[바이오 스페셜]Merck eats a patented coronavirus treatment “Cannot produce generic drugs in Korea”

[이데일리 김유림 기자] As Merck unlocked the patent for Molnupiravir, a new drug to treat COVID-19, it became possible to manufacture generic drugs for free through UN-affiliated organizations. However, it is limited to low-income countries, and Korea is not included in the list of open patent countries. Manufacturing generics in countries other than those established by Merck and the United Nations constitutes patent infringement.

‘Molnupiravir’, an oral COVID-19 treatment developed by Merck, USA. (AP=Newsis)

According to the New York Times (NYT) on the 29th, US pharmaceutical company Merck has signed an agreement to manufacture molnupiravir with the Medicines Patent Pool (MPP), a non-profit organization sponsored by the United Nations. In the future, the company selected by the MPP will be able to manufacture the generic molnupiravir drug without royalties. The patent-opening countries negotiated by Merck and MPP are 105 low-income countries, including Pakistan, Cambodia, and Africa, and they are expected to be supplied at a low production cost level.

Developing a new drug requires a lot of capital, and if the product is approved, it is rewarded through an exclusive patent right. There are three types of patents owned by new drug development companies: substance patents, composition patents, and use patents. Exclusive license for 20 years from the filing date.

Merck’s decision is to supply therapeutic agents at low prices to countries that have no choice but to be exposed to infectious diseases defenselessly due to a shortage of COVID-19 vaccines. Merck and Ridgeback Biotherapeutics, a joint developer, filed an emergency use application for molnupiravir with the US Food and Drug Administration (FDA), and approval is expected within this year. Merck expects global sales of molnupiravir to reach up to $7 billion (about 8.2 trillion won) by the end of next year.

In the domestic stock market, some stocks were shaken by expectations for the production of the generic Molnupiravir. 99% of pharmaceuticals produced in Korea are generic, and they are criticized for being the kingdom of clones. Intense litigation is also occurring frequently between original drug pharmacists, whose patents are about to expire, and latecomers developing generic drugs.

However, as a result of E-Daily coverage, it is impossible to produce molnupiravir in Korea. This is because Merck only opened patents to low-income countries, and Korea is not a patent-opening country. In other words, domestic production of molnupiravir generic drugs cannot be done unless a patent is opened for Korea.

It is also impossible to supply to low-income countries after being produced by a domestic pharmaceutical company. Since patents affect exports, production, and imports in that country, making a patent in Korea and handing over Merck’s patents to an open low-income country also constitutes patent infringement. In conclusion, as Korea is not included in the 105 low-income countries designated by Merck, it cannot produce generic molnupiravir in any way.

Merck’s patent opening is expected to affect other companies developing COVID-19 treatments at home and abroad. An executive at a venture capital investment specializing in biotechnology said, “After Merck, Pfizer’s COVID-19 treatment is the most likely. “Pfizer has received a lot of criticism around the world for not agreeing to the temporary opening of the mRNA vaccine patent,” he said.

Currently, among global Big Pharma, Pfizer and Roche are conducting phase 3 clinical trials for oral antiviral treatment for COVID-19. The mechanism of action of these therapeutic agents is known to be similar to that of mulnupiravir. In Korea, Daewoong Pharmaceutical and Jinwon Life Sciences are developing an oral drug.