WTO, TRIPS : A MORE DETAILED OVERVIEW OF THE TRIPS AGREEMENT, accessed on Dec.01st.17 at: https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm

[5] Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments—Results of the Uruguay Round, 33 I.L.M. 1125, 1197 (1994) [hereinafter TRIPs Agreement].

[6] TRIPS Agreement (AGREEMENT ON TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS), available at: https://www.wto.org/english/docs_e/legal_e/27-trips.pdf

[7] Abbot, F.M., Cottier, Thomas, Gurry, Francis, International Intellectual Property in an Integrated Economy, CCH Incorporated, Wolters Klumer, 2015. Page 253.

[8]  Declaration on the TRIPS agreement and public health, DOHA WTO MINISTERIAL 2001: TRIPS, WT/MIN(01)/DEC/2, 20 November 2001. [hereinafter Doha Declaration]

[9] TRIPs Agreement.

[10] CORREA, Carlos M. and World Health Organization, Implications of the Doha Declaration on the TRIPS Agreement and public health. 2002. Page vii.

[11] Doha Declaration. Supra note: 8.

[12] TRIPs Agreement. Supra note: 6

[13] Doha Declaration, article 5. Supra note: 8.

[14] Max Planck Institute for Innovation and Competition, Declaration on Patent Protection – Regulatory Sovereignty under TRIPs, Munich, 2014, accessed on Dec.10.2017, available at: http://www.ip.mpg.de/fileadmin/ipmpg/content/forschung_aktuell/04_declaration_on_patent/patent_declaration_en.pdf

[15] Idem, Page: 9

[16] Feroz, Ali, Nexavar: The First Market-Initiated Compulsory Licence, 9 NUJS L. Rev. 229, 258 (2016), page 234.

[17] Tellez, Viviana Munoz, Patent Reform in India: The campaign to protect public health, Page: 1

[18] Casey Jr., Robert P, Advances by Pharmaceutical Companies Have Saved Lives, Create Jobs And Boosted PA’s Economy but Intellectual Property Violations from India Are a Threat, BOB CASEY, June 7, 2013, accessed on Dec.08.2017 at: https://www.casey.senate.gov/newsroom/releases/casey-200-000-pa-jobs-40-billion-industry-is-threatened-by-intellectual-property-violations-in-india

[19] Jodie Liu, Compulsory Licensing and Anti-Evergreening: Interpreting the TRIPS Flexibilities in Sections 84 and 3(d) of the Indian Patents Act, 56 Harv. Int’l L.J. 207, 228 (2015) – Page 212.

[20] Indian Patent Act of 1970, amendment and updated versions, available at: http://www.ipindia.nic.in/acts-patents.htm

[21] Bayer Corp. v. Natco Pharma. Ltd., Order No. 45/2013, para. 50 (Intellectual Property Appellate Board, Chennai, 2013).

[22] Indian Patent Act of 1970. Supra note: 20

[23] Jodie Liu, Compulsory Licensing and Anti-Evergreening: Interpreting the TRIPS Flexibilities in Sections 84 and 3(d) of the Indian Patents Act, 56 Harv. Int’l L.J. 207, 228 (2015) – Page 216.

[24] Max Planck Institute for Innovation and Competition, Declaration on Patent Protection – Regulatory Sovereignty under TRIPs, Munich, 2014, accessed on Dec.10.2017, available at: http://www.ip.mpg.de/fileadmin/ipmpg/content/forschung_aktuell/04_declaration_on_patent/patent_declaration_en.pdf. Page 9

[25] Liu, Jodie. Supra 23, Page 217.

[26] Indian Patent Act. Supra note: 20.

[27] Novartis AG v. Union of India, 2007 A.I.R. 24759 (2013)

[28] Jodie Liu, Compulsory Licensing and Anti-Evergreening: Interpreting the TRIPS Flexibilities in Sections 84 and 3(d) of the Indian Patents Act, 56 Harv. Int’l L.J. 207, 228 (2015) – Page 222.

[29] Brazilian Industrial Property Law – Law 9.297/96, accessed on Dec. 12, 2017, available at  http://www.planalto.gov.br/ccivil_03/leis/L9279.htm

[30] VIANNA, Joao Luis D’OREY FACCO, MORO, Maitê Cecilia FABBRI,  The impact of public health issues on exclusive patent rights, AIPPI Committee nb. Q 202, accessed on Dec.10.2017, available at: http://aippi.org/wp-content/uploads/committees/202/GR202brazil.pdf

[31] Correa, M. Carlo, The Use of Compulsory Licences in Latin America, in: HILTY, Reto M.; LIU, Kung-Chung (Ed.). Compulsory Licensing: Practical Experiences and Ways Forward. Springer, 2014. Page 50.

[32] Bis, page 49.

[33] [33] Correa, M. Carlo, The Use of Compulsory Licences in Latin America, in: HILTY, Reto M.; LIU, Kung-Chung (Ed.). Compulsory Licensing: Practical Experiences and Ways Forward. Springer, 2014. Page 52

[34] Arun, Kumar and Arun, Nanda, Ever-greening in Pharmaceuticals: Strategies, Consequences and Provisions for Prevention in USA, EU, India and Other Countries , in: Pharmaceutical Regulatory Affairs: Open Access, Page 6. Accessed on Dec. 11, 2017, available at: https://www.omicsonline.org/open-access/evergreening-in-pharmaceuticals-strategies-consequences-and-provisions-for-prevention-in-usa-eu-india-and-other-countries-2167-7689-1000185.pdf.

[35] WTO: https://www.wto.org/english/tratop_e/trips_e/par6laws_e.htm

[36] BRAZIL, Brazilian Chamber of Deputies, A Revisão da Lei de Patentes inovação em prol da competitividade naciona, available on Jan.01st, 2018, at: http://www2.camara.leg.br/a-camara/estruturaadm/altosestudos/temas/seminarios/lancamento-patentes-9-10-13/a-revisao-da-lei-de-patentes, page 18.

[37] Mercosur, Meeting of Ministers of Health (MerCosul / rMs / aCorDo No. 09/09), in BRAZIL, Brazilian Chamber of Deputies, A Revisão da Lei de Patentes inovação em prol da competitividade naciona, available on Jan.01st, 2018, at: http://www2.camara.leg.br/a-camara/estruturaadm/altosestudos/temas/seminarios/lancamento-patentes-9-10-13/a-revisao-da-lei-de-patentes, page 125.

[38] BRAZIL, Amendment to Law Proposition Nb. PL 5402/2013, Deputies Chamber, available on Feb. 5th, 2018, at: http://www.camara.gov.br/proposicoesWeb/prop_mostrarintegra;jsessionid=54BD46B2FF62941069C9754815069A62.proposicoesWebExterno2?codteor=1078755&filename=PL+5402/2013, page 30.

[39] PWC – Price Waterhouse Coopers, From vision to decision Pharma 2020, page 20, available on Dec. 01st, 2017, Accessible at: www.pwc.com/pharma2020

[40] PWC – Price Whaterhouse Coopers, The pharmaceutical sector in Brazil, Page 3, accessed on Dec. 01st 2017, available at: www.pwc.com/pharma2020

[42] Abbot, F.M., Cottier, Thomas, Gurry, Francis, (2015) “International Intellectual Property in an Integrated Economy”, CCH Incorporated, Wolters Klumer, N.Y. 3rd edition. Page 140.