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PHARMACEUTICAL PATENTS AND THE RIGHT TO HEALTH - PORTUGAL AND

BRAZIL

RUBEN BAHAMONDE DELGADO

rbahamonde@autonoma.pt

Associate Professor at the Law Department of Universidade Autónoma de Lisboa (Portugal).

Coordinator and Integrated Researcher at Ratio Legis – Centre for Research and Development in

Legal Sciences of Universidade Autónoma de Lisboa [Project: Self-tutelage and implementation of

Private Law].

Abstract

The defence of the patent system's legitimacy, namely in the pharmaceutical field, is

consolidated, although it is not exempt from criticism. Historically, when the patent law, a

legal monopoly right, is confronted with the right of access to health, which includes the right

to the medicines necessary for its care, the mechanisms that have been established are scarce

and weak. Nonetheless, one must recognize due merit in the search for a balance between

the exclusive right of the holder of the legal monopoly and the right of the community to

generalized access to medicines necessary to fulfil the right to health. In the current context

of the covid-19 disease, where access to health care for all countries, rich and poor, is at

stake, it seems that there is a greater will to make the right to health prevail over the property

right of the holder of a pharmaceutical patent.

Keywords

Pharmaceutical patents; right to health; access to essential medicines

How to cite this article

Delgado, Ruben Bahamonde (2022). Pharmaceutical patents and the right to health – Portugal

and Brazil. In Janus.net, e-journal of international relations. Vol13, Nº. 1, May-October 2022.

Consulted [online] on the date of the last visit, https://doi.org/10.26619/1647-7251.13.1.11

Article received on Sepember 29, 2021 and accepted for publication on February 18,

2022

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e-ISSN: 1647-7251

Vol. 13, Nº. 1 (May-October 2022), pp. 171-189

Pharmaceutical patents and the right to health – Portugal and Brazil

Ruben Bahamonde Delgado

172

PHARMACEUTICAL PATENTS AND THE RIGHT TO HEALTH -

PORTUGAL AND BRAZIL

RUBEN BAHAMONDE DELGADO

Introduction

The problem resulting from the confrontation between the right to health and industrial

property rights is not new, nor exclusive to the Portuguese-Brazilian reality. However,

the new challenges, namely those resulting from covid-19, require a greater and better

clarification of this confrontation

. Indeed, the traditional paradigm of the interaction

between the right to health and industrial property that has as its object medicines has

focused on the confrontation of interests between rich or developed countries, where

there are several companies holding pharmaceutical patents, and poor or less developed

countries, where there are few economic and financial means to guarantee access to

such medicines and where there are serious and widespread health problems. In the

current context, one can say that covid-19 has levelled state economies, as many

countries traditionally considered rich or developed do not have the industrial property

necessary to produce a drug/vaccine to treat covid-19, thus becoming dependent on the

solutions that appear on the market, obviously protected by industrial property, in order

to be able to provide timely and adequate access to healthcare for its citizens. In these

cases, although the countries concerned have the means to acquire the medicines

protected by patents, they may not be available in the desired quantities, prices and

dates. This situation reveals a scenario of high selling prices of the solutions found,

protected by pharmaceutical patents, assuming that the normal and free functioning of

the market will allow access to such solutions to those countries that are in the best

conditions to pay a higher price, thus relegating to the background countries that have

fewer economic resources. Covid-19 is not HIV/AIDS, nor bronchitis, nor tuberculosis. It

affects all layers of society in all societies in all countries of the world in very worrying

numbers and without there being a standard of very clear prevention/protection in terms

of effectiveness. The problem is not new, but the fact that in the current context a

significant number of human beings belonging to rich or more developed countries are

Article translated by Carolina Peralta.

Covid-19 is the official name of the disease caused by the severe acute respiratory syndrome coronavirus

2 (SARS-CoV-2), first identified in 2019, and which in this work we will refer only as covid-19.

https://www.volp-acl.pt/index.php/item/covid-19

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affected, should generate greater pressure/availability to face this situation from another

perspective.

Patents in the international context

Patents have as their object inventions and consist of an exclusive right or legal

monopolies conferred by the corresponding entities to those who apply for them,

provided that the enabling legal requirements for that purpose are met (Bahamonde,

2016, pp. 163-167). In order for an invention to be granted this protection, it will be

necessary that the requirements of novelty, inventive capacity and industrial use are

cumulatively met

. Inventions for which patent protection can be claimed may concern

objects, a particular substance or a device, or they may concern procedures, where what

is protected is not the result, but the sequence of steps taken to achieve this particular

result. In this context, inventions regarding medicines or specific procedures to obtain

substances useful for the treatment of diseases are also likely to benefit from the

protection conferred by the patent system.

The patent system is characterized by being nationally based, i.e. the patent is granted

by the competent authority of a state and is valid for that state. However, due to the

important role that patents play in economic legal traffic, and specifically for the

development of markets tending to be characterized by the need to promote their growth

through internationalization and globalization, the need to homogenize this matter arose.

Thus, it can be said that the first positive interest in creating a system that would allow

homogenizing the patent system was at the Paris Union Convention for the protection of

Industrial Property of 1883

. Without intending to refer exhaustively to the

aforementioned legislation, it is worth highlighting its main characteristics related to our

topic. In this sense, the unionist priority was established (Article 4/C-1). It was the

possibility of granting compulsory licences in the face of abusive exercise of the exclusive

right granted by the patent (5A-2) and the possible introduction of patent expiry as a

subsidiary measure to the system of compulsory licences (5A-3)

Much more recently, in the Final Act of Marrakech of 1994, which contained the results

of the Uruguay Round negotiations, within the scope of the World Trade Organization

(WTO), and had its precedents in the General Agreement on Customs and Trade (GATT)

the Agreement on Trade-Related Industrial Property Rights (TRIPS) was adopted. Since

the main scope of the aforementioned agreement is the adoption of measures and

procedures that allow the reduction of distortions to international trade related to the

In Portugal, see Article 1 of Decree-Law no. 110/2018, of 10 December, which approved the new Industrial

Property Code. In Brazil, see Article 1 of Law No. 9.297, of 14 May 1996, diploma that regulates rights and

obligations related to industrial property

Paris Convention for the Protection of Industrial Property of 20 March 1883, last amended on 2 October

1979, available at https://www.wipo.int/edocs/pubdocs/pt/wipo_pub_201.pdf.

