Access to affordable Medicines in India and the Instrument of Compulsory Licensing: Case of Nexavar

Patents in India are granted to encourage inventions and to secure that it is worked on a commercial scale. The Indian Patent Act ensures that a Patentee should not be able to enjoy a monopoly for the importation of the patented article. The Patent Act provides measures by way of compulsory licensing (CL) to ensure that the patents do not impede the protection of public health and nutrition and the patent rights are not abused by the patentee. The CL therefore serves to strike balance between two disparate objectives- rewarding patentees for their invention and making the patented products, particularly pharmaceutical products, available to large population in developing and under developed countries at cheaper and affordable cost.

As is known, CLs allow third parties to exploit a patented invention without the consent of the patentee. They there, deprive patentees of their most important right, i.e. the right to say ‘no’ to the exploitation of their invention by the third parties. CLs are usually granted through administrative procedures managed by a governmental body. CLs are granted by governments which, thereby, substitute their authority for the consent of the patent owner. They therefore are in the nature of administrative contracts.

On March 9, 2012, India’s first CL was granted by the Patent Office to Natco Pahrma Ltd. for producing generic version of Bayer Corporation’s patented medicine Nexavar, used in the treatment of Liver and Kidney cancer.  The Controller decided Bayer on all the three grounds in the Patents Act for the grant of CL (reasonably requirements of the public not being satisfied; non-availability to the public at a reasonably affordable price, and the patented invention not being worked in the territory of India). While the multinational giant was selling the drug at INR 2.80 lakh for a month’s course, Natco promised to make available the same at a price about 3% (INR 8800) of what was charged by Bayer. Natco was directed to pay 6% of the net sales of the drug as royalty to Bayer. Among other important terms and condition of the non-assignable, non-exclusive license were directions to Natco to manufacture the patented drug only at their own manufacturing facility, selling the drug only within the Indian Territory and supplying the patented drug to at least 600 needy and deserving patients per year free of cost.

Aggrieved by the Controller’s decision, Bayer immediately moved to the Intellectual Property Appellate Board (IPAB) alleging that the grant of CL was illegal and unsustainable. On March 4, 2013, IPAB upheld the country’s first compulsory license to a pharmaceutical product.  Specifically, the decision upheld a compulsory license issued to Natco Pharma Ltd., an Indian generic drug manufacturer, to sell Bayer’s patented chemotherapy drug Nexavar (sorafenib tosylate).  The Board rejected Bayer’s appeal holding that if stay was granted, it would definitely jeopardize the interest of the public who need the drug at the later stage of the disease. It further held that the right of access to affordable medicine was as much a matter of right to dignity of the patients and to grant stay at this juncture would really affect them. Given the economic consequences of this compulsory license, Bayer is expected to further appeal this decision.  It is important for companies procuring patents and doing business in India in all industries to understand the country’s compulsory licensing laws.

A compulsory license is a statutorily created license that allows certain parties to use or manufacture a product encompassed by the claims of a patent without the permission of the patent owner (patentee) in exchange for a specified royalty.  The Indian Patent Act (Act) contains very broad compulsory licensing provisions.  The two provisions of the Act that allow for compulsory licenses are Sections 84 and 92.

Compulsory Licenses in India

As mentioned above, the IPAB upheld the compulsory license to Nexavar on March 4, 2013, which was originally granted by the Controller in March 2012.  Since 2012, compulsory licenses have been granted or are in process of being granted for several pharmaceutical products as shown by below:

Drug	Company	Indication	When Issued
Nexavar®	Bayer	Hepatocellular carcinoma	March 2012 – Decision upheld March 2013 (Article 84)
Herceptin®	Genentech	Breast cancer	In process by the Department of Industry Property and Promotion (DIPP) (Article 92)
Ixempra®	BMS	Breast cancer	In process by the DIPP (Article 92)
Sprycel®	BMS	Leukemia	In process by the DIPP (Article 92)

Compulsory licenses issued in other countries

India is not the only country that has issued compulsory licenses for patented pharmaceutical products.  While the compulsory license laws vary country-by-country, as shown in the below table, compulsory licenses have been issued by several countries for a number of different pharmaceutical products, as under-

