In summary, Data Protection comprises a sui generis intellectual property right related to the clinical data of pharmaceutical or agrochemical products. Clinical data, the information used to demonstrate that a product is safe and effective to be administered, is guarded against unfair use or blocked for third parties who may depend on it during a regulatory approval process.
Data protection is considered by the Trade-Related Intellectual Property (TRIPS) Agreement, the document which sets the basic provisions governing intellectual property matters amongst members of the World Trade Organization, under a nondisclosure approach. Parties are required to avoid the disclosure of the data or protect it against an unfair commercial use (Article 39, paragraph 3, of the TRIPS Agreement).
TRIPS Agreement: The basic provisions for data protection
Although the TRIPS Agreement establishes the basic provisions for data protection, multilateral treaties may require a higher level of protection. For Mexico, the North American Free Trade Agreement (NAFTA) further required it to protect the data by blocking third parties which may rely on it during the regulatory approval process.
During the period when NAFTA was in force, 1994 – 2020, Mexico did not explicitly establish a procedure in its national law for obtaining data protection. It is assumed that these rights were automatically conceded whenever an innovative marketing approval was approved. In addition, interested firms could also obtain these rights through judiciary or administrative proceedings. Upon a favorable decision from the Mexican judiciary or Administrative Court, the Mexican Regulatory Authority was forced to acknowledge this protection and block potential third parties marketing approvals.
In 2018 The Mexican Regulatory Authority replied to a public inquiry on the data protection given from 2013 until 2018. The response shows that data protection was linked either to marketing approvals or new indications.
NAFTA has been updated to the United States Mexico Canada (USMCA) Agreement
Now, the NAFTA has been updated to the United States Mexico Canada (USMCA) Agreement and though some elements have been kept from the NAFTA, it establishes new rules for data protection; for example, data protection for agrochemical products is now granted for 10 years. Interested firms must consider these amendments when seeking to obtain data protection in Mexico.
According to the USMCA final provisions, Mexico may take up to five years to implement the obligations in regard to data protection; however, this does not seem to be a hindrance for interested firms as the agreements are currently in force.
Data protection remains a supplementary mechanism through which innovative firms may obtain the exclusivity of their products. There is previous data of its acknowledgment in the country, and, although it may take some time to incorporate it into the national law, interested firms could benefit without waiting for the amendments.Read More
The recent agreement between the United States of America, the United Mexican States, and Canada (USMCA) was published on the Mexican Official Gazette on June 29, 2020, replacing the previous North American Free Trade Agreement (NAFTA). In Mexico, the entry of this treaty is expected to bring several changes to the intellectual property framework. For example, copyrights, industrial property, plant varieties, imports, and exports, among others.
On the industrial property, a recent proposal of amendment to the Mexican Industrial Property Law has been passed to lower chambers of the Mexican Congress. This proposal of amendment comprises several changes for which we highlight the following:
Empowering the Mexican Institute of Industrial Property (IMPI). IMPI is empowered to condemn and quantify the amount of the respective compensation resulting from the damages to the rights affected owners.
Improving on the electronic means of communication. Expanding on the electronic presentation and processing of applications, including the use of electronic mail, as well as the advanced electronic signature or any other means that allows the identification of individuals.
Modifying the Bolar clause. The proposal dismisses the period of three or eight years in which a third party makes the necessary preparations to obtain the marketing approval of a drug related to a patent that is about to expire.
Extending the protection for the utility models. The modification grants further protection time for utility models, from ten to fifteen years.
Providing further rules for the substantive examination of patents. IMPI will not be required to evaluate the fulfillment of any other patentability requirement when the impediment is seen on a lack of clarity, subject matter which may not be considered an invention, subject of a patent, or absence of an industrial application.
Patent term extension because of administrative delays. The interested party may request a complementary certificate to adjust the term of the patent whenever the IMPI incurs in a delay of more than five years, between the filing date of the application in Mexico and the granting of the patent.
The exclusion for the reduction of rights during a pending procedure. The waiver, rectification or limitation of rights will be discarded when there is pending resolution for a procedure regarding the validity of the patent.
The possibility that a trademark may cover several classes. A single trademark application may be claimed in different classes. Additionally, a trademark may be rejected when it does not meet its distinctive purpose.
Additional mechanisms for the protection of IP holders. New provisional measures related to the suspension of the free movement of goods destined for import, export or transit, and the suspension, blocking, removal of content, or cessation of acts that constitute a violation of the Law through any virtual, digital, or electronic means.
Special subjects such as the Mexican Linkage System may be changed once the proposal of the amendment is published. In summary, modifications are expected to allow further participation from the patent holder while maintaining the same responsibilities for the authorities in charge of the system.
Although some modifications may be controversial, it is clear that these aim to further improve the position of IP holders as well as increasing IMPI’s responsibilities.
LXIV Legislature. Parliamentary gazette of the senate. Retrieved from: https://www.senado.gob.mx/64/gaceta_del_senado/documento/109519
Office of the United States Representative. Agreement between the United States of America, the United Mexican States, and Canada 12/13/19 Text. Retrieved from: https://ustr.gov/trade-agreements/free-trade-agreements/united-states-mexico-canada-agreement/agreement-betweenRead More
by Marta García
New trade agreement – USMCA
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.
Key provisions of the USMCA
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.
Conclusion of the USMCA
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.
Source: https://ustr.govRead More