Study Suggests Several Changes to Legislation on Patents, Marketing Authorizations, and Government Procurement

[author: Juan Luis Serrano*]

In July of 2016, the Federal Commission for Economic Competition announced a broad ranging study on the entry of generic drug alternatives to the Mexican market, both for private purchasing and government procurement.  The results of this study were released last week, along with a press statement[1], which outlined the following main findings:

• Entry of generic drugs to the market is unduly slow.
• Patent expiration has not caused enough competition in the market.
• Entry of generic drugs has not caused enough price reductions in comparison to other jurisdictions.
• Industry regulations is affecting competition conditions.
• Some of the current rules have provide incentives for innovator companies to engage in litigation.

In this study, the Commission makes several recommendations, addressed at the Patent Office (IMPI), the Regulatory Authority (COFEPRIS), the Ministry of Health (Secretaría de Salud) and Congress, which affect different aspects of relevance to the industry, such as patent-marketing authorization linkage, limitation of grant of certain patents, regulatory data exclusivity, prescription rules, substitution/interchangeability, and government procurement rules.

Whereas each of these recommendations will be subject to specific analysis and future blog entries, we’ll start the series with a highlight of the study as a callout by the competition authority for an overhaul of the regulatory framework under which both innovator and generic companies participate in the Mexican Market.

Even though the study does not constitute a mandate for other authorities to act upon it, it does provide insight based on current official information, numbers of approvals, market penetration, and comparison with other legislations with a strong message of a need for change.

It will certainly be interesting to follow up on the fallout of this study, including possible endorsements or criticisms to its conclusions and recommendations.

* Mr. Serrano is Of Counsel with ROMO DE VIVAR V.IP SERVICES, S.C.

[1] https://www.cofece.mx/cofece/index.php/prensa/historico-de-noticias/cofece-el-vencimiento-de-patentes-no-se-ha-traducido-en-suficiente-presion-competitiva-en-el-mercado