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 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)

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 SMALL MOLECULES SOLVING BIG PROBLEMS: PRESENT AND FUTURE OF DRUG DISCOVERY

2018 ◽  
Vol 9 (1) ◽  
Author(s):  
Anna Lucia Fallacara ◽  
Iuni Margaret Laura Tris ◽  
Amalia Belfiore ◽  
Maurizio Botta
Keyword(s):  
Drug Discovery ◽  
Drug Development ◽  
Small Molecules ◽  
Rational Design ◽  
Development Process ◽  
New Drugs ◽  
Drug Development Process ◽  
Development Models ◽  
The Past ◽  
The Cost

The Drug development process has undergone a great change over the years. The way, from haphazard discovery of new natural products with a potent biological activity to a rational design of small molecule effective against a selected target, has been long and sprinkled with difficulties. The oldest drug development models are widely perceived as opaque and inefficient, with the cost of research and development continuing to rise even if the production of new drugs remains constant. The present paper, will give an overview of the principles, approaches, processes, and status of drug discovery today with an eye towards the past and the future.

scholarly journals Drug Repurposing: A Review

2021 ◽  
pp. 161-169
Author(s):  
Rani Teksinh Bhagat ◽  
Santosh Ramarao Butle
Keyword(s):  
Drug Development ◽  
Research And Development ◽  
Development Process ◽  
Drug Repositioning ◽  
Drug Repurposing ◽  
New Drugs ◽  
Preclinical Development ◽  
Therapeutic Uses ◽  
Original Application ◽  
Approved Drugs

The drug development is a very time consuming and complex process. Drug development Process is Expensive. Success rate for the new drug development is very small. In recent years, decreases the new drugs development. The powerful tools are developed to support the research and development (R&D) process is essential. The Drug repurposing are helpful for research and development process. The drug re-purposing as an approach finds new therapeutic uses for current candidates or existing candidates or approved drugs, different from its original application. The main aimed of Drug repurposing is to reduce costs and research time investments in Research & Development. It is used for the diagnosis and treatment of various diseases. Repositioning is important over traditional approaches and need for effective therapies. Drug re-purposing identifies new application for already banned or existing drugs from market. In drug design, drug repurposing plays important role, because it helps to preclinical development. It reducing time efforts, expenses and failures in drug discovery process. It is also called as drug repositioning, drug redirecting, drug reprofiling.

Pharmaceutical Development Process

2019 ◽  
pp. 133-157
Author(s):  
Yaashikaa Ponnambalam Ragini
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Drug Development ◽  
Development Process ◽  
Human Life ◽  
Drug Application ◽  
New Drugs ◽  
Pharmaceutical Drug ◽  
Pharmaceutical Development

The most significant attribute of the pharmaceutical industry is its creations and advancements. The innovation of new drugs is necessary for improving the quality of human life and duration. Pharmaceutical drug development is a time-consuming, costly, and crucial process. The essential goal of drug development is to discover a dosage or dosage scale of a drug application that is both efficient in curing the desired disease and safe. Clinical trials including newly developed drugs that are directed in a progression of successive steps called stages to decide the security and efficacy of the new drug moreover the viability against the targeted diseases. There are four phases through which clinical trials are conducted. An investigational item can be assessed in more than one stage all the while in various clinical trials, and some clinical trials may cover two unique stages.

Significant role of chemistry in drug development: a systematic journey from traditional to modern approaches with anti-HIV/AIDS drugs as examples

2021 ◽  
Vol 27 ◽  
Author(s):  
Madhu Yadav ◽  
Ritika Srivastava ◽  
Farha Naaz ◽  
Rajesh Verma ◽  
Ramendra K. Singh
Keyword(s):  
Drug Discovery ◽  
Drug Development ◽  
Development Process ◽  
New Drugs ◽  
Computer Assisted ◽  
Synthetic Chemistry ◽  
Drug Development Process ◽  
Drug Molecules ◽  
Hiv Aids

