Stephen Yang , Wei Yang and Zunxia Li
IP March

This article was first published in "The Intellectual Property Review", Dominick A Conde ed., 10th ed., Law Business Research Ltd, May 4, 2021.

  I   Forms of intellectual property protection  

China patent law provides for three types of patent rights, namely invention patents, utility model patents and design patents, which are collectively called 'invention-creations'. An invention patent protects products, methods and use. A utility model patent only protects products, and not methods or use. A design patent only protects the appearance of a product, but not the technical aspects thereof. The term for an invention patent is 20 years, the term for a utility model patent is 10 years and the term for a design patent is 15 years, counted from the filing date. Patent term adjustments and patent term extensions for drug patents are available.

Trademark and copyright protection are respectively provided for in China trademark law and China copyright law, and trade secret protection is provided for in anti-unfair competition law.

II  Recent developments  

Shortly after a patent linkage system became available in China when the fourth amendment of China's Patent Law took effect on 1 June 2021, on 4 July 2021, the National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) jointly issued 'Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)', which provide detailed rules.2 On the same day, China's Patent Information Registration Platform for Approved Drugs formally started operations.3 The Platform is considered equivalent to 'Approved Drug Products with Therapeutic Equivalence Evaluations' in the US (i.e., the 'Orange Book').

Bolar exemptions, patent term extensions for drug patents and patent term adjustments are provided for in Articles 75 and 42 of China's Patent Law. The protection of drug experimental data is provided for in Article 34 of the Regulations for the Implementation of Drug Administration Law, which prescribe that within six years from the date when a drug manufacturer or seller obtained a licence to make or sell drugs containing new chemical ingredients, NMPA does not grant licences to any other applicants who, without the consent of the drug manufacturer or seller, use its data to apply for a licence.4

Therefore, the major elements of the Hatch-Waxman Act can be found in China, with Chinese characteristics, such as the administrative resolution in the patent linkage.

It is to be noted that Article 11 of the Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial) prescribes that market exclusivity will be given to the chemical generic drug that is the first to successfully challenge a patent and is the first to be approved for marketing. Within 12 months from the date of approval of this drug, NMPA does not approve any other generic drugs of the same type.

III Obtaining protection  

i   Absolute novelty  

China has an absolute novelty standard and requires that any patent should not belong to any prior art or prior design, which means any technology or any design known to the public, in China or abroad, before the date of filing. An invention is known to the public when the technical solution is in a state where it is accessible to the public. The public refers to non-specific persons. It is not relevant if the technical solution is actually accessed by anyone. As long as it is in such a state, it is considered known to the public and thus a disclosure. A typical example is that a product containing an invention is sold publicly, but the technical solution of the invention can only be obtained through reverse engineering. In this case, the technical solution is still considered as being disclosed to the public. In contrast to what is known in the US as 'on sale bar', which does not exist in Chinese patent practice, a secret sale or a sale to any party under a confidentiality agreement is not considered a disclosure. An exhibition does not constitute a disclosure as long as the technical solution is not accessible to the public.

China's Patent Law offers a grace period. Specifically, an invention-creation does not lose its novelty if, within six months before the date of filing:

a.   it was first made public for the purpose of public interest when a state of emergency or an extraordinary situation occurs in China;

b.   it was first exhibited at an international exhibition sponsored or recognised by the Chinese government;

c.   it was first made public at a prescribed academic or technological meeting; or

d.   it was disclosed by any person without the consent of the applicant.

It is to be noted that the international exhibitions and academic or technological meetings that qualify for a grace period are very limited, and hence it is difficult to take advantage of this provision. However, the grace period does provide a remedy in cases where a party that has a confidentiality obligation discloses the invention.

ii   Utility models  

Pros and cons

Utility model and design patent applications do not go through substantive examination but they must undergo a preliminary examination, which not only includes a formality examination but also an examination on obvious substantive defects. Currently, the average pendency for utility model applications is about six months.5 Therefore, a utility model patent is easier, quicker, and thus cheaper, to obtain. On the other hand, as it has a lower threshold for inventive steps, it is sometimes more difficult to be invalidated. The downside of the utility model includes shorter terms of protection, unstable validity and limited subject matter that can be protected. There may also be an additional obligation when a utility model or design patent is enforced; for example, some relevant authorities may require a patent right evaluation report produced by CNIPA as preliminary evidence about patent validity. This patent right evaluation report is essential for filing complaints with e-commerce platforms for taking-down actions or for the registration of IP rights at Chinese customs.