Country	Drugs
Brazil	Efavirenz
Cameroon	Lamivudine, Nevirapine
Canada	Oseltamivir
Ecuador	Lopinavir/Ritonavir
Ghana	Generic HIV and AIDS medicines
Indonesia	Lamivudine, Nevirapine
Israel	Hepatitis B vaccine
Italy	Imipenem/cilastatine, Sumatripan succinate
Malaysia	Didlanosine, Zidovudine
Mozambique	Lamivudine, Stavudine, Nevirapine
Thailand	Lopinavir/Ritonavir, Clopidrogel, Erlotinib, Letrozole, Docetaxel
Zambia	Lamivudine, Stavudine, Nevirapine

Conclusion

The issue of compulsory licenses in India is something that every company should be concerned about when procuring patents and conducting business in India.  While most of the recent attention has centered on compulsory licenses for patented pharmaceutical products, it is important to remember that India’s Patent Act provides for broad compulsory license provisions that are not limited to just pharmaceutical products but encompass products from any technology.

Interfaces between Intellectual Property and Consumer Protection Law: A Review

Globalization has made the world smaller by integrating the global markets. It has given consumers a greater choice of products and brands with lower costs. However, this has also exposed them to various unfair practices adopted by the producers. It is generally recognized that a strong intellectual property right (IPR) regime is a critical precondition for enhancing and stimulating economic growth in the country. It facilitates greater investment into the research and development as well as provides means to improve the quality of life of people of the country. IPR not only protects the innovative and creative capacity of competitors and owners of IP rights that supply goods and services, but it also concern itself with the interests of the consumers of those goods and services, directly or indirectly. The existence of such rights is necessary for overall development of society. The areas of intellectual property that are most relevant for consumer protection are Trade Marks, Geographical Indications and Protection against unfair competition. A trade mark is a sign which is used in the course of trade and distinguishes goods or services of one enterprise from those of other enterprises. While, a geographical indication is an indication used to identify goods having special characteristics originating from a definite geographical territory. These IP rights help the consumers in buying quality products and protect them from use of substandard products which may cause health and safety hazards. Thus, the proper operation of IP rights and their enforcement is very important for consumers. Further, it is the core of IP system that people of the country must be protected from unfair competition, that is, from any act of dishonest practice in trade and business.

Protection against unfair competition has been recognized as one of the main objectives of intellectual property system, which prohibits any act of competition that is contrary to honest practices in industrial or commercial matters, referred to as "unfair competition". The acts of unfair competition not only adversely affect the competitors, which tend to lose their customers and market share; but also affect consumers as they are likely to be misinformed and mislead and tend to suffer economic and personal prejudice. Whatever form unfair competition may take, it is in the interest of the honest and legitimate entrepreneur, the consumer and the public at large that they should be prevented from it as early and as effectively as possible. Free and fair competition between enterprises is considered to be the best means of satisfying supply and demand in the economy as well as of serving the interests of consumers and economy as a whole. This stimulates innovation and productivity and leads to the optimum allocation of resources in the economy; reduces costs and improves quality; as well as accelerates economic growth and development. The paper attempts to undertake a review of the above interfaces between IPR and Consumer Protection regime in India.

What we can do to protect our environment?*

The major challenge of today’s industrialized world is to establish the proper balance between the “three Es: environment, energy and economic development”. I think economic growth and environmental conservation can go together for sustainable growth. We should not do things only for today, but we should care about tomorrow. Mahatma Gandhi famously said “Earth provides enough to satisfy every man’s need, but not every man’s greed.”

Since it is better to prevent problems from happening than to fix them later, the key to the solution lies in prevention and control. First and foremost, governments should adopt rules and regulations to promote sustainable development, for example, to encourage the use of renewable power instead of non-renewable energy, and to encourage policies for availability of clean sources of energy. Moreover, it is essential to educate people and create awareness in the society about how economic growth and environmental conservation can go together. It is very important to understand that environmental problems are everyone’s problem, and require everyone’s involvement. Our local actions affect the whole world. The solution lies in thinking and planning globally, and acting locally. Each person has a duty and role in protecting the environment as part of the society. There are a lot of things that one can do to promote sustainable growth. We should join hands in the global movement for the protection of environment. Wangari Muta Maathai, the winner of the 2004 Nobel Peace Prize started environmental conservation movement in Kenya, and then it expanded to become a global environmental phenomenon. Humans are the key to everything. So, do economic growth and environmental conservation go together? I would say “yes” if we can educate people to make them realize how we can be a part of a better solution that makes both economic growth and environmental conservation work together for the sustainable development of us all.

