The Impact of Patent Rights on Access to Medicines in India

Public Health and Patent Rights in India

Introduction

Access to life-saving medicines has long been both a moral and legal challenge in India. The conflict between Intellectual Property protection and affordable Healthcare resurfaces whenever patients with rare diseases face the burden of costly patented drugs. The case of Spinal Muscular Atrophy (SMA) — a severe genetic disorder affecting muscle control — highlights how patent laws can come into tension with the right to life and health.

1. What is SMA and why is it important?

Spinal Muscular Atrophy (SMA) is a rare genetic condition caused by mutations in the SMN1 and SMN2 genes. It leads to progressive muscle weakness, breathing difficulties, and in severe cases, early mortality. India records a significant number of SMA cases among infants, making equitable access to treatment a critical public health priority.

2. What treatments exist for SMA?

Recent breakthroughs have produced effective therapies that can slow or even halt the disease’s progression. Among them, Zolgensma (a gene therapy) and Risdiplam (an oral medication marketed as Evrysdi) have shown remarkable results. However, their costs — ranging from ₹6 lakh to ₹18 crore — make them unaffordable for most Indian families.

3. Why are these drugs so costly?

These medicines are protected by patents that grant pharmaceutical companies exclusive manufacturing and marketing rights. This monopoly allows them to set high prices to recover research and development costs, leaving patients dependent on government aid or crowdfunding to access treatment.

4. What is the government’s role in such situations?

Under Article 21 of the Indian Constitution, the right to life encompasses the right to health. The National Policy for Treatment of Rare Diseases (NPTRD) 2021 provides limited financial support of up to ₹50 lakh per patient. However, this amount remains inadequate given the exorbitant cost of patented rare-disease drugs.

5. What does India’s patent law say?

The Patents Act, 1970 strikes a balance between promoting innovation and safeguarding public health. Under Section 84, the government can issue compulsory licences when patented medicines are excessively priced or not available in sufficient quantities. This provision enables other manufacturers to produce generic versions at affordable rates.

6. Has compulsory licensing been used before?

Yes. In 2012, Natco Pharma was granted a compulsory licence to produce Sorafenib Tosylate, a cancer drug patented by Bayer. The price of the medicine fell dramatically — from ₹2.8 lakh to about ₹6,000 per month — setting a global precedent for affordable access to life-saving drugs.

7. What happened with Risdiplam in India?

Natco Pharma proposed manufacturing a generic version of Risdiplam priced at ₹15,900 per bottle — almost 90% cheaper than Roche’s patented product. However, Roche filed a lawsuit for patent infringement. The Delhi High Court initially recognized the public health urgency, but prolonged legal proceedings have delayed access for patients, underscoring how litigation can obstruct life-saving care.

8. What ethical dilemma does this raise?

The SMA case raises a profound ethical question: should corporate profit take precedence over human survival? Denying access to essential drugs undermines not only the constitutional right to health but also society’s moral obligation to protect life.

9. What can be done now?

The Union Government can invoke compulsory licensing for Risdiplam and similar therapies to ensure affordable access. Parliament should pass a resolution supporting low-cost generics, while state governments and health departments must collaborate with patient organizations to build a sustainable framework for rare disease care.

10. What lesson does the SMA case teach India?

The SMA episode underscores that patents must serve humanity, not restrict it. Ensuring affordable access to medicines is not an act of charity — it is the constitutional and ethical duty of the state.

Synopsis

India’s SMA crisis exemplifies the ongoing conflict between public health and patent rights. While innovation deserves protection, drugs priced beyond reach threaten the right to health. Through compulsory licensing and decisive policy reforms, India can reaffirm its role as a global leader in affordable medicine and uphold the principle of health justice for all.