This to inform you about recent developments concerning the request and obtention of Sanitary Registrations (SR) -which is the authorization needed in Mexico for a medicament to be granted access to consumers-, specifically of those medicaments involving patent-protected pharmaceutical compounds, i.e., active pharmaceutical ingredient (API).
In this sense we are glad to announce the latest procedure implemented by the Mexican Federal Commission for the Protection against Sanitary Risks (COFEPRIS), as the authority tasked with granting SR’s; such government Agency has recently implemented what could be conceived as an “opposition” system of sorts designed for owners of pharmaceutical patents, as now they will be able to formally oppose the granting of the sanitary registrations for generic medicaments that could be infringing their corresponding patent rights.
In this sense and notwithstanding the fact Mexico currently operates a linkage system by means of which COFEPRIS has a legal obligation to request to the Mexican Patent Office (IMPI) a technical opinion when a new authorization request involves a medicament involving a patent-protected API that could be infringing a valid patent, there could be some instances where the applicable information is unclear and as a consequence, COFEPRIS could move forward and grant a SR for a medicament that could incorporate a patent-protected drug or compound.
Considering such a possibility, this new “opposition” mechanism is aimed at providing patent holders with an option to protect their rights and impede third parties from obtaining a SR in favor of a generic medicament that could be infringing their patent rights.
Considering the above and as part of this new system, COFEPRIS will publish -for one time only- those companies that are requesting a sanitary registration for their generic drugs. The publication will be made weekly and will include the name of the company, the generic name of the API, and the date of publication; once published, any third party will have a 10-day term to lodge its inconformity (i.e., the opposition) before such Regulatory Authority.
Having this in mind and since no additional information is provided in the publication made by COFEPRIS, it is very difficult to know if the generic drug for which a sanitary registration is being requested is or is not actually infringing patent rights, especially considering the patents requested for protection before the MPO do not include within its respective title, the generic name of the compound that is being protected.
Taking this into consideration, we invite our clients to provide us the Active Pharmaceutical Ingredient (API), generic name or compound name that correspond to their patent(s), so we can include the same in our system and at the time the publications are made by COFEPRIS, and thus be able to identify any generic name for which a sanitary registration is being requested, that might be infringing a valid patent in our country.
The above will not generate any expenses to our clients and as a consequence, patent holders will have one more protection option to avoid the violation of their rights in our country, in the event that the Mexican authorities make an omission when considering that a patent is not being violated by a generic drug and, consequently, a health registration is granted contrary to the law.
If you and/or your clients are interested in the above, please feel free to contact us, so we can include the relevant information in our dockets.
Janett Lumbreras / firstname.lastname@example.org
José Luis Ramos-Zurita/ email@example.com
Carolina Ponce / firstname.lastname@example.org