On 13th August 2010 the Mexican Trademark and Patent Office (IMPI) made available through its website the new edition of the Linkage Gazette. Regrettably, IMPI excluded formulation patents, limiting the inclusion criteria to compound patents. Formulation patents are included in the list, but derived from court orders.

The non-inclusion of formulation patents disregards the petition by the Pharmaceutical Association of R&D Companies and does not follow the jurisprudence of the Supreme Court ruling that formulation patents are to be included in the Linkage Gazette.

Legally speaking, as an administrative authority, IMPI is not bound to follow judicial precedent; nevertheless, there is broad dissatisfaction with the political decision taken by IMPI regarding the decision not to include formulation patents in the Linkage Gazette, since following the Supreme Court’s criterion would have avoided further litigation from patent holders.

The non-inclusion of valuable formulation patents is contestable within 15 working days from publication of the new edition. Any litigation proceeding at this point will benefit from the Supreme Court’s precedent, which is mandatory for district and circuit courts and provides guidelines to decide these cases.

Of course, inclusion of formulation patents in the Linkage Gazette provides grounds to prevent or challenge marketing authorisations granted to third parties in violation of formulation patents, which in many cases have expiration dates beyond the initial compound patent.

Additionally, inclusion of formulation patents is pivotal, as the formulation of drugs is reviewed by the regulatory authority (COFEPRIS) on studying applications for marketing authorisations. Since safety and efficacy of a drug reviewed by COFEPRIS are not limited to compounds, there is no rationale for limiting the linkage regulation to compound patents by the linked authorities (IMPI and COFEPRIS), particularly when the highest court in Mexico has decided that the formulation patents for allopathic medicines that include an identified compound should be included in the gazette.

This article first appeared in IAM magazine. For further information please visit www.iam-magazine.com