TRIPS Agreement Research Articles

„Handlowe aspekty własności intelektualnej” jako część Wspólnej Polityki Handlowej – konsekwencje dla bezpośredniej skuteczności TRIPS

Przedmiot badań: Nieustanny rozwój technologiczny sprawia, że znaczenie własności inte­lektualnej rośnie, a ochrona prawna m.in. wynalazków nabiera ogromnego znaczenia, zwłasz­cza dla państw, których gospodarki oparte są na innowacyjności. Na przestrzeni lat Wspólna Polityka Handlowa Unii Europejskiej podlegała zmianom traktatowym, co skutkowało m.in. ewolucją jej zakresu przedmiotowego. Również charakter kompetencji Wspólnot Europejskich, a następnie Unii Europejskiej w tym zakresie zmieniał się. Jednym z najistotniejszych, a zara­zem powodującym najwięcej kontrowersji jest kwestia skutku bezpośredniego TRIPS w pań­stwach członkowskich Unii Europejskiej. Istotność tego zagadnienia wynika z postanowień TRIPS, które gwarantują minimalny zakres ochrony praw własności intelektualnej. Cel badawczy: Autor zmierza do ustalenia, jakim zakresem kompetencji dysponuje Unia Euro­pejska w odniesieniu do TRIPS. Artykuł ma na celu odpowiedzenie na pytanie – jak ewolucja Wspólnej Polityki Handlowej Unii Europejskiej wpłynęła na stosowanie TRIPS w państwach członkowskich Unii Europejskiej.
 Metoda badawcza: W artykule wykorzystano głównie metody: formalno-dogmatyczną oraz hi­storyczno-prawną. W zakresie badania orzecznictwa Trybunału Sprawiedliwości posłużono się metodą empiryczno-prawną.1
 Wyniki: Charakter kompetencji Wspólnot Europejskich, a następnie Unii Europejskiej w odnie­sieniu do Wspólnej Polityki Handlowej zmieniał się wraz ze zmianami postanowień traktatów. Od dnia wejścia w życie Traktatu z Lizbony (1.12.2009 r.) Wspólna Polityka Handlowa wchodzi w zakres jej kompetencji wyłącznych oraz obejmuje handlowe aspekty własności intelektualnej. Orzecznictwo Trybunału Sprawiedliwości potwierdziło, że TRIPS w całości objęty jest kompe­tencją UE, z czego mogłoby wynikać, że dla oceny skutku bezpośredniego jego postanowień miarodajne są – wbrew kontrowersjom w uprzednim stanie prawnym, gdy TRIPS miał charakter tzw. umowy mieszanej – unijne reguły skutku bezpośredniego. Z drugiej strony, Trybunał nie zdecydował się na zakwestionowanie dotychczasowego orzecznictwa w tym zakresie, co może prowadzić do wniosku, że odmowa skutku bezpośredniego TRIPS pozostaje w mocy. Niemniej problem stracił na znaczeniu praktycznym, bowiem postanowienia TRIPS zostały (po zakończeniu okresów przejściowych) recypowane do prawa krajowego państw członkowskich.

Trips Agreement – World Trade Organization

Trips Agreement – World Trade Organization

Access to Medicine and TRIPS Agreement: A Mapping of the Tradescape

The tumultuous tradescape, which references the landscape of the trade regime, provides the background for this chapter and hopes to outline a historiographic mapping of the struggles of diverse actors for access to medicine rupturing established global structures over three generations. The historiographic mapping traces the changes in the patent discourse terrain by analyzing the metamorphosis of IP ideology, particularly patents. In doing so, this larger book captures the different sets of actors such as states, transnational business corporations, civil society groups, and the (re)framing of patent discourses within and among these actors. Our intergenerational analyses of the legal issues surrounding the access to medicine question provides an insight into the structures within which the actors have operated along with the dynamic relationship between structures and actors. The term structure refers to the economic system within which various actors operate. The influence of structures over the behavior of actors and in turn, the influence exerted by actors over structures eventually caused generational shifts in the debate on the role of patents, trade, and access to medication. The book examines the influences over established global protocols, national and international agreements, and state and non-state entities. In doing so, we acknowledge that the history of patent harmonization discourse is a story of dynamic actors, whose interactions with established structures continue to shape the global patent regime.

