Liu Xin

（Centre for Studies of Intellectual Property Rights,Zhongnan University of Economics and Law,Wuhan 430073,China）

Abstract: The patent protection of gene editing achievements means the property right of relevant technical achievements,which is an important institutional guarantee for the development of gene editing.Due to the differences in the technical level and the political orientation,there are great differences in the patent protection mode of gene editing technologies all around the world. The product-mode, which is represented by the United States,and the utility-mode, which is represented by Germany, are the two main legislative choices at present. At the same time, a series of severe ethical risks, including the instrumentalization of human beings and the one-sided eugenics strategy,also restrict the effective operation of the patent protection mechanism for gene editing achievements.Therefore,It is necessary to choose the appropriate political orientation and protection mode based on the national condition and set up ethical standards and review mechanisms for gene editing patents to resolve the ethical risks in the practice of patent protection of gene editing achievements to realize the reasonable patent protection of gene editing achievements in China.

Keywords:gene editing;patent protection;legislative policy;ethical risk

At present,with the emergence of gene editing technology,people” s research on DNA molecules has evolved from traditional gene sequencing and gene separation to transcription and synthesis involving gene editing.Since the birth of the world” s first” gene editing baby with AIDS immunity” in November 2018,legal questions and ethical criticisms related to gene editing have been raised one after another, which have been strongly condemned by public opinion. People generally believe that this ” gene editing baby” behavior is an irresponsible scientific exploration that is reckless and lacks an ethical bottom line. Coincidentally, most of the scholars” discussions on this event also take a more cautious attitude toward gene editing.They give a series of countermeasures for the potential risks of gene editing.For example,some scholars have made corresponding thoughts on gene editing technology at the level of moral and legal philosophy[1],some scholars have put forward the viewpoint of classified governance of technical risks and ethical disputes involved in gene editing based on the life constitution[2], and some scholars have designed a legal system to regulate gene editing experiments based on the current legal norms in China[3]. However, there is little discussion on the patent protection of gene editing achievements among many academic viewpoints. Although life substances such as genes have long been considered non-patentable[4], the huge commercial value has shaken the theoretical consensus of the non-patentability of life materials with the emergence of gene editing and other related technologies. Meanwhile, the high capital investment and huge market risk in the research and development of these technologies have undoubtedly prompted people to try to protect gene editing achievements by patent law. Therefore, it is necessary to clarify the scope and degree of gene editing achievements patent protection from the perspective of patent legislation and policy and,on this basis,respond to the ethical disputes of gene editing achievements patent protection with the value orientation of” science and technology for the good” .

Since the 1980s,the fourth scientific and technological revolution has swept the world.As a typical representative of new technologies, gene technology has developed rapidly. It has experienced the technological transformation from initial gene sequencing to gene separation and then to gene editing. It not only deepens people” s understanding of biological genetic resources but also makes them benefit from the practical application of gene technology. At the same time, driven by industrial interests, patent legislation for gene editing and other related technological achievements also came into being.Developed countries such as the United States and Germany have successively recognized the patentability of gene editing and other related technological achievements and constructed a relatively sound legal framework. However, in terms of specific rule design, different countries have made different policy choices. For example,the United States adopts the product protection mode,protects gene patents with product claims,and treats the gene sequence generated by gene editing as a chemical composition. Its scope of rights covers the whole field of gene editing achievements, including both the gene sequence itself and all uses of the gene sequence. Germany adopts the utility protection mode to protect the gene patents with the use claims, and its right scope only involves a specific use of the gene sequence generated by gene editing. The different patent examination modes for gene editing achievements mean that the patent law has different protection scope and intensity for related objects, which is essentially a policy choice made by various countries according to their own gene technology development levels and weighing the advantages and disadvantages of gene technology patent protection. Therefore, it is advisable to use the successful patent legislation of the United States and Germany on gene editing and other related technologies as an example to explain in detail the connotation,advantages,and disadvantages of the two gene editing achievements patent protection policies of” product protection mode” and” utility protection mode” .

