I. INTRODUCTION
One of the most controversial provisions of the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) patent regime is the compulsory product patent protection for pharmaceutical inventions. In order to comply with the TRIPS obligation, India introduced product patent protection from 1 January 2005. In doing so, India in a way reinstated the patent regime, which is believed to favour the pharmaceutical Multinational Corporations (MNCs). While carrying out the amendment, Indian policy makers were confronted with two major concerns, viz. the future of the Indian pharmaceutical industry and access to affordable medicines within the country and other developing countries. Thus the “major concern was how the adoption of intellectual property regimes would affect their efforts to improve public health, and economic and technological development more generally, particularly if the effect of introducing patent protection was to increase the price and decrease the choice of sources of pharmaceuticals”. To make use of the flexibilities available within and outside of TRIPS turned out to be the most pragmatic solution available for developing countries, including India, to address the concerns on the availability and accessibility of medicines. According to this approach, TRIPS provides only minimum standards of protection and does not set the universal common standard for the
In 1970 the government passed two new regulations that has effect on the pharmaceutical industry. “The India Patent Act prohibited
Paragraph 5 of the Preamble of the TRIPS Agreement provides that “the underlying public policy objectives of national systems for the protection of intellectual property, including developmental and technological objectives” Accordingly, the Preamble is not an operative provision. Therefore, Professor Grosse Ruse-khan suggests that the position of the Preamble “merely opens a door” for other national interest to be taken into consideration, nonetheless the interest would not necessarily prevail. He contends that non-economic interest would be only considered as an “exception” to the right. Through the use of the flexibilities embedded in TRIPS, Professor Gervais contends the Preamble recognizes developing countries’ need to realize their developmental objects, such as innovation policy. However, he also stresses that the flexibility should be used in a manner that “[creates] a sound and viable technological
The key multilateral economic institutions provide financial support though grants and loans as a way to enable economic and social development to occur in developing countries. The three main institutions i will be talking about include the World Bank, International Monetary Fund and the World Trade Organisation. These organisations provide loans, grants and practical assistance to governments, in addition to loaning money to assist private businesses within developing countries. They also play a significant role in the privatisation and overseeing of public utilities and natural resources. The World Bank (WB) and the International Monetary Fund (IMF), often called the Bretton Woods Institutions, are duplicate intergovernmental pillars
Canadian-based company Research In Motion (RIM) is an excellent case study in the challenges associated with Intellectual Property rights, especially in light of the company’s need to operate within the Intellectual Property frameworks of countries across the globe. Started by then twenty-three year old, Mike Lazardis in 1984, RIM has been involved on both sides of patent infringement law suits since the year 2000.
In a general term, intellectual property is any person’s human intellect, which is often protected by law, in order to safeguard its use from another person. The possession of such kind of property generates limited monopoly in the safeguarded property. Intellectual property can be subdivided into copyrights, patents, trademark and trade secrets (Intellectual Property Rights, 2014).
Trade-Related Intellectual Property Rights (Trips) Have Been Adopted With A View To Encourage Fair Competition At The International Level, But Trips Rules Tilt The Balance In Favour Of Imperfect Competition With Each Country And Exacerbates International Inequalities.
Moreover there is fear that strong implementation of IPRs will have adverse effect on life saving drug prices and local industries. Implementation of strong IPRs law before and during the Uruguay Round was strongly opposed by developing countries. Developing countries fear that implementation of strong IPRs rules and regulation will disturb the strategies of providing new life saving drugs and medicines at low cost. Drugs and essential medicines will not be easily available if local firms do not specialize in the production of affordable generic versions of new drugs. According to Mishra, V. (2001), stronger implementation of IPRs could lead to restrict the capacity of local firms to produce generic products in domestic market as well as international market.
India for that case has already established a global footprint, supplying generics to many countries . They are enthusiastic about the direction of their strategy – global expansion. The reason is simple as healthcare systems around the world are pushing for the use of generics. It is desired even in the USA as huge savings have been made in the healthcare system and penalties have been issued when generic prices rise ahead of inflation . Also, there is a positive forecast that generic usage will be increased close to 40% by 2020 . Knowing that exporting of generics is a lucrative part of the business, is also a big reason to why Indian companies and the government are beefing up the standards of pharmaceutical factories within the country . Strategies for global expansion are set out for long term goals, by being loyal to their plans, eventually the quality standards of ‘Pharmerging’ countries will be accepted
1. Eli Lilly’s entry into the Indian market seems apt in view of India's large population. This is particularly so given that the demographics are predominantly middle-class. Therefore, this group offers a huge growth potential for Eli Lilly, since they are perceived to command higher disposable income that would allow them to afford Eli Lilly’s premium pharmaceuticals. Secondly, Eli Lilly’s timing to enter into the Indian market is apt due to India’s economic reformation, which allowed foreign firms like Eli Lilly to hold majority ownership in a joint venture. This mitigates Eli Lilly’s risks of losing technology to its local partner by allowing Eli Lilly to exert more control over the JV. Thus, this allows Eli Lilly to maintain its competitive advantage in a foreign market. Thirdly, the cost of running clinical trials in India
In recent years there has been much discussion both within Australia and internationally on the extent to which countries benefit from international trade agreements. In this case study we aim to focus on the global context of the pharmaceutical industry, in particular the effect of governmental intervention through the use of international trade agreements, highlighting the problematic patent system and how it affects the market place both internationally and domestically.
This thesis argues the IPAB correctly held discrimination not able to be found, because patent rights indeed “available” to the patentee. The non-discrimination obligation in article 27.1 of the TRIPS Agreement entails Members of the WTO to make patent rights “available” to applicants. The IPA article sets out the obligation of granting countries:
The concept of product patent for pharmaceutical products is likely to make life saving medicine beyond the reach of the poor and deprived section of the society around the world.
The World Trade Organization (“WTO”) Dispute Settlement System and the International Centre for the Settlement of Investment Disputes (“ICSID”) are two of the most widely used methods of international dispute settlement.
India is a massive country known as a leader in cultural diversity, and also has the second largest population in the world. India has been opening its business environment to welcome foreign investors as well as foreign companies. The pharmaceutical industry in India has become one of the most attractive investment places in the world, which is estimated to be worth US$20 billion, and expected to grow over about 15 percent per annum (IBEF, 2016). Moreover, the country ranks very high in the third world, regarding technology, quality and range of medicines manufactured, as stated in the book written by NPCS Board (2013). Therefore, in order to start a pharmaceutical business and be successful in India, we will analyze the Indian business environment before completing the business plans and strategies.
The decision of this instance requires the starting of a short report of the Indian pharmaceutical industry, to expose the trip about its recent times of progress. India’s pharmaceutical industry was famous for duplicating the majority of the patented drugs from the organizations of the Western world and Japanese nation. The scheme occurred before passing a contract with the world trade organization. The statement mentioned above procedure result from the U.S. only, between the develop markets. Nonetheless, the ratification of the contract with the world trade organizations in 2005, brought the Indian pharmaceutical industry to compliance of defending the knowledgeable belongings rights