In the last several years, business leaders, policymakers, and inventors have complained to the media and to Congress that today’s patent system stifles innovation instead of fostering it. But like the infamous patent on the peanut butter and jelly sandwich, much of the cited evidence about the patent system is pure anecdote--making realistic policy formation difficult. Is the patent system fundamentally broken, or can it be fixed with a few modest reforms? Moving beyond rhetoric, Patent Failure provides the first authoritative and comprehensive look at the economic performance of patents in forty years. James Bessen and Michael Meurer ask whether patents work well as property rights, and, if not, what institutional and legal reforms are necessary to make the patent system more effective. Patent Failure presents a wide range of empirical evidence from history, law, and economics. The book’s findings are stark and conclusive. While patents do provide incentives to invest in research, development, and commercialization, for most businesses today, patents fail to provide predictable property rights. Instead, they produce costly disputes and excessive litigation that outweigh positive incentives. Only in some sectors, such as the pharmaceutical industry, do patents act as advertised, with their benefits outweighing the related costs. By showing how the patent system has fallen short in providing predictable legal boundaries, Patent Failure serves as a call for change in institutions and laws. There are no simple solutions, but Bessen and Meurer’s reform proposals need to be heard. The health and competitiveness of the nation’s economy depend on it.

Introduction to Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk

Introduction: The globalization of the pharmaceutical supply chain has introduced new challenges, chief among them, fighting the international criminal trade in fake medicines. As the manufacture, ...

A review of existing and emerging digital technologies to combat the global trade in fake medicines

Objective: To explore the evidence available of poorquality (counterfeit and substandard) medicines in the literature. Design: Systematic review. Data sources: Databases used were EMBASE, MEDLINE, PubMed and the International Pharmaceutical Abstracts, including articles published till January 2013. Eligibility criteria: Prevalence studies containing original data. WHO definitions (1992) used for counterfeit and substandard medicines. Study appraisal and synthesis: Two reviewers independently scored study methodology against recommendations from the MEDQUARG Checklist. Studies were classified according to the World Bank classification of countries by income. Data extraction: Data extracted: place of study; type of drugs sampled; sample size; percentage of substandard/counterfeit medicines; formulations included; origin of the drugs; chemical analysis and stated issues of counterfeit/substandard medicines. Results: 44 prevalence studies were identified, 15 had good methodological quality. They were conducted in 25 different countries; the majority were in low-income countries (11) and/or lower middle-income countries (10). The median prevalence of substandard/counterfeit medicines was 28.5% (range 11–48%). Only two studies differentiated between substandard and counterfeit medicines. Prevalence data were limited to antimicrobial drugs (all 15 studies). 13 studies involved antimalarials, 6 antibiotics and 2 other medications. The majority of studies (93%) contained samples with inadequate amounts of active ingredients. The prevalence of substandard/counterfeit antimicrobials was significantly higher when purchased from unlicensed outlets (p<0.000; 95% CI 0.21 to 0.32). No individual data about the prevalence in upper middle-income countries and high-income countries were available. Limitations: Studies with strong methodology were few. The majority did not differentiate between substandard and counterfeit medicines. Most studies assessed only a single therapeutic class of antimicrobials.

https://bmjopen.bmj.com/content/bmjopen/3/8/e002923.full.pdf

Substandard and counterfeit medicines: a systematic review of the literature

In this second part of a 2-part series on the global burden of cardiovascular disease, we review the proven, effective approaches to the prevention and treatment of cardiovascular disease. We specifically review the management of acute cardiovascular diseases, including acute coronary syndromes and stroke; the care of cardiovascular disease in the ambulatory setting, including medical strategies for vascular disease, atrial fibrillation, and heart failure; surgical strategies for arterial revascularization, rheumatic and other valvular heart disease, and symptomatic bradyarrhythmia; and approaches to the prevention of cardiovascular disease, including lifestyle factors, blood pressure control, cholesterol-lowering, antithrombotic therapy, and fixed-dose combination therapy. We also discuss cardiovascular disease prevention in diabetes mellitus; digital health interventions; the importance of socioeconomic status and universal health coverage. We review building capacity for conduction cardiovascular intervention through strengthening healthcare systems, priority setting, and the role of cost effectiveness.

Reducing the Global Burden of Cardiovascular Disease, Part 2: Prevention and Treatment of Cardiovascular Disease.

