Use Of Compulsory Licensing Research Articles

Advancing Global Pharmacoequity in Oncology.

Limited availability and affordability of cancer drugs contribute to staggering disparities in cancer survival between high-income and low- and middle-income countries (LMICs). As infrastructure for cancer care rapidly develops, there is an urgent need to reduce prices and improve access to cancer medicines in LMICs to advance pharmacoequity globally. Prior strategies to expand access to cancer medicines in LMICs have primarily relied on charity or differential pricing and have yielded limited results. Policymakers at the World Health Assembly recently proposed several strategies to increase global access to cancer drugs. Reviewing empirical data and lessons learned from medication access programs for HIV, COVID-19, and other infectious diseases, 3 strategies that multilateral organizations can use to reduce prices of cancer drugs in LMICs are discussed herein. These include (1) building regional technology transfer and manufacturing hubs, (2) expanding and streamlining use of compulsory licenses, and (3) implementing global standards for drug price transparency. Counterpoints to the critiques of these policies are critiqued and how programs can use these strategies to build on existing disease-centered initiatives is discussed. Lessons learned from the global response to HIV and COVID-19 show that international collaboration and support from the World Health and Trade Organizations can ensure a unified, coordinated agenda for advancing access to care in LMICs. Building on these lessons and implementing similar approaches for cancer drugs can play a critical role in expanding accessibility and affordability of cancer medicines in LMICs. With a growing burden of cancer morbidity and mortality in LMICs, redoubled efforts to deliver essential cancer medications to LMICs would have an immense impact on global cancer control and achieving the United Nations Sustainable Development Goals.

Compulsory Licensing During Pandemic Times: Possible Lessons From the Efavirenz Case

During the Covid-19 pandemic, partnerships between Brazilian laboratories and international companies were impor tant for the local production of the vaccine, due to the necessity to find an effective measure to preserve public health. However, it is necessary to investigate these partnerships beyond their benefits in order to understand their implications. Compulsory licensing consists of an exception to the transfer of technology contracts to guarantee the Brazilian’s population access to the vaccine and possible new drugs developed against Covid-19. Compulsory licensing has already been implemented in Brazil. In 2007, it was used by the federal government to solve the problem of access to efavirenz, an antiretroviral needed in the treatment of HIV/AIDS. Considering the similarities between the epidemics, this article aimed to answer, through empirical analysis, what the efavirenz case reveals about the legaleconomic process of patent exclusivity and the use of compulsory licensing during times of pandemic crises, such as the one of Covid-19. Based on the analysis of the bureaucratic process applied to the Efavirenz case, it was possible to infer that the compulsory license should have been executed by the Brazilian government to guarantee access to medical products during national emergencies.

Intellectual Property Rights Issues in Indian Pharmaceutical Industry

Historically, India has neglected, and even made a farce of, pharmaceutical patents. In fact, it was not until 2005 that India offered patent protections for pharmaceutical companies at all. This has led to abuses of the compulsory licensing agreement with the World Trade Organisation, and has led to major criticisms of other global pharmaceutical companies like Pfizer, Roche, and Bayer. According to these companies, India’s generic drug manufacturing industry is destroying R&D funding and future innovation. This is because the companies which invented the brand name drugs are not receiving royalties; and therefore, losing out on profit, a lot of which would have been put back into R&D. While the World Trade Organisation under the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement (Doha Declaration) has provided for the use of compulsory licenses (temporary patent rights for life-saving pharmaceuticals), recently India has been more lenient in its use of this stipulation. In fact, the first use was in 2012 for Nexavar. Since then India has used the compulsory licensing provision at least five times. The total numbers of Indian Pharmaceutical Companies those who are having Research and Development facilities and also having Intellectual Property Rights for the past five years consecutively are take for this study.

Application of Compulsory Licensing in the Context of the Covid-19 Coronavirus Pandemic

The article reveals the features and legal grounds for the application of the mechanism of restriction of patent rights through compulsory licensing of inventions. The analysis of the legislation on the regulation of these relations is carried out. The EU experience in the use of compulsory licensing is analyzed and prospects for Ukraine are considered. Theoretical positions on the subject of research are analyzed. It is substantiated that in emergency situations the state should defend the public interests to the detriment of the interests of the patent owner and may apply a compulsory license. Compulsory licensing is a common practice and an important legal institution. The conditions and features of granting a compulsory license for objects of patent law in accordance with the provisions of Ukrainian legislation are revealed. The terms of the compulsory license are not based on the mutual consent of the licensor and the licensee but are determined by the competent state body. The correlation of the Ukrainian legislation with the international obligations of Ukraine is investigated. Analysis of foreign sources shows that compulsory licensing is one of the effective mechanisms for reaching a compromise between the public interests and the patent owner. The paper confirms the expediency of shifting the balance of interests from the patent owner to society in the context of the COVID-19 pandemic. Recommendations for improving Ukrainian legislation are provided.

