From Registration to Enforcement: China’s Administrative Pathway for Patented Drugs

Introduction

For originator pharmaceutical companies, China is no longer only a major commercial market. It is also a jurisdiction where drug registration strategy and patent strategy need to be planned together from an early stage. As the world’s second-largest pharmaceutical market, China has become a key part of many overseas originator companies’ global product plans.

In practice, originator companies often build multi-layered patent portfolios around a drug, covering the compound itself, crystalline forms, manufacturing processes, medical uses and other technical aspects. These patents may form an important basis for market exclusivity. Once a product moves towards launch in China, however, patent protection does not operate in isolation. Companies also need to understand the administrative rules governing drug registration and approval, as well as China’s patent-related administrative protection procedures.

This is where practical difficulties often arise. Some overseas originator companies encounter delays in launch timelines, or find their patent interests affected by generic competition, because they are not sufficiently familiar with China’s drug marketing authorization process, the drug patent linkage regime, or the administrative adjudication procedure for patent infringement disputes. These procedures involve different authorities, different timelines and different legal functions. Misunderstanding one step may affect the overall enforcement strategy.

This article provides a structured overview of China’s registration and approval process for patented drugs and the key administrative protection procedures available to originator companies. It also discusses representative drug patent linkage cases and administrative adjudication examples involving post-approval pharmaceutical patent infringement disputes. The aim is to offer overseas originator companies a practical reference for drug registration, patent protection and enforcement planning in China.

I.              Drug Registration, Marketing Approval and Regulatory Oversight for Patented Drugs in China

China’s drug registration system is built around whole life-cycle regulation, category-based review and approval, and the marketing authorization holder responsibility system. In practice, the review pathway may differ depending on the type of drug, such as chemical drugs or biological products, and on whether the manufacturing site is in China or overseas. For patented originator drugs, the registration process therefore needs to be considered together with both drug regulatory requirements and patent protection planning.

1.     Core Legal and Regulatory Framework

The marketing approval and patent protection of patented originator drugs in China rest on a two-layer framework.

The first layer is the drug regulatory framework. Key instruments include the Drug Administration Law of the People’s Republic of China, the Provisions for Drug Registration, the Provisions for the Supervision and Administration of Drug Manufacturing, the Implementation Measures for Drug Trial Data Protection, and the Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Marketing Authorization Holders. Together, these rules set out the main requirements for drug review and approval, manufacturing, importation, post-approval supervision and post-market regulatory responsibilities.

The second layer is the patent protection framework. Key instruments include the Patent Law of the People’s Republic of China, the Measures for the Implementation of the Mechanism for Early Settlement of Drug Patent Disputes (Interim), and the Measures for Administrative Adjudication and Mediation of Patent Disputes. These rules provide the basis for China’s drug patent linkage regime, administrative adjudication of patent-related disputes, and patent invalidation proceedings.

2.     Registration and Approval Pathways for Different Types of Patented Originator Drugs

China applies different registration and approval pathways to originator drugs depending on the product category and the place of manufacture. For overseas pharmaceutical companies, the key distinction is usually between chemical drugs and biological products, and between products manufactured outside China and those manufactured within China.

2.1 Overseas-Manufactured Originator Chemical Drugs

For an originator chemical drug manufactured outside China, the product will generally proceed through the marketing authorization pathway for imported drugs. The main steps usually include the following:

Clinical trial application (IND):The overseas applicant may need to submit an IND/clinical trial application, including the protocol for an international multi-centre clinical trial, pharmaceutical research data and non-clinical research data. After the application is accepted by the Center for Drug Evaluation of the National Medical Products Administration, the statutory review period for a drug clinical trial application is generally 60 working days. If the application is approved, or deemed approved under the statutory mechanism, the clinical trial may proceed.

Marketing authorization application: After completion of Phase III clinical trials, the applicant may submit a marketing authorization application. The dossier usually includes pharmaceutical research, clinical data, pharmacology and toxicology materials, and relevant patent information. During this stage, the CDE conducts technical review. Where required, registration inspection of the overseas manufacturing site and sample testing may also be carried out in parallel.

Administrative approval and import-related filing: Once the technical review and approval process is completed, the National Medical Products Administration issues the Drug Registration Certificate. For an overseas marketing authorization holder, a China-based enterprise legal person designated by the overseas MAH should assume the relevant life-cycle responsibilities in China. Before commercial supply, the product must also complete the applicable import-related filing, customs and distribution requirements.

