On March 8, 2018, 11 countries signed the free trade agreement formerly known as the Trans-Pacific Partnership (TPP), which has been renamed the “Comprehensive and Progressive Agreement for Trans-Pacific Partnership” (CPTPP). The signing members are: Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam.
The key differences between the original TPP and the recently signed CPTPP are: 1) the absence of the United States as a participating member and 2) some substantial provisions contemplated by the former TPP that are now suspended in the CPTPP, including several relating to IP and the life sciences listed below:
- Patentable Subject Matter – Article 18.37.2 and 18.37.4 (Second Sentence)
- Patent Term Adjustment for Unreasonable Granting Authority Delays – Article 18.46
- Patent Term Adjustment for Unreasonable Curtailment – Article 18.48
- Protection of Undisclosed Test or Other Data- Article 18.50
- Biologics – Article 18.51*
*Source: “Intellectual Property Watch”
William E. New
I.- The TPP contemplated that Regulatory Data Protection (RDP) should be no less than three years for new formulations, new indications, or new methods of administration, and no less than five years for new chemicals. Two options for biologics were provided by the TPP, the better option being no less than 8 years of RDP.
As this matter has been suspended, we consider that Mexico will continue granting five years of RDP for chemicals. Certain legal strategies will be required to achieve protection for new indications of orphan drugs and biologics.
II.- Patent Linkage is not suspended in the CPTPP.
III.- Regarding patent term adjustments due to unreasonable delays in the patent prosecution and unreasonable curtailment on patent protection due to the regulatory processes, taking into consideration that this issue has been suspended, the patent term under domestic law will remain in place, i.e. the life term of a patent for non-extendable 20 years as from the international filing date.
No amendments to the Mexican IP and the Health Law are expected in the near future, unless other treaties also under negotiation, such as the North American Free Trade Agreement (NAFTA) and the Free Trade Agreement between Mexico and the European Union (TLCUEM) include similar patent term compensations schemes.
Bearing in mind the hierarchy of international treaties in the Mexican legal system, CPTPP will be an important part of the legal framework for life sciences companies in Mexico. International Agreements to be effective in Mexico requires the ratification of the Mexican Senate, which is expected within this year.
Given the suspension of the above-mentioned provisions, the impact of the agreement will not be as positive as expected with respect to elevating IP standards in Mexico and in this regard is quite disappointing; however, it is a welcome development for international trade and for certain aspects of IP protection and regulatory matters.