torresigner / iStockphoto.com
A new facet of Mexico’s linkage system between patents and pharmaceutical drugs raises several questions that necessitate a careful approach from patent assignees and agents, as Mariana Gonzalez-Vargas of Becerril, Coca & Becerril reports.
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:
- 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.
“The intention of the IMPI is not clear when it emphasises that it is considered an administrative infraction to make products appear as patented when they are not.”
Moreover, IMPI erroneously interprets, as it has been described, that only patents covering a substance or mixture of substances with a therapeutic, preventive or rehabilitative effect per se should be included in the SGM. This criterion then leaves out second medical use patents (Swiss or EPC style claims), which must be litigated in order to achieve their inclusion.
In total, 48 requests rejected based on the provisions of article 47bis of the IPLR are published.
Regarding the requests rejected because the patent that was attempted to be listed did not protect the subject matter indicated in such request, IMPI recalls that according to article 21 of the IPL, the rights conferred by a patent are determined only and exclusively by its granted claims, and that according to section II of article 213 of the same law, it is considered an administrative infraction to make products appear as patented when they are not.
Overall, 28 requests rejected based on an error of the identification of the patented matter are published.
Each rejected petition for inclusion in the SGM publishes the following information:
- Grant number of the issued patent.
- Name of the assignee of record.
- Name of the person filing the request (legal representative).
- Filing date of the request.
- Information provided by the applicant justifying the inclusion of the patent in the SGM, comprising: international non-proprietary name (INN) of the related active ingredient, patent type (ie, active principle, formulation, use, etc), and number of the relevant claims.
- IMPI’s resolution explaining the rationale of the rejection.
In this new Official Gazette, the IMPI states that the technical and legal reasons considered by it as an impediment to include a patent in the SGM are not a pronouncement on the validity or enforceability of such patents against third parties, since the effect of a patent does not derive from its inclusion in the reference list of the SGM.
A lot of questions regarding this new Official Gazette arise. For instance, it is not defined if the IMPI will continue to publish it and how often. Moreover, the intention of the IMPI is not clear when it emphasises that it is considered an administrative infraction to make products appear as patented when they are not, as it even states that this behaviour could be sanctioned ex officio by IMPI.
It seems as a warning for patent assignees and Mexican patent agents in order to assess carefully whether a patent is indeed covering the subject matter indicated in the request, or not. Thus, it is strongly recommended to perform a serious technical and legal analysis of those patents that are planned to be listed in the SGM to assure eligibility based on Mexican laws and technical precision on the petition.
Mariana Gonzalez-Vargas is junior partner at Becerril, Coca & Becerril. She focuses her practice on substantive issues of patent litigation, technological competitive intelligence, health regulation and strategic knowledge management, as well as other activities related to technology transfer. She is responsible for all patent analysis and drafting patents. She can be contacted at: email@example.com
Mexican linkage system, patents, pharmaceuticals, Becerril, Coca & Becerril, IMPI