Post-approval regulation: After the product enters the Chinese market, it remains subject to post-approval regulation. This may include adverse drug reaction monitoring, annual reporting, product quality review, registration inspections and other risk-based regulatory measures. For certain overseas-marketed originator drugs that address urgent clinical needs in China, special or priority review pathways may be available. In appropriate cases, overseas clinical data may also be accepted, which can shorten the overall review and approval timeline.

2.2 Overseas-Manufactured Originator Biological Products

Biological products, such as monoclonal antibodies, recombinant proteins and vaccines, are generally subject to more demanding technical review than chemical drugs. In addition to the ordinary registration materials, applicants may need to provide data on biological characterisation, process validation, batch consistency, quality control, and cold-chain storage and transportation.

For overseas-manufactured biological products, the CDE’s review will usually pay close attention to safety, quality consistency, immunogenicity, and, where relevant, comparability or bioequivalence issues. Overseas manufacturing site inspection may cover research and development, manufacturing, quality control and other key parts of the product life cycle. For vaccines and certain other biological products, additional regulatory requirements may also apply, including lot release requirements.

2.3 Domestically Manufactured Patented Originator Drugs

Where an overseas pharmaceutical company establishes a manufacturing base in China, the product may be filed as a domestically manufactured drug. Compared with an overseas-manufactured product, this pathway may reduce certain cross-border procedural burdens. For example, overseas manufacturing site inspection would generally not be required for the domestic manufacturing site, and the applicant may submit domestic research, development and manufacturing materials directly.

Under China’s marketing authorization holder system, the MAH may also entrust a qualified domestic manufacturer to manufacture the drug, provided that the statutory requirements for entrusted manufacturing and quality management are met. In practice, a domestically manufactured product may have a shorter and more controllable review and supply timeline than a product manufactured overseas, although the actual timeline will still depend on the product category, data package, inspection requirements and CDE review process.

3.     The Role of Patents in Drug Registration and Marketing Approval

Patents play a practical role in China’s drug registration system, particularly where an originator product may later face generic or biosimilar applications. For overseas originator companies, patent protection is not only a matter of post-launch enforcement. It may also affect how competitors file their applications, how early disputes are raised, and how market exclusivity is maintained during the patent term.

3.1  Mandatory Disclosure of Patent Information

During the marketing authorization process for an originator drug, the marketing authorization holder is required to register and disclose relevant patent information on China’s Patent Information Registration Platform for Marketed Drugs. This information then serves as the statutory reference point for patent declarations made by applicants seeking marketing approval for chemical generics, traditional Chinese medicines of the same name and formula, or biosimilars.

For originator companies, this means that patent information should be reviewed and recorded carefully at the registration stage. Incomplete or inaccurate platform information may affect the later operation of China’s drug patent linkage regime.

3.2  Patent Linkage as an Early Procedural Filter

When a generic or biosimilar applicant files a marketing authorization application, it must make a patent declaration by comparing its proposed product against the patent information recorded on the platform. This declaration may trigger China’s early dispute resolution mechanism for drug patent disputes.

The purpose of this mechanism is to identify, before approval and launch where possible, whether the proposed generic or biosimilar falls within the scope of relevant listed patent rights. For originator companies, the mechanism creates an earlier point of intervention, rather than waiting until the competing product has already entered the market.

3.3  Basis for Patent-Based Exclusivity During the Patent Term

A valid and enforceable patent right remains the legal basis for an originator drug’s patent-based exclusivity during the patent term. Without an enforceable patent right covering the relevant product, use, formulation, crystalline form, process or other protected subject matter, an originator company may lose the opportunity to rely on this important form of exclusive market protection.

For this reason, patent portfolio management should not be treated as separate from drug registration in China. The practical value of a patent depends not only on grant and maintenance, but also on whether the relevant patent information is properly recorded, monitored and used within the registration and early dispute resolution framework.

II.            Administrative Protection System and Practice for Marketed Patented Drugs

China has developed an administrative protection framework for marketed patented drugs that operates across several stages. In broad terms, it consists of early dispute resolution under the drug patent linkage regime, post-approval administrative handling of patent infringement disputes, and patent validity challenges through invalidation proceedings.

For originator pharmaceutical companies, these administrative procedures can be a practical and relatively efficient enforcement option. They are often less costly and procedurally faster than full civil litigation, although the appropriate route will depend on the patent, the product, the timing of the generic or biosimilar application, and the evidence available.

