Only an IP owner or licensee has the standing as plaintiff to sue. An exclusive licensee can sue independently; a sole licensee may file a suit on its own if the IP owner chooses not to sue in writing; and a non-exclusive licensee can litigate alone only with the IP owner’s authorisation and waiver of its suing right. An IP owner cannot solely authorise a third party rather than a licensee to sue under such party’s own name. Recordal with the China National Intellectual Property Administration (CNIPA) is not a pre-condition for a licensee to sue; nevertheless, when an infringement action is brought by a licensee, proof of standing is required, and a recordal certificate would be an easy way to prove it.

In the pharmaceutical sector, plaintiffs are usually IP owners, market approval holders or manufacturers.

In principle, when a registered IP right is co-owned, all owners should be listed as co-plaintiffs. If one co-owner files a lawsuit, the other co-owners should be listed as co-plaintiffs unless they expressly waive their suing rights. In practice, co-owners can authorise any one of them to sue, or waive their suing rights in writing for the other co-owners to bring the action. As an exception, in administrative cases raised from a patent invalidation decision, one co-owner is allowed to defend the co-owned IP alone.

A patent can be attacked through an invalidation action, which any individual or entity may initiate before the CNIPA. In practice, the petitioner is usually the alleged infringer, a competitor or anyone else with a commercial stake in the right. Filing an invalidation in the name of a “strawman” used to be quite common in practice, but the CNIPA has started to curb the “strawman” approach in patent invalidation cases. In a recent invalidation decision in the pharma industry (4W119452), issued by the CNIPA on 15 November 2025, the CNIPA dismissed the invalidation petition filed by an individual named Tailing Wang (ie, a strawman) based on the reasoning that such action does not reflect the true legal intention of said individual.

Differing from patent invalidation, qualified petitioners in trade mark opposition and invalidation proceedings vary in accordance with the legal basis on which the opposition or invalidation is filed, as follows:

• any individual or entity is entitled to file an opposition or invalidation against a disputed mark based on the “absolute grounds” (ie, concerning public interest or statutory prohibitions, such as deceptive or misleading marks); and
• only the prior right-holder or a party of interest may file an opposition or invalidation based on the “relative grounds”, such as conflicts with prior marks or other prior rights.

In patent infringement disputes, any individual or entity who exploits the patent without authorisation, for commercial purposes, can be listed as a defendant, although there are some exemptions. In practice, generics, API manufacturers, exporters and pharmacies are routine targets. Online pharmacies are allowed in China, and thus, e-commerce platforms could be actionable as well, in certain scenarios. Regulatory authorities, government tender offices and hospitals are not usually listed as defendants for various reasons, but they could also be listed as defendants if they exploit a patent for commercial purpose.

If there are multiple infringers, the plaintiff has the right to choose any of them as a defendant. Having said that, upon the defendant’s request, or at the court’s discretion, a party of interest to the lawsuit could be added as a co-defendant or third party in the infringement proceedings.

In a trade mark or trade dress infringement dispute, any participant in the chain of commerce can be listed as the defendant, such as manufacturers, distributors and e-commerce platforms.

Regulatory authorities could be listed as defendants in certain IP disputes. For example, the CNIPA may be listed as the defendant in administrative proceedings relating to patent term extension (PTE), patent term adjustment (PTA) and invalidation. IP offices could be listed as defendants for their decisions in administrative patent infringement actions in the follow-up administrative proceedings.

Preliminary injunctions (PIs) are only available in civil actions in China. A party may apply before filing a lawsuit (ie, pre-suit PI) or after the action is docketed (ie, intra-suit PI). If the situation is urgent, the court must rule within 48 hours after the PI motion is docketed. The PI order is immediately effective once issued by a court.

For a PI, the applicant must demonstrate:

• a likelihood of success on the merits for infringement and patent stability;
• a balance of hardships favouring the applicant;
• irreparable harm;
• impacts on public interest; and
• urgency, which is required only for intra-suit PI requiring urgent handling and for pre-suit PI.

The irreparable harm and likelihood of success are the most challenging factors to be established in patent infringement cases.

No statutory time limit exists for filing a motion for PI; however, the urgency standard may not be satisfied if the applicant causes an unreasonable delay (eg, if it files a pre-suit PI after knowing of the infringement for a significant time period).

After a pre-suit PI is granted, the applicant must file a lawsuit within 30 days; otherwise, the PI order will be lifted by the court.

PI against imminent infringement (ie, quia timet relief) is also available in China. Typical scenarios include trade secrets about to be illegally disclosed, infringement about to occur at a trade fair or a peak sales season, and the disputed IP about to be assigned or disposed of illegally.

Generally, before granting a PI, the court shall question both the applicant and the respondent. However, if the situation is urgent or if any such inquiry may frustrate the enforcement of the PI, the court may proceed without questioning the respondent.

In a patent infringement dispute, a civil action could be filed with a competent court, or an administrative action could be initiated before a competent IP office. Parallel enforcement is also available. The civil action could comprise two instances, and the first instance judgment would be pending and not enforceable if an appeal is filed. The administrative action is only one instance, and the decision takes effect once issued, albeit subject to judicial review.

An enforcement action would usually prompt the defendant to file an invalidation action against the patent at issue. An invalidation action can only be filed before the CNIPA after the patent is granted. A patent enforcement action and a patent invalidation action are two separate proceedings, heard by courts/IP offices and the CNIPA respectively. However, there has been a case in which the court of the enforcement action overruled the claim construction concluded by the CNIPA in the invalidation action. A decision invalidating the patent claims used in the enforcement action would cause the dismissal of the enforcement action.

Although the enforcement and invalidation proceedings are bifurcated in China, there are some experimental practices to try synchronous handling of both proceedings. In Nanjing Sanhome v Hunan Warrant, the Supreme People’s Court formed one panel to handle the appeal cases relating to both patent enforcement and related patent invalidation. In another patent infringement dispute, the Shenzhen court co-operated with the CNIPA to conduct joint hearings for the enforcement case and related invalidation case – ie, the first section is the invalidation oral hearing held by the CNIPA and audited by the court, and the second section is the infringement trial held by the court and audited by the CNIPA.

