In connection with the COVID19 pandemic, the Hungarian Government declared special legal order (State of Danger). During this period, the Government may adopt decrees by means of which it may, as provided for by a cardinal Act, suspend the application of certain Acts, derogate from the
provisions of Acts and take other extraordinary measures.
The Government Decree 212/2020 (16 May) on public health compulsory licences for exploitation within Hungary, based on Art 31 of the TRIPs Agreement, creates a public health compulsory license for exploitation within Hungary.
With a view to satisfying the needs arising within Hungary in connection with the health crisis, the Hungarian Intellectual Property Office (hereinafter “HIPO”) shall issue a public health compulsory licence for the exploitation of
a) a medicinal product or an active substance under patent or supplementary protection, or a medical device or an investigational medicinal product under patent protection (hereinafter jointly “healthcare product”), or
b) a procedure, equipment or tool under patent protection that is required for the production of a healthcare product.
On the basis of a public health compulsory licence, the compulsory licence holder shall be entitled to exploit the healthcare product, procedure, equipment or tool solely for satisfying the needs arising within Hungary as set out under Art 1(1) of the Government Decree.
The public health compulsory licence shall not confer exclusive right of exploitation; on the basis of the public health compulsory licence, the public health compulsory licence holder may not grant any licence for exploitation.
The period and fees of the compulsory license is determined by HIPO.
Healthcare products produced on the basis of a public health compulsory licence shall be distinguished from products produced by the patent holder by a unique marking. The fact that a healthcare product was produced on the basis of a public health compulsory licence granted by the HIPO for the sole purpose of placing it into market in Hungary shall be clearly indicated on the packaging and any related documents.
Upon the termination of the State of Danger, the Government Decree shall cease to have effect.