Hainan Boao Lecheng International Medical Tourism Pilot Zone (the "Pilot Zone") was established with the approval of the State Council in 2013 and granted many preferential policies including special approval for drug import. At present, the Pilot Zone has established cooperation relationship with more than 80 multi-national enterprises including Pfizer, Novartis, Roche etc. and has imported more than 200 kinds of drugs and medical devices for urgent clinical needs.
I. Difference of trademark protection for drug names between “imported drugs marketed within China” and “imported drugs for urgent clinical needs in the Pilot Zone”
In this article, "imported drugs marketed within China" refer to drugs produced abroad that have obtained Imported Drug Registration Certificate in accordance with the provisions of the drug regulatory department of the State Council.
"Imported drugs for urgent clinical needs in the Pilot Zone" (hereinafter “drugs in the Pilot Zone”) refer to drugs imported into the Pilot Zone, which have been approved for marketing in the US, the EU and other countries or regions, but not in China. They cannot be replaced by domestic registered drugs, and do not include vaccines and other drugs under special administration.
As "imported drugs marketed within China", their names must be registered trademarks in China. But as "drugs in the Pilot Zone", their names are not necessarily registered trademarks in China.
A. Imported drug names marketed within China must be registered trademarks.
To satisfy examination requirement for imported drug registration, certificate proving registration of the drug name as a trademark needs to be submitted. Therefore, imported drug names marketed within China must be registered trademarks covering “medicine for human use and etc.” in Class 5 in China.
(a) Imported drugs marketed within China must obtain Imported Drug Registration Certificate.
Article 24 of Drug Administration Law reads “Drugs to be marketed in the territory of the People’s Republic of China shall be subject to approval by the drug regulatory department under the State Council to obtain Drug Registration Certificate, except for Chinese medicinal materials and prepared slices of Chinese crude drugs which are not subject to review and approval administration.” Therefore, drugs marketed within China needs to pass the examination proceeding of drug registration.
(b) Under the requirement of drug registration examination, trademark certificate of the drug name is necessary.
Application for drug registration needs to be filed according to the category of the drug. Article 4 of Measures for Administration of Drug Registration effective from July 1, 2020 requires that the registration application of drugs produced abroad should be filed in accordance with the detailed classification of drugs. On July 2, 2020, Center for Drug Evaluation, National Medical Products Administration (NMPA) issued Guidelines for Acceptance and Examination of Chemical Drug Registration (Trial), which stipulates that "For application for use of drug name, certificate proving registration of the drug name as a trademark should be filed". Accordingly, drug name either in foreign language or in Chinese for imported drug marketed within China should be a registered trademark in China.
B. Drug names in Pilot Zone are not necessarily registered trademarks in China.
Drugs in the Pilot Zone belong to "imported drugs for urgent clinical needs". According to relevant regulations, such drugs do not need to be registered, and no authority will examine whether their names are registered as trademarks. Therefore, drug names in the Pilot Zone are not necessarily registered trademarks.
(a) Imported drugs for urgent clinical needs do not need to obtain Imported Drug Registration Certificate.
Under Article 65 of Drug Administration Law, where a medical institution has urgent clinical needs for a small quantity of imported drugs, such drugs may be imported upon approval by the drug regulatory department under the State Council or by local government authorized by the State Council. This means imported drug for urgent clinical use do not need to obtain Imported Drug Registration Certificate.
Moreover, Article 36 of Implementation Regulation of Drug Administration Law also states that to import drugs for urgent clinical needs, medical institutions only need to have Medical Institution Practice License, but do not need to own Imported Drug Registration Certificate.
Given the above, there is no registration examination proceeding for imported drugs for urgent clinical needs and accordingly their names are not required to be registered trademarks.
(b) Drugs in the Pilot Zone belong to “imported drugs for urgent clinical use” and their drug names do not need to be registered trademarks in China.
In a circular released in 2018 by State Council, a change to drug import administration in the Pilot Zone was announced. According to the circular, the State Council made temporary adjustment of appliance of Article 36 of Implementation Regulation of Drug Administration Law, allowing Hainan provincial government to approve import of drugs for urgent clinical needs in the Pilot Zone. This means drugs in the Pilot Zone belong to imported drugs for urgent clinical needs and thus do not need to obtain drug registration. As a result, drug names in the Pilot Zone are not necessarily registered trademarks in China.
II. Potential risk under the frame of Trademark Law of using unregistered drug names in the Pilot Zone.
A. Examples.
(a) Trademark applications for drug names in the Pilot Zone have been refused by the CNIPA.
On June 2, 2021, COSELA drug was imported into the Pilot Zone bringing international advanced treatment to patients with small cell lung cancer. On July 8, 2021, its holder filed trademark application for COSELA covering "pharmaceutical preparations" in Class 5. However, this trademark application was refused by the CNIPA in October 2021, probably because of citation of prior similar mark on same or similar goods.
(b) Drug names in the Pilot Zone have been registered as trademarks by others.
In June 2018, LEUKINE was approved in the United States for treatment of acute radiation syndrome. Then LEUKINE was imported into the Pilot Zone. But so far, its holder has not filed trademark application for LEUKINE. Instead, a Chinese company’s trademark No. 31116762 has been registered in February 2019 in Class 5 in China.
