應對公共健康危機的藥品專利強制許可實施困境與對策

馬樂

Dilemmas and Countermeasures on Implementing Compulsory Licensing of Pharmaceutical Patents to Cope with Public Health Crisis

Ma Le

（School of International Law， East China University of Political Science and Law， Shanghai 200042， China）

Abstract： Compulsory licensing of pharmaceutical patent as a system coping with the public health emergency has been acknowledged by legislations and policies both at national and international level. Controversies have surrounded it due to the complexity of diverse interests involved since it came into being. When it comes to implementation， there are even more uncertainties concerning both process and effect. Although some countries have enforced compulsory licensing to address COVID-19 pandemic， controversies still exist regarding the poor capability of developing countries， uncertainties in addressing intellectual property rights within the pharmaceuticals other than patents and low invocation of TRIPS 31bis. China has established a systematic set of rules including legislations and policies on compulsory licensing. However， it still lacks clear procedural provisions in terms of compulsory licensing of pharmaceutical patents decided by government in the context of the public health crisis. Guided by the approaches of modesty， prudence and flexibility， China needs to perfect the implementing mechanism of compulsory licensing of pharmaceutical patents on the basis of effective protection of the patentee's rights.

Key words： Public Health; Pharmaceutical Patents; Compulsory Licensing; Implementation

CLC：D 923 ? ? ? ? ? ? ? ? ? DC： A? ? ? ? ? ? ? ? ? ? Article ID：2096-9783（2021）02-0141-08

1 Introduction

The public health crisis caused by the outbreak of COVID-19 Pandemic （hereinafter referred to as "COVID-19"） has made compulsory licensing on patents discussed intensively again. Some Chinese scholars believed that the pandemic of COVID-19 had already met the requirements of implementing compulsory licensing according to international treaties and Patent Law of P.R.C.. They suggested that competent producers and other eligible entities can apply to the China National Intellectual Property Administration （hereinafter referred to as "CNIPA"） for compulsory license based on the law to produce necessary patented products for COVID-19 response， including but not limited to antiviral drugs and medical protective masks[1]. In the view of the controversy caused by the use of patented Remdesivir by Wuhan Institute of Virology Chinese Academy of Sciences1， someone holds that China has a system of compulsory licensing to restrict the patent holdout made by foreign manufacturers[2]. In contrast， the attitude from the government seems more cautious on enforcing compulsory licensing of pharmaceutical patents. Experts from National Health Commission of China （hereinafter referred to as "NHC"） gave their view that on the basis of the practice of compulsory licensing of pharmaceutical patents， we should use it flexibly according to our demands while being careful and seeking production authorization actively[3]. Notably， the NHC is the competent authority to put forward a proposal of implementing compulsory licensing when there is an outbreak of major infection and other public health emergencies or a shortage of major preventive medicines which poses a serious threat to public health safety， according to the Opinions on Reforming and Improving the Policy of Generic Drug Supply Guarantee and Use （hereinafter referred to as "the Opinion"） issued by the General Office of the State Council in 2018.

Regardless of the active or prudent standpoints of the above， undeniably， compulsory licensing of pharmaceutical patents has become an issue that cannot be ignored in response to the public health crisis at present and for some time to come， which has to be taken seriously. Considering the theoretical disputes associated with compulsory licensing of pharmaceutical patents and the reality that China as a medicine-thirsty country has never implemented this as a means to address public health crisis， it is vital to look into the issue that how to treat the necessity and feasibility of the implementation of this system calmly.

2 Controversies over Function of Compulsory Licensing

2.1 Rationality of the System

Pharmaceuticals are the hardcore method to respond to the public health crisis. Medicines with practical value will be applied for patents once they are invented， because the research， development as well as production of these require tremendous costs in sense of intelligence， finance and duration. Therefore， it can be regarded as the affirmation and reward for the inventors' innovation. As the most important feature of patent rights， the prohibitive right that no patented product may be produced or manufactured without the authorization of the patentee makes the availability of patented drugs problematic， especially to the poor. Hence， accessibility and affordability of patented drugs become the key to tackle the public health crisis.

