FEDERATION TO THE WORLD TRADE ORGANIZATION 47 страница

1267. In spite of the fact that the representative of the Russian Federation had clarified that the Russian Federation defines the term "designation of place of origin" consistently with Article 22 of the WTO TRIPS Agreement, some Members expressed concerns regarding the compatibility of the provisions of Article 1516 of the Civil Code with Article 22.1 of the WTO TRIPS Agreement. According to Article 22.1, an indication did not necessarily have to be a geographical place to be protected as a geographical indication. A geographical indication was any kind of designation which points to a given country, region or locality and which possesses a specific quality, reputation or other characteristics which were essentially due to a particular geographical environment, but not necessarily the name of a geographical place: it may be a geographical name or an indication that was not a geographical name as long as the indication evokes an association with the place of origin. In these Members view, this concept was wider than the concept of appellation of origin as set-out in the Lisbon Agreement which refers to the fact that the appellation must be a geographical name of a country, region or locality.

1268. The representative of the Russian Federation responded that Article 1516.1 stipulated the connection between the goods and the designation of the place of origin of goods through the indication of "special characteristics" of the goods, which were "exclusively or mainly determined by the natural conditions and/or human factors characteristic for the given geographic locale". He explained that this definition not only was not in contradiction with Article 22.1 of the WTO TRIPS Agreement, but also covered "given quality", "reputation" or other "characteristic" stipulated by this Article, noting that in Russian legal practice, the term "characteristic" had quite a wide scope.

1269. Recognizing the concerns of Members of the Working Party in respect of the scope of protection of geographical indications in the Russian Federation, the representative of the Russian Federation confirmed that Article 1516 of the Civil Code had been amended to include the definition of geographical indications as set-out in Article 22 of the WTO TRIPS Agreement to state that the term "designation of place of origin" would also cover the indications which identify a good as originating in the territory, or a region or locality in that territory, where a given quality, reputation or other characteristic of the good was essentially attributable to its geographical origin without necessarily including the name of a geographical place.

1270. Some Members expressed concern regarding the provisions of the Civil Code on obtaining registration of a foreign indication of place of origin and requested clarification of procedures that would apply in the case of a Member that provided protection for geographical indications through means other than registration, e.g., through forms of trademarks, unfair competition laws, and other means.

1271. In response, the representative of the Russian Federation explained that Article 1517.2 of the Civil Code does not require that protection for a designation of the place of origin of goods be provided through registration in the country of origin of the geographical indication. He noted that some Members had implemented the TRIPS section on geographical indications through legislation on unfair competition, on the protection of certification marks, implementation of norms of common law, and other means. To confirm protection in the country of origin, an applicant for protection in the Russian Federation could submit registration certificates, a court decision or other evidence establishing that the indication was protected in its country of origin. The Ministry of Education and Science had issued Order No. 328 of 29 October 2008 which established procedures for a right-holder to submit such documents. The Working Party took note of this commitment.

Industrial Designs and Patents

1272. The representative of the Russian Federation stated that industrial designs and patents were protected by the provisions of Chapters 69 and 72 of the Civil Code. Chapter 72 "Patent Right" related to the legal protection of inventions, useful models and industrial design. It covered the traditional patent law provisions, reflecting the substance of the Patent Law of the Russian Federation No. 3517-1 of 23 September 1992, including administrative norms required for regulation of creation, existence, and civil turnover of patent rights, and which establish the procedure for State Registration of objects of patent rights and issue of patents. The issue of the content of the exclusive right in an invention, useful model or industrial design and means of use of this right was highlighted in this chapter. For the first time, the right to a patent was determined as separate alienable right of the author of the invention, useful model or industrial design (Article 1357).

1273. Under the provisions of the Civil Code, a patent might not be obtained in relation to the following: plant varieties, animal breeds, and layout designs of integrated microcircuits that were not new, or did not involve an inventive step, or were not capable of industrial application, and inventions violating social interests or humanitarian and moral principles. In his view, this provision corresponded to Article 27.3 of the WTO TRIPS Agreement. Under Article 1363 of the Civil Code, the validity term of patents for inventions was 20 years; for utility models was ten years; for industrial designs was 15 years, starting from the date when the application was submitted. This term corresponded to the relevant provisions of Article 33 of the WTO TRIPS Agreement. Article 1363.2 of the Civil Code provided for the possibility of extending the term of protection for pharmaceutical products (medicines), pesticides and agricultural chemicals, if their use required consent of an authorised State body. In such cases, the general 20 year term could be extended for up to five years. The Civil Code established civil liability for illegal use of patents, inventions and industrial designs. In his view, these provisions were in conformity with the Paris Convention and the relevant provisions of the WTO TRIPS Agreement.

