3D Bioprinting and Biologics: A Look at Patent and FDA Market Exclusivity Strategies

The industrialization of 3D printing opens the possibility of making products efficiently with complex structure previously thought impossible or impractical using the tools of the first industrial revolution. Early industrial applications of 3D printed metal parts lowered the weight and reduced the number of components for highly engineered components, such as jet aircraft engine parts. As innovators seek to increase applications, much effort has been underway to expand available materials to include biopolymers and even tissue or cells. 

3D bioprinting employs 3D printing and similar techniques to combine cells, growth factors, and biocompatible materials to fabricate products that mimic natural materials such as printed bone, skin, arteries, and even whole organs. The promise of 3D bioprinting is to leverage the computer-controlled, layer-by-layer additive process of 3D printing to selectively deposit cells to build complex living tissues that can be used in patients. Because the cells can come from the patient, there would be no need for organ donors, and lessened risk of transplant rejection.    

Bringing these 3D bioprinted products to market will require significant investment in order to gain marketing approval from the Food & Drug Administration (FDA). The question immediately arises as to whether innovators in 3D bioprinting will be able to leverage enough patent and FDA marketing exclusivity to make their investment worthwhile. Both (1) the type of patents available and (2) the regulatory pathway chosen will determine the amount of exclusivity available for first movers.

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