【线上云德】疫情期间律师说（九）|从瑞德西韦之争谈药品专利权的法律问题

2020年春节期间，突如其来的新冠疫情席卷全国，在疫情防控期间，科研工作者迅速投入工作，不断有利好消息传来。多种药物可能对新冠病毒引起的肺炎有效，其中之一就是“瑞德西韦”。

2月4日，武汉病毒研究所在官网发布消息，称其在抑制新冠病毒药物筛选方面取得进展，同时表示“对在我国尚未上市，且具有知识产权壁垒的药物瑞得西韦，我们依据国际惯例，从保护国家利益的角度出发，在1月21日申报了中国发明专利（抗2019新型冠状病毒的用途），并将通过PCT（专利合作协定）途径进入全球主要国家。如果国外相关企业有意向为我国疫情防控做出贡献，我们双方一致同意在国家需要的情况下，暂不要求实施专利所主张的权利，希望和国外制药公司共同协作为疫情防控尽绵薄之力。”同时，根据网上信息，国家药品监督管理局在2月2日批准了瑞德西韦跳过第一期和第二期临床实验，直接进行三期临床试验。

该消息迅速在网上引起热议，有人认为武汉病毒研究所的行为属于抢注专利，有人说瑞德西韦的研发方吉利德科学公司是在利用中国人做实验“小白鼠”，各种观点，不一而足。笔者以瑞德西韦专利权争议为切入点，剖析药品专利权

的相关法律问题。

During the Spring Festival of 2020, a sudden outbreak of the epidemic swept across the country. During the epidemic prevention and control period, scientific researchers quickly put into work and kept getting good news. Several drugs may be effective against pneumonia caused by the epidemic, one of which is Remdesivir.

On February 4, a news from Wuhan Institute of Virus website, said the drug screening in inhibition of new virus progress, "In our country is not listed, and the drug with intellectual property rights barriers to the west, we according to international practice, from the perspective of protecting the interests of the state, on Jan. 21, to declare the Chinese invention patent (2019 New Coronavirus USES resistance), and through the PCT patent cooperation agreement way to enter the world's major countries. "If relevant foreign companies have the intention to contribute to the prevention and control of the epidemic in China, we both agree that we will not seek to implement the rights claimed by the patent when the country needs it, and we hope to work with foreign pharmaceutical companies to contribute to the prevention and control of the epidemic." Meanwhile, according to online information, the state drug administration on Feb. 2 approved Remdesivir to skip phase I and phase ii trials and proceed directly to phase Ⅲ trials.

The news quickly sparked a heated debate online, with some arguing that the Wuhan virus institute's action was a patent fraud, while others said that Gilead sciences, the company that developed Remdesivir, was using Chinese people as "guinea pigs". Based on the patent dispute of Remdesivir, the author analyzes the related legal issues of drug patent.

1、瑞德西韦尚未上市，并非合法药品

《中华人民共和国药品管理法》第二十四条：除未实施审批管理的中药材和中药饮片外，在中国境内上市的药品，应当经国务院药品监督管理部门批准，取得药品注册证书；对申请注册的药品，国务院药品监督管理部门应当组织药学、医学和其他技术人员进行审评,对药品的安全性、有效性和质量可控性以及申请人的质量管理、风险防控和责任赔偿等能力进行审查；符合条件的，颁发药品注册证书。

根据上述规定，瑞德西韦并未在我国取得药品注册证书，也没有生产批文，其属于在中国尚未上市的药品。根据网上公开渠道查询到的资料，瑞德西韦是吉利德科学开发的主要用于治疗埃博拉病毒的光谱抗病毒药，其并未在全世界任何一个国家取得上市批注。因此说，瑞德西韦是一种在研药，并非可以上市销售的药品。

1. Remdesivir is not yet on the market and is not a legitimate drug

Article 24 of the drug administration law of the People's Republic of China: with the exception of Chinese medicinal materials and ready made slices of traditional Chinese medicine that have not been subject to examination and approval, drugs listed in China shall be subject to the approval of the drug regulatory department under the state council and obtain a drug registration certificate. The pharmaceutical supervisory and administrative department under the state council shall organize pharmaceutical, medical and other technical personnel to evaluate the drugs for registration, and examine the safety, effectiveness and quality control of the drugs, as well as the applicant's capacity for quality control, risk prevention and control and liability compensation. A drug registration certificate shall be issued to those who meet the requirements.

