Patent Linkage as a Legal Tool to Protect Intellectual Property Rights in the Pharmaceutical industry

With the development of the pharmaceutical industry and the invention of new drugs, the protection of intellectual property has become a very significant issue among many pharmaceutical companies. In contrast, the aspect of prompt marketing approval of generic drug causes a big discussion in society as it constitutes a very important social policy of accessibility of drugs. For this reason, the research aims to discuss patent linkage as a special regulatory instrument to accomplish balance between the intellectual property rights on a patented innovative drug and generic drug, its advantages and drawbacks and the possibility of implementation in the Russian Federation. Firstly, a definition of patent linkage is provided with a sort of theoretical analysis of the scheme, then the research demonstrates the comparison of some jurisdictions with the different ways how patent linkage is implemented in legislation (or vice versa). It concludes by analyzing the situation in the Russian Federation and suggesting the ways of implementation of patent linkage and the possible impact on the market for drugs.