1.     Administrative Procedure under the Drug Patent Linkage Regime: Early Resolution of Disputes

China’s drug patent linkage regime was introduced following the 2020 amendment to the Patent Law of the People’s Republic of China and became operational in 2021 through supporting rules issued by the National Medical Products Administration and the China National Intellectual Property Administration. The system links the drug marketing approval process with the resolution of certain patent disputes, so that disputes concerning the relevant patent right may be addressed at an earlier stage, before the competing product is approved or launched where the statutory conditions are met.

During the review and approval process for a generic drug, this mechanism allows the relevant parties to seek a determination on whether the technical solution of the drug applied for registration falls within the protection scope of the listed patent right.

1.1 Key Steps in the Administrative Procedure

The administrative route under China’s drug patent linkage regime generally follows four key steps:

Patent information registration: The originator company should ensure that eligible patent information is recorded on China’s Patent Information Registration Platform for Marketed Drugs. Depending on the product and patent type, this may include eligible listed patents, such as active ingredient compound patents, pharmaceutical composition patents and medical use patents for chemical drugs, as well as eligible patent types for traditional Chinese medicines and biological products under the applicable rules. Crystalline-form patents, preparation-process patents, intermediate patents, metabolite patents and testing-method patents should not be described as patent types eligible for registration on the platform, although they may still be relevant to the company’s broader patent portfolio and post-approval enforcement strategy. The platform records key information such as the patent number, patentee, patent type and patent term.

Patent declaration by the generic applicant: When filing a marketing authorization application, the generic applicant must make a patent declaration by reference to the patent information recorded on the platform. A Category IV declaration is the most important trigger for a dispute. It usually states that the relevant listed patent right should be declared invalid, or that the technical solution of the generic drug does not fall within the protection scope of the relevant listed patent right.

Administrative adjudication or court action: If the patentee or an interested party disagrees with a Category IV declaration, it may take action within 45 days from the date on which the national drug evaluation agency publishes the generic drug application. The patentee or interested party may either file a lawsuit before the competent people’s court or request administrative adjudication from the CNIPA. The issue is whether the technical solution of the drug applied for registration falls within the protection scope of the relevant patent right.

Waiting period during drug review: Where the statutory conditions are met, a nine-month waiting period may apply to the chemical generic drug application. This waiting period does not suspend the CDE’s technical review. Instead, it affects the timing of the marketing approval decision while the relevant judicial or administrative procedure is underway. The waiting period is set only once.

1.2 Role of the CNIPA

In the administrative route under Article 76 of the Patent Law, the CNIPA is responsible for handling administrative adjudication cases concerning drug patent disputes during the drug review and approval process. The CNIPA has established an Administrative Adjudication Committee for the Early Resolution Mechanism for Drug Patent Disputes to organise and conduct this work.

Its role is to decide whether the technical solution of the drug applied for registration falls within the protection scope of the relevant listed patent right. This should be distinguished from a patent invalidation proceeding. If some claims of the patent involved have been declared invalid, the CNIPA may base its administrative adjudication on the claims that remain valid. If all relevant claims have been declared invalid, the adjudication request may be rejected. The filing of an invalidation request does not necessarily suspend the administrative adjudication.

After an administrative adjudication is made, the decision is served on the parties and copied to the drug regulatory authority under the State Council. The patentee or interested party should also submit the decision to the national drug evaluation agency within the prescribed period. In practice, this result may affect how the drug regulatory authority handles the relevant generic drug application under the patent linkage rules.

The administrative route can be relatively fast. For example, the CNIPA reported that the first batch of administrative adjudication cases under the early resolution mechanism was concluded within six months. That said, the actual timeline will still depend on the complexity of the patent, the number of claims involved, the evidence, confidentiality issues and whether parallel invalidation or court proceedings are underway.

1.3 Differences Between Administrative Adjudication and Judicial Proceedings

1.4 Representative Cases: Everolimus and Baloxavir Marboxil

The everolimus case shows how China’s patent linkage system can operate when a generic applicant takes an active patent challenge strategy.

Novartis’ originator everolimus tablets were protected in China by several patents. When Chia Tai Tianqing filed its generic drug application, it made Category 4.1 declarations, asserting that the relevant listed patent rights should be declared invalid. It also filed invalidation requests before the CNIPA against three Novartis patents relating to everolimus.