Enforcement

The statute of limitations for IP infringement litigation is three years, counted from the date on which the plaintiff knew or should have known of the asserted infringement. The defendant may raise the defence of limitation, but the court cannot proactively dismiss a case based on the limitation. If the infringement is still ongoing, the plaintiff can seek permanent injunction relief, which is not subject to the statute of limitations and damages for the three years prior to the filing of the complaint.

The defendant is normally served electronically or by post, or by public announcement if those methods fail (30 days after the announcement). Service takes effect immediately. The plaintiff may apply for deferred service to prevent the defendant from knowing of the lawsuit, if it files motions for evidence and/or asset preservation.

A domestic defendant may file a written answer and a jurisdiction objection within 15 days after the service of the compliant, and an appeal against a first instance judgment within 15 days after service of the judgment.

A foreign defendant could be served via the channels provided by an international treaty or bilateral judicial assistance agreement, and via its wholly owned enterprise, representative office, branch or authorised business agent in China. Furthermore, the 15-day period is doubled for a foreign defendant.

After the service of a complaint, the court may arrange evidence-exchange sessions or pre-trial conferences and trial hearings, at its discretion; these steps have no fixed timetable and are not mandatory. The court issues summonses to the parties in advance (at least three days before the event). In practice, the court takes a lenient approach to evidentiary deadlines – usually, the evidence shall be submitted prior to the trial hearing. However, there have been cases in which evidence was filed after the start of the trial hearing. After the trial hearing, the court hands down its judgment.

The procedure of an administrative enforcement action is similar to that in a civil action.

There are deadlines for the closure of patent enforcement actions. In terms of civil action, if no foreign party is involved, a court should conclude the case within six months after docketing, although this period can be extended. There is no statutory case closure deadline for lawsuits involving a foreign party. In practice, a first instance could be concluded after around 18 months, due to the overwhelming case volumes. In terms of administrative action, the IP office should conclude the case within three months after docketing, although this period can also be extended. In practice, it may take around one year to conclude the case.

Patent Invalidation

There is no statute of limitation or cap on the number of filings against a patent. In other words, after the patent is granted, any entity or individual may file multiple invalidation petitions against the patent at any time, even after the patent term expires.

If an infringement proceeding has been commenced and the defendant wishes to seek a stay of the civil case, the defendant must file the invalidation petition during its answering period in the civil case.

The CNIPA serves documents in the proceeding to the parties electronically or by post. Service is deemed completed on the 15th day of the dispatch via postal service, and on the date when the document enters the electronic system designated by the parties.

Within one month after filing the initial invalidation petition and evidence, the petitioner is allowed to file supplementary briefs and additional evidence. Upon the receipt of the invalidation petition through the CNIPA, the patentee has one month to submit a response, amendments and counter-evidence. The same one-month deadline applies to any later supplementary submissions from the petitioner through the CNIPA. An oral hearing is usually held by the CNIPA, although this is not mandatory. After the oral hearing, the CNIPA renders its decision, which may take around six months after the filing of the initial invalidation petition.

Trade Mark Invalidation

The statute of limitations is five years if one files an invalidation against a registered trade mark based on the relative grounds.

There is no statute of limitations for filing an invalidation based on the absolute grounds, nor against malicious registration of a well-known trade mark based on the relative grounds.

An enforcement action can only be filed after the grant of a patent, against any infringement that occurred during the term of the patent. The plaintiff needs to provide at least:

• the asserted patent claims;
• the identity of the defendant;
• evidence proving the validity of the patent at issue and the asserted infringement acts; and
• remedies sought from the enforcement.

For a civil action, the plaintiff also needs to prove evidence related to damages.

For a manufacturing process patent for a novel product, the burden of proof is shifted to the defendant to provide evidence proving that its process differs from the patented one.

Moreover, if the plaintiff successfully demonstrates that it already exhausted reasonable efforts to produce evidence proving the infringement, the court may shift the burden of proof to the defendant.

There is no provision for pre-action discovery/disclosure in China. However, the plaintiff can file a motion of evidence preservation prior to the filing of a complaint, under the condition that the circumstances are urgent and that evidence may be lost or become difficult to obtain in the future.

It is also possible to use materials obtained overseas as evidence in China. China’s accession to the Convention Abolishing the Requirement of Legalisation for Foreign Public Documents streamlines the recognition of evidence collected in other signatories. Since 7 November 2023, public documents issued in other signatories of the Convention are recognised for use in China after being apostilled in the issuance country. Furthermore, the plaintiff can file a motion to ask the court to collect evidence in overseas jurisdictions via the official channel under the Hague Convention on the Taking of Evidence Abroad in Civil or Commercial Matters.

Evidence preservation is an available remedy for the plaintiff to search and seize evidence in the defendant’s possession that is related to the lawsuit. The plaintiff needs to demonstrate to the court that such evidence is likely to be destroyed or difficult to obtain at a later stage. A motion can be filed prior to or during the lawsuit, and a bond is required. Upon the court’s grant of the motion for evidence preservation, the court may search, copy, photograph, video-record or take samples to preserve the evidence controlled by the defendant.

In addition to evidence preservation, court investigation and evidence submission orders provide additional remedies for the plaintiff to collect evidence during the lawsuit.

A declaratory judgment (DJ) action is available in China. When the following steps are met, the party directly or indirectly receiving a warning from a right-holder is entitled to file a DJ action against the right-holder:

• the right-holder sends a warning to the recipient in relation to IP infringement;
• the recipient, upon receiving the warning, sends a written demand asking the right-holder to either file a lawsuit or withdraw its warning; and
• the right-holder neither withdraws the warning nor files a lawsuit within one month of receiving the written demand or within two months from the date of issuance of the warning.

