ip and hr- open challenges on patenting

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Intellectual Property and Human Rights: open challenges on patenting

Enrico Amarante, Margherita Leder, Laura Menozzi, Giulia Provino, Laura Somaini

From when it was purely a technical subject, and its administration required nothing but mechanical

expertise, intellectual property has come a long way through supranational and national legal

frameworks. Along with its established economic perspective, intellectual property rights are now

intrinsically intertwined with human rights, on matters that are continuously dealt with by States in

the international arena.

After the creation of the United Nations in 1945, the World Intellectual Property Organization

(hereinafter, WIPO) succeeded the United International Bureau for the Protection of Intellectual

Property and became an agency of the UN family. Its mandate combines two concurrent objectives:

the protection of creators moral and material interests and the access to socio-economic and

cultural benefits worldwide.1 Up until the early 90s, the WIPO had been the only international

institution in its field; however, economic aspects related to intellectual property started to be

vividly recognized and a need for protection was sponsored by many nations. Along with Europe,

the United States aimed for a higher protection standard of their IP-related goods by framing

intellectual property rights in a more rigid set of rules. Therefore, contemporarily with the passage

from the GATT to the WTO, States incorporated intellectual property rules in the Trade Related

Aspects of Intellectual Property Rights Agreement (hereinafter, TRIPs Agreement) in 1994.

Issues among signatory States emerged soon after the ratification and establishment of the WTO.

Developing countries, whose Constitutions upheld principles such as the right to health, were

concerned that the lack of flexibility of IP rights could harm their instable socio-economicsituations. The ratification of the TRIPs meant a cultural and moral recognition of IP rights,

granting them equal dignity as other human rights; moreover, those rights were shielded by overly

strict enforcement measures.

Consequently, developing countries resorted to the means of the so called regime shifting. This

practice protected State interests by transferring law-making processes towards more sympathetic

venues. As a matter of fact, developed countries were the first to exploit the comparative advantage

of differentiating the multitude of international organizations. Such institutions, such as the FAO

and the WHO, were chosen due to their in-depth field expertise and with the express mandate to

promote a wide range of human rights. At the end, developing countries not only challenged the

TRIPs on moral and socio-economic grounds: they also created strategic inconsistencies in the IP

legal framework.

The reaction of developed countries was made manifest by committing to bilateral agreements, as

the US and European countries began interacting with singular counterparts through an enhanced

type of agreements, as the TRIPs Plus, setting even tougher conditions to enact intellectual property

laws. The case of medicines is just one out of many. Countries like Brazil and China were

compelled to extend the term of a patent longer than the twenty-year minimum, or to introduce

provisions that restricted generic competition or limited the use of compulsory licensing.

Currently, the international framework consists of an overlapping, multilateral and multiregional

regime in which intellectual property and human rights coexist in an extremely complex way. It

1WIPO Intellectual Property Handbook, 2008


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encompasses treaties as well as declarations of intents, and provides different hierarchies of

principles. Some of those instruments call for the participation of non-State parties, such as NGOs

and mere individuals, whose impact has become increasingly stronger and more relevant.

The ongoing dispute regarding intellectual property rights, compulsory licensing and parallel

importation of medication is clearly displayed in the South African case.

The HIV/AIDS crisis that spread across the African continent in the late Nineties, reached epidemic

proportions in South Africa: the 2000 UN Global Report on the disease reported that, with a total of

4.2 million infected people, South Africa had the largest number of people living with HIV/AIDS in

the world. While treatments were widely accessible for patients in the West and allowed them to

live decent lives, treatment in Africa was practically non-existent. This was due to the fact that U.S

and European pharmaceutical companies held exclusive patents on the drugs and set prices that not

even South Africa Africas most developed nation could afford.

The debate was started by the changes brought to the international patent rights framework by the

TRIPs Agreement. Before the TRIPs, the protection of patent rights was considered to be mainly a

prerogative of national sovereignty. The preservation of IP rights depended upon the level of

protection that each jurisdiction offered to its own citizens. This regime pushed many states to

avoid issuing patents for pharmaceuticals and caused the proliferation of copies of patented drugs,

which came with lower price tags and ensured that the majority of the infected population could

access medications.

