scholarly journals Patents as a Spur to Subsequent Innovation? Evidence from Pharmaceuticals

2016 ◽  
Vol 8 (4) ◽  
pp. 189-221 ◽  
Author(s):  
Duncan S. Gilchrist
Keyword(s):  
Development Process ◽  
Patent Protection ◽  
Market Exclusivity ◽  
Generic Entry ◽  
One Year ◽  
Clinical Advances

This paper examines how an incumbent's patent protection acts as an implicit subsidy toward non-infringing substitutes. I analyze whether classes of pharmaceuticals whose first entrant has a longer period of market exclusivity (time between approval and generic entry) see more subsequent entry. Instrumenting for exclusivity using plausibly exogenous delays in the development process, I find that a one-year increase in the first entrant's market exclusivity increases subsequent entry by 0.2 drugs. The effect is stronger for subsequent entrants that are lesser clinical advances, suggesting it is driven primarily by imitation. (JEL K11, L65, O31, O34)

scholarly journals Patents, Data Exclusivity, and the Development of New Drugs

2020 ◽  
pp. 1-49
Author(s):  
Fabian Gaessler ◽  
Stefan Wagner
Keyword(s):  
Drug Development ◽  
Development Process ◽  
Patent Protection ◽  
Sole Source ◽  
New Drugs ◽  
Market Exclusivity ◽  
Pharmaceutical Firms ◽  
Data Exclusivity ◽  
One Year ◽  
And Shifts

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.

scholarly journals ANALISIS FAKTOR-FAKTOR YANG MEMPENGARUHI INVESTASI DALAM NEGERI DI JAWA TENGAH TAHUN 1980-2002

2007 ◽  
Vol 8 (1) ◽  
pp. 62
Author(s):  
Eni Setyowati ◽  
Siti Fatimah NH
Keyword(s):  
Economic Development ◽  
Development Process ◽  
Research Model ◽  
Domestic Investment ◽  
Correction Model ◽  
Central Java ◽  
Long Run ◽  
Short Run ◽  
Research Benefit ◽  
One Year

Investment is one of important component for sustainable economic development process. The research objective that want achieved is to estimate influence of labour, inflation, PDRB, and interest rate to domestic investment (PMDN) in Central Java. The research benefit was to clarify factors that influenced domestic investment and gave insight and input for local government in formulating economy policy.One of method for analysing long-run and short run influence was by using dynamic model. In this research, model which applied was ENGLE GRANGER ERROR CORRECTION MODEL (EG-ECM) based on granger representation theoremResult of this research indicated that domestic investment one year ago was variable which influenced significantly in short run while rate of interest influenced in long run.

Developing a Homegrown Course Management System

2006 ◽  
pp. 154-170
Author(s):  
Brian G. Mackie ◽  
Norbert L. Ziemer ◽  
Nancy L. Russo ◽  
Wayne E. Mackie
Keyword(s):  
Management System ◽  
Development Process ◽  
Critical Issue ◽  
Course Management Systems ◽  
Course Management ◽  
Student Centered ◽  
Working Together ◽  
Process Perspective ◽  
One Year ◽  
Interaction Management

This case describes the development of a unique, student-centered, online course management systems (OCMS). The system grew from a fairly straightforward grade reporting system into a full-blown collaborative system within a short — in traditional information systems development terms — timeframe of approximately one year. The Community/course Action/interaction Management System, known as CAMS©, was developed iteratively with specifications derived from faculty and students working together to address the limitations of existing OCMS and to identify new functions and features that would contribute to the value of the educational experience. To address the most critical issue identified — limited interactive functionality — the participant became the focus of the development process. This case describes the evolution of CAMS© from both a product and a process perspective. Changes made to the system and the factors motivating the changes are discussed, as are challenges faced before, during, and after the development process.

