Case Brief: Bayer Corporation v Union of India (2014) Bombay HC
Case Brief: Bayer Corporation v. Union of India (2014)
Court: Bombay High Court
Year: 2014
Area of Law: Patent Law / Compulsory Licensing
1. Parties
Petitioner: Bayer Corporation (a multinational pharmaceutical company)
Respondents:
Union of India (through Controller General of Patents)
Natco Pharma Ltd. (Indian generic drug manufacturer)
2. Background / Facts
Bayer Corporation held an Indian patent for the drug Sorafenib Tosylate, marketed as Nexavar, used in the treatment of liver and kidney cancer.
The drug was extremely expensive — around ₹2.8 lakhs (INR) per month — making it unaffordable for most Indian patients.
Natco Pharma applied for a compulsory license to manufacture and sell a cheaper generic version of the drug at around ₹8,800 per month.
In 2012, the Controller of Patents granted the compulsory license to Natco under the provisions of Indian patent law.
3. Legal Issue
Whether the grant of compulsory license to Natco Pharma by the Controller of Patents was valid.
Bayer challenged the order on the ground that it still held exclusive rights over the patented drug and that Natco’s license infringed on those rights.
4. Bayer’s Arguments
The compulsory license was unjustified because:
The patented drug was available in India, even if expensive.
Bayer claimed it had a right to set its own price for a patented invention.
Bayer also argued it had made efforts to make the drug accessible through patient assistance programs.
5. Natco’s & Government's Position
Natco argued that Bayer had not made the drug reasonably affordable or sufficiently available to the Indian public.
The Union of India supported the Controller's decision, saying it was in public interest to allow cheaper access to life-saving medication.
6. Judgment (Bombay High Court, 2014)
The Bombay High Court upheld the Controller’s decision, stating:
Availability at a high price is not true availability under the law.
The patented product must be reasonably affordable and accessible to the general public.
The court emphasized the balance between patent rights and public health.
Compulsory licensing is a legitimate mechanism to ensure that patented products serve public welfare, especially in essential areas like healthcare.
7. Key Legal Principle Established
The price of the drug plays a crucial role in determining availability under patent law.
Compulsory licenses can be justified when patented inventions are not available to the public at an affordable price.
Patent law does not solely protect commercial interests but must serve the larger public good.
8. Significance of the Case
First-ever compulsory license granted in India for a patented pharmaceutical product.
Landmark ruling balancing IPR (Intellectual Property Rights) with public health concerns.
Established that patent rights are not absolute, and affordability is essential for access.
Reinforced India’s role as a provider of affordable generic medicines.
Summary Table
| Element | Details |
|---|---|
| Case Name | Bayer Corporation v. Union of India (2014) |
| Court | Bombay High Court |
| Petitioner | Bayer Corporation |
| Respondents | Union of India & Natco Pharma Ltd. |
| Issue | Validity of compulsory license granted to Natco |
| Holding | License upheld; price and accessibility are critical |
| Key Principle | Patent rights must be balanced with public interest |
| Significance | Promoted access to affordable medicines |
Conclusion
The Bayer v. Union of India (2014) case is a milestone in Indian patent jurisprudence. It reaffirmed that patent monopolies must not override the public's right to life-saving medicines, and it upheld the role of compulsory licensing as a lawful and necessary tool to promote public health over private profit.
RELATED Blog
0 comments