Patenting Of Bioprinting 3d Organs
Author: LawSphereX
Category: Intellectual Property
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PATENTING OF BIOPRINTING 3D ORGANS
Niranjana K A, Alliance University
ABSTRACT
Bioprinting is the 3D printing of organs or tissues, which is the hope to resolving the shortage of organ transplantation. In today’s patent laws, patenting bioprinting does face few challenges. This article explores into the patentability of bioprinting of organs in US and India, the various challenges of patenting of bioprinting. This also delves into understanding what is bioprinting and the mechanisms of bioprinting and the usage of biomaterials. Bioprinting has the potential to become the alternate option for many for organ transplantation. Keywords: Bioprinting, 3D organs, human embryotic stem cells, bioprinted products
INTRODUCTION
In our world, where new innovations emerge regularly, patents plays a crucial role in protecting these innovations. Patent is an intellectual property right given for inventions, this provides the inventor to commercially exploit his invention and prevent others from doing the same without the inventor’s authorization, for a limited period of time of 20 years. This is provided to inventors to earn a profit from their invention and also to boost innovations in the society. Patents covers a wide range of inventions like machines and processes, this includes biotechnology. From agriculture to medicine, Biotechnology is a field that is rapidly evolving, it merges the use of biologicals or living organisms with cutting edge technology to make a product. This has been used in various sectors like agriculture, medicine, environmental remedies.
The best way of protecting biotechnological inventions is through patent, but it has faced few hurdles to receive patent protection, because of the use of biologicals and under patent living organisms are non-patentable. The landmark judgement of the case Diamond vs. Chakrabarty, brought the challenges of patenting biotechnological innovations to the limelight. In the case, a scientist who created a genetically modified bacteria capable of breaking down crude oil sought patent for his invention and this brought the issue whether living organism could be patented and later the US Supreme Court ruled in favour of Chakrabarty for this invention. 1 This case has had a significant impact in the field of biotechnology and opened the doors for patenting biotechnological inventions, positively impacting the advancements in medicine, agriculture and the protection of environment.
There are various fields in which biotechnology has been used like Genetically Modified Crops, Biofertilizers, Biofuels, Biosensors, Vaccines, Gene Therapy, Bioprinting etc. In the recent times, bioprinting has been an upcoming technology used to print 3D organs or tissues which have the capabilities to function like real organ or tissues. In the global scenario there is organ transplant shortage, especially for lifesaving transplants, the potential solution to this is 3D printing of organs. 2
1 Diamond vs. Chakrabarty, 447 U.S 303 (1980)
The Guardian, https://www.theguardian.com/technology/2017/jul/30/will-3d-printing-solve-the-organtransplant-shortage WHAT IS BIOPRINTING?
Until 2015 the word “Bioprinting” was not recognized, around this year it was added into the Oxford dictionary. 3 Bioprinting is the use of technology and biomaterials to create to live 3D tissue models. 4 This process of bioprinting is similar to the process of printing 3D objects; it uses an image as a reference to print the desired object layer by layer. 3D printing is to make jewelleries, toys, furniture, parts of cars etc and uses inorganic materials to make them, whereas bioprinting would use bioinks and live cells to print 3D organs. Bioprinting organs and tissues can have various applications like research in medicine, drug development, tissue engineering. 5 Printing 3D organs allows customization of organ which would fit each individual patient perfectly.
The advancements in the field on bioprinting has the potential to create transplantable customized organs, which would reduce the risk of organ rejection, the process of bioprinting 3D organs to fit a patient would use the patient’s own cells to print the desired new tissue or organs. 6 This is potential solution to deal with the ongoing organ transplant shortage, if it is developed to its fullest potential, it could be cheaper alternate to the traditional organ transplant. The main goal of bioprinting is to solve the ongoing organ donor issue, patients have to wait on organs waitlists which could take years. Bioprinting provides a solution to this issue, as it has the potential to print 3D organs and reduce the waiting time for them.
In the case children and young adults, the organs they might require needs to be acquired from young donors, bioprinting organs could tackle this issue, a bioprinted organ which grow along with other organs. 7 Bioprinting 3D organs seems to be the better alternative to the use of genetically altered cells or use of embryotic cells. There are so many biotechnological companies in the business of bioprinting, developing bioprinters, making biomaterials which would be used in the bioprinters to develop bioprinted
3 3D Print.com, https://3dprint.com/47533/bioprinting-definition/
4 Cellink, https://www.cellink.com/blog/bioprinting-explained-simply/
5 Dr Mirjana Stankovic, Dr Bratislav Stankovic, Ravi Gupta, Patentability, Global Development and Ethical Considerations of Bioprinting, World Bank, https://thedocs.worldbank.org/en/doc/a5f01b13b6f78768a5931f97edcba111-0260012017/original/patentbioprininting.pdf
6 Cellink, https://www.cellink.com/blog/3d-printed-organs/
7 Niki Vermeulen, Gill Haddow, Tirion Seymour, Alan Faulkner-Jones and Wenmiao Shu, 3D bioprint me: a socioethical view of bioprinting human organs and tissues, Vol. 43, Journal of Medical Ethics, 618-624, 621, (2017) organs. Organovo develops functional human tissue for medical and research purposes, Cellink develops bioprinters and bioinks, TeVido Biodevices use 3D printers for reconstructive and cosmetic surgeries, Advanced Solution Life Sciences produces robotic arms for the bioprinters.8 HOW DOES BIOPRINTING WORK?