The expiry action can only be activated two years after the granting of the first compulsory licence. With

regard to compulsory licences, based on speech or insufficient use, they cannot be requested before the

expiry of the period of four years from the filing of the patent application, or three years from the granting

of the patent. The longest term will be applicable (5A-4).

General Agreement on Tariffs and Trade established in 1947, which, through the Uruguay Round, gave rise

to the World Trade Organization in 1994 (Marrakech Declaration of 15 April 1994). For additional

information, see https://www.wto.org.

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effective protection of intellectual property rights, the special needs of the least advanced

signatory countries are expressly recognized, requiring, in these cases, a more flexible

application of the rules in question so that a viable technological base can be created. In

this context, the agreement establishes the possibility for the signatory countries to

exclude the patentability of inventions whose commercial use in their territory must be

prevented in order to protect the health or life of people and animals. It also provides for

the possibility of using the patent granted without the holder's consent in national

emergency situations

Despite the aforementioned mechanisms, the relationship between the pharmaceutical

industry and the signatory States, namely those less evolved in terms of ownership of

industrial property rights in the pharmaceutical field, increased the tension between the

protection of property and the right to health that the States must guarantee to their

citizens. In this context, the DOHA Declaration on the TRIPS Agreement and public health

was made on 14 November 2001

. This declaration was based on the seriousness of the

public health problems that affected many developing countries, with particular relevance

to HIV/AIDS, tuberculosis, malaria and other epidemics, namely in Brazil, South Africa

and India (Orsi, 2007: 1997-2003; Polônio, 2006: 68; Cullet, 2003: 147-154). Despite

the recognition of the fundamental importance of intellectual property protection for the

development of new medicines, the legitimacy of the Member States to adopt measures

aimed at protecting public health is also underlined, imposing the obligation that the

TRIPS agreement be interpreted in the sense of supporting the right of WTO Members to

protect health. The document reiterates the possibility for States to grant compulsory

licences and their right to determine what constitutes, in each case, a national emergency

or other circumstances of extreme urgency. To avoid further confusion, it is specifically

recognized that public health crises, including those related to HIV/AIDS, tuberculosis,

malaria and other epidemics, may represent a national emergency or other

circumstances of extreme urgency

. Finally, the most relevant aspect of this document

is the recognition of the inefficiency of the compulsory licensing system when it comes

to countries whose manufacturing capacities in the pharmaceutical sector are insufficient

or non-existent, which will necessarily lead to more creative solutions in this type of

situation (Pontes, 2017: 49). To try to overcome this difficulty, after the DOHA

Declaration, several decisions were adopted in order to allow cheaper generic medicines

manufactured under compulsory licences in case the importing countries are not able to

Article 27(2) of the TRIPS requires that this deviation from the rule, in addition to being supported by the

corresponding legislation, must be based on the reasons provided for the protection, among others, of

health. In addition, and without prejudice to the protection of the invention through a patent, article 31

establishes several situations in which the right in question can be used by third parties without the

authorization of the holder. Namely, paragraph b) refers to national emergency situations or situations of

extreme urgency or cases of public non-commercial use.

Article 27(2) of the TRIPS requires that this deviation from the rule, in addition to being supported by the

corresponding legislation, must be based on the reasons provided for the protection, among others, of said

health. In addition, and without prejudice to the protection of the invention through a patent, article 31

establishes several situations in which the right in question can be used by third parties without the

authorization of the holder. Namely, paragraph b) refers to national emergency situations or situations of

extreme urgency or cases of public non-commercial use.

WTO Ministerial Conference (DOHA, 2001): TRIPS, WT/MIN/(01)DEC/2, 20 November 2001, available at

https://www.wto.org/spanish/thewto_s/minist_s/min01_s/mindecl_trips_s.htm

See point 5(c) of the Declaration on the TRIPS Agreement and public health.

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manufacture them themselves. Thus, exporting countries were exempted from the

obligations arising from subparagraph f) of article 31 of the TRIPS, allowing any Member

country to export generic pharmaceutical products manufactured under compulsory

licences to satisfy the needs of importing countries, provided that certain conditions are

met

. In 2017, it was decided to add article 31bis to the Agreement, thus allowing

importing countries to distribute the imported medicinal product under licence in

countries belonging to the same economic area and facing the same health emergency

situation

Following this path, the European Union has also sought to clarify the problem of the

supply of generic medicines manufactured using compulsory licences when its Members

are States experiencing public health problems (Fernández-Nóvoa, 2017: 201-206)

It is also important to mention that the problems resulting from the exercise of rights

arising from pharmaceutical patents are not limited exclusively to the least developed

countries. Indeed, as far as the most advanced countries are concerned, and with the

means to produce the drugs in question, the question arises in terms of assessing from

which moment the knowledge protected by a pharmaceutical patent can be used, to give

initiation to the necessary legalization procedures, aimed at the production and

subsequent commercialization of a generic drug. This issue gave rise to the well-known

