Patents & Trademarks: China
An outline of the legal situation around patents and trademarks for pharmaceuticals in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99.
1. What are the basic requirements to obtain patent and trademark protection?
Please refer to Question 3 below.
2. What agencies or bodies regulate patents and trademarks?
In China, patents are regulated by the China National Intellectual Property Administration (“CNIPA”) and trademarks are regulated by the China Trademark Office (“CTMO”).
The PRC Patent Law was amended in 2020 (the “2020 Patent Law”) and came in effect on June 1, 2021. The 2020 Patent Law outlined a mechanism which may be regarded as a patent linkage system for new drug applications in China. The implementation rules will be jointly formulated and enacted by NMPA and CNIPA.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
Inventions (new technical solution proposed for the shape and structure of a product, or the combination thereof, which are suitable for practical applicability), utility models (new technical solution proposed for a product, a process or the improvement thereof) and designs (new designs of the shape, pattern, the combination thereof, or the combination of the color with shape and pattern embodied in the entire or part of a product, which create an aesthetic feeling and are suitable for industrial application) may be protected as patents in China.
The term of patent is 20 years from the date on which the patent application has been filed with the CNIPA. The 2020 Patent Law provides a patent term extension for an invention in a new drug for up to five years, upon the request of the new drug applicant, to compensate for curtailment of patent term occasioned by NMPA regulatory approval procedures. But the total adjusted patent term for a new drug shall not exceed 14 years post-marketing.
An invention or a utility model patent that is patentable should meet the following requirements:
- Novelty, which means that an invention or a utility model is neither an existing technology nor disclosed in other patent applications filed in China prior to the date of application of such invention or utility, but published after the date of such application.
- Creativity, which means that an invention has prominent as well as substantive features and indicates remarkable advancements, or a utility model possesses substantive features and indicates certain advancements.
- Practical applicability, which means that an invention or a utility model may be used for manufacturing or be utilized, and may have a positive effect.
A design patent that is patentable should meet the following requirements
- Novelty, which means that a design does not fall under any existing design.
- Distinctiveness, which means that a design is distinctly different from any of the existing designs or a combination of such designs.
- No conflict with other rights, which means that a design should not conflict with the existing legal rights acquired by others.
The following will not be granted as patents:
- Scientific discoveries.
- Rules and methods for intellectual activities.
- Methods for the diagnosis or treatment of diseases.
- Animal and plant varieties.
- Methods for nuclear transformation and substances obtained by means of nuclear transformation.
- Designs that are mainly used for marking the pattern, color or combination of these two elements.
- Inventions that violate applicable laws or social morality in China, or that harm public interests.
- Inventions that are accomplished based on genetic resources and the acquisition or use of which breaches related laws and regulations.
Generally speaking, any sign capable of differentiating the commodities of a natural person, a legal person or any other organization from the commodities of others, including, but not limited to, words, graphics, letters, numerals, three-dimensional signs (shapes), combination of colors, and sounds, as well as a combination of the above elements, may be registered as a trademark.
Furthermore, a sign registered as a trademark should meet the following requirements:
- It should not be a mark that cannot be registered as a trademark (see below, the signs that cannot be used or registered as trademarks).
- It should be distinctive and easily distinguishable.
- It should not be identical or similar to a trademark that has been registered or preliminarily approved for use on the same or similar commodities.
- There must be no conflict with any prior rights enjoyed by a third party.
The following signs cannot be used or registered as trademarks:
- A sign identical with, or similar to, the state name, national flag, national emblem, national anthem, military flag, military emblem, military anthem, or medals of the People’s Republic of China or identical with the name or emblem of a central state organ, the name of specific location that is the domicile of a central state organ, or the name or design of its landmark building.
- A sign identical with, or similar to, the state name, national flag, national emblem, or military flag of a foreign country, except with the consent of the government of such foreign country.
- A sign identical with, or similar to, the name, flag, or emblem of an international intergovernmental organization, except with the consent of the organization or except where the chance of misleading the public is slim.
- A sign identical with, or similar to, an official sign or a hallmark indicating control or warranty, except otherwise authorized.
- A sign identical with, or similar to, the name, sigh or mark of the Red Cross or the Red Crescent.
- A sign with an indication of ethnic discrimination.
- A sign that is deceptive and is likely to cause public confusion in respect of the quality, other characteristics or place of production of relevant goods.
- A sign identical with the name of an administrative division at or above the county level and the name of a foreign place that is known to the public, unless any such name has other meanings or is an integral part of a collective or certification mark. If a trademark containing a place name has already been registered, the trademark shall remain valid.
- A sign that is detrimental to socialist morality and custom or has other adverse effects.
- The drug names listed in the state drug standards are the common names of the drugs. Where common names of drugs have been used, such names should not be used as trademarks for the drugs.
