Download or read book Evergreening Patent Exclusivity in Pharmaceutical Products written by Frantzeska Papadopoulou and published by Bloomsbury Publishing. This book was released on 2021-09-23 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyses 4 central pieces of EU pharmaceutical regulation: the Orphan Drugs Regulation, the Paediatric Regulation, the Supplementary Protection Certificate Regulation, and the ATMP (Advanced Therapy Medicinal Products) Regulation. These four regulatory instruments constitute focal points in the pharmaceutical industry's approach to modern business and legal strategy. Their central role is justified by the way these regulatory instruments interact with each other and with the patent system, and by the considerable impact they (as a whole) have for the evergreening of exclusive rights on pharmaceutical products. The book guides the reader through the latest case law and legislative developments and discusses how these influence strategic legal and business choices in the pharmaceutical industry. It brings to the forefront the often-overlooked significance of the legislative architecture of the EU pharmaceutical regulatory framework, and evaluates its results through the lens of the efficiency test. The book is an important resource for academics and practitioners interested in updated case law and an in-depth analysis of these four regulations. It is also important for those interested in legislative studies, evaluation of legislation and a critical approach to legislative architecture.
Download or read book The Generic Challenge written by Martin A. Voet and published by BrownWalker Press. This book was released on 2020-05-01 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Sixth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.
Download or read book Evergreening Patent Exclusivity in Pharmaceutical Products written by Frantzeska Papadopoulou and published by Bloomsbury Publishing. This book was released on 2021-09-23 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyses 4 central pieces of EU pharmaceutical regulation: the Orphan Drugs Regulation, the Paediatric Regulation, the Supplementary Protection Certificate Regulation, and the ATMP (Advanced Therapy Medicinal Products) Regulation. These four regulatory instruments constitute focal points in the pharmaceutical industry's approach to modern business and legal strategy. Their central role is justified by the way these regulatory instruments interact with each other and with the patent system, and by the considerable impact they (as a whole) have for the evergreening of exclusive rights on pharmaceutical products. The book guides the reader through the latest case law and legislative developments and discusses how these influence strategic legal and business choices in the pharmaceutical industry. It brings to the forefront the often-overlooked significance of the legislative architecture of the EU pharmaceutical regulatory framework, and evaluates its results through the lens of the efficiency test. The book is an important resource for academics and practitioners interested in updated case law and an in-depth analysis of these four regulations. It is also important for those interested in legislative studies, evaluation of legislation and a critical approach to legislative architecture.
Download or read book Intellectual Property in Industrial Designs written by John R. Thomas and published by DIANE Publishing. This book was released on 2011 with total page 21 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a print on demand edition of a hard to find publication. Under current intellectual property laws, industrial designs (ID) may potentially be protected through design patents, trade dress, and copyright. In addition, the Vessel Hull Design Protection Actestablished a specialized, or sui generis, intellectual property right for the protection of boat hull designs. Some experts argue that the present intellectual property regime does not adequately protect ID. Contents of this report: (1) ID and Intellectual Property: Copyright; Trade Dress; Design Patents; Vessel Hull Design Protection; (2) Current Issues in ID Protection: Intellectual Property Rights in Fashion Designs; U.S. Adherence to the Hague Convention; Auto Spare Parts; Judicial Developments Concerning ID Patents; (3) Issues in Innovation and Competition.
Download or read book Drug Wars written by Robin Feldman and published by Cambridge University Press. This book was released on 2017-06-09 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Download or read book Impact of Patent Evergreening on Access to Medicine written by Sheikh Sajid and published by LAP Lambert Academic Publishing. This book was released on 2016-01-06 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt: Impact of Patent Evergreenig on Access to Medicine, as the title suggests is a reference book which deals with one of the prominent issues which hinder access to medicine i.e. Evergreening of Patents. Patents on the pharmaceutical product or process may be used to block generic completion by evergreening. This means getting patent on the product which is not novel but a simple change of existing known product. This blocks the access to affordable drugs posing a great threat to Public Health. In the developing world, where few people can afford original patented medicines, evergreening of patents poses a huge threat. This book is for students and scholars who want to understand this issue in depth and want to come up with probable solutions.
Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Evergreening of Pharmaceutical Patents written by PhD Abbas (Muhammad Zaheer) and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Evergreening of pharmaceutical patents has emerged as a serious challenge for access to affordable drugs as it aims to delay the generic competition by extending the length of the exclusivity period beyond the legitimate patent term without any considerable improvement in therapeutic benefits of the already patented pharmaceutical drug. This paper endeavors to question the legitimacy of the ever-greening of pharmaceutical patents. This study applies all the recognized theories in support of the patent system -namely the 'natural law' or 'natural rights' theory, the 'reward by monopoly' theory, the 'monopoly-profit incentive' theory, the 'exchange for secrets' theory or the 'contract' theory, and the 'prospect' theory- to the practice of ever-greening of drug patents in order to check whether or not any of these theories can be used to justify the practice. The study concludes that the practice of ever-greening is not consistent with any of these theories and therefore lacks any plausible justification.
