Supplementary Protection Certificates

– Law of Ukraine on the Protection of Rights to Inventions and Utility Models, in force since July 1, 1994, last amended on March 20, 2023.

Procedure

Application: the holder of a patent for an invention, the object of which is an active pharmaceutical ingredient of a medicinal product, the process of obtaining a medicinal product, or application of a medicinal product, animal protection product, plant protection product, the introduction of which in Ukraine is granted by the relevant competent authority according to the current legislation of Ukraine, has the right to extend the validity of intellectual property rights to such an invention (additional protection), which is confirmed by a supplementary protection certificate. The rights to supplementary protection are limited by the product (active pharmaceutical ingredient or set of active pharmaceutical ingredients of the medicinal product), the introduction of which in Ukraine is allowed by the relevant competent authority according to the current legislation of Ukraine, and by its use as a medicinal product, animal protection product, plant protection product within the rights granted by the respective patent as of the day of submitting the application for supplementary protection certificate, and are valid subject to the validity of such permission. The holder of a patent for an invention, the object of which is a medicinal product, animal protection product, plant protection product, shall have the right to extend the validity of intellectual property rights if the application for permission of the competent authority to introduce a medicinal product, animal protection product, plant protection product in civil circulation in Ukraine was filed within one year from the date of submission of such an application for the first time in any country.

Term extension: the term of additional protection shall equal the period between the date of application submission to the Institution and the date when the patent holder obtains the first permit of a competent authority decreased by five years. The term of additional protection shall not exceed five years. For an invention the subject of which is an active pharmaceutical ingredient of a medicinal product, which has been the subject of studies in the field of use for children, the results of which are shown in the information on the medicinal product authorized by the competent authority, the term of additional protection shall be prolonged by six months.

Procedure: the supplementary protection certificate is issued at the request of the patent holder. A fee is levied for the submission of such request. The holder of a patent for an invention, the object of which is a medicinal product, animal protection product, plant protection product, shall have the right to extend the validity of intellectual property rights if the application for permission of the competent authority to introduce a medicinal product, animal protection product, plant protection product in civil circulation in Ukraine was filed within one year from the date of submission of such an application for the first time in any country. The request for supplementary protection must be received by the NIPO within six months from the date of publication of the information on state registration of the invention or from the date of issuance of the first permit of the relevant competent authority (whichever comes last). The application shall be accompanied by documents confirming the right of the patent holder to supplementary protection. The request shall be considered by the NIPO.

Filing requirements:
1. A Request, (which must be sealed) and must include the following particulars: patent number; application number and filing date; title of the invention; full name of the patent owner (natural person or legal entity, his residence or domicile; address for correspondence. The request must be signed by the patent owner (or by all the owners, or by an authorized person in the case of a legal entity). The signature must include full name of the official who signs the request, personal signature, initials, surname and date;
2. A certified copy of the document authorizing to use the means, issued by the competent authority (copy of the certificate of registration, etc.);
3. A power of attorney executed according to the requirements of the current legislation if the request is filed on behalf of the owner by a representative or another authorized person.

Grant: if the request and accompanying documents meet the prescribed requirements, the NIPO takes a decision on the extension of the patent term. Based on this decision, the information on the extension of the patent term is introduced into the Register and published in the Official Bulletin. The supplementary protection certificate shall be issued by the NIPO within one month after the state registration of supplementary protection. The rights and obligations of the holder of the supplementary protection certificate shall be the same as the rights of the holder of the respective patent.