The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has implemented a mechanism to oppose applications for marketing authorizations of generic or biosimilar drugs that could involve active pharmaceutical ingredients (APIs) protected by patent. This mechanism gives patent holders the opportunity to express themselves in the face of such applications for marketing authorization of generic or biosimilar medicines when their rights are violated.
In Mexico, for several years, a linkage system has been in operation by which COFEPRIS must request a technical opinion from the IMPI when an application for marketing authorization involves a drug that could incorporate an API protected by a valid patent. However, in cases where the information is unclear or incomplete, there is a risk that a marketing authorization may be granted to a medicine that may de facto incorporate a protected compound and potentially infringe patent rights. This scenario has led to the adoption of the new opposition mechanism as an additional layer of safeguard.
Last year, a new agreement was published between the Mexican Institute of Industrial Property (IMPI) and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), where the technical collaboration mechanism between both institutions is announced to provide the information required within the marketing authorization process, safeguarding at all times the confidentiality of the corresponding information.
On the other hand, COFEPRIS has established a procedure that allows patent holders, licensees or sublicensees to formally express themselves against applications for marketing authorizations of generics and biosimilars that could affect their rights. In practical terms, the model works as a preventive administrative opposition: once the application for marketing authorization of a generic or biosimilar has been published, any third party with a legitimate interest can present their disagreement so that COFEPRIS considers relevant technical and legal elements before deciding on the granting of the marketing authorization.
As part of this scheme, COFEPRIS will publish for a single time the applications for marketing authorization for generic and biosimilar medicines. The publication will be weekly and will contain, in a limited manner, the name of the requesting company, the generic name of the API and the date of publication. From that date, a 10-day window will be opened for interested parties to file their opposition with the Regulatory Authority.
The information submitted through the opposition will be integrated into the COFEPRIS-IMPI Cooperation Form, which reinforces the traceability between the regulatory process and the protection of industrial property rights. This makes it easier that, if there are sufficient elements, COFEPRIS is warned about the possible infringement of a current patent and a more exhaustive analysis is motivated before ruling on the marketing authorization. This inter-institutional coordination does not replace the legal actions available in administrative or judicial headquarters, but it does enable timely intervention in the phase prior to the granting of the marketing authorization.
However, its effectiveness depends on having continuous monitoring mechanisms and precise mappings between generic names, synonyms, and international denominations.
If you and/or your clients are interested in the above, please do not hesitate to contact us, to carry out the corresponding monitoring of your APIs, and when appropriate, to present the opposition form in a timely manner, and avoid possible risks of infringement, strengthening the preventive defense of your rights.
By: Janett Lumbreras
jlumbreras@uhthoff.com.mx
