Protecting Clinical Data in Mexico’s Sanitary Registrations

Industry, in general, has tools to protect the intellectual property developed for its products in Mexico through the Federal Law of Protection of Industrial Property (LFPPI) by means of legal figures that range from the most common with minor investment, to the less common with bigger investment. We are talking about the registration of trademarks, slogans and non-traditional trademarks, such as soundmarks or trade dress, as those that require less investment, although still important, and figures created to protect inventions, such as industrial designs, utility models and patents, where the cost of investment is much higher and for which there is the need for technical and legal support.

Talking specifically about the pharmaceutical industry, which is facing the need to develop new products, or new uses of existing products, to address the new health issues generated by current lifestyles or due to the changes in our bodies, intellectual property is a great tool to generate competitive advantages with new developments in medicines or medical devices.

In parallel, the Sanitary Regulation (RIS) is an incentive for investment in the pharmaceutical industry whose corresponding authority has to demonstrate the safety and efficiency of the new product or new use (Article 179 RIS), through the technical and scientific information provided by laboratories, where said information is generated by an important effort of human, technical and financial resources that should be protected to generate the competitive advantage. However, there is no legal figure within the LFPPI that enables us to obtain that specific protection.

However, there is a special consideration on the information presented during the applications for commercial authorization (sanitary registration) of a medicine, as said information has the character of confidential, or reserved information, as that set forth in the international treatises of which Mexico is a signatory. In other words, it is protected against disclosure to third parties. This is established in Article 20.48: protection of clinical data or other non-divulged data in the treaty signed with Canada and the US: USMCA.

Said protection cannot be petitioned directly before the Federal Commission for the Protection of Sanitary Risks (COFEPRIS), as said authority has not issued the requirements to apply. The only precedent generated by this authority regarding the protection of clinical data was Memorandum No. CAS/01/OR/896/2012 dated 2012, where it mentions an amendment to Article 167 RIS that sets forth the obligation to file the information related to the existence of a patent or license of use during the application for authorization of commercialization, which should be registered before the Mexican Institute of Industrial Property (IMPI); as well as the consideration of confidential or reserved information established in the USMCA, where the commitment to protect clinical data was first enacted.

This Memorandum establishes six guidelines to protect confidential information:

1. The confidential, or reserved, information, will be that which is received at the moment of filing and application of sanitary registration of an API (Active Pharmaceutical Ingredient), object of protection against the unlawful commercial use and against its disclosure from COFEPRIS.
2. The protection time frame of the confidential information will be for a period of up to five years after the granting of the corresponding Sanitary Registration.
3. The owner of the Clinical Data will have a protection of up to five years during which, without his/her consent, no person can use said data in authorization proceedings for the commercialization of an API.
4. COFEPRIS can only grant sanitary registrations of generic medicines once the five-year period after the granting of the sanitary registration corresponding to the new chemical product, unless the new applicant has produced its own data.
5. The interested party will have to prove:

          5.1. It is the data mentioned in Article 167 of the Health Products Regulation.

          5.2. They are data on experiments, or other information not published previously to its filing before this authority.

          5.3. They are data on chemical products that use new chemical compounds.

          5.4. Are data necessary for determining the safety and efficiency of the use of said products.

          5.5. That the obtaining of the data supposed a considerable effort.

     6. The protection of Clinical Data referred to in this guideline will apply exclusively to new chemical entities/products.

As mentioned in the guidelines, these have not been updated to the new conditions under which USMCA was signed, nor has a procedure been created to apply for this protection before COFEPRIS, for which we must explore other options such as obtaining this protection through the Specialized Court of Intellectual Property Matters of the Federal Court of Administrative Matters.

This Clinical Data protection may aid in protecting the large-scale investments made during clinical trials, by providing an exclusivity in the commercialization of at least five years.