Karla Islas from Dumont, Bergman Bider, S.C., briefly explore the possible impact of the Trans-Pacific Partnership Agreement dispositions in the patent industry in Mexico.
The Trans-Pacific Partnership (TPP) and Intellectual Property (IP) Rights
As it is broadly known, negotiations for a new Free Trade Agreement (FTA) among some economies in the Pacific Rim were set last year and finally the agreement was signed last February 4th, 2016. The Countries that signed this treaty were: USA, Japan, Mexico, Canada, Australia, Malaysia, Chile, Singapore, Peru, Vietnam, New Zealand and Brunei. The current negotiating economies are said to account for about 40% of the global Gross Domestic Product.
As most of contemporary FTA's, the TPP contemplates an IP Chapter, wherein several dispositions regarding IP rights were set for traditional IP figures such as patents, trademarks, copyrights, industrial designs, plant variety rights among others. During negotiations, critics from academics, analysts, media, and the general public in many countries were received due to the secrecy under which the talks took place, despite justifications from negotiating governments explaining that some measures of discretion were needed to preserve negotiating strength and to encourage parties to be willing to put issues on the table they may not otherwise. Accordingly, the comments expressed herein are directed to provide a general idea of possible dispositions in patents rights that might impact the Mexican market.
Possible impact in the Mexican Patent System
Prosecution of patent applications is open for public inspection in various countries but not in Mexico. The TPP states that countries shall make available to the public at least the following information for patent applications and granted patents: a) Search and examination results, including details of, or information related to, relevant prior art searches; B) As appropriate, non confidential communications from applicants; and C) Patent and non-patent literature citations submitted by applicants and relevant third parties. This provision would considerably affect Mexico since our current Law states that prosecution of patent applications should be confidential until granting and once the Treaty enters into force in our Mexico, we would have to implement a type of public file inspection, which should include divisional applications.
Harmonization of patentability requirements might be seen generally as a positive aspect, except that there are fields for which Mexico has a tradition of not allowing patents e.g. patents for animals; diagnostic, therapeutic and surgical methods for the treatment of humans or animals; methods of doing business, and pure software. However, the TPP states that no considerable changes will happen in these dispositions and will remain practically the same.
Perhaps one of the hottest topics in the TPP is patent term adjustment. Currently Mexico grants patents with a term expiring twenty years after the filing date. The TPP has included an amendment as to compensate unreasonable delays that occur in the granting of the patent, at the patent owner request, by means of adjustment of the patent term, unless the delay is attributable to the applicant. An unreasonable delay at least shall include a delay in the issuance of a patent of more than five years from the date of filing of the application in the territory of the Party, or three years after a request for examination of the application has been made, whichever is later. A Party may exclude, from determination of such delays, periods of time, that do not occur during the processing of, or the examination of, the patent application by the granting authority; periods of time that are not directly attributable to the granting authority; as well as periods of time that are attributable to the patent application. Since Mexico has shortened prosecution times for patents, it would be very rare that a patent application would fall within this provision. Additionally, it is our thought that the Mexican Patent Office will try to avoid delays in prosecution to also avoid granting patent term adjustment. It is understood that Mexico shall implement this provision at the very time the Treaty enters into force in the country.
In the pharmaceutical field, TPP also will compensate curtailment of the effective patent term as result of the marketing approval process, e.g. sanitary registration.
Any kind of patent term adjustment that may be introduced by the Mexican government now that the TPP has been signed, may lead into opposition from a plurality of players and the general public to enforce the disposition would be triggered. A tension between patent owners and other interested parties has been playing an important role in the Mexican patent system for at least the past twenty years. An unsteady but seemingly compromising situation has been reached with the current twenty-year patent term framework which includes measures in the marketing approval to try to prevent infringement of patent rights by the generic industry. A change introducing patent term adjustment would undoubtedly result in a rearrangement of such situation which may imply intense litigation. It is understood that Mexico shall implement this provision 4.5 years after the Treaty enters into force in the country at the latest.
Finally, another patent related issue in the TPP was data protection for sanitary approval of pharmaceutical, biotechnological and agricultural chemical products. The innovative industry seems to be strongly pushing dispositions for preventing other parties to use data generated to obtain or renew registration of their products without consent. Mexico has agreed to provide protection for such data at least in the pharmaceutical field in at least a previous FTA (NAFTA-1994).Sometimes this protection is only reached by litigation. The TPP would result in Mexico actually modifying the domestic Law to specifically include the five-year protection, eliminating the need for litigation on the matter. For new clinical information submitted in support of a marketing approval of a previously approved product covering a new indication, new formulation or new method of administration, the protection under the TPP would be at least the three years.
As to biological products, data protection is established in the Treaty to be at least 8 years, or at last five years from the first marketing approval in other country. It would be likely that Mexico will choose the first option for biologics. It is understood that Mexico shall implement these provisions five years after the Treaty enters into force in the country, at the latest.
Mexico was an active negotiating party of the TPP Agreement. As briefly discussed, the Intellectual Property Chapter of said Agreement contains a plurality of dispositions addressing, or being related to, patent rights. Now that it has been signed, some of such dispositions would impact the Mexican system, making it necessary to introduce deep changes in the Mexican Industry Property Law for complying with the obligations, some of which are seen as necessary and generally beneficial, some might be controversial and subject to discussion, and others might trigger legal issues which may need to be decided by Courts. Anyhow, the fact that Mexico had the chance to participate in the talks before reaching a final draft is undoubtedly an opportunity to try to put some of its internal concerns on the negotiating table.