Since 19 September 2003, Mexico has been managing a patent linkage system. The system consists mainly of the Mexican Patent Office's (IMPI) biannual publication of the list of allopathic medicines covered by patents (Linkage Gazette), as well as the intra-governmental communication between COFEPRIS, the Mexican health authority in charge of granting sanitary registrations, and IMPI, prior to the granting of sanitary registrations for allopathic medicines.
Linkage Regulation
The Mexican Linkage Regulation is made up of Article 47bis of the Mexican IP Regulations and Article 167bis of the Health Law:
- Article 47bis of the IP Regulations established the publication of IMPI's Linkage Gazette, which contains information on patents in force that cover allopathic medicines, excluding those patents covering processes of both formulation and production.
- Article 167bis of the Health Law establishes that a marketing authorisation applicant must prove it is the owner or licensee of the corresponding The law also allows COFEPRIS to request technical information from IMPI regarding the scope of protection of the published patents.
The main purpose of the Linkage Regulation is to prevent the granting of marketing authorisations to non-authorised third parties in violation of patent rights. The system has been governed at a regulatory level by both the regulations of the abrogated Industrial Property Law and the Health Supplies Regulation.
In the past, the linkage system was wrongly interpreted by the authorities, which were corrected by the judiciary, through decisions on legal actions filed by patent owners to secure complete compliance with the original function and nature of the patent linkage system to prevent violations of exclusive rights covering the technology of allopathic medicines, including active ingredients, formulations and their medical uses.
Case law precedents and jurisprudence of the Supreme Court were necessary to secure the inclusion of formulation patents in the Linkage Gazette and their observance in the marketing authorisation or regulatory approval processes. The courts studied patent owners' arguments that, according to a broad and correct interpretation of the past linkage regulations, patents covering medicines in the Linkage Gazette should be included, except for process patents, which are expressly excluded from publication. Case law obtained from the Supreme Court in 2010 has been observed by IMPI since 2012 but is limited in relation to the inclusion of formulation patents in the Linkage Gazette.
Other remarkable precedents have been obtained from the courts regarding the consideration of formulations and use patents in the process of granting marketing authorisations, as well as granting the patent owners hearing rights derived from the processes.
The previous linkage system involved listing patents covering active ingredients and formulations in the Linkage Gazette via a request without the need for litigation. Use-limited and purpose-limited product patents, however, required litigation by titleholders.
Benefits of the system
The main benefit of the linkage system is its preventative effect. IMPI's inclusion of patents in the Linkage Gazette and their consideration by COFEPRIS should, in theory, prevent the grant of approvals to non-authorised third parties or should put patent owners in a better position to defend themselves against violations of valid patents included in the Linkage Gazette, avoiding the long road of patent enforcement (ie, with the infringing product in the market). It is not necessary to have an approved product for the corresponding patents to be listed in the Linkage Gazette.
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Originally published in IAM Life Sciences 2021
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