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.

The Right to Repair: Patent Law and 3D Printing in Australia

Considering recent litigation in the Australian courts, and an inquiry by the Productivity Commission, this paper calls for patent law reform in respect of the right to repair in Australia. It provides an evaluation of the decision of the Full Court of the Federal Court in Calidad Pty Ltd v Seiko Epson Corporation [2019] FCAFC 115 – as well as the High Court of Australia consideration of the matter in Calidad Pty Ltd v Seiko Epson Corporation [2020] HCA 41. It highlights the divergence between the layers of the Australian legal system on the topic of patent law – between the judicial approach of the Federal Court of Australia and the Full Court of the Federal Court of Australia, and the endorsement of the patent exhaustion doctrine by the majority of the High Court of Australia. In light of this litigation, this paper reviews the policy approach taken by the Productivity Commission in respect of patent law, the right to repair, consumer rights, and competition policy. After the considering the findings of the Productivity Commission, it is recommended that there is a need to provide for greater recognition of the right to repair under patent law. It also calls for the use of compulsory licensing, crown use, competition oversight, and consumer law protection to reinforce the right to repair under patent law. In the spirit of modernising Australia’s regime, this paper makes a number of recommendations for patent law reform – particularly in light of 3D printing, additive manufacturing, and digital fabrication. It calls upon the legal system to embody some of the ideals, which have been embedded in the Maker’s Bill of Rights, and the iFixit Repair Manifesto. The larger argument of the paper is that there needs to be a common approach to the right to repair across the various domains of intellectual property – rather than the current fragmentary treatment of the topic.

Why a COVID IP Waiver Is not a Good Strategy

The COVID-19 pandemic has a profound influence on all aspects of society. The development of successful vaccines in record speed is almost a miracle. But despite the successful development and approval of multiple vaccines, many people still die of this terrible disease, and there is an urgent need to see more vaccines manufactured and distributed across the globe. The proposed COVID-19 IP waiver has been touted by some to be the perfect solution to a terrible problem. We all agree that there is a terrible problem of insufficient vaccines to inoculate the world population. An IP waiver is not a good strategy however, to tackle this crisis. There are multiple more effective solution conceivable which do not require a very disruptive IP waiver. The problem of insufficient supply is much more complicated than a simple IP waiver suggests. This is a complex ecosystem, and there are many moving parts. Moreover, IP rights are only part of the problem relating to more supply of vaccine or therapeutics. In view of the complexities, it will probably take many months to negotiate any kind of IP waiver system that would be acceptable to all WTO member states, if consensus could be reached at all. And the end result is likely to satisfy very few if any countries. The legality of an IP waiver can be doubted, and it would require retro-active effect, a concept that should be extremely sparingly used. A multitude of complex issues needs to be sorted out. There are hundreds of patents to navigate. A waiver to the equally patented vaccine platform technology (covering many patents), which may be used to develop any other vaccine, will make those companies who have invested heavily into developing it very nervous indeed, to say the least. Crucial manufacturing know-how is often not protected by IP rights, but is kept secret, and it will be difficult to force companies to disclose that information, also because one does not know what to ask for. The present IP waiver proposal also provides for a disclosure of commercially very sensitive information. Companies did not have a chance to adapt their regulatory disclosure strategies to this new reality, which means that information which will be disclosed under the waiver could very well have a major negative impact on future innovation strategies, and may also hamper competitive advantage or leverage. Market exclusivity is arguably not covered by the IP waiver, which means that separate national statutory intervention will be required to ensure that this market exclusivity is set aside, absent of which the IP waiver cannot have any practical effect. A quick and determined use of compulsory licensing could be a better way forward, as they have the potential to be a powerful tool. There are inefficiencies in using the instrument however, and invoking them when the need is high will require a relatively long lead time before they sort practical effect. They also require additional statutory intervention to ensure that regulatory exclusivities do not block their practical effect. And they might not necessarily work as well with low and middle-income countries, who would have less leverage in the negotiations. More efficient solutions can be arrived at by introducing hard clauses into contracts in the context of push and pull mechanisms. Those obligations are much more likely to result in more supply in the shorter to medium term if they are agreed upon long before the vaccine enters the market. It is obviously too late for the contracts that have been concluded in the past, but it should be a template for the future.