According to the above provisions, Remdesivir has not obtained the drug registration certificate in China, nor has it obtained the production approval document. It is a drug not yet listed in China. Remdesivir, a spectroscopic antiviral developed by Gilead sciences to treat the Ebola virus, has not been marketed in any country in the world, according to information available online. So Remdesivir is a drug in development, not a drug that can be marketed.

2、药品专利权的特性

药品研发属于资本密集和技术密集型行业，在现代社会，每一种药品都会涉及到很多技术，也就意味着很多个专利。药品专利的特性就是，药研企业会为每一种新药申请多个专利，构筑专利壁垒，确保自己的高额投入不会因为专利权争议产生不必要的风险。

专利一般包括产品专利、方法专利、用途专利等。对于药品来说，其专利一般分为核心专利和外围专利，也称为一级专利和二级专利。在一种新药漫长的研发过程中，随着研究的进展，会在不同的阶段逐步申请专利，形成专利池，构筑专利壁垒。

通常情况下，一种新药的研发分为临床前研究，临床实验两个阶段，前后穿插着临床实验审批，新药上市审批等程序性阶段。对于新药专利的申请，基本原则是尽早申请核心专利即化合物专利。在临床前研究早期的化合物发现阶段，通常会申请一种或多种化合物专利，以供后期筛选并进行药理毒理研究。化合物专利属于产品专利，也是一种新药的核心专利。随着研究进展，逐步开始申请一些外围专利，包括晶型、活性化合物盐、酯等专利；在临床实验阶段，开始申请组合物专利，包括各种剂型、制备工艺专利即用途专利等。

2. Characteristics of drug patent rights

Drug r&d is a capital-intensive and technology-intensive industry. In modern society, every drug involves many technologies, which means many patents. The characteristic of drug patents is that pharmaceutical research enterprises will apply for multiple patents for each new drug, build patent barriers, and ensure that their high investment will not generate unnecessary risks due to patent disputes.

Patents generally include product patents, method patents, utility patents, etc. For pharmaceuticals, patents are generally divided into core patents and peripheral patents, also known as primary patents and secondary patents. In the long process of research and development of a new drug, with the progress of research, patents will be applied for in different stages, forming patent pool and constructing patent barriers.

Generally, the research and development of a new drug can be divided into two phases: preclinical research and clinical trial, which are interspersed with the approval of clinical trials, the approval of new drugs for market and other procedural stages. For the application of new drug patent, the basic principle is to apply for the core patent as early as possible, that is, the compound patent. In the early stage of compound discovery in preclinical studies, patents for one or more compounds are often applied for later screening and pharmacological and toxicological studies. The compound patent belongs to the product patent and is also the core patent of a new drug. With the research progress, gradually began to apply for some peripheral patents, including crystal type, active compound salt, ester and other patents; In the clinical trial phase, the application for composition patents begins, including various dosage forms, preparation process patents i.e. utility patents, etc.

3、药品专利权申请的限制

《中华人民共和国专利法》第二十五条规定：对下列各项，不授予专利权： ……（三）疾病的诊断和治疗方法；

根据专利法的规定，疾病的诊疗方法属于不予授予专利权的客体。专利法作出这种规定，一般认为是为了免除医生和医院的责任，避免其在治疗病人时承担侵权风险，该规定在大多数国家都适用，例如欧盟，但是，美国是允许对疾病诊疗方法申请专利的。那么，武汉病毒研究所所称的对瑞德西韦治疗此次新型冠状病毒的用途申请专利，是否违反了这条规定。

