Table of Contents
INTRODUCTION: Patents and health care
CHAPTER I:Patent law in india and uk
CHAPTER II:implementation of trips flexibilities
CHAPTER III:FRAMEWORKS FOR BALANCING RIGHTS TO ACCESS TO MEDICINES AND INTERESTS OF PHARMACEUTICAL COMPANIES
Conclusion: Saving National Interest?
This paper is a work of in-depth research and thorough analysis. It would not have been possible without the help, motivation and guidance of my supervisor Dr. Hayleigh Bosher. I would like to take the opportunity to thank Dr. Bosher for her efforts in helping me through all the difficult times that I have faced and giving her valuable comments on my work whenever required. Her guidance has been truly useful and inspiring at all times. The present dissertation is important to me as I have a learnt a lot and the supervision I have gained throughout will be useful even in my future career aspects.
I also, take immense pleasure to thank my family and friends for being there for me and supporting me throughout the writing of this paper.
A patent is an intellectual property right that is granted to an inventor of a product, to exclude others from manufacturing, selling, importing an invention without the permission of the inventor. It is a social contract whereby the patentee is granted a monopoly over their invention, and in return society receives innovation. Therefore, it is an incentive scheme to benefit inventors and society as a whole.
There are several laws which regulate Patents, such as patent protection, increasing the life of a patent, reducing patentability standards and extending patent protection to undesirable products increase monopolies. The patent owners gain exclusive rights in the form of patents or an exclusive license, thus leading to an increase in the cost of such products. In addition, the patent owners adopt strategies to extend the scope of patent gain additional patents which protect the underlying ingredient of the medicine.
Many pharmaceutical products are protected by Patents. The generic drug manufacturers in the pharmaceutical industry are affected such laws, which in turn affects the price of medicines available to patients. This creates a problem of access to affordable means of healthcare and further affects public health. This research undertakes a review of available studies to conduct a critical analysis of the impact of patent protection in developing health care innovations and further on public health.
Health care costs are rapidly increasing in India and UK. These countries are, for this study, considered as being representatives of developing countries and developed countries respectively. A comparison between the approach followed by India and UK in the field of new patents in technology and access to health care will be conducted to develop an understanding of the Patent laws of both the countries in compliance with the Trade Related Aspects of Intellectual Property Rights (TRIPS) regime and the flexibilities existing in and beyond the boundaries of TRIPS agreement. The relevant patent laws which will be primarily focussed in this study are the Indian Patent Act 1970 and the UK Patents Act 1977. This study will consider the manner in which the TRIPS must be interpreted and implemented to increase access to affordable medicines for example the use of strict standards for patentability in India and UK. This is useful because the countries are free to accommodate the flexibilities specified under their own patent laws, depending on their development needs, to ensure balance between their aim to provide enough incentives for future inventions as well as their aim of affordable access to medicines.
In the UK, almost all the diagnostic services are carried out by the NHS (National Health Service) and sometimes by private companies. The UK has a tradition of ignoring several patents as most of them are under the payment arrangement of NHS. Whereas India does not have a national health services system and healthcare is dispersed in private and government hospitals and there is no standard insurance system where most of the expenses are paid out of pocket
Both the nations are a member of the World Trade Organisation (WTO) and implement the TRIPS and there are striking common features in the manner in which the flexibilities under the agreement are promoted. Such an analysis will lead to an understanding of how the competing interests in the context of access to medicines are being balanced in these countries and what can both the countries learn from each other to further improve their patent practices and balance it with right to access to medicines. Concluding that the situation and needs of both the countries being different, there is still a lot of scope for amendment in the patent laws to the standards of patentability. The research will provide recommendations such as a framework of price control model to ensure sufficient access to medicines, and other recommendation for future of the progressing patent system of both the countries.
INTRODUCTION: Patents and health care
The minimum standards for intellectual property protection are set out by the World Trade Organization (WTO) in the agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) which includes pharmaceutical patents. Under which, the members of the WTO must provide patent protection for at least twenty years. Patents confer the right on the patentee to exclusively manufacture, use or sell the patented invention and stop others from doing the same without their permission. The reason behind patent system is to enable the patentee to gain financial rewards using the exclusive rights and recognise the creativity of the inventor which would then encourage innovation.
