Legal Aspects of the Balance of Interests: Pharmaceutical Companies Innovators and Generic Manufacturers

The paper deals with the problems of entering the market of generic drugs in the light of protecting the interests of copyright holder-originators. It is emphasized that the main method of protection lies in the area of intellectual rights. The protection of patent rights by companies that are copyright holders of innovative medicines comes out on top. Attention is drawn to issues related to the data exclusivity regime that are especially important in the context of establishing a balance of interests not only between the copyright holders of original medicines and generic manufacturing companies, but also between representatives of the medical community. The paper considers individual rules of special normative legal acts regulating relations related to the circulation of medicines in Russia and abroad. The author draws attention to the fact that there is some terminological ambiguity, which creates difficulties in the implementation of legal regulation. Possible restrictions on the rights of companies that put into circulation generic medicines should act as a certain guarantor in the implementation of the proper legal mechanisms for the protection of the results of intellectual activity in the pharmaceutical sector and contribute to the stimulation of innovation.

Holistic understanding of contemporary ecosystems requires integration of data on domesticated, captive and cultivated organisms

Domestic and captive animals and cultivated plants should be recognised as integral components in contemporary ecosystems. They interact with wild organisms through such mechanisms as hybridization, predation, herbivory, competition and disease transmission and, in many cases, define ecosystem properties. Nevertheless, it is widespread practice for data on domestic, captive and cultivated organisms to be excluded from biodiversity repositories, such as natural history collections. Furthermore, there is a lack of integration of data collected about biodiversity in disciplines, such as agriculture, veterinary science, epidemiology and invasion science. Discipline-specific data are often intentionally excluded from integrative databases in order to maintain the “purity” of data on natural processes. Rather than being beneficial, we argue that this practise of data exclusivity greatly limits the utility of discipline-specific data for applications ranging from agricultural pest management to invasion biology, infectious disease prevention and community ecology. This problem can be resolved by data providers using standards to indicate whether the observed organism is of wild or domestic origin and by integrating their data with other biodiversity data (e.g. in the Global Biodiversity Information Facility). Doing so will enable efforts to integrate the full panorama of biodiversity knowledge across related disciplines to tackle pressing societal questions.

Availability, affordability and drug utilization of biosimilar medicinal products, containing monoclonal antibodies in Bulgaria

The entry of the biological medicinal products (BMPs) in the clinical practice more than 10 years ago raised complex regulatory issues as well as significant pharmacoeconomic concerns, because the costs of treatment is higher than the costs of the conventional products. The “data exclusivity” of BMPs expired and biosimilar medicinal products (BSMPs) are available on the market. The market share of BSMPs is expected to increase gradually and lead to cost reductions of biological treatment. Aim: To analyze the availability, affordability and drug utilization of BSMPs containing monoclonal antibodies in Bulgaria. Materials and methods: Retrospective study of the public data from EMA, National Council on Prices and Reimbursement and National Health Insurance Fund for 2015–2019. Descriptive statistical analysis was performed. Results and Discussion: On the ЕU level, BSMPs with Marketing Authorization are Adalimumab, Infliximab, Rituximab, Bevacizumab and Trastuzumab. In the Bulgarian Positive Drug List, there are 12 BSMPs with the same INN, excluding Bevacizumab. The total cost of BMPs is 691 673 158 BGN – the share of BSMPs is 34 139 639 BGN (4.7%). The access of BSMPs in Bulgaria is still very limited. BSMPs are available with the lower price, but the reference products are the preferred treatment. The reason for this could be the lack of national standards for the switching/interchangeability of BMPs with BSMPs, and the prescribers distrust of the so-called replacement therapies and aggressive drug promotion to the healthcare professionals are also of great importance.

Patents, Data Exclusivity, and the Development of New Drugs

Pharmaceutical firms enjoy market exclusivity for new drugs from concurrent patent protection and exclusivity of the clinical trials data submitted for market approval. Patent invalidation during drug development renders data exclusivity the sole source of protection and shifts the period of market exclusivity. In instrumental variables regressions we quantify the effect of a one-year reduction in expected market exclusivity on the likelihood of drug commercialization. The effect is largely driven by patent invalidations early in the drug development process and by the responses of large originators. We hereby provide estimates of the responsiveness of R&D investments to market exclusivity expectations.

A Comparative Study of Pharmaceutical Incentives to Patents in India, USA and Europe

Background:: Protection of Intellectual Property Rights is a clear incentive to innovations; yet, several countries have provided further incentives to patents in pharmaceuticals because the full patent term of 20 years is largely exhausted, before marketing authorization. Objective:: The purpose of this article is to describe the various incentives to patents in the form of financial support, data exclusivity and most importantly extended market exclusivities and comparison of various incentives to patents in the United States of America, European Union and India. Methodology:: The detail of incentives is collected from various articles, latest topics, books, and newspapers. Result:: These incentives create a positive surrounding to encourage the drug development process, strengthen economic growth and improve a balance between new pharmaceuticals in the market and access of that medicine to general public at a reasonable price. Conclusion:: European Union and the United States of America are leading in the field of incentives to patenting in phar-maceuticals as compared to India. Indian Patent Act, 1970, needs to be re-looked in terms of data exclusivity and patent term extensions.

TRIPS AGREEMENT AND MALAYSIAN INTELLECTUAL PROPERTY LAWS: DATA EXCLUSIVITY v PATENT

This study analyses the provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement with respect to the various intellectual property protection mechanisms. The main purpose of this study is to demonstrate that Malaysia is a TRIPS compliance country and have established intellectual property laws including the incorporation of data exclusivity laws. This study also illustrates that data exclusivity and patent are two different intellectual property protection mechanisms required under the TRIPS Agreement. Moreover, this study clarifies the misconception that data exclusivity and patents are somehow related; such that data exclusivity is an extension of patent rights and that it is often regarded as a TRIPS-plus provision. The study is conducted based on qualitative research, predicated on primary sources such as the TRIPS Agreement and the various laws with respect to intellectual property in Malaysia. It is further supported by secondary sources from journals and information provided on relevant authorities’ websites. The results of the study show that Malaysia is a TRIPS compliance country and that data exclusivity is an intellectual property protection mechanism that is established pursuant to Article 39.3 of the TRIPS Agreement. Hence, this study concludes that member countries of the TRIPS Agreement that have established data exclusivity protection mechanism to protect undisclosed data submitted to their respective authorities for the purpose of marketing approval of pharmaceutical or agricultural chemical products, including Malaysia, are indeed in compliance with the obligation set under Article 39.3 of the TRIPS Agreement.