The Indian Patent Office granted more than one lakh patents in 2023-24, a near three-fold increase compared to the previous year. While the milestone might be a cause for celebration for some, the fact that it was achieved with roughly the same number of patent examiners could raise concerns about the quality of patents being granted: Are these patents thoroughly examined, or is there a rise in unmerited grants? Unmerited patents can have serious implications, particularly for public health, as they can lead to unwarranted monopolies on lifesaving medicines. The recent Patent (Amendment) Rules, which aim to streamline the patent granting process, may further exacerbate the effects on public health.

Globally, we see an increase in patent numbers in countries such as the US and China. However, both countries are now struggling to maintain quality standards and are actively working to minimise unmerited patents.

India has historically championed a stringent model of patent laws, emphasising rigorous checks and balances to eliminate bad patents, promote transparency and ensure the public benefits from the patent. This model’s success is most evident in facilitating global access to affordable medicines by sustaining generic competition and significantly reducing prices of HIV, TB and cancer medicines, which were originally patented and priced beyond reach. A key aspect of this success has been India’s efforts to curb patent evergreening, a practice of patenting minor changes to existing medicines to extend monopolies beyond the existing 20-year period of protection.

However, there are concerns that India’s patent model, which many developing countries have emulated, risks losing its effectiveness. This is due to external pressures on the patent system and the unnecessary urge to match the higher grant rates of foreign patent offices, which are often criticised for their lax examination standards.

External pressures

In recent years, external pressures on the Indian patent system have intensified. One significant source of these pressures is free trade agreements (FTAs) that often push for broader harmonisation of patent laws, exceeding international rules. While India has successfully excluded some of the problematic provisions in recent negotiations with the European Union and the UK, the March 2024 FTA with the European Free Trade Association (EFTA) weakens its crucial procedural safeguards. The agreement requires India to change its rules related to pre-grant opposition procedures, filing patent working details, and disclosing foreign patent information.

The pressure isn’t limited to FTAs; multinational pharmaceutical corporations and their lobbies have also been making domestic and international efforts to undermine these safeguards in the guise of promoting ease of doing business. These corporations target these safeguards through channels like the United States Trade Representative’s (USTR’s) Special 301 Report, a tool the US uses to arm-twist countries with the threat of unilateral sanctions into changing their intellectual property laws and policies. The motive is clear — pharmaceutical corporations want to evergreen monopolies to continue charging high prices for longer.

Perhaps succumbing to these pressures, India notified the Patent (Amendment) Rules in March 2024 to streamline the patent office operations and implement the provisions of the India-EFTA agreement. Unfortunately, these changes risk diluting the safeguards crucial for ensuring patent quality, transparency within the system, and protecting generic competition.

Dilution of safeguards

One of the major limitations of the new rules is the dilution of the pre-grant opposition mechanism. This mechanism allows the public, including patient groups, to challenge bad patent applications that could create unjust monopolies. While the primary legislation allows “any person” to file an opposition, the amendments could give the patent controller additional powers to decide who can file such challenges. The undue power granted to the controller could limit public participation in patent examination, leading to unmerited patents.

Though often criticised, the open model of pre-grant opposition has contributed extensively to ensuring access to lifesaving medicines. For example, two tuberculosis (TB) survivors recently used this mechanism to challenge an evergreening patent application for the anti-TB drug bedaquiline. Their challenge led to the patent’s rejection, enabling generic competition and reducing the medicine’s prices by over 50 per cent after the 20-year monopoly on the drug expired in July 2023.

Secondly, the amendment has diluted the requirement for disclosing patent working details. Previously, patent holders had to file annual detailed statements to show that the public benefits from the patent’s use in India. The amendment requires the filing of this statement only once every three years now. It also eliminates the need to disclose vital information like manufacturing/importing details and value/revenue accrued to the patentee or licensee. Such a detailed statement for the cancer drug Sorafenib proved that it was not affordable to the public, leading to India’s first compulsory licence. This resulted in a dramatic price reduction from ₹2.8 lakh to ₹8,800 for a month’s treatment. The significant relaxation of this transparency requirement could hinder competitors from seeking compulsory licences due to a lack of evidence of the non-working of a patent.

Finally, the requirement for patent applicants to periodically disclose the status of foreign filings has been weakened. This information helps the patent office assess the grounds for the refusal of similar applications in other countries, aiding their decision-making. The new rules shift this responsibility onto the patent office, requiring them to find critical information from external sources that the applicants could readily provide. The already overburdened patent office could end up missing crucial patent-related data, potentially leading to unmerited patents and hindering access to affordable medicines.

India stands at a crossroads, where the urge to streamline processes must be balanced with the need to maintain safeguards. India’s legacy lies in striking a balance between patent protection and ensuring access to medicines, and upholding this legacy requires a well-resourced patent office committed to upholding stringent standards, not just chasing numbers.

John is a lawyer and works on intellectual property issues. Gour is a lawyer and works as an Editor and Researcher at SpicyIP. Views are personal

Related Topics