scholarly journals An Analysis of the Transformation of Mega-Pharma’s Business Model toward the Emerging Market

2020 ◽  
Vol 4 (4) ◽  
pp. 253-262
Author(s):  
Yaeko Mitsumori
Keyword(s):  
Patent Protection ◽  
Business Models ◽  
Emerging Market ◽  
Patent Application ◽  
Pharmaceutical Products ◽  
Patent Law ◽  
Pharmaceutical Market ◽  
Pharmaceutical Companies ◽  
Indian Market ◽  
Application Data

The Trade-Related Aspects of Intellectual Property Rights（TRIPS) requires all member countries of the World Trade Organization (WTO) to introduce a TRIPS-compatible patent law into their countries. Due to the enforcement of TRIPS in 1995, India in 2005 revised its patent law and enacted the Patents (Amendment) Act, 2005. The 2005 ACT included product patent in pharmaceutical field. Due to the new patent law with product patent protection, large foreign capital pharmaceutical companies one after another re-entered the Indian market and started engaging in both R&D and production targeting the Indian market. However recent data shows the number of patent applications has been declining over the past several years and the number of patented drugs launched in India did not increase so rapidly. This study analyzes transitions of business models of foreign pharmaceutical companies in India based on the patent application data, and the trend of patented drugs in the market. A data analysis and a series of interviews with stakeholders were conducted. As a result of both a quantitative and a qualitative analysis, it was found that foreign pharmaceutical companies changed their strategies in the Indian pharmaceutical market. Since India was required to introduce product patents in the pharmaceutical area, there have been many arguments that once India introduces a product patent, the Indian pharmaceutical industry may decline due to the rapid introduction of foreign pharmaceutical products in the country; many academic papers were published in this context during that time. However, since 2005, when product patents were actually introduced in India, few academic papers were published. This study is unique as it discusses the effects of the introduction of product patents on the Indian pharmaceutical market.

Is 'evergreening' a cause for concern? A legal perspective

1969 ◽  
Vol 13 (4) ◽  
Author(s):  
Scott Parker ◽  
Kevin Mooney
Keyword(s):  
Patent Protection ◽  
Cost Effective ◽  
Pharmaceutical Products ◽  
Patent Law ◽  
Patent System ◽  
Pharmaceutical Companies ◽  
Generic Competition ◽  
Legal Perspective ◽  
The Uk ◽  
Weak Patents

A number of fundamental principles (and misconceptions) of patent law and of the system for granting and enforcing patents lie at the heart of the so-called 'evergreening' debate on patent protection for pharmaceutical products. The purpose of this paper is to consider 'evergreening' from a legal perspective and to evaluate the extent to which the patent system operates to safeguard against the claimed abuses. In the authors' view the allegation that pharmaceutical companies have been able to delay substantially the entry of generic competition by 'evergreening' many of their patents simply does not reflect the reality and mischaracterises how the patent system operates in the context of technological innovation. A patent over an improvement does not restrict a generic company from launching a competitor of the originator product and, in the UK at least, the procedure and attitude of the court is conducive to the speedy and cost-effective challenge of 'weak' patents.

scholarly journals THE EVERGREENING STUDY OF UKRAINIAN PHARMACEUTICAL MARKET

2021 ◽  
Author(s):  
Оксана Кашинцева ◽  
Mykyta Trokhymenko
Keyword(s):  
Patent Application ◽  
Pharmaceutical Products ◽  
Patent Law ◽  
Pharmaceutical Market ◽  
Law Reform ◽  
The Novel ◽  
Access To Treatment ◽  
Ukrainian Patent ◽  
Close Cooperation ◽  
The Subject