*Amit Singh

Negotiating New International Order on Climate Change: Challenges & Prospects*

Global warming is a subject which sharply divides nations of the world, so much so, that the present day non-absolute concept of sovereignty takes up the centre stage. Kyoto Protocol of the United Nations Framework Convention on Climate Change (UNFCCC) was a remarkable agreement reached by the international community in 1997 at Kyoto, Japan, which made the industrialized nations (who are historically the biggest contributors of green house gases which causes global warming) cut emissions of their green house gases (GHGs) by 2012 to 5.2 percent below 1990 levels. Developing countries were encouraged to adapt to climate change by adopting environment-friendly technologies in their production processes. United States betrayal of the Kyoto Agreement is well known; when in February 2002 it refused to ratify it. In contrast, the European Union (EU) as a whole, and some countries such as Luxembourg, Germany, Great Britain in particular took lead in implementing their commitments under Kyoto treaty. The Kyoto Protocol requires the EU to cut its GHGs by 8 per cent from its 1990 level during 2008-2012. In fact, EU went beyond its commitment under Kyoto Protocol, and accepted a substantial emissions cut for itself, i.e. to reduce 20 percent of its GHGs by 2020.
The success or failure of the Kyoto Protocol is yet to be thoroughly ascertained. However, it is also to be noted that this only international agreement on climate change will expire in 2012. Therefore, the international community has made serious efforts in the recent past to renew its GHG mitigation commitment, and to adopt a climate change regime in post-2012 scenario. The main focus of the thirteenth Conference of Parties to the UNFCCC (COP 13) and third Conference of Parties serving aqs the Meeting of Parties to the Kyoto Protocol (COP/MOP 3) held at Bali, Indonesia in December 2007 was to lay down the future road map of the Kyoto Agreement in areas such as-mitigation, adaptation, transfer of technology and financing. The Bali Summit resulted in the issue of adaptation gaining predominance despite the climate change regime’s primary focus on mitigation. The decision to crate Adaptation Fund in Bonn, Germany bore fruit at the Bali COP/MOP 3. Bali Agreement referred to ‘nationally appropriate mitigation actions by developing country parties in the context of sustainable development supported by technology and enabled by finance and capacity building in a measurable, reportable and verifiable manner’. This decision is different from the general obligation assumed by all countries including developing country parties. Bali Summit can be said to be one of the stepping-stones to the post-Kyoto climate change regime.
The recently concluded Conference in Copenhagen (COP 15) was convened to negotiate the new international agreement on climate change in post-Kyoto scenario beyond 2012. The significance of the Copenhagen meeting lies in the fact that an unprecedented number of heads of governments—almost 120 were present—decided to come at Copenhagen to provide political leadership and give the final push for the new ‘international climate order’. The outcome of the Copenhagen meeting may be seen as a failure, if we judge it on the basis of the high degree of optimism arising out of the presence of an unprecedented number of heads of government. The Copenhagen Accord—the substantial outcome of negotiations—does not impose actual and verifiable obligations or binding emissions targets in particular or finance contributions. In spite of this fact, there have been significant progress in at least three area—financing, deforestation and adaptation.
In such a complex background, this paper will attempt to capture the possible scenarios that may arise in the near future with respect to reaching upon a new international agreement on climate change for the post-Kyoto world by the international community.

*Abstract of my paper accepted for presentation during the International Conference on "Cooling the Earth: Tactics for Restoring Climate Order and Saving the Living Planet" to be held on 15-17 November, 2010 at G.B. Pant University of Agriculture & Technology, Pantnagar, Uttarakhand.

Juvenile Justice & Child Protection: Case of India

The issues related to children’s welfare and juvenile justice came to the fore during 80s and 90s, when the international community recognized the need of taking concrete action in protecting child rights and stops their abuse and exploitation. United Nations formulated Standard Minimum Rules for the Administration of Juvenile Justice (Beijing Rules) in 1985. General Assembly of the United Nations adopted the Convention on Rights of the Child in 1989. UN again adopted Rules for the Protection of Juveniles Deprived of their Liberty in 1990. In fact way back in the year1979, UN observed International Year of Child. A World Summit on Child was also convened in 1990. At the level of SAARC the issue of child rights was duly recognized and the member countries have devoted the decade of 1990s towards girl child. These international developments triggered action at the domestic level as well. Various governments enacted special legislation and adopted policy measures for the protection of child rights in their domestic jurisdiction.