Pesticide Patent and Data Protection - How They Help Indian Farmers and Indian Industry

Respecting intellectual property rights is one of the basic prerequisites for creating an innovation and R&D based value-added manufacturing sector in any country. Agrochemicals have been chosen as one of the champion sectors. But how can India be a global supply hub without harmonizing with global regulatory policies and practices? This paper is aimed at establishing the benefits of both patent and data protection for Indian agriculture and Indian industry. Many Governments appointed Committees and also the Parliamentary Standing Committee for Agriculture (2008-09), after detailed deliberations and interaction with all stakeholders and all sections of industry, have recommended protection of regulatory data (PRD). This is to encourage introduction of new molecules for the Indian farmers, and to honour India’s obligation under the TRIPs agreement. The recommendations by such eminent authorities should not be overlooked. Almost all countries of the world give PRD for 6–15 years for any molecule registered for the first time in their country.

Accelerating COVID-19 Vaccine Production via Involuntary Technology Transfer

This policy brief explains that the currently discussed proposals at the WTO related to increasing the production of COVID-19 vaccines, including the EU proposal to clarify the use of compulsory licensing and the submission by South Africa and India on the intellectual property (‘IP’) waiver, require complementary mechanisms to rapidly improve the production of COVID-19 vaccines that is urgently needed today. The key problem is that to accelerate the manufacture of COVID-19 vaccines, access to knowledge and know-how, which are protected by trade secrets owned by several pharmaceutical companies, is required. It is, therefore, important that governments implement an additional mechanism of compulsory licensing of trade secrets that would allow an involuntary transfer of COVID-19 vaccine technologies. Such a mechanism would be compliant with the TRIPS Agreement and be relevant both in case of the adoption of the TRIPS IP waiver and if such a mechanism cannot be agreed upon. While this mechanism must provide full access to the information necessary to manufacture the vaccine in question, it must also ensure the protection of the transferred trade secrets.

Pandemic, Patents and Public Health

The COVID-19 pandemic has compelled a relook at public healthcare and the patent systems. It has brought to halt livelihoods with devastating consequences to people’s lives national economies. Global health security is at stake as there is a need to develop and deploy more vaccines, repurpose medicines and increase medical infrastructure support. Collaboration and collective response is imperative at international and national levels. IPR access is crucial in relation to public health. Many countries have issued new policies and enacted laws to make it easier for them to supply medicines to their population during the pandemic. Compulsory licensing has been used as an important mechanism to open up IP without the permission of patent holders. The present study analyses amendments to patent law and IP legislations that are effected from a cross country perspective during the pandemic time. It also examines international cooperation in the context of public health and IP under the TRIPS Agreement in view of the on-going consultation at the WTO. The study reveals differences in approaches to ‘governmental use’ of patents and access to know-how under the statutory framework. Improving the scope of use of products and process patents, suspension of patent term extension, consolidating the compulsory licensing mechanism, removal of inequity are the predominant aspects that are part of the amendments to patent law in the countries. Pandemics like COVID-19 need legislative initiatives to secure healthcare system access for all citizens. Healthcare access includes ready availability of basic vaccines, drugs, medical devices and medical infrastructure. There is often a clash between access to healthcare as a fundamental right on one hand and the need to award monopolies in the form of IP rights as an incentive for innovations from the pharmaceutical industry on the other. Hence, obstacles arise in decision-making to balance innovation incentives and ensuring rights to access healthcare. Judicial decision-making and public policy-making have been always at the centre stage in earlier epidemics and now in the current pandemic making it imperative for countries to protect the health interests of their citizens.

Recognition and protection of copyright objects under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights

The article is devoted to the problem of copyright protection under the existing agreements of the World Trade Organization. The analysis of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) which occupies the central place in the system of WTO normative legal acts is presented in the study. The paper reveals certain categories of intellectual property rights subject to protection under this Agreement, procedural aspects of the acquisition and preservation of copyrights, as well as minimum standards for the intellectual property rights protection adopted by WTO member states. It is concluded that copyright protection depends not only on substantive rules that provide for minimum standards of protection, but also on procedural and legal mechanisms that provide effective ways to ensure compliance with these rules. The article highlights the unique role of the TRIPS Agreement in the sphere of copyright and intellectual property rights protection in international trade.

