Generic drug entry prior to patent expiration an FTC study

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

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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:

Drug Wars

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Publisher : Cambridge University Press
ISBN 13 : 131673949X
Total Pages : 165 pages
Book Rating : 4.3/5 (167 download)

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Book Synopsis Drug Wars by : Robin Feldman

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.

The Generic Challenge

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

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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.

WIPO Guide to Using Patent Information

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Publisher : WIPO
ISBN 13 : 9280526510
Total Pages : 44 pages
Book Rating : 4.2/5 (85 download)

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Book Synopsis WIPO Guide to Using Patent Information by : World Intellectual Property Organization

Download or read book WIPO Guide to Using Patent Information written by World Intellectual Property Organization and published by WIPO. This book was released on 2018-04-30 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Guide aims to assist users in searching for technology information using patent documents, a rich source of technical, legal and business information presented in a generally standardized format and often not reproduced anywhere else. Though the Guide focuses on patent information, many of the search techniques described here can also be applied in searching other non-patent sources of technology information.

The Use of Intellectual Property in Chile

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Publisher : WIPO
ISBN 13 :
Total Pages : 83 pages
Book Rating : 4./5 ( download)

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Book Synopsis The Use of Intellectual Property in Chile by : World Intellectual Property Organization

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.

A Patent System for the 21st Century

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Publisher : National Academies Press
ISBN 13 : 0309089107
Total Pages : 186 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis A Patent System for the 21st Century by : National Research Council

Download or read book A Patent System for the 21st Century written by National Research Council and published by National Academies Press. This book was released on 2004-10-01 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: The U.S. patent system is in an accelerating race with human ingenuity and investments in innovation. In many respects the system has responded with admirable flexibility, but the strain of continual technological change and the greater importance ascribed to patents in a knowledge economy are exposing weaknesses including questionable patent quality, rising transaction costs, impediments to the dissemination of information through patents, and international inconsistencies. A panel including a mix of legal expertise, economists, technologists, and university and corporate officials recommends significant changes in the way the patent system operates. A Patent System for the 21st Century urges creation of a mechanism for post-grant challenges to newly issued patents, reinvigoration of the non-obviousness standard to quality for a patent, strengthening of the U.S. Patent and Trademark Office, simplified and less costly litigation, harmonization of the U.S., European, and Japanese examination process, and protection of some research from patent infringement liability.

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

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

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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:

Patent Term Extensions and Adjustments

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Publisher :
ISBN 13 :
Total Pages : 22 pages
Book Rating : 4.:/5 (1 download)

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Book Synopsis Patent Term Extensions and Adjustments by :

Download or read book Patent Term Extensions and Adjustments written by and published by . This book was released on 2016 with total page 22 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report surveys the law on extensions and adjustments of patents in nine jurisdictions: Australia, Canada, the European Union, France, Germany, Israel, Japan, South Korea, and the United Kingdom. All of the surveyed jurisdictions provide for a standard patent term of twenty years, and all of them except Canada provide for extensions of protection for certain products that are subject to regulatory approval before they can be marketed. For the European Union and France, Germany, and the United Kingdom, supplementary protection certificates (SPCs) are available that extend the protections of patents for medicinal and plant protection products to cover the period needed for regulatory approval of the product, typically to a maximum of five years. Australia similarly provides for extensions of patent protections for pharmaceutical substances to account for the period needed for regulatory approval up to five years. Israel permits the term of basic pharmaceutical patents to be extended for a period equal to the time between submission and granting of the marketing license application, up to five years. Israel also permits extension of related patents held in the United States, Italy, Britain, Germany, Spain, and France where there is patent extension or SPC in the country of origin. Japan allows an extension of the duration of a patent right by up to five years when the patented invention is subject to certain regulatory approval processes that take a considerable time to complete, including those for agrochemicals and pharmaceuticals. South Korea likewise allows for the extension of patent terms for up to five years with respect to medicines and agricultural chemicals to account for the period of product registration. In addition, South Korea provides for adjustment of patent terms due to delayed patent registrations. While Canada currently does not have legislation providing for extensions of patent protection, it is currently negotiating a trade agreement with the European Union that in draft form provides for patent term extensions of two to five years for qualifying pharmaceutical products.

