Author: Papers

Patent Trolls and Small Business Employment

Authors: Ian Appel, Joan Farre-Mensa, Elena Simintzi Abstract: We analyze how frivolous patent-infringement claims made by “patent trolls” affect small firms’ ability to create jobs, raise capital, and survive. Our identification strategy exploits the staggered passage of anti-patent-troll laws at the state level. We find that the passage of this legislation leads to a 1.8% increase in employment at small firms in high-tech industries, which are a frequent target of patent trolls. By contrast, the laws have no significant impact on employment at larger or non high-tech firms. Anti-troll legislation is also associated with fewer business bankruptcies. Financing appears to be a key channel driving our findings: in states with an already established VC presence, the passage of anti-troll laws leads to a 19% increase in the number of firms receiving VC funding. Consistent with this financing channel, we find that the effect of patent laws on employment is driven by states with above-median VC presence. Our findings suggest that measures aimed at curbing the recent explosion in patent litigation may play an important role in reducing both real and financing frictions faced by small businesses. Citation: Appel, Ian and Farre-Mensa, Joan and Simintzi, Elena, Patent Trolls and Small Business Employment (December 18, 2016). Full text on SSRN:...

Read More

The Regional Comprehensive Economic Partnership, Intellectual Property Protection and Access to Medicines

Authors: Belinda Townsend, Deborah Gleeson, and Ruth Lopert Abstract: The inclusion of elevated standards of intellectual property protection in the recently negotiated Trans Pacific Partnership (TPP) Agreement has raised serious public health concerns regarding access to medicines. A lesser-known trade agreement under negotiation in the Asia Pacific region is the Regional Comprehensive Economic Partnership (RCEP). Framed as an attempt to reassert ASEAN’s position in response to the United States-led TPP, RCEP includes key players China and India, as well as several low and middle-income countries (LMICs). Leaked drafts of intellectual property provisions proposed by Japan and South Korea raise similar concerns for access to medicines in the Asia-Pacific region. This paper identifies TRIPS-Plus provisions in leaked negotiating texts and examines their implications for those LMICs that are not also parties to the TPP: Cambodia, Indonesia, Laos, Myanmar, the Philippines, Thailand, China, and India. Citation: Townsend, Belinda and Gleeson, Deborah and Lopert, Ruth, The Regional Comprehensive Economic Partnership, Intellectual Property Protection and Access to Medicines (June 27, 2016). Asia Pacific J, Vol. 28, No. 8, November 2016. Full Text on SSRN:...

Read More

Copyright Protection and Cumulative Creation: Evidence from Early Twentieth Century Music

Author: Stephanie Holmes Didwania Abstract: This paper uses data from an online database of music sampling to estimate the effect of copyright protection on the cumulative use of music. Using a unique panel dataset that links upstream and downstream music, I use regression analysis to examine the rates at which early twentieth-century musical works were used before and after entering the public domain over the years 1923-2013. The results suggest that copyright protection causes an upstream work to be used roughly 25 to 50 percent as often as it would if it was in the public domain after conditioning on upstream-song and downstream-year fixed effects. Placebo regressions in which the copyright expiration date is artificially shifted by two, five, and ten years yield no significant results, suggesting an immediate effect of copyright expiration on cumulative use. Citation: Didwania, Stephanie Holmes, Copyright Protection and Cumulative Creation: Evidence from Early Twentieth Century Music (September 1, 2016). Full text on SSRN:...

Read More

Intellectual Property and Access to Science and Culture: Convergence or Conflict?

CEIPI/ICTSD Publications Series, Issue 3 The Centre for International Intellectual Property Studies (CEIPI) is very pleased to announce the publication of the third issue in the CEIPI/ICTSD series on Global Perspectives and Challenges for the Intellectual Property System, produced jointly with the International Centre for Trade and Sustainable Development (ICTSD). The new issue, “Intellectual Property and Access to Science and Culture: Convergence or Conflict?”, edited by Professor Christophe Geiger, Director General and Director of the Research Department at the CEIPI, explores the relationship between intellectual property (IP) rights and the right to science and culture. This topic has recently served as the basis for an increasing body of legal scholarship and reports from international organisations, including two well-noted reports in 2014 and 2015 issued by the United Nations Special Rapporteur in the field of cultural rights, which shed some light on the complex interactions between IP regimes and access to science and culture, but also generated further discussion. The volume includes papers authored by prominent scholars from both the intellectual property and human rights fields, including an introduction by the former UN Special Rapporteur, Farida Shaheed, herself. The CEIPI/ICTSD publication series provides high quality academic and policy-oriented papers dealing with topics that are of global relevance because of their normative pre-eminence, economic relevance, and socio-economic impact. Click here to download the...

