Beyond specific regulations relating to manufacturing and safety, broader legal issues accompany the entire ‘journey’ of a cell therapy product: from procurement of the starting material to efforts of testing and development and operating in a medical marketplace. This chapter charts some legal considerations including the USA, EU, and UK law relating to consent, privacy, preclinical and clinical research, placing on the market, intellectual property protection, and medical commence as they uniquely shape innovation trajectories in cell therapies. These factors need to be considered from the inception of cell therapy and addressed strategically throughout its lifecycle.

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Challenges in the Patent and Legal Environment for Cell Therapies

  • Sebastian Sethe

摘要

Beyond specific regulations relating to manufacturing and safety, broader legal issues accompany the entire ‘journey’ of a cell therapy product: from procurement of the starting material to efforts of testing and development and operating in a medical marketplace. This chapter charts some legal considerations including the USA, EU, and UK law relating to consent, privacy, preclinical and clinical research, placing on the market, intellectual property protection, and medical commence as they uniquely shape innovation trajectories in cell therapies. These factors need to be considered from the inception of cell therapy and addressed strategically throughout its lifecycle.