However, the pharmaceutical industry complained about commercial losses, attributed to the

weakness of IP rights protection, particularly in newly industrializing countries. IP-intensiveindustries felt the need to protect their products from unfair commercial use and sought a regime

that could offer a minimum standard protection. The goal was reached with the TRIPs.

Nevertheless,it should be noted that the Agreement contains also safeguards allowing countries to

protect public health of citizens. In fact, the TRIPs Agreement allows both compulsory licensing

and parallel importing. These two practices can be used by states to lower the price of

pharmaceuticals either by bringing competition into the market or by comparison-shopping for the

world's best market price.

This original TRIPs regime led, on the one hand, to NGOs and AIDS activists calling on Western

pharmaceutical companies to drastically reduce the prices of AIDS medication in the developing

parts of the world. On the other hand, it led to drug companies asserting that the cost of patented

drugs is directly proportional to their research and development costs and that revenues are

necessary to the production of life saving drugs. Reality, for the majority of people in developing

countries, is that they continue to die of treatable diseases because they cannot afford medication.

At the end of the nineties, an anti-HIV regimen of drugs for one patient, at US prices, cost $15,000

annually. In South Africa, treating all 4.2m patients would have cost $63b - more than 20% of the

nation's GDP at the time. Because of these prices, only .001% of Africa's AIDS patients could

receive anti-retroviral treatment.2

2Rick Hink, AIDS TRIPS: Intellectual Property and AIDS Medication in South Africa,http://www.american.edu/ted/aidstrips.htm


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The situation faced by the South African Government was to fulfill its international commitments in

order to participate in the global economy while, at the same time, protecting its citizens rights to

health and life.

The Governments response was to embrace a new policy aimed to promote the availability of

affordable drugs. The main act of this policy was the Medicines and Related Substances Control

Amendment Act of December 19973. It included several measures aimed at lowering the cost of

pharmaceutical products. The effects of these provisions would have been to allow parallel

importation of medicines, generic substitution without the consent of the prescriber, and

compulsory licensing.

The governments attempt of creating a more competitive market didnt go unnoticed by the

international pharmaceutical industry. In 1998, forty-two pharmaceutical companies, including

local companies, subsidiaries of transnational corporations, and the multinational corporations

themselves, united in the Pharmaceutical Research and Manufacturers of America (hereinafter,

PhRMA), commenced litigation against the Amendment to the Medicines Act. They challenged its

constitutionality and claimed an infringement of international law. In particular, they held that the

Act constituted an arbitrary deprivation of their constitutional property rights, or alternatively, an

expropriation without compensation, contrary to section 25 of the South African Constitution.

Moreover, they maintained that the Governments interpretation of the provisions regarding

compulsory licensing and parallel importation based on the safeguarding of health and equity

were inconsistent with the TRIPs Agreement.

The defensive strategy of the South African Government was led by the Treatment Action

Campaign (hereinafter, TAC), a non-governmental organization dedicated to ensuring treatment

access to South Africans infected with HIV/AIDS. The campaign aimed to uphold the

Governments rights to preserve its citizens right to health and to ensure an easy access tomedicine for all. The right to health is recognized both as a human and as a constitutional right. The

South African Constitution guarantees the right for everyone to access healthcare (subject to

available resources), to emergency medical treatment and the right to an environment that is not

harmful to health.4

Sadly for those who study this topic, no formal precedent was decided: PhRMA withdrew legal

action in 2001. We can therefore only speculate on the impact this may have had. Given the

arguments that the parties upheld and the recognition of both rights in the constitutional writing, if

the Court had decided the case, it might have been required to explicitly balance the two

constitutional rights (one might say therefore they are both fundamental).

In any case, outside the Courts rooms, TACs participation to the initial litigation succeeded in

making the world aware of South Africas public health issues. The cooperation between civil

society, developing countries and international NGOs that originated from this situation demanded

a rebalancing of the social needs of their citizens and the claims of economic globalization .5

People from all over the world protested, signed petitions and marched to support the South African

cause. The developing world realized that its issues on balancing human rights and complying with

international obligations were shared by other states. Thus, through regime shifting, developing

3Act 90 of 19974South African Constitution, 1996, par. 27 and 24.

5Heinz Klug Campaigning for life: building a new transnational solidarity in the face of HIV/AIDS and TRIPS, In B.