Read More

The Trans Pacific Partnership Agreement and Access to HIV Treatment in Vietnam

Authors: Hazel Moir, Brigitte Tenni, Deborah Gleeson & Ruth Lopert Abstract: In the Trans Pacific Partnership (TPP) Agreement negotiations, the USA successfully pursued intellectual property (IP) provisions that will affect the affordability of medicines, including anti-retrovirals (ARV) for HIV. Vietnam has the lowest GDP per capita of the 12 TPP countries and in 2013 provided ARVs for only 68% of eligible people living with HIV. Using the current Vietnamese IP regime as our base case, we analysed the potential impact of a regime making full use of legal IP flexibilities, and one based on the IP provisions of the final, agreed TPP text. Results indicate that at current funding levels 82% of Vietnam’s eligible people living with HIV would receive ARVs if legal flexibilities were fully utilised, while as few as 30% may have access to ARVs under the TPP Agreement – more than halving the proportion currently treated. Citation: Hazel V. J. Moir, Brigitte Tenni, Deborah Gleeson & Ruth Lopert (2016): The Trans Pacific Partnership Agreement and access to HIV treatment in Vietnam, Global Public Health, DOI: 10.1080/17441692.2016.1256418. Full Paper:...

Read More

Global Report on Access to Hepatitis C Treatment: Focus on Overcoming Barriers

Stefan Wiktor, Françoise Renaud and Peter Beyer World Health Organization | October 2016 Excerpt from Executive Summary:  This is the first-ever global report on treatment access to hepatitis C medicines. The report provides the information that countries and health authorities need to identify the appropriate HCV treatment, and procure it at affordable prices. The report uses the experience of several pioneering countries to demonstrate how barriers to treatment access can be overcome. It also provides information on the production of new hepatitis C drugs and generic versions worldwide, including  where  the  drugs  are  registered,  where  the  drugs  are  patented  and  where  not,  and  what  opportunities  countries have under the license agreements that were signed by some companies as well as current pricing of all recommended DAAs, including by generic companies all over the world. Click here for the full...

Read More

Is it Copyright’s Role to Fill Houses with Books?

Author: Rebecca Giblin Abstract: Proposed copyright reforms are typically situated as being pro-user/anti-author (or vice versa). When it comes to making normative judgments about how far copyright rights ought to extend however, we need to ask more than whether a change might make one or another interest worse off. Since copyright isn’t zero sum, we need to ask who loses how much in exchange for who gaining what. This is particularly important when considering normative questions relating to copyright’s role in human and economic development, which are regaining urgency as the marginal cost of copying continues to drop for the world’s least advantaged populations, increasing the deadweight loss attributable to copyright. This paper adapts a Rawlsian conception of the public interest to develop an objective framework that can enable more nuanced evaluation of the merits and demerits of global copyright policy proposals. By refocusing the debate from what is being won and lost by individual stakeholders towards the broader possibilities enabled by digital abundance, it shines fresh light on copyright’s potential to help vulnerable people live a ‘good life’, lift populations out of poverty and stimulate fresh creation. Citation: Giblin, Rebecca, Is it Copyright’s Role to Fill Houses with Books? (October 18, 2016). Susy Frankel and Daniel Gervais, Intellectual Property and Regulation of the Internet: The Nexus with Human and Economic Development (2017 Forthcoming). Full text on SSRN:...

