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A COVID-19 treatment drug known as Avigan, also known as favipiravir, has been in the eyes of the Chinese military as of recent. Originally developed and patented by Fujifilm Toyama Chemical Co. Ltd. (Fujifilm) in Japan, in 1998, as an antiviral for the national influenza stockpile, the company has been not only conducting clinical trials directly targeting COVID-19 but also entering into licensing deals with pharmaceutical companies around the world to provide a relatively economical treatment for early-onset, mild-to-moderate SARS-CoV-2 in low-to-middle income countries (LMICs). While the original patent for influenza expired, the company has been actively developing the product in Japan, hence the move by the Academy of Military Medical Sciences (AMMS), a Chinese military-backed research arm, represents a questionable, egregious action.
Fujifilm Holdings has warned the Japanese government that the AMMS may claim intellectual property rights over Avigan as a COVID-19 treatment. The move indicates the Japanese company’s concern over growing Chinese clout in the medical supply chain as the world continues to grapple with the pandemic. Losing the patent could also be another blow for Fujifilm’s global ambitions for the drug, as the company is trying to transform itself into a potent health care player.
Patent filings in China show that a division of the AMMS was granted a patent for “use of favipiravir for the treatment of coronavirus infections,” whereby an initial application was filed on January 21, 2020, and resubmitted in June in that year. The patent passed screening on March 29, 2021, and was published after that on May 4, 2021. Patent lawyers said that the early application in January 21, 2020 was barely a week after the first COVID-19 case was discovered outside of China, giving it an advantage in securing patents outside of China. Using the Patent Cooperation Treaty (PCT), companies and research institutions can use the original patent date to file for patent protection in 153 countries. It is unclear whether the AMMS has actually used this standard due to nondisclosure rules.
Is this a cause for concern for Fujifilm in Japan?
Apparently, yes. The approval for the patent in China was unusually fast. Back in 2019, it took an average of 22.5 months for a patent application to be approved in China. In this case, the quick approval is “an indicator that the patent was considered valuable and worth prioritizing.” If the AMMS formally starts the application process in Japan, Fujifilm may lose out on selling Avigan as a coronavirus treatment in the country, dealing another blow to Fujifilm’s ambitions for the drug.
However, there are speculations that China’s patent will be used both domestically as well as for low-and middle-income countries (LMICs), such as places in Africa.
Ongoing issues with Avigan
Avigan was unique in that it prevented viruses from replicating inside cells and was shown to be somewhat effective in curbing growth and spread of viruses. However, not enough funding could be secured to conduct clinical trials when Avigan was first developed, something that Fujifilm was able to solve when Toyama Chemical was acquired in 2008.
In 2014, Japan’s health ministry approved of Avigan but with major conditions: It can only be administered as an emergency measure against new or re-emerging influenza, not for treating existing influenza. As a result, the government stockpiled Avigan for two million people, but the drug was not widely distributed. COVID-19 offered a potential breakthrough opportunity for the drug, whereby Chinese health authorities reported that favipiravir was effective against COVID-19 back in March 2020. By May 2020, the former Japanese Prime Minister, Shinzo Abe, had sought government approval for Avigan. Nevertheless, the review took months, and Japan’s health ministry postponed approval of the drug in December, citing insufficient data. Fujifilm has not given up yet and has restarted clinical trials in April 2021, with Phase 3 trials also underway in the U.S. and Canada.
Outlook and Prospects
Since Toyama Chemical’s original patent has expired in most countries, Fujifilm is competing with local drug makers which produce generic versions of the drug.
The following countries have authorized Avigan (favipiravir) for the COVID-19 indication:
- Russia
- UAE (United Arab Emirates)
- India
- 泰国
- 马来西亚
- 印度尼西亚
- Turkey
It is to be known also, that Fujifilm licensed favipiravir to a Chinese pharmaceutical company known as Zhejiang Hisun Pharmaceutical Co. (Hisun) back in 2016, in which the pharmaceutical company touted the drug’s effectiveness in combating the coronavirus in China back in July 2020. However, it was noted that the report was via China press, hence the true accuracy and details were opaque and questionable.
A boost in Avigan sales will help Fujifilm achieve its aggressive push into healthcare. Kazuyoshi Saito, an analyst at IwaiCosmo Securities, said Avigan is a relatively small but profitable business for Fujifilm because it does not need to spend on research. Hospitals in Japan have been acquiring the drug, evidenced by sales for another 1.6 million tablets worth approximately $100 million. Fujifilm is apparently also monetizing all the partnerships in Russia, India, Turkey, and the likes.
There is still cause to be concern, especially so if the AMMS decides to file for a patent application for the use of favipiravir in Japan. The race to end the pandemic is still ongoing and many are looking to capitalize on it.
SOURCE
Avigan maker Fujifilm faces China military risk to patent – Nikkei Asia