Alejandro Luna F.
Partner Litigation and Life Sciences Co-chair
OLIVARES
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View from the Top

Mexico's Weak Health Regulations Threaten Well-Being

By Miriam Bello | Thu, 06/04/2020 - 11:40

Q: What opportunities will emerge from the industrial property (IP) law the Senate is considering?

A: Mexico has the priceless opportunity to review, amend and improve its entire IP system, both substantially and procedurally, with pending and older issues. The eventual proper review and update of the entire IP law would be positive for all industrial, commercial and productive sectors, but there is no doubt that the healthcare sector will see a favorable impact.

Q: How can Mexico improve the enforcement of IP law regarding pharmaceutical products?

A: For many years, new uses of known products, including primary and secondary medical uses, have been patented by the Mexican Patent and Trademark Office (IMPI). The express recognition that new uses are patentable would provide the required legal certainty for these products. Better definitions and clear standards for novelty, inventive step and utility, along with the preparation and issuance of an Examiner’s Manual would benefit the patent law with particular impact on the pharmaceutical sector.

A specific improvement for the pharmaceutical sector is expected through the establishment of a system of compensation due to delays in the granting of patents by IMPI. It is important to mention that the time frame for granting patents in Mexico is not a real problem. However, the establishment of this compensation mechanism would assure good practices from IMPI in the granting of patents and could be helpful in the exceptional cases when IMPI may delay the granting of patents.

Q: What impact is piracy of medications having in Mexico?

A: Counterfeiting in Mexico represents not only a challenge for owners of IP rights, patents and trademarks, but also a serious threat to the health of Mexicans. To combat piracy, our system provides a number of venues: administrative actions before IMPI, the Customs and the Consumer Bureau; claims before the General District Attorney and other local authorities in charge of pursuing criminal actions and, with respect to regulatory and health concerns, proceedings before COFEPRIS. Decisions on the best course of action or a combination of these available venues is considered on a case-by-case basis, as there are important pros and cons for each.

Q: With the ratification of USMCA, what would you identify as the main concern the pharmaceutical industry has regarding IP protection?

A: The concern would be proper implementation of some obligations established in USMCA. Important areas for implementation relate to patentability, including new uses, although this is not a USMCA obligation. It is necessary to review IMPI’s current practice and the integrity of patent linkage, including the eventual amendments to notices in the Mexican patent linkage process. Also, there is need for the proper establishment of patent term compensation for unjustified delays in the patent process.

Regarding enforcement, there are very important opportunities for improvement, such as direct civil remedies available in case of any violation of IP rights, including trade secrets. The current system in which the titleholder is required to exhaust two different proceedings, administrative and civil, in order to get as compensation an award of damages derived from the violation of an IP right is inefficient, absurd and only encourages illegal activities due to the long period of time before there is a real sanction.

Q: USMCA includes stronger protections for data regarding biotechnological medicines. How will these impact the sector?

A: Unfortunately, Mexico lost the opportunity to get a definition of the data or regulatory protection for biologics when the US removed the obligation to provide 10 years of regulatory protection to these products. This situation will be resolved through further litigation aimed at gaining the proper recognition and duration of protection for biologics through NAFTA and/or USMCA, as such protection has not been explicitly banned. What is not established in the law or the treaties is the duration of protection for biologics.

Q: How will the recently approved labels for food and non-alcoholic beverages hurt or benefit the goal to reduce obesity and overweight in Mexico?

A: I do not believe in the rationale behind the Official Standard recently enacted. In my opinion, the NOM is illegal. One of the main concerns refers to provision 4.1.5, which states that pre-packaged food and non-alcoholic beverage products that include one or more warning seals or a sweetener inscription shall not include on the label children’s characters, animations, animated cartoons, celebrities, athletes or mascots, interactive elements such as visual-spatial games or digital downloads (all of them addressed to children) that encourage or promote consumption, purchase or selection of products that have an excess of critical nutrients or sweeteners and shall make reference on the label to unrelated elements of the product. It must be stated that this NOM violates the human rights protected by our Constitution, such as freedom of profession, industry, commerce or work, information rights, freedom of speech, property rights, economic rights and copyrights. It also contravenes provisions that preserve the use of intellectual property contained in our IP Law, Federal Copyright Law and Federal Law for Protection of the Consumer. It also violates several international treaties to which Mexico is a party.

It is also deplorable that this NOM was enacted during a state of emergency in Mexico in response to the COVID-19 outbreak, at a particular time in which all national or transnational producers of all types of food and beverages require the consideration and support of the government. Instead, the government’s response was to enact this NOM, which not only violates the rights of producers to distinguish their product but also requires them to change their entire production and labeling processes.

Q: How can Mexican healthcare regulations improve to generate a better environment for companies interested in investing in healthcare?

A: There are many opportunities for improvements. One is domestic legislation for regulatory data protection, confirming the precedents previously issued by the Mexican courts. Express protection should be provided in relation to the subject matter and duration: five years for new chemicals, three years for new uses, formulations and administrations and 10 years for biologics. Legislation is also required for enforcement thereof.

Legal certainty in the application of the entire Mexican healthcare legislation should not be an exception, but rather the norm.

Q: How could regulations improve the healthcare environment for patients?

A: All regulations should be issued and approved bearing in mind the patient. Notwithstanding some significant exceptions, there are few general federal policies providing education on healthy habits for hygiene, sanitation and nutrition at all levels, especially in the early stages of the education system.

Q: What are OLIVARES’ short-term goals regarding the protection of IP in healthcare?

A: We are focusing on strengthening our civil litigation department, as we expect that the system could change shortly and that direct civil remedies to claim damages derived from IP violations could be available very soon.

 

OLIVARES is law firm specialized in intellectual property (IP) law. It works with some of the world’s biggest brands. The firm specializes in areas such as patents, trademarks, copyright, IP and civil litigation, regulatory, administrative and constitutional law

Miriam Bello Miriam Bello Journalist and Industry Analyst