1274. Some Members of the Working Party expressed concerns about compliance of Articles 1239, 1360 and 1362 of the Civil Code on compulsory licensing with the requirements of Articles 13 and 31 of the WTO TRIPS Agreement. Responding to those concerns, the representative of the Russian Federation informed Members of the Working Party that the requirement prohibiting assignment of a compulsory licence, if there were dependent inventions stipulated by sub-item "I (iii)" of Article 31 of the WTO TRIPS Agreement was contained in paragraph 1 of Article 1362.2 of the Civil Code. He further explained that Article 1362.2 provided that the right to use the invention granted on the basis of the compulsory licence, might not be transferred to other persons except in case of alienation of the second patent. In his view, this provision was in conformity with the requirement of Article 31 (e) of the WTO TRIPS Agreement which said that such use was non-assignable, except with that part of the enterprise or goodwill which enjoyed such use. In his view, the second patent was a part of a goodwill which enjoyed use of the invention received on the basis of compulsory licence. According to paragraph 3 of Article 1362.2, the holder of a patent for an invention or utility model that was the subject of a compulsory licence must also receive a cross-licence for the use of a patented invention which was dependent on the patented invention that was subject to the compulsory licence. In his view, this provision corresponded with the requirement of the Article 31 (l) (ii) of the WTO TRIPS Agreement which said that the owner of the first patent was to be entitled to a cross-licence on reasonable terms to use the invention claimed in the second patent.

1275. With respect to the requirements set-out in Article 31 (c) of the WTO TRIPS Agreement, the representative of the Russian Federation agreed that they were not reflected in Article 1362 of the Civil Code and confirmed that the Civil Code had been amended to comply with this obligation.

1276. Some Members of the Working Party raised questions about compliance of Article 1349 of the Civil Code on exclusions from patentability with the provisions in paragraphs 2 and 3 of Article 27 of the WTO TRIPS Agreement. In response the representative of the Russian Federation informed Members of the Working Party that the term "societal interests", which was used in the Article 1349 of the Civil Code, in his view did not contradict Article 27.2 of the WTO TRIPS Agreement. Article 27.2 of the WTO TRIPS Agreement, referred to the "protection of morality, protection of human, animal or plant life or health, environment" in addition to "public order" and the same purposes were covered by the term "societal interests" in Russian legislation.

1277. The representative of the Russian Federation confirmed that Article 1349 of the Civil Code would be interpreted and applied in compliance with Article 27.2 and 27.3 of the WTO TRIPS Agreement. The Working Party took note of this commitment.

1278. Some Members of the Working Party expressed concerns about the compliance of sub-paragraph 4 of Article 1359.1 of the Civil Code with Article 30 of the WTO TRIPS Agreement. In particular, these Members considered that this provision permitted use of any invention, utility model, or industrial design under conditions that in some cases could exactly correspond to the intended use of the invention, design or model. In these Members' view, this exception could exceed what was permitted under Article 30 of the WTO TRIPS Agreement. In responding to these concerns, the representative of the Russian Federation stated that under this exception, use of an invention, utility model, or industrial design without right-holders' consent for the satisfaction of personal, family, home or other needs which were not connected with entrepreneurial activity did not constitute an infringement, if the purpose of such use was not the receipt of profit or income. In his view, this exception was covered by the general provision of Article 30 of the WTO TRIPS Agreement, which permitted limited exceptions from patent rights, which "do not unreasonably conflict with a normal exploitation of the patent and, do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties". Moreover, a patent owner who considers that his rights were unreasonably prejudiced as a result of use permitted by sub-point 4 of Article 1359 of the Civil Code, might seek a remedy from the court for infringement of his rights.

