12 Aug The Linkage System under the Federal Law for the Protection of Industrial Property enacted on 1st July 2020
The Mexican Senate passed a bill on 1st July 2020 which enacted the Federal Law for the Protection of Industrial Property in México. The new law will replace the current Law on Industrial Property as from 5th November 2020 when it will become effective.
The new statute governing Industrial Property in Mexico contains a number of relevant changes that will basically affect all forms of Industrial Property, from prosecution to maintenance and on to the enforcement of said rights. In consideration of the rather diverse scope of these changes and to ease on their analysis, we will provide you with specific comments on what we consider to be the key issues addressed in the new law.
The Linkage System in Mexico is currently supported on legal provisions contained in both, the Regulations to the Industrial Property Law and in the Regulations for Health Supplies which govern the regulatory market authorization for medicaments, among other issues. A fundamental change in the legal structure of the Linkage System is that its legal support will now be provided for in Federal Law, which stands with a higher hierarchy when in conflict with any and all legal provisions contained in so-called Regulations. When in conflict, legal provisions contained in a federal law passed by Congress will always prevail over those contained in Regulations which are enacted by the executive branch. In line with this legal principle, Transitory Provision Fourth of the new law provides that while the current Regulations will remain effective until the new law is provided with its own, any rule understood in contradiction or to provide against those contained in the new law will be rendered ineffective and void. Under the noted hierarchy principle, any and all rules contained in the Regulations for Health Supplies understood to counter those contained in the new law shall also be considered ineffective and void.
Based on the above considerations, what could have well been considered an irrelevant addition in the new law results in a fundamental restructure of the substantive elements that conform the Linkage System. The material inclusion of the Linkage System into the new law transcends even potential amendments to the Regulations which govern the same for the time being, since neither could provide for guidelines or rules contrary to those contained in the new statute. Constitutional provisions would render those potential rules providing against the new law contrary to it and thus ineffective.
Article 162 of the new law provides for the publication of the customary Gazette twice a year, which is to contain “… a list of patents related to inventions susceptible of being employed in medicaments, in the terms provided for in Article 167 Bis of the Regulations for Health Supplies.” It is further established that the Mexican Patent Office is to work with the Regulatory Authority to provide whatever information may be required during the prosecution of applications for the market approval of medicaments. Nothing more is provided for in the new law; the otherwise complex and even confusing language contained in the currently valid Regulations to the Industrial Property Law which gave way to a number of conflicts on interpretation appear to have been reduced to one fundamental consideration, namely, that the Gazette under which the Linkage System will be supported is to contain a list of patents which subject matter claimed is susceptible of being employed in medicaments. A fair conclusion of the new text could very well be that the Linkage System is to apply in favor of all patents claiming inventions susceptible of being employed in medicaments. While the reference contained in the new statute directing to Article 167 Bis of the Regulations for
Health Supplies may pose some questions as to the extent of the Linkage System, particularly because only active ingredients are referred to therein, let us not forget that federal law prevails over legal provisions contained in Regulations when potential conflicts in their interpretation arise. Accordingly, since federal law provides for a rather broad protection under the Linkage System over all patents claiming inventions susceptible of being employed in medicaments, a narrower coverage resulting from the current market approval Regulations shall be understood contrary to law.
The scope of protection defined in the new text of the law is far more comprehensive in as much as it implicitly covers all patents, whether those claiming an active ingredient, a formulation, a specific dosage or even second uses of a given compound or formulation. Under the text of the new law, it would appear to suffice for the subject matter claimed to be susceptible of being employed in medicaments to merit inclusion in the Gazette and thus to be awarded coverage under the Linkage System. Wording in the Regulations governing market approval which could be understood to narrow the extent of the coverage provided for in the new law should be rendered void for being contrary to legal provisions contained in federal law.
So far as procedure is concerned, the current communication between the Regulatory Authority (COFEPRIS) and the Mexican Patent Office which entails a written request in a proforma may well experience a change. The fifth transitional provision in the new law provides that the Mexican Patent Office will participate with the Ministry of Health through the Regulatory Authority (COFEPRIS) to establish a mechanism for technical collaboration pertaining to inventions claiming subject matter related to medicaments. The new mechanism is to become effective as from 18th December 2020 albeit not even a hint as to what said mechanism will entail is contained in the new law. We may only hope that the rather poor proforma currently being used by COFEPRIS to request information from the Patent Office, which has been the reason of so many errors in the implementation of the Linkage System is replaced by a reliable means of effective and comprehensive communication, sufficient to ensure the needed enforcement of the Patents listed in the Gazette, on the one hand, and to provide a secure environment for generics. The mechanism shall aim to provide legal certainty in that valid patents awarded protection under the Linkage System are not infringed.
Aside from the rather academic analysis above, it would be naïve to expect no complications from the Regulatory Authority and even from the Mexican Patent Office when efforts aimed to enforce the Linkage System on patented inventions claiming a second use for a given compound, for instance, as the new law contains general provisions aimed to prevent double patenting and even to favor public domain which could very well be misrepresented. While the text of new Article 162 above leaves us in no doubt as to the new extent to which the Linkage System has been restructured, only time will tell how officials at the Mexican Patent Office and at the Regulatory Authority (COFEPRIS) will react both, when publishing the Gazette and when requesting information to be considered before issuing market approval for generics.
The considerations above shall not be interpreted to constitute specific advice and should rather be understood a general overview of the new scenario provided for in the new law for the Linkage System. We will be certainly pleased to provide specific advice and to answer any questions on request.
Carlos Pérez De La Sierra
August 2020
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