‘No-one is Safe Until Everyone is Safe’ – Patent Waiver, Compulsory Licensing and COVID-19

Recent months have seen intensified global calls for an intellectual property waiver of COVID-19 related vaccines, treatments and related products. Where one side of the debate elevates Intellectual Property Rights as on obstacle to affordable and expeditious global access to vaccines and treatments, the other side of the debate points to the existing TRIPS flexibilities such as compulsory licensing, the necessity of Intellectual Property Rights for future innovation as well as other factors such as manufacturing capacity and know-how being of greater importance. This dualistic approach risk ignoring the manifold law, economics, and policy nuances inherent in the intersection of intellectual property law and Right-to-Health, as well as innovation and health policy. A balanced approach guided by real world indicators regarding law and economics of pharmaceutical innovation, procedural feasibility of compulsory licensing and legal applicability of an IPR waiver is needed. Thus, the key to understanding the current debates lies in a holistic approach to ratio legis of intellectual property rights, innovation policy and health policy. The innovation inducing facets of monopoly rights, and interconnected monopoly profits, need to be balanced against public policy rationales such as Right-to-Health, but also against the ratio legis of IPRs, which focuses on maximizing societal welfare. After the introduction framing the background regarding unequitable global access to COVID-19 vaccines and treatments paving the way to the current debates on patent waiver and compulsory licensing, the Article proceeds as follows. Section II briefly sketches the main contours of the debate on right-to-health and intellectual property rights from a law and policy perspective. Section III details the legal, historical and procedural background of international codification of patents and the compulsory licensing instrument within the TRIPS agreement, as well some instances of compulsory licensing during COVID-19. Section IV recounts the patent waiver proposal at TRIPS Council and the arguments for and against the proposal. Section V concludes with some law and policy reflections on the balance between Right-to-Health, intellectual property rights and innovation policy.

COVID-19 Pandemic: Should Nations Resort to Compulsory Licensing of Drugs and Vaccines? An Analysis of the Effect of Such Pervasive Steps and Non-Market Price-Setting on the Economics and Political Economy of Creative Industries

A license, in the context of a patent, stands for a contract by which the licensor (patentee) authorizes the licensee to exercise defined rights over the patent. The effect is to give to the licensee a right to do what he/she would otherwise be prohibited from doing. A license may be voluntary or compulsory.Compulsory licensing has been defined to be a governmental grant to someone to produce a patented product without having the patent- holder's consent . It is a balance between the needs of technology consumers and producers- between a governmental grant and preservation of patent holder rights . It implies a waiver to patents, at least during the persistence of a crisis and can step in whenever there is a potential conflict- for instance between health and medical patents rendering the availability of some medicine scarce due to an exclusive right or an extremely high price.Under a compulsory license, the licensee is per force required to offer his intellectual property for a predetermined royalty or for a royalty to be decided by the authority on a case to case basis. The provisions for grant of compulsory license are aimed at making best use of the patented invention - not to restrict the rights of the patentee, but to stop abuse and misuse and to safeguard the interests of the public. Public health principles, in the context of access to medicines, are supported by a range of national and international legal and policy instruments. The TRIPS agreement is a milestone in this. It provides patent protection, for a minimum of 20 years, for products in almost all fields of technology including pharmaceuticals. One of the most debated provisions of the TRIPS Agreement is compulsory licensing, its meaning, purpose and application. Article 31 of the TRIPS Agreement, read along with the Paris Convention and Doha Declaration on Public Health and the August 2003 Waiver Decision of the WTO (concerning the para 6 mechanism) largely govern the international legal regime concerning ‘use without authorization’ of the right holder. Although not specifically worded, it includes compulsory licenses in the public interest as a judicial remedy and for government use of patented inventions. It is also worth mentioning here that many countries have historically allowed ‘use without authorization’ within their patent laws - for causing general inconvenience, affecting trade, unreasonable prices or for nonlocal ‘working’ among other reasons – or under the competition law regime – for abuse of patent rights which may be price related or otherwise. However TRIPS does not specify grounds for the issue of compulsory licenses but does prescribe conditions for grant and use. The WTO members are left with considerable leeway in providing in their national laws grounds concerning compulsory licenses. Many developing countries have issued compulsory licenses in the post- TRIPS context primarily to address public health concerns.The study examines the pros and cons of compulsory licensing as a possible way for developing countries to overcome patent protection and in that way facilitate - among other things- access to drugs at affordable prices especially in the backdrop of the pandemic. The hypothesis “Compulsory licensing of essential drugs/vaccines in the backdrop of the COVID-19 pandemic will only backfire and cannot be a panacea to achieve the felt need of increasing production of essential drugs/vaccines to meet the surging demand “ is proved statistically. The paper concludes with the finding that the best course would be to embark on a path of voluntary licenses and that any exercise of statutory powers can only prove to be counter-productive at this stage.

