Intellectual Property Protection Policy Research Articles

Comprehensive UHPLC–MS screening methods for the analysis of triazolopyrazine precursor and its genotoxic nitroso-derivative in sitagliptin pharmaceutical formulation

A case study on Sitagliptin drug products and Sitagliptin/Metformin drug products concerning contamination with N-nitrosamines was performed using two newly developed analytical methods for determination of N-nitroso-triazolopyrazine (NTTP; 7-nitroso-3-(trifluoromethyl)–5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine) and its precursor triazolopyrazine (3-(trifluoromethyl)–5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine). The method for determination of triazolopyrazine was previously unpublished, the method for determination of NTTP was published only for analysis of active pharmaceutical ingredient Sitagliptin and not the drug forms. Solving the N-nitrosamine contamination is requested by regulatory authorities all over the world and thus is vital for all pharmaceutical companies. The solution always requires a sensitive analytical method. Both newly developed methods use liquid chromatography coupled with mass spectrometry (single quadrupole analyzer in case of triazolopyrazine and triple quadrupole analyzer in case of NTTP). Separation of triazolopyrazine was achieved on a column Acquity CSH C18 using a mobile phase consisting of aqueous ammonium formate buffered at pH 4.2 and acetonitrile. Detection was performed using positive electrospray and selected ion monitoring at m/z 193. Separation of NTTP was achieved on a column Acquity HSS T3 using a mobile phase consisting of 0.1 % formic acid in water and methanol. Detection was performed using positive electrospray and multiple reaction monitoring at transitions m/z 222.15→42.05 (collision energy 17 eV) and m/z 222.15→192.15 (collision energy 11 eV). Two issues specific to NTTP and triazolopyrazine previously not described in scientific literature were successfully troubleshooted. Spontaneous degradation of Sitagliptin to triazolopyrazine and methyl (R)–3-amino-4-(2,4,5-trifluorophenyl)butanoate was solved by using N,N-dimethylformamide as sample solvent during development of the method for quantitation of triazolopyrazine. A bad peak shape of NTTP due to the presence of rotamers of NTTP was successfully troubleshooted by increasing column temperature. Both methods were used during an optimization study of manufacturing of Sitagliptin and Sitagliptin/Metformin drug products. The goal of the study was to decrease NTTP content in the final drug product under the strict legislative limit set by Federal Drug Agency. The efficacy of several solutions was proven, but could not be fully disclosed due to Intellectual Property Protection policy of Zentiva. Instead, a brief review of recently published strategies to cope with N-nitrosamine contamination is presented.

The Impact of R&D Subsidy and IPP on Global Supply Chain Networks System—A Technology Spillover Perspective

In the current globalized business environment, multinational competition has become the norm for companies. This paper considers technology spillovers among manufacturers and develops a global supply chain network equilibrium model. Firstly, the optimal decision-making behaviors of manufacturers, retailers, and demand markets are characterized separately. Secondly, based on the variational inequality theory, the optimal decision-making behaviors of global supply chain members are transformed. Finally, the model is solved and analyzed using the Euler algorithm. The primary objective is to explore the impact of research and development (R&D) subsidies and intellectual property protection (IPP) strategies on manufacturers’ research and development technological levels. Furthermore, the study delves into their effects on the production and transactions of the global supply chain network and social welfare. The following conclusions are drawn: (1) Technology spillovers have a positive effect on the technological level achieved by manufacturers through research and development investment and social welfare. However, intense technological competition may harm manufacturers’ profits. (2) Under the symmetric subsidy policy, higher subsidies may lead to a decrease in social welfare. (3) Under symmetric intellectual property protection policies, increasing the intensity of intellectual property protection benefits manufacturers but is detrimental to retailers and social welfare. However, under an asymmetric intellectual property protection strategy, implementing high-intensity intellectual property protection by high-technology countries is advantageous for retailers and social welfare. This conclusion has contributed to the technical research and development and production operation decision making of global supply chain members, as well as government policy formulation, and has also provided a new perspective for theoretical research in the field of global supply networks.

Налоговые инструменты стимулирования инноваций в странах ЕС

Solow–Swann’s neoclassical theory of economic growth shows that without technological progress, capital accumulation can only lead to a short-term increase in the growth rate of output per capita. The challenges of sustainable innovative development in many countries are coming to the fore today. The creation, dissemination and use of innovations occur in companies, universities, scientific organizations (micro-level), between economic entities within the framework of regional (meso-level) and national (macro-level) innovation systems, as well as at the international level. Innovation support is carried out at the meso-level, focuses on companies and organizations, and is evaluated at the level of the country as a whole. State support for innovation is necessary for the following reasons: 1) the ease of information transfer puts manufacturing companies in a less favorable position compared to consumer companies; 2) the difficulty of obtaining a loan for R&D with the risk of information leakage and lack of confidence in the final results; 3) the socio-economic system of the country receives more benefits from innovation than all companies in the aggregate. The article discusses such types of support as government subsidies and grants, tax incentives, measures for the development of human capital in an innovative environment, competition and intellectual property protection policy. In the international practice of stimulating innovation, tax incentives are used, 1) allowing to reduce R&D costs, 2) based on non-reduction of R&D expenditures and 3) preferential tax regimes derived from innovation activities. It is shown that the methodological approaches used to assess the effectiveness of tax measures are the B-index (calculated and published by the OECD by country), the analysis of the validity of tax instruments and the use of the European Tax Analyzer model – computer modeling. The analysis of innovative development showed that the European Union in terms of the number of patents, residents and non-residents, the share of researchers in the total population and the share of R&D expenditures in GDP for 2000–2022 is often inferior to China, the USA, Japan and Korea, but generally has a positive development trend. The most popular tools in the European Union countries are tax deductions, “super deductions”, R&D grants and other incentives. There is no direct correlation between the number of benefits and the level of innovation development. At the same time, it is noticeable that countries using a large number of support tools are becoming attractive to innovative companies and entrepreneurs. The article analyzes the measures of state support for R&D during the COVID‑19 pandemic. Of these, the most relevant are grants and subsidies, and tax benefits. The analysis of tax instruments for stimulating innovation carried out in the article may be useful in the implementation of appropriate policies in other countries.

