Data Exclusivity in Pharmaceutical Drug Products

Download Data Exclusivity in Pharmaceutical Drug Products PDF Online Free

Author :
Publisher :
ISBN 13 : 9783346005762
Total Pages : 86 pages
Book Rating : 4.0/5 (57 download)

DOWNLOAD NOW!


Book Synopsis Data Exclusivity in Pharmaceutical Drug Products by : Ali Demirbas

Download or read book Data Exclusivity in Pharmaceutical Drug Products written by Ali Demirbas and published by . This book was released on 2019-07-08 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt: Master's Thesis from the year 2007 in the subject Law - European and International Law, Intellectual Properties, Marmara University (EUROPEAN UNION INSTITUTE), course: DEPARTMENT OF EUROPEAN UNION LAW, language: English, abstract: Data exclusivity in pharmaceuticals is one of the best protection systems among other type of regulatory drug product exclusivities such as patent protection, patent term extension and some other type of marketing exclusivities. Data exclusivity provides the right holder protection on his undisclosed information, in particular the results of tests in humans and animals and clinical trials which are given to the national authorities in order to obtain marketing approval for the drug product for which the application is made. In this regard data exclusivity means that, the second applicant can not use or rely on that data during the exclusive time period in order to obtain marketing approval for the same drug product which was already granted marketing approval first time. Like the second applicant, national regulatory authorities also can not rely on that data in order to grant marketing approval to the second applicant for the same drug product during that exclusive time period. By this reason data exclusivity differs from other type of drug product marketing exclusivities since marketing exclusivity in pharmaceutical drug products may last after data exclusivity time period expires like in the EU system. In the EU normally, while there is 8 year data exclusivity, marketing exclusivity is 10 year. Also data exclusivity differs from patent protection. In part one; firstly the focus is on the regulatory drug product exclusivities and then data exclusivity generally. In part two; data exclusivity is analyzed extensively in international law, in the EU law, in the U.S. law and lastly in Turkish law.

Pharmaceutical Test Data Exclusivity

Download Pharmaceutical Test Data Exclusivity PDF Online Free

Author :
Publisher : Kluwer Law International B.V.
ISBN 13 : 9403501367
Total Pages : 250 pages
Book Rating : 4.4/5 (35 download)

DOWNLOAD NOW!


Book Synopsis Pharmaceutical Test Data Exclusivity by : John C. Todaro

Download or read book Pharmaceutical Test Data Exclusivity written by John C. Todaro and published by Kluwer Law International B.V.. This book was released on 2022-08-12 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data exclusivity gives pharmaceutical companies a limited period of time in which clinical test data are exclusive to the innovator. Internationally, however, aside from prohibition against unfair commercial use, there are no specifics as to how these data are protected; exclusivity is available on a jurisdiction-by-jurisdiction basis. This book, the only one of its kind, provides expert guidance, chapter by chapter, on test data exclusivity rights for pharmaceutical products in twenty-two major markets worldwide. For each jurisdiction, in addition to explaining the available regulatory data protection – including both substantive and formal requirements for approvals and testing, protection of undisclosed data, confidentiality, and enforcement in practice – local experts provide detailed information and guidance on the degree to which test data exclusivity may be achieved in such areas of pharmaceutical research as the following: infectious disease products; paediatrics products; chemical and biological products; agricultural products; animal health products; orphan drugs; and new chemical entities. This book originated from a project conducted by the Pharma Committee of the International Association for the Protection of Intellectual Property (AIPPI), the world’s leading non-profit association dedicated to the development, expansion, and improvement of international and regional treaties and agreements and national laws relating to intellectual property. Many committee members and observers are authors of chapters in this book. An unmatched starting point for innovator pharmaceutical companies and their advisers to evaluate data exclusivity rules and opportunities around the world, this book will be an invaluable resource for IP professionals, governments, non-governmental organizations, and international organizations to promote and share IP laws and practices.

Generic drug entry prior to patent expiration an FTC study

Download Generic drug entry prior to patent expiration an FTC study PDF Online Free

Author :
Publisher : DIANE Publishing
ISBN 13 : 1428951938
Total Pages : 129 pages
Book Rating : 4.4/5 (289 download)

DOWNLOAD NOW!