2.1 Product Protection Mode of Gene Editing Achievements: Taking the United States as An Example

Based on its leading position in the R&D and application of gene technology,the United States has adopted a relatively wide range and relatively high intensity product mode in the patent protection of gene editing achievements,which fully meets the demands of relevant industries to transform technical advantages into market advantages.According to Article 103 of the U.S.Patent Law,” a composition biotechnology method with novelty and non-obviousness” can be patented,and its claims include” composition used in the method” and” composition manufactured by the method” .In other words, under the product type patent protection mode of the US Patent Law, the gene sequence generated by gene editing,as a composition,can be not only the basic resource of the method patent but also the product of the method patent.Its protection scope includes not only the gene sequence itself but also its various potential uses.

As shown in Figure 1,in the US product type patent protection mode,the grant of patent rights is based on the specific achievement generated by gene editing, ” Gene X” , and all of its uses, such as ” Use 1” , ” Use 2” , ” Use 3” , and” Use 4” are within the protection scope of” Patent X” ,even if the relevant uses have not been fully revealed at present.In this way,the patentee can not only monopolize the” Gene X” generated by gene editing but also monopolize the various uses derived from ” Gene X” . From this point of view, the product type protection mode of the U.S. Patent Law undoubtedly gives gene editing achievements strong patent protection. Such a legislative choice is made by the United States based on its own leading gene editing technology and developed industry,so as to create conditions for it to control or even monopolize the global gene medicine and gene diagnosis market.

Figure 1 Product Type Protection Mode of Gene Editing Achievements

Figure 2 Utility Type Protection Mode of Gene Editing Achievements

Under the product type patent protection mode of the US,the patentee can not only effectively control the gene sequence itself transcribed and edited,but also all uses of the gene sequence are under the control of the patentee.Based on this, the patentee can fully control the application of gene editing achievements and fully occupy the relevant market. This institutional design of strong patent protection for gene editing achievements is undoubtedly consistent with the characteristics of high investment,long cycle,and high risk of gene editing technology.However,The economic return provided by the patent system for the development of gene editing and other related technologies is realized by giving the inventor an exclusive monopoly on inventions,and the huge social cost brought by technology monopoly is often accompanied[5]. Under the product type protection mode with wide protection scope and high intensity, there is often a tragedy of ” anti-commons” , because gene editing achievements are monopolized by a few patentees and restrict people” s gene benefit sharing[6].Going further,due to the close relationship between gene editing achievements and public health, the control of gene patentees in developed countries over gene editing achievements may cause a public health crisis in developing countries with relatively backward technology,and even turn the contradiction between gene patentees and patients into a contradiction between developed and developing countries[7].

2.2 Utility Protection Mode of Gene Editing Achievements: Taking Germany as An Example

In order to avoid the abuse of gene patents by patentees due to the wide scope of protection,Germany has adopted the mode of use claims to protect the specific gene sequences generated by gene editing.According to the provisions of paragraphs (3)and(4)of article 1a of the German Patent Law,when applying for a patent with gene technology,the inventor or related person shall specify the industrial practicability of the gene sequence in the process of explaining the use of the gene sequence and write this description into the claims.In other words,under the utility type patent protection mode of the German Patent Law,the protection of gene editing achievements in the patent law should be based on the specific use of editing and generating gene sequences,and other potential uses of gene sequences that are not mentioned in the patent application are not within the scope of patent protection.

As shown in Figure 2,under the utility type patent protection mode of Germany,the grant of patent rights is based on the specific use of the specific gene sequence generated by gene editing.” Gene X” has many uses such as” Use 1” ,” Use 2” , ” Use 3” and ” Use 4” . Each user can become a separate patent. For example, ” Use 1” can become a separate patent,” Patent 1” .In practice,a patent can contain multiple specific uses of a specific gene editing sequence,but they must be expressed in the patent application,and uses not mentioned or not known at present cannot be included.Therefore,compared with the product-type patent protection mode of the US,the utility-type patent protection mode of Germany undoubtedly leaves space for follow-up research and avoids the patentee” s excessive monopoly on gene editing achievements.

