President Jokowi Issues Regulation on Implementation of Favipiravir Drug Patent
President Joko “Jokowi” Widodo Wednesday (10/11) has signed Presidential Regulation Number 101 of 2021 on the Government’s Patent for COVID-19 Drug Favipiravir.
The document of the regulation can be accessed here on Cabinet Secretariat’s JDIH website.
The Presidential Regulation was issued based on a consideration that the World Health Organization (WHO) has declared the spread of coronavirus disease 2019 (COVID-19) as a Global Pandemic and the Government has also declared the non-natural disasters caused by the spread of COVID-19 as a national disaster.
“That in regards with an urgent need in efforts to overcome COVID-19 in Indonesia, it is necessary to establish a policy on access to the drug Favipiravir which is currently still protected by patents,” reads the consideration of the regulation.
The Regulation further stated that based on the provisions of Article 109 paragraph (3) of Law Number 13 of 2016 on Patents as amended by Law Number 11 of 2020 on Job Creation, that the implementation of patents by the Government is stipulated by a Presidential Regulation.
As stated in Article 1 of the Regulation, the Government enforces patent rights on Favipiravir in order to meet the availability and urgent need for the treatment of COVID-19.
For the record, the implementation of drug patents will be applied for a period of three years from the Presidential Regulation coming into force. If the pandemic has not ended after the specified period, the Government will extend the patent implementation until the ending of COVID-19 pandemic is declared.
“The implementation of the Government’s patent for COVID-19 drug Favipiravir covers the name of active substance, the patent holder, the patent application number, and the title of the invention as contained in the attachment, which is an integral part of the Presidential Regulation,” Article 2 of the Regulation states.
According to Article 3 of the Regulation, the Minister who administers government affairs in the health sector appoints the pharmaceutical industry as the executor of the Favipiravir drug patent for and on behalf of the Government in accordance with the provisions of laws and regulations. The pharmaceutical industry in question carries out its duties as the executor of the Favipiravir drug patent on a limited basis to meet domestic needs and is non-commercial.
The pharmaceutical industry must meet several requirements, including having facilities and being able to implement the patent; not assigning the implementation of the patent to another party; and having good methods of production, distribution, and supervision in accordance with the provisions of laws and regulations.
“The pharmaceutical industry as referred to in Article 3 provides compensation to the patent holder in the amount of one percent of net selling value of the drug Favipiravir,” Article 4 of the Regulation reads.
Furthermore, as stated in Article 5, the provision of compensation is carried out annually according to the time period.
The Presidential Regulation shall apply from the promulgation by Minister of Law and Human Rights Yasonna H. Laoly on 10 November 2021.
The names of active substance, the patent holder, the patent application number, and the title of invention are as follows:
|Name of Active Substance||Name of Patent Holder||Patent Application Number||Title of inventions|
|Favipiravir||Fujifilm Toyama Chemical Co., Ltd||W00201000982/IDP0032152||Organic Amine Salts of 6-Fluoro-3-Hydroxy-2-Pyrazincarbonitrile and Its Manufacturing Methods|
|W00201301813/IDP000045023||Sodium Salt of 6- Fluoro-3-Hydroxy-2- Pyrazine Carboxamide|
|W00201301812/IDP000040569||Meglumine Salt of 6-Fluoro-3-Hydroxy-2-Pyrazine Carboxamide|
|W00201103243/IDP000046140||Granulated Tablets and Powders Containing 6-Fluoro-3-Hydroxy-2- Pyrazinacarboxamide|
|W00200902268/IDP000034309||Pharmaceutical Compositions Containing Pyrazine Derivatives, and Methods of Using Pyrazine Derivatives in Combined|