By Moeller IP.
Patent Linkage in Mexico
The Mexican linkage system refers to the cooperation between the Mexican Institute of Industrial Property (IMPI) and the Federal Commission for Protection against Health Risks (COFEPRIS) to avoid the granting of marketing authorizations for allopathic drugs which may infringe any in-force patent.
This linkage system was issued on September 19, 2003. It is established in articles 167 bis of the Health Supplies Regulations and article 47 bis of the Industrial Property Regulations which state the system procedure.
Authorization for an allopathic drug
Allopathic drugs are defined in article 224 of the Mexican Health Law as natural or synthetic substances having therapeutic, preventive or rehabilitative effects, which may be identified by their pharmacological activity, physical, chemical or biological characteristics and are presented in a pharmaceutical form.
Whenever a marketing authorization application for an allopathic drug is submitted to COFEPRIS, the applicant is required to either submit the documents which demonstrate that owns the patent or patents related to the active pharmaceutical ingredient (API), possess the corresponding license, both registered at the IMPI, or, according to the Mexican Linkage Gazette, declare under oath that it complies with the provisions applicable in patent matters.
In the case of the latter, COFEPRIS will request IMPI to confirm this statement. COFEPRIS will file a form detailing the following information about the marketing authorization application and deliver it to IMPI:
- Applicant of the marketing authorization
- Name of the API, salts as APIs or International Nonproprietary Name
- Chemical name according to the International Union of Pure and Applied Chemistry
- Structural formula of the API
- Pharmaceutical formulation, API and excipients
- Dosage form
- Therapeutic indications
- Drug presentations
- Drug characteristics
- Any additional information submitted by the applicant
The above information is considered confidential, thus only COFEPRIS and IMPI are aware of its contents.
Based on the information received, IMPI will have ten business days to confirm whether an in-force patent may be infringed. If no patent is found to be infringed, the marketing authorization application will comply with this administrative requirement and follow its normal procedure. Otherwise, IMPI will notify COFEPRIS which in turn will notify the applicant of the possible infringement. COFEPRIS will request the applicant to submit the corresponding license and if the applicant fails to do so the marketing authorization will be denied.
Mexican Linkage Gazzete
Regarding the Mexican Linkage Gazette, this document is published semi-annually by IMPI and its purpose lies in keeping a record of the in-force Mexican patents associated with specific APIs.
Patents listed in the Mexican Linkage Gazette include those of composition of matter, formulations, medical uses or combination thereof. These are listed automatically by the IMPI whenever a patent is granted. Alternatively, patent owners may also request the Mexican PTO to include a certain patent in the Gazette. Lastly, patents related to processes or methods of producing the drugs are expressly excluded from being published in the Mexican Linkage Gazette.
Mexican Patent Linkage System is limited to cases related to IMPI and COFEPRIS involving potential patent litigation between patent owners and applicants submitting new marketing authorizations. It was designed to avoid unnecessary litigation from these private parties, thus Its current design does not allow the direct participation of the patent owners or applicants of new marketing authorizations.
Patent owners may participate indirectly through ensuring its most relevant patents are listed in the Mexican Linkage Gazette. On the other hand, applicants of new marketing authorizations may submit additional information to argue its product does not infringe the patents listed in the Mexican Linkage Gazette.
Given the limited participation from the parties in the current Patent Linkage System so far, patent owners have resorted to filing patent infringement procedures to prohibit the production and commercialization of the infringing products while applicants of new marketing authorizations have resorted to nullity actions over patents. Both procedures are handled by the IMPI and its ruling may be appealed before the Federal Court of Administrative Justice, which, in turn, may be appealed before the Collegiate Courts.
Overall, in our opinion, the Mexican Linkage System remains imperfect as it could benefit from increasing the transparency of the procedure to both parties, patent owners and applicants of new marketing authorizations.