Protecting the same invention with an invention application and a utility model application

If an applicant files on the same day a utility model application and an invention application relating to an identical invention-creation, the applicant can get a utility model patent first and, when the invention application is ready to be granted, is allowed to abandon the granted utility model and choose to have a patent for invention granted.

This popular strategy may lose its merits due to a recently proposed amendment to the guidelines for patent examination that states, if an applicant files an invention patent application and a utility model patent application on the same day, the examination of the invention application will be deferred for four years.6

iii   Patentability of pharmaceutical and biotech inventions  7

There are several provisions in the Chinese Patent Law that prescribe the patentability of pharmaceutical and biotech inventions as follows:

Article 25.1(3)

Article 25.1(3) provides that methods for the diagnosis or treatment of diseases are non-patentable subject matter:

a.  methods for the diagnosis of diseases include a method for evaluating a subject's risk of having a certain condition; and

b.  methods for the treatment of disease include, inter alia, a method for treatment via a surgical procedure or medicines or psychotherapeutics, methods for preventing diseases and methods of immunisation.

Normally, such claims can be rewritten into 'Swiss type' claims, such as 'use of a substance for manufacture of a medicament for diagnosis or treatment of a disease', or into product claims, such as 'a system for diagnosis or treatment of a disease, comprising a unit/module configured to. . .', with the units or modules corresponding to respective steps, if the methods are implemented on a computer.

Article 25.1(4)

Article 25.1(4) provides that animal and plant varieties are non-patentable subject matter.

Embryonic stem cells of an animal, an animal at various stages of formation and development, such as a germ cell, an oosperm, an embryo or a transgenic animal, fall into the definition of animal variety and hence are not patentable. In contrast, somatic cells, tissues and organs of an animal (except an embryo) do not fall within the definition of animal variety and hence are patentable.

Plants, including transgenic plants, and plant seeds fall within the definition of plant variety and hence are not patentable. Cells, tissues and organs of a plant normally are not patentable unless they cannot grow by synthesising carbohydrates and proteins from inorganic substances such as water, carbon dioxide and inorganic salts via photosynthesis.

Methods for producing an animal or plant variety can be patentable as long as such methods are not an essentially biological method, depending on the extent of technology intervention.

Genes, including plant or animal (including human) genes, if they are isolated from nature for the first time and have an established industrial utility, are patentable. Methods of isolation thereof are also patentable.

Micro-organisms, except those that occur in nature, do not fall within the definition of animal or plant variety and hence are patentable.

Article 5.1

Article 5.1 provides that no patent right shall be granted for any invention that is contrary to the law or social morality, or that is detrimental to the public interest. Accordingly, the following are not patentable:

a.   a process for modifying the germ line genetic identity of human beings or a human being thus modified;

b.   a process for cloning human beings or a cloned human being;

c.   use of human embryos for industrial or commercial purposes; or

d.   a process for modifying the genetic identity of animals that is likely to cause them suffering without substantial medical benefit for human beings or animals.

The human body at various stages of formation and development, such as a germ cell, an oosperm, an embryo or an entire human body, is not patentable.

As an exception, an invention that relates to stem cells from a human embryo that is within 14 days of fertilisation and has not gone through in vivo development, including such stem cells per se and the preparation method thereof, is patentable.

Article 5.2

Article 5.2 provides that no patent right shall be granted for any invention where the acquisition or use of the genetic resources on which the development of the invention relies is not consistent with the provisions of the law or administrative regulations. Accordingly, if an invention is made relying on genetic resources that have been obtained or exploited in ways that violate Chinese laws, no patent shall be granted.

Article 22.4

Article 22.4 provides that any granted patent should have industrial applicability. Surgical procedures for non-treatment purposes (e.g., cosmetic surgery) that do not have any therapeutic effect are not methods of treatment, but lack industrial applicability and hence cannot be granted a patent right.

