Pfizer and The Medicines Patnet Pool (MPP) Sing Licensing Agreement for COVID-19 Oral Antiviral Treatment

Last November, the pharmaceutical company Pfizer announced that it had signed a voluntary license agreement with the Medicines Patent Pool (MPP), which is a public health organization based in Geneva, Switzerland and supported by the United Nations (UN), in order to its oral antiviral PAXLOVID against covid-19 can be manufactured and distributed by generic drug manufacturers, through sub-licenses granted to said manufacturers.

The foregoing will only be in 95 low and middle-income countries, among which is Mexico, according to World Bank data, and exclusively while the covid-19 pandemic continues to be classified as a public health emergency of international concern for the World Health Organization.

lt is important to mention that said pharmaceutical company has declared to waive its royalties derived from the manufacture and distribution of said drug, in order to increase access and facilitate the development of life-saving drugs for low and middle- income countries.

As of today, the drug PAXLOVID has not been authorized by any regulatory authority in the world; however, it is expected to happen soon, considering the clinical studies that the pharmaceutical company has filed to demonstrate the safety and efficacy of said drug.

Therefore, once the antiviral PAXLOVID is approved by the corresponding regulatory authorities in each country, the manufacturers of generic drugs to which sublicenses are granted will be able to distribute said antiviral in combination with the drug RITONAVIR, which is an antiviral from Pfizer, in the 95 low and middle-income countries.

lt is worth mentioning that Pfizer did not announce the free use of its patent for the drug PAXLOVID, to any pharmaceutical company in the world or in an unlimited manner, reason why said pharmaceutical company did not fully renounce its patent royalties during the term of 20 years.

Since the only way in which a generic drug manufacturer can manufacture and distribute the PAXLOVID drug without being subject to legal action against it, is to have the proper sublicense granted by the Medicines Patent Pool and carry out such distribution only in the 95 designated low and middle-income countries, while the COVID-19 pandemic continues to be classified as a public health emergency.

Likewise, it is worth mentioning that Pfizer will commercialized the PAXLOVID drug in the rest of the countries that are classified as upper-middle-income, so that even when the covid-19 pandemic continues to be classified as a public health emergency, said pharmaceutical company you will not waive its royalties worldwide.

In the specific case of Mexico, as it is considered a low and middle-income country, generic drug manufacturers who wish to distribute the PAXLOVID drug must have their respective sub-license granted by the Medicines Patent Pool, although it is not mandatory to record it before the Mexican Institute of Industrial Property, in order to avoid the risk of Pfizer initiating any legal action against them.

However, if once the covid-19 pandemic is no longer classified as a public health emergency and therefore the sublicense has ended, a generic manufacturer continues to manufacture and/or distribute the drug PAXLOVID, it may be subject to an infringement action against them or where appropriate, pay damages caused to Pfizer for the royalties that said pharmaceutical company did not receive for the unauthorized use of its patent.

Therefore, it is clear that Pfizer has not granted the free use of its patent for the drug PAXLOVID against covid-19 for any interested party to manufacture and/or distribute it in any country and/or at any time, but rather specifically granted a license to the Drug Patent Fund, for this organization to grant sub-licenses only in 95 countries, so clearly said pharmaceutical company has not waived its royalties.