Exclusive Marketing Rights (EMRs)
Exclusive Marketing Rights (EMRs) are special rights granted by a government to a company, usually a pharmaceutical firm, to market and sell a new drug or product exclusively for a limited period. These rights are given even before a full patent is granted, as long as the company has filed a patent application and received regulatory approval for marketing the product.
Meaning of Exclusive Marketing Rights (EMRs)
Exclusive Marketing Rights refer to the authority granted to a manufacturer or inventor to market a product without competition. This concept is most commonly applied in the pharmaceutical sector. It ensures that once a new drug is approved for sale, only the developer of that drug can sell it for a specific period. No other company can produce or market a generic version during this period, even if the product is not yet patented.
Purpose of EMRs
The main aim of EMRs is to encourage innovation, especially in sensitive and high-investment sectors like pharmaceuticals. Developing new drugs involves a long, expensive process that includes research, clinical trials, and regulatory approvals. EMRs help protect these investments by giving companies a fair return before generic competitors enter the market.
Conditions for Granting EMRs
In India, EMRs were governed by the Patents (Amendment) Act, 1999 under the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement. To obtain EMRs, the following conditions must be met:
- A patent application must be filed in India after 1st January 1995.
- The invention must have been granted a patent in another WTO member country.
- Marketing approval must be obtained in that foreign country.
- The company must receive marketing approval in India.
If these conditions are fulfilled, the Indian government may grant EMRs for five years or until a patent is granted or rejected, whichever is earlier.
Impact of EMRs
EMRs create a monopoly in the market for a short time. This can have both positive and negative impacts:
- Positive: Encourages innovation and investment in R&D. Provides financial support to continue research.
- Negative: Higher prices for consumers due to lack of competition. Essential drugs may become unaffordable for the poor.
Example
In India, Novartis was one of the first companies to be granted EMRs for its anti-cancer drug Glivec in the early 2000s. This prevented other Indian generic manufacturers from producing and selling cheaper versions of the drug during the EMR period.
EMRs vs Patents
| Feature | EMRs | Patents |
|---|---|---|
| Basis | Granted before patent approval | Granted after full patent process |
| Duration | Up to 5 years | Usually 20 years |
| Scope | Marketing rights only | Full monopoly on production and marketing |
| Legal Standing | Temporary protection | Legally enforceable right |