It should be noted here that taking public view is important at the time of granting patents. The traditional system of granting patents, did involve public participation to some extent as the demonstration of inventions was through working models. But, patent law developed and there was minimal public participation as the invention could then be demonstrated in a descriptive manner by using words and figures, which thereby added the ‘intellectual’ to intellectual property (IP) law. The patent system today requires the disclosure of invention to the public to promote public dissemination of knowledge and further development by third parties.
On the other hand, it is believed that even though Article 8 of TRIPS also recognises the need to promote public health for protection of public interest, the current patent system does not sufficiently address the public health crisis. It is argued that the commercial incentives provided by patent system are not enough to ensure development of new drugs and medicines to deal with neglected diseases. And the patent rights, enforced on the basis of commercial considerations prevent access to, or increase prices of essential medicines. This will require an intensive critical analysis of relevant case laws to study the approach followed by courts. Therefore, this research will be conducted using doctrinal approach. A doctrinal study focuses on case laws, statutes and other legal sources such as law books, law journal, newspapers, etc. Chapters I and II will deal with the patent system of India and UK. This will enable the author to draw upon the studies of normative conflicts in the approach followed by UK and India, to make it possible to read and interpret the TRIPS as reconciling the international human rights law, as will be demonstrated in Chapter III.
How does the patent system affect public health and access to medicines?
The concept of granting monopoly rights in exchange of new technologies began in England in 14th century, primarily aiming to attract skilled craftsmen from abroad. The patent system ensures the market exclusivity and right to produce and distribute the medicines which leads to companies increasing the costs for profits which is often done to regain the associated research and development and productions costs in all. Even though the system of patents provides incentives for innovation, research and development in the pharmaceutical industry, these companies increase the cost of drugs and medicines as compared to their production costs. This gives rise to the problem of lack of access to essential medicines.
The present dissertation will focus on this controversial topic of the impact of patent protection on access to medicines. While doing so, the main aim will be to analyse the co-relation between the patent practices and access to medicines in two countries namely, India which is, for this study, considered as a representative of developing countries and UK, which is considered as a representative of developed countries. The selection of these countries can be justified on the following grounds: -
Firstly, the number of residents facing the access problem in India is huge and India is seeing some increasingly creative innovations in need of strong patent protection. As an emerging economy, the country has a rich political and legal culture and can ably deploy the domestic legislation in international arena. Some of the world’s largest manufacturing firms are located in India and the world relies on India for supply of generic medicines. The pharmaceutical firms in India have become a noteworthy provider of healthcare products by meeting up to approximately 95 percent of the pharmaceutical needs of the country. But when India became a member of the TRIPS agreement, it was a requirement that India introduces patent protection for products along with processes by January 2005. This had a huge impact on access to pharmaceutical drugs in poorer countries as the supply of generic drugs was reduced. India also provides for constitutional protection for the right to health and therefore it is important to study how India manages to balance between the patent rights and public health concerns.
Whereas, UK has most of the health care problems being dealt with by the National Health Service (NHS). NHS is the primary client of the pharmaceutical industry which spends about 80% of the drugs bill on branded medicines. However less priority has been given to health and there is an increase in ‘medicalisation’ of society as the industry is more money oriented.
Secondly, whilst UK and India have similar patent laws, there are still many differences in the health and development needs. For example, in India, the health care costs are borne by the individuals, whereas in UK costs are mainly covered by state or through insurance schemes. It is hoped that the comparison between the two will enable the countries to reconfigure their domestic patent laws to control the patenting of pharmaceutical drugs and enable generic competition.
This section will set out the key issues that the thesis focuses on, including the implementation of TRIPS flexibilities and access to medicine and enlist the research questions which will be addressed in the thesis.
1. Analysing implementation of TRIPS Flexibilities
The TRIPS agreement provides some flexibilities such as compulsory licensing to remedy the lack of access and allow countries to use the safeguards when patents become barriers for access to medicines. These provisions allow the governments to provide for exclusions, exceptions and limitations for addressing national emergencies. It must also be noted that health and development needs of the developing countries are different from those of the developed countries. Therefore, the minimum standards of patent protection as set out in the TRIPS regime, which are mostly derived from the developed countries, must be interpreted and implemented in a manner most suitable for the developing countries.
This dissertation will therefore outline the number of flexibilities adopted in India and the UK, to analyse the relationship between patents and right to health by revisiting potential conflicts between TRIPS and human rights of access to medicines.
