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Sanitary registration and Intellectual Property linkage in Mexico

The link between health and Intellectual Property authorities in pharmaceutical matter is referred as “linkage”. Linkage aims to verify that any new sanitary registration, granted by the health authority, does not infringe any granted patent rights. Linkage is promoted by international pharmaceutical companies assignees of granted patent documents, in order to prevent illegal marketing of generic drugs.

In Mexico, the health authority is the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) and the Intellectual Property authority is the Instituto Mexicano de la Propiedad Industrial (IMPI). Mexican linkage system was established in September 2003 by official Decree. This Decree simultaneously amended the Regulation of Health Supplies (RIS) and the Regulation of Intellectual Property Law (RLPI).

The amending in RIS refers to the inclusion of article 167 BIS. This article stablishes two pathways to demonstrate the non-infringement of patent rights by a new sanitary register applicant:

Attach to the sanitary register application the documentation showing that the applicant is the assignee of the patent, or holds a patent license.
Demonstrate under oath, that according to the list of ongoing (in force) drug patents referenced in Article 47 BIS of RLPI, the sanitary register applicant satisfy the legislation applicable to patents (not infringement) regarding the drug object of the register.
For the second case, in order to confirm the existence of in force patents claiming the drug, it is responsibility of COFEPRIS require IMPI technical cooperation through the allopathic patent consultation format, IMPI has 10 working days to issue his answer. In the case that patent documents are infringed, COFEPRIS will notify the sanitary register applicant. The applicant should demonstrate that he is the patent assignee or holds a patent license within a period stablished by the COFEPRIS (not less than 5 working days). According to this amendment, it is possible to apply for the sanitary registration of a generic drug, as long as the expiry of the patent is no further than three years; that is, only for clinical studies or experimental production (similar to bolar clause) in order to save time for the commercialization of the generic. In this case, the sanitary register will be granted immediately at the expiring of the patent.

On the other hand, the amending to RLPI refers to the inclusion of article 47 bis, which establishes the obligation of IMPI to publish a list of ongoing (in force) drug patents. The list includes: 1) Generic name (trade name), 2) Pharmaceutical identity, 3) Patent number and 4) Expiring date. This list have been published since November 2003.

Mexican linkage system seeks to establish a fair market for both patent holders and generics producers; however, the application of this system is still a challenge for Mexican authorities. Clarke Modet & Co Mexico offers to pharmaceutical companies interested in the sanitary register of generic drugs, an analysis of Mexican patents related to its product. This allows: (1) verify the non infringement of patent rights, (2) identify the date for starting with sanitary register, (3) support a sanitary register application and (4) take informed manufacturing and marketing decisions.