Please refer to the responses to the Checklist on Issues of Enforcement.

Please refer to the responses to the Checklist on Issues of Enforcement.

Please refer to the responses to the Checklist on Issues of Enforcement.

Please refer to the responses to the Checklist on Issues of Enforcement.

Please refer to the responses to the Checklist on Issues of Enforcement.

Please refer to the responses to the Checklist on Issues of Enforcement.

Please refer to the responses to the Checklist on Issues of Enforcement.

Please refer to the responses to the Checklist on Issues of Enforcement.

Please refer to the responses to the Checklist on Issues of Enforcement.

Please refer to the responses to the Checklist on Issues of Enforcement.

Please refer to the responses to the Checklist on Issues of Enforcement.

Please refer to the responses to the Checklist on Issues of Enforcement.

Please refer to the responses to the Checklist on Issues of Enforcement.

According to paragraph 1 of Article 6 of the Patent Law inventions shall be protected if they are new, involve an inventive step, and are capable of industrial application. Paragraph 2 of Article 6 of the Patent Law provides that patent protection shall be available to inventions in any field of technology whether products or processes as required by Article 27 of the TRIPS Agreement. Exceptions are provided in paragraph 3 of Article 6 according to which the Patent Law does not recognize as inventions: (i) discoveries; (ii) scientific theories; (iii) mathematical methods; (iv) methods of economic organization and management; (v) symbols, schedules, and rules; (vi) rules and methods for mental activities; (vii) algorithms per se and computer programs; (viii) projects and plans of buildings and structures, and land development; (ix) proposals concerning solely the outward appearance of manufactured goods; and, (x) proposals that are contrary to the public order, humanitarian principles and morality. At the same time, diagnostic, therapeutic and surgical methods can also be protected as inventions under the Article 6 criteria. Abovementioned exceptions were discussed with the members during the process of Kazakhstan’s accession to the WTO and it was agreed that they comply with exceptions allowed under the Article 27 of the TRIPS Agreement.

Paragraph 2 of Article 11 of the Patent Law stipulates the requirement that a patented invention be used, while "use" is defined as manufacturing, application, importation, offer for sale, sale, as well as other means of putting the industrial property into circulation, including storage in view of subsequent use. Therefore, in the case of importation of a patented product, non-use for the purpose of compulsory licensing cannot be established under Kazakhstan's Patent Law.

All the conditions enumerated in Article 31 of the TRIPS Agreement can be found in paragraphs 4 and 5 of Article 11 of the Patent Law of the Republic of Kazakhstan. According to the abovementioned provisions, when the patentee does not use the industrial property object and refuses to conclude a licensing agreement on acceptable commercial terms within 90 calendar days from the day of request, any person have the right to apply to a court with a claim on being granted a compulsory non-exclusive license when the object of industrial property was not continuously used after the first publication of information on the issue of the protection document on the industrial property object during any three years preceding the date of submission of such claim. If the patentee does not prove that the non-use is stipulated by good reasons, the court grant the indicated license with determination of limits of use, deadlines, amount and procedure for payments. The amount of payments is established not lower than the market price of the license as defined in accordance with the established practice. Compulsory license in respect of an invention in the field of semi-conductor technology is only granted for public non-commercial use or where a judicial body has determined that the existing practice is in violation of anti-competitive legislation of the Republic of Kazakhstan and that the grant of compulsory license can remedy such practice. Any compulsory license is issued in the first instance for providing for demands of the domestic market of the Republic of Kazakhstan, except when the compulsory license concerns a patent claiming a pharmaceutical product or a process to obtain a pharmaceutical product, and the purpose of the license is to export the patented product or the product manufactured by the patented process to a territory with no or insufficient manufacturing capacity, in accordance with international agreements, ratified by the Republic of Kazakhstan. The right to use the indicated industrial property object may be assigned by the person to whom the compulsory license was granted to other person only together with the relevant production in which this item is used. The compulsory license is subject to revocation by the court in the case of termination of the circumstances which were the reason for its issue. The patentee who cannot use the object of industrial property without infringing the right of the holder of another patent who has refused to conclude a licensing agreement on acceptable commercial terms has the right to apply to the court with application claim on being granted a compulsory non-exclusive license to use the object of industrial property in the territory of the Republic of Kazakhstan. If the patent holder who cannot use the object of industrial property without infringing the rights of the holder of another patent proves that his industrial property object represents an important technical advance and has a considerable economic significance in relation to the object of industrial property of another patent, the court may decide to grant him a compulsory license. When granting the indicated license the court determines the limits of use of the object of industrial property the patent on which belongs to other person, deadlines, amount and procedure for payments. In this respect, the amount of payments is established not lower than the market price of the license as defined in accordance with the established practice. The right to use the object of industrial property obtained on the basis of the present paragraph may be assigned only with the assignment of the protection document on this object of industrial property in connection therewith this right is granted. In the case of granting in accordance with this paragraph of a compulsory license to the patent holder of protection document the right to use on which was granted on the basis of indicated license will also have a right to receive a license to use the dependent invention in connection therewith compulsory license was granted.

With regard to reversal of the burden of proof in civil proceedings concerning the infringement of process patents, it must be mentioned that the requirements of Article 34 of the WTO TRIPS Agreement are not covered by the Patent Law, but contained in Article 65 of the Civil Procedure Code, which stipulates that each party is responsible for providing proof for its own claims and statements. Other parties involved in the process can also provide evidence.

According to paragraph 19 of Article 71 of the Code of the Republic of Kazakhstan "On People's Health and Healthcare System" of 18 September 2009 (further – the Health Code) State Expert Organization as well as state body in the field of circulation of pharmaceutical products, medical devices and equipment shall not be allowed without consent of the applicant to disclose and use with commercial purpose of undisclosed information contained in application for state registration, documents on examination as well as in registration dossier of pharmaceutical product that contain new chemical entities during the period of 6 years after state registration of a pharmaceutical product. With regard to agrochemical products it must be mentioned that according to Law No. 302-III "On Safety of Chemical Products" of 21 July 2007 and Government Resolution No. 1396 "On Approval of the Rules on Registration and Production Testing and State Registration of Pesticides" of 30 November 2011, registration requirements for chemical products, pesticides and poisons are the same for every applicant and does not permit the reliance on undisclosed data developed or submitted by another applicant to obtain product registration.

According to paragraph 19 of Article 71 of the Code of the Republic of Kazakhstan "On People's Health and Healthcare System" of 18 September 2009 State Expert Organization as well as state body in the field of circulation of pharmaceutical products, medical devices and equipment shall not be allowed without consent of the applicant to disclose and use with commercial purpose of undisclosed information contained in application for state registration, documents on examination as well as in registration dossier of pharmaceutical product that contain new chemical entities during the period of 6 years after state registration of a pharmaceutical product. Based on decision of the court, disclosure and use of undisclosed information indicated in paragraph 19 of Article 71 of the Health Code shall be allowed if: 1) supplies of pharmaceutical product are not sufficient for satisfaction of needs of population during the period of 12 month from the date of registration in the Republic of Kazakhstan; 2) it is necessary to protect health of population in emergency or guarantee national security; 3) legislation of the Republic of Kazakhstan in the field of competition was infringed".

As it was mentioned above, the period of such protection is 6 years after state registration of a pharmaceutical product.