Read More

The Trans Pacific Partnership Agreement and Pharmaceutical Regulation in Canada and Australia

Authors: Joel Lexchin and Deborah Gleeson Abstract: The Trans Pacific Partnership Agreement (TPP) is a large regional trade agreement involving twelve countries. It was signed in principle in February 2016 but has not yet been ratified in any of the participating countries. The TPP provisions place a range of constraints on how governments regulate the pharmaceutical sector and set prices for medicines. This paper presents a prospective policy analysis of the possible effects of the TPP on these two points in Canada and Australia. Five chapters of relevance to pharmaceutical policy are analyzed: chapters on Technical Barriers to Trade (Chapter 8), Intellectual Property (Chapter 18), Investment (Chapter 9), Dispute Resolution (Chapter 28), and an annex of the chapter on Transparency and Anti-Corruption (Chapter 26, Annex 26-A). The paper concludes that the TPP could have profound effects on the criteria these countries use to decide on drug safety and effectiveness, how new drugs are approved (or not) for marketing, post-market surveillance and inspection, the listing of drugs on public formularies, and how individual drugs are priced in future. Furthermore, the TPP, if ratified and enforced, will reduce future policy flexibility to address the increasing challenge of rising drug prices. Citation: Lexchin J and Gleeson D. (2016) The Trans Pacific Partnership Agreement and Pharmaceutical Regulation in Canada and Australia. International Journal of Health Services, 46(4):597-613. doi: 10.1177/0020731416662612. Full text on SSRN:...

Read More

TRIPS-Plus, Public Health and Performance-Based Rewards Schemes Options and Supplements for Policy Formation in Developing and Least Developed Countries

El-Said, Mohammed K. (2016). American University International Law Review: Vol. 31: Iss. 3, Article 2.  Available at: http://digitalcommons.wcl.american.edu/auilr/vol31/iss3/2 Excerpt follows. Introduction: The debate surrounding the creation of a balanced patent protection regime in countries is not new. For decades, policy makers experimented with the levels of protection.[3] For example, the Netherlands abolished patents in the field of chemistry for decades between 1869 and 1910, in order to catch up with other European countries such as Germany.[4] Similarly, between 1960 and 1980 a number of Asian economies—often referred to as the Tiger economies—adopted a systematic national policy of reverse engineering and imitation.[5] When South Korea introduced patent protection in 1961, the protection term was limited to only twelve years and protection did not extend to foodstuffs, pharmaceuticals, or chemicals.[6] Similarly, many of the developed nations adopted a relaxed protection regime during their initial stages of development, utilizing their preferred intellectual property regime only after reaching a certain level of advancement.[7] This debate remains as relevant as ever.[8] A 2013 report published in Australia sums up the dilemma facing many governments in the area of public health, noting: Thus the question of how much patent protection to offer is crucial. Pharmaceutical patent rights that run for too long or that are defined too expansively will deprive people of drugs because purchasers, including Governments, cannot afford them. They can also constrain follow...

Read More

Movie Piracy and Displaced Sales in Europe: Evidence from Six Countries

Authors: Benedikt Herz and Kamil Kiljański Abstract: This paper presents estimates of lost movie sales due to unpaid movie consumption. We are the first to provide estimates that are recent, representative of the internet-using population, and cover multiple countries. Based on an online questionnaire with almost 30,000 respondents, we document that one unpaid (first) viewing of a movie displaces about 0.37 units of paid viewings. Using a back-of-the-envelope calculation, we show that this implies that unpaid movie viewings reduced movie sales in Europe by about 4.4% during the sample period. Lost sales differ substantially by country: they are in the range of 1.65% for Germany and 10.4% for Spain. We also find that 94% of lost sales are due to unpaid viewings by a small group of only 20% of consumers. Our findings have important implications for copyright policy. Citation: Herz, Benedikt and Kiljański, Kamil, Movie Piracy and Displaced Sales in Europe: Evidence from Six Countries (September 22, 2016). Full text on SSRN:...

