1736 records matched your query
03660aam a2200445 i 4500 001 41689AF2072811ED93C2E7E557ECA4DB 003 SILO 005 20220719010102 008 210520t20212021enk b 001 0 eng 010 $a 2021024006 020 $a 150995032X 020 $a 9781509950324 020 $a 1509950281 020 $a 9781509950287 035 $a (OCoLC)1242910816 040 $a DLC $b eng $e rda $c DLC $d OCLCO $d OCLCF $d UKMGB $d YDX $d SILO 042 $a pcc 043 $a e------ 050 00 $a KJE2751.M44 $b P37 2021 100 1 $a Papadopoulou, Frantzeska, $e author. 245 10 $a Evergreening patent exclusivity in pharmaceutical products : $b supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs / $c Frantzesksa Papadopoulou. 264 1 $a Oxford ; $b Hart, $c 2021. 300 $a xxix, 277 pages; $c 25 cm 504 $a Includes bibliographical references and index. 505 0 $a Regulating the EU pharmaceutical sector : a multilayered challenge -- Setting the stage for regulatory rights : the regulatory agencies and the marketing authorisation procedure -- Data exclusivity -- The supplementary protection certificate -- The paediatric extension -- Orphan drugs -- Advanced therapy medicinal products -- How effective is the effectiveness test in the field of regulatory rights? 520 $a "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"-- $c Provided by publisher. 650 0 $a Drugs $z European Union countries $x Patents. 650 0 $a Patent extensions $z European Union countries. 650 0 $a Patent medicines $x Law and legislation $z European Union countries. 650 0 $a Patent laws and legislation $z European Union countries. 650 7 $a Drugs. $2 fast $0 (OCoLC)fst00898761 650 7 $a Patent extensions. $2 fast $0 (OCoLC)fst01054820 650 7 $a Patent laws and legislation. $2 fast $0 (OCoLC)fst01054823 650 7 $a Patent medicines $x Law and legislation. $2 fast $0 (OCoLC)fst01054849 651 7 $a European Union countries. $2 fast $0 (OCoLC)fst01269470 655 7 $a Patents. $2 fast $0 (OCoLC)fst01423842 776 08 $i Online version: $a Papadopoulou, Frantzeska. $t Evergreening patent exclusivity in pharmaceutical products $d Oxford ; New York : Hart, 2021 $z 9781509950300 $w (DLC) 2021024007 941 $a 1 952 $l OVUX522 $d 20230517011759.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=41689AF2072811ED93C2E7E557ECA4DBInitiate Another SILO Locator Search