The process of Bioprinting flows in three stages as following; pre-bioprinting, bioprinting, post-bioprinting. Pre-Bioprinting involves creating a file for the 3D printer to read, this step also involves preparing the printing material – bio ink and the cells that be used in the printing process. 9 Bioprinting stage is when the researcher loads all the materials into the printer and sets the dimensions for the desired shape, different 3D tissue models would require researchers to use different cells, apparatus and bioinks. 10 Post-Bioprinting stage is when the printed structed is cross linked i. e. the structure is treated by either a ionic solution or UV light, after which will be stored in an incubator for cultivation.
11 PATENTING BIOPRINTING As many inventions, bioprinting process and bioprinting products require protection, one can acquire protection for these products through patent. There are two types of patent protection; one is related to bioprinting machines and apparatus like bioprinters and the other type of protection is bioprinting processes and products. 12 Patenting 3D printing of biological products like organs and tissues are complicated than patenting 3D printing of non-biologicals, it has to pass patent eligibility. US Approach Under the US patent act provides patentable subject matter – process, machines, manufacturers
8 The Medical Futurist, https://medicalfuturist.com/top-bioprinting-companies/
9 Cellink, https://www.cellink.com/blog/bioprinting-explained-simply/
10 Cellink, https://www.cellink.com/blog/bioprinting-explained-simply/
11 Cellink, https://www.cellink.com/blog/bioprinting-explained-simply/
12 Nabeel M Althabhawi and Zinatul Ashinqin Zainol, NIH(ncbi), The Patent Eligibility of 3D Bioprinting: Towards a New Version of Living Inventions Patentability, https://www. ncbi. nlm. nih. gov/pmc/articles/PMC8773692/ and compositions of matter. 13 In the landmark judgement of Diamond vs. Chakrabarty, it was established that living organisms can be patented if it is altered through human intervention and isn’t naturally occurring, this was the first-time living organisms was granted patent. This led to the two-prong test, • it should be nonnatural occurring and • product of human ingenuity i. e. human invention. To patent Bioprinting it needs to pass the eligibility criteria, it requires human intervention and should be nonnatural occurring. Since Bioprinting is a man-made invention, it qualifies the human intervention requirement.
The issue arises as bio-printed products are living organisms or live tissue or live organs which are not patent-eligible subject matter. 14 The current bio printed human live tissues are functionally similar but structurally different than the real live tissues, because of this it is clear to be patent eligible matter. India’s Approach The 3D bioprinting of live tissue or organs is the new technology which addresses the issue of organ transplantation, especially in India with a vast population the waiting period for organ transplantation increases. Biotechnological inventions have faced certain issues related to patenting in India, this applies to patenting bioprinting inventions. Under the Patent Act 1970, an invention needs to meet the criteria – it must be novel, inventive and industrial applicable and Bioprinting meets these criteria.
Under section 3j of the Patent Act, “plants and animals in whole or any part thereof other than the micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals. ”15 causes a hurdle in patenting bioprinted products. As the end results of bioprinted products are live human tissue or organs which would be considered as part of animals under the Indian Patent Act. It would require the inventor to showcase that the bioprinted products in non-natural to receive patent and as previously mentioned, that
13 USPTO,
https://www.uspto.gov/web/offices/pac/mpep/s2106.html#:~:text=THE%20FOUR%20CATEGORIES- ,35%20U.S.C.,reach%20of%20patentable%20subject%20matter 14 Jasper L. Tran, JOLT Digest, Patenting Bioprinting, https://jolt.law.harvard.edu/digest/patenting-bioprinting
15 The Patent Act, 1970,
current bioprinting products are only functionally similar and not structurally similar to the real biologicals used, therefore it maybe be patented in India. Bioprinting requires the use of biomaterials like live cells to create bioprinted products, these cells could be human embryotic stem cells. These human embryos are killed to acquire their cells and this process is against the moral grounds of the society. Under section 3b of the Patent Act of 1970, “an invention the primary or intended use or commercial exploitation of which could be contrary to the public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment” , therefore the use of human embryotic cells in the bioprinted product would make the invention non-patentable.
