Our lawyers have represented in courts of first, appeal and cassation levels, a leading American biotechnology company (“Plaintiff”) focused on development and sale of medicines for cancer and inflammatory diseases, on the issues of the Plaintiff’s right defense through applying the legislative novel (amendments to the legislation were made as a part of Kazakhstan accession to the WTO) - the data exclusivity institute.

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Pharmaceutical Data Exclusivity notion and institute is a legislative novel for the Republic of Kazakhstan (hereinafter – “RK”). The health legislation of RK envisages “data exclusivity” provisions, however, it does not define this particular term. This circumstance plays a prominent role and has significant consequences both for developers and manufacturers of original medicines and for companies manufacturing the generic drugs.

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A new law entitled 'On Amendments to Certain Legislative Acts of the Republic of Kazakhstan on Informatization' (24 November 2015 No. 419-V) was published on 26 November 2015 and made amendments to the law entitled 'On Personal Data and Protection Thereof' (21 May 2013 No. 94-V) (the Personal Data Law).

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The article is part of the Multi-jurisdictional Guide to Establishing a Business worldwide. It gives an overview of the key issues in establishing a business in Kazakhstan.

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