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The relationship between patents and the pharmaceutical industry is both complex and important. While many believe that patents are manipulated by the pharmaceutical industry for its own economic ends, a historical approach to the utilization of patents combined with an analysis of current patent issues places this relationship in its proper context. Though patents were created long before the pharmaceutical industry reached its current status as a major industry in the United States, a historical, analytic approach shows that the pharmaceutical industry has adjusted to constantly evolving legislation enacted to provide the most effective and efficient system by which to research, invent, regulate and patent new medicines.

This chapter examines the role of pharmaceutical patents in the on-going support of pharmaceutical innovation. The social value of pharmaceutical innovation and the importance of its sustained growth are explained. The government buy-outs of patents to reduce drug prices for all American consumers while preserving vital drug innovation are proposed.

The World Health Organization estimated that in 1999 roughly one-third of the world's population lacked access to essential medicines that would have saved or improved their lives. Our analysis focuses on how pharmaceutical product patents restrict access to essential medicines in developing countries. It is well established that pharmaceutical product patents provide little incentive for pharmaceutical companies to develop new medicines designed to treat diseases prevalent in developing countries or to market in developing countries those patented medicines developed to treat diseases prevalent in developed countries. Economists have developed theoretical models showing that these incentives could be changed if (1) developing countries provided intellectual property protection for new pharmaceutical innovations and (2) an international regulatory framework were established to facilitate pharmaceutical companies setting lower prices in developing countries and higher prices in developed countries for patented medicines. We develop an index of property rights in pharmaceutical innovations covering 129 countries from 1960 to 2005. It shows that in 1960 only a handful of countries provided significant protection for pharmaceutical innovations, but by 2005 over 95 percent of countries in our sample provided significant statutory protections. However, an international framework to allow pharmaceutical companies to price discriminate has not been put in place. We conclude that international price discrimination mechanisms, compulsory patent licenses, and regional patent buyouts are not viable mechanisms for providing access to essential medicines to patients in developing countries. Global patent buyouts are more likely to achieve this goal, as they are not founded on an impractical separation of pharmaceutical markets in developing and developed countries and they provide critical incentives to develop new essential medicines.

The paper aims to study how global pharmaceutical companies such as Pfizer have managed the challenges of pharmaceutical patent expiry.

A case study method was applied. The best-selling brand drug over the past 10 years – Lipitor – was chosen as the case target.

For dealing with this, this paper describes all the details of the corresponding strategies of Pfizer before and after patent expiration of Lipitor. Before patent expiry, Pfizer undertook the activities of direct-to-consumer marketing, pricing strategy for competition, legal delay and me-too drug R&D. After patent expiry, Pfizer chose to carry out continuous marketing for brand, rebate strategy, authorized generics and change to over-the-counter. In addition, diversity and globalization strategy was applied before and after patent expiry.

This research provides strong implication for managing pharmaceutical products before and after patent expiry.

It is strongly recommended for both brand and generic drug companies to design strategies to meet the challenges of pharmaceutical patent expiry.

For the global pharmaceutical market, a conclusion can be drawn that, nowadays, the “patent cliff” is the most significant factor influencing decision-makers to consider futuristic policies. Further, it is also a considerably effective solution for reducing health-care costs for policymakers.

This paper contributes to the field of patent expiry management in high-tech industries such as pharmaceuticals.

This paper aims to analyse the impacts of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) as adopted by the World Trade Organization (WTO) on the pharmaceutical regulation and pricing of drugs in Bangladesh. The purpose of this paper is to explore how Bangladesh could adjust obligations for patent and pharmaceutical law reforms in the context of TRIPS Agreement while maintaining societal goals to ensure access to medicines. Another prime objective of this study is to examine viability of arguments regarding pharmaceutical patents for affordability and accessibility of pharmaceuticals in Bangladesh.

This paper used doctrinal research and case study using surveys and interviews in Bangladesh to understand the perceptions of different stakeholders regarding TRIPS and possible impacts on the local pharmaceutical industry and also consequences as to access to pharmaceuticals in terms of pricing, availability and affordability.

This study suggests that in the case of Bangladesh, the main health bottleneck is not patents or any drugs, but the lack of proper healthcare service, health infrastructure and lack of efficient healthcare personnel. Again, most of the necessary drugs for the local market are off patent, but patented drugs, issues of price, availability and affordability could become a concern for Bangladesh in situation of multi-drug resistance and for diseases like HIV AIDS, cancer and cardio-vascular problems.

This study was based on randomly selected interview and surveys. To get a broader picture of the impacts of TRIPS compliant patent law and pharmaceutical patents in a country like Bangladesh, more in-depth socio-legal studies need to be conducted. Due to shortage of time and resources, it was not possible to conduct broader socio-legal studies; therefore, this study may not reflect views of all related stakeholders.

This paper will guide how countries like Bangladesh could adopt intellectual property policies for pharmaceuticals in a way not only adjusting societal goals for accessibility and affordability of pharmaceuticals but also promoting innovation and capability of local industries.

Countries like Bangladesh should adopt intellectual property policies balancing not only investment and innovation side but also societal goals to ensure access to medicines for the vast majority of poor populations.

This study is an original study based on primary sources as collected during field studies in Bangladesh. It also used doctrinal research, and related materials are duly referred.

The purpose of this paper is to value the patents of pharmaceutical companies using discounted cash flows, and compare the value-relevance of these assets against alternative intangible asset measures such as reported intangible assets and R & D capital.

The study values pharmaceutical intangibles using three methods: an income method; the sum of unamortised R & D expenditures; the firm’s reported intangible assets. Value-relevance tests use ordinary least squares regression and Vuong and Clarke tests.

