India’s unhealthy patent amendments

Illustration: Yogendra Anand / CSE

It was ultimately the narrative of a change foretold. The Narendra Modi government has notified amendments to the rules governing India’s Patent Act, coolly ignoring the protests and petitions against these changes, which would alter the character of the country’s unique law on patents rights and obligations. As top law firms welcome the amendments and rejoice that these changes bring India’s patent law “almost in line” with those of the US, it underscores the serious consequences for patient and voluntary groups that campaign on public health concerns.

The ostensible aim of the amendments was to streamline the working of the Indian Patent Office, which was clearly needed. In the process of improving efficiency, the amendments have gone way beyond the spirit and limits set by the Patent Act, which was enacted in 2005 after years of debate, soul searching and wide-ranging consultations between political parties and civil society to meet the country’s obligation under new World Trade Organization rules. The government in power then was the Congress-led United Progressive Alliance under Manmohan Singh, and it is no secret that the communist bloc, led by the Communist Party of India (Marxist) or CPI (M) and the opposition Bharatiya Janata Party (BJP), were instrumental in ensuring that the law safeguarded public health issues while ensuring the rights of innovators. But then, institutional memory is short in the present ruling regime.

This is a dangerous failing, as the Modi government has shown little understanding of the importance of India’s unique patent regime, starting with its first Union Minister for Commerce and Industry Nirmala Sitharaman. In 2014, she publicly declared that India did not have an intellectual property rights policy and that had stopped the country “from establishing our rights in a forceful way” (see ‘Pursuing a nationalist IPR policy’, Down To Earth, 1-15 October, 2014). If anything, it was the other way around. Developing countries, in fact, had been beating a path to New Delhi to emulate India’s unique patent safeguards while Big Pharma was doing its best to hammer away at the law. Since then, the government has done little to use the safeguards to improve public health. Not even during the COVID-19 pandemic did it invoke the many provisions in the law to issue compulsory licences (CLs).

On the other hand, the Modi government has been steadily diluting these unique provisions. In its recent rush to accommodate the demands of the industrialised countries, with which it is anxious to sign free trade agreements, the government has happily withdrawn or watered down those provisions that foreign manufacturers, especially pharma companies, have found irksome. Major changes in the patent law has always been their top demand as they promise to bring investments to India which by the way have proved largely chimeric. As we wrote in October last year, the proposed amendments were nothing but a capitulation to Big Pharma (see ‘These lethal changes in India’s patent rules’, Down To Earth, 16-31 October, 2023). There was no discussion in Parliament and no information on the people consulted, nor any data provided to justify the amendments, despite the significant nature of the changes.

Commentaries by corporate law firms welcoming the amendments, notified on March 15, provides a clear indication as to why these changes were initiated. These analysts dwell on the “substantial changes (made by India) to align with international standards”; others focus specifically on how to close the Indian patent law has become to the US regimen in promoting the rights of innovators by targeting the “key areas of concern in the Indian patent practice and procedures”. Fair enough, from their perspective, and perhaps necessary because the time lag in granting patents was getting rather long. There are also big fee reductions for the innovator companies (do multinationals require this?) and sweeping waivers on information filing requirements. Even where there is failure to provide the required information, delays will be condoned on payment of minuscule fees.

The irony is that at the same time, patient health groups who want to access the patent system in an effort to improve access to life-saving medications are being slapped with heavy fees. These are collectives of needy patients, not even formal organisations, with little access to formal funding, yet the amendments now require such individuals and patient networks to pay substantial fees to file pre-grant oppositions. There were no fees earlier. Worse, it is now left to the discretion of the Controller of Patents to accept or reject pre-grant opposition petitions although the Indian judicial system has already vetted their validity. 

To understand the serious consequences of this amendment recall how two young women, frail tuberculosis survivors, exposed drug behemoth Johnson and Johnson (J&J) by filing a pre-grant opposition to a secondary patent claim on bedaquiline, a crucial drug to fight the killer disease. The pre-grant opposition showing that the J&J claim was frivolous was upheld by the Patent Office, putting the US drug giant on the backfoot. It later withdrew the same secondary claim in a host of other developing countries. The victory of the pre-grant opposition by Nandita Venkatesan from India and Phumeza Tisile from South Africa, which opened the way for manufacturing inexpensive generic versions of bedaquiline cannot be underestimated.

In many other changes, Big Pharma has benefitted enormously from the amendments. Now, the companies no longer need to file Form 27 that compelled patent holders to disclose every year if their patents are being worked in India or not, with details of quantity and value. The form also required innovator companies to reveal information on imports, with amount and pricing details. Now, Form 27 has to be submitted just once in three years and with no insistence of details. After all, as many a commentary by the firms who fight cases for Big Pharma have reasoned, there is no such requirement in the US.

Why is Form 27 in its old format so important? One has only to recall the extraordinary confrontation between a small Hyderabad-based generic firm Natco Pharma and Bayer Corp, one of the top drug companies in the world. Natco’s claim for a CL to make Bayer’s patented cancer drug Nexavar was based on the German giant’s Form 27 filing, which showed that the medication was neither freely available nor affordable. It was a historic moment when Patent Controller PH Kurian granted the country's first CL to Natco in 2012.

What we are witnessing now is the unmaking of India’s patent law and its uplifting history.