Strong Intellectual Property Protection Research Articles

Making Use of Trips Flexibilities: Implementation and Diffusion of Compulsory Licensing Regimes in Brazil and India

As their economic clout increases, emerging powers are becoming policy-shapers in their own right. This chapter evaluates the ways in which emerging countries have made use of the flexibilities available under the TRIPS Agreement to espouse their social and economic concerns. We consider one of the most significant and controversial of these flexibilities: compulsory licensing as a tool for providing access to essential medicines. Our analysis focuses on India and Brazil as the two most vocal actors on the international scene opposing strong intellectual property (IP) protection. It compares Brazil and India’s patterns of domestic implementation so as to gain a more granular understanding of the law and practice of compulsory licensing in these countries. A further aim of the chapter is to determine whether coordination, learning or emulation has taken place between these countries. If it has, does it explain the diffusion of compulsory licensing practices and, if not, what has led to the particular implementation design chosen? The results are somewhat puzzling, but all the more interesting as they reveal that India and Brazil, despite their shared IP strategies at the international level, have chosen different TRIPS implementation paths domestically. We find no evidence of coordination but of processes of learning and emulation taking place.

Intellectual Property Monopolies: Towards a New Mercantilism

The agreement on the Trade-Related Aspects of Intellectual Property (TRIPs), signed within the GATT framework in 1994, set the international standards and objectives for the protection of intellectual property. Although the agreement was very favorable to western intellectual property oriented firms, the few concessions to developing countries, such as a ten-years delay to implement harsher intellectual property regulations, left some core country corporations dissatisfied. Indeed, as soon as the TRIPs agreement was signed, intellectual property firms, along with and via their respective states, started pushing for harsher intellectual property legislations in bilateral Free Trade Agreements, thus bypassing global regulations. Drawing from the debate on the state and globalization, as well as the question on the relation between intellectual property and capital accumulation, this paper exposes the new collusions between state and capital that rendered possible the emergence of strong intellectual property protection legislations virtually all over the globe, and proposes to interpret that evolution as a signal telling of the new functioning of the world economy. The author makes the case that one can define the current IP regime as a mercantilist system in which states, far from losing power against the growing internationalization of economic regulations, put their capacities in service of “their” IP-intensive corporations. In conclusion, the author suggests a further research agenda in which intellectual property issues can provide a window into our understanding of current trends in the workings of the world economy.

Making use of TRIPS flexibilities: Implementation and diffusion of compulsory licensing regimes in Brazil and India

As their economic clout increases, emerging powers are becoming policy-shapers in their own right. This chapter evaluates the ways in which emerging countries have made use of the flexibilities available under the TRIPS Agreement to espouse their social and economic concerns. We consider one of the most significant and controversial of these flexibilities: compulsory licensing as a tool for providing access to essential medicines. Our analysis focuses on India and Brazil as the two most vocal actors on the international scene opposing strong intellectual property (IP) protection. It compares Brazil and India’s patterns of domestic implementation so as to gain a more granular understanding of the law and practice of compulsory licensing in these countries. A further aim of the chapter is to determine whether coordination, learning or emulation has taken place between these countries. If it has, does it explain the diffusion of compulsory licensing practices and, if not, what has led to the particular implementation design chosen? The results are somewhat puzzling, but all the more interesting as they reveal that India and Brazil, despite their shared IP strategies at the international level, have chosen different TRIPS implementation paths domestically. We find no evidence of coordination but of processes of learning and emulation taking place.

Accordo trips, brevetti e resistenze interne in India: uno scenario frastagliato

This paper deals with the “difficult relationship” between India and pharmaceutical patents. Throughout the article, the strictly juridical dimension of the problem is let on the background. The aim is to highlight the multifarious, complex and stratified reasons of Indian resistance towards a strong intellectual property protection for medicines. The roots of said behavior go from cultural motives to pharmaceutical industries’ unfair practices, from sanitarian and humanitarian aspects to the peculiar social and economic Indian situation.

