Alejandro Luna
View from the Top

Mexico a Key Stakeholder in the Trans-Pacific Partnership

Wed, 09/07/2016 - 14:38

Q: What are the most common administrative violations in industrial property in the life sciences industry and how does the Trans-Pacific Partnership (TPP) aim to regulate them and strengthen the intellectual property system in Mexico?

A: Nowadays, the most common violation to intellectual property (IP) rights is the infringement of patents. Patent linkage has reduced patent infringement for pharmaceuticals but it only prevents the infringement of compound patents. Other patents within the life sciences industry either do not fall under patent linkage regulation or are disregarded by the corresponding authorities. The claims may be unjustified and thus disregarded by the Mexican Patent Office and COFEPRIS, or they may be prevented from patent linkage to avoid the granting of marketing authorizations in violation of these patents. There is no reason to exclude medical patents from the linkage regulation but the authorities do.

The TPP includes certain obligations: country members should accept as patentable subject matter the new uses of known products to avoid in all aspects the discrimination of these patents, including patent linkage. The TPP will also clarify data exclusivity for biologic products.

Q: It has been said that Mikel Arriola, Commissioner of COFEPRIS at that time, negotiated a balanced agreement for the Mexican industry, protecting both the innovative and the generics’ industry. To what extent do you agree with this perception?

A: Due to my participation in the so-called “cuarto de junto” I witnessed Mikel Arriola and the Mexican delegation defending and looking for better conditions on behalf of the country. It is no secret the IP Chapter in TPP, specifically the issues related to pharmaceutical patents and data package exclusivity, were highly debated during the negotiations, precisely due to the irreconcilable position of some generics companies which pushed against the measures to protect innovation. Mexican negotiators addressed these conflicting interests by trying to reconcile them and establish a balance between the need to protect and promote innovation with the need to launch products into the market. Indeed, Mexico was a leader in these discussions on this highly debated topic which led to the inclusion of a transitional period for Mexico before being obliged to adopt the obligations of TPP. My opinion is that such a transitional period was not necessary and in the case of data protection for example, it will only delay the fulfillment of Mexico's obligations which are now Mexican court orders based on other international treaties such as NAFTA and TRIPS.

Q: Some stakeholders argue the TPP would limit the entry of up to 5,000 generic medicines in the next five years; yet some others believe it will bring further foreign direct investment to the pharmaceutical industry. Will the TPP help improve the perception of Mexico among other countries regarding support and protection of innovation?

A: There is no basis to say TPP obligations alone would hinder the entrance of generics to the Mexican market. Statistics show penetration of generic products in the Mexican market is growing year on year and this trend is not going to be changed by the TPP, as indeed there is nothing in the TPP that would ban the entrance of generic pharmaceutical products. The various legal instruments in place in Mexico are only recognized or clarified in the TPP, for example patent linkage, data package exclusivity for new molecules and second-use patents is a matter within the Mexican office. The few new matters contained within the TPP such as data exclusivity for biologics and compensation of patent terms are not bans to the entry of generics, only the necessary recognition of a longer period of protection for biologic products, which is recognized by generic companies when requesting a Roche-Bolar exception of eight years for bio-comparable products.

In general terms, the TPP will provide a higher degree of certainty for investment in Mexico compared with the current legal framework in various aspects of IP. I am convinced proper and effective protection of IP is a driver for innovation. In the life sciences sector, the opportunities and expectations of the TPP on IP protection were higher than the final result.