Section 92A of Patent Act 1970 allows Indian companies to make and export patented medicines to countries that can’t produce them. Section 92A shows the support for the Doha Declaration which says patents shouldn’t block access to medicines during health crises. It’s especially important for pharmaceutical patents, where exclusive rights can make medicines too expensive. By letting generic companies in India produce and send these drugs abroad under certain conditions, Section 92A promotes fair access to healthcare worldwide. This article explains Section 92A, its rules, steps, and impact in a way that’s clear for legal professionals and students.
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What is Section 92A of Patent Act?
Section 92A of Patent Act sets up a system for granting compulsory licenses to export medicines during public health emergencies. It focuses on pharmaceutical products to ensure patented drugs reach countries without manufacturing ability.
Sub-section (1): Conditions for Availability
This part says a compulsory license can be granted to make and export patented medicines to a country with little or no ability to produce them. The importing country must face a health crisis and either issue its own compulsory license or allow imports from India. This rule prevents misuse by requiring proof of need from the importing country.
Sub-section (2): Granting the License
This section allows the Controller of Patents to issue the license after an application is filed. The license is only for making and exporting medicines, with clear rules set by the Controller. These rules might include paying royalties to the patent owner, labeling drugs to avoid misuse, and ensuring the medicines go to the right country.
Sub-section (3): Non-Prejudice Clause
This part clarifies that Section 92A’s export rules don’t affect other export options under the Patent Act, like those from domestic compulsory licenses.
Explanation: Definition of Pharmaceutical Products
The Act defines “pharmaceutical products” broadly to include any patented drug or product made through a patented process needed for health issues. This covers active ingredients, drug formulations, and diagnostic kits.
Procedure for Obtaining a Compulsory License under Section 92A
The process for Section 92A is outlined in the Patents Rules, 2003. A generic drug company files Form 17 with the Controller, listing the patented drug, the importing country’s needs, and proof of the country’s permission to import.
The Controller checks if the application meets Sub-section (1) rules. Unlike Section 84 of the Patents Act, 1970 there’s no waiting period or need to negotiate with the patent owner. Still, the Controller might ask the patent owner’s opinion to be fair, even though the law doesn’t require a formal opposition process.
If approved, the Controller publishes the license terms, including royalties based on factors like research costs. The process is designed to be quick to address urgent health needs.
Historical Background
Section 92A of Patent Act came about in the early 2000s during global talks about patents and health. In 2001, the World Trade Organization (WTO) issued the Doha Declaration, stating that the Trade Related Aspects of Intellectual Property Rights(TRIPS) agreement should support public health by allowing tools like compulsory licensing.
A problem was that TRIPS Article 31(f) limited compulsory licenses to a country’s own market, which hurt poorer nations without drug-making facilities.
In 2003, the WTO created a solution (later called Article 31bis) to allow exports of medicines under compulsory licenses. India, a major producer of affordable drugs, added Section 92A to its Patent Act in 2005 to follow this rule.
This made India a key supplier of medicines to developing countries while meeting global standards. Before this, India’s Patent Act, 1970, focused on local needs, but Section 92A expanded its role to help other countries.
Read about the role of Patent in Intellectual Property Rights.
Comparison with Other Compulsory Licensing Provisions
To understand Section 92A of Patent Act, it helps to compare it with other compulsory licensing rules in the Patent Act, 1970. Sections 84, 92, and 92A have different goals but all balance patent rights with public needs.
Provision | Purpose | Grounds for Grant | Scope | Applicant Requirements | Patentee’s Role |
Section 84 | General license for local use | Public needs unmet; drug too expensive; not made in India | Local production and sales | Apply after 3 years; open to anyone | Can oppose; gets a hearing |
Section 92 | Special license during emergencies | National emergency or public non-commercial use | Local or as notified | Apply after government notice | Limited opposition; faster process |
Section 92A | License for export | Health crisis in a country with no manufacturing | Export only | File application with proof from importing country | No formal opposition, but fairness applies |
This table shows that Section 92A focuses on exports and health crises, unlike the local focus of Sections 84 and 92.
Get to know about Compulsory License Patent in India.