China recognises the doctrine of equivalents (DoE). The legal test of DoE is that the accused technical feature, compared with the patented one, shall:

• employ substantially the same means;
• achieve substantially the same function;
• obtain substantially the same technical effects; and
• enable a person skilled in the art to conceive the substitution without any inventive efforts at the time of infringement occurrence.

To prevent over-expansion of DoE, the doctrine is restricted by the principles of estoppel and donation.

There is no obligation for companies to “clear the way” ahead of a new product launch. However, the court may take the defendant’s negligence or wilfulness into account when ruling on damages.

Experts often appear in Chinese patent infringement proceedings and serve mainly as:

• expert witnesses;
• judicial appraisers; or
• technical investigation officers (TIOs).

Expert Witnesses

Each side may engage experts and submit their witness statement as evidence. Experts can give their opinions on various issues, such as technical issues, damages or even the application of law.

Judicial Appraisers

Judicial appraisal is often utilised in IP infringement disputes, commissioned either by the party or by the court. Experts would be engaged as appraisers by the appraisal centre to address the issues for appraisal.

Technical Investigation Officers

In technically complex IP cases, the court may engage a TIO to provide technical support to the court itself. TIOs may participate in evidence preservation and court investigation, attend trial and make inquiries of the parties on technical issues.

Experiments could be introduced in enforcement and invalidation proceedings. Parties may conduct experiments by themselves or engage external institutes to conduct experiments, and submit the results as evidence.

The experiment results need to meet the requirements to be presented as evidence. In particular, details of the experiment shall be sufficient to repeat the experiment, and the results shall be relevant to the asserted facts.

Regarding invalidation proceedings, the CNIPA’s Examination Guide provides rules on the admission of post-filing experiment data. The data shall be examined to determine whether it is to address the inventiveness, clarity and sufficiency of the patent, and the technical effects demonstrated by the post-filing experiment data shall be derived from the description of the patent. In University of California v CNIPA, the Supreme People's Court affirmed that the patentee is allowed to submit experiment data developed by the same test method described in the patent to support the technical effects asserted in the patent, unless the experiment data is instead used to fix the inherent defects of the patent.

There is no discovery/disclosure procedure in China. However, there are some tools and mechanisms available to assist the plaintiff in collecting evidence – eg, evidence preservation, court investigation and document submission order. Furthermore, the burden of proof could be shifted to the defendant in certain circumstances.

In patent infringement litigation, aside from the non-infringement defence (including not being for commercial purpose and not being within the patent protection scope), the principal defences available for the defendant include:

• the Bolar exemption (often raised by defendants);
• research use (often raised by defendants);
• alleged infringing technology is prior art;
• alleged infringing technology is used prior to the filing date of the patent;
• legitimate source;
• right exhaustion;
• temporary transit; and
• patent abuse.

Stays Caused by Invalidation Procedures

In civil actions, the court would have discretion to decide whether or not to stay infringement proceedings due to the invalidation proceedings initiated by the defendant.

For invention patent infringement cases, the court would not normally stay the infringement proceeding due to the invalidation action initiated by the defendant.

For utility model or design patent infringement cases, the court would normally stay the case if there is a pending invalidation action filed by the defendant during the answering period and the plaintiff does not provide a favourable patent evaluation report issued by the CNIPA. However, the court would not normally stay the infringement proceeding under the following circumstances:

• the defendant files the invalidation action after the answering period of the infringement case and requests the court to stay the infringement case based on such invalidation action;
• the patent at issue has survived through previous invalidation action;
• there is a favourable patent evaluation report to support the validity of the patent at issue;
• the defendant provides sufficient evidence proving that the accused infringing solutions it is exploiting are common knowledge; or
• the invalidation raised by the defendant is obviously groundless.

In administrative actions, the IP office usually stays infringement proceedings due to the invalidation proceedings initiated by the defendant.

Other Influence of Invalidation Procedures

The court would normally require the plaintiff to submit information related to invalidation or other enforcement proceedings in China, as claim amendments and statements may cause estoppel.

If the patent claims used for enforcement were declared invalid in the invalidation proceeding, the infringement case will be dismissed accordingly.

Relevance of Corresponding Foreign Cases

From the legal perspective, foreign litigation or invalidity proceedings have no legal impact on ongoing Chinese infringement actions or invalidation proceedings. However, the claim construction of the counterpart in another jurisdiction may be used for the claim construction of the corresponding Chinese patent under the same patent family.

Patents cannot be amended in infringement proceedings. However, if the defendant raises an invalidation proceeding before the CNIPA, a patentee can amend the patent claims within a certain timeframe during the invalidation proceeding.

If claim amendments are accepted by the CNIPA, the authorities (court or IP office) in the infringement proceedings shall use the amended claim as the basis for infringement analysis.

Civil lawsuits are tried by a panel normally formed by three or five judges. One or two jurors may be invited to form the panel, and a technical investigation officer may be invited as supporting staff.

As administrative action is available in China, the IP office may form a panel of three or five officers to adjudicate a case. A technical investigation officer could also be invited to provide support.

Forum shopping is important for various reasons, including experience and practice. For a patent infringement case, an action can be filed to a competent court where the defendant is located or where the infringement is committed.

For civil actions, China has established a centralised judicial system for handling technical IP cases (pharma/life sciences cases are mainly included within such scope), which improves the consistency and fairness of case adjudication. To be specific, China has currently established four specialised IP courts, in Beijing, Shanghai, Guangzhou and Haikou, and 31 specialised IP tribunals across the nation to handle invention patent infringement cases within their respective jurisdictions. The Supreme People's Court IP tribunal will hear the appeal accordingly.

For administrative actions, the local IP office will try the case; the CNIPA only takes influential cases such as those that cross multiple provincial territories across the nation or that have a significant impact on public health. The decision is subject to judicial review by the corresponding IP courts or IP tribunals.

