The concept of 3D printed pharmaceuticals came with the vision of dosage individualization and thought to be one of the milestones in the advances of medical science. The technology of 3D printing has evolved tremendously in the recent years, and with this, the hope of achieving the goal of dosage individualization has evolved. This is also a reminder of responsibility for government to engage in upbringing of this new technology and frame necessary laws and regulation to improve patentability, infringements, and relevant legal issues. The major challenge can arise from the 3D printing process, materials used for printing, active pharmaceutical ingredient use, and usage in times of emergency and pandemics. Since the 3D printing technology cannot be developed by single person and is even difficult for single company to achieve any landmark in the technology, the regulations are needed to facilitate collaboration at global level for any positive outcome. The chapter sheds light on an imperative information pertaining to current scenario of patentability of 3D pharmaceutical technologies and regulations to safeguard the rights of developer at country level and global level. The scope further extends to novelty, legality, applications, need of skillsets, sales and licencing of technology, and upscaling of technology at industrial level. Nonetheless keeping in mind, the technology must be generalized to population and must not be limited to a section of the population to avoid any disparity and social stigma.

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Patent, Intellectual Property and Legal Issues in 3D Printed Pharmaceuticals

  • Hemraj Singh Rajput,
  • Shweta Bhandari,
  • Avinash Khadela,
  • Sagar Pamu

摘要

The concept of 3D printed pharmaceuticals came with the vision of dosage individualization and thought to be one of the milestones in the advances of medical science. The technology of 3D printing has evolved tremendously in the recent years, and with this, the hope of achieving the goal of dosage individualization has evolved. This is also a reminder of responsibility for government to engage in upbringing of this new technology and frame necessary laws and regulation to improve patentability, infringements, and relevant legal issues. The major challenge can arise from the 3D printing process, materials used for printing, active pharmaceutical ingredient use, and usage in times of emergency and pandemics. Since the 3D printing technology cannot be developed by single person and is even difficult for single company to achieve any landmark in the technology, the regulations are needed to facilitate collaboration at global level for any positive outcome. The chapter sheds light on an imperative information pertaining to current scenario of patentability of 3D pharmaceutical technologies and regulations to safeguard the rights of developer at country level and global level. The scope further extends to novelty, legality, applications, need of skillsets, sales and licencing of technology, and upscaling of technology at industrial level. Nonetheless keeping in mind, the technology must be generalized to population and must not be limited to a section of the population to avoid any disparity and social stigma.