B. Under the framework of Trademark Law, potential risk of using drug names that are not registered as trademarks.
(a) Possible delay of process for marketing within China
For a trademark, the average period from filing date to registration date is 7 months under general conditions, namely without meeting any office action. To complete registration of import drug, trademark registration certificate of the drug name is required. Therefore, if the drug name has not been registered as a trademark, the drug registration process will be delayed at least for 7 months.
For holder of the above-mentioned COSELA drug, to obtain trademark registration for COSELA, it is necessary to remove the obstacle caused by prior cited mark by means of opposition, invalidation or assignment. It is also necessary to file review on the refusal to maintain the trademark application alive. These measures interact with each other and will extend the time required for obtaining trademark registration for the drug name.
(b) Risk of loss of prior rights
First-to-file principle is applied in China. Under Article 30 of Trademark Law, if a trademark application is identical with or similar to a registered trademark covering same or similar goods, its registration shall be refused.
If drug names in the Pilot Zone are registered as trademarks in China, they will block others’ same or similar trademark application filed on same or similar goods. In this way, any possible confusion caused by co-existence of others’ same or similar trademarks with drug names in the Pilot Zone will be effectively avoided.
If drug names in the Pilot Zone are not registered as trademarks, in opposition or invalidation against others’ same or similar mark on drugs, the holder of the drug name needs to submit a lot of evidence proving the drug name had been used as a trademark and had obtained certain influence before filing date of the opposed/disputed mark. This is not cost-effective. In contrast, registering drug names as a trademark will provide more efficient protection for the drug name under the framework of Trademark Law.
(c) Risk of dilution of drug name into generic name
Article 9 of the Trademark Law stipulates that " A trademark registrant shall have the right to display the wording ‘Registered Trademark’ or a sign indicating that it is registered ". If not registered as a trademark, drug names in the Pilot Zone cannot be used together with these signs. This will be disadvantages in educating the publics to realize that the drug name is also a trademark exclusively owned by the pharmaceutical company, but not any generic name. Having the drug name registered as a trademark will contribute to maintaining the distinctiveness of the drug name.
(d) Risk of being sued for trademark infringement
As for the above-mentioned drug name LEUKINE, because others have previously registered the same trademark LEUKINE covering goods in Class 5, the use of LEUKINE on imported drugs in the Pilot Zone will face the risk of being sued for infringement by the owner of the prior registered trademark LEUKINE. Of course, the claims that LEUKINE is used as a drug name, and such use is allowed under the special provisions for imported drugs for urgent clinical needs in the Pilot Zone will be strong defenses. But such potential risks will undoubtedly cause unnecessary trouble to pharmaceutical enterprises.
To sum up, under the frame of drug administration, drug names in the Pilot Zone are not necessarily registered marks. However, in the long run, protecting the drug names in the Pilot Zone as registered trademarks will not only bring commercial benefits to pharmaceutical enterprises, but will also be advantage for safeguarding publics’ health interests.
III. Advice for trademark protection of drug names for drugs in the Pilot Zone
A. Make early plan for overall arrangement of trademark registrations for drug names in the Pilot Zone.
(a) Early registration for drug names in the Pilot Zone as a trademark helps to acquire Imported Drug Registration Certificate and successful entrance into China’s market.
Under general circumstance, it will take 7 months for a trademark application to mature into registration without meeting any office action. Therefore, with trademark registration certificate in the hands, for drug registration proceeding, the pharmaceutical enterprises will avoid waiting for 7 months at least.
(b) Early registration of drug names in the Pilot Zone as trademark will realize the advantages of real-world data in the Pilot Zone in accelerating the process of drug registration.
In April 2021, the State Food and Drug Administration (SFDA) accepted the application of new drug for treatment of chronic non-infectious uveitis, which is developed by OcuMension. The real-world data of 28 subjects for the drug collected during its use in the Pilot Zone are submitted to the SFDA. With this data, the commercialization process of this drug is accelerated for about one and a half years. For drugs in the Pilot Zone, the combination of real-world data herewith and trademark registration of drug name will be substantially helpful in accelerating the drug’s entrance into China’s broad market.
B. Make comprehensive strategy for trademark registration of Chinese drug names in the Pilot Zone
The drugs in the Pilot Zone are using packaging of foreign markets and there is only drug name in foreign language on the packaging. It is likely that its Chinese drug name has not been decided.
To obtain Chinese drug name, trademark registration certificate of the Chinese drug name is required. Therefore, pharmaceutical enterprises are advised to prepare three to five candidates of Chinese drug names and conduct trademark searches for them. Based on the results, trademark applications for two or three of them, which have higher chance of being registered, should be filed. In this way, the drugs can have their own "Chinese names" to be registered as both drug name and trademark as soon as possible.
C. Make in-depth trademark search and investigation to clear up potential obstacle for trademark registration of drug names in the Pilot Zone.
Pharmaceutical companies are advised to conduct trademark search for drug names of their drugs in the Pilot Zone. This is to find out if there is any prior trademark covering “medicine for human use, etc.” in Class 5 same with or similar to their drug names. If yes, actions under the frame of Trademark Law should be taken to clear the possible citation, such as opposition, invalidation, non-use cancellation, assignment negotiation, etc. Such preemptive action will also decrease the risks of being sued for trademark infringement.
The aim of some imported drugs in the Pilot Zone is to start commercialization process and to enter China’s broad market. Trademark registrations of their drug names are necessary guarantee to achieve this goal. Providing multi-dimensional trademark protection strategies will help the imported drugs in the Pilot Zone to be marketed in China at an early date and will bring benefit to domestic publics’ health.
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