De Sousa Santos, C.A. Rodrigues-Garavito (eds),Law and Globalization from Below, Cambridge, 2005.


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countries sought attention from the developed world, tackling the same problems together and by

moving tofora more sensitive to their interest.

In response to the South African case, the WTO Doha Ministerial Conference in November 2001,

has seen Ministers issuing a separate Declaration on the TRIPS Agreement and Public Health,

which stressed that the TRIPS should not prevent members from taking measures to protect public

health ... [and] that the agreement can and should be interpreted and implemented in a manner

supportive of WTO members rights to protect public health and, in particular, to promote access to

medicines for all.

It also highlighted the States ability to use flexibility instruments, such as compulsory licensing

and parallel importing, and eventually extended exemptions on pharmaceutical patent protection for

least-developed countries until January 2016. This interpretation brought to the amendment of art. 8

of the Agreement, now stating may, in formulating or amending their laws and regulations, adopt

measures necessary to protect public health and nutrition, and to promote the public interest in

sectors of vital importance to their socio-economic and technological development, provided that

such measures are consistent with the provisions of this Agreement.

Although it is difficult to single out the role of the right to health in the international and domestic

politics around the South African Medicines Amendments Act, it is clear that it began to change the

international intellectual property and trade regimes. It created a new solidarity among actors

agitating for health: human rights, health and development activists, some Governments and the

generic pharmaceutical industries.

Continuing on the pharmaceuticals field, an important instance took place in one of the planetslargest and most populated countries and among the new leading economies of the world: the

Republic of India, inNovartis v. Union of India & Others(hereinafter,Novartis).

It is well known that India is a major international supplier of drugs, to countries where these

products have not been patented yet. The Novartis case concerns Glivec, a drug used in the

treatment for multiple types of cancer (e.g. chronic myeloid leukemia), able to control and limit

cellular action, preventing the cancers growth, but sadly incapable of curing it6. The main

compound of the drug is a salt called imatinib, which was invented in the 1990s and initially

patented in various states, by the Swiss pharmaceutical company Novartis; the patents scope

covered all of its pharmacologically acceptable salts. In 1998 Novartisfiled an application for a

beta crystalline form of the compound, imatinib mesylate, which is the specific form of the drug

sold as Glivec, in 2003, in India, among other countries, and obtaining exclusive marketing rights

for it. At the time, various Indian producers sold generic versions of the same drug at lower prices,

but consequently had to withdraw from the product and sales markets of generic drugs, both in the

domestic market and in the exportations business to other developing countries. Due to the massive

price increase of the drugs generic versions, the Cancer Patients Aid Association (CPAA) and

other NGOs, had to suspend their medical support to cancer patients.

6For instance, patients suffering from chronicle myeloid leukemia must take it for the rest of their lives.


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In the past, India had denied patent protection to the production of pharmaceuticals, granting

protection only for the related processes7. In 2005, India become fully compliant with the TRIPs

Agreement and the Patent Act of 1970 was amended, providing patent protection for

pharmaceutical inventions. However, Section 3(d) limits patentability: 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, is not regard as a new inventionunless such

known process results in a new product or employs at least one new reactant. This means that salts,

combinations, and other derivatives of known substances shall be considered to be the same

substance, unless they differ significantly in properties, with regard to efficacy . Therefore new

forms of existing substances are patent eligible only if they display a significant increase in

efficacy.

Be duly noted that the right to health is not mentioned explicitly in the Indian Constitution. The

Supreme Court of India attempted to interpret the existence in the constitutional writing of the right

to health, as a derivative of the right to life, provided by article 21.

The Chennai Patent Office examined Novartis patent application in 2005. In the same time, pre-

grant opposition was filed against Novartis patent application for Glivec, based on the provisions

of Section 3(d) of the Indian Patent (Amendment) Act of 2005. The claim8was, firstly, that this

application only concerned a modification of an already existing drug that did not improve its

efficacy; and secondly, that non-availability and non-affordability of any form of imatinib mesylate,

specifically for chronic myeloid leukemia patients would violate their constitutional rights under

article 14 (right to equality before the law9

).Therefore, in 2006, the Chennai Patent Office rejectedNovartis patent claim assessing that it was

only a new form of a known substance without any significant improvement in efficacy.