Under the PRC Patent Law, anyone making, using, offering for sale, selling or importing an infringing product without the patentee’s authorisation commits patent infringement.

Common issues relating to patent infringement in the pharmaceutical industry include the following.

Bolar Exemption

Chinese law exempts making, having made, using, importing, and having imported patented drugs, without the patentee’s authorisation, solely for the purpose of providing information required by the authorities for market approval in China or overseas from infringement.

However, selling and offering for sale is not covered by the Bolar exemption.

Research Exemption

A research exemption is also available in China, which permits the exploitation of a patent without the patentee’s authorisation solely for research purposes. The research exemption is applied strictly in practice. The Supreme People's Court has held that the research exemption applies to the manufacturing of a patented product in small volumes to understand the manufacturing process, but not to the use of a patented product even for scientific research purposes. The research exemption is limited to the party’s own activities, which means that manufacturing, selling, offering for sale and importing a patented product for others’ scientific research is not covered by the research exemption.

Government-Centralised Procurement/Volume-Based Purchase (VBP)

Filing an application to participate in government-centralised procurement and VBP was classified as infringement of offering for sale in the benchmark case of Sandoz v Hansoh.

Offer to Supply After Patent Term Expiry

A statement of offering to supply after a patent expires is not a valid defence, as concluded by the Shanghai IP Office in Bayer v Acebright.

Second Medical Use Patents and Skinny Labelling

China protects second medical use patents, and skinny labelling (ie, carve-out of the patented indication) is a way to avoid infringement.

Parallel Imports

Article 75.1 of the PRC Patent Law legitimises the parallel importation of patented products. However, in practice, the parallel importation of patented drugs is not common, as it would lead to a regulatory compliance issue.

Currently, the Regulations for the Implementation of the Drug Administration Law (2024) (“the Regulations”) issued by the State Council provide general provisions for China’s drug regulatory data protection (RDP) system, although detailed implementing rules are still outstanding.

In March 2025, the National Medical Products Administration (NMPA) issued the Draft Measures for the Implementation of Drug Regulatory Data Protection (Provisional) (Draft for Comments, not effective yet), stipulating more detailed provisions for the implementation of China’s RDP system. The highlights are as follows.

• For innovative drugs, a six-year data protection is available from the first domestic marketing authorisation date of such drug (for innovative drugs that have already been marketed overseas, the protection period shall deduct the gap period between the domestic application acceptance date and the overseas marketed date). The protection scope includes all trial data used to demonstrate the drug’s safety, efficacy and quality controllability. For an innovative drug that obtains approval for multiple indications sequentially, data protection is granted separately for each indication.
• For improved new drugs, a three-year data protection is available from the first domestic marketing authorisation date of such drug (for improved new drugs that have already been marketed overseas, the protection period shall deduct the gap period between the domestic application acceptance date and the overseas marketed date). The protection scope includes new clinical trial data proving clear clinical advantages over known active ingredient drugs.
• For generic drugs, a three-year data protection is available for the first generic drug approved domestically that references an overseas-marketed but domestically unmarketed brand drug. The protection scope includes necessary clinical trial data supporting the approval.

During the protection period, the NMPA shall not accept any new or supplemental domestic marketing authorisation (MA) applications submitted by any other entity that relies on the protected data without authorisation.

In China, experimental use (ie, the research exemption) and activities covered by the Bolar exemption are acceptable pre-launch preparations for generics; see 2.1 Infringing Acts.

Marketing authorisation applications (MAAs) and granted MAs are all public information available on the official websites of the NMPA and the Centre for Drug Evaluation.

The China Patent Information Registration Platform for Marketed Drugs (the “Platform for Marketed Drugs”) is operated by the CDE and serves as the Chinese Orange Book. On the Platform for Marketed Drugs, the MA holder (brand drug) shall register drug and related patent information along with contact information within 30 days after obtaining an MA.

When submitting an MA application for a generic drug, the applicant shall make a declaration for each relevant patent disclosed on the Platform for Marketed Drugs. Within ten working days after accepting a generic drug application, the NMPA shall publish the application information and corresponding declarations, and the generic drug applicant shall notify the MA holder of the corresponding declarations and its supporting evidence.

It is advisable for brand drugs to conduct regular monitoring of the public information of the MAAs and the corresponding patent declarations, so as to obtain related information as early as possible.

Regarding participation in VBP or other centralised procurement activities (which are the main channels for reimbursement), IP infringement risk is a key issue to be addressed. In accordance with the Opinion of the National Intellectual Property Administration and the National Healthcare Security Administration on Strengthening Intellectual Property Protection in the Field of Centralised Pharmaceutical Procurement, the following is required.

• Enterprises participating in centralised procurement or applying for online listing of pharmaceuticals and medical consumables shall determine that the relevant products do not infringe another’s IP. If patent infringement disputes arise after the selection results are announced or online procurement transactions occur, the applying enterprise shall bear the corresponding liability.
• If patent infringement disputes arise, centralised procurement agencies may advise the relevant parties to seek resolution through intellectual property authorities, or to file lawsuits in the people’s courts.
• If infringement is established by the relevant authorities (court/IP office), the centralised procurement agencies shall refuse listing or promptly delist related products, in accordance with laws and regulations.

Regarding pricing, during the annual adjustment period for the National Reimbursement Drug List (NRDL), companies may negotiate with the healthcare insurance authorities regarding the inclusion of their drugs in the list and their pricing. For patented innovative drugs, the healthcare insurance department cannot force price reductions by introducing generic drugs before the patent expiries, allowing brand drug owners to keep pricing leverage for investment return.