Government of India had earlier enacted Juvenile Justice Act in 1986, which it amended by a new legislation Juvenile Justice (Care and Protection of Children) Act, 2000 to make its standards match with internationally recognized standards. However, government lacks capacity to implement these legislative instruments to their full potential, which can be easily seen when children are the most suffered lot in society and can be commonly seen begging on streets or engaged in child labour in India. It is estimated by independent agencies that around 50 million children are working as child labourers in India. Mostly children are grossly abused and exploited all over the country for commercial and personal benefits. In any societal set-up, civil society has a crucial role to play towards its overall development. In a vast country like India, the government alone is insufficient to appropriately fulfill its comprehensive welfare role. As such, the role of NGOs hardly needs to be emphasized. NGOs across the world have fairly performed their role in protecting children from exploitation and rehabilitating/reintegrating them into society, by cooperating with government agencies at the state and national level. In India too, several NGOs are operating for the cause of children. Their role is highly appreciative and need to be appropriately recognized. Child labour is a peculiar problem in almost every society. Indian Constitution and Special laws provide measures for the child rights protection. However, our enforcement machinery needs to be geared-up to face the challenges posed by this inhuman social evil, which bring bad-image for the second-fastest growing economy in the world. It should be the combined efforts of the government, civil society groups and the people at large to bring about transformation in our society, and make it child friendly in the best possible manner.

Commission for Protection of Child Rights- A Welcome Step

India ratified the United Nations Child Rights Convention on 11 December 1992, and the Commissions for Protection of Child Rights Act, 2005 was passed in 2006 as one of the necessary steps to protect the rights of the children in the country. The National Commission for Protection of Child Rights (NCPCR) was constituted in 2007. The Act also provides for setting up of state commissions for protection of children as also children's courts for providing speedy trial of offences against children and violation of child rights. The National/State Commission consists of seven members including a Chairperson and six members, of which at least two need to be women. The chairperson has to be a person of eminence who has done outstanding work for promoting the welfare of children. The members, out of whom at least two shall be women, will be appointed from among persons of eminence and experience in the fields of education, child health care or welfare, juvenile justice, elimination of child labour, child psychology or sociology and laws relating to children, the official said.

The Act empowers the State Government to notify at least a court in the State or a Court of Sessions in each district as a Children’s Court, with concurrence of the Chief Justice of the concerned High Court. For every Children’s Court, the State Government is required to appoint a Public Prosecutor or appoint an advocate who has been in practice for not less than seven years as the Special Public Prosecutor. However, various state governments are yet to implement the provisions of this Act, which must get operational without delay. A well planned rescue and rehabilitation strategy should be evolved by these statutory commissions to provide shelter and compulsory education to all children below the age of fourteen years.

The functions and powers of the National Commission are as following:

• Examine and review the legal safeguards provided by or under any law for the protection of child rights and recommend measures for their effective implementation

• Prepare and present annual and periodic reports upon the working of these safeguards

• Inquire into violation of child rights and recommend initiation of proceedings in such cases

• Undertake periodic review of policies, programmes and other activities related to child rights in reference to the treaties and other international instruments

•Spread awareness about child rights among various sections of society

•Examine and recommend appropriate remedial measures for all factors that inhibit the enjoyment of rights of children affected by terrorism, communal violence/riots, natural disaster, domestic violence, HIV/AIDS, trafficking, maltreatment, torture and exploitation, pornography and prostitution

•Undertake and promote research in the field of child rights

•Inspect institutions meant for juvenile/children

•Inquire into complaints of deprivation and violation of child rights, non-implementation of laws and non-compliance policy decisions, guidelines or instructions

•Undertake other necessary functions for the promotion of child rights. The Commission has the power of a civil court and all criminal cases brought to the same has to be forwarded to a concerned Magistrate who has jurisdiction to try the same.