First, the study finds that the discounted cash-flow valuation of pharmaceutical patents is value-relevant. Second, the value of pharmaceutical patents explains market value better than reported intangible assets but not R & D capital. However, the valuation of pharmaceutical patents is more consistent with the risks of R & D than the valuation of R & D capital which assumes recovery of R & D expenditure.

This is the first known study that values patents using an income method and compares those valuations with reported intangible assets and R & D capital valuation models.

The purpose of this paper is to use a dynamic model of optimal patent design and, in the presence of information externalities, to study the evolution of technological progress in the context of a pharmaceutical industry.

A theoretical analysis approach is adopted to drive the paper’s findings.

Pharmaceutical firms with an active drug discovery program behave strategically in their R&D and in the product markets. It is shown that a firm holding an earlier-expiring patent only chooses to proceed with R&D activates when the patent it holds expires if the expected discounted payoff net of R&D costs yielded by this action is positive. The expected discounted payoff net of R&D costs obtained by this firm is then decreasing in R&D costs, increasing in the cumulative quality discovered in the past R&D activates, and decreasing in the number of past R&D activities, etc.

The preceding literature on the topic works with only one brand, the brand with the highest quality. As well, the demand is assumed to be completely inelastic. In the conventional models of patent design, the role of competitive fringe firms is discussed implicitly. The model presented in this research is a rigorous continuous in-time dynamic model. It considers several differentiated products. Furthermore, the demand for a brand is taken to be a function of income, its price, and the prices of other brands. The interaction of the fringe firm with other patent-holding firms is also explicitly considered under this framework.

The pharmaceutical industry is characterized by high R&D costs and increasing competition. New pharmaceutical products are often provided patent protection to help companies recoup their R&D costs. The end of this period of market exclusivity is a challenging period for these companies. Marketers need to develop creative product, promotional, and pricing strategies for those products nearing patent expiration. First, provides an overview to the history of drug patents. Second, discusses with recommendations the strategies commonly adopted by companies with products facing patent expiration.

The purpose of this paper, focusing mainly on India – and a lesser extent on China – is to examine, broadly, two related issues concerning the rise of pharmaceutical industry in the emerging economies: the strategic response of the emerging‐country pharmaceutical firms to the new patent regime that recognizes and enforces product patents; and its implications for multinational enterprise (MNE) strategies.

The paper is based on extensive review of the relevant conceptual and empirical literature and secondary data.

The strategic response of pharmaceutical firms in the emerging economies (India and China, for example,) to the new patent regime is to develop multiple competencies and position themselves to simultaneously compete and collaborate globally with the MNEs – large firms rapidly moving towards discovery and development of new drugs, and medium and small firms engaged in the production of off‐patent generics and contract manufacturing, respectively.

The trend towards greater collaboration between the emerging‐country firms and the MNEs in the new patent regime raises serious concern about prescription drug prices in the developing as well as developed countries. Given the importance of the pharma industry to the health of nations, firms in rich and poor countries alike will continue to come under public pressure to develop and market the needed drugs at affordable prices.

The paper would be of value to practitioners and scholars interested in the implications – for MNE pricing, outsourcing and R&D strategies, for example – of the rapid rise of pharmaceutical industry in the developing countries such as India and China.

Many people in developing countries are suffering from serious diseases, such as HIV and tuberculosis. On the other hand, drug patents impact the availability of the drug for patients. Pharmaceutical technology transfer is widely used by domestic and foreign pharmaceutical enterprises because it promotes the availability of the drug for patients. The purpose of this paper, which is on drug technology transfer, is mainly to discuss how to solve the conflict between drug patent protection and public health from the perspective of the law, but not from the perspective of economics. To fill this gap, the authors introduce a model in the prescription drug market and analyze how a foreign manufacturer that produces brand name drugs authorizes a domestic enterprise that produces common drugs.

In this paper, the authors consider a situation that if the patent holders are provided a certain amount of compensation, then whether compulsory licensing would be an effective tool to promote competition and improve the availability of drugs. Furthermore, they also consider three different cooperation mechanisms, namely, fixed-fee contract, royalty contract and two-part tariff contract, under the case of technology transfer and give the condition of which contract would be better under different scenarios.

It is found that the product differentiation and the agent behavior of doctor in the domestic market have a deep impact on the foreign enterprise’s decision on technology transfer. If both fixed-fee contract and royalty contract are permitted, foreign enterprise will choose different transfer contracts under different conditions. Under two-part tariff contract, it is equivalent to a fixed-fee or royalty contract under certain conditions. Furthermore, all contracts can improve patients’ benefits, while the royalty contract and the two-part tariff contract would reduce importer’s social welfare under certain conditions.

Prescription drugs can treat many acute diseases and improve people’s quality of life. On the other hand, it requires investment in pharmaceutical research and development and is hard to afford the drug for the people living in poverty. This paper tries to solve the problem by introducing three cooperation contracts. The authors consider an innovative drug company and a regular drug company. The regular drug company can improve the quality of its drug by signing a technology transfer agreement with the innovative company. Three contracts are discussed in this paper; they are fixed-fee contract, royalty contract and two-part tariff contract. The authors examine the impact of different contracts on the companies’ profit, patients’ benefit and social welfare. It is found that quality differentiation of drugs and doctor behaviors can have large impacts on the company’s decision about technology adoption as well as contract choice strategies. In all of the three contracts, patients’ benefit improves, while the profit of the two companies and social welfare can increase or decrease under different contracts.