History, opportunities and challenges for protecting gene therapies: perspectives from private practice and industry

Recent years have seen an explosion of advanced therapies, many of which are based on personalised immune cells, individually edited using gene editing techniques. This technological advancement presents great opportunities to patients and the healthcare industry as a whole, but also presents challenges to established commercial principles, including logistics, pricing, and protection. The patent system provides companies with period of exclusivity in return for the disclosure of their invention. This well-established system allows companies to recoup some of the R&D costs associated with innovation, offsetting some of the costs incurred by innovation which does not reach the market, for example due to low success rate of developing drugs to the clinic. Here we explore the opportunities and challenges facing companies as they look to develop robust patent protection around a gene therapy, considering the challenges and opportunities facing companies looking to protect innovation in this space, and how this differs from protecting traditional therapies, e.g., therapeutic antibodies.

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