For MAs, the China Patent Linkage system links the patent status of brand drugs with the MAAs of generic drugs. To be specific, for generic drugs not launching before the expiry of the registered patent (ie, Type 3 declaration), an approval shall be granted by the NMPA and the generic drugs can only be launched to the market after the expiry of the corresponding patent. For generic drugs that are under a Type 4 declaration but are found by the authority to fall within the protection scope of the registered patent, the MAA shall be held during the patent term and transferred to the administrative approval stage right before the expiration of the patent term.

For Type 4 declarations, procedure wise, where a patentee or an interested party objects to the declaration, it may file a complaint before the Beijing IP Court or before the CNIPA, or both, within 45 days from the publication date of the declaration on the Platform for Marketed Drugs.

For generic drugs, a nine-month suspension period will begin upon the NMPA’s receipt of a copy of the official patent linkage case acceptance notice. The first generic drug applicant that successfully invalidated the patent and obtained an MA shall be granted up to 12 months’ market exclusivity (but not exceeding the original patent term) for its generic drug, which means the NMPA shall not approve any other generic drugs during such exclusivity period from the date of approval of the first generic drug.

The China Patent Linkage system covers patents for active pharmaceutical ingredients (APIs), for pharmaceutical compositions containing APIs, and for pharmaceutical uses (including second use). Manufacturing process patents are not included.

See 2.1 Infringing Acts.

According to the new Draft Measures for the Implementation of Drug Regulatory Data Protection (Provisional) (Draft for Comments) issued by the NMPA in March 2025, a six-year protection period is available for innovative vaccine and biological products, and a three-year protection period is available for improved ones. However, the protection scope for biological products excludes bioavailability, bioequivalence and vaccine immunogenicity data.

Different from generic drugs, biosimilars are excluded from data protection.

See 2.3 Acceptable Pre-Launch Preparations.

See 2.4 Publicly Available Drug and Patent Information.        

Reimbursement and pricing for biologics or biosimilars are basically the same as outlined in 2.5 Reimbursement and Pricing/Linkage Markets, but there are some differences in terms of patent linkage:

• the nine-month suspension period and the market exclusivity awarded based on a successful patent challenge are not applicable to biosimilars; and
• the patent type qualified for patent linkage is limited to sequence patents and use patents.        

Both Patent Term Adjustment (PTA) and Patent Term Extension (PTE) are available in China.

PTA

To compensate for unreasonable delay during the examination of certain patents, PTA has been introduced in China. Only invention patents meeting the following criteria are eligible for PTA:

• invention patents granted more than four years after the patent filing date and after three years from the date of filing a request for substantive examination; and
• invention patents not filed and granted under the situation of Article 9.1 of the Patent Law (ie, twin-filing).

PTA is not automatically granted by the CNIPA when granting a patent. The patentee shall file an application for PTA within three months from the patent grant date. The CNIPA will review the PTA application and determine whether and how the patent term could be adjusted.

The calculation of PTA is based on the actual days of unreasonable delay during examination, referring to the interval between the date that meets the requirement of four years from the patent filing date and three years from the substantive examination request filing date, and the grant date of the patent, minus both reasonable delay and applicant-caused unreasonable delay days.

As to the PTA decision issued by the CNIPA, the patentee or an interested party (eg, a defendant in related patent infringement dispute) is entitled to apply for a judicial review against the decision.

PTE

To make up for time consumed by MAA examination for a novel drug, the CNIPA may extend the term of certain patents that cover approved drugs upon the application of the patentee.

The following types of invention patents related to novel drugs are eligible for PTE:

• a product patent for the API;
• a manufacturing process patent for the API; and
• a use patent for the API.

An application for PTE shall meet the following requirements:

• the patent grant date shall be earlier than the drug approval date;
• the patent is valid when the PTE application is filed;
• the patent has not previously been granted any extension of term;
• the technical solution of the new drug falls into the protection scope of the patent;
• if one drug is covered by two or more patents, only one patent can be used for the PTE application; and
• if a patent covers two or more drugs, the PTE application can be filed for one drug only.

The underlying requirements can be summarised as “one drug, one patent”. These requirements – particularly the “one drug, one patent” rule – would bring some challenges to patent portfolio management, including co-ordination between drug registration and patent prosecution, and divisional application filings.

The term of PTE is calculated based on the following two criteria:

• the number of interval days between the patent filing date and the drug approval date minus five years shall not exceed five years; and
• the remaining patent term after the drug approval date shall not exceed 14 years.

In addition, if applicable, both the PTE and the PTA could be available for one specific patent.

Paediatric extension is currently not available in China.

Currently, there is no provision for paediatric-use MAs in China.

There is currently no special rule for orphan medicines in China. However, the patentee can apply for PTA and/or PTE if the related patent meets the requirements for PTE and/or PTA (see 4.1 Supplementary Protection Certificates).

Preliminary injunctions are available for the plaintiff in civil enforcement proceedings. Under the PRC Patent Law, the court may grant a PI in a patent infringement case after considering:

• the likelihood for the patentee to prevail on merits;
• the possibility of irreparable harm to the plaintiff;
• hardship on both sides; and
• any impacts on public interest.

However, in practice, it is generally quite challenging to obtain a PI in a patent infringement case, considering the difficulty in meeting the irreparable harm and public interest requirements.

For a PI application, the court would require the applicant to provide a bond or case security, the amount of which would be determined by the court based on the consideration of the potential losses the respondent may suffer as a result of the enforcement of the PI. If the application proves erroneous and the respondent suffers damage, the respondent may claim compensation from the applicant. If, during enforcement of the measure, the respondent’s probable losses exceed the security furnished by the applicant, the court may order the applicant to post additional security. If the applicant refuses to do so, the court may lift or partially lift the PI measures. A third party of interest who believes the PI is erroneous could also seek relief during enforcement by filing an execution objection, or they may bring a separate action for damages.

