Patent Linkage System And Its Relevance For Generic Drugs Registration In Uzbekistan And Kazakhstan

This articles addresses issues related to the protection of the rights of brand-name drug patent holders in connection with generic drugs registration by other manufacturers.

The way drugs have to make from a laboratory to a pharmacy is known to be very long and, in addition to research activities, involves certain legal procedures such as obtaining patents, registering brands as intellectual property and drug registration with special healthcare and certification bodies.

Fast-growing economies and large population make CIS countries, such as Uzbekistan and Kazakhstan, high-potential emerging markets both for pharmaceutical giants and smaller drug manufacturers.

Most drugs marketed in these countries are either brand-name or generic (i.e. identical to the original formulations).

Having reviewed our efforts in the sphere of patent protection in the pharmaceutical industry over the last years, we conclude that there is a need for certain improvements to the existing laws to protect the rights of holders of patents to brand-name drugs and to create good faith competition among generics manufacturers.

Our understanding of the pressing issues and possible solutions suggested in this article are based on many months of work of an Almaty (Kazakhstan) based task force consisting of Legalmax specialists, representatives of the leading global pharmaceutical companies, our colleagues from international law firms, and patent attorneys. Officials from the Ministry of Justice and the Ministry of Healthcare and Social Development as well as other stakeholders also contributed to the discussion.

The approach to streamlining the marketing of brand-name drugs and generics boils down to the necessity of harmonizing administrative regulations in the area of drugs registration and approval and laws governing registration and protection of intellectual property rights, including, without limitation, patents which are typically hold by developers of innovator drugs.

The term "innovator (brand-name) drugs" means original drugs first developed/manufactured and protected under valid patents, including, without limitation, entitled to legal protection in a certain country. A "generic drug" is, in turn, a non-patented drug identical to the original brand-name one due to the use of the same active pharmaceutical ingredient for which the term of legal protection has expired.

The lack of legal tools and legal provisions prohibiting registration and market launch of...