Intellectual Property and Consolidation in the Seed Industry

ABSTRACTIntellectual property protections on seeds have increased dramatically in recent decades, from the granting of patent‐like protections on certain types of seeds in 1970 to the enforcement of contract provisions for seeds beyond the first sale in 2013. During this same period, the seed industry has experienced rapid consolidation. Although as recently as the 1970s, it was characterized by thousands of small, mostly family‐owned business, by 2011, just three agrochemical firms controlled more than half of the global proprietary seed market. These trends have resulted in rapidly increasing prices for commodity seeds and reduced farmers' ability to save seeds. Given these important negative impacts, why do these trends continue? Expanding intellectual property protections and reducing the number of competitors are strategies that the largest firms understandably employ to increase their power but government support has also been essential to their success. Policy changes have reduced the enforcement of antitrust laws and increased the enforcement of alleged intellectual property infringements. In addition, synergies between stronger intellectual property protections and consolidation have further reinforced the dominance of top firms at the expense of a freely competitive industry. A better understanding of these trends is unlikely to reverse them in the near term but may increase the effectiveness of creating alternatives to a seed oligopoly.

When to Sell Your Idea: Theory and Evidence from the Movie Industry

I study a model of investment and sale of ideas and test its empirical implications using a novel data set from the market for original movie ideas. Consistent with the theoretical results, I find that buyers are reluctant to meet unproven sellers for early-stage ideas, which restricts sellers to either developing the ideas fully (to sell them later) or abandoning them. In contrast, experienced sellers can attract buyers at any stage, and they sell worse ideas sooner and better ideas later. These results have important managerial implications for buyers and sellers and show that, in such contexts, policy interventions that discourage buyer participation—such as stronger intellectual property protection—may diminish the market for ideas and hurt inexperienced sellers. This paper was accepted by Bruno Cassiman, business strategy.

Intellectual Property Rights Vis-A Vis Right to Health: A Critique

Health is a fundamental human right indispensable for the exercise of other human rights. The Article 25 of the Universal Declaration of Human Rights, 1948 mentioned health as part of the right to an adequate standard of living. The International Covenants, Treaties relating to human rights and the Constitutions of various nations recognize that a number of elements would be encompassed by the right to health from prevention to cure to access to drugs. However, health trends indicate that despite progress made in the last 35 years, millions of the people in the developing countries do not have access to the medicines which are required for treating diseases. One of the significant reasons for the lack of access of essential medicines required for needed treatment is the high prices fixed for those drugs. Strong intellectual property protection keeps prices inflated up to one hundred times the cost of manufacture of drugs. Monopolies are created by patents and they restrict competition in pharmaceutical market and permit patentee to set up high prices. It clearly indicates that the linkage between intellectual property rights and health has been the focus of much debate. Much initiative has been taken by World Intellectual Property Organization, World Trade Organization (WHO) and World Health Organization (WTO) through Trade-Related Aspects of Intellectual Property Rights Agreements (TRIPS), Doha Declaration and then the 30 August 2003 Compulsory License Import Export mechanism for providing safeguards to remedy the patent abuse, giving primacy to the public health over private intellectual property and also clarifying the WTO members States’ rights for using TRIPS safeguards. However, such measures failed to resolve the terrific issue ensuring production and export of generic medicines to developing countries that were incapable to produce them and also certain concepts remained un-clarified demanding clear guidelines to be issued in this respect at the international level for removing various types of controversies which still arise between developed and developing member States. Moreover, the intellectual property rules in TRIPS have been observed to be considerably less stringent than the rules developing countries are increasingly adopting in free-trade agreements known as "TRIPS-plus" agreements with the United States and other Western Governments which put greater restrictions on the use of TRIPS flexibilities like, compulsory licensing and parallel imports making it much more difficult for generic drugs to enter the market upon patent expiration and then extend patent periods beyond twenty years. Consequently, the developing countries that attempt to bring the price of the medicines down have to come under pressure from the industrialized countries and multi-national pharmaceutical industry for implementing patent legislation that goes beyond the obligations of TRIPS. However, in India Glivec case is remarkable because the judgment has a positive impact on affordability and accessibility of medicines. Now, it will be more difficult to indulge in ever-greening in India.This paper attempts to analyze critically at the global and national level two bodies of law, human right to health and intellectual property rights in order to examine certain core issues such as how despite the interactions concluded between both the bodies of law at the international level, the monopoly right conferred via intellectual property legislations transgresses the right to health particularly right to access to drug through the practice of ever-greening and threat of trade sanctions or corporate litigation from both pharmaceutical companies and developed countries. Further this paper aims to study various cases of external pressures put upon the developing countries from the side of developed nations in order to stop the entry of competitive generic medicines in the global market in the context of Indian landmark judgment and then to suggest various measures such as: making coherent, consistent and balanced legal norms at international level clarifying different concepts and issuing clearly stringent and mandatory guidelines/regulations in TRIPS providing a place of supremacy to fundamental right to health over intellectual property right; establishing high patentability standards at international level; developing Publicly funded research or pharmaceutical subsidies as well as creating policies to relax patents and increase the affordability of generic anti-retroviral through coordinated effort of global system. In order to achieve this objective, the doctrinal research is done by studying various Reports, Declarations, and Conventions of United Nations Organization and its different specialized agencies like; World Intellectual Property Organization, World Health Organization and World Trade Organization, free trade treaties among different nations as well as various other relevant national statutory enactments. The important works of a number of jurists contributing towards this field has also been the material of study.