Some methods for producing microorganisms cannot be repeated and hence do not have industrial applicability and are not patentable, such as methods for screening particular microorganisms from the natural environment and methods for producing new microorganisms through artificial mutagenesis by physical or chemical processes, unless repeatability can be proved.

iv   Late filing of experimental data

Under current practice, applicants are allowed to supplement experimental data after the filing date of a patent application to prove inventive steps of an invention, or to meet sufficiency requirements or even to support a claim's scope. It is to be noted that any technical effects the late filed data intend to prove must be obtainable from the original disclosure.

v   Business methods and computer program-related inventions

Chinese practice has become relatively friendly in this regard.

Article 25.1(2) of China's Patent Law

Rules and methods for mental activities are non-patentable subject matter. If a claim only contains abstract algorithms or pure business methods, and has no technical features, it cannot be granted. If a claim includes not only algorithmic features or business method features, but also technical features, then the claim as a whole is not included within the rules and methods for mental activities, and shall not be excluded from patentability in accordance with Article 25.1(2) of China's Patent Law.

Article 2 of China's Patent Law

Having technical features is not enough to pass an examination in accordance with Article 2, which provides for a definition of invention. Chinese examiners examine whether the claimed solution falls under the definition of invention: that is, whether it is a technical solution and, more specifically, whether it adopts technical means in accordance with the laws of nature to solve a technical problem and achieves technical effects in accordance with the laws of nature. It is to be noted that the term technical is not explicitly defined anywhere in patent law, regulations or examination guidelines. A solution that is not based on the laws of nature, even if a claim includes technical features, is still not regarded to be a technical solution.

Novelty and inventive steps

All features, including technical features and algorithmic features or business method features, are considered for the evaluation of the novelty of a claim. However, in the evaluation of the inventive step of a claim, algorithmic features or business method features will be considered only if these features and the technical features in the claim 'support each other functionally and have an interactive relationship'.

vi   Foreign filing licence

It is not required to file first in China for any invention or utility model developed in China. However, if anyone intends to file a patent application abroad for such inventions or utility models, a foreign filing licence must be obtained from CNIPA. The penalty for violating this provision is that no patent shall be granted in China. It is to be noted that no foreign filing licence is required for designs.

In determining whether this provision applies to a particular application, the inventor's or applicant's nationality or residence is not relevant. Where the invention or utility model is developed is the only relevant factor. For example, this provision is applicable if a US citizen makes an invention during a visit to China. This provision is not applicable if a Chinese citizen makes an invention during a visit to the US. The foreign filing licence requirement does not apply to inventions or utility models made outside of mainland China (e.g., in Hong Kong).

If there is joint development across different countries, for example, China and the US, it is possible to meet both countries' requirements as, in both China and the US, a foreign filing licence can be obtained without filing a patent application. A foreign filing licence in China could also be obtained on or after filing a Chinese patent application. Alternatively, a Patent Cooperation Treaty international application filed with CNIPA is deemed to be a request for a foreign filing licence.

IV Enforcement of rights  

i   Possible venues for enforcement

In China, enforcement of patent right can be done via the judicial route or the administrative route. Enforcement via one route does not preclude enforcement via the other, even though enforcement cannot be carried out in parallel through both routes for the same dispute. With the conclusion of administrative enforcement, judicial enforcement could be conducted, such as for further compensation.

Judicial route: courts

In China, a patent lawsuit could be a civil case, an administrative case or a criminal case. Patent civil cases include infringement and, inter alia, disputes over ownership, inventorship, inventor remuneration and licence fees. Patent administrative cases include appeals against CNIPA decisions on the rejection of patent applications or patent validity, or the administrative authority's decisions on IP-related matters. Patent criminal cases are only applicable to patent passing-off, which refers to false patent marking and tampering with patent certificates.

There are four levels of courts: the basic people's court, the intermediate people's court, the high people's court and the Supreme People's Court (SPC). In addition, there are four intellectual property courts: the Beijing IP Court, Shanghai IP Court, Guangzhou IP Court and Hainan Free Trade Port IP Court. The first instance of patent cases usually starts at an intermediate people's court or an IP court where the defendant has its domicile or where the infringing acts take place. However, if the disputed amount is very high, the first instance could start at a high people's court or even at the SPC. For patent cases, there are usually two instances, and the IP court of the SPC acts as the national level appeal court (except for design patents), that is, the second instance. After two instances are concluded, the Retrial Tribunal of the SPC sometimes accepts requests for retrial.

