On 01.12.2023, the Ministry of Finance and Economy submitted for public consultation the draft law “On Patents, Utility Models and Supplementary Protection Certificates” (the Draft Law), which is fully harmonized with the following EU documents:
- Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions;
- Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights;
- Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems;
- Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products;
- Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products;
- Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products;
- Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for pediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004;
- Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products.
The proposed Draft Law aims to regulate all the procedures related to secret licenses, both mandatory and voluntary licenses, certificates of additional protection, as well as patents for biotechnological inventions.
The provisions within a specific law governing patents, utility models, and supplementary protection certificates aim to address any identified legal gaps in practice, while also facilitating complete alignment with EU legislation.
Moreover, the Draft Law incorporates recommendations from international institutions such as the World Intellectual Property Organization (WIPO) and the European Union Intellectual Property Office (EUIPO) on various issues.
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