{"id":"https://openalex.org/W6233636","doi":null,"title":"FDA's proposed rules on patent listing requirements for new drug and 30-month stays on ANDA approval (proposed Oct. 24, 2002).","display_name":"FDA's proposed rules on patent listing requirements for new drug and 30-month stays on ANDA approval (proposed Oct. 24, 2002).","publication_year":2003,"publication_date":"2003-01-01","ids":{"openalex":"https://openalex.org/W6233636","mag":"6233636","pmid":"https://pubmed.ncbi.nlm.nih.gov/12856462"},"language":"en","primary_location":{"id":"pmid:12856462","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/12856462","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Annals of health law","raw_type":"Journal Article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["pubmed"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://lawecommons.luc.edu/cgi/viewcontent.cgi?article=1243&context=annals","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5054527132","display_name":"Yuk Fung Hui","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I44461941","display_name":"University of Houston","ror":"https://ror.org/048sx0r50","country_code":"US","type":"education","lineage":["https://openalex.org/I44461941"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Yuk Fung Hui","raw_affiliation_strings":["University of Houston Law Center, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Houston Law Center, USA","institution_ids":["https://openalex.org/I44461941"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5054527132"],"corresponding_institution_ids":["https://openalex.org/I44461941"],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":true,"cited_by_count":3,"citation_normalized_percentile":{"value":0.00170255,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":87,"max":93},"biblio":{"volume":"12","issue":"2","first_page":"325","last_page":"40, table of contents"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11792","display_name":"Pharmaceutical Economics and Policy","score":0.9984999895095825,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T11792","display_name":"Pharmaceutical Economics and Policy","score":0.9984999895095825,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.00039999998989515007,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10856","display_name":"Intellectual Property and Patents","score":0.0003000000142492354,"subfield":{"id":"https://openalex.org/subfields/1405","display_name":"Management of Technology and Innovation"},"field":{"id":"https://openalex.org/fields/14","display_name":"Business, Management and Accounting"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/fda-proposed-rule","display_name":"FDA proposed rule","score":0.640999972820282},{"id":"https://openalex.org/keywords/new-drug-application","display_name":"new drug applications","score":0.7649999856948853},{"id":"https://openalex.org/keywords/generic-drug-approval","display_name":"generic drug approval","score":0.8379999995231628},{"id":"https://openalex.org/keywords/abbreviated-new-drug-application","display_name":"abbreviated new drug application","score":0.8140000104904175},{"id":"https://openalex.org/keywords/patent-infringement","display_name":"patent infringement","score":0.8009999990463257},{"id":"https://openalex.org/keywords/generic-drug-availability","display_name":"generic drug availability","score":0.7099999785423279},{"id":"https://openalex.org/keywords/drug-costs","display_name":"drug costs","score":0.8230000138282776},{"id":"https://openalex.org/keywords/patent-rights","display_name":"patent rights","score":0.7839999794960022},{"id":"https://openalex.org/keywords/pharmaceutical-industry","display_name":"pharmaceutical industry","score":0.6209999918937683},{"id":"https://openalex.org/keywords/regulatory-loopholes","display_name":"regulatory loopholes","score":0.5690000057220459}],"concepts":[{"id":"https://openalex.org/C2779820595","wikidata":"https://www.wikidata.org/wiki/Q798505","display_name":"Listing (finance)","level":2,"score":0.8398637771606445},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.6541770696640015},{"id":"https://openalex.org/C182306322","wikidata":"https://www.wikidata.org/wiki/Q1779371","display_name":"Order (exchange)","level":2,"score":0.611409604549408},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.5885524749755859},{"id":"https://openalex.org/C2776396487","wikidata":"https://www.wikidata.org/wiki/Q506319","display_name":"Generic drug","level":3,"score":0.5829288363456726},{"id":"https://openalex.org/C2777029862","wikidata":"https://www.wikidata.org/wiki/Q7144498","display_name":"Patent infringement","level":3,"score":0.5566486120223999},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.4288422763347626},{"id":"https://openalex.org/C190253527","wikidata":"https://www.wikidata.org/wiki/Q295354","display_name":"Law and economics","level":1,"score":0.38980644941329956},{"id":"https://openalex.org/C38652104","wikidata":"https://www.wikidata.org/wiki/Q3510521","display_name":"Computer security","level":1,"score":0.34437888860702515},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.3314364552497864},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.27717119455337524},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.26906460523605347},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.21557238698005676},{"id":"https://openalex.org/C162324750","wikidata":"https://www.wikidata.org/wiki/Q8134","display_name":"Economics","level":0,"score":0.17169731855392456},{"id":"https://openalex.org/C34974158","wikidata":"https://www.wikidata.org/wiki/Q131257","display_name":"Intellectual property","level":2,"score":0.16255444288253784},{"id":"https://openalex.org/C10138342","wikidata":"https://www.wikidata.org/wiki/Q43015","display_name":"Finance","level":1,"score":0.1382063329219818},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.12855857610702515}],"mesh":[{"descriptor_ui":"D004345","descriptor_name":"Drug Industry","qualifier_ui":"Q000191","qualifier_name":"economics","is_major_topic":false},{"descriptor_ui":"D004345","descriptor_name":"Drug