Pre-grant opposition is one of the key features of the Indian Patents Act, a peer review mechanism that helps in challenging the grant of patents. Global pharmaceutical majors have long been critical of pre-grant opposition arguing that this system delays granting of patents.

The government seems inclined to accede to the demands of the pharmaceutical majors by proposing a set of amendments to the patent rules governing pre-grant opposition. Clearly, the interests of the pharmaceutical majors seem to be triumphing over those of the critically ill patients.

Pre-grant opposition is significant for realising the objectives of the TRIPS Agreement as peer review of patent applications can help realise two substantive benefits.

Firstly, it effectively thwarts a common practice of the pharmaceutical majors of seeking multiple patents on a single medicine, to ensure enjoyment of patent rights well beyond the 20-year patent term. This is generally called ‘evergreening’ of a product.

And secondly, pre-grant opposition can ensure that patents are granted on innovations that represent substantial technological advancements. In other words, patent claims on minor or “frivolous” innovations can be rejected.

Pharmaceutical majors argue that on an average they invest $4 billion to develop a new medicine and that they need a 20-year patent to recoup their investment. By that reckoning, ‘evergreening’ or minor modifications of existing medicines are not deserving of patent protection.

Including provisions such as those for pre-grant opposition was a salient contribution that the Parliamentarians made nearly two decades ago to make the Patents Act compliant with the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).

It is a unique law for it ensures the patents are granted to the innovators not merely for their enjoyment of rights, but to also allow the society at large to partake of the benefits of the innovations. In short, the Act balances the rights of the innovators with those of the interests of the public at large.

India’s lawmakers have paid considerable attention to public health. Their deliberations thus gave to the country a Patents Act that includes several provisions aimed at ensuring affordable access to critical medicines.

The Patents Act allows ‘any person’ to file a pre-grant opposition after a patent application is published. Patent oppositions can be filed by academic researchers, civil society, health organisations and, most importantly, patient groups. Therefore, it is important not to tamper with the provisions of pre-grant opposition as wrongfully granted patents can directly affect the right to health of individuals.

Thus, the robust knowledge of patent examiners notwithstanding, pre-grant opposition can provide the examiners with additional information from a broad group of stakeholders that can be used to take well-considered decisions regarding the grant of a patent.

Curbing evergreening

During the past 18 years, pre-grant opposition has proved effective in preventing evergreening of several cancer, TB, and HIV/AIDS medicines, giving Indian generic manufacturers opportunities to offer affordable substitutes. The best-known case of using pre-grant opposition is the denial of patent protection to imatinib mesylate (Glivec), a lifesaving medicine for people living with chronic myeloid leukaemia.

Denial of patent on imatinib mesylate helped in reducing the price of this medicine from ₹1,50,000 for a month’s treatment to ₹6,000. Recently, pre-grant opposition was successfully used to deny extension of patent protection on bedaquiline, a critical medicine for drug-resistant TB.

Despite its utility, pre-grant opposition has consistently been criticised for delaying patent grants. However, facts are contrary to this claim.

The Indian Patent Office reported in its annual report for 2021-22 that as against 69,613 published patent applications, only 481 pre-grant oppositions were filed (0.69 per cent). Further, between 2005-06 and 2021-22, 13,76,014 patent applications were published but pre-grant oppositions were only 4,870 (0.35 per cent). These numbers show that pre-grant oppositions did not delay patent grants; the major reason for the delay has been the acute shortage of patent examiners, a fact that that the Economic Survey has alluded to repeatedly.

There is also evidence of a huge pendency in disposing pre-grant opposition representations. A recent study showed that the major reason for the delay in the disposal of pre-grant opposition was the inability of the Patent Office to promptly process the applications.

The Indian Patent Office has proposed several amendments to rules governing pre-grant opposition. The first set allows the Controller General of Patents to decide if there are grounds for maintainability for opposition.

However, there is no clarity as to what these grounds can be, and the Controller General can reject the applications for pre-grant opposition without going into the merits of the case. However, even in cases where the Controller General finds that the opposition was maintainable, the examination of patents would be expedited. This implies that the IP Office was generally expected to expedite their examinations, instead of carefully examining such doubtful applications.

Fee hurdle

The second set proposes steep/dynamic fees for filing pre-grant opposition; there is no fee at present. The fees are a minimum of ₹20,500 for natural persons and ₹40,000 for companies. These fees are linked to those paid by the patent applicants to process their applications, the rationale of which is unclear.

The objective of introducing the fees seems to be to deter individuals, public interest groups, including patient groups, from filing pre-grant oppositions. This could effectively end the possibilities of opposing “frivolous” patents that violate above all, Section 3(d) of the Patents Act and which prevents patenting of combinations and other derivatives of known substances, as also their new uses.

The proposed amendments to the Patents Rules may well be the first step towards the eventual removal of the pre-grant opposition system. This would mark the death knell for the carefully crafted balance in the Patents Act between the owners and the users of patents, since the Patents Act would be reduced to a charter of rights. Patent monopolies would then dominate, adversely impacting access and affordability of critical medicines, and impairing the country’s health security.

Dhar is Distinguished Professor, Council for Social Development; Gopakumar is Legal Advisor; and Rao is Consultant, Third World Network