A PI order takes effect immediately upon issuance and remains in force until the final judgment takes legal effect. The court serves the ruling on the parties. Several procedural deadlines run from the date of service – eg, the five-day period to apply for reconsideration of the PI. The enforcement of the PI will not be stayed during the reconsideration procedure initiated by the respondent. For an urgent PI application, the court shall rule within 48 hours after acceptance of such application. For pre-suit PI, if the applicant fails to file suit or apply for arbitration within 30 days after the court granted the PI, the court shall dissolve the PI. A granted PI is generally not lifted merely because the respondent offers counter-security, unless the applicant consents.

Final injunctive relief (ie, permanent injunction) is available in both civil and administrative enforcement proceedings. It can be awarded upon the plaintiff’s request in a patent infringement case once infringement is established, unless the permanent injunction would harm national or public interests. The permanent injunction will be enforceable after the court judgment or an administrative decision becomes effective.

In civil proceedings, if the defendant fails to obey the injunction, the plaintiff may apply for compulsory enforcement before the court. Normally, the compulsory enforcement will be completed within six months after the application thereof is accepted by the court.

In administrative proceedings, if the defendant fails to obey the injunction and also did not file an appeal before a court against the decision, the IP office may apply to a court for compulsory enforcement within three months from the date on which the appeal period lapses. If the IP office does not apply for compulsory enforcement, the IP owner may apply to a court directly for compulsory enforcement within six months.

If infringement is established, the court would normally award injunction reliefs as claimed by the plaintiff. However, in some cases the court could have discretion as to whether or not to award injunction reliefs requested by the plaintiff.

Regarding PI, the court may especially consider the public interest (eg, public access to related medicines) when deciding whether to grant the PI application filed by the plaintiff.

The court would generally grant a permanent injunction once infringement is established and upon the plaintiff’s request. Nevertheless, based on considerations of national or public interest, the court may instead award reasonable compensation for the ongoing implementation of patented solutions.

Damages are only available in civil enforcement proceedings. Damages can be calculated and determined by the court via the following methods in patent infringement cases:

• the actual losses the plaintiff suffered due to the infringement;
• the illegal profits the defendant gained from the infringement;
• a reasonable multiple of the relevant licence fee for the patent; or
• statutory damages ranging from CNY30,000 (approximately USD4,230) to CNY5 million (approximately USD704,870).

The plaintiff is entitled to apply one of the above methods for damages calculation. The court will rely on statutory damages if it is not possible to ascertain the actual losses, illegal profits and relevant licence fee. In addition, if both the plaintiff and the defendant have previously agreed on damages, the court may adopt such agreed damages.

Punitive damages of up to five times the damages awarded are also available for wilful infringement causing severe circumstances.

Normally, the damages will be calculated from the infringement occurrence date to the complaint filing date. However, if the plaintiff knew or should have known of the infringement but filed the action after the three-year statute of limitation and the infringement continues at the time of filing, the damages shall be calculated based on the three-year period preceding the date of filing the lawsuit with the court. The damages awarded shall be payable as required by the court in the judgment. After the due date stipulated in the judgment, the interest will be calculated for unpaid damages.

Damages will be addressed along with other issues (eg, plaintiff standing, infringement analysis) by the court during the trial. However, if the court considers that all issues cannot be dealt with in a single hearing, it may split the trial for infringement and damages calculation into two hearings. In practice, upon the application of the plaintiff, the court could also issue a partial judgment addressing only the infringement issue and leaving damages for a separate judgment.

Damages claims are also available for the defendant against the plaintiff’s wrongful actions (eg, malicious and wrongful PI action). If an application for a PI is ultimately found to have been wrongful, the applicant may need to compensate the respondent for the loss suffered due to the wrongful PI. In this case, wrongfulness would include the following situations:

• the applicant fails to institute proceedings or arbitration within 30 days after the PI is granted;
• the PI was improper ab initio because, for example, the IP right is declared invalid;
• the final judgment finds no infringement or unfair competition; or
• any other circumstance amounting to a wrongful motion.

In practice, it is relatively rare for there to be a counteraction against wrongful PI action.

The plaintiff’s reasonable legal costs incurred for the enforcement, including attorney fees, judicial appraisal fees, notarisation fees, travel expenses, sample purchase fees and other disbursements, will be calculated and determined by the court upon the plaintiff’s request, which is normally addressed separately from the calculation of damages. In practice, the court will consider all evidence regarding the costs incurred and determine a reasonable amount of legal costs that the defendant shall compensate to the plaintiff if the infringement is established.

Regarding court fees, the court normally would follow the “loser-pays” rule. If the plaintiff prevails, it may recover the court fees pre-paid from the defendant. If the plaintiff partially prevails, the court would allocate the court fees between the parties on a case-by-case standard. If the defendant prevails, the court fees may be borne by the plaintiff.

Normally, the judgment will expressly identify the party liable for these costs, state the exact amount, and set a period for payment. If the obliged party does not pay voluntarily, the prevailing party may apply for compulsory enforcement after the judgment becomes effective and the payment period expires.

Unfortunately, the plaintiff’s legal costs cannot be claimed in administrative enforcement proceedings.

Normally, the court will not reduce the reliefs available to a plaintiff on account of its own misconduct (once infringement is established), although such misconduct may produce other legal consequences.

If the plaintiff has been silent on enforcement and the three-year statute of limitation has expired, the court will dismiss the case upon the statute of limitation defence being raised by the defendant.

Trade mark disputes and enforcement actions are quite common in the life sciences and pharma sector in China. Right-holders enforce their exclusive trade mark rights against infringers under the PRC Civil Law, Criminal Law, Trade Mark Law, Implementation Regulations and relevant judicial interpretations – a legal framework that applies equally across all sectors. In addition, there are certain requirements regarding the use of pharmaceutical trade marks due to the high regulation of products in the sector.

