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Hungary: Government Decree No. 212/2020 on Public Health Compulsory Licenses for Exploitation Within Hungary

May 17, 2020

Hungary: The Government Decree No. 212/2020 on Public Health Compulsory Licenses for Exploitation Within Hungary entered into force on May 17, 2020, and shall cease to have effect upon the termination of the "State of Danger", which is a so-called special legal order declared by the Hungarian Government.

The Government Decree provides, inter alia, the following elements:

(i) enabling the Hungarian Intellectual Property Office (hereinafter "HIPO") to issue nonexclusive public health compulsory licenses ("license") in order to satisfy domestic needs related to the health crisis situation;

(ii) the subject of a license can be (a) a medicinal product or active substance subject to a patent or a Supplementary Protection Certificate (SPC), or medical device or investigational medicinal product subject to a patent (referred jointly as "healthcare product"); or (b) a procedure, equipment or device necessary for manufacturing a healthcare product;

(iii) the public health compulsory license holder ("licensor") cannot issue a sub-license;

(iv) the period of the license is defined by the HIPO based on the information of the National Institute of Pharmacy and Nutrition (OGYÉI), with regard to the needs for management of the health emergency, but in any event not extended beyond March 31, 2021;

(v) the patent holder is entitled to "appropriate" remuneration for the license, which is determined by the HIPO;

(vi) healthcare products produced on the basis of a license shall be distinguished from products produced by the patent holder by a unique marking, with the packaging and related documents clearly indicating that such product was produced on the basis of a license; and

(vii) decisions granting licenses shall be entered into the HIPO's patent/SPC registers and published in the Official Journal of the HIPO.