Background: Traditionally, various plant extracts having interesting biological properties were the main source of new drugs. In the last 30 years, the role of chemistry in combination with new technologies, like various computational techniques in chemistry, has witnessed a major upsurge in drug discovery and targeted drug delivery. Objective: This article provides a succinct overview of recent techniques of chemistry that have a great impact on the drug development process in general and also against HIV/AIDS. It focuses on new methods employed for drug development with an emphasis on in silico studies, including identifying drug targets, especially the proteins associated with specific diseases. Methods: The rational drug development process starts with the identification of a drug target as the first phase, which helps in the computer-assisted design of new drug molecules. Synthetic chemistry has a major impact on the drug development process because it provides new molecules for future study. Natural products based semisynthesis or microwave assisted synthesis is also involved in developing newly designed drug molecules. Further, the role of analytical chemistry involves extraction, fractionation, isolation and characterization of newly synthesized molecules. Results: Chemistry plays a key role in drug discovery and delivery by natural process or with the help of synthetic nanoparticles or nanomedicines. So, nanochemistry is also deeply involved in the development of new drugs and their applications. Conclusion: The previous era of drug discovery was dominated only by chemistry, but the modern approaches involve a comprehensive knowledge of synthetic chemistry, medicinal chemistry, computational chemistry and the concerned biological phenomenon.

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

2020 ◽  
Vol 07 ◽  
Author(s):  
Renu Kadian ◽  
Arun Nanda
Keyword(s):  
United States ◽  
European Union ◽  
Intellectual Property Rights ◽  
United States Of America ◽  
Financial Support ◽  
Development Process ◽  
The United States ◽  
Drug Development Process ◽  
Data Exclusivity ◽  
Patent Term

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.

Intelligent Drug Development

2014 ◽  
Author(s):  
Michael Tansey
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Drug Development ◽  
Clinical Research ◽  
Development Process ◽  
Drug Development Process ◽  
Individual Trial ◽  
Specific Technology

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.

Predictivity/Translatability of Toxicities Observed in Nonclinical Toxicology Studies to Clinical Safety Outcomes in Drug Development: Case Examples

2019 ◽  
Vol 39 (2) ◽  
pp. 141-150
Author(s):  
Nicola J. Stagg ◽  
Hanan N. Ghantous ◽  
Robert Roth ◽  
Kenneth L. Hastings
Keyword(s):  
Drug Development ◽  
Annual Meeting ◽  
Clinical Studies ◽  
Early Termination ◽  
New Drugs ◽  
Clinical Safety ◽  
Case Examples ◽  
Palm Springs ◽  
Starting Dose ◽  
Good Concordance

Nonclinical toxicology studies are conducted to characterize the potential toxicities and establish a safe starting dose for new drugs in clinical studies, but the question remains as to how predictable/translatable the nonclinical safety findings are to humans. In many cases, there is good concordance between nonclinical species and patients. However, there are cases for which there is a lack of predictivity or translatability that led to early termination of clinical studies due to unanticipated toxicities or early termination of programs before making it to the clinic due to unacceptable nonclinical toxicities assumed to be translatable. A few case examples of safety findings that are translatable versus safety findings that are not translatable and why they are not translateable were presented as a symposium at the 38th Annual Meeting of the American College of Toxicology in Palm Springs, California, and are discussed in this article.

scholarly journals Cathepsin L plays a key role in SARS-CoV-2 infection in humans and humanized mice and is a promising target for new drug development

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Miao-Miao Zhao ◽  
Wei-Li Yang ◽  
Fang-Yuan Yang ◽  
Li Zhang ◽  
Wei-Jin Huang ◽  
...  
Keyword(s):  
Drug Development ◽  
Cathepsin L ◽  
Human Cells ◽  
New Drugs ◽  
Disease Course ◽  
Promising Target ◽  
First Time

AbstractTo discover new drugs to combat COVID-19, an understanding of the molecular basis of SARS-CoV-2 infection is urgently needed. Here, for the first time, we report the crucial role of cathepsin L (CTSL) in patients with COVID-19. The circulating level of CTSL was elevated after SARS-CoV-2 infection and was positively correlated with disease course and severity. Correspondingly, SARS-CoV-2 pseudovirus infection increased CTSL expression in human cells in vitro and human ACE2 transgenic mice in vivo, while CTSL overexpression, in turn, enhanced pseudovirus infection in human cells. CTSL functionally cleaved the SARS-CoV-2 spike protein and enhanced virus entry, as evidenced by CTSL overexpression and knockdown in vitro and application of CTSL inhibitor drugs in vivo. Furthermore, amantadine, a licensed anti-influenza drug, significantly inhibited CTSL activity after SARS-CoV-2 pseudovirus infection and prevented infection both in vitro and in vivo. Therefore, CTSL is a promising target for new anti-COVID-19 drug development.

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