Registration and Registrability of Pharmaceutical Trade Marks

The current Trade Mark Law and Drug Administration Law do not require drugs to carry registered trade marks for market launch in China. However, the Administrative Provisions on Pharmaceutical Package Inserts and Labels mandate that any trade mark used on package inserts and labels must be registered. In addition, the Guideline for Acceptance and Review of Chemical Drug Registration (Trial) and the Guideline for Acceptance and Review of Biological Product Registration (Trial), both promulgated in February 2025 and collectively referred to as the “Guidelines”, require submission of a trade mark registration certificate if the drug name is to be used on the product. In such cases, pharmaceutical companies should carefully plan the timing of their trade mark applications to ensure that the trade mark registration is completed prior to filing the product with the NMPA.

Under the PRC Trade Mark Law, a mark shall not be registered if it:

• consists solely of the generic name, device or model of the goods;
• is merely descriptive or otherwise lacks distinctive features;
• is misleading or has other negative meanings; or
• conflicts with prior third-party trade marks or other rights.

Therefore, the drug names listed in national drug standards are not registrable as trade marks. To secure exclusive trade mark protection for a drug name or drug trade mark, pharmaceutical companies are advised to select distinctive marks and to conduct clearance searches to increase the chance of successful registration.

Use of Pharmaceutical Trade Marks

In addition to the requirements for use of a registered trade mark stipulated by the relevant laws and regulations, a registered trade mark used on pharmaceutical labels and package inserts must also comply with the relevant formality requirements specified in the Administrative Provisions on Pharmaceutical Package Inserts and Labels, including the position, size and presentation of the trade mark.

Non-use cancellation poses a significant legal risk in the pharmaceutical sector after trade mark registration, due to long product development cycles, which may leave trade marks dormant for years. Under the PRC Trade Mark Law, any party may petition to cancel a trade mark after three consecutive years of non-use. To mitigate this risk, pharmaceutical companies should maintain comprehensive documentation demonstrating actual use or intent to use their trade marks, including but not limited to business plans, collaboration agreements, clinical trial reports and drug registration application materials, to defend against potential non-use cancellation actions.

Trade Mark Infringement and Counterfeiting

When facing trade mark counterfeiting or infringement, pharmaceutical companies have remedies similar to those available to right-holders in other industries, including the following.

• Civil litigation: companies may seek injunctions and monetary compensation. Trade dress protection against copycat packaging may also be pursued under unfair competition claims. In December 2024, an appellate court awarded over USD8 million in damages in a trade mark infringement and unfair competition dispute between two Chinese pharmaceutical companies (Chang Xiu Lin v Chang Shu Lin). The court recognised the plaintiff’s trade mark as being well-known, and the drug packaging has sufficient market influence for trade dress protection.
• Administrative enforcement: companies may seek fast and effective action through the local Administration for Market Regulation to stop ongoing infringement. Administrative enforcement can also facilitate the preservation and collection of evidence by government authorities, which can subsequently be used in civil and criminal proceedings.
• Criminal prosecution: for stronger deterrence, rights-holders may report counterfeiting activities to local Public Security Bureaus to pursue criminal remedies under the PRC Criminal Law. Relevant criminal offences include:
1. drug-related crimes, such as manufacturing or selling counterfeit drugs (Article 141) and manufacturing or selling substandard drugs (Article 142), which primarily affect public health and safety and hence are subject to more severe penalties that may exceed ten years of imprisonment and, in exceptionally serious cases, life imprisonment or even the death penalty;
2. medical device-related crimes, such as manufacturing or selling fake or substandard medical devices (Articles 145), which also primarily affect public health and safety and may incur penalties comparable to those for drug-related crimes; and
3. trade mark-related crimes under Articles 213–215, which affect intellectual property rights and market order, with statutory penalties of up to ten years of imprisonment.

Where counterfeit or substandard drugs or medical devices bear counterfeit registered trade marks, the conduct may constitute both drug or medical device-related crimes and trade mark crimes. In case of statutory concurrence, Chinese courts generally apply the principle of selecting the offence carrying the more severe penalty. Under current judicial practice, courts generally prioritise drug or medical device-related charges, as they safeguard public health and safety and are subject to more severe criminal penalties than trade mark offences.

Copyright disputes in China’s life sciences and pharma sector are less common than patent, trade secret and trade mark disputes, but they do occur. Disputes may arise around software, packaging designs and informational contents, and may carry both civil and criminal consequences. The main legal sources include the PRC Copyright Law, Implementing Regulations and related judicial interpretations.

Key issues in this sector include:

• software copyright ownership and infringement;
• copyright claims over pharmaceutical packaging design; and
• the copyrightability of instructions for use.

For example, the copyrightability of instructions for use was a contested issue in China roughly a decade ago. Under the general principle that copyright protects an expression of ideas and not the functional or informational elements such as technical instructions, procedures or concepts, and based on policy considerations for China’s pharmaceutical industry, Chinese courts have generally held that the instructions for use are unlikely to qualify as copyrightable works under PRC law.

Severe copyright infringement may also lead to criminal liability under the PRC Criminal Law (Article 217). For instance, in a 2023 criminal case involving the intentional circumvention of technical protection measures using a dongle to infringe the copyright of medical device operating software, three defendants were sentenced to imprisonment ranging from one year to three years and two months.

Trade secret disputes are increasing in the life sciences and pharma sector in China, particularly involving former employees and collaboration partners. The key issues include:

• whether the defendant(s) had access to the trade secret;
• evidence collection;
• whether the defendant’s alleged misappropriated technology is identical or substantially similar to the plaintiff’s claimed trade secret;
• how to calculate damages (eg, R&D investment and future market value), and whether punitive damages should be applied; and
• whether interim injunctions should be granted.

The main legal sources are:

• the Anti-Unfair Competition Law for civil and administrative enforcement (the primary law governing trade secrets);
• the Criminal Law; and
• judicial interpretations.

In China, the parties have the right to appeal, and do not require court approval.

Reconsideration of PI

Parties may apply for review against a PI ruling within five days of the receipt thereof. The court shall review the application and the PI ruling and issue its decision within ten days. During the reconsideration, the court reviews the likelihood of success, the balance of hardships favouring the applicant, irreparable harm and public interest. No further review or appeal is available. It is worth noting that the application for review will not stay the execution of the PI.