这个问题的分析要从欧洲专利公约谈起，由于对疾病的诊疗方法不能授予专利权，我国借鉴了欧洲的规定。

欧洲药企为了避免权利要求落入欧洲专利局划定的“不可授予专利权客体”范围内，瑞士企业在申请专利时，率先采取了一种撰写方法，被称为瑞士型权利要求，具体撰写形式是“化合物或组合物X在制备用于治疗Y疾病的药物中的用途”，这种撰写方法一度被欧洲专利局接受。当然，根据现行的欧洲专利公约，这种撰写方式已经被终结。但是我国适用的就是瑞士型权利要求的撰写方法。根据我国《专利审查指南2010》规定，如果物质是用于制造药品，则可依法被授予专利权。根据该规定，在物质的医药用途权利要求中，不授权的情形包括“用于治疗疾病”；“用于诊断疾“作为药物的应用” ；可授权情形包括“在制药中的应用”“在制备治疗某病的药物中的应用”“化合物X在制备治疗Y病药物的应用”，所以说，将药物用途申请专利，并不违反专利法的规定。

3. Restrictions on drug patent applications

Article 25 of the Patent Law of the People's Republic of China stipulates that no patent right shall be granted for any of the following:... (3) methods for the diagnosis and treatment of diseases;

According to the provisions of the patent law, the diagnosis and treatment of diseases belong to the object of the patent right. The patent law, which is supposed to exempt doctors and hospitals from the risk of infringement in treating patients, applies in most countries, such as the European Union, but the United States allows patents on methods of diagnosing and treating diseases. So, does the Wuhan institute of virology's claim to patent the use of Remdesivir for the treatment of the New Coronavirus violate this provision?

The analysis of this problem should start from the European patent convention, because the diagnosis and treatment of diseases can not be granted patent rights, our country draws lessons from the European provisions.

European drug companies in order to avoid claim falls into the European Patent Office designated "object" is granted a patent right within the scope of the Swiss enterprises when applying for patents, first adopted a method of writing, known as the Swiss type claim, specific written form is "compound or combination X in preparation for the treatment of disease of the drug Y use", this kind of writing method, once accepted by the European Patent Office. Of course, under the current European patent convention, this writing has ended. But what applies in our country is the writing method of Swiss claim. According to China's patent examination guidelines 2010, a substance can be legally granted a patent if it is used to make a drug. According to the regulation, in the claim for the medical use of a substance, the circumstances under which it is not authorized include "for the treatment of a disease"; "Application as a drug" for the diagnosis of diseases; The circumstances of authorization include "application in pharmaceuticals", "application in the preparation of a drug for the treatment of a disease" and "application of compound X in the preparation of a drug for the treatment of disease Y". Therefore, applying for a patent for the use of a drug does not violate the provisions of the patent law.

4、瑞德西韦在中国的专利现状

回到之前的瑞德西韦专利权，刚才我们说到，每一种药品都有很多不同类型的专利，在药品研发的不同阶段陆续申请，已经在国外进行到临床实验三期的瑞德西韦同样申请了很多专利。根据在国家知识产权局专利检索系统的查询，目前吉利德公司有六项与瑞德西韦相关的专利或专利申请，两项专利已经获得授权，分别保护瑞德西韦化合物、药物组合物及其针对副黏病毒科病毒感染的制药用途；保护与瑞德西韦结构相似的卤代化合物、药物组合物及其针对副黏病毒科病毒感染的制药用途。有四项仍在专利申请过程中，分别保护瑞德西韦的制备方法、针对丝状病毒科、沙粒病毒科、冠状病毒科病毒感染的制药用途以及瑞德西韦的晶型结构。

4. The patent status of Remdesivir in China

Going back to the Remdesivir patents, as we just mentioned, there are many different types of patents for each drug, which are applied in different stages of drug development. Remdesivir, which has been in phase iii clinical trials abroad, has also applied for many patents. According to the search in the patent retrieval system of the state intellectual property office, Gilead currently has six patents or patent applications related to Remdesivir, two of which have been authorized to protect Remdesivir compounds, pharmaceutical compositions and their pharmaceutical USES against paramilitary virus infection; Protect the similar structure of Remdesivir hairslide compounds, pharmaceutical compositions and their pharmaceutical use against paramilitary virus infection. Four are still in the patent application process, protecting the preparation of Remdesivir, its pharmaceutical use against fluoridate, sarcophagi, and Coronavirus infections, and the crystalline structure of Remdesivir.

