The battle between generic and patents pharmaceuticals in Mexico

A new chapter in the battle in Mexico between the owners of patents for pharmaceutical products and the supporters of the so-called ?generic? or interchangeable drugs, was written on September 19, 2003, by the publication in the Mexican Official Gazette of the linkage mechanism between the registration of new pharmaceutical products and existing patents.

By way of background, the confrontation that echoes the long-time international quarrel among these two positions , gained new strength last December 2002, when the Green (Ecological) political party (Partido Verde Ecologísta) presented to the House of Representative a bill to amend the Industrial Property Law. This bill intended to reduce the duration of patent protection (from 20 to 10 years) in the case of pharmaceutical patents for the treatment of serious illnesses. Although nobody can deny the seemingly altruistic purpose of the proposal, the fact is that behind it there were private interests worth many millions of dollars. When passed to the Senate, the bill had evolved from the limitation of the patent period, to the granting of compulsory licenses. The draft is yet to be voted by the Senate. Lobbing for both extremes has been extensive and closely covered by the media.

However, the September 19, 2003 publication in the Official Gazette has to do with another related front of this same battle, which has taken place before the Mexican Commission for the Protection of Sanitary Risk, the nation?s equivalent to the FDA (Comisión Federal para la Protección contra Riesgos Sanitarios or ?COFEPRIS?). Surprisingly, the COFEPRIS had held until now that it was not bound to take patent status into account when authorizing new products, in violation ?at the very least? of article 1711.6 of NAFTA.

The reform includes the addition of article 167-bis to the Regulation of Health Related Components (Reglamento de Insumos para la Salud) and article 47-bis to the Industrial Property Law (Ley de la Propiedad Industrial).

Basically, the reform provides that, commencing September 20, 2003, the COFEPRIS, assisted by the Mexican Industrial Property Institute (Instituto Mexicano de la Propiedad Industrial or ?IMPI?, Mexico?s patent office) will need to verify that any applicant for approval for a new pharmaceutical product is the owner or has the right to exploit the patent covering such product. If the applicant does not have such rights, the request will be denied. Although the provision does not reject the possibility of requesting the registration of a ?generic? product its approval , when applicable, will only be granted after the expiration of the patent in question.

It is worth mentioning that although these amendments clearly represent a victory for pharmaceutical patent holders, Mexico did not go as far as its NAFTA partners, by limiting this type of linkage only to product patents (active ingredients), expressly excluding process production patents. Both the US and Canada link product and use patents.