Employment growth heterogeneity under varying intellectual property rights regimes in European transition economies: Young vs. mature innovators

Young innovative companies are supposed to be key drivers of sustainable economic growth. This study examines the employment growth of young, small innovative firms (denoted as innovative youngsters) and contrasts it with the employment growth of established ‘mature innovators’ in 23 European transition economies, where varying degrees of intellectual property protection apply. The growth figures of the two firm groups vary significantly across different intellectual property rights (IPR) regimes. Innovative youngsters seem to benefit from strong intellectual property protection, while mature innovators exhibit the highest employment growth rates when IPRs are rather weak. These findings point to important undiscovered differences in employment growth patterns, which might explain some of the ambiguous results of former research on IPRs, and provide a reason why certain countries might benefit from strong IPRs while others might not.

International and domestic dynamics of intellectual property protection

I examine the variation in the extent of intellectual property (IP) protection across countries. Combining insights from the ‘old’ and ‘new’ institutional perspectives, I argue that global pressures stemming from commitments to the World Trade Organization influence IP protection, but countries differ in their sensitivity to external pressures due to differences in domestic characteristics. The presence of a domestic interest group positively moderates the relationship between WTO commitment and stronger IP protection while domestic public health concerns negatively moderates this relationship. Data on IP protection for 65 countries during the period 1995–2006 provide support for the hypotheses.

Public Health and the Trans-Pacific Partnership Agreement

The Trans-Pacific Partnership Agreement (TPP) has an ambitious agenda and could radically reshape trade in the Asia-Pacific. At the same time, TPP obligations have the potential to significantly restrict the ability of governments to regulate in the interests of public health. This paper examines the impact the TPP could have on two areas of public health regulation—tobacco control and access to medicines. It concludes that a number of legitimate concerns arise from the known content of the TPP, that the inclusion of a general health exception would be the preferable means of safeguarding the regulatory space of governments in relation to public health, and that the United States’ proposals for stronger intellectual property protections be resisted. With negotiations shrouded in secrecy, TPP parties’ desires to promote international trade and investment must not overshadow the need of governments to be able to implement sensible and effective public health policy.

Role of Intellectual Property Protection on the Economy

This paper discusses the role played by the protection of intellectual property rights on the economy of the country as a whole. It takes examples of the weak and strong intellectual property protection countries to come to the conclusion as what is the optimum level of protection a country should implement to generate maximum economic benefit from the Intellectual Properties protected by it, so that it serves the need of the people without hindering the rights of the intellectual property owners.

