“Owning the sun” by Alexander Zaitchik seems to be a good book on the ills of drug patents. I’ve not read the entire book but I’ve read parts where it talks about India by searching for relevant keywords. I think it gets the Indian policy on drug patents and its effects right in broad strokes but gives a misleading impression on who conceded to make the 1970 Patents Act TRIPS-compliant and under whose government did the law get enacted in the first place.
India held out a little longer, but by 1990 had also succumbed to US pressure. Under the terms of TRIPS, the country would have ten years from the date of signing to revise its 1970 Patents Act to fit a mold cast by Western drug giants. The Nehru-era patent act was more than an institution of national pride—it was the foundation for a generics industry known as the pharmacy to the poor, the source of affordable treatments for malaria, cancer, and tuberculosis across the global south. When the news reached India, street protests against the government of Rajiv Gandhi broke out across the country.
Well, Rajiv Gandhi was Prime Minister till December 2, 1989, not 1990, so I’m guessing the author is referring to India’s agreement to the inclusion of substantive norms and standards for the protection and enforcement of IP in the TNC meeting of April 1989, which should be viewed in the context of India’s document tabled in July 1989 that noted its desire for flexibility/exceptions for the food and pharmaceutical sectors. This contention was carried in the text reached at the Brussels meeting. Refer Part IV Chapter 11 of WTO’s publication, “The Making of the TRIPS Agreement.”
Some relevant excerpts:
India also thought that, once the substantive norms and standards for protection of IPRs was brought into the mandate, efforts could be made to balance protection of IPRs with the developmental, technological and policy objectives of the host countries, to carve out exceptions for the special needs of developing countries, and to obtain sufficiently long transition periods for switching over to the new regime. There were indications, at least from some developed countries, that differential treatment for developing countries in this manner could be worked out during the course of negotiations. […] After the finalization of the negotiating mandate in the TNC meeting of April 1989, India tabled, for the first time, a comprehensive document setting out its views on norms and standards for protection of various types of IPRs.[6] It did not suggest their formulation in legal terms but was about the principles that must inform them, from a developing country’s perspective. With respect to patents, the document argued for freedom and flexibility for developing countries in the matter of grant of patent protection in sectors such as food and pharmaceuticals.
Reference [6] says that the document was tabled in July 1989, i.e. under the prime ministership of Rajiv Gandhi.
it stated that, while patent protection will be available in all fields technology, a licence of right will also be automatically available to any person wanting to work the patent in the case of food and medicines; it is for each national legislature to determine the duration of patent protection it wants to grant; a patent owner has the obligation to work the patented invention in the territory of grant, failing which a compulsory licence is liable to be granted; a compulsory licence may also be granted, where necessary, in the public interest to secure free competition; and the agreement shall be implemented in the relevant international organization.
(emphasis mine)
On their part, the industrialized countries had already tabled their proposals in early 1990, taking equally strident positions that focused only on watertight protection and enforcement of IPRs. According to them, a compulsory licence could be granted only in narrowly defined circumstances and certainly not for the non- working of patents. The negotiations therefore lingered on in this phase without any tangible meeting ground until the text was reached at the Brussels ministerial meeting in December 1990. That text merely put in brackets the contentious proposals of each side on issues such as duration of patents, obligation to work patents, exclusion from patentability of food, chemical and pharmaceutical products, and forum of implementation of the agreement. With the breakdown of the Brussels ministerial meeting for other reasons, this phase of the negotiations went into limbo.
So, if any, future PMs and MPs, who agreed without any exceptions for pharma and legislated those changes, should be blamed. Read the following excerpt from this paper and decide for yourself which governments should be blamed:
India became a member of the Paris convention and signed the Patent cooperation treaty with effect from December 7, 1998. Since then, amendments to the Patent Act were enacted in April 1999 and May 2002. The third amendment became due. The necessary bill to make the Indian Patents Act TRIPS-compliant was supposed to have been tabled during the 2004 winter session of Parliament; instead, an ordinance was passed on December 26, 2004, which came into effect on January 1, 2005. This ordinance modified the Indian Patents Act. This ordinance was itself modified and the Patents (Amendment) Bill was passed by the Lok Sabha and Rajya Sabha on March 22 and March 23, 2005, respectively. The President signed the bill on April 5, 2005, making it an Act of Parliament.
Apart from this, it calls the 1970 Patents Act, “The Nehru-era patent act” when Nehru was not even alive in 1970 and the actual patent law during Nehru’s government had both process and product patent. This changed in 1970 under, his daughter, Indira Gandhi’s government.
But the more important factor behind India’s opposition to TRIPS was the character of the Indian Patents Act 1970 and the Indian pharmaceuticals industry that it had spawned. Under British rule, India had the Patents and Designs Act 1911, which granted product and process patents in every sector and prohibited compulsory licences without the involvement of the patent holder. Local pharmaceutical production by Indian companies was therefore at a standstill and imported medicines held sway in the marketplace, albeit at unaffordable prices. This situation led to the formation of the Indian Drug Manufacturers Association in 1961 and it lobbied strongly for the enactment of a new patent law that would encourage local production of pharmaceuticals and thereby make them available to people at low prices. Following the recommendations of a committee appointed under the chairmanship of a High Court judge, a new law, namely, the Indian Patents Act 1970, was enacted, which repealed the 1911 Act insofar as it related to patents. The new Patents Act 1970 came into force on 20 April 1972.
The new law was truly a turning point for the domestic pharmaceuticals industry. Five features of the new law are worth noting here to show how far apart it was from the TRIPS Agreement. First, the Act provided for only process patents, and prohibited product patents, in the food, pharmaceutical and chemicals sectors. Second, the Act provided for a term of only seven years for process patents in the food and pharmaceuticals sectors, while for process patents in the chemicals sector, and for product or process patents in all other sectors, the term was 14 years from the date of filing. Third, compulsory licences could be granted liberally under the Act, including for non-working of the patents. Fourth, the Act allowed for automatic “licences of right” in the food, pharmaceuticals and chemicals sectors, under which anyone could produce and sell such products on payment of a royalty not exceeding 4 per cent. Fifth, in the case of process patents also, the owner of the patent had to prove the alleged infringement of his or her patent in a court of law. In a nutshell, the Indian Patents Act 1970 did not allow a patent worth its salt in the food, pharmaceuticals and chemicals sectors.
The Act was a shot in the arm for the domestic pharmaceuticals manufacturers. Thanks to the abundant skilled manpower available in India in chemical technology, especially in the synthesis of chemical molecules, the domestic pharmaceuticals industry started producing new patented chemical entities through reverse engineering, choosing pharmaceuticals that had proved their safety and efficacy in the industrialized world and that had also become commercial blockbusters there. In addition, governmental regulations that compelled the manufacture of medicines from the basic stage, prohibiting simply the transformation of intermediate products into bulk pharmaceuticals or formulations, as well as the setting up of public sector undertakings in the pharmaceuticals sector, also helped India acquire the necessary skills in the manufacturing of pharmaceuticals. Within three to five years of new drugs being introduced into the world market, they were introduced in India at a fraction of their world prices. Although this did not lead to new drugs being discovered in India for diseases relevant to India (a point to which I will return), it is not an exaggeration to say that, if India today is a major supplier of generic drugs to the world market, the seeds of it were sown by the Indian Patents Act 1970.
Nevertheless, thwarting foreign drug patents to stimulate the domestic industry is one theme that transcends international borders.
One episode I learned about is how Woodrow Wilson broke German pharma patent thickets during World War I, which essentially created the modern American pharmaceutical industry. - Matt Stoller on Twitter