The absence of specific regulations makes it difficult to defend the exclusivity period granted to pharmaceutical companies over the clinical trial results that allow new drugs to be brought to market.
Pharmaceutical companies operating in Europe and the United States are very familiar with the concept of regulatory data exclusivity, which the European Medicines Agency defines as “the eight-year period from the initial authorization of a drug during which the marketing authorization holder enjoys exclusive rights over the preclinical and clinical trial results of the drug.” Once this period has passed, the holder must make this information available to companies seeking to develop generic versions of the drug, and the regulations allow for approvals based on interchangeability.
The United States-Mexico-Canada Agreement (USMCA) also requires member countries to grant exclusivity to the developer of clinical data on new pharmaceutical products, establishing a minimum protection period of five years that prevents the approval of generic or biosimilar products.
However, this exclusive right has not been properly regulated in Mexico. The Federal Law on the Protection of Industrial Property provides that the information necessary to determine the safety and efficacy of pharmaceutical or agrochemical products with “new components” will be protected in accordance with the “applicable legislation or, as the case may be, international treaties,” without further detail.
The lack of specific rules has led the Mexican regulatory agency (Federal Commission for the Protection against Health Risks, COFEPRIS) to reject exclusivity requests, forcing companies to resort to administrative litigation to obtain protection. COFEPRIS typically defends these proceedings by arguing that:
i) exclusivity is unnecessary when the data remains confidential;
ii) patent rights and the linkage system in Mexico provide sufficient protection;
iii) protection should not be granted for new indications, combinations, biological products, or orphan drugs.
This stance by the authority could pose a risk for innovative companies, as the marketing of generic or biosimilar products could be approved within the five-year exclusivity period.
Therefore, it is essential to carefully analyze the portfolio of innovative products authorized in Mexico, reviewing the studies submitted to COFEPRIS to determine whether they are candidates for protection, as well as the exclusivity derived from patents, since in some cases both protections are complementary.
To achieve the exclusivity mandated by the USMCA, pharmaceutical companies require proper legal advice that enables them to obtain favorable suspensions and final rulings, like those that have already forced COFEPRIS to recognize exclusivity and preserve rights over clinical data for oncology drugs and those intended for rare diseases, among others, in cases that have been supported by our professionals.