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12 November 2018AmericasMariana Gonzalez-Vargas

Mexico: new links between patents and pharmaceuticals

The so-called Mexican linkage system aims to improve the communication between the Federal Commission for Protection against Health Risks (COFEPRIS), which is the health regulatory agency in Mexico, and the Mexican Institute of Industrial Property (IMPI), in order to prevent the granting of marketing authorisations (MAs) for generic versions of pharmaceutical drugs which might fall within the scope of valid patents.

The Mexican linkage system is currently implemented via a published special edition of the Official Gazette called Special Gazette for Medicaments (SGM), which consists of a list of granted patents arranged by active ingredient (more information about the SGM can be found here).

The SGM is issued by the IMPI according to article 167bis of the Health Supplies Regulations (HSR) and article 47bis of the Industrial Property Law Regulations (IPLR). According to article 47bis of the IPLR, the SGM should include only granted patents related to a product considered an “allopathic medicament”. Process or method patents are expressly excluded.

A new Gazette

On August 17, 2018, the IMPI issued a different special edition of the Official Gazette that publishes the petitions to list a patent in the SGM which were rejected either for not complying with the provisions of article 47bis of the IPLR, or because the patent that was attempted to be listed did not protect the subject matter indicated in such a petition.

Rejected petitions published in this new Official Gazette are categorised in two sections according to each of the referred reasons to deny the inclusion of a patent in the SGM.

It appears that the IMPI is publishing only rejected petitions filed after 2013, as there are no rejected petitions before then.

Regarding those petitions rejected on basis of the provisions of article 47bis of the IPLR, the interpretation of what is understood as an “allopathic medicament” is referred to in section I of article 221 and section I of article 224 from the General Health Law.

“Article 221, for the purposes of this Law, it is understood as:

  1. Medicament: any substance or mixture of substances, natural or synthetic, having a therapeutic, preventive or rehabilitative effect, that it is presented in a pharmaceutical form and is identified as such due to its pharmacological activity and its physical, chemical and biological characteristics.

When a product contains nutriments, it will be considered as a medicament, provided that it is a preparation containing individually or in combination: vitamins, minerals, electrolytes, amino acids or fatty acids, in concentrations higher to those found in natural food and that is also presented in a defined pharmaceutical form and the indications of use considers therapeutic, preventive and rehabilitative effects.

(…)

Article 224, medicaments are classified:

(…)I. Allopathic: any substance or mixture of substances of natural or synthetic origin, that has a therapeutic, preventive or rehabilitatory effect, that is presented in a pharmaceutical in form and that is identified as such by its pharmacological activity, physical, chemical and biological characteristics, and is registered in the Pharmacopeia of Mexico for allopathic medicines, (…)”

Thus, according to IMPI, a patent covering an allopathic medicament is one directed to a substance or mixture of substances with a therapeutic, preventive or rehabilitative effect for a disease. On this basis, excipients, dietary supplements, and veterinary products are not eligible for inclusion in the SGM.

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