Chapter 18 of the TPP hits the Life Science industry in Mexico
The Mexican Government just released a text of the final negotiations of the TPP and some specific issues such as regulatory data protection (RDP), patent linkage and patent term compensations will impact the Mexican legal system in connection with the life science industry.
I.- RDP. The protection would be at least three years for new formulations, new indications or new methods of administration or at least five years for new chemicals. Parties may limit the period of protection for three and five years respectively. Currently, Mexico is granting “de facto” five years for chemicals. It will be interesting how the Mexican government will conciliate the possibility to limit to five years the term of protection while NAFTA states a minimum of five years of data protection for chemicals.
One of the most debated cases during the negotiations, the term of data protection for biologics; it was established for at least eight years or five years plus, consisting in “other” measures, recognizing the market circumstances also contribute to the effective market protection to deliver a comparable outcome in the market.
Hopefully, in the case of biologics, Mexico will opt for the eight years period of protection instead of the five-plus scheme which has a wide range of discretion and interpretation. If this latter scheme of five “years plus” is adopted, unfortunately, we expect further litigation for the term of data protection for biologics.
II.- Regarding the linkage regulation, the text allows Mexico to maintain their actual patent linkage which does not include use patents. Therefore, the Mexican Patent linkage will not be impacted very much by the TPP, although, there are positive issues such as the recognition of second uses as a subject matter patentability which obviously will help the entire enforcement of use patents and also would help to confirm the inclusion of these types of patents through court orders.
III.- TPP contemplates patent term adjustments due to unreasonable delays in the patent prosecution and unreasonable curtailment on the patent protection due to the regulatory processes; taking into consideration that our current law expressly limits the life term of a patent to 20 years as from the filing date, in this particular case, the Mexican IP and the Health Law should be amended.
IV.- There are transitional periods for some countries to be obligated to comply with the specifications of TPP, in the case of Mexico is five years for any case of RDP and four and a half for unreasonable curtailment in the life term of patent due to regulatory delays.
Finally, there is a multiparty scheme for the agreement to enter in force but in any event, the expectation is that TPP may be part of our legal system in Mexico within the next two years but notwithstanding the time, having in mind the hierarchy of international treaties in our legal structure, certainly TPP will shape the legal frame for the life science industry and entire IP Law in Mexico.
We hope you find this newsletter useful and we will continue to provide information on the impact of the TPP to other industries and IP matters.