Russia’s patent office made a ground-breaking decision to reject a patent application for molnupiravir, a treatment for COVID-19, which was developed by Merck Sharp & Dohme (MSD). The World Health Organization (WHO) recommends molnupiravir for people who are at high risk for hospitalization from COVID-19, if nirmatrelvir-ritonavir is unavailable. This milestone has been hailed by the Make Medicines Affordable (MMA) campaign.
The urgent need for access to, and more production of molnupiravir during the height of the COVID-19 pandemic led MMA partners in Eastern Europe and Central Asia (ITPC-EECA) to oppose the giant pharmaceutical firm’s patent application on molnupiravir by filing a third-party observation with Rospatent. ITPC-EECA launched a challenge against the patent in the Eurasian Patent Office in mid-March 2022, submitting the third-party observation against patent application number EA202091005. In 2023, ITPC and MMA filed another third-party observation against a similar patent application (RU2020116571), which is also pending in the Russian patent office. In May 2023, the patent was rejected by the Federal Institute of Industrial Property, although further hearings on the application are ongoing.
“This decision, though being an interim one, is very inspiring and encouraging of everyone in the field of making much-needed medicines available to everyone. It is a demonstration that all voices can be instrumental in the final decision,” says Maria Shibaeva, treatment access legal specialist at ITPC-EECA, who states this is a precedent-setting case for civil society.
According to Euronews, WHO stated that molnupiravir’s price and lack of availability threatened to “exacerbate health inequity,” especially in low- and middle-income countries (LMIC). To facilitate access to more affordable generic versions of molnupiravir, the Medicines Patent Pool (MPP) signed a voluntary license (VL) agreement with Merck in October 2021, but only 9% of people diagnosed with COVID-19, worldwide, live in countries that are included in the VL. Countries that are not eligible to purchase generic molnupiravir through the VL must pay whatever price MSD sets for the drug.
Though in October 10, 2023 another EAPO patent № 045093 (based on challenged patent application EA202091005) was granted, notwithstanding ITPC-EECA arguments, which could be considered as a 1.5 year delay in the granting of the patent due patent opposition. During this period, generic versions of molnupiravir were marketed at a lower price than the branded version in Russia, saving the country millions of dollars. It costs approximately USD $20 to produce a generic, five-day treatment course of molnupiravir, according to a 2021 study by Harvard University – but Russia was paying 8,644 Rubles (USD $126) for each Lagevrio pack (200mg, 40 capsules) in 2022.
Due to the procurement of a generic version of molnupiravir, the cost of the drug per pack dropped last year to 4,897 Rubles (USD $58) in the aftermath of the case. With a total budget of 246,442,334 Rubles for more than 50,000 packs bought in 2023, it is estimated that the country saved more than US $2.24 million in comparison to if the drugs had been procured at the 2022 price from the originator.
According to Shibaeva, access to molnupiravir is important, despite the drug being less effective than nirmatrelvir-ritonavir.
“High drug prices exclude many patients from desperately needed medication and burdens the healthcare,” she says. “Rejecting unjustified patient applications will avail cheaper and equally effective alternatives that will not only plug the access hole but also free up the public health economy to refunnel the saved funds to buy more needed health products.”
As ITPC-EECA closely monitors the situation to determine if the originator will enforce its Eurasian patent, the network emphasizes the need for a concerted effort from civil society actors to help prevent harmful monopolies in healthcare.