Importance Substandard and falsified medicines burden health systems by diverting resources to ineffective or harmful therapies, causing medical complications and prolonging illnesses. However, the prevalence and economic impact of poor-quality medicines is unclear. Objective To conduct a systematic review and meta-analysis to assess the prevalence and estimated economic burden of substandard and falsified essential medicines in low- and middle-income countries. Data Sources Five databases (PubMed, EconLit, Global Health, Embase, and Scopus) were searched from inception until November 3, 2017. Study Selection Publications were assessed to determine whether they examined medicine quality and the prevalence and/or economic burden of substandard and falsified medicines in low- and middle-income countries. Studies with a sample size of 50 or more were included in the meta-analysis. Data Extraction and Synthesis The study is registered in PROSPERO and reported via the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines. Study quality was assessed using an adapted Medicine Quality Assessment Reporting Guidelines scoring metric. Multiple reviewers conducted the data extraction and quality assessment independently. Main Outcomes and Measures Prevalence and/or estimated economic impact of substandard and falsified medicines. Results Two hundred sixty-five studies that estimated the prevalence of poor-quality essential medicines in low- and middle-income countries were identified. Among 96 studies that tested 50 samples or more (67 839 total drug samples), overall prevalence of poor-quality medicines was 13.6% (95% CI, 11.0%-16.3%), with regional prevalence of 18.7% in Africa (95% CI, 12.9%-24.5%) and 13.7% in Asia (95% CI, 8.2%-19.1%). Of studies included in the meta-analysis, 19.1% (95% CI, 15.0%-23.3%) of antimalarials and 12.4% (95% CI, 7.1%-17.7%) of antibiotics were substandard or falsified. Eight approximations of the economic impact, focused primarily on market size, with poor or undisclosed methods in estimation were identified, ranging from $10 billion to $200 billion. Conclusions and Relevance Poor-quality essential medicines are a substantial and understudied problem. Methodological standards for prevalence and rigorous economic studies estimating the burden beyond market size are needed to accurately assess the scope of the issue and inform efforts to address it. Global collaborative efforts are needed to improve supply-chain management, surveillance, and regulatory capacity in low- and middle-income countries to reduce the threat of poor-quality medicines. Trial Registration PROSPERO Identifier:CRD42017080266

/pdf/prevalence-and-estimated-economic-burden-of-substandard-and-45ba4x47vl.pdf

Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis.

In what must rate as a momentous occasion in Indian copyright history, the Copyright Amendment Bill, 2012 cleared both Houses of Parliament after 12 years of intense debate, discussion and politicking. These set of amendments were particularly celebrated for fostering social justice through provisions that included a special copyright exception for the disabled and a mandatory royalty sharing arrangement for hitherto exploited Bollywood artists.However, despite the general euphoria surrounding the passage of these highly progressive provisions, there are causes for concern. In particular, the abrupt deletion of a clause legalising parallel imports, contrary to the suggestion of an expert Parliamentary Committee, raised many an eyebrow. It would appear that publisher lobbies prevailed upon the government to effect this last minute volte-face. The main claim advanced by publishers to effectuate this change of heart was that the Indian market was well served with the latest books at affordable prices, rendering redundant the very need for a provision legalising parallel imports.In this paper, the authors limit themselves to empirically testing this claim. The data from three different libraries demonstrate that the Indian versions sold by international publishing houses are often old and outdated editions. The latest versions are available only through imports via websites (or through mainstream distributors) and costs as much, or more than their western counterparts. Further, the legality of such imports is uncertain under the present copyright regime.Based on this evidence, the authors argue in favour of retaining Section 2(m) of the Indian Copyright Act, 1957. They also argue that legal policy ought to favour free market competition, unless the evidence suggests that the gains from such competition are outweighed by the harm to the copyright owner and the growth of the indigenous publishing sector. As of today, no such countervailing evidence has been proffered.

Exhausting Copyrights and Promoting Access to Education: An Empirical Take

This report is a descriptive one that explores the system of ‘compulsory licensing’ in India. In particular, it examines the history/background/rationale of the present ‘compulsory licensing regime’ in India. It then outlines the scope of the ‘compulsory licensing’ regime as it stands today. In particular, it deals with the grounds for compulsory licensing, procedure involved, decisions on compulsory licensing and TRIPS compliance issues.Given the recent transition of India to a pharmaceutical product patent regime, it is expected that a number of generic companies are actively looking to exploit the compulsory licensing windows.

https://papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID2019505_code339749.pdf?abstractid=1685129&mirid=1&type=2