Plant Variety and Animal Breed Protection

1279. The representative of the Russian Federation explained that plant varieties and animal breeds were protected in accordance with the Chapter 73 of the Civil Code, which related to objects, protection of which had been introduced by the Law of the Russian Federation No. 5605-1 of 6 August 1993 "On Selection Achievements". For the most part, this chapter repeated the provisions of this Law. However, they were modified to take into account the requirements for their codification. These norms were brought into conformity with general principles of the protection of intellectual rights in the Civil Code, while addressing specific issues related to the particularities of biological objects, which were the subject of protection of selection achievements. In his view, these provisions were in conformity with international legal instruments, such as the UPOV Convention and the WTO TRIPS Agreement.

1280. One Member of the Working Party asked the representative of the Russian Federation to confirm that plant variety protection would be accorded to natural persons and legal entities of all WTO Members from the date of the accession. The representative of the Russian Federation confirmed it.

Layout Designs of Integrated Circuits

1281. The representative of the Russian Federation said that layout designs of integrated circuits were protected in accordance with the Chapter 74 of the Civil Code. Protection for layout designs of integrated circuits was originally provided under the Law of the Russian Federation of 23 September 1993 No. 3527-1 "On lawful protection of integrated circuit layouts". In his view, the provisions of Chapter 74 were in conformity with the provisions of the Treaty on Intellectual Property in Respect of Integrated Circuits (Washington Treaty) and the relevant provisions of the WTO TRIPS Agreement.

Requirements on undisclosed information, including

trade secrets and test data

1282. The representative of the Russian Federation said that the legislation of the Russian Federation contained a number of normative legal acts which regulated and determined the mechanisms for ensuring protection of undisclosed information, namely the Civil Code of the Russian Federation, Federal Law No. 24-FZ of 20 February 1995 "On Information, Providing and Protecting Information" (as amended by Federal Law No. 15-FZ of 10 January 2003), Federal Law No. 98-FZ of 29 July 2004 "On Commercial Secrets" (as last amended on 24 July 2007), as well as a number of regulations, in particular the President Decree No. 188 of 6 March 1997 (as last amended on 23 September 2005) "On Approving a List of Confidential Data".

1283. These measures prohibited disclosure of undisclosed information and/or its use without the consent of the owner. They granted the owners and other eligible persons protection of their rights, inter alia, by prohibiting actions, which could infringe or threaten an infringement of their rights. These measures also provided protection for undisclosed information that was legally required to be submitted to Government bodies or organizations authorised by the Government to receive and deal with such information.

1284. According to Federal Law No. 24-FZ of 20 February 1995 "On Information, Providing Information and Protection of Information", confidential information was understood as documentary information, the access to which was limited in accordance with Russian legislation. Presidential Decree No. 188 of 6 March 1997 established the list of data of a confidential character. This list included: (i) secrets of private (individuals) lives (information on the facts, events and circumstances of the life of a citizen allowing the identification of his/her personal identity (personal data), except for the information subject to dissemination in the mass media in cases envisaged by Federal laws; (ii) information related to professional activity with limited availability according to the Constitution of the Russian Federation and Federal laws (medical, notarial, legally privileged information, secrecy of correspondence, telephone conversations, mail, telegraph and other messages, etc.); (iii) State secrets; (iv) commercial secrets; and (v) information on the contents of inventions, utility models and industrial designs prior to the official publication of information about them. The protection of such information was guaranteed by the application of the civil, labour (employment), administrative and criminal legislation.

1285. The representative of the Russian Federation explained that Article 139 of the Civil Code established legal protection for undisclosed information, which constituted official or commercial secrets, including information related to products yet to be patented. According to Article 139 of the Civil Code, the information constituted an official or commercial secret when such information had real or potential commercial value because it was secret, i.e., was not known to third persons, when there was no free access to it, and its holder had taken steps to protect its confidentiality. Russian legislation provided instruments for protection of the legal rights of the right-holder, including the right to put an end to activities violating his/her rights or threatening to violate them.

1286. Persons who obtained information containing official or commercial secrets by illegal means were obliged to compensate for any damages caused. Employees having disclosed an official, commercial or other secret in violation of their labour contract, contract, or law, and contractors having disclosed an official, commercial or other secret in violation of their civil contract were also liable under Articles 57 and 243 of the Labour Code of the Russian Federation. Different kinds of liability (administrative, criminal, etc.) could be applied to officials having disclosed an official or commercial secret, including officials who had used undisclosed information related to clinical tests of medicinal products without the consent of the right-holder (see the Section on "Enforcement" below).