In Germany” s utility patent protection mode,the scope of rights controlled by the patentee is effectively limited to the specific use of gene editing achievements, ensuring that gene resources are contacted by others other than the patentee and providing the opportunity for subsequent research and development. In other words, the patent utility type protection mode adopted by the German Patent Law essentially limits the scope of the patent right of gene editing achievements to the specific use category, effectively avoiding the monopoly problem caused by the too wide range of rights under the product type protection mode,and realizes the reasonable patent protection of gene editing achievements.However, with the continuous increase in the number of relevant patents, problems such as ” patent jungle” , which restricts the sustainable development of gene editing technology, often appear in the operation of the German utility protection mode.Specifically,in the utility type protection mode,the acquisition of gene editing patents is based on specific uses rather than specific gene achievements as in the product type protection mode. Therefore, there would be the phenomenon of a ” patent thicket” in which multiple gene editing patents with different uses are issued for the same source gene editing achievement[8]. This situation would undoubtedly hinder the subsequent research and development of gene editing technology because many of the gene editing achievements that have been separated from organisms and transcribed by editing are basic, and it is difficult for anyone to bypass the complex ” patent thicket” for subsequent gene editing research and development[9].

There is no doubt that the patent protection of gene editing achievements can greatly improve the work enthusiasm of researchers and the investment of investors and provide legal incentives and institutional guarantees for the development of gene pharmaceuticals, gene testing, and other related gene industries. However, opportunities and risks often coexist. While giving patent protection to gene editing achievements, the ethical disputes caused by gene editing technology would extend to the patent protection of related objects and further evolve into ethical problems at the level of system operation,inducing people” s concerns and doubts about the patent protection of gene editing achievements[10].

3.1 Origin of Ethical Issues in Patent Protection of Gene Editing Achievements

Generally speaking,the ethical issue closely related to technological achievement is whether technology can benefit mankind and ensure harmonious coexistence between man, nature, and society. Accordingly, in scientific research activities,people always face the ethical measurement of” what they could do” and” what they should do”[11].If the patent protection of this technology is carried out, the moral choice of ” what could be done” and ” what should be done” will inevitably evolve into an ethical choice of ” whether to protect” and ” how to protect” . Especially for gene editing technology with prominent ethical disputes, the patent protection of related technical achievements would undoubtedly extend the technical and ethical problems such as moral contradictions and value conflicts derived from the research and development of gene editing achievements to the patent legal practice and then induce severe ethical problems in the patent protection of gene editing achievements. Although in the technical field, where prominent ethical disputes like gene editing arise, relevant ethical reviews would be carried out before the start of R&D work to prevent and control technical risks, these ethical reviews could only exclude a small number of obvious social hazards or serious ethical conflicts,and most technology R&D with both welfare utility and ethical challenges would not be blocked.

Since the emergence of gene editing technology,people” s moral criticism has never stopped.From the” dehumanization” dispute caused by the erosion of natural order by gene editing achievements to the ethical questioning on the subject of rights, technical standards, and responsibility in the process of ” artificial life” , ethical disputes related to gene editing emerge one after another. In practice, with the in-depth research and application of gene editing, the requirements for patent protection are becoming stronger and stronger, which undoubtedly makes the relationship between the patent system and ethics closer and more complex[12].Indeed,the theorists have always believed that there is a huge ethical risk in the patent protection of gene editing achievements,especially the life-sustaining substances contained in them. It is unethical to give life-sustaining substances patent protection. However, the high capital investment and huge market risk in the development and application of gene editing achievements induce people to start a practical attempt to give them patent protection. Although patent protection is the most appropriate and effective institutional model for gene editing achievements, it is also the most prominent ethical problem. The ethical debate highlighted in the development and application of gene editing achievements would not be reduced but would even become a moral criticism of the rationality of patent system design.

