What drug was involved in this case?

Nexavar (sorafenib), used for treating certain kidney and liver cancers.

What did the Court decide?

It upheld the compulsory licence in favour of Natco. The petition was dismissed.

How did the Court balance rights and health?

By stressing that patents must also serve public requirements and affordable access, not only exclusivity.

Does high price alone justify a licence?

Price is one ground. The Controller examines all three grounds—public need, affordability, and working in India—based on evidence.

Bayer Corporation v. Union of India

Q: When can a compulsory licence be granted?

After 3 years from grant, if public needs are unmet, price is not reasonably affordable, or the invention is not worked in India (Section 84).

Quick Summary

This case explains when India can allow someone else to make a patented drug. Under Section 84, a compulsory licence may be granted if public needs are unmet, price is not reasonably affordable, or the invention is not worked in India. For Nexavar, the authorities granted a licence to Natco so patients could access the medicine. The Court did not interfere with that decision.

Issues

Can a compulsory licence be granted in favour of Natco for Nexavar?
Were Section 84(1) grounds satisfied: public requirement, reasonable price, and working in India?

Rules

Section 84(1): After 3 years from grant, any interested person may seek a compulsory licence if:
- Public requirements are not met;
- The invention is not available at a reasonably affordable price;
- The invention is not worked in India.
The Controller and appellate bodies review evidence on all three grounds.

Facts (Timeline)

Patent & Drug: Bayer owned the patent for Nexavar (sorafenib), a cancer medicine.

Voluntary Licence Bid: Natco asked Bayer for a voluntary licence to make and sell the drug in India at affordable prices.

Rejection: Bayer declined. Natco said public needs were unmet, price was high, and the invention was not worked in India.

2011 Controller: Granted a compulsory licence to Natco under Section 84.

IPAB: Upheld the Controller’s decision.

High Court: Bayer appealed. The Court found no reason to interfere and dismissed the petition.

Timeline showing voluntary licence request, Controller’s order, IPAB, and High Court dismissal

Arguments

Appellant (Bayer)

Exclusive rights should continue; Natco did not meet the strict grounds of Section 84.
Price and supply were within lawful control of the patentee.
Controller and IPAB erred in their assessment.

Respondent (Union of India/Natco)

Public requirement was unmet; the drug was not affordable to most patients.
The invention was not worked in India sufficiently to meet demand.
All Section 84 grounds were satisfied; licence was rightly granted.

Judgment

The Court did not interfere with the compulsory licence granted to Natco. It held that the approach of the Controller and the IPAB was proper under Section 84. The petition was dismissed.

Balance: Patent rights must align with public health and access to essential medicines.
Purpose: To increase availability at reasonable prices when statutory grounds are met.

Judgment concept image: balancing patent rights and public health

Ratio

Where evidence shows unmet public need, unaffordable price, or lack of working in India, a compulsory licence may be granted after three years from grant. Courts will not disturb such orders if the statutory test is properly applied.

Why It Matters

Defines how Section 84 balances exclusivity with access to medicines.
Clarifies the meaning of reasonably affordable price and working in India in practice.
Guides future applicants and patentees on compliance and evidence.

Key Takeaways

Compulsory licence needs proof on one or more Section 84(1) grounds.
Affordability and availability are central public-interest checks.
Patentees should plan for local supply and pricing that meets public needs.

Mnemonic + 3-Step Hook

Mnemonic: P-A-W — Price • Access • Worked.

Price: Is it reasonably affordable?
Access: Are public needs met?
Worked: Is the invention worked in India?

IRAC Outline

Issue

Whether Natco could get a compulsory licence for Nexavar under Section 84.

Rule

After three years, licence may be granted if public needs are unmet, price is not reasonable, or the invention is not worked in India.

Application

Authorities found high price, limited supply, and inadequate local working—triggering Section 84 grounds.

Conclusion

Compulsory licence upheld; petition dismissed.

Glossary

Term	Easy Meaning
Compulsory Licence	Legal permission to make/use a patented product without the owner’s consent, under conditions set by law.
Reasonably Affordable Price	A price that ordinary patients in India can pay, considering local realities.
Worked in India	Manufactured or made available in India at a level that meets demand.
Controller	The patent authority who decides applications like compulsory licences.

FAQs

Unmet public requirements, lack of reasonably affordable price, and failure to work the invention in India.

To make Nexavar available at affordable prices and to meet patient demand in India.

It upheld the grant of the compulsory licence and dismissed Bayer’s challenge.

Price is a key ground, but the Controller looks at all Section 84 factors and the evidence together.

Related Cases

Pharma & Compulsory Licensing

Decisions applying Section 84 to ensure access to essential medicines.

Public interest Patent law

Affordability & Working

Cases interpreting “reasonably affordable price” and “worked in India”.

Section 84 Access to medicines