Reed F Beall, Tali Glazer, Haris Ahmad, Mikayla Buell, Slane Hahn, Adam R Houston, Aaron S Kesselheim, Jason W Nickerson, Warren Kaplan
{"title":"医疗器械组合产品专利“常青”：全球视野。","authors":"Reed F Beall, Tali Glazer, Haris Ahmad, Mikayla Buell, Slane Hahn, Adam R Houston, Aaron S Kesselheim, Jason W Nickerson, Warren Kaplan","doi":"10.12927/hcpol.2022.26973","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Patenting medicine-delivery devices (inhalers and pens) is controversial when it extends market protections beyond that of the underlying therapeutic agent. We evaluated how common device patenting is, internationally.</p><p><strong>Method: </strong>Using a product sample (n = 88) and an international patent database, we assessed the issue's scope.</p><p><strong>Results: </strong>When comparing the 88 patent portfolios for each product in each country, Canada was found to be among the most impacted, with 90% of the portfolios containing at least one device patent and 35% of the portfolios containing device patents exclusively.</p><p><strong>Conclusion: </strong>Patenting of delivery devices impacts major pharmaceutical manufacturing centres worldwide. International consensus among stakeholders (regulators and payors) is needed on which device modifications represent meaningful clinical value.</p>","PeriodicalId":39389,"journal":{"name":"Healthcare Policy","volume":"18 2","pages":"14-26"},"PeriodicalIF":0.0000,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9764446/pdf/","citationCount":"1","resultStr":"{\"title\":\"Patent \\\"Evergreening\\\" of Medicine-Device Combination Products: A Global Perspective.\",\"authors\":\"Reed F Beall, Tali Glazer, Haris Ahmad, Mikayla Buell, Slane Hahn, Adam R Houston, Aaron S Kesselheim, Jason W Nickerson, Warren Kaplan\",\"doi\":\"10.12927/hcpol.2022.26973\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Patenting medicine-delivery devices (inhalers and pens) is controversial when it extends market protections beyond that of the underlying therapeutic agent. We evaluated how common device patenting is, internationally.</p><p><strong>Method: </strong>Using a product sample (n = 88) and an international patent database, we assessed the issue's scope.</p><p><strong>Results: </strong>When comparing the 88 patent portfolios for each product in each country, Canada was found to be among the most impacted, with 90% of the portfolios containing at least one device patent and 35% of the portfolios containing device patents exclusively.</p><p><strong>Conclusion: </strong>Patenting of delivery devices impacts major pharmaceutical manufacturing centres worldwide. International consensus among stakeholders (regulators and payors) is needed on which device modifications represent meaningful clinical value.</p>\",\"PeriodicalId\":39389,\"journal\":{\"name\":\"Healthcare Policy\",\"volume\":\"18 2\",\"pages\":\"14-26\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9764446/pdf/\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Healthcare Policy\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.12927/hcpol.2022.26973\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Healthcare Policy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.12927/hcpol.2022.26973","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
Patent "Evergreening" of Medicine-Device Combination Products: A Global Perspective.
Background: Patenting medicine-delivery devices (inhalers and pens) is controversial when it extends market protections beyond that of the underlying therapeutic agent. We evaluated how common device patenting is, internationally.
Method: Using a product sample (n = 88) and an international patent database, we assessed the issue's scope.
Results: When comparing the 88 patent portfolios for each product in each country, Canada was found to be among the most impacted, with 90% of the portfolios containing at least one device patent and 35% of the portfolios containing device patents exclusively.
Conclusion: Patenting of delivery devices impacts major pharmaceutical manufacturing centres worldwide. International consensus among stakeholders (regulators and payors) is needed on which device modifications represent meaningful clinical value.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