Administrative route: local IP offices and administrations of market regulation

Local IP offices are the administrative authorities that handle patent infringement disputes, in which they decide on whether infringement can be established and mediate between the parties regarding the amount of compensation. They also mediate in other patent disputes.

Patent passing-off cases are handled by the administrations of market regulation (AMRs).8 AMRs have the power to 'raid' offenders. Local IP offices do not have such power.

The procedure at the local administrative authorities is similar to, but simpler, faster and less costly than, the procedure in court. A patent infringement case at a local IP office should be concluded within three months, and may be extended by one month.9 While the judicial procedures are more expensive and time-consuming, more remedies are available.

ii    Requirements for jurisdiction and venue

China adopts a bifurcated system in which infringement lawsuits and validity lawsuits are handled separately by different authorities.

Invalidation procedure

Starting from the date of the announcement of a patent grant by CNIPA, any party may request the Re-examination and Invalidation Department (RID) of CNIPA to declare a patent invalid. Invalidation requests should be filed with RID only, and cannot be filed with a court.

Rule 65 of the Implementing Regulations of the Chinese Patent Law prescribes specific grounds on which a request for invalidation can be made. Other grounds, such as fraud or inequitable conduct, cannot be used. The invalidation procedure is an inter partes proceeding, and an oral hearing is usually held.

RID's decision can be appealed to the Beijing IP Court. The Beijing IP Court's decision is further appealable to the IP court of the SPC. If any of these courts overturns the RID's decision, the case is remanded to RID to make further examination and a new decision on the validity which again is appealable based on new evidence or grounds. Courts do not directly rule on patent validity. RID has the ultimate authority on patent validity.

Bifurcated system

A patent infringement lawsuit may start at any intermediate people's court or a specialised IP court that has the proper territorial jurisdiction.

As a common defence, the alleged infringer files an invalidation request with RID. Depending on various factors, such as the type of patents concerned, the availability and nature of RID decisions on validity and timing, etc., the court handling the infringement lawsuit may or may not stay the infringement case. Therefore, the infringement lawsuit and the validity lawsuit could proceed in parallel. As both cases can be appealed to the IP court of the SPC, contradictory decisions may be avoided by combining the two lawsuits. The second instance court could maintain or change the first instance court's decision or remand the case to the first instance court to be retried. It is to be noted that a design patent infringement lawsuit is the exception, as the second instance is usually a high people's court instead of the IP court of the SPC.

Declaratory judgment

Where a right holder sends a warning to others for infringing a patent right and the warned party urges the right holder in writing to take action, if the right holder neither withdraws the warning nor files a lawsuit within one month from receipt of the written urging, or within two months from the sending of the written urging, the warned party could request from a court a declaratory judgment of non-infringement.10 The alleged infringer has an opportunity to choose a court that has territorial jurisdiction.

Early resolution of drug patent disputes

The Beijing IP Court has jurisdiction over first instance lawsuits in which the applicant for marketing approval for a generic drug or the patentee of the drug patent requests the court to make a judgment on whether the technical solution of the generic drug falls within the scope of protection of the drug patent.11

The patentee of the drug patent may file the lawsuit with the Beijing IP Court within 45 days from the date on which NMPA publishes the application for drug marketing approval.12 The same time limit applies when the patentee chooses to request an administrative ruling from CNIPA. CNIPA's administrative ruling can be appealed to court and the Beijing IP Court has jurisdiction. It is to be noted that only when the patentee does not file a lawsuit or request an administrative ruling with 45 days can the applicant for drug marketing approval file a lawsuit or request an administrative ruling.

The fact that an administrative ruling has been requested cannot be used to request the Beijing IP Court to reject or stay the lawsuit for the same dispute.13 However, if a lawsuit has been accepted by the Beijing IP Court, CNIPA does not accept the request for administrative ruling for the same dispute.14

iii   Obtaining relevant evidence of infringement and discovery

There is no discovery like that found in the US. Therefore, plaintiffs need to collect evidence through their own channels and, in most lawsuits, bear the burden of proof. However, the burden of proof is reversed under certain circumstances.