The article presents the results of the research on the part of «evergreening patents» in the pharmaceutical market of Ukraine focusing on the daft laws registered in the Ukrainian Parliament (Verkhovna Rada) of Ukraine. The authors analyse the criteria of patent abuse as obstacles to access to treatment, and analyse the novel initiatives aimed at overcoming such abuse. In particular, it concerns thepatentability's criteria of inventions on pharmaceutical products, the possibility to oppose the applications on inventions by a person whose rights or interests are violated by a patent application and prohibition of patenting substances as the utility models.At the level of the national legislation patent reform was initiated by the Parliament of Ukraine on the first reading by the draft Law of Ukraine «On Amendments to Certain Legislative Acts of Ukraine (on Patent Law Reform)» as of October 10, 2019.For the national experts, drafting the mentioned Law, the necessity to provide evergreening research in the field of health care was obvious from the 2014. In 2014 year, the National Academy of Law Sciences of Ukraine in close cooperation with NGO 100 % of Life started the global research — Harmonization of Human Rights and Intellectual Property Rights in the Field of Medicine and Pharmacy. We have to stress that only the evergreening patent research in the pharmaceutical market of Ukraine took near three years. The Research reflects that the gaps of the Ukrainian patent system which causes the possibility to grant evergreening patents have the straight impact on access to vital treatment. The methodology of the research is based on the Guidelines on Examination of the Patent Application in the field of Medicine and Pharmaceuticals based on the recommendations of the WHO and Guidelines for the Examination of Patent Applications Relating to Pharmaceuticals of the UNDP.Thus, the subject of the research is 132 patents covering vital medicines in the field of HIV, hepatitis C, tuberculosis, oncology, rheumatoid arthritis and others. The basis for the research is the followings: the patented single-source medicines, the part of which in the centralized procurements exceeded $ 100,000 in 2017 and the medicines that part of which in hospital and pharmacy procurements exceeded 50 million hryvnia (UAH) in 2017. The research also includes the patented medicines which are or which were not available because of the patent status.

The Influence of TRIPS Compliant Patent Laws on Indian Pharmaceutical Industry

2014 ◽  
Vol 4 (1) ◽  
Author(s):  
Rupesh Rastogi ◽  
Virendra Kumar
Keyword(s):  
Pharmaceutical Industry ◽  
Patent Protection ◽  
Uruguay Round ◽  
Pharmaceutical Products ◽  
Trips Agreement ◽  
Patent Law ◽  
Patent Laws ◽  
The Impact ◽  
First Time ◽  
Indian Pharmaceutical Industry

The first legislation in India relating to patents was the Act VI of 1856. The Indian Patents and Design Act, 1911 (Act II of 1911) replaced all the previous Acts. The Act brought patent administration under the management of Controller of Patents for the first time. After Independence, it was felt that the Indian Patents & Designs Act, 1911 was not fulfilling its objective. Various comities were constituted to recommend, framing a patent law which can fulfill the requirement of Indian Industry and people. The Indian Patent Act of 1970 was enacted to achieve the above objectives. The major provisions of the act, provided for process, not the product patents in food, medicines, chemicals with a term of 14 years and 5-7 for chemicals and drugs. The Act enabled Indian citizens to access cheapest medicines in the world and paved a way for exponential growth of Indian Pharmaceutical Industry. TRIPS agreement, which is one of the important results of the Uruguay Round, mandated strong patent protection, especially for pharmaceutical products, thereby allowing the patenting of NCEs, compounds and processes. India is thereby required to meet the minimum standards under the TRIPS Agreement in relation to patents and the pharmaceutical industry. India’s patent legislation must now include provisions for availability of patents for both pharmaceutical products and processes inventions. The present paper examines the impact of change in Indian Patent law on Pharmaceutical Industry.

Which Types of Bioinformatics Inventions Are Eligible for Patent Protection?

2015 ◽  
Vol 21 (2) ◽  
Author(s):  
Trent Ostler ◽  
Michael Gollin
Keyword(s):  
Patent Protection ◽  
Patent Application ◽  
Trade Secret ◽  
General Purpose ◽  
Patent Law ◽  
Step Test ◽  
Copyright Laws ◽  
The Supreme Court ◽  
General Purpose Computer ◽  
Purpose Computer

The field of bioinformatics is flourishing, and strong growth is only projected to continue. Like any cutting edge technology, bioinformatics requires an integrated IP strategy involving patent, trade secret, and copyright laws. The patent system in particular can be a powerful protection for commercializing bioinformatics inventions as long as a corresponding patent application meets certain patent law standards. Recently, the most rapidly evolving of these patent law standards—patent eligibility—came to a crescendo last year when the Supreme Court in Alice v. CLS Bank introduced a two-step test for determining whether computer-implemented inventions are patent-eligible. Since then, other courts and the USPTO have applied the test on inventions implemented on a computer and/or using the Internet with fact-dependent results. Here, we discuss how these decisions relate to bioinformatics inventions. We then analyze bioinformatics patents that have recently issued post-Alice. While the law remains relatively underdeveloped, it becomes clear that relying on a general purpose computer to perform routine or conventional steps in a claim will not infuse patent-eligibility into a claim. However, bioinformatics inventions remain patentable, especially when the patent prosecution team properly and persuasively presents the technical improvements and commercial embodiments.

