Before products like medicines, agrochemicals, or medical devices can be sold, they need the green light from the proper regulatory body. This process ensures that the products are safe and effective for public use. For brand-new chemical or biological products, this approval process is usually very demanding, involving full clinical trials. On the other hand, generic or biosimilar products often have an easier path, since they can rely on data that has already been generated from the original product.
To get approval, a generic manufacturer still has to show that its product is “bioequivalent” to the original medicine. This typically involves collecting and testing samples. The complication is that even if the company intends to launch its product only after the patent on the original medicine has expired, using that patented invention during testing may be seen as patent infringement.
To deal with this issue, many countries have introduced special rules known as Bolar exemptions. These allow companies to use a patented invention strictly for the purpose of seeking regulatory approval, without it being considered an infringement. The idea is simple: by allowing generics to complete their approval process while the patent is still active, they can enter the market right after the patent expires, rather than being delayed by years of extra testing and red tape. The World Intellectual Property Organization (WIPO) has noted that more than 65 countries have adopted some form of this exemption, though each country’s approach is different.
Looking at Latin America, we see that many countries have adopted these exemptions into their laws. These include:
Argentina also has provisions under its data confidentiality law that could act like a Bolar exemption, but this has not yet been tested in the courts.
The Andean Community (Bolivia, Colombia, Ecuador, and Peru) allows its members to create Bolar exemptions under regional rules. So far, only Colombia and Peru have passed specific laws to implement them.
How broad the exemption is depends on the country. In some, like Argentina, Brazil, and Uruguay, it applies to any product that needs regulatory approval. In others, it’s limited only to medicines (such as Chile, Costa Rica, and Mexico) or to medicines and agricultural chemicals (like in El Salvador and Peru).
What activities are allowed under these exemptions also varies. Some countries simply say that the patented invention can be “used” for regulatory purposes. Others are more detailed, permitting actions such as “selling,” “offering for sale,” “importing,” or even “exporting” when connected to regulatory approval.
Despite these efforts, challenges remain. According to WIPO, many laws still lack clarity on how far the exemption goes, and in several countries, businesses that could benefit are often unaware that such exemptions even exist.
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