Read More

Commentary to the U.S. Copyright Office Regarding the Section 512 Study: Higher Education and the DMCA Safe Harbors

Authors:  Christopher Anthony Cotropia and James Gibson Abstract: The nearly twenty-year history of the Digital Millennium Copyright Act’s safe harbor provisions has been marked by criticism from content owners, online service providers, and end users. Content owners complain about the cost of monitoring online content and sending take-down notices. Online service providers complain about the cost of receiving and processing the notices. And end users complain about their legitimate use of copyrighted works being subject to DMCA take-down. Colleges and universities have been at the forefront of this controversy; as providers of online services to their students, they have been a focus of both Congress and copyright owners. To study the effect of the safe harbor provisions on such institutions, and particularly the nature, volume, and cost of the notice-and-takedown system, we surveyed colleges and universities about their copyright and DMCA practices. The results expose infirmities in the administration of the DMCA system, both within the world of higher education and within the U.S. Copyright Office, and suggest that colleges and universities need to (1) take better advantage of the safe harbors and (2) correct certain fundamental misunderstandings of important and essential aspects of the DMCA. Citation: Cotropia, Christopher Anthony and Gibson, James, Commentary to the U.S. Copyright Office Regarding the Section 512 Study: Higher Education and the DMCA Safe Harbors (September 30, 2016). Full text on SSRN:...

Read More

TTIP and Affordable Medicines

How TTIP may obstruct progress towards sustainable access to medicines [Tessel Mellema, Sophie Bloemen and Peter Maybarduk, Link, (CC-BY-NC)] The Transatlantic Trade and Investment Partnership (TTIP) negotiations pose serious risks to Europeans’ access to medicines and affordable healthcare. TTIP is likely to help entrench a broken medical innovation system rather than seize today’s opportunities to advance medical innovation and affordable access to medicines for all. Pharmaceutical corporations charge European Union (EU) Member States and the United States (U.S.) increasingly higher prices for medicines. EU Member States and the U.S. are facing a looming access to medicines crisis as they struggle to afford new, patented, high-priced medicines. At the same time, since the 1980s, no new truly valuable antibiotics have reached the market. Despite stringent intellectual property (IP) rules and continued lengthening market monopolies, there has been a striking lack of medical innovation. EU Member States have therefore rightly questioned whether excessive IP rights and additional market monopolies, which are now at the disposal of the pharmaceutical industry, function well as drivers for pharmaceutical innovation in their 2016 Council Conclusions. The Dutch Health Minister leading these Conclusions has called for a new balance between IP protection and affordable and sustainable access to medicines, prioritizing the exploration of alternative research and development (R&D) models. Leading public health institutions, academics and the World Health Organization (WHO) have questioned the current monopoly-driven incentive...

Read More

Patent Barriers to Medicine Access in South Africa: A Case for Patent Law Reform

Catherine Tomlinson, Yuan Qiong Hu, Julia Hill and Claire Waterhouse Fix the Patent Laws Campaign Full Text (PDF) Executive Summary: In this report, we present nine case studies that demonstrate how systemic shortcomings in South Africa’s patent laws negatively impact on access to medicines to treat a wide range of diseases in both the public and private sectors. The case studies illustrate how a flawed system can allow pharmaceutical companies to prolong their monopoly periods in South Africa for years – and sometimes even decades – after their patent protections have expired in other parts of the world, to the detriment of millions of patients. To prolong their periods of patent protection, companies commonly apply for multiple patents on individual medicines over time – a tactic known as evergreening. Due to shortcomings in South Africa’s laws – namely, a lack of examination for patent applications –  ‘evergreening’ occurs frequently. The result is that South Africa’s patents office grants patents that are rejected in other countries, and also grants patents that may not stand up to national patentability criteria. Additionally, patents that are overturned in other countries through opposition or legal procedures are often unchallenged or upheld by courts in South Africa. The complexity of identifying when patent monopolies actually expire in South Africa and the conservative approach of the country’s courts in ruling on patent challenges (see explanation on...

