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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of December 4, 2013 No. 877

About approval of the Procedure for provision by the Cabinet of Ministers of Ukraine of permission to use of the patented invention (useful model) which concerns medicine

(as amended on 23-12-2020)

According to part three of article 30 of the Law of Ukraine "About protection of the rights to inventions and useful models",  "About medicines" the Cabinet of Ministers of Ukraine decides parts eleven of article 9 of the Law of Ukraine:

1. Approve the Procedure for provision by the Cabinet of Ministers of Ukraine for permission to use of the patented invention (useful model) which concerns medicine it (is applied).

2. Item 1 of the Procedure for provision by the Cabinet of Ministers of Ukraine permissions to use of the patented invention (useful model) or the registered topography of integral chip, the Cabinet of Ministers of Ukraine approved by the resolution of January 14, 2004 No. 8 (The Official Bulletin of Ukraine, 2004, No. 2, Art. 38; 2011, No. 71, the Art. 2673) to add with the paragraph of the following content:

"Action of this Procedure does not extend to the procedure of provision by the Cabinet of Ministers of Ukraine of permission to use of the patented invention (useful model) which concerns medicine.".

Prime Minister of Ukraine     

N. Azarov

Approved by the Resolution of the Cabinet of Ministers of Ukraine of December 4, 2013, No. 877

The procedure for provision by the Cabinet of Ministers of Ukraine for permission to use of the patented invention (useful model), concerns medicine

This Procedure determines the procedure of provision by the Cabinet of Ministers of Ukraine of permission to use of the patented invention (useful model) which concerns medicine (further - permission), without the consent of the owner of the patent and with payment of compensation to it.

2. For the purpose of ensuring public health care, including counteraction to HIV infection/AIDS and other socially dangerous diseases, the Cabinet of Ministers of Ukraine can provide to person determined by it permission in case of documentary confirmation of availability of such circumstances at the same time:

the patentee cannot satisfy the need for the corresponding medicine with forces and capacities which are usually applied to such medicine;

the patentee it is groundless refused to the applicant licensing for use of the invention (useful model).

3. Permission is issued with observance of the following requirements:

the amount and duration of use of the patented invention (useful model) are determined taking into account the purpose of the provided permission;

permission to use of the patented invention (useful model) does not deprive of the owner of the patent of the right to provide permissions to use of the patented invention (useful model);

the right to use the patented invention (useful model) is not transferred to the third parties, except case when it is transferred together with that part of the company in which this use is performed;

use of the patented invention (useful model) is allowed for requirements satisfaction of the domestic market of medicines;

based on the decision of the Cabinet of Ministers of Ukraine on provision of permission to use of the patented invention (useful model) compensation according to economic value of the invention (useful model) at the expense of means of person to whom such permission is provided is paid to the owner of the patent.

4. Permission can be provided to the subject of managing performing production of medicines in full or on final production stage of medicine with use of active pharmaceutical ingredient of other producer on the production sites located in the territory of Ukraine based on the license for production of medicines or the subject of managing performing import to the territory of Ukraine of medicines based on import licenses of medicines both wholesale and retail trade by medicines.

The interested subject of managing addresses to the Ministry of Health with the petition for provision by the Cabinet of Ministers of Ukraine of permission (further - the applicant) in which it is specified:

international unlicensed name of medicine;

name of the invention (useful model);

number of the patent, information about its owner (owners), its address or location;

the name of the applicant, its location, the authorized signature with documentary confirmation of such powers.

Are applied to the petition:

reasons for need of use of the patented invention (useful model) with indication of specific circumstances of the main point and necessary effective period of permission to use of the patent;

feasibility statement on opportunity, conditions and procedure for use of the patented invention (useful model);

documentary confirmation of groundless refusal of the owner of the patent in licensing for use of the invention (useful model) for the corresponding address of the applicant;

calculation of the amount of compensation offered by the applicant to the owner of the patent for medicine is performed according to Item 13 of this Procedure.

The petition shall be signed by the applicant or his authorized person with addition of the document certifying it powers to act on behalf of the applicant. The petition and appendices to it are taught in Ukrainian and are provided the Ministry of Health in triplicate, one of which remains in the Ministry of Health, the second returns to the applicant with mark about acceptance to consideration, and third goes to the owner of the patent within ten working days. If owners of the patent a little, the applicant in addition gives the corresponding number of copies of petitions and appendices.

The owner of the patent can give the relevant information on the petition within 30 working days from the date of receipt of the patent by the owner, is confirmed by mark in the assurance of receipt of the mailing.

5. In case of violation of requirements of Items 3 and 4 of this Procedure for the Ministry of Health within five working days from the date of receipt of the petition returns the received materials together with reasons for return. After remedial action during the established MOZ of term the applicant can repeatedly submit the petition. The Ministry of Health considers the relevant information given the owner of the patent.

If during consideration of the petition in the Ministry of Health the petition from other applicant for provision of permission arrives, forming of offers on determination of person to which permission can be provided is performed by MZ taking into account the feasibility statement on opportunity, conditions and procedure for use of the invention (useful model).

6. In case of acceptance to consideration of MOZ received the petition directs it with the corresponding request to:

National authority of intellectual property about provision of information of rather patented invention (useful model);

authorized body about provision of information on compliance of the amount of compensation offered by the applicant, Item 13 of this Procedure.

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