It would be unlikely that the public health emergency can be addressed without effective pharmaceuticals. After the outbreak of the COVID-19 pandemic， in addition to controlling the number of infected， countries all over the world are speeding up the research and development （hereinafter referred to as "R&D"）， including China， with the hope to have medicines effectively inhibit COVID-19 as soon as possible. No matter who the first problem conqueror is， applying for patent will be the overwhelming choice of the inventor. Such a patent layout is not only permitted by law， but also conforms to international practices. It also can explain the fact that Wuhan Institute of Virology intended to apply for a patent of the usage of Remdesivir in its earlier statement. Whether or not Remdesivir can eventually be the right one that effectively inhibits the virus in clinical trials and no matter who can get the patent， once the patented medicine is available， others will not be able to produce and sell it without the patentee's authorization. Although compulsory licensing as an exception of patent infringement has been acknowledged by international law and national law， its implementation is often accompanied by controversies.

Compulsory licensing of patents as a provision first appeared in the Paris Convention for the Protection of Industrial Property （as amended on September 28， 1979） （hereinafter referred to as "Paris Convention"）. According to Clause 2 Paragraph A of Article5 of Paris Convention， "Each country of the Union shall have the right to take legislative measures providing for the grant of compulsory licenses to prevent the abuses which might result from the exercise of the exclusive rights conferred by the patent， for example， failure to work." Since then， the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights （hereinafter referred to as "TRIPS"） has further clarified the restriction on patent rights and set up the compulsory licensing of pharmaceutical patents in Article 31bis. The fourth Ministerial Conference of WTO adopted the Declaration on the TRIPS Agreement and Public Health（hereinafter referred to as "Doha Declaration"）on November 14th， 2001 in order to enhance the enforceability of this provision. Then the WTO General Council adopted the Decision on Implementation of Paragraph 6 of Doha Declaration on TRIPS Agreement and Public Health （hereinafter referred to as "Paragraph 6 System"） to clarify members' right to make full use of the flexibility of the relevant provisions of TRIPS such as compulsory licensing when addressing public health issues[4].

"Compulsory licensing of patents as a restriction on the abuse of intellectual property" is the basic rationality widely accepted by academia. Some hold that "the compulsory license system for patent is an important way to protect the public interests and prevent the abuse of patent monopoly"[5]， and "compulsory licensing has been an effective means to restrict the abuse of exclusive rights by the patentee through administrative measures since the Paris Convention in 1883"[6]. More specifically， "it was first developed in the Paris Convention with the purpose of preventing patentees from abusing their rights to hinder the implementation and utilization of inventions and the development of science and technology， so as to keep the balance of interests between patentees and the public and to realize the goal of fairness and justice"[7]. Therefore， it has always been anticipated that compulsory licensing consists of the solution， easing the tension between the patentee and public interests， for which a consensus is reached.

2.2 Skepticism on Effects of Compulsory Licensing to Favor Public Health

However， when it comes to coping with public health crisis such as COVID-19 pandemic， the function of compulsory licensing on pharmaceutical patents is controversial and problematic. Some views speak highly of its positive role with the argument that "faced with the threat of major drug shortages to the safety of public health， it is imperative to promote the development of high-quality generic drugs through compulsory licensing of drug patents"[8]. The necessity of this means is acknowledged in that "compulsory licensing of pharmaceutical patents is necessary to improve access to medicines in low-income countries. Under this system， countries with public health emergency can allow a third party to produce generic drugs without the patentee's authorization， and then provide these to patients in their own country at a low price， so as to alleviate the public health crisis"[9]. Further， "it is an effective way for developing countries to have access to affordable medicines to conquer their public health crisis despite the strong opposition from the countries requesting higher protection of patents during the negotiation of TRIPS".

Despite the above optimism， there are others with reservations or even skepticism in terms of the function of compulsory licensing. A few scholars believed that this system only plays a positive role in a limited scope[10]. Some opinions hold that the system hasn't shown high practical value to solve the public health crisis since its establishment， except producing awareness by WTO members of national health crisis in developing countries. Compulsory licensing adopted by some countries is more likely to make a negative impact in the long run on their economic development and the accessibility to pharmaceuticals， though the public health crisis has been temporarily eased. In addition， some scholars from the western world hold the view that it will also cause negative effects of inhibiting innovation. There is an example， as some scholars put forward， that the recently launched compulsory licensing in India， is creating a risk of resisting the R&D of new medicines[11]. Therefore， they believe that if there is no strict limit on compulsory licensing to the extent that pharmaceutical companies are given enough incentive to develop new medicines， this system will be a resistance to the innovation and development of the global pharmaceutical industry， and even become a major threat to the development of new medicines by pharmaceutical companies. However， some scholars demonstrated that this kind of statement that compulsory licensing directly harms innovation may be incorrect after they studied the examples of compulsory licensing on pharmaceutical patents. It does not necessarily lead to a decline of innovation. Rather， it should be used wisely as a policy to improve access to medicines[12].

