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Pharmaceutical Patents Under The Spc Regulation
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Book Synopsis Pharmaceutical Patents under the SPC Regulation by : Callesen Klinge, Ulla
Download or read book Pharmaceutical Patents under the SPC Regulation written by Callesen Klinge, Ulla and published by Edward Elgar Publishing. This book was released on 2022-10-07 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by an experienced European Patent Attorney and scholar, this book sets out in detail the framework for protection of pharmaceutical innovation under the SPC Regulation. With a focus on both biotechnological innovation and secondary innovation, and through extensive reference to the case law, Ulla Klinge surveys the court’s evolving interpretation of legal and technical eligibility for this extended term of protection. This book provides clear and pragmatic tools to reflect and guide future practice, while offering key explanations and insights as to why and how technological developments challenge the legal SPC framework.
Book Synopsis Supplementary Protection Certificates (SPC) by : Marco Stief
Download or read book Supplementary Protection Certificates (SPC) written by Marco Stief and published by . This book was released on 2015-07 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
Book Synopsis European SPCs Unravelled by : Alexa von Uexküll
Download or read book European SPCs Unravelled written by Alexa von Uexküll and published by Kluwer Law International B.V.. This book was released on 2018-11-08 with total page 763 pages. Available in PDF, EPUB and Kindle. Book excerpt: While supplementary protection certificates (SPCs) are governed by the same substantive rules in all Member States of the European Union and the European Economic Area, they are national IP rights. The formal requirements and procedural practices of the national patent offices granting SPCs still differ significantly, and these divergences can have a substantial impact in the prosecution of SPCs across Europe. This one-of-a-kind handbook provides an easily accessible overview of SPC law in Europe, covering all substantive and procedural aspects of prosecution, enforcement and invalidation, as well as SPC-related aspects of unfair competition law. Following an overarching European chapter, which addresses general considerations and the relevant European Union law, including the jurisprudence of the Court of Justice (CJEU) and the EFTA Court, this book contains separate national chapters for eleven key jurisdictions ? i.e., Germany, the United Kingdom, France, the Netherlands, Belgium, Italy, Spain, Portugal, Sweden, Iceland, and Switzerland, as well as a concluding chapter summarizing the fundamentals of SPC law and practice in sixteen further European countries. The contributors to this book, all experts in the field of SPCs in their respective jurisdictions, provide clear and hands-on guidance on a range of specific topics of practical and strategic relevance, including: • What is or is not an ‘active ingredient' amenable to SPC protection? • What is required for an active ingredient to be ‘protected' by a basic patent? • What relevance has the ‘core inventive advance' of the basic patent? • Can SPCs be obtained for ‘loose' combinations of separately formulated active ingredients? • Which basic patent should be chosen for an SPC filing? • Which types of marketing authorizations can be relied upon? • Under which conditions can SPCs be obtained for a new specific salt, ester or other derivative of a previously approved active ingredient, for a new specific enantiomer of a previously approved racemate, and for new therapeutic applications of previously approved active ingredients? • Can affiliated companies obtain several SPCs for the same product? • Does the revocation of an SPC enable the filing of a new SPC for the same product? • What are the limits to the filing of ‘unfriendly' SPCs based on third-party marketing authorizations? • What relevance does the product definition of an SPC have for its scope of protection? • What is the scope of protection of an SPC in relation to derivatives of an active ingredient? • How is the SPC term calculated, and how can an erroneous term be corrected? • How can SPCs and paediatric extensions be invalidated, and which grounds of invalidity can be invoked? • What pitfalls must be avoided in terms of unfair competition law? This book provides invaluable assistance to IP practitioners in devising successful pan-European SPC filing strategies. Its practice-oriented, country-by-country format makes it easy to compare the national practices and the respective national case law of the different European countries.
Book Synopsis Pharmaceutical Innovation, Competition and Patent Law by : Josef Drexl
Download or read book Pharmaceutical Innovation, Competition and Patent Law written by Josef Drexl and published by Edward Elgar Publishing. This book was released on 2013-01-01 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators.
Book Synopsis Patent Protection for Second Medical Uses by : Jochen Bühling
Download or read book Patent Protection for Second Medical Uses written by Jochen Bühling and published by Kluwer Law International B.V.. This book was released on 2020-10-13 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: AIPPI Series, Volume Number 2. The second edition of Patent Protection for Second Medical Uses is a practical guide on the ever-relevant and controversial topic ‘Second Medical Use’ (SMU) patents, which play a significant role in the potential second-line patent protection and have become increasingly important. This edition’s analysis sheds light on the availability of protection for second medical use claims and its legal basis, followed by a detailed look at the specifics of various jurisdictions. Following the abandoning of ‘Swiss-type claims’ at the European Patent Office (EPO), applicants had to develop new filing strategies while such claims are still allowable in a number of national jurisdictions worldwide; the consequences of this have not yet fully been explored in practice. Jurisdictions around the world show significant differences in the treatment of such claims, although they share common approaches in patent law overall. This second edition furnishes a detailed and elaborate analysis, providing clarity, insight and guidance on legal issues and practical implications of SMU claims in twenty-four jurisdictions (the EPO and twenty-three individual countries). What’s in this book: This book, published under the aegis of the esteemed International Association for the Protection of Intellectual Property (AIPPI), contains a chapter-wise analysis by carefully chosen authors known for their expertise and experience in this field. Each chapter highlights such issues and topics as the following: availability and scope of protection; validity of claims; enforcement; infringement and investigations; and procedural aspects and tactical recommendations. The AIPPI studied certain aspects of second medical use claims on the occasion of its Congress in Toronto in 2014. This led to its Resolution Q 238 – ‘Second medical use and other second indication claims’, which triggered this comparative law analysis and a copy of which is found at the end of this book. How this will help you: This book is an enlightening compendium of contributions from across the globe. It not only renders guidance to interested legal practitioners when filing a patent application and assessing risks of conflict with existing patents or patent applications but also explains the key issues and contains practical advice when enforcing such claims or defending against an action. Also, this book will prove to be of immense practical interest for patent lawyers and patent attorneys and for the industries involved, applicants for pharmaceutical patents and third parties.
