Does Mexico allow the Bolar exception?
Yes, although the insertion of the Bolar exception in the Mexican law was quite deficient. The Rules for Health Supplies provide that a generic manufacturer is allowed to obtain authorization from the Mexican FDA to perform tests and experimental production aimed to obtain the marketing authorization of a drug three years in advance of the expiration of the patent. However, the Industrial Property Statute (the Rules are lower rank provisions) does not stipulate this limitation, thus the effectiveness of the Bolar exception against a patent infringement claim is arguable.
