The perils of patent amendments

A formidable pharmaceutical industry has turned India into a powerhouse of generic drugs, enabling the country to substantially reduce the disease burden of malaria, HIV and leprosy. As a leading generic drug producer, India fulfills more than 60 per cent of the global demand for vaccines, and within the realm of vaccines, India plays a critical role by meeting 40-70 per cent of the World Health Organization’s demand for DPT and BCG vaccines, as well as 90 per cent of the global demand for measles vaccine.

But despite this achievement, India has long been struggling with access to good quality and affordable medicines. Soaring costs of healthcare, including medicines, push 3 per cent of Indians into poverty every year.

The Economic Survey 2023, projects the share of out-of-pocket-expenditure (OOPE) in healthcare at 48.2 per cent of the total expenditure, which is significantly higher than the global average of 18 per cent. Since medicines constitute 20-60 per cent of total healthcare expenditure, affordable medicines have a huge role to play in stopping the slide of vulnerable people into poverty.

The widespread availability of generic medications decreases dependence on costly alternatives, and the provision of high-quality drugs is an essential prerequisite for effective treatment.

The growth of India’s pharmaceutical industry was fuelled by the Indian Patents Act of 1970, which introduced a significant change in patent law by allowing the granting of process patents while simultaneously prohibiting the patenting of end-products. This innovative approach empowered manufacturers to explore and create alternative methods of producing existing proprietary products.

An equally noteworthy aspect of the Act was the introduction of a shorter term for patent protection. This change had a transformative effect, particularly in the pharmaceutical industry, where it provided the necessary impetus for growth and innovation.

Our patent law aligns with the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, effectively striking a harmonious balance between recognising innovators’ rights to profit from their valuable inventions and ensuring the protection of public health.

But the pharma industry now seems to be heading for the eye of a storm. The Department for Promotion of Industry and Internal Trade, which oversees the operations of the Patent Office has proposed amendments to the Patent Rules 2003, which threatens to turn the patent regime on its head. Two of the amendments directly influence the standard of patents granted by the Patent Office, while the third amendment affects the transparency of the patent system in India.

Harmful amendments

India’s battle to ensure affordable and accessible medicines for its population may just get tougher if the Draft Patents (Amendments) Rules, 2023 are actually implemented. The 2023 draft amendments propose several significant changes including the introduction of fees for pre-grant opposition filings and centralising authority with the patent controller.

These amendments depart from the existing practice of not charging fees for pre-grant opposition filings and allow anyone to provide crucial information to the patent office under Section 25(1) of the Indian Patents Act, 1970.

Moreover, they propose extending the working statement submission interval from annual to once every three financial years, while also eliminating the need to disclose whether patented products are made in India or imported, along with their pricing details. If these proposals indeed become part of policy, they could have a disastrous effect on the healthcare system.

The proposed amendment to Rule 55 can potentially limit the capacity of patient groups to initiate pre-grant oppositions, which are essential in preventing the issuance of undeserved patents for medicines, thus endangering the timely availability of quality-assured, cost-effective generic medications.

Another worrying aspect of the proposal is vesting discretionary powers with the patent controller to determine who may file pre-grant oppositions. The proposal exceeds the jurisdiction defined by the Patents Act and runs counter to previous judicial decisions, which unambiguously permitted both organisations and individuals to submit pre-grant oppositions.

These changes would weaken the safeguards in India’s patent system. This particular proposal discouraging pre-grant opposition is all the more ironical given that in March this year, the Indian Patent Office rejected US pharmaceutical giant Johnson & Johnson’s subsidiary Janssen’s application to extend its monopoly on the key tuberculosis drug, Bedaquiline, which ultimately expired in July.

In 2022, two TB survivors had filed a second pre-grant opposition application against Janssen’s move to get the patent extended for the drug, which eventually led to the rejection.

Prolonging the time frame for submitting working statements from one year to three years, along with eliminating the obligations to specify manufacturing details (whether the product is made in India or imported) and approximate prices of patented products, has the potential to substantially obstruct the procedure for obtaining compulsory licences. Consequently, these may hinder the accessibility of essential medicines to the public at affordable rates.

Need to stand firm

India must confront the challenges to patents and intellectual property rights and vehemently oppose any attempt to restrict the waiver of patents for drugs and vaccines. It is worth noting that India is already in compliance with the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, and all provisions of the Patent Act are harmonised accordingly. The accessibility of affordable medicines is a lifeline for vulnerable communities around the world.

As India is regarded as the pharmacy of the world and has now become the most populous country, it is even more imperative for the government to explore avenues that ensure high-quality medications remain within reach and economically viable for the vast segments of the impoverished and marginalized population, both domestically and abroad.

The Indian Patent Office faces a glut of patent applications, straining its capacity to handle the workload effectively. The objective of these amendments is to simplify the patent application and granting process. While these amendments may alleviate the burden of the patent office, there are concerns that they may disproportionately benefit global pharma majors. The regulations governing our patents play a crucial role in ensuring access to a wide array of newer medicines.

However, these amendments are anticipated to negatively impact the availability and accessibility of medicines. They would also encourage monopolies and profiteering by big pharma. So the government must reconsider the proposed amendments to safeguard the accessibility of affordable medicines and remove those suggested provisions which benefit the big global pharma industry.

The writer is a former Union Health Secretary

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