“Bolar provision”, which relates to the interpretation of Article 30 TRIPS and the

possibility, widely contemplated in legal systems, of allowing the use of knowledge

protected by a patent for experimental or research purposes

. The Bolar provision goes

beyond this situation, establishing an exception that allows the experimental use of a

product protected by patent to carry out the necessary administrative procedures aimed

at authorizing the marketing of the generic product in question, essentially based on the

requirement to respond to social needs , namely the rapid introduction of affordable

medicines (Tudor, 2018: 300-308)

Alongside these instruments, and collaborating in the search for solutions to the exposed

problems, there are other important international organizations such as the World

Intellectual Property Organization (WIPO)

or the World Health Organization (WHO),

namely through the Commission on Intellectual Property Rights, Innovation and Public

Decision of 6 December 2005 — Amendment of the TRIPS Agreement; Decision to extend the deadline for

accepting the amendment to the TRIPS Agreement, 2015; Decision on application by least developed

member countries — Obligations under Article 70(8) and (9) of the TRIPS Agreement relating to

pharmaceuticals, 2015 and Decision on the extension of the transition period under Article 66(1) of the

TRIPS Agreement for least developed member countries in relation to certain obligations relating to

pharmaceuticals, 2015.

See Article 31bisd in full, updated in March 2020

https://www.wto.org/english/res_e/publications_e/ai17_e/trips_art31_bis_oth.pdf

Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on the granting

of compulsory licences for patents relating to the manufacture of pharmaceutical products intended for

export to countries with public health problems.

See. subparagraph c) of no. 1 of article 103 of the Portuguese Industrial Property Code and item II, article

43, of Law no. 9.297, of 14 May 1996, which regulates rights and obligations related to industrial property

in Brazil.

In any case, the aforementioned clause does not preclude the need for the basic patent or the

complementary protection certificate to be expired in order to start marketing the generic product.

See https://www.wipo.int/patent-law/en/developments/publichealth.html

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Health

, which, with their studies and recommendations, have greatly contributed to the

evolution of the treatment given to pharmaceutical patents when related to access to the

right to health in developing or less developed countries. Industrial property, as a

property right or as a protection for the authorship of creations, finds a legal basis in the

Universal Declaration of Human Rights of 1948, namely in article 17 on the right to

property and in paragraph 2 of article 27 on moral and material interests of authors

and in the International Covenant on Economic, Social and Cultural Rights, (1966/1976)

which recognizes, in paragraph c) of point 1 of article 15, the protection of authors'

interests

In the latter case, it should be noted that the Committee on Economic, Social and Cultural

Rights, in the general observation of Article 17, specifies in its introduction the need to

differentiate between human rights as such and intellectual property regimes, making it

clear that intellectual property rights should not be equated with the human right

recognized in paragraph c) of point 1 of article 15 of the Covenant

. To justify this

position, among other arguments, the Committee specifies that human rights are

fundamental because they are inherent to the human person as such, whereas

intellectual property rights are mainly means used by States to stimulate creativity and

inventiveness, protecting itself through intellectual property regimes, namely commercial

and business investments. The Charter of Fundamental Rights of the European Union of

2000 (Article 17) also protects the right to property in the terms that were already

provided for in the European Convention on Human Rights of 1950

It should also be noted that the treatment of patents at international level has been given

wide prominence, namely through the Patent Cooperation Treaty (PCT), whose objective

is to simplify the procedures for obtaining protection of inventions through patents in the

various signatory States. In the current context of covid-19, the WIPO International

Secretariat has made some rules more flexible, namely interpreting the current pandemic

situation as being covered by the tolerance of delays in meeting the PCT deadlines

. At

supranational level, we have in the European context the Munich Convention on the

European Patent Organization (EPO) of 1973, whose objective is also to simplify the

procedures for obtaining protection for inventions in the signatory States and the much

more ambitious project of the European Patent with Unitary effect, where the ultimate

See https://www.who.int/intellectualproperty/en/

Everyone has the right to the protection of the moral and material interests linked to any scientific, literary

or artistic production of their authorship.

The States Parties to this Covenant recognize the right of every person to (…) benefit from the protection

of the moral and material interests that correspond to them by virtue of scientific, literary or artistic

productions of which they are the author.

UN Committee on Economic, Social and Cultural Rights (CESCR), General Comment No. 17: The Right of

Everyone to Benefit from the Protection of the Moral and Material Interests Resulting from any Scientific,

Literary or Artistic Production of Which He or She is the Author (Art. 15, Para. 1 (c) of the Covenant), 12

January 2006, E/C.12/GC/17. https://www.refworld.org/docid/441543594.html

The European Convention on Human Rights and Fundamental Freedoms (Rome, 04.11.1950) introduced,

through its additional protocol in 1952, article 1 on the protection of property, which states: “No one may

be deprived of his or her possessions except in the public interest and in the cases and under the conditions

provided for by law”.

Patent Cooperation Treaty made in Washington on 19.06.1970, last modified on 30.10.2001. See PCT Rule

82Q.

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objective would be to create a single procedure for the protection in several Member

States of an invention through a patent

With this contextualization, it is evident that the protection of inventions through patents

has achieved a significant homogenization at international level, promoted mainly by

commercial interests (Bahamonde, 2016: 167-171). However, as a counterpoint to

commercial interests, the analysed rules also state a clear concern with the protection of

social interests, namely in the field of health, with several mechanisms being foreseen to

achieve the desired balance between all the interests at stake.

Patents in the Portuguese-Brazilian national context

As seen above, without being exhaustive, there is a vast international treatment of the

protection of inventions as one of the typologies of industrial/intellectual property

, so

the majority of national legal systems tend to be quite homogeneous, namely in the

Portuguese-Brazilian case. Still, it will be interesting to analyse the mechanisms

specifically provided for in each of the legal systems in question, to ensure a certain

balance with regard to patents and other interests.