The CNIPA subsequently declared the three patent rights invalid. Novartis brought patent linkage civil actions before the Beijing Intellectual Property Court, seeking confirmation that Chia Tai Tianqing’s generic everolimus tablets fell within the protection scope of the relevant patent rights. Those civil actions were dismissed because the asserted patent rights had already been declared invalid. Novartis also filed separate administrative lawsuits challenging the CNIPA invalidation decisions, but public reports indicate that those claims were later rejected. Chia Tai Tianqing’s generic everolimus tablets were later approved, and public reports state that the product became the first generic drug to receive a 12-month market exclusivity period under China’s patent linkage system, as it satisfied both conditions: the first successful patent challenge and the first marketing approval.

This case is important, but not only because the generic applicant succeeded. For originator companies, it shows that patent linkage is not a one-way protection tool. Once patent information is listed, the stability of the listed patent rights may come under direct challenge. A well-prepared patent portfolio therefore needs to be tested not only for coverage, but also for validity risk.

The SPC-published baloxavir marboxil case illustrates the other side of the system. The drug involved was an anti-influenza product, and the relevant patent was directed to baloxavir marboxil tablets. During the early period of China’s patent linkage regime, the generic applicant filed its application before the Patent Information Registration Platform for Marketed Drugs was fully in operation, and no patent declaration was made at that time.

After the relevant patent information was recorded on the platform, the patentee requested that the generic applicant undertake not to market the generic product during the patent term. The generic applicant did not provide such an undertaking. The patentee then brought a civil action before the court, seeking confirmation that the technical solution of the generic drug fell within the protection scope of the relevant patent claims.

The court of first instance held that the case could be treated as a situation equivalent to a Category IV declaration and confirmed that the technical solution of the generic drug fell within the protection scope of claims 1 to 9 of the patent. The Supreme People’s Court upheld the first-instance judgment on appeal.

This case became one of the early landmark cases under China’s drug patent linkage regime. It is particularly relevant for transition-period disputes, where the generic application was filed after the amended Patent Law came into force but before all supporting patent linkage rules were fully in place. For originator companies, the case confirms that early judicial relief may be available even where the procedural facts do not fit neatly into the standard patent declaration sequence.

2.     Administrative Complaints and Adjudication for Post-Approval Patent Infringement

After a patented drug has entered the Chinese market, an originator pharmaceutical company may also rely on the administrative route if it believes that a competing product infringes its patent right. This is different from the patent linkage procedure discussed above. Patent linkage deals with certain disputes before approval and launch. Post-approval administrative adjudication deals with alleged infringement that has already occurred in the market.

In this route, the patentee or an interested party may request the competent local department in charge of patent-related work to handle the patent infringement dispute. If infringement is found, the authority may order the infringer to stop the infringing act immediately. This makes administrative adjudication a practical option for originator companies seeking a relatively fast order to stop infringement, although claims for monetary compensation usually need to be addressed through mediation or civil litigation.

2.1 Legal Basis and Competent Authority

The main legal basis is the Patent Law of the People’s Republic of China, especially Article 64 on the scope of patent protection and Article 65 on the administrative handling of patent infringement disputes. The current procedural rules are further set out in the Measures for Administrative Adjudication and Mediation of Patent Disputes.

Under these rules, a patent infringement dispute is generally handled by the department in charge of patent-related work at the place where the infringing act occurs or where the respondent is domiciled. The place of infringement includes both the place where the infringing act is carried out and the place where the infringing result occurs.

The Drug Administration Law of the People’s Republic of China is also relevant in the broader regulatory context, as it establishes the marketing authorization holder system and requires the MAH to be responsible for drug safety, efficacy and quality management throughout the drug life cycle. However, it should not be treated as the direct legal basis for deciding patent infringement. Patent infringement is handled under the patent law framework.

In practice, respondents in pharmaceutical patent disputes often file an invalidation request against the asserted patent before the CNIPA. Depending on the type of patent and the circumstances of the case, the administrative adjudication authority may suspend the infringement proceeding pending the outcome of the invalidation proceeding, or may continue the case if suspension is not required.

2.2 Main Steps in the Administrative Adjudication Procedure

Filing of the request: The originator company submits an administrative adjudication request to the competent authority. The request should normally include proof of standing, evidence showing that the patent right remains valid, the patent certificate or patent register extract, evidence of the alleged infringing acts, and a technical comparison between the asserted patent claims and the accused product or technical solution.

Case acceptance and panel formation: If the request satisfies the filing requirements, the authority will open the case and appoint an odd-numbered collegiate panel of three or more case-handling officers. The respondent will then be served with the request and given an opportunity to submit a defence.