In the process of patent protection for gene editing achievements, the technical ethics problems existing in the original technical achievements would be attached to the patented products such as genetically modified food and genetic drugs with the grant of patent rights and would continue to ferment in the rapid market circulation and even industrialized operation of relevant patented products, which would be transformed into the ethical risk of relevant market operation. Further, if we do not fully measure the ethics of gene editing patents, their scope of influence would expand from the ethical disputes at the technical level to the ethical risks and potential safety hazards at the market level[13].Moreover, if gene editing achievements are granted patents in general, their own technical and ethical problems would continue to extend, affecting the realization of social and public interests and bringing a series of social security and ethical problems.Once the regulation is weak,there would even be a large number of public risks that appear intensively and have a wide impact,far beyond the scope that individuals could understand and control,and threaten health and safety[14].Therefore,when granting patent authorization to gene editing achievements,promoting industrial development is not the only criterion for judgment, necessary ethical restrictions are also needed to deal with the ethical disputes in the patent protection of gene editing achievements[15].

3.2 Expansion of Ethical Risks in Patent Protection of Gene Editing Achievements

Patent protection provides an effective property right incentive for the research and development of gene editing achievements so that researchers could put their research results into the market and obtain benefits. But at the same time, in the patent protection of gene editing achievements, the conflict between technology and ethics has become increasingly prominent and shows a trend of continuous expansion. For example, in the process of patent ownership of gene editing achievements, ” human” is no longer the subject full of mystery; the mystery of the human body has been gradually broken through,and increasingly presents the instrumental tendency of” human” .In the process of engineering the operation of gene editing technology,the combination of eugenics theory and gene editing technology has not only brought eugenics strategy into a new stage but also brought a series of ethical risks.

Specifically, the instrumental tendency of ” human” in the process of the property right of gene editing achievements means that everyone, that is, the gene-carrying individual, is regarded as a tool for the continuous development and progress of gene-editing related patent technology,so as to provide necessary source support and material guarantee for the research and development of gene editing patented achievements. From a medical point of view, a gene is a fragment of DNA molecules with specific genetic effects in the human body[16]. While, In the process of patent protection of gene editing products,human instrumentalization means that an individual has become a simple carrier of genes(” good” genes or” bad” genes),and its” value” should be measured first or only according his contribution to the quality of gene pool[17]. It is true that the instrumental thought of ” human” is the basis and premise to stimulate the technological innovation of gene editing and promote the patent protection of gene editing achievements.However,this instrumental thought is also extremely dangerous. Once the instrumental attribute of ” human” is absolute, it would break through the bottom line of bioethics,and human beings would not be able to live freely and with dignity.In other words,the absolute instrumentalization of” human” means that” human” or its components are treated as ” things” .In order to promote technological progress and maximize benefits,the use of” human” could be unrestricted.This is undoubtedly a subversion of the idea of the sanctity of man and nature in bioethics, and a trample of the basic rights of man guaranteed by the constitution. If it is not restricted and the spread of the instrumentalization trend is allowed, the bioethical function formed in the long-term development of human beings would be belittled, resulting in the loss of the ethical basis for human survival and development in society and the inability to obtain due dignity and care[18].

The new development of eugenics strategy in the engineering process of gene editing technology is the follow-up impact brought by the patent ownership of gene editing achievements. As gene editing achievements are gradually accepted by Patent Law and become the object of the patent right,the implementation of the eugenics strategy is likely to be subject to the patentee. But this is not the biggest crisis faced by eugenics. What is more serious is that those with ulterior motives break through the boundary of bioethics and implement a one-sided eugenics policy in the form of a patent license, which may bring irreversible great damage to human society. For example, the genocidal policy of Nazi Germany in the name of eugenics and the sterilization and discriminatory immigration policy of the United States are both one-sided eugenics policies[19]. While, under the cloak of patented technology, the abuse of eugenics theory has become more hidden and difficult to prevent. In addition, it should be noted that the application of gene editing and other related technologies in human reproduction is likely to weaken the biological basis of parents and children,change the unity of love and reproduction in traditional ethics,and even derive the concept of” technical parents”[20].

