Mexico’s Coming Legal Challenges in IP During COVID-19 PandemicBy Fernando Becerril | Mon, 08/03/2020 - 09:13
The COVID-19 pandemic situates us in a definitely atypical situation. One that, given the circumstances, took not only our country, but the entire world, by surprise. At the end of 2019, this new virus was identified in Asia. Since then, the spread of COVID-19 has put all the countries of the world in crisis and, therefore, has forced not only health systems to react, but has also forced to activate legal conditions in the business environment that offer favorable conditions to better face this health emergency that we have been experiencing in the last 6 months.
On another note, for almost two years, Mexico has been involved in the negotiation of several international treaties (v.gr. TIPAT, USMCA, TLCUEM, etc.), whose rounds, in most cases, were closed several months ago. Finally, the USMCA agreement went into effect on July 1st this year. As part of the negotiations of the USMCA agreement, significant conditions were established in its Chapter 20, the one related to Intellectual Property (IP). It was necessary that Mexico carried out a process of revision of its legislation in the matter and, from there, different actions were taken. In the first instance, reforms were made to the current Federal Copyright Law. Additionally, reforms were proposed to the Federal Plant Variety Law, although unfortunately, they did not end up being even discussed in Congress and, most importantly, a new industrial property law was issued. The new law represents the most representative change in the last 26 years in Mexico regarding IP matters. For almost a year there was an intense work to create a new industrial property law that would abrogate the current one in force and that would not only comply with the requirements of the USMCA but that would also complement all those deficiencies and omissions that appear in the Industrial Property Law still in force today.
The proposed law, presented by the Senate was subsequently analyzed, discussed, lobbied, supplemented and negotiated by all the actors of the intellectual property system in our country for several months and finally, on June 3 of this year, it was voted at the Congress. With an almost absolute majority, the new Federal Law for the Protection of Industrial Property was finally born.
Although the new Law includes some topics that come to correct some deficiencies of the current law, it also incorporates chapters resulting from international commitments that were contracted, defines topics that were not clear enough and, from a general point of view, it has a clear intention of privileging creators’ and innovators’ rights without losing sight of the clear social focus that our current Government envisions. Within the relevant new changes, there are some that, may directly impact the health-related industry and the pharmaceutical industry, which, in a way, might represent challenges to come for the health sector.
It is important to mention that among the large number of changes in the chapter of Inventions, the patentability of new uses is now established in the Law and clarifies both the authorities and applicants in this regard. In the same way, the Linkage System between patents and sanitary registrations is incorporated into the Law. A fact that, until now, was only in the Regulations. The concept of the “Bolar Clause” is included, and with it, the possibility that a third party can use, manufacture, sell or import a product with a patent still in force to carry out tests and experimental production during the entire period of its validity, thereby offering the possibility of having generic products from the day after the expiration of the patent. One of the commitments of the USMCA is the inclusion of a provision that allows patent holders to obtain an adjustment in the patent term in the event of delays attributable to the IP authority. For this purpose, Complementary Certificates are incorporated. They will be granted to adjust the validity as long as the delay to grant the patent exceeds 5 years of the official granting date and if, and only if, this delay is fully attributable to the Authority.
The new Law for the Protection of Industrial Property will enter in force on November this year 2020. The challenge for the following months will be the drafting of a clear Regulation that allows the correct implementation of the Law and that guarantees its correct and balanced application. Until now, beyond the purely technical analyzes, we do not know and cannot be clear about the real impact that this new legislation will have, positively or negatively, in the daily practice.
Now, focusing specifically on the possible impact that the new law will have on the control of the pandemic, it can be considered that, both the current Law and the one that will come into force soon, are perfectly adequate to offer protection for pharmaceutically acceptable products, biotechnological products, medical devices and, in general, to all the relevant technological fields required to attend a sanitary contingency like the one we are living today. It is worth mentioning that the examination conditions that the Mexican Patent Office (IMPI) carries out in our country are in the standards of those carried out in countries considered as leaders in the matter, both from the technical point of view and in the time taken from filing to granting.
In this new Law, the chapter related to licenses remains basically the same as the previous law, where it is provided that public utility licenses may be granted under certain characteristics clearly established in the law itself. Therefore, if it were necessary to grant a public utility license as a result of the current health contingency, it is clear that there will be no obstacle for the granting of the public utility license as long as the appropriate conditions exist.
Today, the legal challenges that are seen in the near future regarding intellectual property due to the COVID-19 health emergency are really not very different from those that exist in any other country in the world. There is a clear commitment on the part of the IMPI to prioritize any procedure that has, or that could have, a direct effect for the better management of the health crisis that we are experiencing. Therefore, it is foreseeable that if there were any procedure that would bring progress to the prior art with products that would help to contain the COVID-19 contingency, all available legal and human systems would surely be activated to do everything they could to accelerate as much as possible the granting of this right.
The ongoing situation brings other challenges that are not necessarily legal. Now it has come essential to start a process of reconfiguring the industry in order to be prepared for the eventual mass production of a drug or of a vaccine, once it is available. It is clear that when launching a pharmaceutically acceptable product that helps contain the disease, all related industries will have to contribute their expertise and manufacturing capacity for the production of the drug or the vaccine, in order to guarantee that, in the shortest possible time, we all globally have access to medicine.
Thus, we can see that solutions are arising to face the many challenges with which the COVID-19 contingency defies us. Health solutions in order to contain the disease, legal solutions that, from many perspectives, are aligning in order to support and protect the innovation systems to ease the pathways of those who are working at a fast pace to develop a vaccine, and finally, the solutions that will arise to face the challenge of the manufacturing and distribution of the product.
Nowadays, we are in an absolutely exceptional situation that humanity has not yet lived through. A disease with the present conditions in terms of ease of dispersal to practically all the world’s population and of the severe global economic impact, can only be tackled with exceptional measures in order to guarantee the fastest way to develop, protect, produce and distribute the drug or vaccine while respecting intellectual property rights. The clock is ticking and we all, each and every one, from our own trenches, must commit to facilitate the conditions that can guarantee health for the more than 7,000 million people on our planet as soon as possible.