The Portuguese Industrial Property Code (CPI) establishes, in line with other codes on

the matter, that patents can be obtained for any inventions, whether products or

processes, in all fields of technology, as long as they are new inventions, imply an

inventive step and are susceptible of industrial use

. Article 50(5) of the CPI also

provides for the possibility of protecting the same invention either through a patent

application or through a utility model application. However, with regard to the specific

field of protection of pharmaceutical products or procedures, it is established that

inventions that affect pharmaceutical substances or compositions and pharmaceutical

processes cannot be object of a utility model

. Thus, inventions that relate to

pharmaceutical products or procedures can only be protected through a patent, thus

guaranteeing a more rigorous system for the protection of these inventions (Sousa e

Silva, 2011: 87-90)

The legal monopoly right granted to the patent holder is not absolute, and, in this line,

the Portuguese legislator has established several mechanisms to limit it in situations of

justified interest. As seen above, the right conferred by the patent does not allow its

holder to prohibit acts for testing or experimental purposes (103/1/c), thus allowing the

Decision 2011/167/EU of the European Council, of 10 March 2011, authorizing enhanced cooperation in the

field of the creation of unitary patent protection. Regulation (EU) No 1257/2012 of the European Parliament

and of the Council of 17 December 2012, which regulates enhanced cooperation in the field of the creation

of unitary patent protection and Regulation (EU) No 1260/2012 of the Council of 17 December 2012, which

regulates enhanced cooperation in the field of the creation of unitary patent protection with regard to the

applicable translation regime and the Agreement on the Unified Patent Court of 19 February 2013.

Intellectual property generically refers to copyright and industrial property itself, so when dealing with the

matter of patents we believe it is more appropriate to use the term industrial property.

See Article 1 of Decree-Law No. 110/2018, of 10 December, which approved the new Industrial Property

Code.

Subparagraph d) of no. 1 of article 121 of the CPI.

In fact, inventions protected through the utility model have a lower requirement for inventive step, which

translates into faster protection, but at the same time more tenuous and precarious.

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protected and published knowledge to immediately contribute to the scientific

development of the respective area of application. Subparagraph b) of the same norm

also excludes from the patent holder's powers the possibility of preventing the

preparation of medicines made at the time and for individual cases or preparatory

procedures. Article 108 of the CPI also provides for the possibility of granting compulsory

licences in the event of lack of or insufficient use of the patented invention (109th), in

the event of dependence between patents (110) and for reasons of public interest (111).

In the latter case, the licence will be granted by order of the member of the Government

responsible for the matter, considering that there is a reason for public interest when the

increase or generalization of the use of the invention, or the improvement of the

conditions under which such utilisation takes place, are of paramount importance to

public health. The possibility of loss or expropriation of the patent is also foreseen in the

case of having to answer for obligations contracted with others or for public utility,

situation in which the rules of the Code of Expropriations will apply

All these limitations result from the balance between the nature of the law in question

and that of other areas of law where friction can occur. It is true that the qualification of

the industrial property right as a property right, i.e., within the scope of article 62 of the

Constitution of the Portuguese Republic (CRP), is not pacific in terms of doctrine, as it

consists, at the limit, of a sui generis property right. However, even with specificities,

what is undeniable is that our legal system recognizes its nature, hence, it can be

expropriated, which corresponds to one of the possible limitations of the property right.

On the other hand, this right could also find protection within the scope of paragraph 2

of article 42 CRP (Freedom of cultural creation)

. In this sense, regarding the nature of

the industrial property right in Portugal, when confronted with the right to health, the

Constitutional Court ruled in judgment no. 216/2015 that despite the evident

constitutional protection of patents and the rights arising from them, it is unequivocal

that they yield to the fundamental right of health protection“

See Article 107 CPI

On the one hand, paragraph 2 of article 42 CRP is a fundamental right that enjoys the enhanced protection

of article 18, and the property right established in article 62 CRP is a fundamental right of a similar nature.

In this sense, see the ruling of the Southern Central Administrative Court (TCAS) of 05.06.2010 in the scope

of case No. 06154/10, where the Rapporteur was Dr Teresa de Sousa, establishing that “The property right

enshrined in art. 62 of the CRP, which covers industrial property rights, including rights based on drug

patents, has been considered a fundamental right similar in nature to the rights, freedoms and guarantees

for the purposes of applying the contents of articles 17 and 18 of the CRP”. This decision is very relevant

as it was pronounced with the losing vote of Dr Benjamin Barbosa, whose reasoning was later confirmed by

the Constitutional Court ruling below.

Decision No. 216/2015 of the Constitutional Court, 2nd section, delivered within the scope of case 207/2013.

The decision in question assessed the constitutionality of Law no. 62/2011 of 12 December with regard to

the procedure for the Marketing Authorization (MA) and the Retail Price (RRP) of generic drugs that could

infringe a patent. In this procedure, INFARMED could not assess the violation of a previous patent, so the

marketing of a generic drug could be approved, although it could later be demonstrated that it violated a

previous right. Quoting Professor Paulo Otero, he echoes the point that "the proximity and essentiality of

guaranteeing health with the dignity of the human person, in a State model where people are worth more

than things or property, and the understanding that the limitation or restriction of exclusive rights arising

from patents translates into an expansion of freedom, in a State model that privileges freedom over

property, lead to an abstract constitutional solution that gives preference to the position that defends the

introduction of generic medicines into the market, in view of the patrimonial content position defended by

patent holders on reference medicines."

