Kazakhstan now protects proprietary data for new originator drugs

Protection of proprietary data in registration dossiers of new originator drugs Almaty Document Number: 2105924 Version: 1 In this Issue: Kazakhstan now ensures protection of proprietary data in registration dossiers of new originator drugs Legal Alert 5 November 2015 Kazakhstan now protects proprietary data for new originator drugs On 27 October 2015 Kazakhstan adopted amendments to certain laws in order to bring national legislation into line with the agreements of the World Trade Organization (the "WTO").1 The amendments coming into effect on 9 November 2015 also cover the regulation of the pharmaceutical market. The code On People's Health and the Health Care System2 (the "Code") has been amended to include provisions that protect the exclusive right of manufacturers of originator drugs to use their research data, which is contained in the relevant registration dossier, for commercial purposes within a specific period after the registration date ("data exclusivity"). Specifically, there will be a six-year ban on the disclosure and third parties' use (for commercial purposes) of data in the registration dossiers of drugs containing new chemical substances without the owner's consent. The state expert organization, which is responsible for accepting information on drugs to be examined by experts for the purpose of state registration, will be in charge of protecting the data from disclosure and preventing its unauthorized use. The new regulation essentially means that for the first six years that an originator drug is registered in Kazakhstan an expert organization should not rely on information the manufacturer provided for such drug for approval of any generics based on bioequivalence studies. To register their products in Kazakhstan, generic manufacturers will be required either to obtain the consent of the owner to use originator drug information or to conduct their own clinical studies. 1 Law No. 365-V On Amending Certain Laws of the Republic of Kazakhstan in Connection with Acceding to the World Trade Organization dated 27 October 2015. 2 Code No. 193-IV of the Republic of Kazakhstan On People's Health and the Health Care System dated 18 September 2009. Legal Alert Protection of proprietary data in registration dossiers of new originator drugs | 5 November 2015 Protection of exclusivity, which is a new concept for Kazakhstani law, was introduced to demonstrate the state's commitment to the multilateral negotiations held as part of the WTO accession process. This specific form of protection, which only exists in the pharmaceutical and agricultural chemistry sectors, is based on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), an international agreement adopted in 1994 that forms part of the series of documents that established the WTO. Protection of data exclusivity is additional to patent protection. Such additional protection is needed due to the significant time required to complete the study and registration of medicinal products and is especially important where, by the time an originator drug reaches the market, its patent expires because its term commenced on the patent application filing date, rather than on the market launch date. We note that the Code specifies several circumstances in which the ban on the disclosure and use of information for commercial purposes will not apply. These include: the issuance of a statutory license to a person entitling the use of the drug in accordance with the Patent Law of the Republic of Kazakhstan; the use, manufacture or import of drugs for non-commercial purposes; failure to meet the needs of the population for a particular drug within twelve months of the date of its registration in the Republic of Kazakhstan; emergency situations; and also violations of the competition protection laws. ******** This LEGAL ALERT is issued to inform clients and other interested parties of time sensitive legal developments which may affect or otherwise be of special interest to them. The comments above do not constitute legal advice or opinion and should not be regarded as a substitute for detailed legal advice in individual cases. www.bakermckenzie.com For further information please contact Azamat Kuatbekov, Partner + 7 727 330 0500 [email protected] e.com Alissa Inshakova, Associate +7 727 330 05 00 [email protected] com Baker & McKenzie - CIS, Limited 8th floor, Samal Towers, 97 Zholdasbekov St., Samal-2, Almaty 050051, Republic of Kazakhstan Tel: + 7 727 330 05 00 Fax: + 7 727 258 40 00 [email protected]