By comparing the legislative policies of gene editing technology patent protection between the United States and Germany and combining the ethical risks in the practice of gene editing technology patent protection, it is not difficult to find that patent protection for gene editing and other related technologies is a very complex problem. We should not only make policy choices on the scope and mode of protection to resolve legislative disputes but also effectively deal with the ethical problems and risks in the practice of patent protection.Therefore,in order to realize reasonable patent protection for gene editing achievements, we should based on our local and national conditions, combined with the practical needs of China” s economic and social development, clarify the legislative policy choice of gene editing technology patent in China,and construct the ethical code and review mechanism of gene editing patent in China.

4.1 Legislative Policy Choice of Patent Protection for Gene Editing Achievements

China” s Patent Law and Patent Examination Guide 2020 protect the products and methods generated by gene editing as ” inventions in the chemical field” . In terms of its protection level, the scope is relatively wide and the intensity is relatively large, which is not completely consistent with the development reality of relatively backward gene editing technology in China. At present, the R&D and application of gene editing technology in China are far behind those in developed countries such as the United States and Europe. The strong patent protection of gene editing technology would undoubtedly aggravate the scarcity of its limited gene resources and hinder the development of the gene editing industry in China. Therefore, compared with the product-type patent protection mode of the US, which gives relatively broad protection to specific gene editing achievements,the utility-type patent protection mode of Germany is more worthy of our reference.

The patent system is a combination of law and policy. In the patent protection of gene editing achievements, what the law wants to solve is the patentability scope and patent protection mode of gene editing achievements, and the formulation of specific protection strategies is more of a policy consideration.At present,as the largest developing country in the world, China is facing social security risks in the patent protection of gene editing achievements, which is undoubtedly a policy risk in the implementation of a gene patent strategy from the perspective of patent policy.Therefore,in order to eliminate the social security risks in the patent protection of gene editing achievements and avoid policy risks, we need to carry out scientific policy planning. As mentioned above, the product-type patent protection mode of the US gives relatively broad protection to the gene achievements generated by specific gene editing,so that the patentee of gene editing obtains the exclusive right based on the corresponding gene sequence and including all its uses.Such a legislative choice would not only make it difficult for subsequent inventions and creations based on the relevant gene achievements generated by gene editing to continue but it would also form an absolute monopoly for the patentee on the relatively limited gene achievements, which would lead to the patentee” s control over the relevant biological resources and information. Therefore, on the premise that the current strong patent protection of gene editing achievements with ” inventions in the chemical field” exceeds the demands of local technology development, China should learn from the experience of Germany and other European countries, adopt the utility-type protection mode that is more conducive to the late development advantage of technology, take the specific use as the right content of the gene editing achievement patent,in order to the increasing scarcity of gene editing achievement patents under the tragedy of” anti-commons” and the restrictive effect on the follow-up research and development of related technologies and the orderly development of related industries[21].At the same time,in order to ensure the orderly operation of the utility-type protection mode,China should also establish matching patent examination procedures and infringement judgment standards to reduce the probability of negative problems such as” patent thicket” under the utility-type protection mode.

4.2 Ethical Regulation Measures for Patent Protection of Gene Editing Achievements

Based on the inherent exclusivity of patent rights,giving gene editing achievements patent protection would inevitably have the side effects of a technology monopoly. In addition, with the high correlation between gene editing technology and life and health,the ethical risks shown in patent protection would be more prominent.In view of this,in order to effectively deal with the ethical risks in the practice of gene editing achievement patent protection, it is necessary to clarify the ethical norms of gene editing achievement patent protection from the basic principles of biomedical ethics and,on this basis,construct the ethical review mechanism for gene editing achievement patent protection.