1287. The representative of the Russian Federation explained that Federal Law No. 98-FZ of 29 July 2004 "On Commercial Secrets" (as last amended on 24 July 2007) further regulated the protection of commercial secrets, designation of information as commercial secrets, transfer of such information, and protection of its confidentiality. This Law also defined the data that could not be considered a commercial secret (for example, data consisting of the constituent documents of a legal entity). The Law applied to information that contained a commercial secret independently of the type of media on which it was stated. Scientific, technical, technological, industrial, financial, economic and any other type of information (including know-how) that had real or potential commercial value because it was secret, i.e., it was not known to third persons, legal access was not freely available, and the holder took steps to maintain its confidentiality, would qualify as a commercial secret.

1288. Federal Law No. 98-FZ also provided the owner of the information with the right and possibility to prevent third persons from obtaining, disclosing, or using confidential information without his/her permission by: (i) limiting or prohibiting access to the information containing a commercial secret and defining the procedure and conditions of access to this information; (ii) requiring natural persons and legal entities who had gained legal access to commercial secrets, and State and local authorities to which the commercial secret had been given, to observe the obligation of confidentiality of the information; and (iii) protecting his/her rights in case of disclosure, illegal receipt or illegal use of the information containing a commercial secret by third persons, including the demand of compensation of damages caused by violation of rights. If necessary, the owner of a commercial secret had the right to apply means and methods of technical protection of confidentiality of information, and other means that were in compliance with Russian legislation.

1289. In addition, Federal Law No. 98-FZ contained provisions protecting confidentiality of information within the framework of labour and civil relations and when such information was provided to State bodies and organizations authorised by State bodies. Article 13 of the Law required State and municipal authorities to create conditions guaranteeing protection of confidentiality of information provided to them by juridical persons and individual entrepreneurs. State and municipal officials could not disclose, or transfer such information to third persons or other State and municipal authorities, except for cases provided by the Law, or take personal advantage of or use, for personal purposes, information containing a commercial secret that had become known to them in the course of their duties, without permission of the owner. In case of violation of confidentiality of information, State and municipal officials were subject to disciplinary actions, as well as civil, administrative, and criminal liability in accordance with Russian legislation. Moreover, the acquisition, use, or disclosure of scientific, technical, production, or commercial information, including commercial secrets, without the consent of the owner were not permitted pursuant to Article 10 of Law No. 948-1 of 22 March 1991 "On Competition and Restriction of Monopoly Activity on Commodity Markets".

1290. The representative of the Russian Federation also explained that Chapter 75 of the Civil Code "Rights to Secrets of Production (know-how)," provided detailed provisions on the legal regulation of this category of objects of intellectual rights. The provisions of Chapter 75 set-out the definition of "know-how", the content of exclusive rights in it, essential features of contracts on alienation of rights to "know-how" and respective licensing contracts (Articles 1468 - 1469), and also relationship of employee and employer related to creation of "know-how". He noted that the scope and definition of know-how in the Civil Code was the same as that set-out in paragraphs 1285 through 1287 above.

1291. The provisions of the above-mentioned laws prohibited the use of undisclosed information (commercial secrets or know-how) without the consent of the right-holder. All of these provisions (including the prohibition of disclosure and use of confidential (undisclosed) information without the permission of the owner) were applicable to the protection of confidential (undisclosed) information related to pharmaceutical and agrochemical products utilizing new chemical substances. These prohibitions on use made it illegal for an applicant to get marketing approval or registration of a medicine/pharmaceutical or agricultural chemical through reliance on undisclosed test or other data of another person without the permission of that person. It was also illegal for a Government official to rely on undisclosed information without the permission of the right-holder in the examination and approval process. Illegal disclosure and use (including unfair commercial use and reliance) by officials of such information would entail civil, administrative, and criminal penalties.

1292. Some Members of the Working Party expressed their concerns that cited legislation did not require the health authorities to provide a period of at least six years of protection against unfair commercial use starting from the date of approval of the application and that during this period no person other than the person who submitted such data could, without the explicit consent of the person who submitted the data, rely on such data in support of an application for product approval. They requested the Russian Federation to bring its legislation in conformity with Article 39.3 of the WTO TRIPS Agreement and to take a commitment reflecting these requirements. These Members also sought confirmation that applicants that sought to register "reproduced medicines" in the Russian Federation were required to submit pre-clinical and clinical test results and other data that were required for registration of "original" medicines and could not rely on others' data without permission for the six-year period of protection against unfair commercial use.