Intellectual Property Protection for Brand Jamaica's Creative Industries

Since the last decade, strategies employed by governments to manage their country brands have evolved beyond tourism marketing techniques. It is quite commonplace now for most governments to hire marketing specialists to design and implement county brand campaigns and policies to promote country brands globally to attract foreign direct investment into that country. Whether it is the arts-based “creative industry” or an “enterprise culture”, these features have evolved to become the drivers of profit in global markets, and give each nation a “competitive edge” over other nations in regards to their national brand. Country brand management is integral for the successful development of industry sectors and is also dependent on good country image. For Brand Jamaica one such industry is the creative industries sector. Brand Jamaica’s creative industries are mostly comprised of the branded tourism accommodations, atmosphere, heritage and culture as well as the indigenous music and recordings of local artistes and singers. For the development of this sector which currently contributes to Jamaica GDP it is interpreted that enforced intellectual property will play a key role especially in the promoting of the brand online. Good management of country brands creative industries involves good business acumen on protecting and developing that sector as it is vital towards translating the intangible wealth of developing countries into economic growth. Enforced intellectual property protection for Brand Jamaica’s music, arts, theatrical productions and creative expressions ultimately lessen the occurrence of infringements of the brand’s assets, piracy and production of counterfeit goods and services produces, while creating future possibilities in cyberspace. Purpose – as a source of unlimited supply of intellectual property, Brand Jamaica requires formal management of those assets especially in the creative industries sector that the brand is globally known for. This research seeks to uncover the extent to which intellectual property protection is important for the social and economic development of Brand Jamaica’s creative industries. Design/methodology/approach – first, it presents a theoretical analysis of scientific literature and monographs on good country brand management and country brand property, as well as the objects of intellectual property that are applicable to good country brand management pursuant to the research. Secondly, the official web page of the World Intellectual Property Office comprising many articles regarding the Economics of Intellectual Property was referenced for this research. New data from survey questionnaires are presented and will test the hypotheses raised. The hypotheses raised explore the influencers that create value for country brands with strong intellectual property rights legislation. From that perception, two hypotheses are made: H1: Trademarks, industrial designs, copyrights and other objects of intellectual property protect Brand Jamaica. H2: Trademarks, industrial designs, copyrights and other objects of intellectual property protection create value for Brand Jamaica. Findings – enforced intellectual property rights indeed create possibilities for country brands, such as Brand Jamaica. This protection is enormous, especially in cyberspace as a branded e-commerce website portal. A branded website portal is ideal for online forums and building brand awareness necessary for its promotion. The findings further indicate that there is a direct relationship between country brand value and intellectual property protection. Research Limitations/Implications – current intellectual property protection is not actively enforced for Brand Jamaica since the right to copyright and trademark the brand by its governing state Jamaica, are withheld by the Paris Convention; as a result the resources needed to protect brand Jamaica against infringement are absent, and consequently the exploitation of the brand’s intellectual property continues. Practical Implications – strong intellectual property protection that generates equity for country brands is the main implication, although the extent to which Brand Jamaica is managed cannot be compared with other country brands of developed countries, where country brand management is undertaken at the national level. Originality/Value – the work is useful for developing countries’ country brand managers faced with the task of marketing country brands without enforced intellectual property legislation and assessing those country brands in order to manage them effectively. Research Type: Research paper, case study, opinion view.

The dynamic state of patents in regenerative medicine

Regenerative cell medicine will change the way the medical community treats disease but the legal framework necessary to encourage development and commercialization of these revolutionary therapies remains uncertain. Although strong intellectual property protection is needed to provide an incentive to undergo the rigorous regulatory scrutiny required to bring regenerative cell therapies to market, concerns over the ability to protect technologies that may be viewed as contrary to public morality or that utilize known cell populations in previously unknown ways continues to stifle investment and commercial development. The legal hurdles facing investigators, clinicians, and entrepreneurs in this rapidly developing field were discussed on March 27, 2013, at the Strategic Forum Panel Discussion on Intellectual Property held at the Stem Cell and Regenerative Medicine Global Congress 2013 in Seoul Korea. Panel Moderator Byung Hyune Choi (GSRAC) presented a series of questions to spark the discussion, and panelists, Jae Sik Choi (Korea Institute of Intellectual Property), Soon-Woong Kim (JungJin Intellectual Property Law firm), Hyojin Lee (Korean Intellectual Property Office) and I, sought to guide the audience through the global legal uncertainty facing the field of regenerative cell medicine today.