Hearing and technical review: The panel may hold an oral hearing, review the technical comparison, and, where necessary, rely on technical investigation or technical appraisal. In pharmaceutical cases, this stage is often central, as the dispute may turn on claim construction, formulation features, crystalline form identification, manufacturing process evidence, or whether the accused technical solution contains all elements of the asserted claim.

Possible suspension pending invalidation proceedings: If the respondent files an invalidation request, the administrative proceeding may be suspended in certain circumstances. For example, suspension is generally required where the patent involved is a utility model or design patent and an invalidation request has been accepted by the CNIPA. By contrast, where the patent involved is an invention patent, the authority may decide not to suspend the case merely because an invalidation request has been filed.

Administrative adjudication: The authority will issue an administrative adjudication after reviewing the facts and evidence. If infringement is found, it may order the infringer to stop the relevant acts immediately, including manufacturing, selling, offering to sell, using or importing infringing products, depending on the nature of the infringing conduct. If infringement is not found, the request will be dismissed.

Judicial review and enforcement: A party that is dissatisfied with the administrative adjudication may bring an administrative lawsuit before the people’s court within 15 days from receipt of the decision. If the respondent neither files a lawsuit within the time limit nor stops the infringing act, the administrative authority may apply to the people’s court for compulsory enforcement.

2.3 Role of Patent Invalidation in the Administrative Procedure

Patent invalidation plays a central role in pharmaceutical patent administrative protection, but it should be described carefully. The local administrative adjudication authority does not itself decide whether the patent right should be invalidated. Patent validity is examined through a separate invalidation proceeding before the CNIPA.

For the administrative adjudication of infringement, the continued existence of a valid patent right, and in practice the continued validity of the relevant asserted claims, is a necessary basis for relief. Where the patent involved in an already-issued administrative adjudication is later declared wholly or partially invalid and the invalidation decision has taken effect, the competent authority shall amend or revoke the adjudication in accordance with the applicable rules. However, any patent infringement dispute handling decision that has already been performed or compulsorily enforced has no retroactive effect.

For originator companies, this means that post-approval administrative enforcement should be prepared together with a validity assessment of the asserted patent. A strong infringement case may still be weakened if the asserted claims are vulnerable to invalidation.

2.4 Representative Case: Administrative Adjudication of Patent Infringement Involving Rivaroxaban

The rivaroxaban case is a useful example of how administrative patent protection may operate in the pharmaceutical sector after a patented drug has entered the market.

Bayer Intellectual Property GmbH, as the patentee, filed a request with the Nanjing Intellectual Property Office against Nanjing Hencer Pharmaceutical Co., Ltd. in relation to rivaroxaban API and rivaroxaban tablets. Bayer alleged that the respondent’s promotional activities, including product information displayed on its website and at exhibitions, constituted an offer for sale of products falling within the protection scope of Bayer’s patent right.

After accepting the case, the Nanjing Intellectual Property Office conducted an administrative adjudication procedure. It found that the respondent’s conduct constituted an infringing offer for sale, and ordered the respondent to remove the relevant promotional materials and stop offering to sell the rivaroxaban API and tablets.

Nanjing Hencer challenged the administrative adjudication by bringing an administrative lawsuit. The first-instance court upheld the administrative decision, and the Supreme People’s Court later dismissed the appeal and maintained the first-instance judgment. The Supreme People’s Court held that displaying the accused products on a website and at exhibitions to an unspecified group of potential purchasers amounted to an offer for sale. It also held that the Bolar exemption for drug and medical device regulatory approval did not apply to an offer-for-sale act.

The invalidation issue was also important. During the related proceedings, invalidation requests were filed against the asserted patent. However, the CNIPA maintained the validity of the amended claims of Bayer’s patent. As a result, the generic company’s invalidation strategy did not remove the basis for Bayer’s enforcement action.

For originator companies, the case is a practical reminder that offer-for-sale conduct may be actionable even before actual sales take place. It also shows that administrative adjudication can be used to address website and exhibition-based promotion of allegedly infringing pharmaceutical products. In the right circumstances, this route may allow a patentee to obtain a relatively quick order to remove promotional materials and stop the offer for sale, while validity issues proceed before the CNIPA in parallel.

