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Analysing THE Patentablity OF 3D Bioprinting Product 11
Business law (301)
Jimma University
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ANALYSING THE PATENTABLITY OF 3D BIOPRINTING PRODUCT AND
IT’S HUMAN RIGHT EFFECTS UNDER TRIPS AGREEMENT AND
ETHIOPIAN PATENT LEGAL REGIME.
ABENEZER TAREKEGN ID. S40117/11-
Table of Contents ABSTRACT .................................................................................................................................................. 2
- INTRODUCTION ................................................................................................................................. 3
- The status of 3D Bioprinting under TRIPS agreement and Ethiopian patent law. ................................ 3 A. The status of 3D Bioprinting under TRIPS agreement ...................................................................... 3 B. The status of 3D Bioprinting under Ethiopian patent law. ................................................................ 4
- The relationship between human right and patent law. ......................................................................... 5 3 ALTERNATIVES TO EXCLUSION: Towards patenting 3D bioprinting ........................................ 6
- Conclusion and Recommendations .......................................................................................................... 7 4 Conclusion ........................................................................................................................................... 7 4 Recommendations ............................................................................................................................... 7 References ..................................................................................................................................................... 8
ABSTRACT
In this modern global environment of rapid technological change, new issues frequently arise that challenge the operation of patent law. 3D Printing/Three dimensional printing is among new technology recently evolved in patent arena, it9s a technology that builds physical objects directly from 3D computer-aided design (CAD) data and adds different materials, layer-by-layer, with the help of a 3D printer Bioprinting is a promising technology a subset of 3D printing that involves the fabrication of a functional living human tissue or organ constructed from a 3D digital model. While there were patents on the bioprinting process filed already and some even approved, the problem of patentability of bioprinting products still remains unsolved. Because, printing from biological materials presents different public policy considerations than printing from non-biological materials. When experimenting with human genetic materials, emerging technological and scientific advances attract strong political, Legal and ethical /moral/religious debates and the societal scrutiny is further heightened because the genetic materials are from humans. The objective of this paper is to analyze the patentability of 3d Bioprinted organ under TRIPS and Ethiopian patent law and its effects on human right. This paper is purely doctrinally conducted paper. Thus, it tries to doctrinally analyze the major legal issues related with 3D bioprinted product. For this purpose, the secondary data from law books, law articles, law journal, newspaper etc. have been used. The paper examines the opposing arguments in light of the legal framework relating to the patentability of tissue engineering product and its implications for IP, especially for patents, at international and domestic (Ethiopia) level. It assesses the consequences (Pros and cons) of granting or denying 3D bioprinting patents on the human right. The human right issue is examined from the perspective of the Human right documents and patent standards (and flexibilities) as required by the TRIPS Agreement. Finally, the author recommend on major points with a view to provide a solution to the major legal problems that surrounds patentability of 3D bioprinted product and Human right issues so identified by this paper and also to make a right balance between the two competing interests of Patentee and the Human right while regulating the patentability of 3D Bioprinted organ. In nutshell this paper is a humble attempt to examine international and national law relating to patents on 3D bioprinted inventions from a doctrinal perspective. Keywords: Patents, TRIPS, 3D printing, 3D Bioprinting
without exception. Paragraph 2 and 3 of Article 27 provides the kind of inventions, member states may exclude from patentability. Patenting of life forms may be excluded based on Article 27/2 of the TRIPS agreement on the ground of protection of morality. However, the exclusion is only available in case when the prevention of the commercial exploitation of the invention is necessary to protect the morality of the society. Based on these discretionary power Member countries of TRIPS agreement had adopted antagonistic approaches regarding 3DBioprinting, While USA allows patent for this invention, European avoids based on morality. 10 So, 3D Bioprinted organ patentability is left as discretionary power of member states under TRIPS.
