In Mexico, it can be tricky to protect data exclusivity, but prospective international agreements may provide a solution, as Jose Trigueros explains.
Data exclusivity is usually discussed in academic circles, mainly due to enforcement complexities and when cases are brought against the Federal Commission for the Protection against Sanitary Risks, the government branch in charge of issuing of marketing authorisations for drugs and agrichemicals.
However, data exclusivity protection is a crucial element for securing marketing exclusivity for both the pharmaceutical and agrichemical sectors, especially for orphan drugs and also for molecules the patent protection of which may be compromised in some manner, or simply unavailable.
For that reason, data exclusivity is a topic which appears regularly in the negotiation of bilateral and multilateral international treaties,including IP clauses, to which Mexico is a party.
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Mexico, pharmaceutical, agrichemical, TPP, COFEPRIS, data exclusivity