What is a pharmaceutical patent in Colombia?
A pharmaceutical patent is an exclusive right granted to the inventor of a new drug medicine. In Colombia, under Andean Community Decision 486 of 2000, patents are valid for 20 years counted from the date of filing of the application.
During this period, the patent holder may prevent third parties from:
- Manufacturing the product
- Offering it for sale
- Selling or using it
- Importing it for commercial purposes
This monopoly seeks to reward the time and money invested by innovative laboratories, but it is not an absolute right, it has limits. One of the most relevant limitations in the field of drug medicines is the bolar exemption.
What is the bolar exemption?
The bolar exemption is a rule that limits the exclusive rights of a pharmaceutical patent. It allows generic drug manufacturers to use patented products before the patent expires, but only to generate the information required by the Colombian regulatory authority (INVIMA) for a future approving of a Marketing Authorization of a generic product.
In other words, laboratories can prepare everything in advance so that once the patent ends, the generic product can enter the market almost without delay.
Example:
Imagine an innovative drug against hypertension has a patent in Colombia valid until 2027. Thanks to the bolar exemption, a generic manufacturer can, in 2026, produce and test that medicine solely with the purpose of filing to obtain a Marketing Authorization (MA) before INVIMA. This way, when the patent expires in 2027, the authorization will already be in place, and the generic version can be marketed immediately, which would benefit both the market and the consumers.
Where is the bolar exemption regulated in Colombia?
This limitation is regulated by Andean Community Decisions 486 of 2000 and 689 of 2008, as well as article 16.9 of the Colombia–United States Free Trade Agreement, and by Decree 729 of 2012.
FAQs
Can a generic manufacturer produce, use, or carry out preparatory acts on a patented product under the bolar exemption?
Yes. Decree 729 of 2012 authorizes generic laboratories to manufacture, use, sell, or offer for sale a patented product in Colombia, as long as it is exclusively to obtain the information required to apply for a MA before INVIMA, without this being considered patent infringement.
Can a generic manufacturer import to Colombia a patented product under the bolar exemption?
Yes, it is possible, provided the importation is intended to obtain the information necessary to obtain a MA before INVIMA. Importing for other purposes, such as sale or commercialization, would constitute patent infringement.
Can those products manufactured under the bolar exemption be exported?
No, Decree 729 of 2012 establishes that a product manufactured under this exemption may only be exported to meet approval requirements in Colombia.
Can a generic manufacturer apply for a MA before INVIMA while the patent is still valid?
Yes. Under the bolar exemption, a generic manufacturer’s application for a MA before INVIMA, even if the innovator’s patent is still valid, does not constitute infringement, as long as it is limited to the purposes authorized by the exemption.
If the generic manufacturer obtains the approval of the MA while the patent is still valid, does it constitute infringement?
No. Obtaining the MA itself does not constitute patent infringement under Colombian patent law. However, while the patent is still in force, the generic manufacturer cannot commercialize the product.
It is also important to note that Decree 677 of 1995 establishes that if a MA is not used (that is, if the product is not marketed) within two years of being granted, the MA will be automatically canceled.
Why is the Bolar exemption important?
- Facilitates access to generic drug medicines: it prevents patients from waiting months or years after the expiration of the innovator’s patent.
- Balances rights: it protects the innovator’s rights during the patent term but ensures immediate access to generics afterward.
- Promotes competition: it allows several laboratories to be ready to enter the market as soon as the patent expires.
Conclusion
If your company is interested in understanding and strategically leveraging this exception to patent protection while reducing litigation risks, Nieto Lawyers provides legal advice to pharmaceutical and biotechnology companies on the strategic use of the bolar exemption, its legal framework, and the associated risks, to ensure compliance and prevent disputes.
At Nieto Lawyers, we have advised pharmaceutical and biotechnology companies on the strategic use of the Bolar exception, helping them prepare early market entry strategies for generics while reducing the risk of patent infringement.
if your company seeks to accelerate market access, ensure regulatory compliance, and minimize litigation risks, schedule a 25-minute initial consultation with our expert team in pharmaceutical law and intellectual property.
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