Sitagliptin (Januvia) patent litigation: Another link in the judicial train of ‘Proactive Infringement’ of patented rights in developing countries

2020 ◽  
Vol 16 (2) ◽  
pp. 64-71
Author(s):  
Zarina Iqbal ◽  
Saima Sadaf
Keyword(s):  
At Risk ◽  
Developing Countries ◽  
Generic Drugs ◽  
Legal Framework ◽  
Patent System ◽  
Patent Litigation ◽  
Market Exclusivity ◽  
Product Life ◽  
Drug Companies ◽  
Patented Product

Driven by increasing instances of successful ‘at-risk’ launch of patented drugs in America and Europe, the strategy of using ‘proactive infringement’ as a legal tool is now getting-in, in developing countries. The rationale behind launch-at-risk is to counterbalance the innovator companies’ strategies of getting the patented product life extended through protecting improvement innovations and maintain market exclusivity even after the expiration of the compound patent. The battle for market and drive for higher profits between generics and innovator drug companies has extended the application of at-risk launch of the generic drugs even when compound patent is still running. Sitagliptin (Januvia) may be ranked at top of the drugs that have been fiercely litigated in the developing countries during their patent term. This article reviews the outcome of sitagliptin patent litigation and impact on the market exclusivity in some developing countries. This takes the position that the existing conflict between the innovators and generics can be resolved by diluting the misconception that patents on improvement innovations are misuse of patent system or inappropriate extension of patented product life on the part of innovator companies. Whether trivial, simplified or complex, if novel and non-obvious, further improvements in the precursor drugs are patentable within the legal framework of the patent system. The real issue is the scope of monopoly granted to the secondary or follow-on patents. Once the compound patent has expired, follow-on patents on improvements relating to the same compound should not be allowed to use as legal-barrier for the generic medicines entry to the market.

International Seminar – Contributions to the Development Agenda on Intellectual Property Rights

2008 ◽  
Vol 10 (2) ◽  
Author(s):  
Ana Celia Castro ◽  
Maria Beatriz Amorim Bohrer
Keyword(s):  
Developing Countries ◽  
Intellectual Property ◽  
Property Rights ◽  
Intellectual Property Rights ◽  
Patent Law ◽  
Patent System ◽  
International Seminar ◽  
Development Agenda

TRIPS as it stands is against the interests of developing countries, and needsreform. In developing their own patent law, developing countries need to recognizethat there is now near consensus among informed observers that patentlaw and practice have, in some cases, overshot, and need to be reformed. Thatis the burden of the recent NAS/NRC report on “A Patent System for the 21stCentury.

Foreign Aid and Family at Risk

2015 ◽  
pp. 425-439
Author(s):  
Kana Takamatsu
Keyword(s):  
At Risk ◽  
Risk Management ◽  
Developing Countries ◽  
Foreign Aid ◽  
Migrant Workers ◽  
Management Tool ◽  
And Migration ◽  
Aid Policy ◽  
Policy Discussion

This chapter examines how the foreign aid policy should and should have supported families facing risks by using the case study of Myanmar. The chapter starts by addressing the issue of poverty, which continues to be the gravest risk in the developing countries, and how family could be the cause of poverty as well as the solution of poverty in foreign aid policy discussion. The situation of poverty and migration as a risk management tool are then examined in the second section of the chapter. Interviews with migrant workers in Thailand and Japan were conducted. Finally, there is a discussion about the developments of Myanmar and how the foreign aid and international community has inadequately responded to the democratization of Myanmar and to the needs of its people.

Patents and Scientific Research

2015 ◽  
pp. 135-155
Author(s):  
Sulan Wong
Keyword(s):  
Quality Of Life ◽  
Business Model ◽  
Scientific Knowledge ◽  
Research Funding ◽  
Scientific Research ◽  
Patent System ◽  
Scientific Development ◽  
Patent Litigation ◽  
Definition Of

It is argued that patents encourage scientific development, benefiting society by creating useful products and services that improve the quality of life. However, by granting exclusive rights of exploitation, patents create situations in which they interfere with the exercise of the freedom of scientific research. This work examines five scenarios where this problem can be seen and the utilitarian function of patents is questioned. Firstly, the effects of research funding in the definition of the lines and research objectives are observed. Secondly, the anticommons is studied, as it is a situation where excessive fragmentation of ownership in scientific knowledge may prevent its use. Thirdly, broad patents and their implications are examined. Fourthly, the deterrent power of patent litigation, which creates an unexpected business model, is analyzed. Fifthly, secrecy is looked upon, as it is encouraged by the logic in which the patent system works.