scholarly journals Correction: Patents, pills and politics: the Australia-United States Free Trade Agreement and the Pharmaceutical Benefits Scheme

2004 ◽  
Vol 28 (3) ◽  
pp. 381
Author(s):  
Ken Harvey
Keyword(s):  
United States ◽  
Developing Countries ◽  
Free Trade ◽  
Free Trade Agreement ◽  
Patent Protection ◽  
Trade Agreement ◽  
Pharmaceutical Products ◽  
Patent Law ◽  
History Of ◽  
Pharmaceutical Benefits Scheme

Re: ?Patents, pills and politics: the Australia? United States Free Trade Agreement and the Pharmaceutical Benefits Scheme?, by Ken Harvey, (Aust Health Rev 2004, vol. 28, no. 2, pp. 218-226). Under the heading ?A brief history of patent law relevant to pharmaceuticals?, in the second paragraph, the second sentence was: ?Before TRIPS, many developing countries provided no patent protection on pharmaceutical products, or they recognised patents on products but not process?. The corrected version should be ?. . .process but not products?.

The importance of the Polish pharmaceutical market for the economy

2019 ◽  
Vol 32 (3) ◽  
Author(s):  
Katarzyna Pogorzelczyk ◽  
Marta Gallas ◽  
Marlena Robakowska ◽  
Przemysław Żuratyński ◽  
Sylwia Jałtuszewska ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Pharmaceutical Industry ◽  
Literature Review ◽  
Research Methods ◽  
National Economy ◽  
Global Economy ◽  
Business Models ◽  
Financial Statements ◽  
Pharmaceutical Market ◽  
Pharmaceutical Companies

The pharmaceutical market is one of the most developed sectors of the global economy at present. The largest pharmaceutical companies flexibly are shaping business models, giving up the consolidation and incorporations for forming diversified organizations concentrated on special fields, restructuring one's research-developmental centres. And so analysis of legislative acts, as well as reports and financial statements of the Polish pharmaceutical industry is a purpose of the work – with the pressure on his development, the production, the sale and planned action with reference to the national economy. Contents and materials, based on which they made following analysis, were based above all on data received directly from pharmacies and pharmaceutical companies. Research methods concentrated on the literature review and an own statistical analysis and descriptive.

scholarly journals MARKETING ASSESSMENT OF DRUGS USED FOR TREATMENT OF ACID-RELATED DISEASES IN BISHKEK

2020 ◽  
Vol 22 (1) ◽  
pp. 67-73
Author(s):  
Elvira Murzabaeva ◽  
◽  
Isabek Ismailov ◽  
Keyword(s):  
Proton Pump Inhibitors ◽  
Proton Pump ◽  
Medical Technology ◽  
Turnover Rate ◽  
Pharmaceutical Products ◽  
Pharmaceutical Market ◽  
Pharmaceutical Companies ◽  
Kyrgyz Republic ◽  
Medical Products ◽  
Colloidal Bismuth

Objective: Marketing assessment of anti-ulcer medicines in pharmacies in Bishkek. Methods: The study was used by data from the Department of Medicines and Medical Technology at the Ministry of Health of the Kyrgyz Republic on the registration of pharmaceutical products in the KR – State Registry of Medicines and Medical Products of 2019, as well as price sheets and invoices of wholesale pharmaceutical companies and retail pharmacies in Bishkek. Results: Depending on the value of the turnover rate (TR), the drugs were divided into three groups: drugs with slow TR (0.5 < К < 1.0); drugs with constant TR (0.26 < К < 0.49); drugs with high TR (0 < К < 0.25). According to the results of studies, proton pump inhibitors and colloidal bismuth-based drugs are high-end drugs of TR. Conclusions: We have determined that the pharmaceutical market in Bishkek demonstrates incomplete saturation of anti-ulcer drugs from the total number of registered medicines. At the same time, the largest part of the range are drugs from the group of proton pump inhibitors. Keywords: Anti-ulcer drugs, proton pump inhibitors, marketing assessment, turnover rate.

scholarly journals Trade Agreements and Pharmaceutical Patent Protection: Implications for the Governance over Pharmaceutical Products in Canada