Read More

Institutional and Normative Considerations for Copyright and Access to Education in Developing Countries: Rethinking Incremental Solutions Through Limitations and Exceptions

Author: Susan Isiko Strba Abstract: This article considers both national and multilateral approaches to facilitate access to copyrighted materials for educational purposes in developing countries. It emphasizes the need for both normative re-ordering and institutional reform. In case of normative re-ordering, the article highlights the role that national institutions like courts, in addition to legislators, might play in crafting case-by-case educational exceptions. However, it argues that limitations and exceptions in themselves are insufficient doctrinal mechanisms on which to place the sole burden of facilitating effective access to educational materials. At the international level, the article proposes an approach that goes beyond the current emphasis on limitations and exceptions. Such an approach should evolve within the international intellectual property (IP) system and its affiliated institutions like WIPO and the WTO. The failure of attempts to provide normative solutions for access to other public goods such as public health or climate-related technologies, strongly suggests that institutional reform and normative re-ordering must be simultaneously pursued in the international arena. The article suggests that in the area of copyright and access to education, WIPO is the best institution to lead in devising multilateral solutions. However, it should minimize its emphasis on treaty making and instead place more emphasis on quasi-legal and non-legal mechanisms. The article evaluates recent institutional and normative reforms in WIPO, including the Development Agenda and the activities of the Standing...

Read More

A Prescription for Excessive Drug Pricing: Leveraging Government Patent Use for Health

Authors: Hannah Brennan, Amy Kapczynski, Christine H. Monahan, and Zain Rizvi Abstract: High drug prices are creating serious health and fiscal problems in the United States today. This reality is vividly illustrated by recently approved medicines to treat Hepatitis C. These new medicines can cure nearly everyone with this potentially fatal infection and may even enable the elimination of this disease. But the drugs’ sticker price — close to $100,000 — has meant that very few patients who could benefit from them can access them. This Article describes an approach, available under existing law, to bring about transformative reductions in the prices of these medicines, at least for federal programs and possibly beyond. Under 28 U.S.C. § 1498, the U.S. government can buy generic versions of these medicines at less than 1% of their list price plus a reasonable royalty. This power has received almost no academic attention, despite the fact that it is regularly used by the government in other sectors, including defense. Indeed, though it has now been forgotten, the federal government relied on this provision numerous times to procure cheaper generic drugs in the 1960s. We recover this history and show how § 1498 can once again be used to increase access to life-saving medicines, addressing several important interpretive questions about the application of the provision along the way. We also offer the first sustained efficiency...

Read More

Copyright’s Digital/Analog Divide

Author: Matthew Sag Abstract: This Article shows how the substantive balance of copyright law has been overshadowed online by the system of intermediary safe harbors enacted as part of the Digital Millennium Copyright Act (“DMCA”) in 1998. The Internet safe harbors and the system of notice-and-takedown fundamentally changed the incentives of platforms, users, and rightsholders in relation to claims of copyright infringement. These different incentives interact to yield a functional balance of copyright online that diverges markedly from the experience of copyright law in traditional media environments. This article also explores a second divergence: the DMCA’s safe harbor system is being superseded by private agreements between rightsholders and large commercial Internet platforms made in the shadow of those safe harbors. These agreements relate to automatic copyright filtering systems, such as YouTube’s Content ID, that not only return platforms to their gatekeeping role, but encode that role in algorithms and software. The normative implications of these developments are contestable. Fair use and other axioms of copyright law still nominally apply online; but in practice, the safe harbors and private agreements made in the shadow of those safe harbors are now far more important determinants of online behavior than whether that conduct is, or is not, substantively in compliance with copyright law. The diminished relevance of substantive copyright law to online expression has benefits and costs that appear fundamentally incommensurable. Compared...

Read More

Innovation and the Global Expansion of Intellectual Property Rights: Unfulfilled Promises

South Centre Research Paper No. 70 Author: Carlos M. Correa The incorporation of intellectual property into trade agreements has not proven to bring about the promised benefits. The premises that have underpinned the global strengthening and expansion of intellectual property through such agreements – namely that the same standards of protection are suitable for countries with different levels of development and that innovation will be boosted – do not match the reality. The effects of high standards of protection – as those mandated under the TRIPS Agreement and further extended under FTAs – have been critically examined in the developed countries themselves: “[i]ntellectual property is …a social contrivance purportedly designed to increase welfare, by supposedly enhancing innovation (though… it may actually have exactly the opposite effect)”. If intellectual property does not work in developed countries as generally described by their proponents, the situation can only be worse in developing countries with weak science and technological infrastructures, scarcity of risk capital and unsophisticated production profiles. These countries are currently paying the price of a system which primarily serves as a platform to extract rents (in the form of royalty payments and high prices) and which does little to promote local innovation and economic development. The scenario for innovation in the pharmaceutical sector clearly illustrates that the conception underpinning the TRIPS Agreement was flawed from a global perspective. The rate of...

