On 5 May 2021, the Department of Intellectual Property (DIP) of Thailand rejected a Thai patent application for a granulated powder tablet containing 6-fluoro-3-hydroxy-2-pyrazinecarboxamide, also known as Favipiravir, which is a drug used to treat viral infections including COVID-19. Favipiravir has been used in many countries including Thailand to treat COVID-19 patients.
With the spiking numbers of COVID-19 infections, demand for Favipiravir has soared with fears of shortage. As Favipiravir can currently only be imported into the country, Thailand aims to establish a production hub for the Favipiravir tablets to meet growing demands. Previously, however, they could not accomplish this as the formulation of the Favipiravir tablets has been applied for patent protection in Thailand.
Favipiravir was originally formulated by a Japanese pharmaceutical company, Toyama Chemical Co., Ltd. (presently known as FUJIFILM Toyama Chemical Co., Ltd.) in 1998. The first patent application for the compound was filed in 2000 via the Patent Cooperation Treaty and was designated in 27 countries. Thailand was not one of the countries. The patent of the original compound expired in 2020 and the applicant has filed more patent applications relating to different formulations/forms of the drug since. In Thailand, FUJIFILM Toyama Chemical filed three patent applications relating to Favipiravir, but only the application for the Favipiravir tablet has been rejected.
The Director-General of the DIP of Thailand has stated that the patent application for the Favipiravir tablet was rejected because it lacks an inventive step. He commented further that, in the meantime, there is no monopolization on the original compound (as there is no patent filed in Thailand) or the granulated powder Favipiravir tablet, and the Government Pharmaceutical Organization (GPO) or other local producers is able to produce the drug.
In this sense, Thailand appears to get what its people need: freedom to produce the drug domestically.
Historically, the patent application for the Favipiravir tablet, which is now rejected in Thailand, was filed via the Patent Cooperation Treaty in 2010 and designated into approximately 24 countries, including Japan, the United States of America, Europe, India, and Thailand. In February 2021, the Thai application faced problems as it was issued an Office Action on the ground of lacking inventive step. Despite the applicant’s response, the examiner was not convinced and issued a Rejection Order on 5 May 2021 under the same ground.
In contrast, all the corresponding applications in other designated countries have been granted, except in India where the applicant did not continue with the appeal. It is also worthwhile noting that the Rejection Order in Thailand cited the same prior art documents as those cited in Europe and Japan. Nonetheless, the applications in Europe and Japan were deemed inventive in the face of the citations and have been granted in 2013 and 2014 respectively.
This has called into questions as to the validity of this Rejection Order, but the rationale behind the order is plain and understandable: lives are at stake.
In any event, the Rejection Order is not the end of the Favipiravir tablet patent in Thailand. The applicant still has a chance to appeal to the Patent Board and also to the Court. Should the applicant file an appeal, it would take at minimum years to reach the final decision. In the meantime, the patent application for the Favipiravir tablet will remain pending. Any production of the Favipiravir tablet in Thailand could still be subject to a patent infringement action even if and when the patent application is granted.
The COVID-19 pandemic has taken the world aback. The World Health Organization has called for a waiver on patent rights on vaccines to fight COVID-19. This waiver means patent holders must put a pause on their rights so that others can produce the patented products freely or, at least, with low royalty rates.
This Rejection Order appears to grant temporary relief for Thailand to produce the drug, but it is still appealable and may not protect against future potential infringement action. This raises a question whether there was any alternative way to deal with this delicate situation, one that would allow the applicant to enjoy benefits of the patent right and also increase availability of the drug to the public.
The answer is compulsory licensing (CL). Under the Thai Patent Act, the Public Health Ministry may issue a compulsory license on the drug to prevent a shortage and grant some loyalty to the proprietor in return. If the Favipiravir patent application were fast-tracked and granted in Thailand as it had in many other countries, a CL may be a justifiable and balanced solution considering the current predicament.