2012 ◽  
Vol 1 (1) ◽  
Author(s):  
Danalyn Byng
Keyword(s):  
Patent Protection ◽  
Trade Agreements ◽  
Pharmaceutical Products ◽  
Pharmaceutical Market ◽  
Brand Name ◽  
International Trade Agreements ◽  
Pharmaceutical Patent ◽  
Canadian Health ◽  
Brand Name Drugs

This paper was prepared for a course on Canadian health policy. Its purpose is to expose the harmful ramifications of international trade agreements on the pharmaceutical market in Canada and the governance surrounding this market. This paper will explore the various implications that trade agreements have on the affordability of drugs, the strength of intellectual property protection, and the transfer of authority and influence from government to “Big Pharma.” This paper will unravel the reality that trade agreements are not beneficial to the Canadian people looking to access an affordable pharmaceutical market, but rather, act quite contrary to this. Facts will show that trade agreements work to put money into the pockets of large brand-name pharmaceutical companies in the forms of billions of dollars of revenue and profit. This paper will encourage readers to question the feasibility of extending patent legislation for brand-name pharmaceutical products, the increasing role of trade agreements and the pharmaceutical industry in Canada, and the substitutability of brand-name drugs over cheaper generic alternatives.

Relationship between Cross-Border Mergers and Acquisitions and International Trade: The Case of Russian Pharmaceutical Industry

2020 ◽  
pp. 81-94
Author(s):  
Alexandra V. Chugunova ◽  
Olga A. Klochko
Keyword(s):  
International Trade ◽  
Mergers And Acquisitions ◽  
Volume Growth ◽  
Pharmaceutical Products ◽  
Pharmaceutical Companies ◽  
Cross Border ◽  
Export Volume ◽  
Relationship Of ◽  
Geographical Diversification ◽  
The Relationship

This research studies the relationship of cross-border mergers and acquisitions to international trade through the lens of Russian pharmaceutical market. To this aim, the study analyses the woks of foreign economists dedicated to evaluating the link between foreign direct investment and international trade, and the influence of mergers and acquisitions on countries’ export and import flows. The research also presents a correlation analysis between the volume of Russian pharmaceutical exports and imports and cross-border deals performed by foreign pharmaceutical companies in Russia. We characterize these deals and conduct a comparative analysis of the regional structure of Russian pharmaceutical exports and imports as well as of the countries of origin of buyers in cross-border mergers and acquisitions. The results of the analysis indicate a positive relationship between cross-border mergers and acquisitions and Russian pharmaceutical exports, which is reflected in the export volume growth and its geographical diversification. However, it is outlined that particular problems of the industry hinder the amelioration of Russian positions in international exports. Similarly, the relationship between cross-border deals and Russian imports is positive: the major pharmaceutical products supply flow occurs from the countries of origin of buyers in cross-border mergers and acquisitions conducted in the Russian pharmaceutical sector.

Glembotskaya G.T., Eremin S.Yu. Scientific and practical approach to optimizing costs on development and promotion of drugs

2019 ◽  
Vol 2019 (3) ◽  
pp. 47-53
Author(s):  
Галина Глембоцкая ◽  
Galina Glembockaya ◽  
Станислав Еремин ◽  
Stanislav Eremin
Keyword(s):  
Scientific Literature ◽  
Pharmacological Action ◽  
Pharmaceutical Market ◽  
Pharmaceutical Companies ◽  
Strategic Development ◽  
The World ◽  
The Russian Federation ◽  
The Cost ◽  
Further Development ◽  
Registration Phase

In order to identify promising strategic development possibilities for the pharmaceutical industry in the Russian Federation, a pilot study was conducted, which has analyzed the main trends in the development of innovative medicines. As a result of the content analysis of available sources of scientific literature, the characteristics of options used in the world practice for increasing the innovative activity of individual subjects and the pharmaceutical market as a whole are presented. Possible reserves for the further development of the innovative component of the pharmaceutical market within the framework of the concept of personalized medicine according to the P4 principle (predictive - personalized - preventive - participatory) are identified and structured. The results of use by individual pharmaceutical companies of scientifically and practically justified approaches to optimizing the costs of development and promoting drugs are presented. The advantages and real prospects of a generally accepted method to reduce the cost of development by «expanding the pharmacological effect» (label expansion) of already existing drugs with a known safety profile in the world practice are shown. A scientific generalization and structuring of the goals and results of the post-registration phase of clinical trials to expand the pharmacological action of a number of drugs already existed at the market have been carried out.

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