Enforcement Of Use Patents In The Mexican Linkage System
The patent linkage system between COFEPRIS and the Mexican Institute of Industrial Property (IMPI) aims to prevent the granting of marketing authorizations in violation of patent rights. According to the linkage regulation established in article 147bis of the Industrial Property Law Regulation (RLPI) and article 167bis of the Health Supplies Regulation (HSR), IMPI must publish a "Linkage Gazette" every six months. Besides expressly stating that patents protecting allopathic medicines (products) must be included, the only patents that are explicitly excluded by these regulations are those that protect production and formulation processes of medicines. Therefore, formulation and use patents should also be included in the Linkage Gazette, as confirmed by the jurisprudence issued on this matter by the Mexican Supreme Court in 2010.
However, in contravention of the above, COFEPRIS still considers that in accordance with the Linkage System provided by article 167bis of the Health Medical Supplies Regulation, it is exclusively bound to observe the existence of active ingredients patents when processing a marketing authorization application for a pharmaceutical product, expressly disregarding formulation and use patents published in the Linkage Gazette.
OLIVARES has already processed several successful litigations related to the enforcement of formulation and use patents by COFEPRIS. However, in...
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