Reed F Beall, Tali Glazer, Haris Ahmad, Mikayla Buell, Slane Hahn, Adam R Houston, Aaron S Kesselheim, Jason W Nickerson, Warren Kaplan
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引用次数: 1
Abstract
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.
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