Appeal of Patent Infringement

In patent infringement cases, a party may appeal within 15 days after service; those who have no domestic domicile have 30 days. Appellate courts (ie, the Supreme People’s Court) may currently hold a hearing around six months after docketing, and conclude the appeal around another six months afterwards. During the appeal, the court usually reviews the appeal grounds, including the fact findings and application of law. A party dissatisfied with the appellate judgment may apply for a retrial.

If the patent is later invalidated or if the case was rejected in a final judgment, the court will, on its own motion, issue a ruling lifting the PI. The party subject to the PI could also apply for a release, and the court must rule to lift the measure within five days after review.

Appeal of Patent Validity

In patent invalidation cases, a party dissatisfied with the CNIPA’s invalidation decision may file a lawsuit with the Beijing IP Court within three months of receiving such decision. The court may currently hold a hearing around six months after docketing, and conclude the case around another six months afterwards. The court usually only reviews the grounds raised by the plaintiff. Judgments may uphold, annul or partially annul the CNIPA decision. If dissatisfied with the first instance judgment, a party may appeal to the Supreme People’s Court within 15 days of service of the judgment. If still dissatisfied with the appellate judgment, the party may apply for a retrial.

The panel handling an appeal must be composed solely of judges, who may or may not have technical backgrounds. The court may engage a technical investigation officer to address the technical issues of a case.

IP litigation is governed by several judicial interpretations, including:

• Provisions on Several Issues Concerning the Intellectual Property Court;
• Provisions on Evidence in Civil Procedures Involving Intellectual Property Rights;
• Provisions on Issues Concerning the Application of Law in Cases Involving the Review of Preliminary Injunctions in Intellectual Property Disputes;
• Provisions on Trials Concerning Patent Examination;
• Provisions on Issues Concerning the Application of Law in the Trial of Civil Cases Involving Trade Secrets Misappropriation;
• Provisions on Issues Concerning the Participation of Technical Investigators in the Litigation Activities of Intellectual Property Cases;
• Provisions on Trials Concerning Trade Mark Examination;
• Interpretations on the Application of Punitive Compensation in the Trial of Civil Cases Involving Infringement of Intellectual Property Rights;
• Interpretations on Issues Concerning the Application of Law in the Trial of Patent Infringement Disputes;
• Interpretations on Issues Concerning the Application of Law in the Trial of Monopoly Civil Disputes;
• Interpretations on Issues Concerning the Application of Law in the Trial of Copyright Civil Disputes;
• Interpretations on Issues Concerning the Application of Law in the Trial of Trade Mark Civil Disputes;
• Interpretation on Property Preservation of Registered Trade Mark Rights;
• Interpretation on Issues Concerning the Application of Law in the Trial of Civil Disputes Involving the Protection of Well-known Trade Marks; and
• Interpretation on Issues Concerning the Application of Law in the Handling of Criminal Cases Involving Infringements upon Intellectual Property Rights.

For the protection of pharmaceutical patents, in addition to filing a civil lawsuit in court or requesting an administrative adjudication from an IP Office, patentees may also ask Customs to cease the import or export of infringing goods in China.

Under the Regulations on Customs Protection of Intellectual Property Rights, where a patentee has recorded its patent with Customs, it may submit an application for the detention of alleged infringing goods with a bond. Customs may then grant such application after reviewing the application at the ports. Customs may also proactively examine the goods to be imported or exported in light of the infringement and notify the patentee, although this situation is rare. After the detention, the patentee shall file a lawsuit with the court and seek a court order for continuous Customs detention.

The operation of the EU's Unified Patent Court has little impact on life sciences and pharma IP litigation in China, but it could bring certain intervention or conflicts in cross-border IP disputes in the future.

Disputes can be resolved through mediation, arbitration, administrative adjudication or negotiation.

Mediation includes commercial mediation, court mediation and administrative mediation. A neutral facilitator helps the parties reach a settlement. China is starting to introduce pre-lawsuit mediation to judicial practice. Chinese courts may encourage recourse to mediation but cannot compel the parties to participate.

Mediation and arbitration offer a confidential, party-driven alternative: the parties can jointly appoint arbitrators with specialised life sciences expertise, ensuring both technical accuracy and the protection of proprietary data.

Patentees may also seek an administrative ruling from the local patent office; this route is attractive to parties that need a quick injunction.

When pharmaceutical companies enter into settlement agreements, they must be mindful of antitrust scrutiny (eg, pay for delay term – see AZ v Ask (2021 SPC Civil IP Final No 388)). Such an arrangement without justification may constitute a horizontal monopoly agreement, which is prohibited by Article 17 of the Anti-Monopoly Law. The following factors are typically considered:

• whether the consideration paid or promised to the generic company markedly exceeds the litigation costs of the underlying patent dispute and is incapable of reasonable justification; and
• whether the agreement materially extends the patentee’s period of market exclusivity or impedes, delays or otherwise influences the generic’s entry.

There are class actions under the Civil Procedure Law, but they are rare in the life sciences/pharma sector in China.

A class action can be filed if the subject matter of the action for each party is the same or is of the same kind.

Rights and Obligations

Where the parties in the class action have common rights and obligations regarding the subject matter, the conduct of anyone in the same group could bind the remaining group members upon their recognition.

Representative

Where there is a significant number of members on one side of a group claim, such group may recommend one representative or several representatives to participate in the litigation. The conduct of such representatives shall bind the whole group. However, such representatives must obtain consent from all members of the group in order to modify or relinquish any claims, admit any claims of the opposing party or reach a settlement.

Drug Safety

For a class action related to food and drug safety, an authority or relevant organisation as prescribed by law may institute a class action in a court. If the authority or organisation does not file a lawsuit, the procuratorate office may file a lawsuit instead.