Potential Legal Implications for Patent Medicine and the Treatment for COVID-19 in Mexico
The coronavirus disease 2019 (COVID-19) is a highly transmissible viral infection caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), which emerged in Wuhan, China, in late December 2019.1 It is characterized by an upper respiratory tract and pulmonary infection, which may lead from a mild or asymptomatic illness to a more severe disease that may result in fatal pneumonia.
On Jan. 30, 2020, the emergency committee of the World Health Organization (WHO) declared the COVID-19 acute respiratory disease a public health emergency of international importance.2 On March 12, 2020, the WHO announced that it was a pandemic catastrophe.3
The mortality rate of the COVID-19 disease may rise from 2.9 to 3.6 percent worldwide, and vaccine protection may still not be available for at least another 12 to 18 months. There is an urgent need both for an effective treatment to treat symptomatic patients and also to decrease the virus load and the time of carriage to limit community transmission.4
As there are currently no clinically approved antiviral drugs to treat COVID-19, many nations have tried to use broad-spectrum antibiotics, antiviral drugs and interferon-alpha nebulization with minimum effects in reducing the viral load.
Studies have demonstrated that Remdesivir by itself, as well as in combination with chloroquine or interferon beta, significantly blocks SARS-CoV-2 replication. However, its secondary side effects have limited the use of these drugs only for exceptional circumstances.5
Patents protect many of the actual antiviral drugs that treat most common viruses. Pharmaceutic speculations about the health and economic impact of successfully treating the COVID-19 disease are racing all around the globe, but what if a patent-protected drug currently available in the pharmaceutical market resulted in the missing piece of a successful and safe treatment for COVID-19?
If favorable effects were found and confirmed as a result of the clinical trials and analysis performed by scientists with existing drugs, and such drugs were under patent protection, Mexico's Industrial Property Law provides a specific regulation on account of a national emergency.
According to Article 77 of Mexico's Industrial Property Law:
- Based on national emergency causes, including severe diseases declared by Mexico's National Health Council (NHC) as requiring priority attention, the Mexican Institute of Industrial Property (IMPI), through a declaration published in Mexico's Official Federal Gazette (DOF), shall determine exploitation of certain patents by granting public utility licenses in cases that otherwise will result in prevention, obstruction or price increase of production, provision or distribution of medicine to the population.
- In case of severe diseases determined as an emergency cause, the NHC shall make the declaration of priority attention. Once published in the DOF, pharmaceutical companies shall request a public utility license from the IMPI. The institute shall grant the request after a hearing out the parties, with the promptness required by the corresponding case according to the NHC's opinion, within a term that shall not exceed 90 days following the date of the requested submission date.
- Mexico's Ministry of Health shall set the conditions required for production and quality, duration and scope of the license, as well as the qualifications and technical capacity needed for the applicants. The institute shall establish, after hearing both parties, a reasonable amount of royalties for the patent holder.
- The license may cover the right to manufacture, use, sell, offer and import the corresponding product or process, as applicable.
- On March 23, 2020, the NHC published in the DOF a declaration acknowledging COVID-19 as a severe disease that requires priority attention.
- On March 30, 2020, the NHC published in the DOF a declaration stating that the disease caused by COVID-19 is a health emergency due to force majeure.
As a result of the NHC's declarations acknowledging COVID-19 as a severe disease and a health emergency, if patent medicine was confirmed as a safe, effective and approved treatment for COVID-19, then the following may apply:
- IMPI may determine the exploitation of the corresponding patent(s) through public utility licenses.
- IMPI may grant such license to pharmaceutical companies requesting it, as long as such companies have the required conditions, qualifications and technical capacity established by Mexico's Ministry of Health.
Holland & Knight attorneys have extensive experience in intellectual property matters in a wide variety of industries. For more information, contact the author or Holland & Knight's Mexico City office.
Holland & Knight has established a COVID-19 Response Team to help clients respond to a variety of business and legal issues they may be facing in this crisis. Please visit Holland & Knight's Response Page for the latest COVID-19 news and updates important to your business.
DISCLAIMER: Please note that the situation surrounding COVID-19 is evolving and that the subject matter discussed in these publications may change on a daily basis. Please contact the author or your responsible Holland & Knight lawyer for timely advice.
Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem. Moreover, the laws of each jurisdiction are different and are constantly changing. If you have specific questions regarding a particular fact situation, we urge you to consult competent legal counsel.
1 Hussein A. Rothan, Siddappa N. Byrareddy, Et al. The epidemiology and pathogens is of coronavirus disease (COVID-19) outbreak. Journal of Autoimmunity. February 26, 2020.
2 WHO Director-General's statement on IHR Emergency Committee on Novel Coronavirus (2019-nCoV). January 30, 2020.
4 Philippe Gautret, Jean-Christophe L., Et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. International Journal of Antimicrobial Agents. March 20, 2020.
5 Muhammad Adnan Shereen, Suliman Khan, Et al. COVID-19 infection: origin, transmission, and characteristics of human coronaviruses. Journal of Advanced Research. Volume 24 (2020), pages: 91-98.