Protection of patent holders’ rights under a conflict of drug patents

Introduction: Recently, there have appeared new features in the confrontation between the interests of rights holders and society. Nowadays the discussions on whether it is possible to patent generic drugs and provide compulsory licensing in the pharmaceutical industry came to the fore in the field of intellectual property law. Purpose: to define methodological and dogmatic bases for limiting patent monopoly of the rights holder to the extent necessary for society and taking into account the principles of good faith of participants in civil relations and reasonable state intervention into private affairs. Methods: in course of research both general and specific scientific research methods were used, such as dialectical, comparative legal, historical, formal legal and linguistic ones. Results: the article considers problems arising in judicial practice when resolving conflicts of patent rights between a holder of the patent for the reference drug and a holder of the patent for a generic drug. Special attention is given to the concept ‘bioequivalence’ and its relation to the concept ‘equivalent features provided in the independent claim of the patent application’. Conclusions: Russian patent law allows for conflicts between patent rights in general, not only in respect of Eurasian and Russian patents or between patents on original and dependent inventions. At the same time, the mechanism for resolving conflicts of patent rights is only defined in respect of original and dependent inventions. In judicial practice, there has developed a common rule applied if there are two patents on the protected item, based solely on the detection of identical or equivalent features in the patents. A conflict between patent rights arises when the rights to reference and generic drugs have been registered. The presence of equivalent features stated in the independent claim of the patents on reference and generic pharmaceuticals is presumed, as the very fact of the official registration of a generic drug indicates its bioequivalence to the original (reference) drug. If there are two patents with different priority dates, the proper remedy for the exclusive right is to invalidate it under administrative (non-judicial) procedure. Compulsory licensing under Article 1362 of the Civil Code of the Russian Federation is a market mechanism to provide balance between the rights holder and public interest in using the innovation, especially in the pharmaceutical industry, when so called patent monopoly does not encourage but impedes innovative development. The exhaustive list of conditions for the court to issue a compulsory license for the use of a dependent invention is set by the law. An unreasonable expansion of this list or a wider interpretation of such conditions prevents the application of compulsory licensing and promotes abuses by holders of patents for inventions which are used in dependent inventions.