1293. Some Members of the Working Party also expressed concerns about the transparency of the process for registration of medicines and requested that the Russian Federation establish procedures so that an entity submitting undisclosed test data to obtain registration of a medicine in the Russian Federation would be informed if another application was filed seeking registration of a medicine with a similar active ingredient. These Members sought assurances that those entities that had a registration or pending application for a medicine with the same or similar active ingredient had an opportunity to provide information to the officials of the Russian Federation on whether other applicants had permission to use the undisclosed data of the first applicant, and to bring to the attention of the officials of the Russian Federation issues regarding the development and submission by a subsequent applicant of its own test data and other information. Members also requested information on whether the officials of the Russian Federation would deny registration of medicines if the applicant did not provide its own data and other information and on the status of medicines that were improperly registered. In particular, on whether medicines that were registered based on applications that did not include the own test data of the applicant and other information would be removed from the market until such legal requirements were satisfied.

1294. In response to questions of some Members on prevention of unfair commercial use of undisclosed information provided for State Registration of agrochemicals, the representative of the Russian Federation confirmed that this information was protected against disclosure and unfair commercial use in accordance with the Law "On Commercial Secrets", Civil Code, Criminal Code, and Code on Administrative Offences. Moreover, the Law "On Safe Handling with Pesticides and Agrochemicals" provided for the same registration procedures for each applicant, there were no abbreviated or reductive procedures for registration and there was no difference in the list of documents which each applicant was required to provide or in other registration requirements. Federal Law No. 109-FZ of 19 July 1997 "On Safe Handling with Pesticides and Agrochemicals" (Articles 9 and 11) required a test to be conducted prior to the registration of each agrochemical. The organization authorised by the Federal authority responsible for registration conducted this test. To obtain registration, the applicant had no right to rely on data and other information other than results of this test. He confirmed that with regard to agricultural chemicals, the legislation of the Russian Federation does not permit the unauthorised reliance on undisclosed data developed or submitted by another to obtain product approval/registration. The Working Party took note of this commitment.

1295. The representative of the Russian Federation confirmed that the Russian Federation had enacted legislation and would adopt regulations on the protection of undisclosed information and test data, in compliance with Article 39.3 of the WTO TRIPS Agreement, providing that undisclosed information submitted to obtain marketing approval, i.e., registration of pharmaceutical products, would provide for a period of at least six years of protection against unfair commercial use starting from the date of grant of marketing approval in the Russian Federation. During this period of protection against unfair commercial use, no person or entity (public or private), other than the person or entity who submitted such undisclosed data, could without the explicit consent of the person or entity who submitted such undisclosed data rely, directly or indirectly, on such data in support of an application for product approval/registration. Notice of subsequent applications for registration would be provided in accord with established procedures. During the six year period, any subsequent application for marketing approval or registration would not be granted, unless the subsequent applicant submitted his own data (or data used with the authorization of the right-holder) meeting the same requirements as the first applicant, and products registered without submission of such data would be removed from the market until requirements were met. Further, he confirmed that the Russian Federation would protect such data against any disclosure, except where necessary to protect the public or unless steps were taken to ensure that the data were protected against unfair commercial use. The Working Party took note of these commitments.

1296. In response to Members' concerns about registration of "reproduced medicines", the representative of the Russian Federation explained that under Federal Law No. 61-FZ "On the Circulation of Medicines", the six-year prohibition on the receipt, disclosure, and use for commercial purposes and for applications for State Registration of medicines of information on the results of preclinical studies of a drug and clinical studies of a medicine set-out in Article 18 of that law also applied to reproduced medicines, including in expedited or abbreviated registration procedures. Further, during the six-year period, applicants to register reproduced medicines were required to submit the same information on the results of clinical studies that was required of the first registrant as well as information establishing bioequivalence and effectiveness.

Responsible Authorities

1297. The representative of the Russian Federation explained that several governmental bodies were responsible for the regulation and enforcement of intellectual property rights in the Russian Federation, namely:

- The Ministry of Education and Science of the Russian Federation and the subordinate Federal Service for Intellectual Property, Patents and Trademarks (Rospatent);