Process of making a new product

In any infringement dispute related to a process of making a new product, the burden of proof is reversed. The party who makes an identical product must prove that its process is different from the patented process. A 'new product' must not be known to the public in China or abroad before the filing date of the patent concerned.15

Process of making a product that is not new

In an infringement dispute related to a process of making a product that is not new, the plaintiff should first prove that:

a.   the product made by the defendant is identical to that made by the patented process;

b.   the product made by the defendant is very likely to have been made by the patented process; and

c.   the plaintiff has made reasonable efforts in proving the defendant's use of the patented process.

The court can then require the defendant to prove that its process differs from the patented process.16

Reversed burden for calculating damages

Where the right holder has tried his or her best to provide evidence but the account book and materials related to the infringement are mainly in the possession of the infringer, in order to determine the amount of damages, the court may order the infringer to provide such evidence. If the infringer fails to provide this evidence or provides fake evidence, the court may determine the amount of damages based on the claim made and the evidence provided by the right holder.

iv   Trial decision-maker

At trial, a case is usually heard by a collegial panel that consists of an odd number of members and at least three members.

People's assessors

There is no jury in trial but there are people's assessors in the first instance. People's assessors and judges form a collegial panel with a judge acting as the presiding judge. A three-member collegial panel may be formed, or a seven-member collegial panel may be formed by three judges and four people's assessors. People's assessors on a three-member collegial panel have right to vote on the finding of facts and the application of law. People's assessors on a seven-member collegial panel have a right to vote on the finding of facts but not on the application of law.17

Technical investigators

Technical investigators may appear in trials of technical IP cases (e.g., patent cases).18 They may also participate in administrative adjudication of infringement dispute of patent and integrated circuit layout designs.19 Technical investigators independently issue and sign technical investigation opinions which are not publicly disclosed. The technical investigation opinions serve as references for the collegial panel but not as evidence. Moreover, technical investigators cannot vote on judgements or administrative rulings. If technical investigators participate in a case, they must be named in the judgement or administrative ruling.

Judicial appraisal

Expert opinions play an important role in litigations in China. Usually, a judicial appraisal institution is appointed by court or agreed upon by the relevant parties to issue judicial appraisal opinions in which judicial appraisers use science and technology or expertise to identify and judge the specialised issues involved in a litigation.20 In contrast to technical investigation opinions, judicial appraisal opinions are evidence that is crucial to fact-finding in trial.

v    Structure of the trial

Before trial, a pre-trial conference may be summoned by the court at which relevant parties exchange and even cross-examine evidence and address key issues in dispute. A trial consists of two sequential sessions: a court investigation followed by a court debate. The court investigation consists of questioning led by judges and includes the statement of the relevant parties, the testimony of witnesses, and the presentation of evidence, judicial appraisal opinions and transcripts of inquisition. Court debates consist of free speeches by the relevant parties in a prescribed order. This format is a hybrid of the inquisitorial system and the adversarial system.

A judgment can be made in trial after the court debate or after the trial is concluded. Although there is no separate proceeding like the Markman hearing for patent infringement cases, interpretation of the scope of claims is conducted in trial or even at pre-trial conference. The above procedures apply to both civil lawsuits and administrative lawsuits.

vi   Infringement

The following feature in Chinese patent litigation: the all-element rule, the doctrine of equivalents, file history estoppel, the donation principle and the means-plus-function feature, etc. Some draw on US practice.

Simply put, the all-element rule means all the technical features of the claim concerned should be examined, and if the allegedly infringing technical solution lacks at least one technical feature of the claim or its equivalent, it does not fall into the scope of protection.21

The doctrine of equivalents requires examining each technical feature and adopts the test of using substantially the same means, performing substantially the same function and producing substantially the same effect, to determine equivalents. The time point of determination is the time that the alleged infringing act takes place.22

File history estoppel is applicable to the abandonment of any technical solutions for any reason during prosecution or invalidation.23 The file history includes the file history and the history of administrative lawsuits of any divisional applications. However, if such abandonment has been explicitly denied by the relevant authority, it is not subject to estoppel.24

The donation principle means that any technical solution that is described but not claimed is considered donated and cannot be incorporated into the scope of protection.25