5、武汉病毒研究所能否对瑞德西韦的新用途申请专利

答案是肯定的，既然我国专利法并未禁止对药物用途申请专利，那么武汉病毒研究所做法的合法性毋庸置疑。而对于瑞德西韦化合物尚在专利保护期内这一情形，并不会对武汉病毒研究所申请专利的合法性产生影响。在专利期内，他人有权利用该专利技术进行科学研究进而再作出发明，该行为本身并不为法律所禁止，反而是法律所鼓励的。

在药物研发领域，法律并未规定只有化合物的专利权人才能对其进行进一步的研究开发。如上文所述，鼓励他人对现有的专利技术进行进一步的研究、开发，有利于整个社会的技术进步，是应该鼓励的。一种新的化合物的出现，会吸引很多业内同行参与到其后续开发之中，只要其研发成果符合新颖性、创造性、实用性，申请时又能充分公开，就能获得专利授权。

但是，需要关注的是，对他人拥有专利权的化合物进行研究开发，取得的专利权并非强专利，其应用需要取得化合物专利权人的授权，无法单独使用。

另一个问题是，吉利德公司对瑞德西韦治疗冠状病毒科病毒感染的用途已经申请了专利，虽然尚未获得授权，但已经进入到实质审查阶段，也就是说，该用途已经被公开，是否会导致武汉病毒研究所的申报无法取得授权。

根据《专利审查指南》的规定，已公开的上位概念并不破坏下位概念的新颖性。也就是说，吉利德对于瑞德西韦治疗冠状病毒用途的公开不能破坏武汉病毒研究所对于瑞德西韦治疗本次新型冠状病毒用途的新颖性。当然，不破坏新颖性并不意味着武汉病毒研究所一定会获得专利授权，决定专利授权的审查是全面的，要根据其提交的申请是否符合专利法的规定来决定。

5. Can the Wuhan Institute of Virology apply for a patent for the new use of Remdesivir

The answer is yes, since China's patent law does not prohibit the application of patents for the use of drugs, then the legality of the Wuhan Virus Institute's practice is beyond doubt. However, the fact that the Remdesivir compound is still under patent protection will not affect the validity of the patent applied by Wuhan Institute of Virus. During the patent period, others have the right to use the patented technology for scientific research and then make inventions, which is not prohibited by law, but encouraged by law.

In the field of drug development, the law does not stipulate that only the patentee of a compound can conduct further research and development. As mentioned above, it should be encouraged to encourage others to carry out further research and development on existing patented technologies, which is conducive to the technological progress of the whole society. The emergence of a new compound will attract many industry peers to participate in its subsequent development. As long as its research and development results meet the requirements of novelty, creativity and practicability, and the application can be fully disclosed, the patent can be granted.

However, it should be noted that the research and development of a compound patented by others does not result in a strong patent, and its application requires the authorization of the patentee of the compound and cannot be used alone.

Another question is whether Gilead has filed a patent for Remdesivir's use in treating Coronavirus infections, which has not yet been authorized but is already under substantive review. That is, the use has been disclosed, which would prevent the Wuhan institute of virology from obtaining the license.

According to the patent examination guide, the disclosed epistemology does not destroy the novelty of the inferior epistemology. In other words, Gilead's disclosure of Remdesivir's use in the treatment of Coronavirus cannot undermine the novelty of the Wuhan institute of virology's use of Remdesivir in the treatment of this novel Coronavirus. Of course, not destroying novelty does not mean that Wuhan institute of virology will necessarily obtain patent authorization. It is decided that the review of patent authorization is comprehensive, depending on whether the application submitted complies with the provisions of the patent law.

