Confusion of the concept and identification of generic names
Drug names listed in the National Drug Standards shall be recognized as generic names, which can be referred to as the “generic name in form” recognizing principle. The recognizing principle, further considering the generalized factor, shall be referred to as “generic name in substance.” Courts at different levels do not possess unified standards on whether a sign constitutes generic names; however, for the trademark registration of generic names, all cases on maintaining or not maintaining exhibit a internal logical identity. The “generic names in substance” principle is upheld by Chinese courts, which indicates that when determining whether to allow the registration of a drug name, they carefully consider whether the name is listed in the National Drug Standards and whether it has been generalized. In Chinese court practices, generalized drug names are difficult to register, whereas non-generalized ones may be registered.
In judicial practices, the standard of generalized or non-generalized tends to further identify whether this drug is operated by only one particular enterprise or there are other operators. The sign should not be identified as “been generalized” if the drug name sign’s owner is the only provider of the drug and if the sign forms a one-to-one corresponding relationship with the drug provider, which apparently indicates the source of the drug.
The CTML does not exclude the trademark registration of generic names. Article 11 stipulates that a generic name that has acquired prominent characteristics through use and is easy to identify may be registered as a trademark. The aforementioned provision stipulates two requirements for registering a generic name as a trademark, namely “acquired distinctive characteristics through use” and “easy to identify.” Since there is only one enterprise that supplies the drug, the drug name has the mixed attributes of a generic name indicating the type of product and a brand indicating the source of the product (Shipley and David 1978). There is a one-to-one correspondence between the commercial symbol and the drug provider, and the drug name becomes exceedingly distinguishable. The drug name involved in the “SanLieTong,” “GangTai,” and “YingMaDaZheng” cases has a one-to-one corresponding relation with the operator of the drug, which is exceedingly distinctive (Kong 2016). This scenario satisfies the requirements of distinctiveness and identification, as well as the requirements for the registration of generic name trademarks from the CTML perspective.
This identification method is apparently rational if we recognize that generic names can acquire distinctiveness through use. The CTML stipulates that a sign may obtain distinctiveness through use and does not exclude the trademark registration of generic names, and judicial practices adopt the same opinions. However, this arrangement would undermine the foundation of the generic names concept and lead to immense confusion on generic names. Essentially, generic signs refer to the words or symbols that communicate what type of product or service is offered; they do not refer to the source of product or service. Generic signs are different from descriptive signs. Unlike descriptive signs, the generic signs’ function of class indicator determines that they could not acquire a secondary meaning because it refers to the product or service category. The role of the generic name and that of the trademark are inherently conflicting and incompatible.
It is widely accepted that generic names cannot acquire distinctiveness. The WTO specifications do not affirm the issue pertaining to the distinctiveness of generic names, neither do they include a provision for the registration of generic names. Under the Paris Convention for the Protection of Industrial Property (hereinafter referred to as Paris Convention), trademarks that may serve in trade to designate the kind of goods or have become customary in the contemporary language or the bona fide owner may be denied registration or invalidated. According to the Paris Convention, generic and descriptive terms belong to the same signs devoid of distinctive characters. Under Article 15 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS), signs are not inherently capable of distinguishing the relevant goods or services, and members may attain registrability depending on the distinctiveness acquired through use. This provision provides a legal basis for registering descriptive signs but not for registering generic signs. From the perspective of intellectual property rules, the generic name apparently bears no inherent distinctiveness, and there is no possibility of obtaining distinctiveness by use. In the United States, Lanham Trade-Mark Act prevents the trademark protection of generic terms. A descriptive mark can acquire a secondary meaning in customers’ minds, whereas a generic mark cannot gain a secondary meaning because it relates to a product or service category. Even in East Asia, the trademark laws of Japan and those of the Republic of Korea also preclude the possibility of trademark registration for generic terms based on the lack of distinctiveness.
Damage to the stability and authority of drug names
Drugs are exceptional commodities with particular regulatory systems. For the trademark registration of drug names, Chinese courts ignore the particularity of drug administration laws and regulations and emphasize the principle of “generic name in substance” from the CTML perspective. Such an identification method without distinguishing the particularity of the CDAL can lead to a scenario in which the “statutory generic name” concept in the CDAL exists just in name. The Supreme People’s Court of China issued a judicial interpretation aimed at determining whether a sign constitutes a generic name. Under Article 10 of the Provisions of the Supreme People’s Court on Several Issues concerning the Trial of Administrative Cases involving Trademark Authorization and Confirmation, a trademark that is the name of a commodity under the provisions of the law or the national standards and industry standards shall be recognized as a generic name. Specifically, the National Drug Standards are national and industry standards in pharmaceuticals. Drug names in the National Drug Standards should be regarded as generic names. Article 28 of the CDAL states that the National Drug Standards are the Pharmacopoeia of the People’s Republic of China and drug standards promulgated by the drug regulatory department under the State Council. Article 29 stipulates that the drug names listed in the National Drug Standards shall be generic. Lawmakers propose the following: All the medicine names listed in the National Drug Standards are generic drug names, which are commonly utilized “statutory names”. The generic names of drugs are formulated by the State Committee and reported to the State Food and Drug Administration. Drug names listed in the National Drug Standards are the generic names of drugs and the “statutory generic names” that individuals are familiar with. The generic names of drugs are derived from the National Drug Standards and are commonly utilized nationwide, and they also reflect the fundamental differences of normalized appellation between different classes of drugs. If the drug names listed in the National Drug Standards are not considered the generic names of drugs, the existence of legal generic names is prohibited. Moreover, the naming of the generic names of drugs is not arbitrary. The generic names of the drug are approved first as the legal names to prevent the confusion occasioned when one drug has multiple names. The names utilized as trademarks shall not be included in the National Drug Standards. The names can either be utilized once generic names have been approved or registered as trademarks, preventing prescription errors occasioned by name ambiguity and ensuring public health and safety.