Patent Politics

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Publisher : University of Chicago Press
ISBN 13 : 022643785X
Total Pages : 299 pages
Book Rating : 4.2/5 (264 download)

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Book Synopsis Patent Politics by : Shobita Parthasarathy

Download or read book Patent Politics written by Shobita Parthasarathy and published by University of Chicago Press. This book was released on 2017-02-21 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction -- Defining the public interest in the US and European patent systems -- Confronting the questions of life-form patentability -- Commodification, animal dignity, and patent-system publics -- Forging new patent politics through the human embryonic stem cell debates -- Human genes, plants, and the distributive implications of patents -- Conclusion

Innovation, Economic Development, and Intellectual Property in India and China

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Author :
Publisher : Springer Nature
ISBN 13 : 981138102X
Total Pages : 513 pages
Book Rating : 4.8/5 (113 download)

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Book Synopsis Innovation, Economic Development, and Intellectual Property in India and China by : Kung-Chung Liu

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.

The Impact of Patent Protection on Health Care in India and the UK. A Comparative Analysis

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Author :
Publisher : GRIN Verlag
ISBN 13 : 3346103498
Total Pages : 61 pages
Book Rating : 4.3/5 (461 download)

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Book Synopsis The Impact of Patent Protection on Health Care in India and the UK. A Comparative Analysis by : Priyanka Jain

Download or read book The Impact of Patent Protection on Health Care in India and the UK. A Comparative Analysis written by Priyanka Jain and published by GRIN Verlag. This book was released on 2020-01-24 with total page 61 pages. Available in PDF, EPUB and Kindle. Book excerpt: Doctoral Thesis / Dissertation from the year 2017 in the subject Law - European and International Law, Intellectual Properties, grade: 1, Coventry University, language: English, abstract: This research undertakes a review of available studies to conduct a critical analysis of the impact of patent protection in developing health care innovations and further on public health in India and the UK. A patent is an intellectual property right that is granted to an inventor of a product, to exclude others from manufacturing, selling, importing an invention without the permission of the inventor. It is a social contract whereby the patentee is granted a monopoly over their invention, and in return society receives innovation. Therefore, it is an incentive scheme to benefit inventors and society as a whole. There are several laws which regulate Patents, such as patent protection, increasing the life of a patent, reducing patentability standards and extending patent protection to undesirable products increase monopolies. The patent owners gain exclusive rights in the form of patents or an exclusive license, thus leading to an increase in the cost of such products. In addition, the patent owners adopt strategies to extend the scope of patent gain additional patents which protect the underlying ingredient of the medicine. Many pharmaceutical products are protected by Patents. The generic drug manufacturers in the pharmaceutical industry are affected such laws, which in turn affects the price of medicines available to patients. This creates a problem of access to affordable means of healthcare and further affects public health. Finally, the research will provide recommendations such as a framework of price control model to ensure sufficient access to medicines, and other recommendation for future of the progressing patent system of both the countries.

The Generic Challenge

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Author :
Publisher : Brown Walker Press
ISBN 13 : 9781599424446
Total Pages : 183 pages
Book Rating : 4.4/5 (244 download)

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Book Synopsis The Generic Challenge by : Martin A. Voet

Download or read book The Generic Challenge written by Martin A. Voet and published by Brown Walker Press. This book was released on 2008 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explains clearly and understandably the role of patents, FDA regulations of generic drugs and the Hatch Waxman Act on conventional and biological drug product development today and how directed innovation can result in enhanced care for patients while extending the commercial lives of the drugs. The Generic Challenge is a must-read for pharmaceutical executives and managers, and regulatory, legal, business development, R&D and strategic marketing professionals and anyone who has an interest in the future of the leading American pharmaceutical and biotechnology industries and the high value jobs they provide. It explains clearly and understandably the role of patents, FDA regulation of generic drugs and the Hatch Waxman Act on drug development today and how improvements in innovative drug products provide enhanced benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind available on this important subject. REVIEWS I read The Generic Challenge in one evening. It is easy to read, anecdotal and short. It is hard to believe that so much information and seasoned advice is packed into this little book. Patents and FDA Exclusivity form the bedrock foundation of today's pharmaceutical and biotechnology industries. I would recommend this book to virtually everyone working in those industries -- from the CEO down to the drug reps and lab techs -- regardless of whether they will deal directly with patents. DENNIS CROUCH, Associate Professor of Law, University of Missouri, Editor of Patently-O.com

Patents and Patent Term Restoration

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Publisher :
ISBN 13 :
Total Pages : 362 pages
Book Rating : 4.:/5 (859 download)