B. The status of 3D Bioprinting under Ethiopian patent law.
In Ethiopia patent administration belongs to Ethiopian Intellectual property office. 11 Legally in Ethiopia the issue of patent is governed by Proclamation No. 123/1995. Under this law article 3 patents is granted upon fulfillment of three conditions namely: Novelty, Non- obviousness; and Industrial application. In addition to this the Eligibility and adequate disclosure are also incorporated under Ethiopian law. All the conditions listed above are to be fulfilled for an invention to be patentable. However there is pro and Anti arguments on Patentability 3D Bioprinting of organs. Regarding Pro arguments they argues that the non-natural occurrence of the bioprinted product, difficult to fabricate artificially a tissue or organ to exactly natural tissue or organ, and they are modified version of human body not original human body. 12 According to this line of argument the patentable subject matter includes < anything under the sun that is made by man .=Even the sun made by man is patentable. 13 However there is Anti arguments on patentability of 3D product because they fail to fulfill novelty criteria, their success will depend on the degree to which they resemble naturally occurring ones. It is believed that 3D bioprinting is nothing but a duplication of natural organs. So they are not patentable. 14
In addition, Article 4/1 of the proclamation is one such provision which has restricted the scope of protection given to creative inventions. Article 4 provides that: Inventions contrary to public order on
10 John Linarelli, <Trade-Related Aspects of Intellectual Property Rights and Biotechnology: European Aspects,=6 Singapore Journal of International and Comparative law,2002,Page 11 Prior to 2003 patent Administration in Ethiopia was fragmented The patent was administered by the science and technology commission, copy right is administered by youth, sport and culture ministry and trade mark was handled by the ministry of trade and industry. 12 D. Resnik, The commercialization of human stem cells: ethical and policy issues, Health Care Anal. 10 (2002) page 127– 154. 13 John Linarelli, <Trade-Related Aspects of Intellectual Property Rights and Biotechnology: European Aspects,=6Singapore Journal of International and Comparative law,2002,Page 14 Hsiao, J.-H. Patent Eligibility of 3d Bioprinted Organs in Taiwan. Albany Law J. Sci. Technol. 2018, page1–22.
morality are non patentable. As we understand from the above article, Firstly the morality clause is incorporated into our patent laws in order to achieve equilibrium and coherence between science and culture. Fikeremarkos Merso argued claiming patent on life forms is like claiming to be the creator and this contradict with the religious belief of the society. As per Article 4(1) (a) of the proclamation, 3D bioprinting inventions may be excluded based on the ground of morality. 15 Granting bioprinting patents condones and validates humans <playing God.= If humans play God, they risk offending many people, especially those who belong to established religions. 16 Secondly under Ethiopian civil code Human body is extra commercium this highly contests with the commercialization of bioprinted product. In addition to this Rights of personality and constitutional liberties are extra-commercium ; i. - they are not subject to legal transactions (Art. (9/1). Finally There are also unanswered Ownership questions regarding printed organ. Does the donor of cells have the authority over the final bioprinted product? Which may be a tissue or organ? Or does the ownership lie with the clinician/ technologist who bioprinted the product using these cells? Or shared ownership? If no, why? If yes, in what way? In legal system the law should support and correlate to each other, based on this we can mouth fully say that 3D bioprinted organ is out of patent protection under Ethiopian law.
3. The relationship between human right and patent law.
One of the question posed in this paper is whether the human right and patents conflict or coexist. This question is examined from the perspective of author or patentee and from the perspectives the right to health as set out in the ICESCR and patent standards (and flexibilities) as required by the TRIPS Agreement. There are two distinct conceptual approaches with respect to the interface between patent and human rights: the conflict and coexistence approach. 17
A) Conflict Approach: Some find that patent and human rights are in fundamental conflict with each other. This view sees strong Patent protection as undermining a range of human rights obligations, especially with respect to socio-economic rights. The United Nations (UN) Sub Commission on the Protection and Promotion of Human Rights, for example, stated that 8there are apparent conflicts between the intellectual property rights regime embodied in the TRIPS Agreement, on the one hand, and 15 Fikeremarkos Merso, <Ethiopian9s WTO Accession: A Strenuous Step For a Poor Nation Seeking Economic Prosperity, Action AID Ethiopia Publications,2005,P 16 Peter Dabrock, Playing God? Synthetic Biology as a Theological and Ethical Challenge , 3 Systems & Synthetic Biology 4717 – 54 (2009). Yu PK (2006–2007) Reconceptualising intellectual property interests in a human rights framework. Univ Calif Davis Law Rev 40:1039–1150 page 709-
4. Conclusion and Recommendations
4 Conclusion
This paper has discussed current practice and patent strategies relating to the emerging technology of 3D bioprinting 3D bioprinting is a subset of 3D printing. Recently, the american organization Organovo received patents on 3D printed tissues. since this product is patented in foreign country under Ethiopian patent law we provide patent of introduction for this inventions. Regualting 3D bioprint product is mandatory because unregulation paves the way for piracy and it's risky for the societal healthy. Under TRIPS agreement patenting Bioprinted organ is left as discretionary power of member states and Member countries of TRIPs agreement had adopted antagonistic approaches regarding 3Dbioprinting, While USA allows patent for this invention, European avoids based on morality. Ethiopia law could not invite 3 Bioprinted organ because the product could not pass morality test. When we look at the relationship between human right and patent right there two approaches Conflicting approach and coexistance approach which analyses patent in societal perspectives and patentee perspectives respectively. For Ethiopia it's better if we patent and recognize the 3D Bioprinted product as ordinary medicines by recognizing its patentability.