2. Access to medicines
It must be stated that the report of the Special Rapporteur in the 23rd Session of UN Human Rights Council called upon the member states to shift from a market-oriented approach on access to medicines towards a right-to-health paradigm to promote access to medicines. This indicates that access to medicines is considered to be the key element of treatment, prevention and control of diseases but whether the decisions must be left to the trade forum in which patent rights are given more importance is the key issue here. It also addresses the debates at World Health Organisation (WHO) about new methods for research and development.
It is an accepted fact that patent protection is essential for the development of new ground-breaking drugs or medical equipment and enhanced patent protection leads to increased investment in research and development for new medicines. But it also limits price competition on new medicines by generic producers. This debate will be addressed in the course of the dissertation by using and answering the following research questions:
1. In what way is the implementation and enforcement regime of patents in India different from UK? Further, do the courts in both countries succeed in effectively implementing the flexibilities in the TRIPS agreement to ensure adequate patent protection and by protecting public health at the same time?
2. Whether the impact of pharmaceutical patents on public health is the same in India as compared to UK?
3. Are the international standards for patent protection suitable for India and/or the UK?
4. What are the frameworks which can be implemented by both the countries to further improve the practices for balancing between patent rights and access to medicines?
These questions are important because it is difficult to observe directly the impact of patenting in developing country market. Therefore, a comparative approach will facilitate a deeper understanding into the issue of access and how the TRIPS-related public health flexibilities such as compulsory licensing, parallel importation can be useful in order to gain legal access to new medicines and for the producing country to manufacture low-cost products for the purpose of export. Increased patent protection affects access to medicines in the country which produces the medicines as well as the country which imports. This study analyses the relevant legislation and aims to recommend improvements to maximize the TRIPS–compliant flexibilities by conducting a review of the following issues:-
- Measures adopted in India and UK for making medicines easily available.
- Improving patients access in India to currently available drug therapies.
- Improving the prospects for the development of new medicines for diseases endemic in India and UK.
Further by highlighting the acts and omissions of the adjudications of both the countries, through looking at case studies in India and UK, this dissertation will outline and ascertain the shortcomings in the implementation of Patent laws of these countries and discuss whether pharmaceutical patents are beneficial for public in the long run. This will help in assessing whether the obligations in relation to TRIPS regime are being complied by these countries. This will then be useful for answering the research questions.
Assessment of the statutory Patent Law of India and UK and the problem of balancing between patent rights and right to access to medicines.
The first official legislation dealing with the granting of patents in India was the Patents and Designs Act 1911, which was replaced by The Patents Act 1970. This was amended in the year 2005 by the Patents (Amendment) Act. In UK, the Patent Act 1977 and the European Patent Convention are the primary means to protect the patent rights for a period of twenty years. Patent rights limit competition by generic companies as the patented products take the monopoly of the market and thereby affects patients access to medicines.
This chapter will examine and critically analyse the statutory provisions and the adjudications to protect the right of access to medicines adopted by India and UK and the impact of pharmaceutical patents on healthcare. More explicitly, the author shall outline the key characteristics which influence the effective operation of patent law and outline the methods adopted by India to balance between the patent rights and right to healthcare and medicines, such as requirements of patentability standards such as newness, inventive step and industrial application, requirement of disclosure of information.
Comparison of Statutory Patent Law of India and UK
The minimum standards of patent protection were prescribed under the TRIPS agreement and the member nations were required to follow the same. India has been a member of the WTO since 1995 and therefore required to comply with the provisions of the TRIPS Agreement. India was therefore bound to make patents available for products or process, or any kind of invention in all fields of technology. For which, several amendments were introduced in the Indian Patent Law. One of them was the Patent (Amendment) Act 2005, through which product patent was introduced as well as provisions in relation to pre-grant and post grant oppositions in granting of patent were modified. By means of this amendment product patent was extended to all fields of technology which included pharmaceutical drugs. Along with these safeguards, the Drug Price Control Order 1970 was also introduced which provided for a limit on the price of drugs by setting a maximum price for which the drug should be made available.
The current legislation in UK in relation to patents consists of the Patents Act 1977 as amended by the Copyright, Designs and Patents Act 1988 and then by Patents Act 2004, Subsequently amended by the Patents (Compulsory Licensing and Supplementary Protection Certificates) Regulations 2007. The primary effect of the Patents Act 1977 is to bring the patent law of UK closer to the European trading partners, in compliance with the provisions of European Patent Convention (EPC). The criteria for patentability in UK is derived from the EPC.