6、如果武汉病毒研究所的专利申请被授权，能否直接使用瑞德西韦来治疗新冠肺炎患者

答案是否定的，从两个方面来说：

首先，我们上文也说了，专利授权和药品审批是完全不同的两件事，武汉病毒研究所即使取得专利，并不意味着其制造的用于治疗新冠肺炎的药品就可以上市销售，还需要进行药品注册。

其次，单就制造药品来说，吉利德掌握着瑞德西韦化合物的核心专利，因此，武汉病毒研究所要想制备该药品，仍需取得吉利德的授权。当然，如果武汉病毒研究所的专利申请被授权，吉利德公司就不能使用瑞德西韦制造用于治疗新冠肺炎的药品，除非取得武汉病毒研究所的授权。在这种情况下，两个主体必须交叉授权方可将该专利最终转化为药品，任何一方都不能单独将其应用于新冠肺炎。

综上，瑞德西韦在全世界范围内都为取得上市审批，并非可以上市销售的药品。吉利德公司已经对瑞德西韦化合物及其用于治疗冠状病毒的用途申请了专利，但并不影响武汉病毒研究所的专利申请，武汉病毒研究所的专利申请是合法且有可能获得授权的。如果武汉病毒研究所的专利申请获得授权，仍无法单独使用瑞德西韦，需要取得吉利德公司的授权方可进行。

6. If the patent application of Wuhan Institute of Virus is authorized, can we directly use Remdesivir to treat patients with new coronary pneumonia

The answer is no, in two ways:

First of all, as we have mentioned above, patent authorization and drug approval are two completely different things. Even if the Wuhan Virus Research Institute obtains the patent, it does not mean that the drugs manufactured by it for the treatment of new coronary pneumonia can be sold on the market and need to be registered.

Second, Gilead alone holds the core patent for the Remdesivir compound, so the Wuhan institute of virology still needs Gilead's license to produce the drug. Of course, if the Wuhan institute of virology's patent application is granted, Gilead will not be able to use Remdesivir to make a drug for the treatment of new Coronavirus, unless licensed by the Wuhan institute of virology. In this case, the patent must be cross-licensed by the two parties before it can be converted into a drug, and neither party can apply it to the new coronary pneumonia alone.

To sum up, Remdesivir is not a drug that can be marketed for approval for marketing worldwide. Gilead has filed a patent for the Remdesivir compound and its use in the treatment of Coronavirus, but this does not affect the Wuhan institute of virology's patent application, which is legal and potentially licensed. If the Wuhan institute of virology's patent application is authorized, it is still not possible to use Remdesivirr alone, which requires Gilead's authorization.

笔者认为，武汉病毒研究所的专利申请合法且不悖于行业内的惯例，属于常规操作，无需对此进行过度解读。作为一个律师，笔者关注的是其积极申请专利权的行为，本身就代表了对法律和知识产权的重视，虽然武汉病毒研究所的声明中将其定性为应对疫情所需。

在国家高效有力的防控措施下，本次疫情严重程度已经有所缓和，相信我们很快就能恢复正常的工作和生活。虽然我们国家的科研能力与发达国家还有所差距，但笔者希望科研机构、企业和高校，在没有疫情的日子里，也能重视法律规则、重视知识产权，能够积极主动的参与到世界范围内的科研竞争中。技术的差距已经越来越小，不能让法律意识的缺失毁掉来之不易的科研成果。

The author thinks, the patent application of Wuhan Virus Research Institute is legal and not against the practice in the industry, it is a routine operation, there is no need to over-interpret it. As a lawyer, I am concerned that his active patent application represents an emphasis on legal and intellectual property rights, although the statement from the Wuhan Institute of Virology characterizes it as necessary to deal with the outbreak.

Thanks to the country's effective prevention and control measures, the severity of this outbreak has been alleviated. I believe we will soon return to normal work and life. Although there is still a gap between China's scientific research capacity and that of developed countries, the author hopes that scientific research institutions, enterprises and universities can also attach importance to legal rules and intellectual property rights when there is no epidemic, and actively participate in the worldwide scientific research competition. The technological gap has narrowed, and a lack of legal awareness cannot be allowed to destroy hard-won scientific achievements.