In connection with the COVID-19 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 (hereinafter mentioned as Government Decree 212/2020), based on Art 31 of the TRIPS Agreement, created a public health compulsory licence for exploitation within Hungary.
The special legal order (State of Danger) was terminated on 18th of June 2020, and thus Government Decree 212/2020 ceased to have effect on that day.
Act LVIII of 2020 on Transitional Rules related to the Termination of State of Danger and on Epidemiological Preparedness amended necessary modifications regarding the termination of the special legal order, including the modification of the Hungarian Patent Act (Law No. XXXIII of 1995 on the Protection of Inventions by Patents, hereinafter mentioned as HPA), which came into force on 18th of June 2020. This modification enacted the public health compulsory licence to the HPA, with slight modifications compared to Government Decree 212/2020.
The main difference between Government Decree 212/2020 and the HPA's compulsory licence is that under HPA it is possible to acquire a licence for uses in connection with export, if the invention is not protected by patent or supplementary protection certificate in the destination country, or the destination country also issued a compulsory licence regarding the invention.
With a view to satisfying the needs arising 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 in connection with pandemic situations.
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 licence 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 or a specific destination country shall be clearly indicated on the packaging and any related documents.