Abstract：
UNASSIGNED: Medical devices can seek patent term extensions (PTEs), which extend market exclusivity to compensate for delays related to clinical trials and regulatory review. Pharmaceutical companies commonly use PTEs, but their use by medical device companies has not been clear.
UNASSIGNED: We examined the use of PTEs by medical device companies between 1984 and 2024 using a database published in the Federal Register and a list published by the Patent and Trademark Office.
UNASSIGNED: Only 178 medical device submissions were linked to a PTE application. They were mostly concentrated in 116 product codes associated with 15 medical specialties; nearly half were associated with cardiovascular devices. Numbers increased significantly in the past decade. Successful applications restored 987 days on average.
UNASSIGNED: The patent restoration opportunity appears underutilized. It is unclear whether some companies do not recognize the opportunity it promises, or whether it does not meet their needs. Different business features and marketing strategies in device versus pharmaceutical industries may decrease the usefulness of the PTE program for these types of medical products. However, the finding that a small subset of manufacturers operating in competitive markets adopted patent extension strategies more commonly suggests a significant competitive advantage when competition increases.
UNASSIGNED: We examined the use of PTEs by medical device companies between 1984 and 2024 using a database published in the Federal Register and a list published by the Patent and Trademark Office.
UNASSIGNED: Only 178 medical device submissions were linked to a PTE application. They were mostly concentrated in 116 product codes associated with 15 medical specialties; nearly half were associated with cardiovascular devices. Numbers increased significantly in the past decade. Successful applications restored 987 days on average.
UNASSIGNED: The patent restoration opportunity appears underutilized. It is unclear whether some companies do not recognize the opportunity it promises, or whether it does not meet their needs. Different business features and marketing strategies in device versus pharmaceutical industries may decrease the usefulness of the PTE program for these types of medical products. However, the finding that a small subset of manufacturers operating in competitive markets adopted patent extension strategies more commonly suggests a significant competitive advantage when competition increases.
摘要：
■医疗器械可以寻求专利期限延长（PTE），扩大市场独占性，以弥补与临床试验和监管审查相关的延误。制药公司通常使用PTE，但是医疗器械公司对它们的使用还不清楚。
■我们使用《联邦公报》上公布的数据库和专利商标局公布的列表，检查了1984年至2024年间医疗器械公司使用PTE的情况。
■只有178个医疗设备提交与PTE应用程序相关联。它们主要集中在与15个医学专业相关的116个产品代码中；近一半与心血管设备相关。在过去的十年中，数字显着增加。成功的申请平均恢复了987天。
■专利恢复机会似乎没有得到充分利用。目前还不清楚一些公司是否没有意识到它承诺的机会，或者它是否不满足他们的需求。设备与制药行业的不同业务特征和营销策略可能会降低PTE计划对这些类型医疗产品的有用性。然而,这一发现表明，在竞争激烈的市场中经营的一小部分制造商更普遍地采用专利扩展策略，这表明当竞争加剧时，竞争优势显著。
■我们使用《联邦公报》上公布的数据库和专利商标局公布的列表，检查了1984年至2024年间医疗器械公司使用PTE的情况。
■只有178个医疗设备提交与PTE应用程序相关联。它们主要集中在与15个医学专业相关的116个产品代码中；近一半与心血管设备相关。在过去的十年中，数字显着增加。成功的申请平均恢复了987天。
■专利恢复机会似乎没有得到充分利用。目前还不清楚一些公司是否没有意识到它承诺的机会，或者它是否不满足他们的需求。设备与制药行业的不同业务特征和营销策略可能会降低PTE计划对这些类型医疗产品的有用性。然而,这一发现表明，在竞争激烈的市场中经营的一小部分制造商更普遍地采用专利扩展策略，这表明当竞争加剧时，竞争优势显著。