Process Claims It can be noted, that one cannot patent living organisms, and bioprinting which relies on live cells can be classified as living organisms and the end product of bioprinting which could be an organ can be classified as a part of an animal or living organisms. This could potentially lead to non-patentability of this bioprinting, as bioprinted products could be opposed. One can patent “process”, Applicants should consider patenting their process claims one over the product claims of their bioprinted products to avoid rejection of the patent. 16
CHALLENGES
IN BIOPRINTING While Bioprinting seems to be the hope to solve the crisis of lack of organ donors, there are a few challenges bioprinting and bioprinted products could face that would impact the patenting of the Bioprinting inventions. If these challenges are addressed, then patenting bioprinting would become easier. The challenges are of the following; Use of living cells The process of bioprinting involves the use of living cells taken from a human body to produce bioprinted live tissues or organs which will be placed into the recipient’s body. This carries the risk of cells infected with cancer cells which could negatively impact the recipient. The other issue of using living cells is the use of Human Embryonic stem cells (ESC) which has been a highly controversial topic as the ESC are derived after killing human embryos. The ethical
16 Jasper L. Tran, JOLT Digest, https://jolt.law.harvard.edu/digest/patenting-bioprinting
concerns revolving killing human embryos to derive stem cells for scientific purposes as been an unresolved controversy. The other controversy is the use of the induced pluripotent stem cells (iPSCs), these are adult cells that have been genetically programmed to have ESC properties. While these cells are a better option that ESC, it carries the risk of producing tumours, which could potentially harm the public’s trust in iPSC. 17 The use of ESC or the use of iPSC is against the moral grounds of the society and public will reject such inventions. Ownership The question arises on, who owns the bioprinted products? It is still an ongoing discussion regarding who owns the bioprinted products, is it the bio-company who has ownership of the technology, or the doctor who implanted it, or the patient who received the implantation.
It also questions the ownership of the person who donated the cells as biomaterials. The autonomy the patient who received the bioprinted organ would have on his/her own body. It is important for the legislatures and interested parties like researchers, companies to collaborate together to establish guidelines regarding the management of bioprinted products. 18 Accessibility Bioprinting of 3D Organs has the potential to be the solution to the lack of organ donors, but there are few issues regarding the affordability and accessibility to bioprinted organs for the people in need for organs. The use of 3D printing of organs in developing countries are still at an early stage compared to the developed countries and thus people of developing countries would not have access to this bioprinting technology.
The technology developments in some countries might advance from others because of less government intervention and this would impact the public. While some organs can be bioprinted for cheaper rates, there are organs which would be complex to bioprint and can be expensive can and if bioprinting organs is expensive than current medical treatments, then only the rich would be able to afford and enjoy the benefits of bioprinted products. 19 Once patent is granted to bioprinted products, the patent holder would have exclusive rights over the bioprinting technology and create monopolization,
17 3D Natives, Bioprinting under the microscope: Are the current standards ethical?
https://www.3dnatives.com/en/bioprinting-under-the-microscope-are-the-current-standards-ethical-2508234/
18 Ibid
19 Dr Mirjana Stankovic, Dr Bratislav Stankovic, Ravi Gupta, Patentability, Global Development and Ethical Considerations of Bioprinting, World Bank, https://thedocs. worldbank. org/en/doc/a5f01b13b6f78768a5931f97edcba111-0260012017/original/patentbioprininting. pdf this could again lead to high costs on the bioprinted products and the only certain section of the society would be able to afford such expenses. Vascular system Real organs in the human body are constantly supplied with nutrients through the blood flow for the organs to survive. Bioprinted organs also would require supplement of nutrients for it to stay alive, this requires the creation of vascular network, not just to supply nutrients also as a network for waste disposal.
Building these vascular network through bioprinter is one of the challenges in bioprinting, as the capillaries could be the size of 3 μm and bioprinter might use droplet the size of 20 μm, if setback is not dealt in time could lead to the compromise of the cell’s life. 20 Therefore, to sustain a bioprinted organ, it requires a complex vascular system and one would have to print this complex vascular system within the bioprinted organ.
CONCLUSION
Bioprinting is a potential solution to the organ transplant shortage situation faced in many countries around the world. Though bioprinting is advancing, it is still in the developing stages. Once this technology is fully developed and tackles the challenges it can be alternate to many patients who require organ transplantation, there will be a time when patients would not have to wait for long periods of time to receive organ transplants. It is important for law makers to deal with the laws and guidelines regarding the ownership of bioprinted products, to prevent stagnation of developing bioprinting and to prevent chaos. It is also crucial to address the use of human embryotic stem cells or induced pluripotent stem cells, as the use of these kind of cells is against the moral and ethics of a society.
Bioprinting is not just an alternate to developing organs, it can be used to make prosthetics for people who have lost their arms and limbs. With bilateral agreements or international collaborations, developing countries can also access highly-advanced bioprinting technology and bioprinters from the developed countries, to develop these bioprinted organs to meet the needs of their nationals. Providing patent to the bioprinted organs or bioprinters will foster innovations and led to the advancement in the field of bioprinting. Patenting bioprinting organs is necessary to ensure that this technology benefits everyone and not just who can afford it. 20 Elliot S. Bishop, Sami Mostafa, Mikhail Pakvasa, Hue H. Luu, Michael J. Lee, Jennifer Moriatis Wolf, Guillermo A. Ameer, Tong-Chuan He, Russell R.
Reid, 3-D bioprinting technologies in tissue engineering and regenerative medicine: Current and future trends, Genes & Diseases,Volume 4, Issue 4, 185-195, 193, (2017)