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 January 2009, the government introduced the Protection and Utilisation of Public Funded Intellectual Property Bill, 2008 in the Rajya Sabha. The bill is currently undergoing scrutiny by a Parliamentary select committee, after which it will be placed before the two houses of Parliament for approval. The Indian bill is based to some degree on the US Bayh Dole Act, which according to the Economist unlocked "all the inventions and discoveries that had been made in laboratories throughout the US with the help of taxpayers' money" and one that helped "reverse America's precipitous slide into industrial irrelevance." We are in broad agreement with commentators who are skeptical of the oft touted one sided wonders of the US Bayh Dole and its impact on innvoation. However, we argue that these skeptics have missed an important advantageof this historic legislation, namely the possibility of regulating the patenting of publicly­ funded esearch, which hitherto proceeded uncontrolled. American universities were patenting their research even before Bayh­ Dole, but such patenting progressed unimpeded on par with other private patenting in a relative regulatory vacuum. Bayh­Dole changed this to some extent, since it made patenting subject to additional “public interest” controls, such as “march­in” provisions and restrictions on exclusive licensing. Furthermore, it prohibited assignments unless the assignee manufactures products using the patent in the United States, a clear protectionist measure meant to favor local industry. This is not to suggest that the current Bayh­Dole structure is optimal, but that it provides a skeletal model which can be fleshed out and modified by countries adopting it to construct an optimal egulatory regime. This is particularly attractive for countries, such as India, that are contemplating transplanting the Bayh­Dole structure but are worried about the potential negative effects of increased patent numbers. The Indian government introduced the Protection and Utilisation of Public Funded Intellectual Property Bill, 2008 in the Rajya Sabha in January 2009. The Bill is currently undergoing scrutiny by a Parliamentary standing committee, after which it will pass before the two houses of Parliament for approval. Since the Indian Bill draws inspiration from the United States the “Bill.” Much like its parent, the Indian Bayh­Dole Bill vests institutes with the right to acquire patents over inventions deriving from publicly­funded R&D. However, instead of a facilitative framework encouraging patent applications, it imposes a harsh punitive framework mandating institutional patenting under threat of serious sanctions. Secondly, the Bill’s purview extends beyond patents, covering other forms of intellectual property such as copyright, plant varieties, semiconductor layout, and most problematically, trademark. The current Indian transplant effort could be even more flawed than the original. In fact, the grafting has been so badly conceptualized and executed that not only is it likely to face rejection by the host legal regime, but it also might end up poisoning it. Thus, we offer some concrete recommendations in this paper to make the proposed Bill more palatable to the ndian audience. We propose regulating the patenting of publicly­ funded research by incorporating more public interest safeguards: mandating affordable pricing of all products deriving from publicly­funded patents, making licensing of such patents compulsory in appropriate cases, favoring SMEs and local manufacturing, and vesting more discretion in the individual inventor to determine how to disseminate his invention. Some of these suggestions could be useful for other developing countries that are considering transplanting the U.S. Bayh­ Dole Act to their respective legal regimes. We also reflect on he “secret” history of the Bill and how it was for­ formalistically drafted without thorough study and investigation of the realities pertaining to publicly funded research and patenting activities in India. The paper will show that the passage of the Bill demonstrates non­ transparency of the highest order and lessons in he “don’ts” of lawmaking in a healthy democracy.

https://papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID1655985_code339749.pdf?abstractid=1546403&mirid=1

Outsourcing 'Bayh Dole' to India: Lost in Transplantation?

This paper considers the impact of the new Indian patent regime on the important issue of access to affordable drugs. Access is dependent, in part, on the ability of generic manufacturers to produce cheap generic drugs. Working with the bird flu patent example, this paper will demonstrate that far from abetting 'genericide', the new regime provides adequate legal windows to aid the continued production of affordable generics. However, the mere existence of such windows/flexibilities is not enough - generic manufacturers will only exploit such windows when it is economically and politically viable to do so.

India's New Patent Regime: Aiding 'Access' or Abetting 'Genericide'?

With an impending Avian influenza or bird flu pandemic, the issue of patents and public health has once again taken centre stage. Oseltamivir (known by its brand name 'Tamiflu'), a patented antiviral pill, has emerged as the world's first line of defence against bird flu. A key priority for most nations is to create sufficient stockpiles of this pill that can then be easily distributed and administered during a pandemic. Keeping this end in mind, this paper explores the patent position in India and looks at ways to work around a patent, should one issue in future. The paper recommends various strategies for creating an optimal and affordable stockpile and calls on the government to take a more definite stand in the matter.

https://papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID889868_code339749.pdf?abstractid=889868&mirid=5&type=2

Taming of the Flu: Working Through the Tamiflu Patents in India

1. Navigating the Interface between Utility Patents and Copyright 2. The Overlap between Patent and Design Protection 3. Patents and Trade Secrets 4. Interfaces in Plant Intellectual Property 5. Patents and Utility Models 6. Patents and Regulatory Data Exclusivity for Medicinal Products 7. When Copyright and Trade Mark Rights Overlap 8. The Design/Copyright Overlap: Is there a Resolution? 9. Overlapping Forms of Protection for Databases 10. Moral Rights or Economic Rights 11. Protection of 'Famous' Marks under Trade Mark Law and Passing Off 12. Overlapping Rights in Designs, Trade Marks and Trade Dress 13. Overlaps between Trade Marks and Geographical Indications 14. Domain Names and Trade Marks 15. Publicity Rights, Trade Mark Right, and Property Rights 16. The Relationship between Trade Mark Rights and Unfair Competition Law 17. The Relationship between Intellectual Property Rights and Competition Laws

Overlapping intellectual property rights

Section 3(d) of India’s Patents Act forbids patents on pharmaceutical substances that do not demonstrate a significantly enhanced efficacy over and above prior known substances. This article discusses the long and tortuous history of the provision. Only after an extended period of difficulty did India get to grips with World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and interpret it strategically to benefit the nation and its industry. This sophistication reached a near crescendo with the emergence of section 3(d), its crude drafting notwithstanding. India’s efforts to tailor its patent regime to promote the national interest whilst remaining compliant with TRIPS stands in stark contrast to a number of other countries that have simply toed the line of the developed world’s maximalist intellectual property (IP) agenda. As such, it represents a significant milestone and a valuable lesson in the IP and development debates.

Shamnad Basheer

Papers

Outsourcing 'Bayh Dole' to India: Lost in Transplantation?

India's New Patent Regime: Aiding 'Access' or Abetting 'Genericide'?

Taming of the Flu: Working Through the Tamiflu Patents in India

Overlapping intellectual property rights

Trumping TRIPS: Indian patent proficiency and the evolution of an evergreening enigma