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In turn, the Brazilian Industrial Property Law also establishes several limitations to the

patent holder's right in the same way as the Portuguese legal system. In fact, the patent

holder cannot prevent acts performed by unauthorized third parties, with experimental

purposes, related to scientific or technological studies or research (43/II), nor prevent

the preparation of medicines according to medical prescription for individual cases

performed by a qualified professional, as well as the drug thus prepared (43/II). A central

role in this set of limitations is the compulsory licence that may be imposed when the

object of the patent is not used in Brazilian territory, due to lack of manufacture or

incomplete manufacture of the product (68 §1/I) and when the commercialization of the

protected object or process does not satisfy the needs of the national market (68 §1/I)

and, likewise, in the event of dependence between patents (70). Finally, in situations of

national emergency or public interest, declared in an act of the Federal Executive branch,

as long as the patent holder or its licence holder do not meet this need, a compulsory

licence may be granted

With regard to the constitutional protection of patents in Brazil, it is worth noting the

greater clarity with which the Brazilian constituent expressed it when specifically

enshrining in Title II of the Constitution of the Federative Republic of Brazil (CRFB), on

fundamental rights and guarantees, the guarantee that “the law will grant the authors of

industrial inventions a temporary privilege for their use, as well as protection of industrial

creations, the ownership of trademarks, company names and other distinctive signs, with

a view to social and technological interest and the country's economic and technological

development”

. In other words, the Brazilian Magna Carta directly views patents not as

a property right, but as a temporary privilege, subjecting their attribution and exercise

to the technological and economic social interest.

At first glance, we can point out the following relevant differences between the

Portuguese and the Brazilian legal systems. In the Portuguese one, the possibility of

expropriation of the patent right was expressly foreseen when based on reasons of public

utility, which is not provided for in Law n. 9.279 of 14 May 1999 (LPI) in Brazil. This is

evaluated positively, as it recognizes a preventive function, allowing patent holders to be

aware of the serious consequences that can arise from a deficient use of their right, also

making it easier to justify drastic decisions in extreme situations, such as during the

current pandemic, within its corresponding regulatory framework

In Brazil, the legislator specifically provided for the possibility of granting compulsory

licences if the patent holder abusively exercises the rights arising therefrom, or through

it practices abuse of economic power, proven under the law, by administrative or judicial

decision (68). In this case, we do not find a similar principle in the Portuguese CPI,

perhaps because if this behaviour were to occur, we would be faced with a possible

This issue was developed by Decree No. 3.201, of 6 October 1999, which provides for the granting, ex

officio, of a compulsory licence in cases of national emergency and public interest, as provided for in art.

71 of Law No. 9.279 of 14 May.

See item XXIX of article 5 of the CRFB.

Despite the goodness of the rule, at present, it is not known any situation when the Portuguese State has

applied it in practice.

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situation of abuse of a dominant position within the scope of article 11 of the Competition

Law or article 102 of the Treaty on the Functioning of the European Union

However, as there is a wide interaction and/or complementarity (Pérez, 2018: 372-393;

Bahamonde, 2016: 166-167) between industrial property law and competition law, this

provision in the Brazilian legal system seems to us to be systematically relevant, as it

reinforces legal certainty in the application of this mechanism, unlike what happens in

Portugal

Both legal systems focus their reaction mechanism in the face of lack of use or insufficient

use by the patent holder in the field of compulsory licences (Palmela, 2016). Regarding

them, it is necessary not to be too encouraging with the prospects for the future, because

in fact, it has never been used in Portugal, and in Brazil (EFAVIRENZ) it was only used

once

. However, we believe that the mere affirmation of the possibility of compulsory

licencing will allow any negotiations between the parties involved to be more

compromised.

The central role of compulsory licences

From the above, it follows that compulsory licences are the most common mechanism to

offset possible imbalances arising from the exclusivity right conferred by a

pharmaceutical patent

The compulsory licencing regime in Brazil and Portugal basically provides for two

modalities with regard to patents related to medicines. Firstly, a compulsory licence,

which requires confirmation of insufficient use of the invention to supply the national

market. In these circumstances, the Portuguese rule requires, prior to its granting, that

the applicant has made efforts to obtain from the patent holder a contractual licence

under acceptable commercial conditions, and that such efforts are not successful within

a reasonable period (108/3). In turn, the Brazilian rule requires that the applicant has a

legitimate interest and technical and economic capacity to carry out the efficient use of

the object of the patent (68/§2). In fact, these two rules coincide in the need to confirm

that the applicant is a serious candidate and that he has the conditions and commitment

to use the licence to supply the market. In both systems, this licence is expected to be

non-exclusive, non-sublicensable, revocable, and remunerated

Secondly, we have compulsory licences justified by national emergency situations or

public interest, in which case pre-requisites for granting them are waived. In these

Law No. 19/2012, of 8 May, which established the new legal system for competition.

This was also the option of the Spanish legislator provided for in article 94 of Law 24/2015, of 24 July, on

Patents.

Through the publication in the Official Gazette of the Union of Decree no. 6.108, of 4 May 2007, which

granted the compulsory licencing, in the public interest, of the patents related to EFAVIRENZ, for the

purpose of non-commercial public use.

See articles 30 and 31 of the TRIPS agreement, article 109 of the CPI and article 68 and following of Law

No. 9.279, of 14 May 1996. However, its use is very scarce, so it is common to say that it fell far short of

the expectations placed in it (Fernández-Nóvoa, 2017: 197-206).

This similarity of the norms under analysis results from the imposition that arises for the States of the TRIPS

agreement, specifically from article 30.

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situations, the Brazilian legislator allows the granting of a compulsory licence when it is

shown that, in the face of a national emergency or public interest, the patent holder does

not meet this need (Remédio, 2011: 399-400; Couto, 2005: 116-119). For its part, the

Portuguese legislator also requires a public interest reason for the use of this measure.