Intellectual Property and Human Rights: A Conceptual Analysis in the Light of Developing Countries

This paper examines some competing legal frameworks that governments, NGOs, and intergovernmental organizations are using to conceptualize the intersection of human rights and intellectual property. Among the two approaches examined, the first approach views the two areas of law as in fundamental conflict, with strong intellectual property protection standards in particular those of the TRIPS Agreement undermining a broad spectrum of human rights. The second approach sees both areas of law as concerned with the same basic question .This paper aims to critically analyze different provisions of the intellectual property and to search for the implications of them for the developing countries in line with the Human right. Finally an attempt is made to explore ways and means in mitigating or addressing the problems arising out of the TRIPS which are peculiar to the developing countries.

The Location of Overseas Research and Development and Intellectual Property Protection

Do multinationals distinguish between locations on the basis of the local intellectual property laws, in conducting their overseas research and development? We seek to address this question using data on US multinationals spanning the period 1977–2004. Particular care is taken to capture the host location enforcement environment of intellectual property protection. For our sample and time frame, we find that stronger intellectual property protection is not important in determining overseas research and development by these multinationals. The results are robust to disaggregation of the protection measure into its component indices, as well as to disaggregation of overseas research and development by industry. Instead, host country market size and human capital resources are found to be consistently important in explaining the location of overseas research and development.

Targeted Blood-to-Brain Drug Delivery – 10 Key Development Criteria

Drug delivery to the brain remains challenging due to the presence of the blood-brain barrier. In this review, 10 key development criteria are presented that are important for successful drug development to treat CNS diseases by targeted drug delivery systems. Although several routes of delivery are being investigated, such as intranasal delivery, direct injections into the brain or CSF, and transient opening of the blood-brain barrier, the focus of this review is on physiological strategies aiming to target endogenous transport mechanisms. Examples from literature, focusing on targeted drug delivery systems that are being commercially developed, will be discussed to illustrate the 10 key development criteria. The first four criteria apply to the targeting of the blood-brain barrier: (1) a proven inherently safe receptor biology, (2) a safe and human applicable ligand, (3) receptor specific binding, and (4) applicable for acute and chronic indications. Next to an efficient and safe targeting strategy, as captured in key criteria 1 to 4, a favorable pharmacokinetic profile is also important (key criterion 5). With regard to the drug carriers, two criteria are important: (6) no modification of active ingredient and (7) able to carry various classes of molecules. The final three criteria apply to the development of a drug from lab to clinic: (8) low costs and straightforward manufacturing, (9) activity in all animal models, and (10) strong intellectual property (IP) protection. Adhering to these 10 key development criteria will allow for a successful brain drug development.

An overview of intellectual property rights in relation to agricultural biotechnology

The majority of the population in developing nations depends on agriculture. Agricultural biotechnology involves genetic modification and promises a number of important benefits, such as improving agricultural yields by increasing the resistance of crops to pests and facilitating them to flourish in harsh natural environments, improving the productivity of crops, and reducing pesticide use. Also, concerns have been raised about the potential negative impacts of genetic modification. To promote research and development in agricultural biotechnology, intellectual property rights (IPRs) are one of the primary tools. Based on the fact that high investment is required to develop new genetically modified (GM) technologies and products, stronger intellectual property protection is necessary to stimulate research and to allow recovery of investment. As international rules increasingly raise the level of intellectual property protection, there is rising concern about the potential negative impacts on the dissemination of knowledge and important products, further Research and Development, food security, and the conservation of biodiversity among other fundamental areas of public policy. It is thus an important policy challenge to determine application of laws, rules and legislations to agricultural biotechnology. IPRs are woven into innovations, enable entrepreneurship and they allow the leveraging of private resources for resolving the problems of hunger and poverty. Keywords: Biotechnology, intellectual property rights, patents, genetic modification