Obviously， the compulsory license system has been accompanied with controversies since its emergence. Issues about this system relate to the coordination and balance of various binary relationships， such as patent exclusivity and pharmaceutical accessibility， interests of the industry and public as well as protection of the patentee and licensee. Its realization depends on the application of domestic and international law， the coordination of laws among different departments and levels as well as among relevant policies. Due to the complexity of interests involved， legislation and policy making could be very challenging.

As one of the means to deal with the public health crisis， is compulsory licensing of pharmaceutical patents the best solution to accessibility of medicines？ Does the rationality of compulsory licensing necessarily realize the aim of policy？ What other factors should the government consider when implementing compulsory licensing besides taking the applicable conditions stipulated by laws， regulations and policies into account？ Responses to these questions should be considered not only in the process of dealing with the COVID-19 pandemic， but also in the future practice of compulsory licensing of pharmaceutical patents in China.

3 Limitations of Compulsory Licensing Provisions

3.1 Imperfectness of Legislations

Compulsory licensing has been recognized and improved with China's entry to WTO in the past decades. In addition to Patent Law of the People's Republic of China （hereinafter referred to as "Patent Law"） by Standing Committee of the National People's Congress and the Detailed Rules for the Implementation of Patent Law （hereinafter referred to as "DRIPT"） by State Council， the CNIPA as the agency in China to implement compulsory license enacted Measures for Implementing Compulsory Licensing of Patents （hereinafter referred to as "MICLP"） in 2012， offering a set of systematic and further detailed departmental rules for the enforcement.

The current Patent Law （as amended on December 27， 2008） including eleven provisions with regards to compulsory licensing in its Chapter VI （Compulsory License for Exploitation of Patents）， which especially stipulates the legislative determination of the implementing condition of compulsory patents licensing. Based on that， Chapter V of DRIPT further clarifies some issues such as "inadequate implementation"， "pharmaceuticals"， "procedure of compulsory licensing requests"， "royalty award" etc. Accordingly， MICLP makes it even more concrete as to some procedural matters about submission， acceptance and review of compulsory licensing requests as well as determination of the requests in royalty award and so on， which replaces the Measures of Implementing Compulsory Licensing of Patents Involving Public Health Issues （as enacted in 2005）. Thus， a three-level legislative system of compulsory patents licensing with the law， administrative regulations and departmental rules came into being

It is generally accepted that the legislation of compulsory licensing in China conforms to the domestic legislation requirements in article 31 of TRIPS， Doha Declaration and Paragraph 6 System. However， there are opinions holding that the current system of compulsory patents licensing in China fails to take the reality into account in that it only repeats the requirements of TRIPS or even set higher threshold for implementation. Additionally， the process of intellectual property law in China being geared to international standards is slightly hasty. Excessive pursuit of growth and failing to consider reality of China makes the protection of people's right to life and health in a disadvantageous position[13]. In contrast， there's also a point of view showing that the current system fails to provide sufficient protection for the interests of patentee. Specifically， the compensation for the patentee under compulsory licensing is still vague and it needs to be further defined in terms of the standard， scope as well as content[14].

As the legislations show above， the Patent Law distinguishes different types of implementation of compulsory licensing， that is， two approaches according to different initiators. One is that the compulsory licensing it to be implemented at the request of a proper entity or individual before the final decision from the qualified governmental agency， which can be called "application-type"2. The other one refers to a "decision-type"3， which means the compulsory licensing is to be implemented with the direct decision by the governmental agency due to certain scenarios prescribed by the law. The application type is specified by DRIPT. The detailed guiding provisions of procedure in the MICLP are almost made thereto， especially for requesting matters and the valid term. As for decision-type compulsory licensing， there's a lack of alike procedural provisions compared to the application-type.

Notably， the Patent Law （as amended on October 17th， 2020） introduced some modifications regarding rules of patent licensing. Though these amendments do not change the provisions of compulsory licensing directly， they may have certain impacts to implementation of compulsory licensing in China. The most highlighted change is that the five new provisions are introduced into the same chapter as covering compulsory licensing. Starting with emphasizing the implementation and exploitation of patents as stipulated in article 48 and 49 respectively， the new provisions specifically lay down rules of voluntary licensing and open licensing as shown in article 50， 51 and 52， followed by the provisions of compulsory licensing without amendments. Accordingly， the title of Chapter VI is changed into Special Licensing for the Exploitation of Patents. Despite the unchanged provisions of compulsory licensing， the above alteration shows an explicit encouragement to voluntarily open licensing rather than compulsory licensing. In addition to the guidelines therein pertaining to the implementation of open licensing which assures patentees and licensees predictability， paragraph 2 of article 51 stipulates that "During the period of implementation of the open license， the patent annuity paid by the patentee shall be reduced or waived accordingly"， which well proves the encouragement. However， whether this change can have the effect which might limit the use of compulsory licensing is still unknown.