Novartisthen appealed the Patent Offices decision: it challenged Indias obligations as a signatory

to the TRIPs Agreement under article 1(1) and article 27 and it also challenged the constitutionality

of Section 3(d) of the Patent Act, on the grounds that it violated article 14 of the Constitution, as

discriminating against the pharmaceutical sector.

The High Court of Judicature at Madras upheld the validity of section 3(d), as it ruled that India,

being a welfare and developing country, which is predominantly occupied by people below the

poverty line, has a constitutional duty to provide good health care to its citizens by giving them easy

access to life saving drugs. In so doing, the Union of India would be right to take into account the

various factual aspects prevailing in this big country and prevent ever-greening by allowing

generic medicine to be available in the market. The Court also held that the amended section did

not violate article 14 of the Indian Constitution: Section 3(d) does not discriminate against the

7Section 5, Patent Act 1970 (India). Moreover, for medicine and food Section 83, Patent Act 1970 provided that no

patent shall be granted in respect of claim for the substance themselves, but claim for the methods or process of

manufacture shall be patentable

8Text of the Writ Petition No 24759 of 2006 in the High Court of Judicature at Madras. Clause 16.9The State shall not deny to any person equality before the law or equal protection of the laws, within the territory of

India.


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pharmaceutical sector, it only makes a differentiation, which is justified upon the specificity of salt

forms used in the pharmaceutical sector.

It is clear that the drastic level of poverty in India and the problems related to drug access, mainly

because of their pricing, has called here for a reduction of the patents grant scope. On the other

hand, Indias current industrial and innovation imperatives warranted that domestic major

production capacities and exportation potential were protected, objective perpetrated by the

Amendment of 2005.

Moreover, turning to the Western scenario, Association for Molecular Pathology et Al. v. Myriad

Genetics, Inc. et Al. (hereinafter,Myriador Myriad Genetics) displays the fast-developing and up-

and-coming field of biotechnology.

Myriad Genetics, Inc. is a genomic research firm based in Utah, US. In 1994, during their research,

Myriads scientists discovered the precise location and sequence of two genes: today known as

BRCA1 and BRCA2, whose mutation was found to have an influence on the risk of breast andovarian cancer development. This information enabled Myriad Genetics to develop medical tests

aimed at detecting mutations and consequently assess, with an adequate degree of certainty,

whether a patient has an increased risk of developing cancer at some point of her life10.

Litigation over BRCA gene patenting began as early as 1997, just months before Myriad was

granted its first BRCA1 patent, accordingly to the US Patent Offices practice on issuing patents for

isolated gene sequences. Nine laboratories that had been offering BRCA testing withdrew from the

US market, and no one challengedMyriads patents for a decade. Through 2013,Myriadperformed

over one million BRCA tests and generated over $2.8 billion in revenues.A coalition of petitioners (among others: several professional associations of research scientists,

including the Association for Molecular Pathology and the American College of Medical Genetics,

individual researchers, womens health and breast cancer advocacy groups and individual patients)

eventually filed a lawsuit seeking the invalidation of Myriads patents, so that research, tests and

treatments related to the patented genes could be pursued without restrictions. After exhausting all

remedies, in 2013, the case was brought before the US Supreme Court, which reversed, partially,

the Federal Circuits decision, agreeing on the one claim we will speak of with the petitioners.

The petitioners argued that Myriads ownership could have been used to thwart scientific

progress and health care efforts. In fact,Myriadcharged over $3,000 for tests that other labs could

easily offer at a significantly lower price. Also,Myriadpublicly stated that it had provided free tests

to 5,000 women in the past three years, but it turns out that its generosity amounted to less than 1%

of all of the tests it performed during that period.11

The main issue here was understanding whether the isolated DNA sequences could be qualified as a

new and innovative composition of matter or a natural occurring phenomenon, consequently

falling within or without the scope of Title 35 U.S. Code, Section 101. So is the mere act of

10Approximately 7% of breast cancer cases are caused by mutations in the BRCA1 or BRCA2genes. Carriers of amutation in these genes have a condition called Hereditary Breast and Ovarian Cancer (HBOC) syndrome. They havean up to 87% risk of developing breast cancer by age 70. (Source: www.myriad.com)11

As a point of reflection, in the US, 11.9% of females under the age of 65 dont have health insurance coverage(2014). (Source: www.census.gov)


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isolating DNA (which consists of separating a specific gene or sequence of nucleotides from the

rest of the chromosome) an inventive act that entitles the individual who first isolates it to a patent?