Introducing yesterday‘s phage Therapy in today‘s Medicine

The worldwide emergence of ‘superbugs’ and a dry antibiotic pipeline threaten modern society with a return to the preantibiotic era. Phages – the viruses of bacteria – could help fight antibiotic-resistant bacteria. Phage therapy was first attempted in 1919 by Felix d’Herelle and was commercially developed in the 1930s before being replaced by antibiotics in most of the western world. The current antibiotic crisis fueled a worldwide renaissance of phage therapy. The inherent potential of phages as natural biological bacterium controllers can only be put to use if the potential of the coevolutionary aspect of the couplet phage–bacterium is fully acknowledged and understood, including potential negative consequences. We must learn from past mistakes and set up credible studies to gather the urgently required data with regard to the efficacy of phage therapy and the evolutionary consequences of its (unlimited) use. Unfortunately, our current pharmaceutical economic model, implying costly and time-consuming medicinal product development and marketing, and requiring strong intellectual property protection, is not compatible with traditional sustainable phage therapy. A specific framework with realistic production and documentation requirements, which allows a timely (rapid) supply of safe, tailor-made, natural bacteriophages to patients, should be developed. Ultimately, economic models should be radically reshaped to cater for more sustainable approaches such as phage therapy. This is one of the biggest challenges faced by modern medicine and society as a whole.

Trademark and Copyright Enforcement in the Shadow of IP Law

In recent years, as Congress has created new intellectual property (IP) rights and courts have often interpreted those rights broadly, legal scholars have frequently decried the expanded scope of protection afforded IP owners in most substantive areas of IP law. According to this critique, the over-expansion of IP rights throughout the past two decades harms competition, chills free speech, and diminishes the public domain as increasingly broad areas of social life are brought within the scope of strong IP protection. While this over-expansion theory reflects an important — indeed, foundational — policy debate concerning the proper balance between IP owners’ rights and the public’s rights of access to the information, ideas, and expressions that IP protects, it is incomplete because it focuses largely on what Congress or the courts do. In reality, most enforcement of IP rights takes place not in court, but in the everyday practices of IP owners and their lawyers. “Cease and desist” letters, phone calls, and negotiations with alleged infringers constitute the bulk of IP enforcement efforts in trademark and copyright practice. To be sure, these efforts take place in the “shadow” of IP law and are therefore influenced by it. But it is in these everyday practices — and not in trial or appellate courts — that most IP rights are asserted, resisted, and negotiated. Thus, if we want to know whether IP rights are over-enforced or over-extended, we need to know how, why, and to what effect these rights are exercised in the everyday practices of IP owners and their lawyers. To date, however, IP scholarship has focused virtually no attention on this critical arena of everyday practice. This Article presents findings from a qualitative empirical study of the trademark and copyright disputing process outside of court, based on original data derived from semi-structured interviews with experienced IP attorneys who advise clients on how to enforce their rights. This research is one of the first studies to examine how trademark and copyright claims are actually enforced in practice. One significant finding from this study is that “repeat player” trademark and copyright owners (and their lawyers) knowingly assert weak IP claims at times — precisely because it works, as enforcement targets are unable or unwilling to resist claims that may lack legal merit due to the costs and uncertainties of threatened litigation. Moreover, the lawyers who assert weak IP claims have ready practical and ethical justifications for their actions. This study also suggests that legal sanctions directed at deterring over-reaching IP enforcement are unlikely to be effective because most such over-reaching occurs in informal disputing processes outside of the legal system.

Intellectual property and Freedom To Operate in the flax breeding world: Canada in the global context

Through one-on-one in-depth interviews of Canadian public sector flax breeders, this study explores issues around Intellectual Property (IP) and Freedom To Operate (FTP) in flax breeding from a Canadian perspective. The results are supported by a scan of flax breeding efforts worldwide, an in-depth patent analysis (using Patent Lens and the US Patent and Trademark Office (USPTO) databases) and a review of varietal registrations (via the International Union for Protection of New Varieties of Plants (UPOV) Variety Registration database) for countryby-country applications to national listings and Plant Breeders Rights (PBRs). The results suggest that while stronger Intellectual Property Rights (IPRs) seem to hamper research in some crops, flax breeding – overall – has not witnessed the negative effects of stronger IP protection. Relative to other crops, flax production worldwide is small. The flax breeding industry itself is represented primarily by public research institutions with only a few small private companies operating in this area worldwide. Given the significant involvement of the public sector and the limited use of biotechnology, the flax IP landscape is not as complex as that of other oil crops such as canola and soybeans.