An interpretation of functional limitation in a claim makes reference to, but is not necessarily limited to, specific embodiments.26

vii   Defences

An alleged infringer may defend itself in one or more of the following ways:

a.  arguing in the infringement lawsuit that the alleged infringing technology or design does fall within the scope of protection of the relevant patent right;

b.  requesting RID to declare the patent concerned as invalid;

c.  arguing that the alleged infringing technical solution is prior art;

d.  arguing that its act does not belong to the infringing act as defined in Article 11 of China's Patent Law;

e.  arguing that its act is an exception to infringement pursuant to Article 75 of China patent law, namely, exhaustion of right (including parallel import), prior user right, research exemption, Bolar exemption or use in a means of transport temporarily passing through China;

f.   arguing that it got infringing products from a legitimate source and hence is not liable for compensation pursuant to Article 77 of China patent law; and

g.  seeking a declaratory judgment of non-infringement.

viii  Time to first-level decision

For a patent civil case, the first instance court has six months to conclude a case, and this time limit can be extended for another six months. The second instance court has three months to conclude a case, and an extension is available. However, the above time limits do not apply to foreign-related civil cases.27

For a patent administrative case, the invalidation procedure at RID takes 5.9 months on average.28 The first instance at the Beijing IP Court should be concluded in six months, which period is extendible. The second instance should be concluded in three months, which is also extendible. There are no special provisions on the time limit for foreign-related administrative cases.29 In practice, foreign-related civil cases and administrative cases take longer to conclude.

ix   Remedies

Mediation

Mediation is available under the administrative route, and also under judicial route with some exceptions, such as patent rejection or invalidation cases.

Permanent injunction

Under the judicial route, a permanent injunction is almost always available, except where such injunction damages the national or public interest, in which case the court may decide that reasonable royalties be paid by the infringer.30 Under the administrative route, local IP offices could order the infringers to stop their infringing activities.

Behaviour preservation

Behaviour preservation, such as preliminary injunction, property preservation or evidence preservation, is available from courts but not available from the administrative authorities. It can be granted before litigation or during litigation.

Damages

Courts can award damages based on a calculation using the loss of the right holder or the illegal gain of the infringer and reasonable multiples of royalties. In cases of wilful infringement, punitive damages can be as high as five times the calculated amount. If none of the above methods can be used, courts may grant statutory damage between 30,000 yuan and 5 million yuan. Local IP offices have no power to award damages but can mediate between the relevant parties regarding the amount.

Expenses

In addition to calculated damages or statutory damages, courts may order the defendant to pay the plaintiff reasonable expenses incurred by the plaintiff for stopping infringing activities. Local IP offices have no such power.

Fine

Both courts and AMRs can impose a fine on the defendant. However, fines are available only in patent passing-off cases and are paid to the government rather than plaintiffs.

Criminal punishment

Criminal punishment is available from the courts but only in patent passing-off cases. Administrative authorities do not have such power.

Provisional protection

After a patent is granted, the patentee is entitled to compensation from any party who exploits its invention after publication of the invention patent application and before patent grant. This is generally called 'provisional protection'. Courts have power to grant such compensation whereas local IP offices can only mediate.

x    Appellate review

Relevant content regarding this is discussed in subsections ii and viii.

xi   Alternatives to litigation

China's Patent Law does not provide that patent disputes, particularly patent infringement disputes, can be resolved through arbitration. However, it does not explicitly exclude arbitration. According to Article 2 of the China Arbitration Law, contract disputes and other property rights disputes can be arbitrated, but administrative disputes cannot be arbitrated. It follows that if relevant parties specify in a contract that patent disputes should be handled through arbitration, such disputes can be resolved through arbitration. However, questions remain whether patent infringement disputes can be taken to court under such circumstances.

V  Trends and outlook  

Detailed rules on data protection periods for different types of drugs are not yet available. For now, there is only a draft version of the Implementation Measures for the Protection of Drug Experimental Data (Interim) available.31 This draft was published in 2018 for the solicitation of opinions. While no further progress has been made so far, it is reasonable to expect that formal implementation measures will be issued in future.