Book Synopsis Supplementary Protection Certificates for Medicinal Products by : Georgia A. Roussou
Download or read book Supplementary Protection Certificates for Medicinal Products written by Georgia A. Roussou and published by Edward Elgar Publishing. This book was released on 2023-01-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores whether the judicial developments related to the Supplementary Protection Certificate (SPC) regulation correspond to the objectives of the European legislator. Examining the role of SPCs for medicinal products in the European patent system, it highlights both the jurisprudence of the Court of Justice of the European Union and the respective judgements of the member states’ national courts.
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.
Author :United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight Publisher : ISBN 13 : Total Pages :308 pages Book Rating :4.F/5 ( download)
Book Synopsis Patent Term Extension and Pharmaceutical Innovation by : United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight
Download or read book Patent Term Extension and Pharmaceutical Innovation written by United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight and published by . This book was released on 1982 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Supplementary Protection Certificates (SPC) by : Marco Stief
Download or read book Supplementary Protection Certificates (SPC) written by Marco Stief and published by . This book was released on 2021 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Supplementary Protection Certificates Supplementary protection certificates (SPC) extend the effects of patents for medicinal products by a maximum of five and a half years, i.e. the certificate becomes effective at a time when the respective pharmaceutical is widely known on the market and thus generates the maximum revenue. This explains the enormous economic value of SPCs. They protect some of the most valuable products in the pharmaceutical industry. The legal basis for the SPC for medicinal products is a European Regulation. The obtaining provisions of that Regulation, the scope of protection etc. are highly disputed and have been the subject of numerous decisions of the CJEU. This handbook provides valuable insights into the world of SPCs and the most significant case law and legal sources at EU and national level of Germany, the UK, France, Italy, the Netherlands and Switzerland. The second completely revised edition specifically addresses recent developments of SPCs including manufacturing waivers and the implications of “Brexit”
Book Synopsis Pharmaceutical Patent Issues by : United States. Congress. Senate. Committee on the Judiciary
Download or read book Pharmaceutical Patent Issues written by United States. Congress. Senate. Committee on the Judiciary and published by . This book was released on 1997 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Pharmaceutical Patents in Europe by : Bengt Domeij
Download or read book Pharmaceutical Patents in Europe written by Bengt Domeij and published by . This book was released on 2000 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
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.
Book Synopsis Successful Drug Discovery, Volume 3 by : J¿nos Fischer
Download or read book Successful Drug Discovery, Volume 3 written by J¿nos Fischer and published by John Wiley & Sons. This book was released on 2018-06-05 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: With its focus on drugs so recently introduced that they have yet to be found in any other textbooks or general references, the information and insight found here makes this a genuinely unique handbook and reference. Following the successful approach of the previous volumes in the series, inventors and primary developers of successful drugs from both industry and academia tell the story of the drug's discovery and describe the sometimes twisted route from the first drug candidate molecule to the final marketed drug. The 11 case studies selected describe recent drugs ranging across many therapeutic fields and provide a representative cross-section of present-day drug developments. Backed by plenty of data and chemical information, the insight and experience of today's top drug creators makes this one of the most useful training manuals that a junior medicinal chemist may hope to find. The International Union of Pure and Applied Chemistry has endorsed and sponsored this project because of its high educational merit.
Book Synopsis Pharmaceutical Patents by : LandMark Publications
Download or read book Pharmaceutical Patents written by LandMark Publications and published by . This book was released on 2017-08-10 with total page 514 pages. Available in PDF, EPUB and Kindle. Book excerpt: THIS CASEBOOK contains a selection of U. S. Court of Appeals decisions that analyze and discuss issues surrounding pharmaceutical patents. The selection of decisions spans from 2014 to the date of publication."Our patent laws deny a patent to an inventor who applies for a patent more than one year after making an attempt to profit from his invention by putting it on sale." Atlanta Attachment Co. v. Leggett & Platt, Inc., 516 F.3d 1361, 1365 (Fed. Cir. 2008); see City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877) ("[A]n inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law."). Section 102(b)'s on-sale bar is triggered when a claimed invention is: (1) ready for patenting; and (2) the subject of a commercial offer for sale prior to the critical date. [Footnote omitted.] Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67-68 (1998); see Lacks Indus., Inc. v. McKechnie Vehicle Components USA, Inc., 322 F.3d 1335, 1347 (Fed. Cir. 2003). Merck & CIE, Bayer Pharma AG v. Watson Laboratories, Inc., ibid."[A]n inventor who seeks to perfect his discovery may conduct extensive testing without losing his right to obtain a patent for his invention. . . . The law has long recognized the distinction between inventions put to experimental use and products sold commercially." See Pfaff, 525 U.S. at 64 . Because Merck's offer to sell was a premature commercial exploitation of its invention, claim 4 of the patent is invalid under the on-sale bar. Merck & CIE, Bayer Pharma AG v. Watson Laboratories, Inc., ibid.
Book Synopsis The Generic Challenge by : Martin A. Voet
Download or read book The Generic Challenge written by Martin A. Voet and published by . This book was released on 2016 with total page 202 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.
