The failure of global IP regimes in addressing the AMR stewardship paradox

The traditional patent model relies on high sales volumes to recoup costs, a mechanism that directly contradicts the global need to conserve our last-resort antibiotics. This article by Umeshkumar explores the ​“stewardship paradox” and argues for delinkage models to align innovation with public health and sustainable antimicrobial use.

The world’s pharmacy is currently under attack, but it is a silent, microscopic one. As a result of being both a global leader in providing affordable generic drugs, and as a country at the forefront of an increasing wave of antimicrobial resistance (AMR), India is at the centre of this growing problem. At the core of the AMR crisis is a structural conflict, which the scientific community does not discuss enough: the ​“stewardship paradox”.

As it stands now, when pharmaceutical innovations succeed globally, they are based upon their ability to penetrate markets and create high sales volumes. However, for antibiotics, ​“success,” from a public health perspective, requires the exact opposite: they must be used sparingly, strictly conserved, and to the lowest extent possible to delay the onset of resistance. As such, there exists a market failure within the patent system that rewards the behaviour that causes the rapid obsolescence of the drug. As an independent researcher and patent agent, I have witnessed how the ROI generated by the patent system is inconsistent with the R&D required for the stewardship of the drug. In order to generate the next generation of life-saving drugs, we need to separate the cost of R&D from the volume of sales.

The ​“stewardship paradox” in action

For at least thirty years, the typical response to the ​“drought” in the development of new antibiotics has included offering stronger intellectual property rights and/​or longer patents to potential developers of antibiotics. The rationale behind this approach has always been that, by increasing the level of economic reward from developing a new antibiotic (i.e., greater profits), there would be more financial incentive for researchers to develop new antibiotics. Unfortunately, it has been more than thirty years since a new generation of antibiotics has entered clinical use.

The reason for this lack of success with the approach of strengthening the intellectual property rights for antibiotic developers lies in what is referred to as the ​“stewardship paradox”. Unlike most therapeutic classes (e.g., oncology; chronic lifestyle disease), where the primary objective of a patent applicant/​holder is to treat as many patients as possible with their patented compound, the primary objective of an antibiotic developer is to delay resistance by limiting use. Therefore, when a new ​“last-resort” antibiotic enters clinical practice, it simultaneously marks the beginning of its path toward eventual obsolescence. 

A fundamental contradiction arises when public health officials want to restrict the availability of drugs to ensure they remain effective, and pharmaceutical companies want to make money from their products. The commercial success of a drug, particularly a costly one like an antibiotic, depends on high volume sales. Companies cannot recoup their R&D investments if their products are locked away in ​“glass cases” as emergency supplies only. Thus, companies must aggressively promote their products to maximise volume sales. However, in countries where patients pay directly for health care (e.g., India) this typically translates into aggressive marketing to physicians and pharmacists. This leads to exactly the type of overprescribing that generates drug resistance.

The way forward: A delinkage model

The solution lies in moving towards a ​“delinkage model”. Delinking refers to the separation of the financial returns from a drug from the volume of the drug’s sales. Instead of relying on large-scale sales, innovators receive ​“pull incentives”, e.g., market entry rewards or milestone payments.

One widely discussed approach is the ​“subscription model” (also known as the ​“Netflix model” for antibiotics), where governments pay a fixed annual fee to a company for access to an effective antibiotic regardless of whether the antibiotic is used. The subscription model allows companies to generate revenue from their products and provide governments with the means to retain effective drugs ​“in inventory” for stewardship purposes.

Adopting a delinkage model would not only be scientifically necessary for India but also strategically important as the country transitions from a manufacturing-based to an innovation-driven bioeconomy. Domestic startups require predictable returns on investment that do not depend on contributing to the AMR crisis. By integrating delinkage into national science policy, India can lead in creating a system that balances innovation with sustainability.

Reframing innovation for a world resistant to disease:

The tension between 20^th-century patent law and 21^st-century evolutionary forces of microorganisms is no longer simply a theoretical debate – it is a pressing public health crisis. For India to continue to protect its role as the ​“pharmacy of the world”, we need to look beyond the limited focus on volume-based ROI. Protecting and strengthening IP rights in the absence of stewardship-compatible financial incentives will only add to the flames of the fire we are desperately trying to put out.

Addressing this challenge requires a multi-faceted approach: adopting delinkage models, increasing funding for early-stage antimicrobial R&D, and developing national policies that treat antibiotics as a global public good rather than a commercial commodity.

Young researchers and policymakers will play a critical role in shaping this future. The goal must be to create an ecosystem where the value of a drug is measured by the lives it saves over time, rather than the volume of units sold in a quarter. In doing so, India has the opportunity to lead a global model of sustainable innovation — one where science stays ahead of resistance.