Therefore, we propose that, unlike descriptive signs, generic names cannot acquire distinctiveness. The one-to-one correlation between a commercial symbol and the manufacturer of a drug should be considered when choosing whether to register descriptive signs as trademarks; however, it does not apply to the identification of generic signs. The consideration of whether the sign has been generalized only applies to determining whether the registered trademark has become a generic name in the cases of trademark revocation, instead of trademark registration. In regard to trademark registration, the generalization problem should not be considered. In the drugs domain, drug names listed in the National Drug Standards should be considered as the generic names of drugs for drug use safety and public health.
Imbalance of interests among drug operators
The lack of generic names can occasion substantial confusion among providers and patients (Roger and Félix 2012), leading to an imbalance of interests among drug operators. The trademark registration of drug names should be considered not only from the CMTL perspective but also from the CDAL perspective. The CDAL should delimit the boundary between drug names and trademarks.
Drug names listed in the National Drug Standards are Chinese-approved drug names. According to drug administration laws and regulations, any drug operator must conduct drug operations in accordance with the provisions of the drug administration on that kind of drug. Specifically, their operation must follow the National Drug Standards, especially with respect to drug names. Otherwise, they will be punished for violating drug administration laws and regulations. According to the CDAL, the generic names of drugs must be indicated prominently and distinctly on the label or instruction manual. In addition, the Provision on the Administration of Drug Instructions and Labels also provides detailed requirements for labeling generic names and includes specific provisions in regard to the standard position, size, and color of the generic medicine names, thereby facilitating identification through prominent labeling. After such drug names are registered as trademarks, substantial problems arise among these provisions. According to the CTML, using the same or similar trademarks on the same or comparable products without the trademark owner’s permission is forbidden. Prominently and distinctly using generic names according to the CDAL can significantly increase the risk of trademark infringement. The conflicting obligations imposed by the CDAL and the CTML put drug operators in a dilemma—on one hand, they can confront the risks of trademark infringement if they follow drug administration laws and regulations, and on the other hand, if they follow the CTML, they can breach drug administration laws and regulations and be barred from conducting drug business. Where patents are granted for limited terms, trademarks can be perpetually protected (Jeremy and Greene 2013). Accordingly, the scenario in which drug names listed in the National Drug Standards may be registered as trademarks can lead to a subjective permanent monopoly on the specific drug from which other operators can be excluded. With the registration of such trademarks, the trademark owner has the exclusive right to use the trademark. Monopolizing the generic name of the drug can permanently monopolize its production and operation, which may lead to a drug accessibility problem. In the specific cases, the courts of final instance maintain the registration of trademarks of the drug names in the cases, such as “BaBaoDan” “YiMaDaZheng,” and “GangTai”. This leads to such a consequence. The signs of “BaBaoDan” “YiMaDaZheng,” and “GangTai” are the drug names according to the National Drug Standards. Meanwhile, they are also the registered trademarks. If other operators plan to do the particular drugs business, they inevitably should mark the generic names of “BaBaoDan” “YiMaDaZheng,” and “GangTai” prominently and distinctly in the packages to comply with the provisions of the CDAL. But these practices can expose them to the risk of trademark infringement. The fear of infringement risk has discouraged other operators from entering these specific drug industries. Currently these drugs are sold exclusively. And the protection of trademark rights would give trademark owners of “BaBaoDan” “YiMaDaZheng,” and “GangTai” exclusive right to operate the drugs in perpetuity.
The current institutional procedures for the protection of patented or traditional Chinese medicine varieties have resulted in the development of the exclusive business status of pharmaceuticals. The institutional arrangements are impermanent. Drug names can, however, become a permanent monopoly if they are permitted to be registered as trademarks and if there are no remedies or they are not apparent. The decisive competitive advantage is not within the protection scope of the trademark right. The CTML’s value connotation also relates to protecting lawful competition orders (Zhao 2016). The CTML protects two types of fair competition. One is to protect the fair competition interest of trademark owners by preventing confusion. The protection of other operators is also an essential connotation of the protection of the CTML. The CTML rejects generic names without distinctiveness to stop illegal competition occasioned by monopolizing the generic names that market operators must utilize in the form of trademark rights.
In response to this scenario, the CTML has established the “fair use” rule, which has been applied in cases involving the trademark infringement of generic names. Nonetheless, it does not imply that rule of “fair use” properly balances interests between trademark owners and other operators. The “fair use” rule can alleviate the infringement concerns of other operators conducting relevant drug businesses; however, it increases the dilution risk that affects the distinctiveness of generic name trademarks. The trademarks of “BaiLing” and “YiMaDaZheng” also possess the “source identification function” and bear goodwill, which is consistent with the nature of trademark protection. After fair use, the one-to-one correspondence between the drug and drug manufacturers disintegrates, and the connection between trademarks and specific manufacturers is divided. The distinctiveness of the trademarks reduces, and they continually manifest a generalization tendency; moreover, the benefits of trademark owners decreases. It also limits the confidence of trademark owners, who fail to effectively make continuous investments in trademarks, which leads to the failure of the incentive function of trademark law.