Read More

The Impact of Open Licensing on the Early Reader Ecosystem

Authors: Neil Butcher, Sarah Hoosen, Lisbeth Levey, and Derek Moore Summary: Developing early literacy requires access to structured decodable texts and levelled readers, an array of supplementary reading materials (SRMs), and teachers trained in literacy development methods and teaching in language/s spoken in the school where they teach. As children acquire literacy most effectively in their mother tongue, this introduces a significant barrier for those who live in low-income countries and speak local languages for which there is not a viable publishing industry. Even where content has been created, the supply chains that are needed to print and distribute educational materials are typically under-funded, inefficient, and often susceptible to corruption. In addition, these supply chains are often inequitable, are based on unreliable school statistics, have storage and stock control systems that are substandard, depend on poor transportation facilities, and are negatively affected by delayed payments from governments. The problems affecting early literacy have been well documented. However, research in this field has tended to focus on traditional publishing value and supply chains, without taking much account of new possibilities that might be ushered in as a consequence of the digitization of content and how the use of open licences might create new approaches and solutions to these seemingly intractable problems. Consequently, this report focuses its attention on the development of value networks based on open licensing and the extent...

Read More

Fair Use and the Future of Art

Author: Amy Adler Abstract: Twenty-five years ago, in a seminal article in the Harvard Law Review, Judge Leval changed the course of copyright jurisprudence by introducing the concept of “transformativeness” into fair use law. Soon thereafter, the Supreme Court embraced Judge Leval’s new creation, calling the transformative inquiry the “heart of the fair use” doctrine. As Judge Leval conceived it, the purpose of the transformative inquiry was to protect the free speech and creativity interests that fair use should promote by offering greater leeway for creators to build on preexisting works. In short, the transformative standard would ensure that copyright law did not “stifle the very creativity which that law [was] designed to foster.” This Article shows that the transformative test has not only failed to accomplish this goal; the test itself has begun to “stifle the very creativity which that law was designed to foster.” In the realm of the arts, one of the very areas whose progress copyright law is designed to promote, the transformative standard has become an obstacle to creativity. Artistic expression has emerged as a central fair use battleground in the courts. At the same time that art depends on copying, the transformative test has made the legality of copying in art more uncertain, leaving artists vulnerable to lawsuits under a doctrine that is incoherent and that fundamentally misunderstands the very creative work it...

Read More

The Trans Pacific Partnership Agreement and Pharmaceutical Regulation in Canada and Australia

Authors: Joel Lexchin and Deborah Gleeson Abstract: The Trans Pacific Partnership Agreement (TPP) is a large regional trade agreement involving 12 countries. It was signed in principle in February 2016 but has not yet been ratified in any of the participating countries. The TPP provisions place a range of constraints on how governments regulate the pharmaceutical sector and set prices for medicines. This article presents a prospective policy analysis of the possible effects of the TPP on these two points in Canada and Australia. Five chapters of relevance to pharmaceutical policy are analyzed: chapters on Technical Barriers to Trade (Chapter 8), Intellectual Property (Chapter 18), Investment (Chapter 9), Dispute Resolution (Chapter 28), and an annex of the chapter on Transparency and Anti-Corruption (Chapter 26, Annex 26-A). The article concludes that the TPP could have profound effects on the criteria these countries use to decide on drug safety and effectiveness, how new drugs are approved (or not) for marketing, post-market surveillance and inspection, the listing of drugs on public formularies, and how individual drugs are priced in the future. Furthermore, the TPP, if ratified and enforced, will reduce future policy flexibility to address the increasing challenge of rising drug prices. Citation: Joel Lexchin and Deborah Gleeson. The Trans Pacific Partnership Agreement and Pharmaceutical Regulation in Canada and Australia. Int J Health Serv 0020731416662612, first published on August 11, 2016. Conclusion and Comments on PNHP...

Read More