Each Justice on the panel had a different view on the question.

The Supreme Court eventually invalidated Myriads BRCA 1 and 2 patents. It held that, surely,

Myriad had found an important and useful gene, but separating that gene from its surrounding

genetic material did not constitute an act of invention; therefore, Myriads discovery did not fall

under Title 35, Section 101s scope.

The Court also pointed out that there were no method claims: had Myriad created an innovative

method of manipulating genes while searching for the BRCA1 and BRCA2, it could possibly have

sought a method patent. But the processes it had used were well understood by geneticists at the

time. The Court, on the other hand, partially affirmed the Federal Circuits verdict on the claim

regarding another discovery Myriad held a patent for: complementary DNA (cDNA), actually a

synthetically lab-created DNA sequence, hence considered patent eligible under the Patent Act.

Given the strong public reaction in the US to these events and the Courts holding, a few

dramatic, but nevertheless, pivotal questions immediately come to mind: is it even legal for the

US Patent Office, or any other patent office for that matter, to issue patents for genetic material?12

Can one corporation legally control and charge others for all uses of genes it holds a patent for,

possibly dictating the terms in which science and medicine may progress?

Then again, from the opposite standing point, wont limiting intellectual property rights e.g.

compulsory licensing have repercussions on scientific research itself, being privative rights the

prize for research and innovation investment?

In the United States, intellectual property rights enjoy recognition and protection in the Constitutionitself: article 1, section 8, clause 8, the so called copyright and patent clause, provides: [the

United States Constitution grants Congress the power] To promote the Progress of Science and

useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their

respective Writings and Discoveries. This highlights the relevance attributed to IP rights, as an

expression of one of the three primary rights all Americans share.13 Therefore, whenever an IP

right and any other right ranked at a constitutional level collide, a case-specific constitutional

balancing test is in order. InMyriad Geneticsthough, the Supreme Court doesnt perform a proper

balancing test, cunningly avoiding taking sides and reasoning the decision on the technical merits of

the case. One cannot refrain from thinking what a sensitive issue health care accessibility is in the

United States policies. Thus no specific line was drawn for the future.

The European Union has attempted regulation on the matter by means of the European Patent

Convention (hereinafter, EPC), of 1973. Article 52, section 2, point a) states that discovery shall not

be regarded as invention. Also rule 29, of Chapter V, on Biotechnological Inventions, of the

aforementioned convention stipulates that the human body []and the simple discovery of one of

its elements, including the sequence or partial sequence of a gene, cannot constitute patentable

inventions.

12As a point of comparison, 20% of the human genes are patented. (Source: American Civil Liberties Union newsrelease)13

As quoted from the Fifth and Fourteenth Amendments to the US Constitution:Life, Liberty and Propriety.


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More recently, the Biotech Directive14maintains that inventions that are new, that involve an

inventive step and that are susceptible of industrial application are patentable even if they concern a

product consisting of, or containing, biological material. Isolated biological material or produced by

means of a technical process may also be the subject of an invention. Nonetheless, the directive

clearly states the same principle declared in the EPC: the simple discovery of a gene sequence is not

a patent eligible invention. European law hence provides rules that seem quite similar to the

decision inMyriad Genetics. But be noted that these provisions are standards, which must be, and

now are, implemented as substantive law at the individual national level of the EU member states,

pursuant to the common purpose of European legislations harmonization.

An interesting point has been made in Australia in 2002. The Australian Law Reform Commission

(ALRC), after an in-depth inquiry on the matter, has issued various Recommendations: to cite one,

that the Australian Patents Act of 1990 should be amended to include an experimental use

exemption, meaning: allowing experimentation on the patented invention for such purposes as

investigating its properties or improving on it15. Yet to be implemented, these recommendations

could possibly ensure the achievement of a suitable balance in what seems an unresolvable conflict.