The ‘Compulsory Licence’ Regime in India: Past, Present and Future

In what must rate as a momentous occasion in Indian copyright history, the Copyright Amendment Bill, 2012 cleared both Houses of Parliament after 12 years of intense debate, discussion and politicking. These set of amendments were particularly celebrated for fostering social justice through provisions that included a special copyright exception for the disabled and a mandatory royalty sharing arrangement for hitherto exploited Bollywood artists. However, despite the general euphoria surrounding the passage of these highly progressive provisions, there are causes for concern. In particular, the abrupt deletion of a clause legalising parallel imports, contrary to the suggestion of an expert Parliamentary Committee, raised many an eyebrow. It would appear that publisher lobbies prevailed upon the government to effect this last minute volte-face. The main claim advanced by publishers to effectuate this change of heart was that the Indian market was well served with the latest books at affordable prices, rendering redundant the very need for a provision legalising parallel imports. In this paper, the authors limit themselves to empirically testing this claim. The data from three different libraries demonstrate that the Indian versions sold by international publishing houses are often old and outdated editions. The latest versions are available only through imports via websites (or through mainstream distributors) and costs as much, or more than their western counterparts. Further, the legality of such imports is uncertain under the present copyright regime. Based on this evidence, the authors argue in favour of retaining Section 2(m) of the Indian Copyright Act, 1957. They also argue that legal policy ought to favour free market competition, unless the evidence suggests that the gains from such competition are outweighed by the harm to the copyright owner and the growth of the indigenous publishing sector. As of today, no such countervailing evidence has been proffered.

http://nopr.niscair.res.in/bitstream/123456789/14461/1/JIPR%2017%284%29%20335-347.pdf

This paper considers some features of Europe's approach to medicine, public health and patents as it has developed during the decade since TRIPs came into force. It then reviews what rights users have in relation to such patents and what duties right holders may owe users. The following issues are discussed: 1. How patents on medicines are viewed in Europe; 2. How TRIPs has affected European law; 3. How bilateral agreements since TRIPs have affected Europe; 4. How user rights should be viewed under TRIPs; 5. Whether patents in the public health field are a special case.

/pdf/popping-patented-pills-europe-and-a-decade-s-dose-of-trips-1ioxcj8glu.pdf

Popping Patented Pills: Europe and a Decade's Dose of TRIPS

The biblical David vs Goliath paradigm plays out very frequently in international trade disputes. In 2003, a tiny island state, Antigua and Barbuda (hereafter Antigua) took on the United States (hereafter US) in a WTO (World Trade Organisation) dispute, alleging that the US violated GATS (General Agreement on Trade in Services) obligations by effectively foreclosing their borders to overseas internet gambling services. It won at both the panel and the appellate levels. However, to this date, it has been unable to secure compliance by the US.Since "traditional" retaliation (Antigua retaliating in the same sector by suspending its GATS obligations to open up it's various service sectors to US businesses) was more likely to hurt Antigua than the US, such a remedy would have been practically meaningless.Therefore Antigua pleaded for and obtained the right to “cross retaliate” by suspending the intellectual property rights (IPR) of US corporations. Naturally, this retaliation under another agreement (namely TRIPS) has a better potential of inducing compliance by defaulting developed countries such as the US, since strong IP lobbies in such countries are likely to pressurize their governments into a compliance or settlement. The WTO granted such an authorization to Ecuador in 2000 and to Brazil more recently in September 2009, albeit conditionally.Despite the procurement of an authorization to cross retaliate, Antigua is yet to implement it and is currently in negotiation talks with the US. More worryingly perhaps, it has not yet changed its domestic law or announced as to how it would go about operationalising the cross retaliation authorization.One potential reason for Antigua’s failure to come up with any concrete model could be the uncertainty in determining a viable IP suspension model that remains WTO consistent by ensuring that the value of loss from the suspension of IP is equivalent from the losses caused to Antigua. This uncertainty will no doubt be exploited by the US in its negotiation talks with Antigua. This paper therefore seeks to work out a detailed IP suspension model that could help countries such as Antigua. It proposes a “Tiered IP suspension model”, where certain kinds of IP are targeted first for suspension before others, depending on the ease of objectively ascertaining the value of IP and thereby the harm caused by the unauthorized use of such IP and/or the potential to induce compliance by the defaulting state. Illustratively, copyrights over sound recordings that have established rates for public performance are targeted first. If working with this tier of IP subject matter does not yield desired results, then the complaining state moves on to other IP where it is relatively more difficult to compute the loss caused to the IP owner (such as pharmaceutical patents) but which may be a more powerful tool to induce compliance. Such a model could be useful for a large number of developing countries such as India and Brazil, that often find that, despite WTO victories, scofflaw states such as the US and EU fail to comply. Towards this end, this paper offers a very concrete “development” oriented international trade law remedy.

https://papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID1466316_code339749.pdf?abstractid=1093284&rulid=10210911&mirid=5

Shamnad Basheer

Papers

Exhausting Copyrights and Promoting Access to Education: An Empirical Take

The ‘Compulsory Licence’ Regime in India: Past, Present and Future

Exhausting Copyrights and Promoting Access to Education: An Empirical Take

Popping Patented Pills: Europe and a Decade's Dose of TRIPS

Turning TRIPS on It's Head: An IP 'Cross Retaliation' Model For Developing Countries