Industry","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":true},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D010330","descriptor_name":"Patents as Topic","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":true},{"descriptor_ui":"D013997","descriptor_name":"Time Factors","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D016365","descriptor_name":"Liability, Legal","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016568","descriptor_name":"Drugs, Generic","qualifier_ui":"Q000191","qualifier_name":"economics","is_major_topic":false},{"descriptor_ui":"D016568","descriptor_name":"Drugs, Generic","qualifier_ui":"Q000600","qualifier_name":"supply & distribution","is_major_topic":true},{"descriptor_ui":"D017277","descriptor_name":"Drug Approval","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":true},{"descriptor_ui":"D017277","descriptor_name":"Drug Approval","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D017387","descriptor_name":"Investigational New Drug Application","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":true},{"descriptor_ui":"D040541","descriptor_name":"Marketing","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":false}],"locations_count":4,"locations":[{"id":"pmid:12856462","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/12856462","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Annals of health law","raw_type":"Journal Article"},{"id":"pmh:oai:lawecommons.luc.edu:annals-1243","doi":null,"is_oa":true,"landing_page_url":"https://lawecommons.luc.edu/annals/vol12/iss2/9","pdf_url":"https://lawecommons.luc.edu/cgi/viewcontent.cgi?article=1243&context=annals","source":{"id":"https://openalex.org/S7407064349","display_name":"bepress Legal Repository","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Annals of Health Law","raw_type":"text"},{"id":"pmh:oai:repository.library.georgetown.edu:10822/523740","doi":null,"is_oa":false,"landing_page_url":"http://hdl.handle.net/10822/523740","pdf_url":null,"source":{"id":"https://openalex.org/S4306402467","display_name":"DigitalGeorgetown (Georgetown University Library)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4210145449","host_organization_name":"Center for Security and Emerging Technology","host_organization_lineage":["https://openalex.org/I4210145449"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"260206","raw_type":null},{"id":"mag:6233636","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/12856462","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":null,"is_accepted":false,"is_published":false,"raw_source_name":"PubMed","raw_type":null}],"best_oa_location":{"id":"pmh:oai:lawecommons.luc.edu:annals-1243","doi":null,"is_oa":true,"landing_page_url":"https://lawecommons.luc.edu/annals/vol12/iss2/9","pdf_url":"https://lawecommons.luc.edu/cgi/viewcontent.cgi?article=1243&context=annals","source":{"id":"https://openalex.org/S7407064349","display_name":"bepress Legal Repository","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Annals of Health Law","raw_type":"text"},"sustainable_development_goals":[],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W6233636.pdf","grobid_xml":"https://content.openalex.org/works/W6233636.grobid-xml"},"referenced_works_count":32,"referenced_works":["https://openalex.org/W211447969","https://openalex.org/W1971162866","https://openalex.org/W1971264196","https://openalex.org/W1972915587","https://openalex.org/W1992063573","https://openalex.org/W1996478925","https://openalex.org/W2002224654","https://openalex.org/W2012775663","https://openalex.org/W2012851909","https://openalex.org/W2015494448","https://openalex.org/W2018439671","https://openalex.org/W2035261996","https://openalex.org/W2040922044","https://openalex.org/W2041097640","https://openalex.org/W2049165791","https://openalex.org/W2062815987","https://openalex.org/W2068032736","https://openalex.org/W2071114211","https://openalex.org/W2072219714","https://openalex.org/W2075513376","https://openalex.org/W2079767283","https://openalex.org/W2085542509","https://openalex.org/W2086193772","https://openalex.org/W2091001043","https://openalex.org/W2109973761","https://openalex.org/W2122656874","https://openalex.org/W2409533450","https://openalex.org/W2412015580","https://openalex.org/W2419514451","https://openalex.org/W2471264718","https://openalex.org/W2887815066","https://openalex.org/W2914380063"],"related_works":["https://openalex.org/W4233804624","https://openalex.org/W4300279643","https://openalex.org/W2177282154","https://openalex.org/W1703562667","https://openalex.org/W2380296882","https://openalex.org/W1608355873","https://openalex.org/W4230907304","https://openalex.org/W7097741644","https://openalex.org/W3162560322","https://openalex.org/W2313180320"],"abstract_inverted_index":{"In":[0],"order":[1],"to":[2,20,34,80,94],"close":[3],"the":[4,7,30,41,51,66,74,77,85,101,104,112,124],"loophole":[5],"in":[6,65,84],"generic":[8,24,57,88],"drug":[9,17,25,48,58,96],"approval":[10],"process":[11],"that":[12,55],"allows":[13],"a":[14,46,56,69],"brand":[15],"name":[16],"patent":[18,42,70,119],"holder":[19],"delay":[21],"or":[22],"defeat":[23],"application":[26,59],"merely":[27],"by":[28],"technicality,":[29],"FDA":[31,78],"recently":[32],"proposed":[33,105,113],"modify":[35],"its":[36],"regulations.":[37],"Those":[38],"proposals":[39],"affect":[40],"listing":[43],"requirements":[44],"of":[45,53,68,87,103,111],"new":[47],"application,":[49],"and":[50,107,121],"duration":[52],"time":[54],"could":[60],"be":[61],"put":[62],"on":[63,118,123],"hold":[64],"event":[67],"infringement":[71],"suit.":[72],"With":[73],"modified":[75],"rules,":[76],"expects":[79],"see":[81],"an":[82,109],"increase":[83],"availability":[86],"drugs,":[89],"which":[90],"eventually":[91],"will":[92],"lead":[93],"lower":[95],"costs.":[97],"Ms.":[98],"Hui":[99],"discusses":[100],"contents":[102],"regulations":[106],"provides":[108],"analysis":[110],"rule's":[114],"legal":[115],"authority,":[116],"implications":[117],"rights,":[120],"impact":[122],"pharmaceutical":[125],"industry.":[126]},"counts_by_year":[{"year":2021,"cited_by_count":1},{"year":2019,"cited_by_count":1},{"year":2012,"cited_by_count":1}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2016-06-24T00:00:00"}
