药品-器械组合产品的专利“常青化”：全球视角。
Patent "Evergreening" of Medicine-Device Combination Products: A Global Perspective.
机构信息
Assistant Professor, Department of Community Health Sciences, Cummings School of Medicine, University of Calgary, Calgary, AB.
Research Assistant, Department of Community Health Sciences, Cummings School of Medicine, University of Calgary, Calgary, AB.
出版信息
Healthc Policy. 2022 Oct;18(2):14-26. doi: 10.12927/hcpol.2022.26973.
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.
背景
当药物输送装置（吸入器和笔）的专利保护范围超出基础治疗药物时，其专利申请就颇具争议。我们评估了国际上药物输送装置专利申请的普遍程度。
方法
利用产品样本（n=88）和国际专利数据库，我们评估了这一问题的范围。
结果
比较每个国家/地区的 88 个产品专利组合，发现加拿大受影响最大，90%的专利组合至少包含一项装置专利，35%的专利组合仅包含装置专利。
结论
药物输送装置的专利申请影响着全球主要的制药制造中心。利益相关者（监管机构和支付方）需要在国际范围内就哪些装置改进具有有意义的临床价值达成共识。
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