Footnotes

1 Stephen Yang is a managing partner and Wei Yang and Zunxia Li are partners at IP March.

2 Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial) (promulgated by National Medical Products Administration and China National Intellectual Property Administration, 4 July 2021, effective 4 July 2021), https://www.cnipa.gov.cn/art/2021/7/4/art_74_160513.html.

3 Announcement of National Medical Products Administration on Matters Related to the Implementation of Measures for the Implementation of Early Resolution Mechanism for Drug Patent Disputes (Trial)' (No. 46 of 2021), National Medical Products Administration, 4 July 2021: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210703224608174.html.

4 Regulations for the Implementation of the Drug Administration Law (promulgated by the State Council of China, revised 2 March 2019, effective 2 March 2019): 
http://www.gov.cn/gongbao/content/2019/content_5468873.htm.

5 China National Intellectual Property Administration Regular Press Conference for the Third Quarter of 2020, China National Intellectual Property Administration, 9 July 2020, https://www.cnipa.gov.cn/col/col2095/index.html.

6 Draft Amendment to Patent Examination Guidelines (draft for comments), China National Intellectual Property Administration, 3 August 2021, https://www.cnipa.gov.cn/art/2021/8/3/art_75_166474.html.

7 Guidelines for Patent Examination 2010 (promulgated by the China National Intellectual Property Administration, 24 May 24 2006, effective 1 July 2006; revised 21 January 2010, effective 1 February 2010; revised 23 September 2019, effective 1 November 2019), pt. II, ch. 1, §3.1.2, §4.3, §4.4, ch. 10, §2.2, §9.1.1, §9.1.2, §9.4.3, ch. 5, §3.2.4.

8 Interpretation of the Guidelines for Administrative Mediation of Patent Dispute and other documents, China National Intellectual Property Administration, 7 September 2020, https://www.cnipa.gov.cn/art/2020/9/7/art_66_152172.html.

9 Decision on Amending the Measures for Patent Administrative Enforcement (No. 71), China National Intellectual Property Administration, 9 June 2015, https://www.cnipa.gov.cn/art/2015/6/9/art_99_28211.html.

10 Interpretation of the SPC on Issues Concerning the Application of Law in Trial of Disputes over Infringement of Patent Rights (promulgated by the Supreme People's Court, 28 December 2009, effective 1 January 2010), Article 18, http://www.court.gov.cn/fabu-xiangqing-1.html.

11 Provisions of the SPC on Several Issues Concerning the Application of Law in the Trial of Civil Cases Concerning Patent Disputes Related to Drugs Applied for Registration (promulgated by the Supreme People's Court, 4 July 2021, effective 5 July 2021), Article 1, http://www.court.gov.cn/fabu-xiangqing-311791.html.

12 Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial) (promulgated by National Medical Products Administration and China National Intellectual Property Administration, 4 July 2021, effective 4 July 2021), Article 7, https://www.cnipa.gov.cn/art/2021/7/4/art_74_160513.html.

13 Provisions of the SPC on Several Issues Concerning the Application of Law in the Trial of Civil Cases Concerning Patent Disputes Related to Drugs Applied for Registration (promulgated by the Supreme People's Court, 4 July 2021, effective 5 July 2021), Article 6, http://www.court.gov.cn/fabu-xiangqing-311791.html.

14 Administrative Adjudication Measures for Early Resolution Mechanisms for Drug Patent Disputes (promulgated by China National Intellectual Property Administration, 5 July 2021, effective 5 July 2021), Article 10, https://www.cnipa.gov.cn/art/2021/7/5/art_546_160569.html.

15 Interpretation of the SPC on Issues Concerning the Application of Law in Trial of Disputes over Infringement of Patent Rights (promulgated by the Supreme People's Court, 28 December 2009, effective 1 January 2010), Article 17, http://www.court.gov.cn/fabu-xiangqing-1.html.

16 Several Provisions of the SPC on Evidence for Civil Lawsuits Involving Intellectual Property (promulgated by the Supreme People's Court, 16 November 2020, effective 18 November 2020), Article 3, http://www.court.gov.cn/fabu-xiangqing-272241.html.

17 Law on People's Assessors (promulgated by National People's Congress of China, 27 April 2018, effective 27 April 2018), Articles 14, 21, 22, http://www.npc.gov.cn/zgrdw/npc/lfzt/rlyw/2018-04/27/content_2054207.htm.

