Unofficial translation  
 
CABINET  OF MINISTERS  OF UKRAINE  
RESOLUTION  
 
№ 877 of 4 December  2013  
Kyiv  
 
On Approval  of the Procedure  for Granting  Permission  by the Cabinet  of Ministers  of 
Ukraine  to Use the Patented  Invention  (Utility  Model)  concerning  Medicine s  
 
Accord ing to Paragraph 3  of Article 30 of the Law of Ukraine “On Protection of Rights to 
Inventions and Utility Models ”, Paragraph  11 of Article 9 of the Law of Ukraine “On Medicines ” 
the Cabinet of Ministers of Ukraine decides :  
1. To approve the Proc edure for Granting Permission by the Cabinet of Ministers of Ukraine to 
Use the Patented Invention (Utility Model) concerning Medicines  (attached) . 
2. To ad d an additional paragraph to Paragraph  1 of the Procedure for Granting Permission by 
the Cabinet of Ministers of Ukraine to Use the Patented Invention (Utility Model) or Registered 
Topography of Integrated Circuit , approved by the Resolution of the Cabinet of Ministers of 
Ukraine of 14 January 2004 № 8 (the Official Bulletin of Ukraine,  2004, № 2, p. 38; 2011, № 71,  
p. 2673) , with the following content:  
“This Procedure does not apply to the Procedure for Granting Permission by the Cabinet of 
Ministers of Ukraine to Use the Patented Invention (Utility Model) concerning Medicines .”. 
 
 
Prime  Minister  of Ukraine  
  
 
 
 
 
 
 
 
 
  2 
 
 APPROVED   
by the Resolution  of the Cabinet  of  
Ministers  of Ukraine   
of 4 December  2013  № 877  
 
PROCEDURE  
for Granting  Permission  by the Cabinet  of Ministers  of Ukraine  to Use the Patented  
Invention  (Utility  Model)  concerning  Medicin es 
 