The following signs cannot be registered as trademarks:
- A sign only consisting of the generic name, design or model of the commodities concerned.
- A sign only directly representing the quality, primary raw materials, functions, intended uses, weight, quantity or other characteristics of the goods concerned.
- Other signs lacking distinctive features.
- A three-dimensional mark that is only a shape resulting from the nature of the goods, a shape of the goods required for achieving a technological result or a shape that adds substantial value to the goods.
- A trademark contains a geographical indication of goods and the goods are not from the region indicated therein, thus misleading the public. However, those having been registered in a bona fide manner may remain valid.
4. How can patents and trademarks be revoked?
Any organization or individual who believes that the grant of certain patent rights does not conform to the Patent Law may challenge the validity of a granted patent by filing an invalidation application with the Patent Reexamination Board of the CNIPA. A patent can be invalidated under the following circumstances:
- The novelty, creativity or practical applicability of the inventions or the utility models is not duly satisfied.
- The granted design falls under a certain existing design; or certain application has been filed for the same design by any organization or individual with the CNIPA prior to the date of application and such application is recorded in the patent documents announced after the date of application.
- Confidentiality examination related requirements for inventions or utility models made in China were not duly satisfied prior to applying for the patent outside China.
- The description of the patents does not support the claims.
- There was insufficient disclosure.
- Amendments to the patent application documents exceed the original scope.
- The independent claim neither outlines the technical solution of an invention or utility model nor states the essential technical features necessary for the solution of its technical problem.
- A divisional application goes beyond the scope of the disclosure contained in the initial application.
- Two or more patent rights are granted for the same invention.
- The patents fall under those that should not be granted as patents (see Question 3 for more details).
Patent disputes involving new drug applications
According to the 2020 Patent Law, during the process of the NMPA regulatory review of a new drug application, the applicant, the relevant patentee or any interested party can file a complaint for patent infringement with the local court or the CNIPA, requesting the court or the CNIPA to declare whether the patent related to the new drug candidate falls into the valid claims of other patents. The NMPA will take into account the outcomes of judicial or administrative proceedings in determining whether to approve a new drug application or not within a prescribed period.
A registered trademark may be revoked by the CTMO under the following circumstances:
- The registrant changes the registered trademark, the name or address of the registrant without authorization and does not make a correction within a specified time limit required by the local administration for industry and commerce.
- The registered trademark becomes the generic name of goods or it has not been in use for three consecutive years without any justification, and an entity or an individual applies to the CTMO for the cancellation of such registration.
Furthermore, a registered trademark may also be invalidated by filing a request with the Trademark Review and Adjudication Board of the CTMO under the following grounds:
- The registered trademark is one of those that cannot be used or registered as trademarks (see Chapter 6: Patents and Trademarks Question 60 for more details).
- The registered trademark was obtained through deception or by any other illicit means.
- The registered trademark lacks its distinctiveness.
5. Are foreign patents and trademarks recognized and under what circumstances?
Where, within 12 months from the date on which any applicant first filed in a foreign country an application for patenting an invention or utility model, or within six months from the date on which any applicant first filed in a foreign country an application for patenting a design, the applicant files in China an application for patenting the same, he may, in accordance with any agreement concluded between the foreign country and China, or in accordance with any international treaty to which both countries are a party, such as the Patent Cooperation Treaty and the Paris Convention for the Protection of Industrial Property, or on the basis of the principle of mutual recognition of the right to priority, enjoy the right to priority.
Where, within six months from the day when a trademark registration applicant firstly filed an application for registration of a trademark in a foreign country, it applies for registration in China of the same trademark to be used on identical goods, it may enjoy priority according to an agreement concluded between the foreign country and China or an international treaty acceded to by both countries such as the Paris Convention for the Protection of Industrial Property, or on the principle of mutual acknowledgement of the right of priority.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
The NMPA may provide for an administrative monitoring period of five years for new Category 1 drugs approved to be manufactured, starting from the date of approval, to continually monitor the safety of those new drugs. During the monitoring period of a new drug, the NMPA will not accept other applications for new drugs containing the same active ingredient. This works as an effective five-year exclusivity protection for Category 1 new drugs.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
Except for certain general restrictions applicable to all patents or trademarks (see Question 3), there is no special restriction on any type of medicine or device that can be granted patent and trademark protection.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
License agreements do not require the government approval; however, it is mandatory to duly record such agreements before the CTMO or the CNIPA.
A licensing agreement for patent implementation executed between the licensor and the licensee must be filed with the CNIPA within three months from the date on which the contract comes into effect.
For licensed use of a registered trademark, the licensor must file the record of the licensing of the trademark with the CTMO within the validity period of the licensing contract, and the licensing shall be gazetted by the CTMO. Non-filing of the licensing of a trademark will not be contested against a good faith third party.