Biofuels and Food Security Concerns!*

The increasing use of food and feed crops for fuel is altering the fundamental economic dynamics that have governed global agricultural markets for the past century. Investments in crop-based biofuels production are rising steadily as countries seek substitutes for high-priced petroleum products, GHG-emitting fossil fuels, and energy supplies originating from politically unstable countries.

At the global level, the current interest in biofuels is mainly seen in the context of industrial production operating within the framework of an international market governed by globalization rules. Two trends have emerged from the biofuels scene. On the one hand, fossil fuel-importing nations who are seeking an immediate solution to reduce their growing energy expenditures, and on the other hand, countries which are currently-or are interested in becoming-biofuels exporters, are attempting to position themselves strategically within the global energy market. This reflects the great hope for biofuels as key in overcoming the energy crisis, promoting alternative energy, and reducing global warming and its consequences. The industrial scale production of biofuels practiced to date has focused primarily on the conversion of crops such as sugarcane, corn, soyabean etc. as a fuel base. This first generation of biofuels remains contested and is currently the source of a heated debate on the threat that energy security poses to food security.

The former Finance Minister of India, Mr. Chidambaram, while addressing an academic gathering in Singapore observed (2008), that in a ‘climate of food insecurity’ it is ‘outrageous’ that developed countries are turning food crops into biofuels. He said that countries like US were doing so (it is expected that 20% of the corn produced in US goes to making biofuels) while the world’s poor are struggling with surging food prices; and using corn and other crops for fuel is a sign of ‘lopsided priorities’. This reflects the growing divisions between nations on the issue of food security implications of biofuels crops.

*Selected excerpts from one of my earlier Articles!

Tapping North-East Potential for India's enhanced Trade Relations with ASEAN

India's North-East, also known as the land of the seven sisters, comprises the States of Arunachal Pradesh, Assam, Manipur, Meghalaya, Mizoram, Nagaland and Tripura. All the North-Eastern Indian States have distinct advantages, and provide immense economic and trade opportunities to domestic and international corporates. The region shares borders with China in the north, Bangladesh in the South-West, Bhutan in the North-West and Myanmar in the East. This makes the North-East a prospective hub of international trade and commerce. Blessed with biodiversity, huge hydro-energy potential, oil and gas, coal, limestone, forest wealth, fruits and vegetables, flowers, herbs and aromatic plants, rare and rich flora and fauna, Northeast India has all the potential to transform into a commercial hub and tourist paradise. As such, it offers huge opportunities in sectors of strategic importance like energy and infrastructure; oil, natural gas and hydrocarbons; agro, food processing and horticulture; floriculture; IT and ITeS; cement; defense, etc. Despite all these advantages, this region is a huge untapped, emerging market, which should prove to be of interest to large domestic and international investors.

Unlike the rest of India, North-East India has an added demographic advantage, in the sense that it account for7.8 per cent of the country’s total land space but has a population of 3.8 crore, which makes it approximately 3.73 per cent of the country’s population. The region is known for its ethnic, linguistic, cultural, religious and physiographical diversity. North East India Tourism is another potential high growth industry. North-East India is often described as the Gateway to South-East Asia. India’s ‘Look East’ Policy aims at transforming the North-East into a dynamic center of a thriving and integrated economic space, linking the two high-potential regions with a network of highways, railways, pipelines, and transmission lines crisscrossing the region. The huge complementarity arising out of India’s ‘Look East’ Policy and our South-East Asia focus, and the ‘Look West’ Policy of South-East Asian nations like Thailand, gives rise to immense opportunities for India and ASEAN countries to develop their trade and investment relations, using the North-East as a primary focal point.

However, as pointed earlier, despite these great advantages, the North-East has not grown at par with the rest of the country, and the region’s potential has not been tapped properly. Various significant initiatives have been taken by the Government of India to promote economic growth, tourism and development in the North-East region in the recent past. The crucial role played by the infrastructure-related issues like shortage of power generation capacity, over-dependence on hydro-power, absence of proper road connectivity, etc., are crucial for the overall development of the region to its true potential.

If given proper implementation, Indian government’s North East strategy could result in making North East an important site for India’s enhanced trade relations with ASEAN, which both the blocs are aiming under their much-awaited Free Trade Agreement (FTA). India and ASEAN are at the crucial moment of signing the Free Trade Agreement (FTA) at the postponed ASEAN Summit meeting in Bangkok in August 2009, after resolving all their contentious issues.