1. This Procedure determins  the process of granting permission by the Cabinet of Ministers of 
Ukraine to use  the patented invention (utility model) concerning medicines (hereinafter - 
permission ), without the consent of the patent owner , but with payme nt of an adequate 
compensation  to the patent owner . 
2. With  the purpose to protect public health, including in cases of HIV/AIDS and other socially 
dangerous diseases, the Cabinet of Ministers of Ukraine may give the permission  to the person , 
authorized by  it, if there is documentary confirmation of the following circumstances together : 
the patent owner can not meet the needs in appropriate medicines due to its  own abilit ies and 
capacities, which are commonly used for production of such medicines;  
the paten t owner has groundlessly rejected granting a license for the use of the invention (utility 
model) to the applicant . 
3. The permission  shall be granted in compliance with such requirements:  
the scope  and the duration of the use of the patented invention (ut ility model) shall be  
determined by the purpose of the granted permission ; 
the permission  to use the patented invention (utility model) shall not d eprive the patent owner  
of the  right to grant license s for the use of an  invention (utility model);  
the right  to use the patented invention (utility model) shall not transferred to third parties, 
excluding the case , when it is transferred together with th e part of the enterprise, in which this use is 
carried out ; 
the use of  the patented invention (utility model) is permitted to meet the domestic 
pharmaceutical market needs;  
an adequate compensation in accordance with an economic value of the invention (utility 
model) shall be paid to the patent owner at the expense of the authorized person on the basis of the 
the decision of the Cabinet of Ministers of Ukraine concerning granting the permission  to use the 
patented invention (utility model).  
4. The permission  may be granted to business entity , which produces medicines in full-scale 
circle or at the final stages of production of medicines  with the use of active pharmaceutical 
ingredient of other manufacturer on production sites, located in Ukraine, under the license for  3 
production of  medicines, or to business entity , which  imports medicines to Ukraine under the 
licens es for import of medicines and for wholesale and retail trade in medicines . 
The business entity concerned (hereinafter - the applicant) shall submit  a request to the Ministry 
of Health of Ukraine concerning  granting permission by the Cabinet of Ministers o f Ukraine , with 
indication of the  following information:  
International Nonproprietary Name (INN) of medicine;  
the name of the invention (utility model);  
the patent number, information concerning  its owner (s), its (their) address or location;  
the applicant 's name, its location, signature of the authorized person with documentary 
confirmation of such authority.  
The request shall be added with the following:  
justification  of necessity to use the patented invention (utility model) with indicati on of specific  
circumstances and required duration of the permission  for the use of the patent;  
technical and economic  justification  of possibility , conditions and procedure of the use of the 
patented invention (utility model);  
documentary confirmation of unreasonable ref usal of the patent owner to grant license  for the 
use of the patented invention (utility model) on appropriate applicant`s request;  
calculation of the amount of compensation, which shall  be offered to the patent owner  by the 
applicant (such calculation sh ould be made in accordance with Paragraph  13 of this Procedure ). 
The request should  be signed by the applicant or  by its authorized person (the document , 
confirming authority of such person to act on behalf of the applicant, shall be attached ). The request  
and its annexes shall be made  in Ukrainian and submitted  to the Ministry of Health of Ukraine in 
three copies, one of which shall remain at the Ministry, the second one shall be given back  to the 
applicant together with a mark on acceptance for considerat ion, and the third one shall be sent to the 
patent owner within 10 working days. If there are several patent owners, the applicant shall 
additionally submit  appropriate quantity  of copies of requests and annexes.  
The patent owner may submit appropriate inf ormation relating to  the request within 30 working 
days of the date of its receiving. That should be confirmed by the mark in the notice on delivery  of 
postal item.  
5. If the requirements of Paragraphs  3 and 4 of of this Procedure are violated, the Ministr y of 
Health of Ukraine shall return submitted  materials together with explanation of reasons of returning  
within 5 working days of the date of receiving the request . The applicant may re -submit the request 
once again after redressing  all insufficiencies  within the term, set by the Ministry of Health  of 
Ukraine. The Ministry of Health of Ukraine shall consider appropriate information , submitted by 
the patent owner.   4 
If during the process of consideration  of the request the Ministry of Health of Ukraine 
receiv es the request concerning granting the permission from other applicant, the Ministry of Health 
of Ukraine should also prepare proposals on defining the person, to which the permission  may be 
granted, considering technical and economic justification of poss ibility, conditions and procedure of 
the use of the patented invention (utility model) . 
6. If the request is accepted for consideration , the Ministry of Health of Ukrain shall send it to:  
the State Intellectual Property Service , asking to  give information regarding  the patented 
invention (utility model);  
the authorized body , asking to  give information concerning  conformity  of the amount of 
compensation , offered by the applicant, with the requirements of Paragraph  13 of this Procedure.  
