Patent Term Extensions in Mexico Buck Latin American Trend

AMELAF, the organisation that represents domestic drug-makers in Mexico, has renewed its campaign against patent term extensions, which are commonly granted in many developed markets whenever patent life can be extended due to special circumstances. The Reforma newspaper reports that since 2002, judicial decisions arising from litigation have allowed 12 novel molecules to receive term extensions of up to seven years. A number of opposition lawmakers in the Senate have now called on the Supreme Court to analyse the legality of patent term extensions.

Litigation Throws Originators a Lifeline

Patent term restoration enables originators to obtain extra patent life in order to compensate for delays in bringing a product to market, and may also result from official recognition that a patented product has additional uses that were not foreseen at the time of registration. However, the concept is controversial in Mexico because the Intellectual Property Law does not specifically allow local patent officials to grant extensions. Instead, under the transitional article XII of the Law—which was incorporated into Mexican legislation from the NAFTA treaty with the United States and Canada—patent extensions must simply follow the prevailing term in the product’s market of origin. As a result, Mexico effectively imports term extensions granted elsewhere, much to the chagrin of would-be manufacturers of generic versions of original medicines.

Not surprisingly, local drug-makers in Mexico have battled hard to block term extensions through the courts. For example, Reforma reports that Eli Lilly has succeeded in extending the patent term for leading cancer drug Gemzar (gemcitabine) until May 2010, even though the Mexican patent expired on 28 February 2006; in the United States, patents for Gemzar begin expiring in the same year. In the public sector, the drug’s official purchase price is some 2,687 Mexican pesos (US$247) for a standard dose. Elsewhere, Lilly has also secured a term extension for co-marketing partner Takeda’s diabetes drug Actos/Zactos (pioglitazone). The ongoing case has taken a high profile in the media, largely due to the disease’s very high prevalence in Mexico (see Mexico: 21 September 2007: Pioglitazone Fracas Pressures Mexican Drug Regulator). The sale of a copy version manufactured by a local company was suspended pending a “definitive resolution” of the case. For the time being, then, private and public sector purchasers will continue to obtain the original medicine. This would be a significant success for Lilly, given that Mexico’s mammoth public health system has not taken a coherent approach to the issue of patented drugs (see Mexico: 16 July 2007: Mexican Welfare System’s Deals with Foreign Drug-Makers Scrutinised).

In all cases the Mexican patent office, IMPI, has deferred to court decisions, standing aside from ruling on such claims itself. This is in stark contrast to the behaviour of the intellectual property authorities in Latin America’s other major market, Brazil. In mid-2007, French firm Sanofi-Aventis failed to extend the patent on its blockbuster blood thinner Plavix (clopidogrel), as Brazil lacks any legal mechanism whereby patent terms can be altered to reflect extensions granted in the market of origin (see Brazil: 3 August 2007: Sanofi-Aventis’ Blockbuster Anti-Thrombotic Plavix Goes Generic in Brazil).

Outlook and Implications

Mexico thus appears to be an exception to the Latin American norm, which is typified by the current situation in Brazil. Hopes that other countries in the region would include new terms on patent extensions have been largely dashed. A number of revisions to the slew of new trade agreements between Latin American countries and the United States were carried out after the Democratic victory in Congressional elections, and have watered down such measures. As a result, the U.S. research-based pharmaceutical industry association PhRMA has refused to support the new treaty texts, as these merely stipulate that patent life in signatory countries may not outlast the equivalent term in the United States (see Peru: 7 December 2007: U.S. Senate Approval of Peruvian FTA Signals Few Gains for Innovators).