Vol. XLII No. 51 December 23, 2018

Amit Sengupta: Champion of the movement against drug patents in India

J S Majumdar

AFTER the accidental death of Dr Amit Sengupta on November 28, glowing tributes were rightfully paid to him for his significant contribution to people’s health movement. However, his outstanding contribution to formulating the Patent Act,1970 and thereby bringing down the price of life-saving drugs in the country has skipped the attention of many.

Comrade Amit’s contribution to drug patents, over three decades, had a profound impact on the drug manufacturing capacity of Indian companies and had serious political implications. His work has become the foundation for the ongoing struggle in India on drug patents.

After a 20 year-long debate, the Indian parliament resolved to amend the British-made Patent Act, 1911, which was favouring the British capital with neocolonial connotations and enacted a new Patents Act in 1970. The new Act made it clear that there would be no patent on food items and atomic power. Apart from that, ‘product’ patenting of drugs is also not permitted and only ‘process’ patent ie, patent on the process of manufacturing of drugs was allowed to be claimed.

This new Patent Act, 1970 resulted in many Indian pharmaceutical companies developing different processes of manufacturing of many drugs which were inaccessible under the Patent Act, 1911. This led to the fall of drug prices, bringing relief to the Indians and ended the monopoly of a few American multinational companies in the Indian pharmaceutical market.

In a retort, the American pharma companies alleged that the Indian companies were resorting to ‘patent piracy’ and the US government had threatened to punish India. The US Congress, taking steps in this direction, enacted ‘Super 301’ and ‘Special 301’ Acts and the Patents Act, 1970 of India came face to face with the Acts of US Congress. The Indian parliament, however, never submitted before the US pressure on this subject and this aided in India becoming self-reliant in drug production by the early 1980s.

The stand taken by India was commended even by the United Nations Industrial Development Organisation (UNIDO) conference of Lisbon in 1982 and underlined the possibility of technology transfer in the pharmaceutical industry by India to other developing countries. Unable to stand competition, the foreign drug MNCs started leaving India.

However, with the dawn of the neoliberal regime in India in the 1990s, the situation has completely transformed. In 1994, Pranab Mukherjee, the then commerce minister of India, without consulting the parliament, accepted both – transformation of General Agreement on Tariffs and Trade (GATT) to the World Trade Organisation (WTO) and the ‘product’ patents of medicines, in the GATT conference at Marrakesh.

Except, it became difficult for the central government to pass the amendment of Patents Act, 1970 and Comrade Amit Sengupta played a pivotal role in mobilising the opinion against the amendment, in the decade-long struggle. The credit for accommodating ‘product’ patent in the carefully drafted Patent Act,1970, particularly goes to him.

The Left parties, in the parliament, moved an amendment which was inserted in Section 3(d) in the Patents Act, 1970 and was adopted in 2005.  It reads as, “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…is not inventions within the meaning of the Act.” Drug MNC Novartis lost its anti-cancer drug ‘Gleevec’ case in Indian Supreme Court on this ground.

In addition, the judicious use of ‘compulsory licensing’ of Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement commensurate to Patents Act in India ensured that the people can be provided relief with cheaper generic drugs. Compulsory licensing is a provision under the TRIPS agreement where the government allows a company to manufacture and sell patented drugs in public interest without the consent of the innovator company.

Bayer challenged this clause in case of their anti-cancer drug ‘Nexavar’ in the Supreme Court. The court ruled against the company's claim and said that it had not shown any fresh research and development expense figures to warrant court interference. The ‘New Invention’ clause in Section 3(d) is reflected in this judgment as well. The Indian companies, since, have been producing both Gleevec and Nexavar and selling them in India and to the world for a much cheaper price. Because of the above two sections in the Patents Act 1970, the drug MNCs are not able to impose a patent regime fully in India.

Later, in 2014, during Prime Minister Narendra Modi’s visit to the USA, three US-Indo working groups were formed in defence, atomic agreement and pharmaceuticals. Working through these groups, the USA has succeeded in defence agreement and in circumventing ‘supplier’s responsibility’ clause in case of atomic disaster. The working group on drug patents is working hard for the removal of Section 3(d) in Patents Act and the restriction on compulsory licensing.

Even today, various efforts are being made by the Modi government to provide an avenue to introduce a patent regime in India. Such times call for more vigilance and hard struggle from the part of those who are to carry forward the work done by Comrade Amit Sengupta.