Turning to case law, the European Court of Justice has known copious litigation over intellectual

property rights. But the records show that the conflict with IP rights, has, up until now, concerned

only other economic rights, and therefore has been dealt with mostly from an economic point of

view. Fact that doesnt come as much of a surprise given the Unions natural calling. Importantly,

intellectual property has been enshrined, among the right to property, in the Charter of Fundamental

Rights of the European Union, where article 17, paragraph 2 solemnly states intellectual property

shall be protected.The European Court for Human Rights (hereinafter, ECtHR), on the other hand, has recently

addressed the subject. Firstly, the Court has recognized and assessed, in a number of decisions, that

intellectual property is, indeed, a form of property, and thus falls under the protection of Article 1 of

Protocol no. 1 to the European Convention on Human Rights (hereinafter, ECHR), on the

Protection of Property. This acknowledgment recognizes that intellectual property has the same

status, and is hence entitled to the same protection, as any other form of property and possession.

In fact, in the well-knownAnheuser-Busch Inc. v. Portugalof 2007, the ECfHR held that trademark

rights (and therefore, presumably, other forms of intellectual property) fall within the guarantee of

the peaceful enjoyment of ... possessions. Something similar happened in Dima v. Romania, on

copyrightability of design models for state symbols. Even though in both cases no violation of

article 1 was found, it is undisputed that the European Court has granted intellectual property a

dignified fundamental rights qualification, as any other right stipulated by the Convention.

So we can legitimately expect that in the future the European Court for Human Rights will adjudge

more disputes on the matter, and may at some point find itself enacting the balancing test between

an IP right and a human right. And by admitting the legitimacy of the balancing test, we imply that

it is not impossible to imagine a given case where intellectual property rights may actually prevail

over other more fundamental one might say rights guaranteed by the Convention.

14Directive 98/44/EC

15Recommendation 13-1


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One final consideration concerns the case of conflict between developed countries and local tribes,

on the possibility of exploiting natural resources of the territory inhabited by the tribes.

Lawyers have been questioning the possibility of patenting plants, which clearly dont constitute

a human invention, but merely a discovery: the innovative process is totally absent.

Another aspect regards the patentability of the biogenetic codes of these plants. These issues have

been analyzed mainly by: the International Convention for the Protection of New Varieties of Plants

(hereinafter, UPOV); the FAO International Undertaking on Plant Genetic Resources for Food

(hereinafter, FAO Undertaking), the Rio De Janeiro Earth Summit of 1992 and the TRIPs

Agreement, each giving different answers to the problems and creating a complex system, pretty

difficult to abide by.

The UPOV, ratified in Paris in 1961, brought a radical change of mindsets on exploitation of natural

resources. It actually pushed States to allow patentability of plants and their biogenetic codes. The

Convention also recognized the so called farmers privilege to the companies exploiting the

resource. The argument is supported by the necessity of a human action: since biogenetic codes

need human intervention to be actually discovered and modified, a patent responds to the problem

of protecting this action and, also, maybe foremost, attracts potential interests of economic agents.

The aforementioned convention also considers the issue of second generation modified plants: if

companies manipulate an already modified plant, this second alteration is not patent eligible, and its

use is totally free.

A completely opposite perspective is described in the International Undertaking on Plant Genetic

Resources for Food, approved by FAO in 1983. Art. 1 solemnly provides thatgenetic resources are

heritage of mankind. States should accept the exploitation of natural resources when this is called

for by scientific research. The Undertaking qualifies resources as a common good, to be protected

for future generations: the International Community is considered the trustee of the rights related toagriculture, and responsible for preserving the environment as a whole.

The FAOs perspective has slightly changed in a recent Resolution of 1991, where it recognizes

sovereignty to the State on all resources existing in its territory: hence, it can also decide to deny

free access to them. Thus, the tendency is that to consider patent rights only as a limit to free trade

and pure exploitation of resources.

The Rio de Janeiro Biodiversity Convention, stipulated in 1992, encompasses a more modern vision

of the question. Among the results obtained, the Convention is extremely emblematic. It elevated

biodiversity richness to a fundamental concern on socioeconomic, cultural, educational, and even

aesthetic levels. It also established that the exploitation of natural resources had to involve the

holders of such knowledge, so that the benefits resulted therefrom would be equably shared.

Importantly, the right of equal distribution has been recognized to local tribes: distribution of the

revenues that companies and researchers earn post patenting. It introduces instruments that require

the consensus of the sovereign state and it dictates to close agreements with the local community on

distribution and incomes. This system is quite valuable, but implies serious problems of state

control and significant costs, both up and downstream.

