USMCA: Implications for patents and data protection in Mexico
by Marta García
On November 30, 2018, a new trade agreement called the United States-Mexico-Canada Agreement (USMCA) was signed by United States President Donald Trump, Mexican former President Enrique Peña Nieto, and Canadian Prime Minister Justin Trudeau, during the 2018 G20 Summit in Buenos Aires.
The agreement, which must still be ratified by each party, is also unofficially known as “NAFTA 2.0”, since it is intended to replace the North American Free Trade Agreement (NAFTA) currently in force.
The text of the USMCA, which was published on the Office of the United States Trade Representative website shortly after the formal agreement was announced on October 1, 2018, includes an extensive chapter on Intellectual Property covering standards concerning trademarks, geographical indications, patents and undisclosed tests, industrial designs, copyright and related rights, trade secrets, as well as a section regarding IPR enforcement.
Below is an analysis of some key provisions of the USMCA´s patents and data protection chapter, and their implication for the Mexican IP system after the agreement comes into force.
Non-confidentiality of patent files
Article 20.43 of the USMCA establishes that for published patent applications and granted patents, each party shall make available to the public: search and examination results, non-confidential communications from applicants, and patent and non-patent related literature citations submitted by applicants and relevant third parties.
Nonetheless, Mexico already complies with the above provision, since the new IP Law in force since August 2018 establishes that all patent files must be available for public inspection as soon as they are published. Before the enactment of the new IP law, all patent prosecution files were kept confidential until grant.
Currently, voluntary claim amendments can be filed at any time during patent prosecution, as long as they do not broaden the scope of the application as filed. However, granted patents may only be amended by the patent owner in the following circumstances: a) to correct obvious or form errors, and b) to limit the scope of the claims. Therefore, at the moment no claim amendments, other than those aimed at limiting the claims, are possible when the Mexican PTO (IMPI) finds patentable an invention as originally claimed and a notice of allowance is directly issued.
Article 20.42 of the USMCA establishes that each party shall provide a patent applicant with at least one opportunity to make amendments, corrections, and observations in connection with its application. Hence, the USMCA’s implementation will require that Mexico changes its provisions on claim amendments of granted patents.
Article 20.36 of the USMCA on patentable subject matter establishes that patents must be available for inventions claimed as at least one of the following: new uses of a known product, new methods of using a known product, or new processes of using a known product.
Although in practice Mexico already allows novel uses of known compounds, currently there are no legal provisions that specifically regulate these inventions, which will be likely to change as a result of the USMCA.
Patent term adjustment
The patent term extension provisions of the USMCA provide for an adjustment to a patent term due to: (i) unreasonable delays owing to the patent granting authority, and (ii) unreasonable curtailment of the patent term as a result of the regulatory or marketing approval process for pharmaceutical products.
Mexican law does not currently provide for patent term adjustment neither for unreasonable delays in the issuance of a patent by the IMPI nor for unreasonable delays during the marketing approval for pharma products by the regulatory authority (COFEPRIS). Therefore, amendments to the IP and Health laws will be required in order to implement the USMCA provisions regarding patent term adjustments.
At this time there is no indication of which duration the patent term extensions will have. However, regarding patent term adjustment for delays in the granting of a patent, it should be noted that currently the maximum processing time from patent filing to grant in Mexico is on average 5 years. Therefore, very few requests for patent term extension for delays in the granting of a patent are expected to be filed in Mexico.
Current data protection regime
Mexican law is silent with regard to data exclusivity. However, in 2012 COFEPRIS published an internal decree that provided a 5 year-term of data protection for new chemical entities only. Accordingly, Mexico is currently granting five-year protection periods for new chemicals. However, the legal value of the decree is uncertain.
Additionally, the internal guidelines do not apply to biological medicinal products and new indications.
Under the USMCA, Mexico has agreed to extend the term for data protection of new agricultural chemical products, new pharmaceutical products, new indications and biologics as follows:
Data protection exclusivity for new agricultural chemical products under the USMCA
The USMCA prohibits generic manufacturers from referencing undisclosed test or other data concerning safety and efficacy of “new agricultural chemical products” for at least ten years from the date marketing approval was first granted.
A “new agricultural chemical product” is defined in the text of the USMCA as one that “contains a chemical entity that has not been previously approved in the territory of the Party for use in an agricultural chemical product.”
Data protection exclusivity for biologics under the USMCA
The USMCA establishes that parties should not permit generic manufacturers referencing undisclosed test or other data concerning safety and efficacy of new pharmaceutical products that contain a “biologic” for at least ten years from the date marketing approval was first granted.
A biologic is defined in the text of the USMCA as a product that, at minimum, is “produced using biotechnology processes and that is, or, alternatively, contains, a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, for use in human beings for the prevention, treatment, or cure of a disease or condition.”
Data protection exclusivity for new and previously approved pharmaceutical products under the USMCA – Non-biologics
The USMCA prohibits generic manufacturers from referencing undisclosed test or other data concerning safety and efficacy of “new pharmaceutical products” for at least five years from the date marketing approval was first granted.
A “new pharmaceutical product” is defined in the text of the USMCA as “a pharmaceutical product that does not contain a chemical entity that has been previously approved in that Party.”
The USMCA also establishes at least three years of data protection for new clinical information submitted for a previously approved pharmaceutical product covering a new indication, formulation, or method of administration.
The USMCA has not yet come into force, and it will still have to be ratified by each party. From the date of entry into force of the USMCA, Mexico will have four and a half years to implement its obligations with respect to the patent term adjustment for unreasonable curtailment and five years to implement its obligations with respect to data protection.