АНАЛІЗ ОСОБЛИВОСТЕЙ ПАТЕНТНО-ІННОВАЦІЙНОЇ СТРАТЕГІЇ ПРИ СТВОРЕННІ ОРФАННИХ ПРЕПАРАТІВ

Анотація

ANALYSIS SPECIAL ASPECTS OF PATENT-INNOVATIVE STRATEGY FOR ORPHAN DRUG CREATION

E.V. Litvinova

National pharmaceutical university, Kharkov

Summary: It was analyzed issues related to the creation, funding, use of orphan drugs and their cost. It was characterized legal norms of foreign regulators to develop drugs for treatment rare diseases. It was demonstrated that the state support, patents and exclusivity of clinical trials are the main approaches to the provision of incentives for innovative biopharmaceutical research and development in the field of orphan drugs. It has established the algorithm of patent innovation strategy for orphan drug creating.Keywords: orphan drugs, patent, innovation, exclusivity, intellectual resources.

Introduction. Currently, the problem of identifying orphan diseases and their treatment is acute and complex issue for most countries, including the Ukraine. It should be noted the lack of information on the prevalence of these diseases, diagnostics limitations, lack of medicines or their high cost. There is the question to pharmaceutical companies that orphan drugs are used by a small number of patients and as a result their production is unprofitable. But according to the report «Orphan Drug Report 2014», share of orphan drugs in total sales of prescription drugs (excluding generics) by 2020 will make up 19.1% (about $176 billion), while the average growth in the period 2014-2020 in monetary terms will reaching amount to 10.5%.

The aim of the work is analysis of patent-innovation strategy of orphan drugs creating.

Methods. Studies were conducted using a database on the Internet: Ukrainian patent office, patent office of the Russian Federation, the European patent office, the US patent office, the Food and drug administration, European Medicines Agency (EMEA), State enterprise “The State Expert Center” of the Ministry of Health of Ukraine.

Results and discussion. It was analyzed issues related to the creation, funding, use of orphan drugs and their cost. It was characterized legal norms of foreign regulators to develop drugs for treatment rare diseases.

Innovation processes regulation abroad to encourage orphan drugs creating has allowed increasing their accessibility and efficiency in Europe, the US, Japan and others.

Ukrainian legal framework has adopted the accelerated and simplified registration procedure of orphan drugs that meets European requirements. The above will increase the number of registered foreign drugs for the treatment of rare diseases in Ukraine. However, the cost of treatment is inaccessible for patients they need state support.

Orphan drugs creating is the most high-tech industry of pharmacy, which is actively developing.  It requires good governance of intellectual resources and the availability of an effective system of patent protection. The main objects for orphan drug patenting are active pharmaceutical ingredients (APIs), pharmaceutical composition, methods of obtaining APIs or pharmaceutical compositions, methods of treatment. Patent and innovative strategy for  orphan drug creating includes: patent portfolio formation for their development in some countries, using of exclusivity regime, state support in conducting their research.

It has established the algorithm of patent innovation strategy for orphan drug creating taking into account public and private support of innovative model development of pharmaceutical industry, special aspects of intellectual property policy.

Conclusions. Therefore, state support, patents and exclusivity of clinical trials are the main approaches to the provision of incentives for innovative biopharmaceutical research and development in the field of orphan drugs.