3.2 Loopholes of Policies

In addition to the above legislations， China tries to make use of flexibilities of policy as a supplementary approach to address compulsory licensing of pharmaceutical patents. To respond to people's concern of supply and use of generic drugs， the General Office of State Council issued the Opinion in 2018. According to sub-section 12 of Section 3 （Improving Supportive Policies） thereof， the approaches of implementing compulsory licensing on pharmaceutical patents should be made clear. Followed by this keynote， it advocates implementation of compulsory licensing categorically to improve accessibility of pharmaceuticals and encouragement of voluntary licensing by the patentee. Then it specifies the above two types of implementing to some extent. According to this short paragraph， any entity or individual that is qualified for a compulsory licensing may submit a request to the CNIPA in accordance with law. In order to safeguard the public health， the NHC accompanying with Ministry of Industry and Information Technology （hereinafter referred to as "MIIT"）， the National Medical Products Administration （hereinafter referred to as "NMPA"） and other departments shall make an evaluation and demonstration （hereinafter referred to as "E&D"）， and then put forward a proposal for compulsory licensing to the CNIPA which shall make a decision of granting or rejecting the compulsory license in accordance with the law when there is an outbreak of major infection and other public health emergencies or a shortage of major preventive medicines which will pose a serious threat to public health safety.

The Opinion further clarifies that the application-type which may be submitted by the relevant individual or entity should cover pharmaceutical patents. However， as for decision-type compulsory licensing， the Opinion only states the suggestion-giving and decision-making departments. With regards to the E&D by suggestion-giving departments， the Opinion fails to clarify how the E&D will be conducted， what factors will be considered and how long the process will last. As to the decision of implementation， the Opinion acknowledges the power by CNIPA to reject the motion by suggestion-giving departments without showing what this rejection will be based on. Additionally， neither the process of E&D nor the decision-making part offers opportunity to the patentee of participation or gives comments.

Although compulsory licensing of pharmaceutical patents is only one of the issues the Opinion addresses， lack of more specified guidelines should be understandable. However， given the concreteness of the above legislations and the necessity of the policy maker to give further clear guidelines thereunder， the procedural defect would give birth to more vagueness rather than definitiveness.

Undeniably， the public health crisis such as COVID-19 pandemic consists of situation the Opinion states， which refers to that there is an outbreak of major infection and other public health emergencies or a shortage of major preventive medicines which will pose a serious threat to public health safety. But the justification of implementing compulsory licensing of pharmaceutical patents to address it should be accompanied with minimum detriment to certain rights of the patentee. This is also in line with the amendment of Patent Law in terms of its cautious attitude toward compulsory licensing of pharmaceutical patents.

4 Countermeasures to Perfect the Implementation Mechanism

4.1 Approaches to Take

China has formed a system of rules from legislation to policy in the field of compulsory licensing of pharmaceutical patents. However， in the context of the public health crisis caused by the epidemic or other similar circumstances， the implementation of decision-type compulsory licensing still lacks procedural guidelines. The improvement thereof not only needs to make great efforts in filling a vacancy in specific procedures， but also needs approaches based on a thorough understanding of the compulsory licensing of pharmaceutical patents.

In the first place， compulsory licensing of pharmaceutical patents shall be implemented with modesty. Compulsory licensing is essentially a restriction on patent rights. Although the ultimate goal of compulsory pharmaceutical patents licensing is to protect public health， the legitimate interests of the patentee should get the maximized protection during the implementation. As for application-type mentioned above， there are opinions suggesting that we should take the purpose of this system into account， which means to approve the application for compulsory licensing with a view to prevent the patentee from abusing patent rights[15]. The limitation of public power intervention and the premise of private rights protection should be emphasized in the aspect of implementation of compulsory licensing in response to a public health crisis.

Secondly， implementing compulsory licensing of pharmaceutical patents shall be prudential. It is necessary to distinguish pharmaceutical patents from medical patents in the context of dealing with the public health crisis. Taking the epidemic for example， medical supplies， including masks， can be seen as resources needed to cope with the crisis. But it requires more prudence when the patent of medical products other than pharmaceuticals are taken into the scope of the compulsory licensing. For one thing， the R&D term of pharmaceuticals is much longer than other medical products which gives rise to tremendous differences in terms of their scarcity. For another， the Doha Declaration and Paragraph 6 System thereof limit the scope of compulsory licensing to pharmaceuticals. Despite the applicability of compulsory licensing as a system， domestic measures should take a strict and restrictive approach.

