Amendments In Kazakhstan's Medicinal Products Registration System: New Hope For Rights Holders

In January and June 2015 Kazakhstan's legislation was amended in order to protect the interests of developers of new pharmaceuticals and equipment used in healthcare.

Previously, the registration system for medicinal products, medical accessories and medical devices did not provide for the review of the products filed for registration for the presence of protected intellectual property rights. This meant that access to the market for products that violate the rights of patent holders was not adequately prevented. In patent disputes, arguments for permitting the introduction of a medicinal product into circulation in Kazakhstan often prevailed over the protection of the rights to the invention contained in a product.

This issue has been actively discussed for the last 12 months by pharmaceutical companies-developers of new substances and equipment.

As a result of discussions between medical companies and state authorities, the Ministry of Healthcare and Social Development of the Republic of Kazakhstan (hereinafter the "RK MH") has attempted to solve the problem of access to market of products containing protected inventions of third parties.

Rules on State Registration, Reregistration and Amending the Registration Dossier of Medicinal Products, Medical Accessories and Medical Devices 2009 (hereinafter the "Registration Rules") were amended by adding an option to issue a registration certificate for medical products without the right to sell. Medicinal products containing substances protected in the RK may be registered (by a person other than the patent holder) during a patent's validity period, however the sale of those products is possible only after the patent has expired. Currently this option is provided merely...

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