You Are Signing the BPaL Order: Innovation's Reward or a Patient's Access?

One Signature, Two Kinds of Lives: The Ethics Behind India's BPaL Patent Rejection

Imagine you are the officer at the Patent Office who must sign the order on BPaL. It is a six-month, all-oral regimen of bedaquiline, pretomanid and linezolid that cures many drug-resistant tuberculosis patients who once faced up to two years of pills and painful injections.

The applicant is TB Alliance, a US-based non-profit that develops drugs for a disease most companies ignore. The easy answer would be that access always beats profit. But this is not a case of a profit-hungry giant. That is what makes it hard.

The cost of granting the patent India carries about a quarter of the world's TB cases, with an incidence of 187 per lakh people in 2024, according to the WHO.

A patent would give TB Alliance exclusive rights over the combination for years. Even if it licensed generic makers, as it has done with pretomanid through firms like Viatris and Macleods, it would control who produces the regimen, where and on what terms.

In a country where every month of delayed access means more people sick for longer, exclusivity has a human cost. Loon Gangte of the Delhi Network of Positive People said that only those who have lived through more than a year of antibiotics and injections understand what a shorter, oral cure means: the ability to return to work, care for family and rebuild a life.

The cost of rejecting it TB is a neglected disease precisely because it promises little profit.

Non-profit product development partnerships like TB Alliance step in where markets will not. They argue that patents let them control quality and manage access across countries. If patent systems treat their work as unprotectable, the funding model that brought BPaL into existence becomes harder to sustain.

The cost of rejection falls on future patients, those waiting for the next breakthrough that may not be financed.

The framework Two moral frameworks pull in different directions:

• A rights-based view holds that access to a life-saving medicine is part of the right to health, which a monopoly should not override in a high-burden country.
• A consequentialist view of innovation asks what incentives produce the most cures over time and warns that weakening protection reduces future research. Indian law has already chosen how to weigh these. Section 3(d) of the Patents Act, upheld in Novartis v. Union of India (2013) and the requirement of an inventive step reserve monopolies for genuine invention. The opponents showed that the combination had been described in research since 2015 and that putting known medicines together was obvious.

The resolution I would sign the rejection, as the Patent Office did.

The combination lacks the inventive step the law requires and in a country with India's TB burden, granting a monopoly on an obvious combination would cost lives now in exchange for uncertain future benefits. What is sacrificed is real. Rejection weakens one funding channel for non-profit drug developers and future TB research may face a harder path. That cost should be met not by granting weak patents, but by public funding, prizes and partnerships that reward discovery without locking up access.