18 Several Provisions of the SPC on Technical Investigators' Participation in Litigation Activities of Intellectual Property Cases (promulgated by the Supreme People's Court, 18 March 2019, effective 1 May 2019), Article 1, http://www.court.gov.cn/fabu-xiangqing-154952.html.

19 Several Provisions Regarding Technical Investigators' Participation in Administrative Adjudication of Patent and Integrated Circuit Layout Design Infringement Disputes (Interim) (promulgated by China National Intellectual Property Administration, 7 May 2021, effective 7 May 2021), Article 2, http://www.gov.cn/zhengce/zhengceku/2021-05/13/content_5606221.htm.

20 Decision of the Standing Committee of the National People's Congress on the Management of Judicial Appraisal (promulgated by the Standing Committee of the National People's Congress, 28 February 2005, effective 1 October 2005), Article 1, http://www.npc.gov.cn/wxzl/gongbao/2005-04/25/content_5337645.htm.

21 Interpretation of the SPC on Issues Concerning the Application of Law in Trial of Disputes over Infringement of Patent Rights (promulgated by the Supreme People's Court, 28 December 2009, effective 1 January 2010), Article 7, http://www.court.gov.cn/fabu-xiangqing-1.html.

22 Several Provisions of the SPC on Issues Concerning the Application of Law in Trial of Patent Disputes Cases (promulgated by the Supreme People's Court, 22 June 2001, effective 1 July 2001, revised 25 February 2013, effective 15 April 2013, revised 29 January 2015, effective 1 February 2015, revised 23 December 2020, effective 1 January 2021), Article 13, http://www.court.gov.cn/fabu-xiangqing-282671.html.

23 Interpretation of the SPC on Issues Concerning the Application of Law in Trial of Disputes over Infringement of Patent Rights (promulgated by the Supreme People's Court, 28 December 2009, effective 1 January 2010), Article 6, http://www.court.gov.cn/fabu-xiangqing-1.html.

24 Interpretation of the SPC on Issues Concerning the Application of Law in Trial of Disputes over Infringement of Patent Rights (2) (promulgated by the Supreme People's Court, 21 March 2016, effective 1 April 2016, revised 23 December 2020, effective 1 January 2021), Articles 6, 13, http://www.court.gov.cn/fabu-xiangqing-282671.html.

25 Interpretation of the SPC on Issues Concerning the Application of Law in Trial of Disputes over Infringement of Patent Rights (promulgated by the Supreme People's Court, 28 December 2009, effective 1 January 2010), Article 5, http://www.court.gov.cn/fabu-xiangqing-1.html.

26 Interpretation of the SPC on Issues Concerning the Application of Law in Trial of Disputes over Infringement of Patent Rights (promulgated by the Supreme People's Court, 28 December 2009, effective 1 January 2010), Article. 4, http://www.court.gov.cn/fabu-xiangqing-1.html.

27 Civil Procedure Law (promulgated by National People's Congress of China, revised 27 June 2017, effective 1 July 2017), Articles 149, 176, 270, http://www.moj.gov.cn/Department/content/2018-12/25/357_182594.html.

28 China National Intellectual Property Administration 2020 Annual Report, China National Intellectual Property Administration, 27 April 2021, https://www.cnipa.gov.cn/art/2021/4/27/art_2616_158950.html.

29 Administrative Procedure Law (promulgated by National People's Congress of China, revised 27 June 2017, effective 1 July 2017), Articles 81, 88, http://www.moj.gov.cn/pub/sfbgw/flfggz/flfggzfl/202101/t20210122_151167.html.

30 Interpretation of the SPC on Issues Concerning the Application of Law in Trial of Disputes over Infringement of Patent Rights (2) (promulgated by the Supreme People's Court, 21 March 2016, effective 1 April 2016, revised 23 December 2020, effective 1 January 2021), Article 26, http://www.court.gov.cn/fabu-xiangqing-282671.html.

31 Implementation Measures for the Protection of Drug Experimental Data (Interim), National Medical Products Administration, 25 April 2018, https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/zhqyj/zhqyjyp/20180426171801468.html.