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3D printing of Pharmaceuticals: patent and regulatory challenges

机译：3D印刷药品：专利和监管挑战

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摘要

"This article explores some possible issues relating to the procurement and enforcement of intellectual property rights in respect to 3D printing-related products and processes..." Additive manufacturing, specifically 3D printing (3DP), has been in use in the manufacture of medical devices for some time, with the US FDA recently issuing draft guidance for technical considerations in this regard . More recently, however, attention has turned to the use of these techniques in manufacturing pharmaceuticals, in particular pharmaceutical dosage forms including orally administrable dosage forms and drug-loaded implants. In addition to the technical challenges faced by inventors in this field, there are a number of regulatory and legal issues to be addressed. This article explores some possible issues relating to the procurement and enforcement of intellectual property rights in respect to 3DP-related products and processes, and other potential issues arising at the interface of 3 DP pharmaceuticals with regulation and consumer protection.
机译：“本文探讨了关于3D打印相关产品和流程的知识产权采购和执行有关的一些可能的问题......”添加剂制造，特别是3D打印（3DP），已经在医疗的制造中使用设备一段时间，与美国FDA最近发布了这方面的技术考虑草案。然而，最近，注意力已经转向使用这些技术在制造药物中，特别是药物用量形式，包括口服可管理的剂型和药物植入物。除了本发明人面临的技术挑战之外，还有许多监管和法律问题要解决。本文探讨了与3DP相关产品和流程的知识产权采购和执行有关的一些可能的问题，以及在3名DP药物的界面产生的其他潜在问题，具有监管和消费者保护。

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