Notable Cases and Applications of Section 92A of Patent Act
Section 92A of Patent Act, 1970 facilitates compulsory licensing for the export of patented pharmaceutical products to countries with insufficient or no manufacturing capabilities which promotes access to affordable medicines globally. The following cases highlight its interpretation and application in balancing intellectual property rights with public health needs.
1. Controller of Patents Decision in Natco Pharma Ltd. v. Bayer Corporation (2012)
Facts: Bayer held a patent for Sorafenib Tosylate (Nexavar), a drug for kidney and liver cancer, priced at about INR 2,80,000 per month, unaffordable for most Indians. Natco, a generic company, applied for a compulsory license under Section 84, saying Bayer didn’t meet public needs, priced the drug too high, and didn’t manufacture it in India. Natco offered the drug at INR 8,800 per month. Section 92A was mentioned to compare export rules with domestic ones.
Issues:
Did Bayer fail to meet public needs under Section 84(1)(a)?
Was the price affordable under Section 84(1)(b)?
Was the patent “worked” in India under Section 84(1)(c), or did imports count?
How does Section 92A’s export focus differ from Section 84’s domestic focus?
Judgment: The Controller granted Natco the first compulsory license in India under Section 84. Natco had to pay Bayer a 6% royalty and give the drug free to 600 needy patients yearly. The Controller said Section 92A is for exports to countries without manufacturing, while Section 84 is for India’s needs. Bayer’s small imports didn’t meet public needs, and the high price wasn’t affordable. The license was for local sales, not exports.
2. Intellectual Property Appellate Board (IPAB) Decision in Bayer Corporation v. Natco Pharma Ltd. (2013)
Facts: Bayer appealed the Controller’s decision, arguing its patient program and imports met public needs and that “working” a patent didn’t require local manufacturing. Natco said Bayer’s supply was too small and the price too high. The case discussed how Section 92A’s export rules relate to Section 84’s domestic rules.
Issues:
Were the Controller’s findings on public needs, affordability, and patent working correct?
Does “working” a patent mean local manufacturing, or are imports enough?
How do Section 92A’s export rules affect the understanding of “sale” under Section 84?
Judgment: The IPAB upheld the Controller’s decision but raised the royalty to 7%. It said Bayer’s supply met only 2% of patient needs, and the price wasn’t affordable for most Indians. The Board ruled that “working” a patent usually means local manufacturing, not just imports. It noted that Section 92A is a separate rule for exporting to countries without manufacturing, while Section 84 focuses on local access. Bayer’s appeal was dismissed.
Implications for Public Health and the Pharmaceutical Industry
Section 92A of Patent Act impacts global health fairness. It helps poorer countries fight diseases like HIV/AIDS, malaria and COVID-19 by allowing exports of affordable medicines, supporting global health goals. For India, it strengthens the generic drug industry, boosting the economy and India’s reputation as a key medicine supplier.
For patent owners, it reduces their control over patented drugs, which might affect their research funding. However, royalties provide some payment and strict rules prevent misuse. Section 92A balances innovation with the need to help people access medicines.
Summary
Section 92A of Patent Act balances patent rights with public health needs. By allowing compulsory licenses for exporting medicines, it fills a gap in global access to drugs, following TRIPS rules. While issues like unclear terms and economic concerns exist, its potential to save lives in poor countries is clear. Lawyers and legal experts should watch how courts interpret this rule, as future cases could shape its use. Section 92A proves that patents should help society, not block access to essential medicines.
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Section 92A of Patent Act: FAQs
Q1. What is Section 92A of the Indian Patent Act?
Section 92A allows compulsory licensing to export patented drugs to countries lacking manufacturing capabilities to meet public health needs.
Q2. In which circumstances shall a compulsory license under Section 92 be granted?
A compulsory license under Section 92 is granted during national emergencies, extreme urgency, or for public non-commercial use, as notified by the government.
Q3. How do I request to withdraw a patent application?
To withdraw a patent application, submit a written request to the Indian Patent Office before the patent is granted.
Q4. What is Section 94 of the Indian Patent Act?
Section 94 allows termination of a compulsory license if the circumstances that led to its grant no longer exist or the licensee fails to comply with its terms.
Q5. What is Section 94 of the Indian Evidence Act?
Section 94 allows a court to order the production of documents or items relevant to a case if a party refuses to provide them.