Coronavirus, Compulsory Licensing, and Collaboration: Analyzing the 2020 Global Vaccine Response with 20/20 Hindsight

In December 2019, COVID-19, a novel strain of the SARS-2 Virus, appeared in Wuhan, China. Within a year, over ninety million people had been infected and two million had died. Amid all the death and desolation, humanity’s ingenuity and willpower emerged in history’s greatest vaccine race. The global community sought to find novel ways to protect innovation and intellectual property while still collaborating to roll out a vaccine in record time. Despite the presence of compulsory licensing provisions like 28 U.S.C. § 1498 and the Bayh-Dole Act in the U.S., and the TRIPS Agreement at the international level, the journey has been difficult, and thousands died while international players protected proprietary information and ensured that their countries’ citizens are first in line for the vaccine. Although dubbed a “once in a lifetime pandemic,” the COVID-19 outbreak provides a unique opportunity to contemplate ways to unify the world through intellectual property during a time of crisis, as well as a grim portent of what will become the new norm if we do not. This Article examines the impact and effectiveness of intellectual property licensing provisions across the world to suggest improvements that might result in a quicker and more efficient response to future global health crises. By examining and learning from the plagues of the present, we might preserve the health of our future.

Examining the legality of abuse by failure to manufacture patents locally as a substantive condition for granting compulsory licences pursuant to the TRIPS Agreement

Examining the legality of abuse by failure to manufacture patents locally as a substantive condition for granting compulsory licences pursuant to the TRIPS Agreement

Examining the legality of abuse by failure to manufacture patents locally as a substantive condition for granting compulsory licences pursuant to the TRIPS Agreement

This article assesses whether abuse by failure to manufacture patents locally remains a valid condition for granting compulsory licences under TRIPS. The author examines Article 27(1) of TRIPS, which stipulates that patent rights shall be enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced, and Article 5(A)(2) of the Paris Convention, which recognises failure to manufacture locally as an example of the abuse of patent rights, and argues that the former is incorporated into Article 2 of TRIPS, thus validating the same as a condition for granting compulsory licences under TRIPS. This argument rests on the notion that India has used Section 84(1) of its TRIPS-compliant Patent Act, related to a requirement that patented inventions be manufactured locally, as a condition for granting a compulsory licence to Natco, and this decision remains unchallenged within the WTO DSU system.

The WTO TRIPS Agreement and Global Health Progress

The WTO TRIPS Agreement and Global Health Progress

Trade-Related Aspects of Intellectual Property Rights Waiver at the World Trade Organization: A BIT of a Challenge

To augment the global production and distribution of Covid-19 medical products such as vaccines, drugs and other therapeutics, countries are negotiating for temporarily waiving certain provisions of the TRIPS agreement at the WTO. Depending on the conditions that would govern the waiver, countries would amend their domestic intellectual property (IP) laws to effectively implement the waiver. While the waiver would provide immunity to IP-related regulatory measures from legal claims at the WTO, multinational pharmaceutical companies can use the investor-State dispute settlement (ISDS) mechanism under bilateral investment treaties (BITs) to challenge such IP-related regulatory measures. In case of such a challenge to IP-related regulatory measures, will the host State be able to defend these measures? The paper answers this question by dividing the investment treaty practice into those BITs that contain carve-out for IP and those that don’t. The former set of treaties provides greater regulatory autonomy to implement the TRIPS waiver. However, given the fragmented and incoherent nature of the ISDS mechanism, the final outcome would depend on arbitral discretion.

