IP/C/W/587  
 
15 April 2013  
(13-1956)  Page: 1/2  
Council for Trade-Related Aspects of 
Intellectual Property Rights  Original: English  
 
REVIEW OF LEGISLATION 
 
QUESTIONS POSED BY SWITZERLAND 
 
By means of a communication from the delega tion of Switzerland, dated 2 April 2013, the 
Secretariat has received a copy of the following questions that it has communicated to the Russian 
Federation. 
 
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RUSSIAN FEDERATION  
GENERAL 
1.  Are the provisions of the TRIPS Agreement, as far as not implemented in national law, directly 
applicable in the legal system of the Russian Federation?  
 
PATENTS 
2.  Does the legislation of the Russian Federation grant patent protection for inventions relating to 
products and processes in all fields of technology? Are there any exceptions? If yes, please indicate 
these exceptions and explain how they comply  with Article 27 of the TRIPS Agreement. 
 3.  Does the legislation of the Russian Federation, in accordance with Article 27.1 in combination 
with Article 31 of the TRIPS Agreement, consider  importation as “working” a patent and therefore 
preclude compulsory licensing, if a product is being imported?  
4.  Does the legislation of the Russian Federati on make the granting of a compulsory license 
subject to all the conditions enumerated in Arti cle 31 of the TRIPS Agreement? Please cite the 
relevant provisions of the legislation. 
 
5.  Does the legislation of the Russian Federation provide for the principle of the reversal of burden 
of proof in patent litigation? Please cite the relevant provisions of the legislation.  
 
PROTECTION OF UNDISCLOSED INFORMATION 
6.  According to Article 18.6 of Federal Law No. 61-FZ “On the Circulation of Medicines”, in force 
since 22 August 2012, Russia implemented the obligation under Article 39.3 of the TRIPS 
Agreement to protect undisclosed information in marketing approval procedures against unfair commercial use by granting a term of protection of six years against reliance by a second 
applicant. Please explain how this protection is being implemented and enforced in practice, and 
whether a new administrative regulation addressing the practical aspects of the application of Law No. 61-FZ is going to be put in force.  IP/C/W/587 
 
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  7.  Can you confirm that, despite an accelerated procedure for generic products registration as 
provided for in Article 26 of Law No. 61-FZ, the Russian marketing approval authorities do not 
allow reliance on the data submitted by their origin ator for the full term of protection of six years 
from the date of state registration of the medicinal product? 
 
 PROVISIONAL MEASURES 
8.  Do the judicial authorities of the Russian Federation have the authority to adopt, on the request 
of a rightholder, a provisional measure inaudita altera parte  before an action leading to a decision 
on the merits of the case has been lodged? Please cite the relevant provisions of the legislation. 
 
9.  Does the legislation of the Russian Federation provide for any restrictions for obtaining 
provisional measures? If so, what are these restrictions? Please cite the relevant provisions of the legislation. 
 
10.  Please describe the provisional measures pr ovided for in the legislation of the Russian 
Federation, including those for combatting counterfeiting and piracy. Please describe the 
procedures that must be foll owed and cite the relevant provisions of legislation. 
 11.  Please describe the measures provided by the legislation of the Russian Federation to combat 
counterfeiting and piracy at the border. Please  explain whether the competent authorities are 
empowered to act ex officio  and, if so, please indicate the enforcement actions that may be taken. 
Please cite the relevant provisions of the legislation.  
 
ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS 
12.  Please describe how the legislation of the Russian Federation meets the requirements of 
Article 41 of the TRIPS Agreement. Please cite the relevant provisions. 
 13.  Please indicate the authorities responsible for the application of the measures provided by the legislation of the Russian Federation to combat counterfeiting and piracy. Please explain whether 
the competent authorities are empowered to act ex officio  and, if so, please indicate the 
enforcement actions that may be taken. Please cite the relevant provisions of the legislation.  
14.  Please describe any new initiatives that are planned to improve the enforcement of intellectual 
property rights in the Russian Federation. Is there a particular action plan in place?  
 
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