Patent issues and future trends in drug development

10.5912/jcb42 ◽  
1969 ◽  
Vol 9 (4) ◽  
Author(s):  
Faiz Kermani ◽  
Pietro Bonacossa
Keyword(s):  
Drug Development ◽  
Development Process ◽  
Trade Agreements ◽  
Pharmaceutical Companies ◽  
Future Trends ◽  
Patient Access ◽  
Market Exclusivity ◽  
Political Issues ◽  
International Trade Agreements ◽  
Industrial Sectors

The global biopharmaceutical industry has been one of the most productive and profitable industrial sectors; however, the drug development process remains risky and expensive, with no guarantees of success. The industry believes that a system for the effective intellectual property protection is key to its ability to maintain innovation for drug development. But some critics think that the market exclusivity offered by patents simply allows companies to maximise profits without benefiting patients.Social issues such as patient access to new AIDS treatments and political issues such as international trade agreements mean that the manner in which pharmaceutical companies operate at a business level is becoming subject to closer scrutiny.

scholarly journals ONE-YEAR PREMIUM RISK AND EMERGENCE PATTERN OF ULTIMATE LOSS BASED ON CONDITIONAL DISTRIBUTION

2020 ◽  
Vol 50 (2) ◽  
pp. 479-511
Author(s):  
Łukasz Delong ◽  
Marcin Szatkowski
Keyword(s):  
Linear Relation ◽  
Conditional Distribution ◽  
Development Process ◽  
Multivariate Distribution ◽  
Arbitrary Distribution ◽  
Emergence Pattern ◽  
Development Models ◽  
One Year ◽  
The One ◽  
Premium Risk

AbstractWe study the relation between one-year premium risk and ultimate premium risk. In practice, the one-year risk is sometimes related to the ultimate risk by using a so-called emergence pattern formula which postulates a linear relation between both risks. We define the true emergence pattern of the ultimate loss for the one-year premium risk based on a conditional distribution of the ultimate loss derived from a multivariate distribution of the claims development process. We investigate three models commonly used in claims reserving and prove that the true emergence pattern formulas are different from the linear emergence pattern formula used in practice. We show that the one-year risk, when measured by VaR, can be under and overestimated if the linear emergence pattern formula is applied. We present two modifications of the linear emergence pattern formula. These modifications allow us to go beyond the claims development models investigated in the first part and work with an arbitrary distribution of the ultimate loss.

scholarly journals Inequality, Injustice and India’s Forgotten People

2019 ◽  
pp. 1-11
Author(s):  
Jeetesh Rai ◽  
Smriti Soni
Keyword(s):  
Development Process ◽  
Annual Report ◽  
Developmental Process ◽  
Significant Decline ◽  
Global Inequality ◽  
The Media ◽  
Comprehensive Manner ◽  
One Year ◽  
Official Data ◽  
Over Time

It is the Boston Consulting Group’s 15th annual report called ‘Winning the Growth Game: Global Wealth 2015’ that has been extensively reported by the media persons in India. This report came just one year after the Global Wealth Databook 2014 from Credit Suisse wherein the picture of global inequality is presented in a more accurate and comprehensive manner. It is undisputed that over time there has been a significant decline in poverty in India. However, the same is not true about inequality. Has inequality declined with the same rate as the decline in poverty in India? As per the official data collected on all parameters of development in India the tribals are straggling way behind in terms of income, health, education, nutrition, infrastructure and governance. Tribals in India have been the receivers of injustices throughout the process of development. To exemplify, among 65 to 70 million people displaced during the development process in India 40 per cent are tribals. In India, more than 90 per cent of total coal and above 50 per cent of minerals and dams are located in the tribal regions, yet these areas have remained the least developed. In paradox to economic theory, many developed districts in India include pockets of intense backwardness. The paper argues that in India the tribals have remained excluded from the list of beneficiaries in the development process. The paper also discusses the process of marginalization of tribal in the developmental process and towards the end gives some recommendations.

The Utilization of Medicines beyond Patent Expiration

2008 ◽  
Vol 11 (2) ◽  
Author(s):  
Edward C Mansley ◽  
Steven M Teutsch ◽  
Dawn M White ◽  
Jamie D Busza ◽  
Steven S Geisel
Keyword(s):  
Patent Protection ◽  
Generic Competition ◽  
Over The Counter ◽  
Patent Expiration ◽  
Long Run ◽  
Before And After ◽  
High Utilization ◽  
One Year ◽  
Relative Utilization