An invention is patentable if it is new, involves an inventive step and is capable of industrial application. According to the Patent Act 1977 an invention shall be considered to involve an innovative step if it is ‘not obvious to a person skilled in the art’. The term ‘industrial application’ is considered to be insufficient in India as compared to UK because there is no measure on how to determine whether and when a particular invention is capable of being used or applied in an industry. This has created lack of clarity in the interpretation of the patentability standards of an invention. There are not enough consistent case laws to test the standard of non-obviousness and novelty and industrial application of pharmaceutical patents. Even Sec 2 (ta) of the Indian Patents Act 1970 as amended in 2005 only goes to the extent of defining ‘pharmaceutical substance’ as ‘new entity involving one or more inventive steps’. This is vague and there is no mention of this concept anywhere else in this act. The invention does not in itself provide the evidence of industrial utility and the applicant must show substantial, specific and credible utility of the claimed invention.
 Ruth L Okediji and Margo a Bagley, Patent Law in Global Perspective (1st edn, Oxford University Press 2014), page 53.
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 Ibid, page 9.
 Anand Grover and Brian Citro, ‘India: Access to Affordable Drugs and the Right to Health’ (2011) 377 The Lancet, page 976.
 WHO, ‘Intellectual Property and Access to Medicines’ (WHO, 2012) page 3.3 <http://apps.who.int/medicinedocs/documents/s19580en/s19580en.pdf> accessed 27 January 2018.
 The Health Committee, ‘The Influence of the Pharmaceutical Industry Fourth Report of Session 2004–05, Volume I’ (2005) page 3 <www.parliament.uk/parliamentary_committees/health_committee.cfm> accessed 31 January 2018.
 Linda L Lee, ‘Trials and TRIPs-Ulations: Indian Patent Law and Novartis AG v. Union of India.’ (2008) 23 Berkeley Technology Law Journal, page 218.
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 'WTO and the TRIPS Agreement' (World Health Organization, 2018) <http://www.who.int/medicines/areas/policy/wto_trips/en/> accessed 20 April 2018. The TRIPS agreement is a multilateral agreement of the World Trade Organisation (WTO) which came into effect on 1 January 1995. This agreement is expected to have a greatest impact on access to medicines by affecting the pharmaceutical industry.
 Joo-Young Lee, A Human Rights Framework for Intellectual Property, Innovation and Access to Medicines (2nd edn, Routledge 2016), page 3.
 Supra note 9.
 The Health Committee, ‘The Influence of the Pharmaceutical Industry Fourth Report of Session 2004–05, Volume I’ (2005) <www.parliament.uk/parliamentary_committees/health_committee.cfm> accessed 31 January 2018.
 Thomas Pogge, Matthew Rimmer and Kim Rubenstein, Chapter on ‘Access to Essential Medicines: Public Health and International Law’ in Incentives for Global Public Health: Patent Law and Access to Essential Medicines (Cambridge University Press 2010), page 8. See also, Ellen Thoen, ‘TRIPS, Pharmaceutical Patents, and Access to Essential Medicines: A Long Way from Seattle to Doha.(World Trade Organization conferences) (Public Health and International Law)’ (2002) 3 Chicago Journal of International Law, page 39.
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 Feroz Ali Khader, Chapter on ‘ Patent System, Constitution, and the Public’ in ' The access regime : patent law reforms for affordable medicines' (1st edn, Oxford University Press 2016), page 3.
 Ibid, page 5.
 Ibid, page 5.
 Elizabeth Siew-Kuan NG, Chapter on ‘ Global health and development: patents and public interest’ in Thomas Pogge, Matthew Rimmer and Kim Rubenstein, Incentives for Global Public Health: Patent Law and Access to Essential Medicines (Cambridge University Press 2010), page 113.
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 Ibid, that is to reward innovation and foster research and development for the production of new medicines.
 Roger Brownsword, 'An Introduction to Legal Research' (Documentbest.com, 2018), page 3 <http://documentbest.com/q9/3wgny7m4q9> accessed 10 April 2018.
 Joo-Young Lee, A Human Rights Framework for Intellectual Property, Innovation and Access to Medicines (2nd edn, Taylor and Francis 2016), page 177.
 Revesz (n 9) page 83.
