Dr Ashwani Mahajan
Recent visit of American President Barak Obama as chief guest at Republic Day function has been boasted as a major breakthrough in Indian diplomacy. It is being looked upon as an indicator of improving Indo-US relations. Huge delegation of US businessmen had also accompanied US President. Though it may be said that in today’s world, promotion of business requires mutual cooperation between nations; therefore heads of the states sitting together to sort out issues coming in way of the business and investment may be considered a welcome step. However, issues being talked about highly contentions and therefore, India needs to tread cautiously.
Discussion on Patent
Much before the visit of US President, discussion were on that US companies have been impressing upon US administration to help them get rid of the provisions coming in way of their business interests and profiteering. The issue was very much in circulation, when Prime Minister Narendra Modi visited USA taking over the reign of power. During Modi’s US visit, it was decided to constitute a high level Intellectual Property (IP) Working Group, which would work for solution of contentious issues coming in way of investment. This group would function as a part of Trade Policy Forum (TPF). The US-India Trade Policy Forum (TPF) is a government-to-government trade dialogue between the two nations. Joint statement of Modi-Obama on the occassion of Modi’s visit reads as follows
“Agreeing on the need to foster innovation in a manner that promotes economic growth and job creation, the leaders committed to establish an annual high-level Intellectual Property (IP) Working Group with appropriate decision-making and technical-level meetings as part of the Trade Policy Forum,”
Background of the working group is that US companies have been complaining that Indian patent laws are against their business interests and are also in contravention of the international treaties. Indian side has always maintained that Indian Patent Laws do not circumvent or contradict any international treaty. After constitution of this working group, during American President’s, India visit, Prime Minister Modi, while addressing CEOs of USA’s Company, said that “India was willing to accept the suggestions of a joint Indo-US working group on intellectual property rights”
What are these contentious issues, resolution of which American companies want? Yet another important question is, whether resolution of these issues is in the best interest of majority of India’s population.
Public Health versus Business
Generally, two types of patent related issue are raised by US business. First, such issue is related to re- patenting. Indian Patent Office has, so far, refused to accept many patent claims of US companies, citing the provision of Section 3(d), which forbids patenting of other derivatives of known substances.
It is notable that claim of a Swiss Pharmaceutical company was refused after a long legal battle, in which the company was asking for, re-patenting of a cancer drug name ‘Glevec’. Decision of the Supreme Court had upheld the Indian Patent Office’s contention.
As per section 3(d) of India Patent Act, ” the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.”
After losing this legal battle, companies from all parts of the world, have been striving hard to get this Section 3(d) diluted, to facilitate re-patenting of their numerous drugs. Major contentious issue between USA and India, relates to Section 3(d) of the Indian Patent Act. We must keep in mind that the issue of Section 3(d) of Indian Patent Act is primarily linked with the public health. Many companies have been trying for re-patenting of their various high priced medicines. If Section 3(d) is diluted, then it may impact the prices of many drugs useful in treating number of deadly diseases including cancer. Thus we may say that if a decision is taken to dilutes 3(d), it may impact the health care of 127 crore Indians and people around the globe.
Another provision of Indian Patent Act, which is being contended by US companies, relates to the Compulsory Licensing. Indian Patent Act has the provision that, under a compulsory license, an individual or company seeking to use another’s intellectual property can do so without seeking the rights holder’s consent, and pays the rights holder a set fee for the license.
Based on this provision, first compulsory license was issued to ‘Natco Pharma’, a pharmaceutical company, in March 2012 for producing generic cancer drug ‘Nexavar’ with the condition that the company would pay 6 percent royalty to the patent owner company. Multinational company ‘Bayer’ challenged this decision of Indian Patent Office, which was later turned down by the courts. It is notable that the provision of compulsory license had been made in Indian Patent Act, and the same was retained in some other form, when the same was amended in 2004, to safeguard the public health, as it would make it possible to reduce prices of patented products to make the same important tool for the protection of public health. However, the same is irritating the multinational corporations and they are pressuring the US administration to get the same deleted from Indian Patent Act, to desist Indian Patent office to issue Compulsory License.
In fact, general objective of the MNCs from USA and other parts of the globe has been that production of generic drug in the country is discouraged, to maximise their profits. They also want the provision of ‘Data Exclusivity’ incorporated to disable others from using data and formulas of the patented drugs. They also want to introduce the provision of ‘Patent Linkage’ so that Indian companies don’t get the right to market patented drugs.
In the interest of public health, it is imperative for the government not to succumb to the pressure of US administrator. Provision of Indian Patent Act, is very much in tandem with international treaties. There is no reason to dilute any of these provisions, to safeguard public health.
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