III.          Impact of Administrative Procedures on Originator Companies and Practical Protection Strategies

1. Key Impact of Administrative Procedures on Market Entry and Patent Protection

Registration and approval: China’s drug registration system provides different review pathways depending on the drug category, product characteristics and place of manufacture. For overseas originator drugs, international multi-centre clinical trials, priority review and the acceptance of overseas clinical data may, where the statutory conditions are met, help shorten the path to approval. Where a product is manufactured in China, certain cross-border procedural steps may be reduced, although the actual timeline will still depend on the product type, data package, inspection requirements and CDE review.

Patent protection: The drug patent linkage regime allows certain patent disputes to be raised at an earlier stage, before a generic product is approved or launched where the relevant conditions are satisfied. After market entry, administrative adjudication may provide a relatively fast route to stop infringing acts. Patent invalidation proceedings, meanwhile, play an important role in testing the stability of the asserted patent right and the relevant claims. Together, these procedures create a practical connection between patent confirmation and patent enforcement.

Coordination between administrative and judicial routes: China’s system combines administrative procedures with judicial review. Administrative routes may offer speed and procedural efficiency, while the courts remain available for judicial review, final appellate determinations and compensation claims. For originator companies, the key is not to treat these routes as alternatives in isolation, but to select and combine them according to the timing of the dispute, the strength of the patent, the evidence available and the commercial objective.

2. Market Entry and Protection Strategies for Overseas Originator Companies in China

Plan the patent portfolio before market entry: Before entering the Chinese market, overseas originator companies should consider filing a layered patent portfolio covering the compound, crystalline forms, medical uses, formulations, preparation processes and other commercially relevant aspects of the drug. Patent information eligible for China’s drug patent linkage system should also be reviewed and recorded on the official platform in a timely and accurate manner.

Coordinate registration and patent work: Patent information should be prepared alongside the marketing authorization application. Once the product is listed, the originator company should monitor generic and biosimilar applications, patent declarations and platform updates, so that it can decide promptly whether to trigger the patent linkage procedure where a Category IV declaration or equivalent dispute arises.

Use a combined enforcement strategy: Where infringement is suspected after launch, administrative adjudication may be considered as an early option to stop infringing acts, especially where the main objective is to remove infringing products, stop offers for sale or interrupt market-facing promotional conduct. If monetary compensation or broader judicial relief is required, civil litigation may need to be pursued in parallel or at a later stage. Where a generic applicant or competitor files an invalidation request, the originator company should be ready to submit technical evidence, experimental data and claim construction arguments to support the validity of the asserted patent right or the relevant claims.

Build a China-based compliance structure: For overseas marketing authorization holders, the appointment of a qualified domestic responsible entity is a key regulatory requirement. In practice, this is usually the overseas MAH’s China-based affiliate, subsidiary or branch. This domestic entity should be familiar with China’s drug regulatory rules, patent linkage practice and post-approval compliance requirements, so that registration, manufacturing arrangements, regulatory reporting and patent protection can be managed in a coordinated way.

IV.          Conclusion

China has now developed a relatively clear framework combining drug registration, administrative patent protection and judicial review. For overseas originator pharmaceutical companies, this means that market entry and patent protection in China should be planned together, rather than treated as separate workstreams.

Before entering the Chinese market, originator companies should consider building a China-focused patent portfolio covering the compound, crystalline forms, formulations, medical uses, preparation processes and other commercially important aspects of the product. Patent information should also be prepared alongside the marketing authorization application and recorded accurately on the official patent information platform where eligible. Once the product moves towards approval or launch, generic or biosimilar applications and patent declarations should be monitored closely, so that the company can decide in time whether to use the drug patent linkage mechanism or other available procedures.

The drug patent linkage regime, administrative adjudication and patent invalidation proceedings each serve a different function. Linkage procedures may allow certain disputes to be raised at an earlier stage; administrative adjudication may provide a relatively efficient route to stop infringing acts; and invalidation proceedings test the stability of the asserted patent right and the relevant claims. Judicial proceedings remain important for final review, broader relief and compensation claims. In practice, these routes should be selected and combined according to the timing of the dispute, the strength of the patent, the available evidence and the company’s commercial objective.

For overseas marketing authorization holders, a China-based compliance structure is also important. The relevant local responsibilities should normally be handled through a China-based enterprise legal person designated by the overseas MAH, typically the group’s China-based affiliate or subsidiary, rather than being viewed as a matter for an external representative. This structure can help coordinate drug registration, manufacturing arrangements, post-approval compliance and patent protection in China.

Handled properly, these steps can help overseas originator companies bring products to the Chinese market more efficiently while making better use of the patent protection tools available under China’s current regulatory and IP framework.