Book Synopsis Generic drug entry prior to patent expiration an FTC study by :

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:

Making Medicines Affordable

Download Making Medicines Affordable PDF Online Free

Author :
Publisher : National Academies Press
ISBN 13 : 0309468086
Total Pages : 235 pages
Book Rating : 4.3/5 (94 download)

DOWNLOAD NOW!


Book Synopsis Making Medicines Affordable by : National Academies of Sciences, Engineering, and Medicine

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.

The Palgrave Handbook of Philosophy and Public Policy

Download The Palgrave Handbook of Philosophy and Public Policy PDF Online Free

Author :
Publisher : Palgrave MacMillan
ISBN 13 : 9783030067427
Total Pages : 884 pages
Book Rating : 4.0/5 (674 download)

DOWNLOAD NOW!


Book Synopsis The Palgrave Handbook of Philosophy and Public Policy by : David Boonin

Download or read book The Palgrave Handbook of Philosophy and Public Policy written by David Boonin and published by Palgrave MacMillan. This book was released on 2019-11-03 with total page 884 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Access to Medicine Versus Test Data Exclusivity

Download Access to Medicine Versus Test Data Exclusivity PDF Online Free

Author :
Publisher : Springer
ISBN 13 : 3662496550
Total Pages : 269 pages
Book Rating : 4.6/5 (624 download)

DOWNLOAD NOW!


Book Synopsis Access to Medicine Versus Test Data Exclusivity by : Owais H. Shaikh

Download or read book Access to Medicine Versus Test Data Exclusivity written by Owais H. Shaikh and published by Springer. This book was released on 2016-07-25 with total page 269 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the concept of test data exclusivity protection for pharmaceuticals. Focusing on Art 39(3) of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and relevant provisions in selected free trade agreements (FTA) and national laws, it combines normative, historical, comparative and economic analysis of test data exclusivity protection.At the heart of this book is the novel and original Index of Data Exclusivity and Access (IDEAS), which analyzes the effectiveness of test data exclusivity provisions in FTAs and national laws both on the strength of exclusivity as well as on access to medicine. IDEAS provides a framework for the assessment of current test data exclusivity protection standards on the basis of their proximity to Article 39(3) of the TRIPS Agreement, the scope of exclusivity and the flexibilities in FTAs, and subsequently in national laws. This book aims to broaden national and international policy makers’ grasp of the various nuances of test data exclusivity protection. Furthermore, it provides practical recommendations with regard to designing an appropriate legal system with a strong focus on promoting access to medicine for all.

Rare Diseases and Orphan Products

Download Rare Diseases and Orphan Products PDF Online Free

Author :
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.3/5 (91 download)

DOWNLOAD NOW!


Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine

Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Private Patents and Public Health

Download Private Patents and Public Health PDF Online Free

Author :
Publisher :
ISBN 13 : 9789079700851
Total Pages : 181 pages
Book Rating : 4.7/5 (8 download)

DOWNLOAD NOW!


Book Synopsis Private Patents and Public Health by : Ellen F. M. 't Hoen

Download or read book Private Patents and Public Health written by Ellen F. M. 't Hoen and published by . This book was released on 2016 with total page 181 pages. Available in PDF, EPUB and Kindle. Book excerpt: Millions of people around the world do not have access to the medicines they need to treat disease or alleviate suffering. Strict patent regimes introduced following the establishment of the World Trade Organization in 1995 interfere with widespread access to medicines by creating monopolies that keep medicines prices well out of reach for many. 0The AIDS crisis in the late nineties brought access to medicines challenges to the public?s attention, when millions of people in developing countries died from an illness for which medicines existed, but were not available or affordable. Faced with an unprecedented health crisis ? 8,000 people dying daily ? the public health community launched an unprecedented global effort that eventually resulted in the large-scale availability of low-priced generic HIV medicines. 0But now, high prices of new medicines - for example, for cancer, tuberculosis and hepatitis C - are limiting access to treatment in low-, middle and high-income countries alike. Patent-based monopolies affect almost all medicines developed since 1995 in most countries, and global health policy is now at a critical juncture if the world is to avoid new access to medicines crises. 0This book discusses lessons learned from the HIV/AIDS crisis, and asks whether actions taken to extend access and save lives are exclusive to HIV or can be applied more broadly to new global access challenges.

Drugs, Patents and Policy

Download Drugs, Patents and Policy PDF Online Free

Author :
Publisher :
ISBN 13 : 1316512347
Total Pages : 241 pages
Book Rating : 4.3/5 (165 download)

DOWNLOAD NOW!


