Tissue or organ replacement is a medical phenomenon that has saved human lives over the decades. With 3D bioprinting, where functional living human tissues and organs can be fabricated using 3D printing technology, the field has charted a new path, acquired more relevance, and provokes many questions, ethical, medical, legal and beyond. As with any cutting-edge technology, 3D bioprinting is of particular interest in the world of patents, but encounters challenges in various forms in India. This article discusses some of these issues of patenting 3D bioprinting in India.
What is 3D bioprinting?
3D bioprinting is a subset of 3D printing that involves the fabrication of a functional living human tissue or organ constructed from a 3D digital model. The fabrication process involves layer-by-layer printing and positioning of biological materials, biochemicals and living cells, to obtain a tissue or organ that can faithfully replicate a biological function.
The 3D bioprinting process involves three major stages: (i) pre-processing; (ii) processing/production; and (iii) post-processing. In the pre-processing stage, 3D models of the tissue/organ to be printed are constructed using bioimaging and computer assisted design (“CAD”). These models serve as a blueprint for the printing process. The processing/production stage entails the actual printing of the tissue/organ, while post-processing is the phase of maturation and growth of the printed biomaterial.
Patents can be filed at any stage of the process and can encompass diverse technological areas such as CAD technology for developing the 3D models, 3D printer hardware, and the 3D printed tissue/organ itself. This article discusses the last of these, i.e., the 3D bioprinted material, with a particular focus on the Indian jurisdiction.
Are 3D bioprinted materials patentable in India?
The most controversial patents in this field tend to be patents in the production stage, i.e., patents directed towards 3D printed organs, that cover not just the printed biomaterial, but methods of printing the construct and the bioinks used for printing. Subject matter that could pose a challenge here include product claims related to the bioprinted construct, and bioinks. These claims could fall within various exclusions to patentability under Section 3 of the Indian Patents Act (“the Act”), specifically:
- Section 3(b): Morality exclusions;
- Section 3(d): New use for a known substance and new use of known method;
- Section 3(e): A substance obtained by a mere admixture; and
- Section 3(j): Plants and animals in whole or part other than microorganisms.
Section 3(b): Morality exclusions
Section 3(b) bars the patenting of inventions contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment. In the subject area, Section 3(b) is mostly applied to patents which utilize pluripotent or embryonic stem cells (“ESCs”), on the grounds that the use of such ESCs leads to the destruction of the embryo. If a bioprinted construct relies on the use of such cells, an applicant must demonstrate, with reference to the specification, that the ESCs were obtained by methods/sources which do not involve destroying the embryo. Thus, while constructs using induced pluripotent stem cells may still be deemed patentable, if an invention uses human embryonic stem cell lines, it would most likely not be patentable as these also involve destroying the embryo at some point in time.
Section 3(j): Plants and animals
Another significant hurdle to the patentability of 3D bioprinting inventions is posed by Section 3(j) which bars patenting of plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals. 3D bioprinted tissue constructs or organs are often construed as a part of an animal by the Indian Patent Office (“IPO”). As the 3D bioprinting space and inventions related to biomimicry are still only growing in India, limited legal precedence is available. To overcome such objections, one recourse is to demonstrate how the claimed bioprinted construct differs from natural tissue/organs.
While 3D bioprinting seeks to replicate biological structure and function, the printing process poses inherent challenges that make bioprinted tissues and organs different from their natural human counterparts, for instance, in cell density, tissue layer structures, gene expression, and the nature of the materials used to mimic biological function. Thus, overcoming Sections 3(j) requires walking the tightrope between illustrating how ‘unnatural' a bioprinted construct is, without compromising the technical achievement of developing a near-perfect reproduction of a human tissue/organ.
Sections 3(d) and (e): New forms/uses for known substances/processes, and admixtures
Sections 3(d) and (e) are comparatively less challenging hurdles than the exceptions to patentability described previously. Section 3(d) bars the patenting of the mere discovery of a new form of a known substance that does not enhance the known efficacy of that substance, or of a new use for a known substance or process (unless the process results in a new product or employs at least one new reactant).
Objections under Section 3(d) would normally arise when the IPO requires an applicant to demonstrate the technical effect of an invention over the prior art. Method claims directed to 3D bioprinting could be objected to under this provision and thus, the objective would be to demonstrate the technical advance of the printing method over the cited prior art.
Similarly, Section 3(e) could be cited against compositions claimed in a bioprinting patent, such as bioink compositions. This provision is only applicable if the composition does not comprise any novel ingredient [See IPAB decision OA/03/2017/PT/CHN, August 7, 2020]. If the composition does not comprise such a novel ingredient, then the applicant must demonstrate that the combination of the ingredients functions synergistically and achieves a technical effect that is not achieved by the cited prior art. However, if the composition comprises ESCs then patentability could be problematic as it would also fall under the ambit of Section 3(b).
The default position for 3D bioprinted inventions in India would be that they are patentable per se. But, as discussed in this note, some caveats apply. Generally, patents claiming methods of 3D bioprinting tissue/organ constructs have better prospects of patentability, and need to be prepared at best to be challenged by Section 3(d). The difficulty arises with product claims directed to tissue or organ constructs themselves, that are likely to be objected to under Section 3(j). The patentability of such claims will, of course, vary on a case-to-case basis at the IPO, and is dependent upon the applicant successfully arguing the difference between real tissues/organs and the bioprinted ones. Finally, for patent applications using ESCs, it is useful to demonstrate that the use of stem cells did not involve the destruction of embryos citing examples from the specification of the patent application itself.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.