4 Recommendations
The advent of 3D bioprinting opens a door to regenerative medicine and tissue engineering. It raises patients9 hope by sketching a realizable dream of printing human tissues and organs on demand. In our country it's better if we patent 3DBioprinting as a medicine because Proclamation No/2019 Food and Medicine Administration Proclamation article 2/9 defines Medecine as any substance or mixture of substance used in the diagnosis, treatment, mitigation or prevention of human disease, disorder, abnormal physical or mental state, or the symptoms thereof; used in restoring, correcting or beneficial modification of organic or mental functions in human; or articles other than food, intended to affect the structure or any function of the bod y of human and / the amharic version is also more clear which provide /( የሰውነትን ተፈጥ@አዊ ተግባ? በጠቃ መልኩ ለመለወጥ የውል ንኛውም ንጥረ - ነገ? ወይም የንጥረ - ነገ@ች ) This definition can include 3D Bioprinting product because bioprinting is used to correct and modify the human organ, so it's better if we treat and recognize it as an ordinary medicines by avoiding the issue of patentability aside. So it should be patented to protect the right to health of our citizen.
References
BOOKS
Schwabach, Aaron, Intellectual Property-A Reference Hand book,ABC-CLIO,Inc.,USA, Bryan A. ,Garner (ed.), <Black9s Law Dictionary,= 8th edition , Fikeremarkos Merso, Ethiopian Accession; A Strenuous Step for a Poor Nation Seeking Economic Prosperity, Action Aid Publications, Addis Ababa, Rockman, Howard B., Intellectual Property law for Engineers and Scientists, A John Wiley and Sons,Inc.,USA, Fisher, Matthew, Fundamentals of Patent law Interpretation and Scope of Protection, Hart Publishing,USA,
ARTICLES
Pal Prankrishan, Intellectual Property Rights in India General Issues and Implications, Regal Publication New Delhi, (2008), Deven R. Desai & Gerard N. Magliocca, Patents, Meet Napster: 3D Printing and the Digitization of Things , 102 GEO. L. 1691, 1697–99 (2014). Daniel Harris Brean, Patenting Physibles: A Fresh Perspective for Claiming 3D-Printable Products , 55 SANTA CLARA L. REV. 837 (2015) Adams, M. (2015). The 8Third Industrial Revolution9 3D Printing Technology and Australian Designs Law. Journal of Law, Information and Science, Vol. 24 N. Zhang and F. Li: Journal of Machine Design, Vol. 30 (2013) No. K. Wang, X. Huang and H. Yuan: Machine Design and Manufacturing Engineering, Vol. 44(2015) No. David Sher, now it is Time to Commercially De-Liver for Organovo: 3D Printing Industry, (2014). D. Resnik, The commercialization of human stem cells: ethical and policy issues, Health Care Analyse. John Linarelli, <Trade-Related Aspects of Intellectual Property Rights and Biotechnology: European Aspects,=6 Singapore Journal of International and Comparative law,2002,
Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15,1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, [hereinafter TRIPS Agreement] United Nations General Assembly, Universal Declaration of Human Rights, 10 December 1948 UNESCO Universal Declaration on Bioethics and Human Rights 2005, United Nations General Assembly, International Convention on Economic, Social and Cultural Rights, 16 December 1966, United Nation Treaty Series, Vol 993 UN Sub-Commission on the Promotion and Protection of Human Rights, 8Resolution 2000/7. Intellectual Property Rights and Human Rights9, UN Doc. E/CN.4/SUB/RES/2000/
Internet Sources
bioprintingworld/3d-printed-organs-now-a-reality/ organovo wipo/reference/en/ aripo/ip-services/patents/
Analysing THE Patentablity OF 3D Bioprinting Product 11
Course: Business law (301)
University: Jimma University
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