The People's Vaccine: Intellectual Property, Access to Essential Medicines, and the Coronavirus COVID-19

This paper explores intellectual property and access to essential medicines in the context of the coronavirus COVID-19 public health crisis. It considers policy solutions to counteract vaccine nationalism and profiteering by pharmaceutical companies and vaccine developers. This paper considers the campaign for the development of a People's Vaccine led by the People’s Vaccine Alliance, UNAIDS, Oxfam and Public Citizen. The WHO has established the ACT Accelerator in order to boost research, development, and deployment of COVID-19 technologies. However, the operation of COVAX thus far has been falling short of its original ambitions. The Medicines Patent Pool has expanded its jurisdiction to include the sharing of intellectual property related to COVID-19. Meanwhile, Costa Rica has proposed a COVID-19 Technology Access Pool – an idea for a new institutional structure which has been taken up by the WHO. In the context of the coronavirus public health crisis, there has also been discussion of the use of compulsory licensing and crown use to counteract profiteering and anti-competitive behavior. There has been a push by Universities Allied for Essential Medicines (UAEM) and others for the public licensing of COVID-19 technologies developed with government funding. The Open COVID Pledge has been taken by a number of intellectual property owners. In response to the assertion of proprietary rights in respect of COVID-19 technologies, the open movement has championed the development of Open Science models of science. India and South Africa have put forward a waiver proposal in the TRIPS Council to enable countries to take action in respect of COVID-19 without fear of retribution under trade laws. While the United States has been willing to support a TRIPS Waiver for vaccines, there remain a number of opponents to a TRIPS Waiver – including the European Union, Germany, Japan, and Switzerland. This paper makes the case that international intellectual property law should accommodate a People's Vaccine.

Compulsory Licensing V the IP Waiver: What Is the Best Way to End the COVID-19 Pandemic?

This policy brief examines the currently discussed proposals at the WTO that aim to resolve the problem of the production shortages of COVID-19 vaccines. This includes the two key submissions, i.e. the proposal by South Africa and India on the IP waiver, partially supported by the US, and the EU proposal to clarify the use of compulsory licensing. While each of these mechanisms may help to improve the production of COVID-19 vaccines to various degrees, there is intense debate about which of these proposals is the most effective. This policy brief outlines the strengths and weaknesses of each of them with a view to informing the policy decisions by WTO members on the best way to promptly accelerate the vaccine production that is urgently needed today. It concludes that the proposed IP waiver is a more effective solution for addressing the current emergency.

Improving Global Public Health: Responsiveness to Public Interest Considerations in Intellectual Property Law

Over the past few years the WTO Council for Trade-Related Aspects of Intellectual Property Rights recognized the growing concern over an imbalance between intellectual property and public interest. With regard to health technologies in particular, without sufficient use of balancing exceptions and limitations, patents and related monopoly rights primarily serve to protect corporate interests of the pharmaceutical industry. The broadest possible use of compulsory licenses is one of the essential measures that can contribute to increase in responsiveness to public interest considerations in defining the boundaries of the IP-related components that determine access to medicines. Another instrument is the process of interpretation and implementation of the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS), which aims not only at clarifying the meaning of the provisions or determining the intentions of the parties to this treaty, but sets sights on reconciling its competing objectives. The need to interpret and implement the TRIPS Agreement in a way that protects public interest is confirmed by the obligation of acting “in a manner conducive to social and economic welfare” under Article 7 of the Agreement. Moreover, Article 8 allows to 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”. Therefore, in the context of the problem of access to medicines, the important role of human rights as an instrument for the prevention of abuse of intellectual property rights and the restoration of their balance, taking into account the interests of both the beneficiaries of protection and the general public, should be emphasized.