Technological Self-Sufficiency and the Role of Novelty Traps

The COVID pandemic has demonstrated the tragic consequences of technological dependency. Unable to manufacture vaccines for themselves, developing countries must rely on obtaining supplies from other nations. While strong arguments have been made to waive international obligations under the TRIPS Agreement to permit these countries to freely use of COVID-related patented inventions, it is not clear that this move would produce sufficient vaccine to meet global demand. Considerable scholarship has been devoted to the question of how to help these countries reach the technological frontier and become technologically independent. In this paper, we identify a novel source of their problem: a structural feature of modern patent law traps technologies in a legal limbo, where there are inadequate incentives to invest in the adaptations and efforts needed to make technologies effectively available in low-income countries. Moreover, the current regime deprives potential innovators of an opportunity to protect their intellectual contributions and begin to build robust innovative ecosystems. The paper proposes a modified patent regime designed to break what we call the 'novelty trap' and discusses its compatibility with international intellectual property law.

INCORPORATING ARTICLE 31bis FLEXIBILITIES ON TRIPS PUBLIC HEALTH INTO DOMESTIC PATENT SYSTEM: THE INESCAPABLE WAY FORWARD FOR MALAYSIA

The purpose of this study is to highlight the absence of specific provisions on public health under Article 31bis of the TRIPS Agreement, that were not incorporated into the Patents Act 1983 in Malaysia. The main research question of this study is; why should Malaysia immediately amend its Patents Act 1983 to incorporate these flexibilities? Malaysia must develop effective strategies to implement policies, law and governance in managing the country’s public health system. This is to ensure a balance of rights between intellectual property owners and the public, at all times. This study employs a qualitative research methodology that is based on primary sources such as the TRIPS Agreement and the Patents Act 1983, and is further supported by secondary sources such as journals and the contents of authorities’ websites. This study is limited to the issues related to public health and patents. This study includes a discussion on the provisions related to patents and public health, proposed amendments to the Patents Act 1983 that should incorporate the provisions from Article 31bis, and a conclusion on the importance of immediately amending the Patent Act 1983 to incorporate these provisions, especially during the current Covid-19 pandemic. This study proposes that the amendments be made to Section 84 of the Patents Act 1983 in relation to Rights of Government, and not through the compulsory licence mechanism under Part X of the Patents Act 1983. Thus, this study concludes that currently, Malaysia is unable to implement the provisions under Article 31bis, unless the Patents Act 1983 is amended.

Comparative characteristics of trade secret in the legislation of foreign countries and in international law

The purpose of the article is to investigate the place of trade secrets in regulations, international treaties, foreign legislation, and key means of protecting trade secrets in accordance with these regulations. A comparative analysis of current norms and provisions of the system of legislation of foreign countries in terms of protection of trade secrets. An analysis is performed of international treaties and the legal framework of foreign countries, namely, the Paris Convention for the Protection of Industrial Property, the Stockholm Convention establishing the World Intellectual Property Organization of 1967 in terms of protection of trade secrets in order to improve national legislation in this area. It has been emphasized that the definition of trade secrets is similar in the Civil Code of Ukraine and in the TRIPS Agreement, which enshrines three criteria of trade secrets: secrecy, commercial value and taking adequate measures to ensure secrecy. It is noted that legal protection provides for and requires the owner of the commercial secrecy to take appropriate measures to ensure the protection of relevant information from unfair commercial use. Sometimes the misappropriation of a trade secret is the result of industrial espionage, when a person provides classified information to a competitor for monetary or other remuneration. The main provisions of the North American Free Trade Agreement (NAFTA) on trade secrets are analyzed in comparison with the EU legal system, according to which patent law provides additional incentives for the application of the commercial secrecy regime to protect confidential information. Four approaches to understanding this legal regime in the doctrine of Anglo-Saxon legal systems are analyzed: the theory of contractual obligation, the theory of fiduciary (trust) relations, the theory of misappropriation and the theory of unfair competition. It is concluded that the applied criteria for classifying information as a trade secret are similar, in relation to actions that are not appropriation of a trade secret, in particular, in relation to the ‘legalization’ of reverse development, which is relevant for the information technology industry. Ukraine has the prospect of including in its legislation an important legal act – the Law of Ukraine on Trade Secrets, which will have a positive impact on the business climate, promote investment attractiveness, and meet the needs of businesses and the state.