However, it differs from its Brazilian counterpart in that it is not required that the owner

improperly uses the invention, i.e., the owner of the invention may be making every

effort to satisfactorily use the invention, and even to be succeeding, but even then, for

reasons of public health, he may be obliged to grant a compulsory licence. Apparently,

the Portuguese norm is a little more restrictive than the Brazilian norm, although an

extensive interpretation of this norm allows reaching the same understanding in Brazil.

The Portuguese-Brazilian compulsory licencing system is clearly the result of a

“transposition” of article 31 TRIPS, resulting from both countries’ membership of the

World Trade Organization. In practical terms in Portugal, compulsory licences have not

gone beyond paper, insofar as they are only the subject of academic study, as none have

been enforced to date.

In turn, in Brazil there is only one specific situation when a compulsory licence

(EFAVIRENZ) was granted. However, in the global context, the reality is more

encouraging, as it appears that compulsory licences are used more than what is generally

thought or known.

In fact, in a study carried out on the subject, 81 compulsory licences were identified

between 2001 and 2016, which also include developed countries, as a result of the high

price of certain medicines (Hoen, 2016: 186-187).

We can thus conclude that compulsory licences have been used in a very timid way,

having the potential to constitute an adequate response to overcome the barriers that

pharmaceutical patents may pose to the realization of the right to access medicines and,

in turn, to the right to health. Additionally, it can always be argued that its legal provision

gives it a preventive and dissuasive use of deviant behaviour on the part of the patent

holder, which undoubtedly has encouraged the granting of voluntary licences.

The “recent” possibility of drug protection through patents

It is important to point out that both Brazil and Portugal joined the WTO on 01.01.1995,

and that, until that date, protection of medicines through patents was not allowed in

Brazil (Nunes, 2009, pp. 13-18). Indeed, as a result of its accession to the WTO, the LPI,

in the sole paragraph of article 229 of Title VIII, of the transitional and final provisions,

states

“To the requests relating to pharmaceuticals and agricultural chemicals,

which were filed between 1 January 1995 and 14 May 1997, the patentability

criteria of this Law apply on the effective date of filing of the application in

Brazil or of priority, if any, ensuring protection from the date of granting the

Law No. 9.279, of 14 May 1996, whose content was inserted by Law No. 10.196, of 2001.

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patent for the remaining period from the day of filing in Brazil, limited to the

period provided for in art. 40”.

In Portugal, Decree 30679 of 24 August, which approved the Industrial Property Code of

1940, provided that the following could not be subject to patents (Article 5, no. 3:

“food, as well as pharmaceutical products and preparations, intended for

humans or animals, although the devices or systems for their manufacture

may be patented”.

However, with the accession to the European Patent Convention (EPC) in 01/01/1992,

Portugal became the recipient country of a pharmaceutical product patent application.

Indeed, Articles 52 and 53 of the Convention allow for patent protection of a

pharmaceutical invention, with no specific exclusion preventing it.

Paradoxically in this period, in Portuguese territory it is possible to apply through the

European Patent for the protection of a medicine, although its patent protection through

the national route is not allowed.

Although Portugal is obliged to implement the TRIPS Agreement only as of 01/01/1996,

as provided for in article 65, no. 1, its compliance was anticipated with the approval of

the Industrial Property Code, through Decree-Law no. 16/95, of 24 January, which came

into force on 01/06/1995 (art. 9) and adjusted national legislation to the TRIPS

Agreement, allowing the patenting of pharmaceutical products (Articles 47 to 49).

In this analysis, it is important to remember that, prior to the TRIPS Agreement and

despite the existence of rules regarding the protection granted by patents, the CUP

enabled signatory countries to establish their own internal rules, namely, establishing

what could or could not be the subject of patent. In other words, the signatory countries

could choose to protect in their national territories the drug inventions through patents

or, on the contrary, they could prohibit the protection through patents of drug inventions.

In practice, this implied that the fact that an inventor could patent a drug in a given

national territory did not prevent third parties from using the knowledge underlying that

patent in another territory where the invention was not patentable.

From the above, it is clear that there is a national and international regulatory framework

for the protection of inventions of medicines through patents. However, it should not be

forgotten that the inclusion of drug inventions in the protection of patents is very recent,

and that the aforementioned protection was achieved, not so much by virtue of the patent

system to promote the right to health and innovation, but rather as a condition for

benefiting from the economic prerogatives deriving from accession to the WTO.

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The Right to Health

Health in the international context

The Charter of the United Nations signed in San Francisco on 26 June 1945, at the end

of the United Nations Conference on the International Organization, entered into force

on 24 October 1945, and established the need to promote the solution of international

economic, social, health and related problems, as well as international cooperation, of a

cultural and educational nature as a means of maintaining and preserving peace between

peoples (55/a). The Economic and Social Council was also established, whose function

is, among others, to prepare studies and reports on international matters of an economic,

social, cultural, educational, health and related nature, being able to make

recommendations on such matters to the General Assembly

, members of the United

Nations and interested special organizations.

In turn, the Universal Declaration of Human Rights (1948), in its article 25/1, establishes

that everyone has the right to a standard of living adequate for the health and well-being

of himself and of his family, especially food, clothing, housing, medical care and the

necessary social services

The World Health Organization emerged as a specialized body, under the terms of article

57 of the United Nations Charter. Health is seen as a state of complete physical, mental

and social well-being, not merely the absence of disease or infirmity. It is also stated

that enjoying the best possible state of health is one of the fundamental rights of every

human being, without distinction of race, religion, political creed or economic or social

condition

It is also underlined that the health of all peoples is essential for achieving peace and

security and depends on the closest cooperation of individuals and States. The results

achieved by each State in the promotion and protection of health are of value to all. The

uneven development in different countries in terms of promoting health and combating

diseases, especially contagious ones, constitutes a common danger

Also within the scope of the United Nations, the International Covenant on Economic,

Social and Cultural Rights is highlighted. Its article 12 clearly shows the commitment

between the signatories to widely protect the right to health, recognizing all people the

right to enjoy the highest level of physical and mental health and imposing concrete

measures for their protection (Helfer, 2015: 317-318; Sellin, 2015: 445-473).

