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LimeGreenIP News

US: Bioprinting – A life sciences and legal innovation

The patent eligibility of bioprinted products and processes has not been squarely addressed by the legislature or tested in courts. Arlene Chow and Nitya Anand explain what could be done in the future in this article, first published in issue #35 of IPPro Patents.

The medical industry is undergoing a radical transformation, thanks to recent advances in 3D (otherwise known as additive) printing. 3D printing creates three dimensional objects by building up layers of material. A commonly-used analogy is the building of a structure with layer upon layer of lego bricks. Bioprinting, in turn, takes the basic premise of 3D printing and applies it in the context of human cells and tissues—one of bioprinting’s most dramatic applications is the layered printing of living cells to form a 3D organ structure.

The hope is that such 3D printed organs can sidestep rejection (a major concern for organ transplants) and function as well as the original organ within a human. As with many cutting edge technologies, it is unclear whether innovators in this space can adequately protect their inventions with patents and more specifically, whether certain bioprinting products and processes are even eligible for protection.

“There is no legislative guidance on the undefined terms ‘directed to’ and ‘human organism’. This vague wording could negatively affect the patent eligibility of bioprinting innovations” Arlene Chow

“Innovators should capture their inventions with a wide variety of patent claims, framed to emphasise the manmade and non-naturally  occurring aspects of this cutting edge technology” Nitya Anand

The current patent eligibility framework… Read the full article