Trips and the Globalisation of Patent Protection: A Comparative Analysis of the Effectiveness of Compulsory Licenses as a Tool for Improving Access to Cancer Medicines

Pharmaceutical patent protection under the TRIPS agreement has been a controversial subject, not least due to its impact on access to medicines. Flexibilities in the TRIPS agreement, such as compulsory licensing, allow countries to circumvent patent rights in order to facilitate access to medicines. Whilst compulsory licenses have been readily used for HIV/AIDS medicines, their use for cancer medicines is a relatively recent development. Furthermore, wealthier countries are increasingly attempting compulsory licenses to achieve affordable medicines. The purpose of this dissertation is to analyse the effectiveness of compulsory licenses as a tool for improving access to cancer medicines. The analysis will be conducted on the basis of empirical and doctrinal research, and in a comparative manner across countries of different income levels. This dissertation concludes that the effectiveness of compulsory licenses for improving access to cancer medicines is significantly hampered by economic, political and legal barriers. Whilst some of these factors predominantly affect poorer countries, they can potentially hamper the effectiveness of compulsory licenses in countries across all income levels. In light of these considerations, this paper suggests that a more effective strategy for improving access to cancer medicines may be the use of compulsory licenses as a negotiation tool to achieve price reductions on medicines, rather than the actual issuance of such licenses.

Importance of the intellectual property system in attempting compulsory licensing of pharmaceuticals: a cross-sectional analysis

BackgroundRecently, interest in compulsory licensing of pharmaceuticals has been growing regardless of a country’s income- level. We aim to investigate the use of compulsory licensing as a legitimate part of the patent system and tool for the government to utilize by demonstrating that countries with a mature patent system were more likely to utilize compulsory licensing of pharmaceuticals.MethodsWe used a multivariate logistic model to regress attempts to issue compulsory licensing on the characteristics of the intellectual property system, controlling for macro context variables and other explanatory variables at a country level.ResultsA total 139 countries, selected from members of the World Trade Organization, were divided into a CL-attempted group (N = 24) and a non-CL-attempted group (N = 115). An attempt to issue compulsory licensing was associated with population (+) and a dummy variable for other regions, including Europe and North America (−). After controlling for macro context variables, mature intellectual property system was positively associated with attempting compulsory licensing.ConclusionsOur study provided evidence of an association between attempting compulsory licensing and matured patent systems. This finding contradicts our current understanding of compulsory licensing, such as compulsory licensing as a measure to usurp traditional patent systems and sometimes diametrically opposed to the patent system. The findings also suggest a new role of compulsory licensing in current patent systems: compulsory licensing could be a potential alternative or complement to achieve access to medicines in health systems through manufacturing and exporting patented pharmaceuticals.

The potential synergies between industrial and health policies for access to medicines: insights from the Brazilian policy of universal access to HIV/AIDS treatment

ABSTRACTThe purpose of this study is to illustrate how industrial policy can support health policy through the construction of technological and innovation capabilities. This paper provides insights on this topic by examining the Brazilian ability to make patented antiretroviral (ARV) drugs universally accessible to people living with HIV/AIDS in the country. The Brazilian case study demonstrates the crucial role of industrial policy in making the use of compulsory licensing in price negotiations with pharmaceutical multinational corporations to improve the access to patented ARV drugs. The evidence presented in this paper supports that it is indeed possible to achieve synergies between industrial and health policy in order to improve the access to medicines and promote accumulation of technological capabilities in pharmaceuticals. Several policy instruments and initiatives, both horizontal and vertical, were implemented to support the industrial dimension of the successful Brazilian health strategy. These initiatives include direct support to capacity building, public procurement, and institutional changes. Furthermore, industrial policy initiatives can contribute to success of health programmes either immediately or with a time lag. Finally, the lessons learned from the Brazilian experience are re-specified and its relevance to other less developed countries, particularly those deprived of industrial capabilities, is discussed.

Access to hepatitis C virus treatment: Lessons from implementation of strategies for increasing access to antiretroviral treatment

At September’s 2017 United Nations General Assembly, a state-of-the-art HIV medicine was announced to be made available at just $75 per person per year. There have been a number of strategies that the global AIDS community and countries have utilized to reduce prices and make antiretrovirals (ARVs) accessible for people living with HIV/AIDS. There appears to be an opportunity for the treatment of hepatitis C virus infection using direct-acting antivirals (DAAs) to benefit from the often painful and laboured history of driving down the prices of ARVs. In general, the success of lowering prices for ARVs has stemmed from the politics needed to initially support generic entry into the on-patent market. The use of flexibilities present in the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have been used to overcome patent barriers, with the use of compulsory licenses and/or the threat of their use as instruments for strengthening the bargaining power in price negotiations.These strategies have been combined with new financing mechanisms that have promoted more effective procurement and price negotiations. Partnership among the different stakeholders has also been critical in this regard. Countries have also invested in their health systems and implemented several strategies to reduce stigma and discrimination to increase access to and improve utilization of ARVs. This article suggests that any future international initiatives to increase access to DAAs can learn from these lessons surrounding price reduction, improved financing, advocacy, as well as health systems strengthening and stigma reduction. Adopting and reconfiguring these strategies will also incur substantial savings in time, money and lives.