 Carlos M Correa, ‘Public Health and Intellectual Property Rights’ (2002) 2 Global Social Policy, page 261.
 WHO, ‘Intellectual Property and Access to Medicines’ (WHO, 2012), page 3.2 <http://apps.who.int/medicinedocs/documents/s19580en/s19580en.pdf> accessed 27 January 2018.
 Ibid, page 3.2.
 Ruth L Okediji and Margo a Bagley, Patent Law in Global Perspective (1st edn, Oxford University Press 2014), page 56.
 Ibid, page 56.
 'Why India's Generic Medicines Industry Is So Important' (MSF USA, 2010) <https://www.doctorswithoutborders.org/news-stories/field-news/why-indias-generic-medicines-industry-so-important> accessed 25 March 2018.
 Xuan Li, ‘The Impact of Higher Standards in Patent Protection for Pharmaceutical Industries under the TRIPS Agreement - A Comparative Study of China and India’  The World Economy, page 1367.
 Jae Sundaram, ‘India’s Trade-Related Aspects of Intellectual Property Rights Compliant Pharmaceutical Patent Laws: What Lessons for India and Other Developing Countries?’  Information & Communications Technology Law, at page 7.
 Thomas Pogge, Matthew Rimmer and Kim Rubenstein (eds), Incentives for Global Public Health (Cambridge University Press 2010), page 381.
See also Editorial, ‘India’s Choice’, (The New York Times, 18 January 2005).
 Ibid, page 381.
 The Health Committee, ‘The Influence of the Pharmaceutical Industry Fourth Report of Session 2004–05, Volume I’ (2005), page 3 <www.parliament.uk/parliamentary_committees/health_committee.cfm> accessed 31 January 2018
 Ibid, page 3.
 Ibid, page 3 .
 See the Indian Patent Act 1970, the English Patents Act 1977.
 ‘Integrating Intellectual Property Rights and Development Policy’ (2002), page 1 <http://www.bhttp//www.iprcommission.org/graphic/documents/final_report.htm%5Cnhttp://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3388467&tool=pmcentrez&rendertype=abstract>, accessesed 5th March 2018.
 Pogge, Rimmer and Rubenstein (n 28) at page 9, See also, Art 30 and 31 of the TRIPS Agreement deals with the exceptions to rights conferred, and considers other use of patents which do not require authorisation. For example, use of compulsory licenses by giving reasonable compensation and use of system of international exhaustion by placing the product into the market with authorization.
 Ibid, page 9 .
 Rajshree Chandra, Chapter on ‘ The Role of National Laws in Reconciling Constitutional Right to Health with TRIPS Obligations: An Examination of the Glivec Patent Case in India’ in Thomas Pogge, Matthew Rimmer and Kim Rubenstein (eds), Incentives for Global Public Health (Cambridge University Press 2010), page 381.
 Ibid, page 381 .
 Ibid, page 381 .
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 T.G Agitha, 'The Impact of IP On Public Health: The Developed Country Scenario' (2013) 18 Journal of Intellectual Property Rights, page 382.
 WHO adopted global strategy, established the Commission on Intellectual Property Rights, and classified infectious diseases into three different categories to ensure that substantial attention is given to the diseases affecting the rich as well as the poor countries. However, the policies adopted by WHO were criticised for not being concrete and living up to the mark.
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 Druce (n 8), page 5.
 Ibid, page 6.
 Ibid, page 6.
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 Ramesh Subramannd Lea Shaver, Access to Knowledge in India: New Research on Intellectual Property, Innovation and Development (Bloomsbury UK 2011), page 78.
 Ibid, page 79.
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 Sundaram, (n 32), page 7.
 Shaver (n 54) , page 79 , See Art 27.1 of TRIPS.
 Sundaram (n 32) , page 10.
 Ibid, page 1.
 Ibid, page 1.
 Ibid, page 6.
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 The Patents Act 1977 ( as amended ).
 Jan Rosén, European Intellectual Property Law an Edward Elgar Research Review (Edward Elgar Pub 2016), page 3.
 Section 1, 2,3 and 4 of The Patents Act 1977 ( as amended ).
 Ibid, Section 3.
 Michael Burdon, ‘The UK: Can a High-Cost Country Change Its Way?’  WIPOMagazine <http://www.wipo.int/wipo_magazine/en/2010/01/article_0003.html> page 22.
 Ibid, page 22.
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