In healthcare, about 50 per cent cost is that of medicines used. Some medicines cost exorbitantly high on account of patenting. These days generic medicines of certain pharma companies compete with patented medicines, bringing the costs of patented medicines down to some extent. Generics make the medicines affordable.

In early 2024, Indian patent rules have been modified — the objections to patents at pre-grant stage have become difficult. That has made patenting easy, and that has increased the prices of drugs.

There are no provisions in the Indian Patent Act to oppose patenting. If there is successful opposition, it results into generic companies being allowed to produce the same drug. There is competition. There could be opposition to patent even after it has been granted.

In early 1970s, the Patent Act was changed, making drugs affordable. India granted process patents, and not product patents. Any Indian company thus could produce the patented drug by using an alternative process. It made generics available, which were exported. India emerged as a leading generic exporter by late 1980s, and leading generic producer by 1990s.

In 1995, there was TRIPS Agreement (trade-related intellectual property rights). It reintroduced product patents which are novel and inventive. In 2005, the Patents Act was amended in the light of TRIPS. Most of the drugs patented in the US and Europe, however, were only new forms (me-too drugs). There was no significant increase in the therapeutic benefit. India was slipping back to pre-2005 situation.

Political parties and civil society here introduced an amendment to the Patent Act — Section 3(d). It was to ensure that an old drug in a new form would not be patented — unless its therapeutic efficiency is significantly better.

Indian Patent Act was amended to allow opposition to patent at pre-grant and post-grant stages. There could be revocation of patents. Rules were framed to accommodate this. The government can issue licences to other companies without the consent of the patent holder. The flexibility of TRIPS was leveraged.

The rules are sought to altered because of the pressure of big pharma. There is a demand for the repeal of Section 3(d). This is the demand while negotiating FTAs with the US, UK and EU.

PGO (pre-grant opposition) comes from civil society and patient’s groups. Genetic companies are reluctant to file PGOs. PGOs were replied to by the applicant. The opponent filed a rejoinder. It is then the decision of the patent controller. The modified rules allow the patent controller to decide whether PGO is maintainable. It could be dismissed. It is an arbitrary power. In past, opposition scuttled many patents (as they were frivolous). Amendments allow non-deserving patents. The opponent has also to pay fees. It is a financial burden.

The patent holder was to report to the patent controller how the patent is worked out every year. This has to be done now every three years. Now working of patents is one of the bases for seeking a compulsory licence. The public is in the dark. It makes compulsory licensing difficult.