Legalmax Law Firm And Kassilgov & Partners Successfully Defended In Court The Rights Of The Original Medicine Manufacturer Applying The 'Data Exclusivity' Institute

Problem description

One of the current problems the pharmaceutical companies (right holders and original medicine manufacturers) face in the Kazakhstan market is a violation of their rights by individual generic drug manufacturers expressed in using by them the confidential data from the original medicine registration dossier in order to obtain marketing authorization for their own generic drugs.

This issue is particularly relevant for pharmaceutical industry leaders, manufacturers of new medicines, which have no patent protection in Kazakhstan or have the expired patents.

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. Our previous article "Data Exclusivity Institute in Kazakhstan and Its Influence on Activity of Pharmaceutical Companies" demonstrates in more detail the specifics of the legal regulation of the data exclusivity.

The essence of the dispute was as follows: in 2016 the Plaintiff registered in Kazakhstan the original medicine with Azacytidine as an active substance, and imported and marketed it in the country. However, in 2017, the Indian generic company ("Defendant") obtained in Kazakhstan a Registration Certificate for a generic drug ("generic") with the international non-proprietary name "Azacytidine" and introduced it into a stream of commerce along with the original medicine. Since according to the Plaintiff that due to the rules on data exclusivity, registration of a generic for original medicine during the data exclusivity six-year period is illegal, in September 2017, the Plaintiff filed a claim to the Specialized Interdistrict Economic Court of Almaty, to:

Recognize the generic registration in the Republic of Kazakhstan as illegal; Recognize the opinion of the Center for Expertise with regard to generic as illegal; Bind upon the Pharmacy Committee to revoke the Registration Certificate for generic. The co-defendants in the case were Defendant, the Center for Expertise and the Pharmacy Committee. The litigation lasted a year and a half and was resolved in March 2019.

Findings of the courts of first and appeal levels

In the previous publication we...