Broadening the conversation on the TRIPS agreement: Access to medicines includes addressing access to medical devices

Patent laws determine access to medicines and medical devices, and all members of the World Trade Organization (WTO) are obligated to introduce minimum standards of intellectual‐property protection into their national patent laws. In the negotiations that led up to the Trans‐Pacific Partnership Agreement (TPP), in 2016, the United States attempted to introduce patents for diagnostic, therapeutic, and surgical methods to promote the interests of its pharmaceutical and medical‐device industries. These attempts were unsuccessful; however, these actions demonstrate the determination of those who advocate for higher standards of intellectual‐property protection to push for a TRIPS‐plus agenda. The United States has sought to limit the use of flexibilities in the TRIPS Agreement, including the use of compulsory licenses which allows the generic industry to produce cheaper pharmaceuticals. Despite these US actions, many developing countries are becoming emboldened and are issuing compulsory licenses. The position of this paper is to show that, while access to pharmaceuticals and the ability to issue compulsory licenses is crucial to administering proper health care to people living in developing countries, medical devices are equally essential. Therefore, the conversation around access to medicines should be broadened to include access to medical devices in developing countries.

TRIPs Amendment and Public Health: How to Ensure Effective Usee of Compulsory Licensing?

Article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) was amended for the first time and a new Article (31bis) was introduced by inserting Article 31bis after Article 31 as a solution to a problem arising from Paragraph 6 of Doha Declaration which was related to the Public Health and TRIPs. Article 31(f) of the previous TRIPs text deals with the patented invention without the authorization of the patentee under Compulsory Licensing by the member country which clearly states “(f) any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use, which creates challenges for developing countries, especially for the Least Developed Countries which have minimum or no manufacturing capacity. In this context, this paper seeks to analyze some issues and considerations that have been elucidated through answering four key questions: Q1. What constitutes ‘effective use’ of compulsory licensing? Q2. What ‘difficulties’ did the affected countries face? Q3. Does the amendment to TRIPS overcome these difficulties? Q4. How can it be made to enable more effective use of compulsory licensing either (a) through revision or (b) through its practical implementation. In addition, the coverage and scope of the term ‘effective use’ have been identified in this paper. Finally, difficulties faced by developing countries in ensuring ‘effective use’ of compulsory licensing have also been discussed.

U.S. slams countries over weak patent protections

The Trump Administration is sharply criticizing India, China, Indonesia, and several other countries it says are not properly enforcing and protecting the intellectual property rights of U.S. drugmakers and other businesses. In a congressionally required annual report released in late April, the Office of the U.S. Trade Representative (USTR) placed 11 countries on a “priority watch list” for their perceived intellectual property rights abuses, such as failing to prevent the export of counterfeit drugs and inadequately enforcing patents. The report says nearly 90% of counterfeit medicines seized at the U.S. border in fiscal 2016 came from China, Hong Kong, India, and Singapore. USTR says U.S. pharmaceutical companies remain concerned about the potential threat posed to their intellectual property through the Indian government’s possible use of compulsory licensing, which allows local firms to override patents and make cheaper generic copies of brand-name drugs. The report singles out China for its “coercive”

Assessing the Potential Impact of Intellectual Property Standards in EU and US Bilateral Trade Agreements on Compulsory Licensing for Essential Medicines in West African States