Additionally， compulsory licensing in certain occasions works as a strategic but not implementable way. As opinions hold， such measures should not be used as rigid dogmas on accessibility of medicines but should more often be seen as a strategy of pressuring in negotiations. Effective deterrent of compulsory licensing is sufficient， which is like defeating other parties and achieving the goal without any conflicts or bleeding. Although TRIPS and patent laws in other countries have the provisions of compulsory licensing， it is not often taken as measures in practice. As the WIPO COVID-19 IP Policy Tracker indicates， there has been only 7 out of 145 countries with compulsory licensing provisions granting compulsory licenses during the pandemic4. Generally speaking， when the patentee knows what will happen due to his negative cooperation， he will take the initiative to cooperate better. Since the patentee knows best about how to get the best results from the invention patent， reaching a voluntary license is a better way[16].

4.2 Possible Ways-out

Given the above approaches， China may improve its implementing system of compulsory licensing from the following dimensions. On one hand， the legislation should make it clearer on judicial protection of the patentee's right. According to the article 63 of Patent Law （as amended in 2020）， where a patentee is dissatisfied with the decision of the patent administrative department of the State Council on granting a compulsory license for exploitation， or where a patentee， or an entity or individual to whom the compulsory license for exploitation is granted is dissatisfied with the ruling of the patent administrative department of the State Council on the royalties payable for compulsorily licensed exploitation， he or it may， within three months as of receipt of the notification， bring a lawsuit to the people's court. This provision entitles the patentee to use judicial remedy and is assumed to cover application and decision types of compulsory licensing implementation， which should be positively evaluated.

However， the Patent Law with its DRIPT and MICLP fail to address the specificity of lawsuits concerning compulsory licensing from other patent litigations. Given the extreme situation under which the compulsory licensing is implemented， a restricted term of enforcement is always fixed either by law or the governmental decision. For example， according to the BILL C-13， an Act respecting certain measures in response to COVID-19 by Canadian legislature body， the compulsory licensing will last 6 months5. A similar time limitation can be found in Government Decree 212/2020 on public health compulsory licenses for exploitation within Hungary， which enables the implementation to last less than 11 months6. Considering the comparatively short term for implementing compulsory licensing， a fast track dispute resolution concerning compulsory should be set up to protect the legitimate interest of the patentee. Since the new DRIPT corresponding to the 2020 Patent Law has not been made yet， considerations above should be stipulated herein.

On the other hand， procedural improvements should be made for implementing decision-type compulsory licensing of pharmaceutical patents. The basic process noted in the Opinion should be detailed with clarifications of procedures and standards of E&D by relevant agencies and the right of participation and right to comment by the patentee should be acknowledged. In addition， the term for E&D and decision-making should be shortened to the maximum extent.

5 Conclusion

As indicated above， the implementation of compulsory licensing does not necessarily come into being with the stipulated rules， either in legislations or policies， should be perfected as much as possible. The COVID-19 pandemic does not only challenge the responding capacity of individual countries as well as international community， but also offers a possibility to look into the current regime and gives birth to a better way forward. China has built up a systematic set of rules offering guidelines to implement compulsory licensing of pharmaceutical patents. Compared to application-type， the decision-type of compulsory licensing needs improvements as to a better protection of patentee's legitimate interests procedurally.

References：

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摘? ? 要：藥品專利強制許可作為一項應對公共健康危機的制度在國內外均得到了立法與政策體認。鑒于其所關涉利益關系的復雜性，這項制度從產生至今仍然爭議不斷。具體到這項制度的實施，其程序和效果存在更多不確定性。盡管當前一些國家已經通過實施強制許可以應對新冠肺炎疫情，但是圍繞發展中國家能力不足、除了專利之外藥品所涉其他知識產權許可的不確定性以及《與貿易有關的知識產權協定》第31條修正案的低援引率等方面仍然存在諸多爭議。中國雖然建立了從立法到政策的專利強制許可規則體系，但是對于在公共健康危機背景下由政府部門決定實施的藥品專利強制許可仍然缺乏更為明確細化的程序規定。我國需要在謙抑性、審慎性、靈活性的理念指引下，在切實保障專利權人權益的基礎上完善藥品專利強制許可的實施機制。

關鍵詞：公共健康;藥品專利;強制許可;實施