Download or read book Innovation Economic Development and Intellectual Property in India and China written by Kung-Chung Liu and published by Springer Nature. This book was released on 2019-09-06 with total page 513 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book analyses intellectual property codification and innovation governance in the development of six key industries in India and China. These industries are reflective of the innovation and economic development of the two economies, or of vital importance to them: the IT Industry; the film industry; the pharmaceutical industry; plant varieties and food security; the automobile industry; and peer production and the sharing economy. The analysis extends beyond the domain of IP law, and includes economics and policy analysis. The overarching concern that cuts through all chapters is an inquiry into why certain industries have developed in one country and not in the other, including: the role that state innovation policy and/or IP policy played in such development; the nature of the state innovation policy/IP policy; and whether such policy has been causal, facilitating, crippling, co-relational, or simply irrelevant. The book asks what India and China can learn from each other, and whether there is any possibility of synergy. The book provides a real-life understanding of how IP laws interact with innovation and economic development in the six selected economic sectors in China and India. The reader can also draw lessons from the success or failure of these sectors.
Download or read book Strategic Patenting and Evergreening in Pharmaceutical Sector Competition Law as a Panacea written by Monika Mulchandani and published by . This book was released on 2020-10-06 with total page 58 pages. Available in PDF, EPUB and Kindle. Book excerpt: What is the efficacy of Competition Law in regard to scrutinizing strategic patenting practices and evergreening in the pharmaceutical sector under the arrangements of Patent law? The book is a comprehensive study of the pharmaceutical sector in relation to consumer protection whilst considering the excessive price affliction on the availability of affordable health services. It focuses on anti-competitive agreements like cartels, parallel pricing, predatory pricing by pharmaceutical companies including other aspects under competition law, and patients being fettered by patents under intellectual property laws. Drugs being an essential commodity have been part of unfair-trade practices and its implication is leading to extensive price discrimination on a global level. It is a comparative analysis of the implementation of laws in different jurisdictions for the availability of drugs at fair prices, which will include the legal hurdles in the promotion and adoption of low-cost generic drugs by various jurisdictions. The line where fair profits end and the extortion in the name of innovation and exclusivity rights start is a bleak one. This book is aimed at finding that balance that encourages innovation in the pharmaceutical sector as well as makes these innovative drugs affordable and available for common man's use with the efficacy of Competition Law in place. The primary objective of this book is to highlight the capitalist approach of pharmaceutical companies in defeating the larger public interest and the discrepancies of law leading to ethical misconduct.
Download or read book Patent Strategy in Pharmaceutical Industry written by Monica Donghi and published by . This book was released on 2014 with total page 85 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dieses Buch untersucht die Lifecycle-Management-Strategien, die von Pharma-Unternehmen eingesetzt werden, um den Wert ihres Produktportfolios zu maximieren. Solche Strategien werden manchmal von Generika-Unternehmen als "evergreening" bezeichnet. Die Analyse erfolgt anhand zwei zufällig ausgewählter "Blockbuster"--Medikamente, Taxotere und Xalatan und konzentriert sich auf zwei dieser Strategien, nämlich die Produktverbesserung und die Produktlinienerweiterung. Reihe Munich Intellectual Property Law Center - MIPLC - Band 20.
Download or read book Patent Strategy in Pharmaceutical Industry written by Monica Donghi and published by Nomos Verlagsgesellschaft. This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book investigates lifecycle management strategies used by pharmaceutical companies attempting to maximize the value of their product portfolio. Such strategies are sometimes referred to by generic drug companies as "evergreening". The analysis focuses on two of these strategies, namely product improvements and product line extensions. In particular, an evaluation of the patents that follow the basic one and that accompany the development of a drug from research to market is attempted. Two "blockbuster" drugs, Taxotere and Xalatan, were randomly chosen to carry out such analysis. The patent portfolio of the originator companies is outlined and some important patents for each area of research (e.g. formulations, combinations, delivery devices) are shortly described. Patent filing trends for the two drugs, both in regards of the originator and in regards of other competing companies (amongst these also the generics) are schematically shown.
Download or read book Generic Pharmaceutical Patent and FDA Law written by Shashank Upadhye and published by . This book was released on 2008 with total page 643 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Patent Protection for Pharmaceutical Products written by Margaret Smith and published by . This book was released on 1993-01-01 with total page 17 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drugs Money and Secret Handshakes written by Robin Feldman and published by Cambridge University Press. This book was released on 2019-04-11 with total page 201 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the warped world of prescription drug pricing, generic drugs can cost more than branded ones, old drugs can be relaunched at astronomical prices, and low-cost options are shut out of the market. In Drugs, Money and Secret Handshakes, Robin Feldman shines a light into the dark corners of the pharmaceutical industry to expose a web of shadowy deals in which higher-priced drugs receive favorable treatment and patients are channeled toward the most expensive medicines. At the center of this web are the highly secretive middle players who establish coverage levels for patients and negotiate with drug companies. By offering lucrative payments to these middle players (as well as to doctors and hospitals), drug companies ensure that inexpensive drugs never gain traction. This system of perverse incentives has delivered the kind of exorbitant drug prices - and profits - that everyone loves except for those who pay the bills.
Download or read book The Use of Intellectual Property in Chile written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 83 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study describes patterns and trends of intellectual property (IP) use in Chile, drawing on a new database containing all patent, trademark, utility model, and design filings received by the Chilean IP office over the period 1991-2010. Among other things, the study offers insights into the drivers of filing growth, the origin of filings, the distribution of applicants, the importance of different applicant types, the share of filings by different economic sectors, the relevance of IP bundles, and the patenting behavior of Chilean applicants overseas.