E-Documents and E-Signatures in Tanzania

2012 ◽  
pp. 90-122 ◽  
Author(s):  
Ubena John
Keyword(s):  
At Risk ◽  
Information Systems ◽  
Qualitative Study ◽  
Legal Status ◽  
Legal Framework ◽  
Information And Communications Technology ◽  
Communications Technology ◽  
Literature Analysis ◽  
Ict Infrastructure ◽  
The Government

This chapter analyses the use of e-Documents and e-Signatures in Tanzania with a view of establishing their legal status, applicability, and the future of such technologies in e-Government systems. That is important as Information and Communications Technology (ICT) is widely employed in Tanzania. Moreover, the development and application of information systems is influenced by law. Therefore, the problem investigated is twofold: First, legal status, validity, and admissibility of e-Documents and e-Signatures in evidence in Tanzania are questioned. Second, the challenges facing the establishment of e-Government in Tanzania are explored. The chapter is a qualitative study, i.e. library- and desk-based research. Various literatures focusing on e-Documents and e-Signatures are reviewed, analysed, and evaluated so as to draw a conclusion on the relevancy of e-Documents and e-Signatures in the e-Government projects in Tanzania. The literature analysis conducted found that there is a lack of legal framework to recognize e-Documents and e-Signatures compounded with poor ICT infrastructure in Tanzania. This scenario puts e-Government endeavours at risk. It is recommended that the government should enact the laws to recognise e-Documents and e-Signatures to boost e-Commerce as well as e-Government.

Major Technology Trends Affecting Government Data in Developing Countries

2017 ◽  
pp. 127-135
Author(s):  
Saleem Zoughbi
Keyword(s):  
Sustainable Development ◽  
Developing Countries ◽  
Open Data ◽  
Critical Issue ◽  
Legal Framework ◽  
Information And Communications Technology ◽  
Development Goals ◽  
Government Data ◽  
The Government ◽  
Technology Trends

The success of government data platforms and systems do not depend only on technology. There are other issues that affect this progress. Some of these are very essential to the continuity and not only the implementation, such as leadership. Other issues are the absence of a clear well adopted policy and legal framework that governs its data, security of data, cyber legislation and laws. The government-provided ICT resources and the infrastructure would also be an important issue that would affect government data. Financing is also another critical issue. For developing countries, sustainability of development is a necessity for best impact of development projects. As it is adopted by the United Nations, sustainable development goals (SDG's for the agenda of 2030) have substantial dependency on information and communications technology. All goals practically require government data in one way or another, and hence sustainable development is directly related to government data should successful development is sought. Other issues include open data, open government. This chapter discusses such issues and sheds light on ways of handing them.

12 The Intellectual Property–Competition Interface

2020 ◽  
Author(s):  
Cheng Thomas K
Keyword(s):  
Developing Countries ◽  
Intellectual Property ◽  
Competition Law ◽  
Process Innovation ◽  
Patent Law ◽  
Patent System ◽  
Competition Rules ◽  
The Subject ◽  
The One ◽  
Competition Interface

This chapter focuses on the interface between intellectual property and competition laws. The interface is the most complex between competition law on the one hand and patent law on the other hand. Developing countries only engage in what can be called laggard innovation, which includes acquisition of tacit knowledge, imitation, and process innovation. This may call for a reconsideration of the appropriate approach to the patent–competition interface in developing countries because laggard innovations, with the exception of process innovation, are not the subject of protection of the patent system. If laggard innovations are not the subject matter of protection of the patent system, the patent-competition rules should have little relevance for the quest for innovations in developing countries. In fact, one can argue that the patent system is an impediment to one of the main sources of laggard innovation, imitation, and that the patent-competition rules should be adjusted in a way to facilitate it if one were serious about adopting a pro-growth approach to competition law enforcement in developing countries. This implies that for developing countries that do not produce patentable innovations, there is no need to balance between patent and competition policies. There is in fact no conflict between these two policy objectives. Intellectual property rights and Market-sharing and customer allocation Enforcement and procedure

12. Child Protection

Family Law ◽  
2019 ◽  
pp. 825-915
Author(s):  
Joanna Miles ◽  
Rob George ◽  
Sonia Harris-Short
Keyword(s):  
At Risk ◽  
Social Services ◽  
Family Life ◽  
Child Protection ◽  
Well Being ◽  
State Intervention ◽  
Legal Framework ◽  
The Social ◽  
The Law ◽  
Interim Measures

All books in this flagship series contain carefully selected substantial extracts from key cases, legislation, and academic debate, providing able students with a stand-alone resource. This chapter examines the law on state intervention into family life where a child is considered to be ‘in need’ or at risk of significant harm. It discusses the competing approaches to state intervention and the principles underpinning the Children Act (CA) 1989; the legal framework governing local authority support for children in need under Part III of the CA 1989 and the Social Services and Well-Being (Wales) Act 2014; the law and procedure regulating compulsory intervention into family life by means of care proceedings under Part IV; and the various emergency and interim measures available to protect a child thought to be at risk of immediate harm.

Foreign Aid and Family at Risk

2020 ◽  
pp. 154-168
Author(s):  
Kana Takamatsu
Keyword(s):  
At Risk ◽  
Risk Management ◽  
Developing Countries ◽  
Foreign Aid ◽  
Migrant Workers ◽  
Management Tools ◽  
And Migration ◽  
Aid Policy ◽  
Policy Discussion

This chapter uses the case study of Myanmar to examine how the foreign aid policy should have supported families facing risks. The chapter addresses the issue of poverty, which continues to be the gravest risk in the developing countries. Family could be the cause of poverty as well as the solution of poverty in foreign aid policy discussion. The situation of poverty and migration as risk management tools is examined. Interviews of migrant workers in Thailand and Japan were conducted. There is also a discussion about the developments of Myanmar and foreign aid and how the international community has inadequately responded to the democratization of Myanmar and to the needs of its people.

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