7. The State Intellect ual Property Service shall submit information to the Ministry of Health of 
Ukraine concerning conformity of the data, specified in the request, with data, included in the State 
Register of Patents of Ukraine for Inventions or in the State Register of Paten ts of Ukraine for 
Utility Models, within 10 working days of the date of receiving the request .  
The authorized body shall submit information to the Ministry of Health of Ukraine  concerning 
conformity of the amount of compensation, offered by the applicant,  with the requirements of 
Paragraph 13 of this Procedure, within 10 working days of the date of receiving the request , 
specified in Paragraph  6 of this Procedure.  
8. The Ministry of Health of Ukraine  shall develop a draft decision of the Cabinet of Ministe rs 
of Ukraine concerning granting the permission,  within 10 working days of the date of receiving of 
appropriate proposals.  
The f ollowing documents shall be submitted to the Cabinet of Ministers of Ukraine together 
with the draft decision:  
copies of reques t and its annexes , submitted by the applicant;  
information , received from the State Intellectual Property Service , in respect of  the patented 
invention (utility model) concerning medicines , together  with an extract from the State Register of 
Patents of Ukr aine for Inventions or from the State Register of Patents of Ukraine for Utility 
Models;  
information , received from the authorized body concerning the amount  of compensation , which 
should be paid to the medicine patent owner.  
materials concerning  consider ation of the information , submitted by the patent owner.  
9. Development , submission and consideration of the draft desigion of the Cabinet of Ministers 
of Ukraine is carried out under the established procedure . 
The decision of the Cabinet of Ministers of U kraine concerning granting the permission  shall 
include:   5 
the name of business entity, to which the permission  is granted, its location and the name 
of the invention (utility model), the patent number;  
the duration of granted permission ; 
conditions of grant ing the permission  (circumstances , under which the permission  has been 
granted, the scope  of the use of the patented invention (utility model);  
the amount  and procedure of payment of compensation to the patent owner by the applicant.  
If it is necessary, th e Cabinet of Ministers of Ukraine shall entrust the Ministry of Health  of 
Ukraine to carry out additional consideration of the issue concerning the advisability of granting 
such permission . 
10. The Ministry of Health of Ukraine shall inform the applicant a nd the patent owner within  3 
working days of the date of the entry into force of the  decision of the Cabinet of Ministers of 
Ukraine concerning granting the permission . 
11. The State Intellectual Property Service shall publish the decision concerning grant ing the 
permission , adopted by the Cabinet of Ministers of Ukraine, in the official bulletin on intellectual 
property.  
12. During the process of state registration of the medicine business entity may refer to the 
information, specified in the registration dossier of appropriate medicine, authori zed for the use, on 
the basis of the decision concerning granting the permission , adopted by the C abinet of Ministers of 
Ukraine.  
13. The Cabinet of Ministers of Ukraine shall establish  the amount of compensati on for  the use 
of the  patented invention (utility model) in the decision concerning granting the permission , taking 
into consideration the accessibility of medicines for people at the lowest possible price. The amount 
of compensation  should not exceed the maximu m rate of compensation , which is calculated under  
the Tiered Royalty Method, described in Remuneration Guidelines for Non-voluntary Use of a 
Patent on Medical Technologies of the World  Health Organization, in accordance with the 
following  formula:  
(PM x 0, 04 x (PM: PMU) x (IU: I) = MR C, 
where PM – the price per unit of the original  medicine on the market of the country of origin. 
The price of the original  medicine on the market of the country of origin may be determined under  
the data from official sources of information;  
PMU - the price per unit of the original  medicine in Ukraine (the lowest of the following prices: 
officially declared or according to the latest procurements , carried out  by the Ministry of Health of 
Ukraine, or the weighted average  price *); 
_____________________  
* The weighted average price of the medicine, supplied by the company -supplier of original medicines in 
Ukraine, should be considered in the formula.   6 
IU - income per capita in Ukraine according to the data of the International Monet ary Fund ; 
I - income per capita in the country of origin of the original  medicine according to the data of 
the International Monetary Fund;  
MRC - the maximum rate of compensatio n. 
14. The permission shall be revoc ed before the expiry of  its validity period  by the decision of 
the Cabinet of Ministers of Ukraine on the proposal of the Ministry of Health  of Ukraine  in the case 
of: 
submission of the  reasonable request concerning revocation  of the granted permission by the 
business entity , authorized to use  the patented invention (utility model);  
discontinuance  of circumstances under which the permission has been  grant ed; 
non-fulfilment (unfair fulfilment) of the permission grant conditions by the authorized business 
entity;  
termination of the legal entity (merger, connection , division , transformation or liquidation);  
establish ing the fact of submission of false information in the request and its annexes.  
15. Development  and submission of the draft decision of the Cabinet of M inisters of Ukraine 
concerning revocation of the permission  shall be carried out  in accordance to Paragraph s 8 and 9 of 
this Procedure.  
16. The decisions of the Cabinet of Ministers of Ukraine concerning granting the permission  
and its revocation may be ap pealed in court procedure.