Pfizer, a US-based pharmaceutical giant, announced that it has signed a license agreement with the MPP for Paxlovid, an oral antiviral medicine for COVID-19. The MPP is a public health organization in Kenilworth, New Jersey, and is supported by the United Nations and governments including Japan. Patented medicines licensed to the MPP can be produced in generic form without the need to wait for the expiry of the patent. The MPP has a track record of distributing anti-HIV drugs in the past. They offer low- and middle-income countries not only negotiations and licensing agreements, but also technical guidance on manufacturing know-how, etc., which cannot be easily understood from only the description of a patent. The agr eement allows pharmaceutical manufactures in various countries to manufacture Paxlovid without paying patent fees, and thus facilitates the low-cost purchase of Paxlovid in 95 countries which are home to 53% of the world’s population. Another U.S. pharmaceutical giant, Merck has also signed a licensing agreement with the MPP for Molnupiravir, a new oral antiviral medicine for COVD-19.

The “Medicines Patent Pool” is a system that grants third parties access to patents held by drug manufacturers at reasonable prices and allows them to produce and/or improve the patented drugs. A “patent pool” is a system originally designed to facilitate standardization of a certain technology. However, the MPP manages patent rights held by multiple patent holders in the field of pharmaceuticals, and allows generic pharmaceutical manufactures to receive the licenses necessary to produce generic versions of medicines, while the patent holders receive their royalties from the MPP.

Since the research and development of medicines requires extensive budgets and time, pharmaceutical companies that hold patent rights are granted exclusive rights to manufacture and sell their products during the term up until the patents expire (generally 20 years from the filing date). Taking the extensive budgets and time into consideration, this type of protection by patent rights cannot be supplied at reasonable prices. As countermeasures to the above circumstances, several solutions, such as a compulsory licensing system and liberalization of generic medicine sales, have been offered. If a compulsory license is enforced, the technology can be used without permission of the patentee. As for vaccines, there were discussions on the issue of compulsory licenses, but this did not move forward because vaccine production cannot be solved only by the issuance of rights; it also requires advanced production technologies.

In order to ensure the supply of vaccines to low-income countries in the future, many issues still need to be addressed, such as those related to the mass production and supply system of medicines, as well as patent rights. On January 20, 2022, the MPP issued a news release titled “27 generic manufacturers sign agreements with MPP to produce low-cost version of COVID-19 antiviral medication molnupiravir for supply in 105 low- and-middle-income countries”. The MPP noted in this news release that the sublicence agreements are the outcome of the voluntary licensing agreement between the MPP and MSD (a trade name of Merck & Co., Inc.) to expedite affordable global access for molnupiravir.

From: SHIGA(Japan)