Kia Tāwharautia Te Mātauranga Māori: Decolonising the Intellectual Property Regime in Aotearoa New Zealand

This article explores ways to decolonise aspects of the intellectual property system in Aotearoa New Zealand, primarily in respect of trade marks. It considers the seminal Wai 262 report of the Waitangi Tribunal and builds upon its findings and recommendations, while also offering new ideas of legal reform for protecting mātauranga Māori (Māori knowledge and expertise) from undue exploitation. This article also measures those ideas against the objectives and principles of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as well as other internationally recognised rights. Essentially, this article maintains that for any mechanism to be effective in recognising and upholding the tino rangatiratanga (unqualified self-determination) of Māori over their own mātauranga, that mechanism must be founded upon the principles of tikanga Māori (Māori laws and customs), which is a notion crystallised within the Treaty of Waitangi/Te Tiriti o Waitangi. It must also find its own meaningful place in the law of New Zealand that surrounds us today. It is only in this way that the extractive and thereby oppressive binds of the western intellectual property regime can be unpicked and put aside and the tapu (high status and associated sanctity) of mātauranga can be upheld. These words are also an honouring of those who spent countless hours on the Wai 262 report. It is hoped this article gives new and much needed life to the issue of protecting mātauranga Māori, which is still as relevant today as it was then. Kei aku rangatira, kei aku tapaeru, kei aku whakaruakākā, tēnei e ngākau whakaiti nei (an acknowledgement of all those who took part in Wai 262).

Pengaturan Impor Paralel dalam Merek (Studi Perbandingan Hukum Indonesia, India dan New Zealand)

Parallel import is a concept for importing and reselling original products from distributors that are legally obtained from producers at lower prices rather than buying directly from producers. These products are placed on the market in one country with the approval from owner and imported to another country without the permission of the owner. Parallel imports are built on the principle of exhaustion of rights. Basically, there are three principles of exhaustion of rights, namely;the principle of international exhaustion of rights, domestic/national exhaustion of rights and regional exhaustion of rights. Based on the TRIPS agreement, each country is given the freedom to determine and regulate the principle of exhaustion of rights to be applied. The issue under discussion is how the parallel import regulation in brands according to Indonesia, Indian, and New Zealand laws what can be adopted in Indonesia law regarding parallel imports based on these comparisons. In this study, the writer used a normative research method. This research also uses legal comparison as part of its analysis with data collection techniques through literature study. Data analysis method used is descriptive qualitative method. The results of the study showed that Indonesia has no regulation regarding parallel imports. While in India and New Zealand there are related regulations. Regarding disputes settlement regarding parallel imports in Indonesia, civil law is adopted, in India with a judge's decision in accordance with existing regulations. What can be adopted by Indonesia in this case is to explicitly reinforce regulations regarding parallel imports in brands.

A Inconstitucionalidade do Artigo 40, Parágrafo Único, da Lei de Propriedade Industrial sob uma Perspectiva Comparada

The research discusses the constitutional aspects of Article 40, sole paragraph, of the Brazilian Industrial Property Law (LPI, from its acronym in Portuguese). This institute establishes a minimum protection period for invention patents, and the Brazilian Supreme Court is now examining its constitutionality in Direct Action for the Declaration of Unconstitutionality no. 5529. The research aims to understand where this Brazilian provision is within the international landscape. For this purpose, the study compares Brazilian law and data on granting pharmaceutical and non-pharmaceutical invention patents for the period between 2010 and 2019 to intellectual property laws and patent granting in twenty-nine jurisdictions. In a nutshell, the research shows no match for Article 40, sole paragraph, of LPI in any other jurisdiction. Although a minority of the nations studied have mechanisms for additional patent protection, these are restricted to specific cases (e.g., for pharmaceutical products) and are guided by a diverse legal-economic rationale of reduced application, which is subject to certain exceptions and limitations. Therefore, one cannot correctly compare these provisions to the Brazilian one. These conclusions are corroborated by the empirical research results, which show that the minimum term institute is responsible for distortions that extend the duration of patents registered in Brazil beyond the deadlines established by the TRIPS Agreement or by the practices adopted by the international community. Finally, the research provides the Brazilian Supreme Court factual and robust material to decide for the unconstitutionality of Article 40, sole paragraph, of LPI. This decision could be an adequate measure to stimulate Brazilian scientific-technological production, amplify access to healthcare by Brazilians, and, consequently, promote the country's socio-economic development.