An interesting and meaningful example on the matter is the Brazil Amazonia dispute.

Art. 231 of the Brazilian Federal Constitution, of 1988, recognizes Indies the right to their social

organization, costumes, languages, tradition and beliefs and original rights on the lands theytraditional occupy. It is of the Unions responsibility the demarcation, protection and respect of

their good. Moreover, article 170 provides that the environment is protected and the public power


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has the mandate to protect it and check the use of methods, techniques, products and commerce that

could damage it. So the Brazilian state has to endorse the protection of the environment, not only

from aggressive exploitation, but also from commerce that could potentially be harmful.

Brazil has in fact ratified the UPOV, the Rio de Janeiro Convention and the TRIPs. It is, therefore,

constitutionally obliged to protect and safeguard the environment and the rights of the tribes located

in its national territory and to guarantee equal distribution. Yet no steps towards the

implementation of these provisions have been taken. As the world becomes more and more aware

of environmental problems and damages caused by human actions, the protection and defense of the

very few untouched tribal and natural systems remaining on our planet, is a belief the human

society should strive for.

Coming to conclusions, its not easy to draw a straight finishing line, nor to point out a direction

towards which we are going. On the institutional level, a clear future trend in the intellectual

property framework internationally is intergovernmental cooperation. The WHO WIPO WTO

interaction on the global challenge of public health is an admirable example. The guiding principles

of this cooperation are policy coherence and synergy. Since these three international institutions

have different, yet complementary mandates: they must converge their actions and cooperate to

achieve common positive results. On this point, cross-fertilization as well has found fertile soil in

the intellectual property field, especially in the WTO dispute settlement system. In the

Understanding constituting the Court, Each panel shall have the right to seek information and

technical advice from any individual or body which it deems appropriate .16 The Report of the

Panel stated that in the area of copyright, the Berne Convention and the TRIPs Agreement form the

overall framework for multilateral protection. Therefore, the interpretation to adopt is the one that

reconciles the texts of different treaties and avoids conflict between them.17

This clearly advantagesthe WTO in its effort to combine different and sometimes contrasting norms at the international

level; it also further develops a legal relationship with the WIPO consultative body, strengthening

the cooperation in creating a useful IP rights international framework.

Ultimately, States are confronted with countless agreements on IP and human rights signed in

myriads of venues. If this works as a scheme to protect their interests by a more balanced law-

making process, it still leads to far too many international legal obligations. Adjudicative bodies are

the first called to harmonize several equally valid treaties and compose all possible contrasts.

However, those contrasts would be dramatically diminished by cooperation at a supranational level.

The subsidiary role of international institutions is increasingly relevant in coordinating the efforts to

tackle sensitive issues. Moreover, States are now accompanied by civil agents, NGOs and mere

individuals, in the evaluation of principles to enact internationally, thus creating different forms of

participation in the policy-making process.

As we have seen in these questions and disputes, these matters are capable of rising, and certainly

have risen, strong public reactions among civil society. Therefore, it isnt hard to understand why

Courts and Tribunals have avoided taking sides in a straightforward manner: directives must be

decided, potential legal gaps can, and must, be filled only by the Legislator, be it national (as

predominant right now) or supranational and international; as the increasing tendency demonstrates,

16Dispute Settlement Understanding, art. 13

17United States Section 110(5) of the US Copyright Act, Report of the Panel, WT/DS160/R, 15 Jun. 2000


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the latter could be a good response, in securing the rights of citizens, and also in addressing global

concerns. Facts have also shown the necessity to provide states, especially developing countries,

with new means and legal instruments, enabling them to opt for a human rights-based interpretation

of international trade and intellectual property regimes. Therefore, if a human rights perspective is

adopted in addressing IP rights, specifically, for instance, health-related duties could not be

contracted in relation to the rights of innovators. However, many scholars maintain that innovators

rights are equally dignified and must by all means be integrated within the framework of all

fundamental human rights.

But, then again, if innovation aims at the wellbeing of the People, and yet, one-third of the worlds

population is deprived of access to health care, treatments and basic life-saving drugs, and if natural

resources can be bluntly exploited from individuals and habitats that have guarded them for

millennia, could it possibly be that innovation is failing its mission?

ip and hr- open challenges on patenting

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