∗ LLM University of East London; PhD candidate Queen Mary University of London; Law Lecturer, Centre for Intellectual Property and Energy Development, University of Hertfordshire. 1 The term ‘non-voluntary’ or ‘compulsory licensing’ refers to the practice by a government to authorise itself or third parties to use the subject matter of a patent without the authorisation of the right holder for reasons of public policy. See J. Reichman and C. Hasenzahl, ‘Non-Voluntary Licensing of Patented Inventions: Historical Perspective, Legal Framework under TRIPS, and an Overview of the Practice in Canada and the United States of America’, UNCTAD-ICTSD Project on IPRs and Sustainable Development Series, Issue Paper 5 (2003): 10. 2 J. Reichman, ‘Comment: Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options’, 37 Journal of Law, Medicine and Ethics 2 (2009): 250, claiming that a threat of compulsory licensing can rein in the prices of selected essential medicines. See M. Kremer, ‘Pharmaceuticals and the Developing World’, 16 The Journal of Economic Perspectives 4 (2009): 77, calling for the use of compulsory licensing of patents as a threat to lower prices in LDCs. See also M. Z. Abbas and S. Riaz, ‘Evolution of the Concept of Compulsory Licensing: A Critical Analysis of Key Developments Before and After TRIPS’, 4 The Academic Research International Journal 2 (2013): 494 explaining that compulsory licensing is an effective costcutting and access-assuring tool at the hands of developing countries and LDCs to obtain affordable medicines. 3 The Application for a Compulsory Licensing No. 1 of 2011 before the Controller General of Patents and the Order: Mumbai-India (Decision on 9 March 2012), available at http://www.ipindia.nic.in/iponew/compulsory_license_12032012.pdf (accessed 12 February 2014). See also The IPAB’s Decision (Order No. 45 of 2013) for further facts of the case (M.P. Nos 74 to 76 of 2012 & 108 of 2012 in OA/35/2012/PT/MUM, 14 September 2012, available at http://www.ipab.tn.nic.in/045–2013.htm (accessed 7 January 2015).

Reinventing Copyright and Patent

Intellectual property systems all over the world are modeled on the one-size-fits-all principle. However important or unimportant, inventions and original works of authorship receive the same scope of protection, for the same period, backed by the same variety of legal remedies. Metaphorically speaking, all intellectual property is equal under the law. This equality comes at a heavy price. The equality principle gives all creators access to the same remedies, even when those remedies create perverse incentives. Moreover, society overpays for innovation by inflicting on society more monopoly losses than are strictly necessary to incentivize production.In this Article, we propose a solution for these problems in the form of a self-tailored system of intellectual property rights. The self-tailored system would allow inventors and creators to self-select the optimal protection for their intellectual works. Working from the bottom up, our self-tailored system would give each innovator a basic package of intellectual property rights and enforcement powers and then allow her to add additional rights and legal elements in exchange for a fee.Our self-tailored system would reduce wasteful litigation while encouraging wider dissemination and more extensive use of inventions and expressive works. In addition, our proposal would lower the social cost of granting monopoly protection to intellectual goods while at the same time, maintaining an adequate level of economic incentives to create and invent. Accordingly, our self-tailored system would constitute a marked improvement over the extant one-size-fits all design of intellectual property rights.Unlike other proposals for reform that seek to improve access to expressive works and inventions via the use of compulsory licenses and other coercive policies, our model is purely voluntary. It respects authors’ and inventors’ autonomy and uses market mechanisms — specifically, pricing — to recalibrate our intellectual property system in a way that improves societal well-being.

Compulsory licensing of drug products in developing countries

Compulsory licensing of drug products is a very hot issue in today’s pharmaceutical world. Compulsory licensing of a drug product allows the government to issue the license of manufacturing the drug to a third person. The third person has to give some 5–10% royalty to the patent holder (the quantum of royalty is decided by the government and not by the patentee). The issue emerged after developing nations were given TRIPS flexibilities to implement the system when lives of large population are at stake. Compulsory licenses have been given in many countries like Thailand, Brazil, Mozambique, Zimbabwe, Zambia, Rwanda, Malaysia, Indonesia and recently India. India issued compulsory license over Bayer’s anticancer drug Naxaver (Sorafenib) to generic company Natco Pharma Ltd. United States has criticized the Indian decision. United States has also put Thailand on watch list after Thailand has issued compulsory licenses to three antiretroviral drugs. Compulsory licensing of drug products is very beneficial for the patients but is considered a big threat for the pharmaceutical companies. The branded drug makers spend billion dollars to patent a drug product. It is claimed by the pharmaceutical majors that the royalty of 5–10% given by generic drug makers to these companies is not enough to recoup their loss. The present article explores the utilization of “Compulsory Licensing” by several countries, exemplified by India and Brazil in particular, and highlights the patentees’ concerns of losing profits. The authors have attempted to negate the concern of the patentees over the use of compulsory licensing.