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Book Synopsis Patents and Patent Term Restoration by : Stephen A. Kuchta

Download or read book Patents and Patent Term Restoration written by Stephen A. Kuchta and published by . This book was released on 2013 with total page 362 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Patent Term Adjustments (Us Patent and Trademark Office Regulation) (Pto) (2018 Edition)

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Author :
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781729858936
Total Pages : 32 pages
Book Rating : 4.8/5 (589 download)

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Book Synopsis Patent Term Adjustments (Us Patent and Trademark Office Regulation) (Pto) (2018 Edition) by : The Law The Law Library

Download or read book Patent Term Adjustments (Us Patent and Trademark Office Regulation) (Pto) (2018 Edition) written by The Law The Law Library and published by Createspace Independent Publishing Platform. This book was released on 2018-11-26 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patent Term Adjustments (US Patent and Trademark Office Regulation) (PTO) (2018 Edition) The Law Library presents the complete text of the Patent Term Adjustments (US Patent and Trademark Office Regulation) (PTO) (2018 Edition). Updated as of May 29, 2018 The United States Patent and Trademark Office (Office) is revising the rules of practice pertaining to patent term adjustment in view of the decision by the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) in Novartis AG v. Lee. The Federal Circuit confirmed in Novartis that any time consumed by continued examination is subtracted in determining the extent to which the period of application pendency exceeds three years, regardless of when the continued examination was initiated. The Federal Circuit, however, decided that the time consumed by continued examination does not include the time after a notice of allowance, unless the Office actually resumes examination of the application after allowance. Accordingly, the Office is revising the rules of practice to provide that the time consumed by continued examination does not include the time after a notice of allowance, unless the applicant files a request for continued examination after such allowance. The Office also is revising the rules of practice to provide that the submission of a request for continued examination after any notice of allowance has been mailed will constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application and thus result in a reduction of any period of patent term adjustment. The Office is providing an exception to this patent term adjustment reduction provision for a request for continued examination filed solely to submit information cited in a patent office communication in a counterpart application that is submitted to the Office within thirty days of receipt of the patent office communication. Additionally, the Office is clarifying what papers may be submitted after a notice of allowance without the applicant being considered to have failed to engage in reasonable efforts to conclude processing or examination of the application. This book contains: - The complete text of the Patent Term Adjustments (US Patent and Trademark Office Regulation) (PTO) (2018 Edition) - A table of contents with the page number of each section

The Generic Challenge

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Author :
Publisher : Brown Walker Press (FL)
ISBN 13 : 9781627346177
Total Pages : 230 pages
Book Rating : 4.3/5 (461 download)

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Book Synopsis The Generic Challenge by : Martin A. Voet

Download or read book The Generic Challenge written by Martin A. Voet and published by Brown Walker Press (FL). This book was released on 2016-09-07 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Fifth 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.

Biopatent Law: Patent Strategies and Patent Management

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 3642248454
Total Pages : 53 pages
Book Rating : 4.6/5 (422 download)

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Book Synopsis Biopatent Law: Patent Strategies and Patent Management by : Andreas Hübel

Download or read book Biopatent Law: Patent Strategies and Patent Management written by Andreas Hübel and published by Springer Science & Business Media. This book was released on 2012-01-05 with total page 53 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patents protecting biotechnological invention are becoming ever more important. Because biotechnology has many differences with respect to other technologies, lessons learned in other fields of technology cannot simply be transferred to adopt a suitable strategy for dealing with biotechnology inventions. In this volume, general aspects of biopatent law will be discussed. This involves questions of patentability, including ethical issues and issues of technicality, as well as questions of patent exhaustion in cases were reproducible subject matter, like cells or seeds, is protected. Moreover, active and passive patent strategies are addressed. Further, insight will be given into patent lifetime management and additional protective measures, like supplementary protection certificates and data exclusivity. Here, strategies are discussed how market exclusivity can be extended as long as possible, which is particularly important for biopharmaceutical drugs, which create high R&D costs.

Model Rules of Professional Conduct

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Author :
Publisher : American Bar Association
ISBN 13 : 9781590318737
Total Pages : 216 pages
Book Rating : 4.3/5 (187 download)

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Book Synopsis Model Rules of Professional Conduct by : American Bar Association. House of Delegates

Download or read book Model Rules of Professional Conduct written by American Bar Association. House of Delegates and published by American Bar Association. This book was released on 2007 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.