In turn, the Treaty on the Functioning of the European Union, in its Article 9, sets out as

an objective the promotion of a high level of employment, the guarantee of adequate

social protection, the fight against social exclusion and a high level of education, training

and protection of human health. In the same regulation, article 168 provides that in the

definition and implementation of all Union policies and actions, a high level of health

protection will be ensured. Union action, which will complement national policies, will

Constituted by all members of the United Nations (9/1)

Adopted by the United Nations on 10 December 1948.

Preamble to the Constitution of the World Health Organization.

Accordingly, the primary objective of the World Health Organization is the acquisition, by all peoples, of the

highest possible level of health (Article 1).

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focus on improving public health and preventing human illness and disease and reducing

causes of danger to physical and mental health. This action will cover the fight against

major scourges, encouraging research into their causes, forms of transmission and

prevention, as well as health information and education and surveillance of serious

threats to health with a cross-border dimension, alerting in the event of such threats and

the fight against them.

The Charter of Fundamental Rights of the European Union, in article 35 on the protection

of health, establishes that everyone has the right to access prevention in health matters

and to benefit from medical care, in accordance with national laws and practices. In the

definition and implementation of all Union policies and actions, a high level of human

health protection is ensured.

In other words, there is no doubt that the protection of the right to health occupies a

pre-eminent position in the various international instruments, not only as an end, but

also as a means of ensuring peace between peoples and the dignity of the human person.

This right should supersede others of a more materialistic nature.

Health in the Portuguese-Brazilian context

In the Portuguese context, the right to health is enshrined in Article 64 of the CRP, which

establishes that everyone has the right to health protection and the duty to defend and

promote it

. Paragraph 2 of the same document prescribes that the protection of the

right to health will take place through a universal and general national health service,

which tends to be free of charge. It establishes the achievement of economic, social,

cultural and environmental conditions that guarantee the protection of childhood, youth

and old age. Subparagraphs c) and e) of paragraph 3 of article 64 CRP deserve special

interest in the matter that concerns us. They imposes on the State the priority task of

guiding action towards the socialization of the costs of medical and drug care and also

disciplining and controlling the production, distribution, marketing and use of chemical,

biological and pharmaceutical products and other means of treatment and diagnosis.

In line with the above in the international context, it is clear in the Portuguese national

domain that the right to health allows the realization of other constitutionally enshrined

fundamental rights, such as the right to life and the right to moral and physical integrity,

as well as the realization of the principle of human dignity (Monge, 2019: 78; Miranda,

2010: 1309).

In the Brazilian context, health is enshrined in article 196 of the CRFB, as a right of all

and a duty of the State, guaranteed through social and economic policies aimed at

reducing the risk of disease and other aggravations and at universal and equal access to

actions and services for their promotion, protection and recovery. Within the

competences attributed to the unified health system, it is worth mentioning the one that

As stated by the doctrine “The right to health protection comprises two aspects: one, of a negative nature,

which consists of the right to demand from the State (or third parties) that it refrain from any act that

harms health, the other, of a positive nature, which means the right to state measures and benefits aimed

at disease prevention and treatment. … in the second case, it is a social right itself, with the corresponding

constitutional configuration” (Canotilho, 2014: 825).

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refers to controlling and inspecting procedures, products and substances of interest to

health and participating in the production of medicines, equipment, immunobiological

products, blood products and others

. This right fits within the social rights provided for

in article 6 of the Brazilian Constitution, which guarantees individuals’ autonomy,

enabling them to exercise other rights freely through access to educational training,

work, housing, and heath care (Carvalho, 2019: 25-28).

Without having the opportunity to delve further into the legal treatment given to this

right and the consequent obligation imposed on the State, this paper shows that we are

dealing with a right that goes beyond its own borders as an end and is also essential for

the realization of many other rights. Accordingly, when compared with the property right,

it seems evident that the latter must yield to the former, and this superiority does not

imply the elimination or annulment of the property right.

Final considerations

As a result of the analysis carried out in this work, it would be logical to conclude on the

relevant role of compulsory licences as a means to allow greater and broader access to

health when used in a situation where pharmaceutical patents exist. However, if this has

already proven not to be very effective when targeting access to medicines by less

developed countries, in the current context, in which the problem of access to a medicine

or treatment protected by patent that can treat covid-19, extends to most advanced

countries, the role to be played by compulsory licences is manifestly null (Hoen, 2016:

185-193)

Indeed, the recent context of covid-19 has shown that the main tool to promote the rapid

and effective gaining of a pharmaceutical solution to fight the pandemic has been based

on voluntary collaboration between economic agents, in an increase in permissiveness

on the part of pharmaceutical patent holders so that the object of their protection can be

freely used in the production of more effective medicines or vaccines and solidarity

initiatives to finance the acquisition and donation of vaccines (Bartels, 2020: 11-12).

There are several strategies to democratize access to patent-protected medicines in a

“normal ” context, i.e., non-pandemic conditions. Indeed, within the scope of the

mechanisms to boost this access, and as mentioned above, TRIPS enables the possibility

of compulsory licences based on the lack of sufficient use by the holder, and also

compulsory licences based on a situation of national urgency or public interest and non-

commercial purposes. There is also provision for flexibilization of exports from producing

countries, albeit with compulsory licences, to less developed countries without production

capacity and the possibility of exporting these medicines between a country that receives

this aid and another country in the same economic area.