Effect Evaluation of Scientific and Technological Achievements Transformation Policy Mix: Evidence from China's Provincial Panel Data

Nations and regions are increasingly focusing on the transformation of scientific and technological (S&T) achievements. To accomplish this, they look for reasonable paths for policy optimization, and improve the efficiency of transformation. Replying on the panel data of thirty-one provinces in mainland China from 2010 to 2019, this study uses the panel fixed-effects model to analyze the effects of R&D subsidies, intermediary services, intellectual property protection policy tools and their interaction terms on the transformation efficiency of S&T achievements. All results indicate that the interaction between the two policy tools can enhance the efficiency of such transformations. The interaction between R&D subsidy and intermediary service is the strongest, which is the most effective tool combination; the interaction between R&D subsidy and intellectual property protection, the interaction between intermediary services and intellectual property protection, have relatively weak impact on transformation. The combination effect of policy tools will vary depending on the regional innovation capability level. Therefore, it is necessary to tailor the policy mix pattern to suit local conditions.

A study of intellectual property protection policies and innovation in the Indian pharmaceutical industry and beyond

We study the relationship between Trade Related Intellectual Property rights (TRIPS) and innovation. Using export data, this paper aims at assessing the relative impact of TRIPs on innovation, namely the ability of the Indian pharmaceutical industry to enter new markets with existing or new drugs. It examines whether India’s decision to comply with TRIPS influenced its innovation, and develops a theoretical model, where innovation, being measured by the likelihood of exports of one product from one identified country to partner countries, is influenced by factor, demand and trade conditions. The paper draws on quantitative data, using Probit and Logit techniques. The model is illustrated using empirical evidence from the Indian pharmaceutical industry. We find statistically significant evidence that India’s compliance with TRIPS is associated with new trade flows from India to partners. However we do not find statistically significant evidence of a relation between TRIPS compliance and value of exports. The interpretation is that TRIPS compliance has different effects: it is a necessary condition to favor innovation but it is not sufficient to increase exports value (competitiveness). Finally, we study to what extent this model can be generalized to other developing countries and/or industries.

Disentangling the role of universities in academia-industry partnerships success

Why are some universities capable of obtaining better results from the interactions with firms than others? So far, literature in university-industry cooperation (UIC) has answered this question by studying the role of technology transfer offices, incentive and intellectual property protection policies and some organizational features. In this paper we present a systemic framework that explains how universities should organize to outperform their competitors in knowledge exploitation. Our core idea is that the success of universities in collaborative agreements with non-academic organizations, in addition to environmental and individual characteristics, stems from the interaction of four organizational factors, namely, support mechanisms (structures and policies), strategic orientation, management abilities and culture.

From Thalland's Legislative Protection

In recent years, the problems about the protection of intellectual property rights on the traditional medicine has got attentions around the world. Among them, Thailand explored a set of national legislations to protect the intellectual property right about the traditional medicine knowledge, which is very instructive to the developing countries. On the basis of summing up the Thailand traditional medicine intellectual property protection policy, the thesis proposed ideas on the protection of the traditional medicine in China. Key words: Thailand: The law of the knowledge protection and Promotion about Thai traditional medicine: Thetraditional Chinese medicine; Protection of the intellectual property rights.

Welfare Impacts of Cross‐Country Spillovers in Agricultural Research

AbstractThe welfare implications of intellectual property protection (IPP) for private sector agricultural research are analyzed, focusing on the realistic cases where countries provide different IPP levels, technology spills over across countries, and the public sector is involved in research. A model is developed to determine who benefits from, and who should pay for, the associated research. The article contains some interesting results on the implications of a harmonization of IPP policies through multilateral agreements or via technology that allows research firms to prevent the copying of plants and animals that express traits that have emerged from their research.

Strengthening the Technology Transfer Framework in Developing Countries

An internship programme on intellectual property and the management thereof was designed and conducted at Michigan State University for representatives from developing countries. Eleven participants from eight developing countries attended the two-week programme. In addition to classroom work, the interns visited several university technology transfer offices and attended the annual meeting of the Association of University Technology Managers. As a result of the programme, interns are having a positive impact on individuals, institutions, and governments by developing educational programmes and by providing advice in the development of new intellectual property protection policies and laws. Due to its success, planning is underway to conduct the internship programme again during 1997.

Intellectual property protection policy and technology capability

Intellectual property protection policy and technology capability