It is generally believed that ethical principles come from the ethical consensus that has been formed in human social life for a long time.Since the middle and late last century,facing the ethical challenges in biomedical research,the United States has cited the application of universally accepted ethical principles to resolve the lack of precedents and relevant legislation in the Nuremberg Human Experiment Act, which tried human experiment crimes during the Nazi period by the International Court of justice,and took the lead in putting forward four basic principles of biomedical ethics, namely, Nonmaleficence, Benevolence, Autonomy, and Justice have gradually developed into the ethical starting point of modern life medicine in the world.To be exact,these four basic ethical principles,extracted from the universal ethical consensus of mankind,are not only the basic norms of biomedical ethics but also the ethical principles applicable to all branches of applied ethics[22].Therefore,the patent system,which belongs to the research scope of applied ethics such as science and technology ethics, legal ethics, and institutional ethics, is no exception. The above four principles are also the ethical norms for the operation of the patent system[23]. As shown in the following table, in the process of patent protection of gene editing achievements, these four guidelines should be the most practical guidance. The principle of nonmaleficence requires that the gene editing achievements granted patent authorization be without obvious harm to human beings. The principle of benevolence requires that the practical requirements be adhered to in the patent authorization of gene editing achievements and that their remarkable uses should be advocated.The principle of autonomy means that the inventor can choose whether the gene editing product is patented or not.The principle of justice requires equal access to patents for all gene editing achievements.

Table 1 Specific Connotation of Ethical Principles in Patent Protection of Gene Editing Achievements

There is no denying that the above ethical principles run through the whole process of patent protection of gene editing achievements, whether in the process of technology R&D or after the start of technology implementation, due to the high correlation between gene editing and life reproduction. In the practice of patent protection for gene editing achievements, gene sequences or fragments with ” life” elements have property attributes and could circulate freely in the market, which has subverted the traditional bioethics principles of human society to a certain extent. However, the patent system aims to promote technological innovation and could not effectively solve ethical problems[24]. Without restrictions,the development of gene patents is likely to make” humans” lose their subjectivity and lead to serious social crises such as the instrumental danger and eugenics dilemma mentioned above. Therefore, it is necessary to conduct a comprehensive ethical review in two aspects: pre-prevention and in-process evaluation in the process of gene editing technology patent application review and implementation inspection,and strictly distinguishing different technical purposes in the patent application and different technical effects in patent implementation. In order to realize the organic coordination between the patent protection of gene editing technology and the maintenance of social and ethical order,we should give effective patent protection to gene editing technology with a legitimate purpose or effect,such as disease treatment, and strictly restrict gene editing technology with an impure purpose, a poor effect or an effect inconsistent with bioethics principles[25].

With the continuous emergence of various new technologies, new fields, and new business forms, the types of objects protected by the patent system are becoming increasingly rich. From the traditional industrial technology scheme to the emerging business method patent, the property right of intellectual achievements under the patent system is the inevitable choice for the development of technology and industry[26]. In the second half of the 20th century, the fourth scientific and technological revolution in the world gradually opened, and gene technology, as a typical representative of new technology, developed rapidly. At the same time, in order to promote market-oriented development and industrialized operation of gene technology, the voice in favor of using a patent system to protect gene technology is growing. However, due to the high relevance of gene technology to life and health, there are ongoing legal and ethical disputes regarding its patent protection.Especially with the emergence of gene editing technology,there have been continuous criticisms fthe patent protection of gene editing achievements.In specific institutional practice,due to the great differences in the development level of gene technology among countries, most countries do not give patent protection to gene editing achievements based on ethical risk. At present, only a few developed countries, such as the United States and Germany, have stipulated the scope and mode of protection of gene editing achievements in the patent law.However, it is undeniable that the patent protection of gene products is an inevitable trend. As the largest developing country in the world, China should respond actively in the form of legislation by making legislative policy choices that meet the needs of China” s development and setting up corresponding normative mechanisms to deal with ethical risks from national conditions.