Patent and Exclusivity Status of Essential Medicines for Non-Communicable Disease
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Mendeley | Further Information

{"title"=>"Patent and Exclusivity Status of Essential Medicines for Non-Communicable Disease", "type"=>"journal", "authors"=>[{"first_name"=>"Tim K.", "last_name"=>"Mackey", "scopus_author_id"=>"30067646600"}, {"first_name"=>"Bryan A.", "last_name"=>"Liang", "scopus_author_id"=>"36658720400"}], "year"=>2012, "source"=>"PLoS ONE", "identifiers"=>{"sgr"=>"84870675657", "doi"=>"10.1371/journal.pone.0051022", "pui"=>"366215617", "pmid"=>"23226453", "scopus"=>"2-s2.0-84870675657", "issn"=>"19326203", "isbn"=>"1932-6203 (Electronic)\\r1932-6203 (Linking)"}, "id"=>"e3b09373-a9e3-3ab5-8b3d-d9a47fba5361", "abstract"=>"OBJECTIVE: The threat of non-communicable diseases (\"NCDs\") is increasingly becoming a global health crisis and are pervasive in high, middle, and low-income populations resulting in an estimated 36 million deaths per year. There is a need to assess intellectual property rights (\"IPRs\") that may impede generic production and availability and affordability to essential NCD medicines.\\n\\nMETHODS: Using the data sources listed below, the study design systematically eliminated NCD drugs that had no patent/exclusivity provisions on API, dosage, or administration route. The first step identified essential medicines that treat certain high disease burden NCDs. A second step examined the patent and exclusivity status of active ingredient, dosage and listed route of administration using exclusion criteria outlined in this study.\\n\\nMATERIALS: We examined the patent and exclusivity status of medicines listed in the World Health Organization's (\"WHO\") Model List of Essential Drugs (Medicines) (\"MLEM\") and other WHO sources for drugs treating certain NCDs. i.e., cardiovascular and respiratory disease, cancers, and diabetes. We utilized the USA Food and Drug Administration Orange Book and the USA Patent and Trademark Office databases as references given the predominant number of medicines registered in the USA.\\n\\nRESULTS: Of the 359 MLEM medicines identified, 22% (79/359) address targeted NCDs. Of these 79, only eight required in-depth patent or exclusivity assessment. Upon further review, no NCD MLEM medicines had study patent or exclusivity protection for reviewed criteria.\\n\\nCONCLUSIONS: We find that ensuring availability and affordability of potential generic formulations of NCD MLEM medicines appears to be more complex than the presence of IPRs with API, dosage, or administration patent or exclusivity protection. Hence, more sophisticated analysis of NCD barriers to generic availability and affordability should be conducted in order to ensure equitable access to global populations for these essential medicines.", "link"=>"http://www.mendeley.com/research/patent-exclusivity-status-essential-medicines-noncommunicable-disease", "reader_count"=>43, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Librarian"=>1, "Researcher"=>7, "Student > Doctoral Student"=>3, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>3, "Student > Master"=>7, "Other"=>3, "Student > Bachelor"=>9, "Lecturer"=>2, "Lecturer > Senior Lecturer"=>1, "Professor"=>2}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Librarian"=>1, "Researcher"=>7, "Student > Doctoral Student"=>3, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>3, "Student > Master"=>7, "Other"=>3, "Student > Bachelor"=>9, "Lecturer"=>2, "Lecturer > Senior Lecturer"=>1, "Professor"=>2}, "reader_count_by_subject_area"=>{"Unspecified"=>3, "Environmental Science"=>1, "Medicine and Dentistry"=>20, "Agricultural and Biological Sciences"=>4, "Pharmacology, Toxicology and Pharmaceutical Science"=>4, "Business, Management and Accounting"=>1, "Social Sciences"=>6, "Computer Science"=>1, "Immunology and Microbiology"=>1, "Economics, Econometrics and Finance"=>2}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>20}, "Social Sciences"=>{"Social Sciences"=>6}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>4}, "Computer Science"=>{"Computer Science"=>1}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Unspecified"=>{"Unspecified"=>3}, "Environmental Science"=>{"Environmental Science"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>4}}, "reader_count_by_country"=>{"Cameroon"=>1, "United States"=>1, "India"=>1}, "group_count"=>1}

Scopus | Further Information

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Figshare

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  • {"files"=>["https://ndownloader.figshare.com/files/533698"], "description"=>"<p>NCD Drugs and USPTO Criteria for Non-Inclusion in IPR Barrier Analysis.</p>", "links"=>[], "tags"=>["drugs", "uspto", "non-inclusion", "ipr"], "article_id"=>204191, "categories"=>["Science Policy", "Biochemistry", "Biotechnology", "Pharmacology", "Medicine"], "users"=>["Tim K. Mackey", "Bryan A. Liang"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0051022.t004"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_NCD_Drugs_and_USPTO_Criteria_for_Non_Inclusion_in_IPR_Barrier_Analysis_/204191", "title"=>"NCD Drugs and USPTO Criteria for Non-Inclusion in IPR Barrier Analysis.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-02-19 19:27:50"}
  • {"files"=>["https://ndownloader.figshare.com/files/533729"], "description"=>"<p>Orange Book and USPTO Non-Inclusion Criteria Summary and Examples.</p>", "links"=>[], "tags"=>["uspto", "non-inclusion"], "article_id"=>204228, "categories"=>["Science Policy", "Biochemistry", "Biotechnology", "Pharmacology", "Medicine"], "users"=>["Tim K. Mackey", "Bryan A. Liang"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0051022.t002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Orange_Book_and_USPTO_Non_Inclusion_Criteria_Summary_and_Examples_/204228", "title"=>"Orange Book and USPTO Non-Inclusion Criteria Summary and Examples.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-02-19 19:28:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/533764"], "description"=>"<p><b>Additional Note:</b> For Targeted NCD medicines which addressed more than one Targeted NCD, frequency was attributed to all categories addressed.</p>", "links"=>[], "tags"=>["therapeutic", "targeted", "ncd"], "article_id"=>204261, "categories"=>["Science Policy", "Biochemistry", "Biotechnology", "Pharmacology", "Medicine"], "users"=>["Tim K. Mackey", "Bryan A. Liang"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0051022.t003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Frequency_of_Therapeutic_Category_for_Targeted_NCD_Medicines_/204261", "title"=>"Frequency of Therapeutic Category for Targeted NCD Medicines.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-02-19 19:28:10"}
  • {"files"=>["https://ndownloader.figshare.com/files/533790"], "description"=>"<p>Sources: WHO Model List of Essential Medicines, 17<sup>th</sup> List.</p>", "links"=>[], "tags"=>["targeted", "ncd", "medicines"], "article_id"=>204284, "categories"=>["Science Policy", "Biochemistry", "Biotechnology", "Pharmacology", "Medicine"], "users"=>["Tim K. Mackey", "Bryan A. Liang"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0051022.t001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Final_Targeted_NCD_Medicines_List_/204284", "title"=>"Final Targeted NCD Medicines List.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-02-19 19:28:19"}

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Relative Metric

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