In most countries, there are expropriation regimes that can be brought against the patent

right holder when faced with situations of public utility and interest. Voluntary licences

See. Title I of Article 200 CRFB.

These authors advocate that a wider use of compulsory licences would be essential to guarantee better and

broader access to health, both in poor and rich countries.

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also play an important role, as does the currently very limited ability of non-WTO member

countries to exclude vaccines from patentability. We also have altruistic initiatives, such

as the COVAX programme, whose objective is to raise funds to acquire vaccines and

equipment and distribute them to countries with greater difficulties in dealing with the

pandemic situation

Despite all these mechanisms, it has been found that the solution to the pandemic

situation based on the goodwill of patent holders is not enough to build an effective, rapid

and global response, with very “embarrassing” situations occurring with regard to the

vaccination levels of the population

. As a result of this situation, several proposals were

presented to the WTO to suspend the WTO TRIPS agreement on vaccines, treatment and

equipment related to covid-19 and increase production and manufacturing capacity in

developing countries

These proposals were evaluated in the Proposal for a Resolution presented by the

European Parliament of 2 June 2021 on how to face the global challenge of covid-19

Roughly speaking, this document opposes a possible suspension of patents related to the

treatment of covid-19, stating that the patent system is essential to fostering innovation

and safety in the invention ecosystem and that this safety is essential to be able to invest

in finding solutions for new variants of covid-19

. Alternatively, the aforementioned

document recommends that the emphasis should be on encouraging the donation of

vaccines and on permitting the export of vaccines from producing countries to countries

in need of vaccines, among other measures.

This stance is to be regretted, since there are several reasons that would impose a

decision to the contrary

. All existing mechanisms contribute to overcome the pandemic

situation at a global level, but all of them have proved to be insufficient and far from real

needs. Extraordinary situations require extraordinary approaches that lead to

extraordinary solutions.

The protection of medicines through patents is relatively recent and the acceptance of

this protection by several States was based not so much on the conviction of its

advantages, but because it is a necessary requirement to benefit from other advantages

https://www.gavi.org/covax-facility

In fact, the vaccination rate is very high in rich countries, and non-existent or low in less developed

countries. Rich countries “monopolize” vaccines to satisfy their national needs first, and there is a race

between rich countries to that end. Many unnecessary doses were withheld by rich countries. In the free

market, solutions could be sold to the top payer with priority, as was the case of Israel, which paid almost

twice as much for the vaccine as the European Union. https://www.elindependiente.com/vida-

sana/salud/2021/01/21/el-precio-del-milagro-israeli-con-la-vacuna-pagar-mas-y-dar-datos-a-pfizer/. The

WHO has asked rich countries to delay the administration of a third dose of the vaccine and allow for an

increase in vaccination in countries where the first doses have not yet been administered

https://elpais.com/sociedad/2021-08-04/la-oms-pide-una-moratoria-mundial-para-la-tercera-dosis-de-

las-vacunas-contra-la-covid-19.html. Furthermore, pharmaceutical companies did not have any problems

in increasing vaccine prices in contracts signed with the European Union, which is certainly justified by

commercial opportunism. https://www.lavozdegalicia.es/noticia/sociedad/2021/08/01/pfizer-moderna-

suben-precio-vacunas-contra-covid/00031627826051265125579.htm

See https://www.wto.org/english/news_e/news21_e/trip_23feb21_e.htm

See https://www.europarl.europa.eu/doceo/document/B-9-2021-0311_PT.pdf

See Recital L.

See the Human Rights Watch article of 03.06.2021 entitled Seven Reasons the EU is Wrong to Oppose the

TRIPS Waiver. https://www.hrw.org/news/2021/06/03/seven-reasons-eu-wrong-oppose-trips-waiver

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arising from membership of the WTO. In addition, the ability of the patent system in the

pharmaceutical sector to stimulate innovation is far from being peaceful, with studies

showing precisely the opposite effect (Gold, 2010). Another factor to consider is the fact

that many medicines protected through patents are also the result of public investment,

in its various forms, which questions the democratization of investment and the

monopolization of eventual profits (Cross et al., 2021)

In our understanding, the provisional suspension of patents that protect vaccines is the

extraordinary measure that this extraordinary situation requires to build a solid and rapid

response to the global emergency. We disagree with the understanding advocated by the

Chairman of the Board of GAVI – Global Alliance for Vaccines and Immunization, José

Manuel Durão Barroso, in maintaining that this measure would have a negative impact

on research and innovation. Another argument given is the absence of knowledge or

secret know-how to put into practice the use of suspended patents, which is also difficult

to understand (Barroso, 2021: 66). Firstly, as we have seen, there are situations when

a large part of the funding needed to obtain vaccines is public, so an eventual suspension

of patents obtained with that funding would allow for adequate economic compensation

that would reward the public effort made. Secondly, an essential pillar of the patent

system is the publicity of the invention to be protected in such a way that the owner of

the patent right will have to reveal all the necessary procedures for any expert in the

field to reproduce the protected invention. In this context, it is not clear how it can be

argued that there will be an “important know-how” that would prevent verifying the

quality of vaccines produced with the knowledge of suspended patents.

Indeed, if the vaccine is protected by patent, any expert in the field will be able to

reproduce the vaccine following the instructions made public with the patent application.

If, on the contrary, the reproduction of the procedure protected by the patent does not

result in exactly the same vaccine whose protection was requested, due to the lack of

important know-how, then the vaccine could not be protected by patent, and would be

freely used.

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