Summary

The pharmaceutical industry is a sector in which patents on original medicines are an integral part. Patent litigation is an exceptional area that also has a direct impact on the availability of medicinal products in society as a whole. Because of the impact of patent litigation, society should have a particular interest in ensuring that parties have effective means of defending their rights in the proceedings, including both enforcing and opposing patents.

The aim of the article is to clarify whether the Estonian system of enforcing and challenging intellectual property rights ensures a procedural balance in disputes between a manufacturer of an originator medicinal product and a manufacturer of a generic medicinal product, both of which aim to market a medicinal product with the same active ingredient. The focus will be on the situations where issues relating to the balance of fundamental rights of the parties in patent litigation arise most acutely. These are remedies to prevent the placing on the market and subsequent commercialisation of a generic medicinal product by a civil court at the request of the patent holder, as provided for in the Code of Civil Procedure. Furthermore, the manufacturer of a generic medicinal product has the possibility to challenge the validity of the patent before the Board of Appeal in accordance with the procedure laid down in the Principles of Legal Regulation of Industrial Property Act and, alternatively, in the event of the initiation of infringement proceedings by the patent holder in a counterclaim.