BACKGROUND: The utilization of a medicine, both before and after patent expiration, is one of the key determinants of its long-run value to society, as consumer and producer surplus accumulate as utilization occurs. However, while utilization during the years of patent protection is followed fairly closely, usage after that is generally not, as multiple manufacturers are usually involved in the production and sale of generic alternatives. Since utilization beyond patent expiration is poorly understood, we selected a random sample of 60 drugs and assessed their long-term, post-patent use during the period of generic competition.METHODS: At five-year intervals beginning with the year generic competition began (YGCB), we estimated the U.S. utilization of each drug (including all generic and branded formulations) based on the number of prescriptions dispensed as projected by the National Prescription Audit™ (1964 to 2006) conducted by IMS™. These estimates were then compared to each medicine's baseline utilization, defined as the drug's usage during the last full year of patent protection – one year prior to the year generic competition began (YGCB-1). The absolute utilization levels were converted into relative utilization levels, whereby a measure of 1.0 indicates that utilization in that year was equal to utilization in the baseline year.RESULTS: Many drugs continued to be prescribed long after patent protection ended. Even after excluding one medicine that had unusually high utilization 15 to 30 years after generic competition began, relative utilization averaged between 0.64 and 0.99 for the 5-year intervals starting with YGCB+5 and ending with YGCB+30. This was true even though several of the medicines were available over-the-counter (OTC) during some of those years and we did not have data reflecting OTC utilization. After excluding those OTC years (to focus on medicines that had more complete data), relative utilization averaged between 0.88 and 1.15.CONCLUSION: Many medicines continue to be used far beyond their period of patent protection, somewhat countering the view that newer drugs quickly replace older ones. This extended, post-patent utilization can yield additional surplus for society that is over and above the surplus generated during the period of patent protection.

A Brief History of Storytelling

2019 ◽  
pp. 1-14 ◽  
Author(s):  
Recep Yılmaz ◽  
Fatih Mehmet Ciğerci
Keyword(s):  
North America ◽  
South America ◽  
Digital Media ◽  
Development Process ◽  
Digital Storytelling ◽  
Digital Era ◽  
The World ◽  
History Of ◽  
New Form ◽  
One Year

The aim of this chapter is to examine the history of storytelling. This brief history includes the concept of storytelling from myths to the digital era. In the first part of the chapter, the origins of storytelling in primitive communities and its development in later periods are examined. In the second part of the chapter, the development process of digital storytelling is explained. According to this, traditional storytelling has gained a new form called digital storytelling which started with a workshop in 1993 by Dana Atchley. One year later, the Center for Digital Storytelling (CDS) was established in Berkley, CA. The Center for Digital Storytelling has organized workshops and partnered with organizations around the world to hold projects on story facilitation, digital storytelling and other forms of digital media production and since 1993, it has helped more than 20,000 people to share their own stories. Though the digital storytelling movement started in North America, it has also spread in Europe, Australia, Asia, Africa and South America. The movement has found a place in the world of today.

Transferrable Market Exclusivity Extensions to Promote Antibiotic Development: An Economic Analysis

2019 ◽  
Vol 71 (7) ◽  
pp. 1671-1675 ◽  
Author(s):  
Benjamin N Rome ◽  
Aaron S Kesselheim
Keyword(s):  
Fast Track ◽  
Multidrug Resistant ◽  
Market Exclusivity ◽  
Antimicrobial Drugs ◽  
Public And Private ◽  
Societal Costs ◽  
Generic Entry ◽  
Antibiotic Development ◽  
Multidrug Resistant Organisms ◽  
Novel Antibiotics

Abstract Background To address the growing threat of multidrug-resistant organisms, policymakers are seeking ideas to promote development of novel antibiotics. In 2018, the REVAMP Act was proposed in Congress to reward manufacturers of certain novel antibiotics with transferrable market exclusivity vouchers. Methods We estimated the economic impact of this proposal by identifying antimicrobial drugs approved by the FDA from 2007–2016 that would likely have qualified for an exclusivity voucher and matching each drug to the highest-revenue fast-track drug facing generic entry within 4 years after the antibiotic was approved. Assuming a spending decrease of 75% after generic entry, we calculated the per-drug and total societal costs of these transferrable market exclusivity extensions over a decade. Results We identified 10 antimicrobials that would have qualified for an exclusivity voucher, each of which was matched with 1 of 17 fast-track drugs facing generic entry through July 2019. These 10 drugs had a median annual revenue before generic entry of $249 million (range, $26 million–$2.7 billion). Accounting for a 75% spending reduction after generic entry, the median excess spending associated with 12 months of extended exclusivity was $187 million, for a total of $4.5 billion over 10 years. Conclusions While market exclusivity extensions are a politically appealing mechanism to encourage novel antibiotic development, this approach would cost public and private payers billions of dollars over the next decade.

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