Book Synopsis Drugs, Patents and Policy by : Bryan Mercurio

Download or read book Drugs, Patents and Policy written by Bryan Mercurio and published by . This book was released on 2018-06-28 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive review of Hong Kong's pharmaceutical patent law that will influence debate and inform public policy.

Evergreening Patent Exclusivity in Pharmaceutical Products

Download Evergreening Patent Exclusivity in Pharmaceutical Products PDF Online Free

Author :
Publisher : Bloomsbury Publishing
ISBN 13 : 150995029X
Total Pages : 298 pages
Book Rating : 4.5/5 (99 download)

DOWNLOAD NOW!


Book Synopsis Evergreening Patent Exclusivity in Pharmaceutical Products by : Frantzeska Papadopoulou

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.

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade

Download Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade PDF Online Free

Author :
Publisher : WIPO
ISBN 13 : 9280523082
Total Pages : 259 pages
Book Rating : 4.2/5 (85 download)

DOWNLOAD NOW!


Book Synopsis Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by : World Intellectual Property Organization

Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.

How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry

Download How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry PDF Online Free

Author :
Publisher : U.S. Government Printing Office
ISBN 13 :
Total Pages : 94 pages
Book Rating : 4.:/5 (327 download)

DOWNLOAD NOW!


Book Synopsis How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry by :

Download or read book How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry written by and published by U.S. Government Printing Office. This book was released on 1998 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pharmaceutical Medicine and Translational Clinical Research

Download Pharmaceutical Medicine and Translational Clinical Research PDF Online Free

Author :
Publisher : Academic Press
ISBN 13 : 0128020989
Total Pages : 526 pages
Book Rating : 4.1/5 (28 download)

DOWNLOAD NOW!


Book Synopsis Pharmaceutical Medicine and Translational Clinical Research by : Divya Vohora

Download or read book Pharmaceutical Medicine and Translational Clinical Research written by Divya Vohora and published by Academic Press. This book was released on 2017-11-14 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

The Generic Challenge

Download The Generic Challenge PDF Online Free

Author :
Publisher : BrownWalker Press
ISBN 13 : 1627347461
Total Pages : 240 pages
Book Rating : 4.6/5 (273 download)

DOWNLOAD NOW!


Book Synopsis The Generic Challenge by : Martin A. Voet

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.

Intellectual Property Law and Access to Medicines

Download Intellectual Property Law and Access to Medicines PDF Online Free

Author :
Publisher : Routledge
ISBN 13 : 1000398706
Total Pages : 522 pages
Book Rating : 4.0/5 (3 download)

DOWNLOAD NOW!


Book Synopsis Intellectual Property Law and Access to Medicines by : Srividhya Ragavan

Download or read book Intellectual Property Law and Access to Medicines written by Srividhya Ragavan and published by Routledge. This book was released on 2021-07-28 with total page 522 pages. Available in PDF, EPUB and Kindle. Book excerpt: The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors – states, transnational business corporations, or civil society groups – and their influence on the structures – such as national and international agreements, organizations, and private entities – that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.

Resource Book on TRIPS and Development

Download Resource Book on TRIPS and Development PDF Online Free

Author :
Publisher :
ISBN 13 : 9781139444972
Total Pages : 829 pages
Book Rating : 4.4/5 (449 download)

DOWNLOAD NOW!


Book Synopsis Resource Book on TRIPS and Development by : Unctad-ictsd

Download or read book Resource Book on TRIPS and Development written by Unctad-ictsd and published by . This book was released on 2005 with total page 829 pages. Available in PDF, EPUB and Kindle. Book excerpt: NAture of obligations, principles and objectives; Substantive obligations; Intellectual property rights and competition; Enforcemente, maintenance and acquisition of rights; Interpretation and dispute settlement and prevention; Transitional and institutional arragements.

Approved Prescription Drug Products with Therapeutic Equivalence Evaluations

Download Approved Prescription Drug Products with Therapeutic Equivalence Evaluations PDF Online Free

Author :
Publisher :
ISBN 13 :
Total Pages : 336 pages
Book Rating : 4.3/5 (91 download)

DOWNLOAD NOW!


Book Synopsis Approved Prescription Drug Products with Therapeutic Equivalence Evaluations by :

Download or read book Approved Prescription Drug Products with Therapeutic Equivalence Evaluations written by and published by . This book was released on 1984 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.