August 20-22,First-in-the-line drug early R&D and translation conferenceIn Beijing, it was also the Zhuang dynastyLin SongyuanThe hotel was successfully held.
The conference brings together regulatory agencies,Multinational pharmaceutical companiesinvestment institutions, and experts from leading clinical institutions, with more than 10 special forums focused on industry hot topics, focusing on early clinical translation, regulatory science, AI drug supervision, biomarkers, and model guidanceDrug developmentand other core issues, sparking a wave of innovative ideas in pharmaceuticals.

As an important part of the conference segment “Rule Restructuring—Policy, Regulation, and Regulatory Science Driving FIC Global Development,” the special forumData protection and patent linkage”Successfully held on the afternoon of August 21.” Tang Huadong, partner at Zhide Law Firm, was invited to attend and deliver a keynote speech. The forum is centered aroundMonopoly period in the rare disease drug marketPharmaceutical patent linkage practices, innovative drug LOE lifecycle operations, andData protection dual-track coordinationand other topics. The venue was packed, and the discussion was lively.

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1. Forum Opening This

event was hosted by Zhang Jin, Senior Director of Registration Affairs at BeiGene. Mr. Zhang pointed out that China’s pharmaceutical innovation is currently at a critical transition stage from BIC to FIC,Intellectual property protectionIt is no longer just a legal compliance requirement, but also one of the core variables determining the success or failure of global innovative drug development.As China’s pharmaceutical regulatory system moves from a “patent single track” to a dual-track approach of “data protection + patent linkage,” companies must not only “create” IP but also “operate” IP, combining various tools such as patents, data protection, and market exclusivity periods to form a defense system covering the entire product lifecycle.

2. Keynote Speech

Topic 1: Research and Reflections on China’s Rare Diseases and Pediatric Drug Market Monopoly System

examined three perspectives: European and American experience, China’s current situation, and institutional challenges. It systematically analyzes the institutional design and implementation paths during the monopoly period of China’s rare disease and pediatric medication markets. He pointed out that although both the US and EU use market exclusivity periods,Orphan medicineThe core incentive tool developed in development, but the design logic differs significantly:

In the United StatesEpidemicThe core is the threshold for education, with no more than 200,000 patients orR&D costsIf the drug cannot be reclaimed, it will be recognized. After approval, it enjoys a 7-year market exclusivity period, during which the FDA may not approve other applications for the same drug and indication—”identical drug” refers toActive ingredientsFor the same product, subsequent improved new drugs must have clinical advantages to overcome exclusivity limits.
European UnionThe standards are stricter, requiring products to generate “significant benefits” in addition to epidemiological criteria, with an exclusive period of 10 years; if profits at the end of the 5th year significantly exceed R&D investment, the exclusivity period can be reduced to 6 years.
Both regions share a common principle: “protect the parent nucleus.”That is, the first batch of products on the market receives substantial market protection, and subsequent followers must prove themselvesClinicalOnly by having advantages can you enter.

China adopts a rare disease catalog management system and has released two batches totaling 207 disease types, fundamentally different from the dynamic identification models of Europe and the United States. Currently, about 200 rare disease drugs have been approved, focusing on solving the problem of “overseas but not domestically.” Professor Xie suggested that, initially, the catalog should ensure operability, gradually introducing comprehensive mechanisms for epidemiological and disease severity, and clarifying the obligation of supply guarantees for holders.

Regarding pediatric medication, Professor Xie pointed out that compared to Europe and the US, the US requires companies to complete FDA-requested pediatric studies to obtain a 6-month additional market exclusivity period, which is not an additional periodIndications for childrenas the premise; The EU is similar, with six months of exclusivity after completing the study. In contrast, China’s current regulations are results-oriented, granting exclusive rights to new indications for children. Based on data from 23 pediatric drug varieties from 2020 to 2024, the Type I pediatric drug already has patents and data protection, so independent exclusivity is of little significance; Some Class II drugs have no protection, while standalone drugs have some effect but limited coverage. In contrast, additional exclusivity can be stacked on top of the existing protection period, offering broader incentive coverage. He suggested adopting an add-on model, referring to the U.S. approvalOrange BookThe mechanism has been implemented, clearly defining children’s medication to include both specialized and shared drugs, achieving precise incentive delivery.

Topic 2: Latest Trends in Intellectual Property in China, the US, and Europe—Strategies for Innovative Pharmaceutical Companies 

Attorney Tang is known for his expertise in “From Clinical Protocol Patents to Market Blockade: Licensing in China, the US, and Europe.”Patent linkage systemUnder the title “Comparison,” it systematically reviews the pharmaceutical market in China, the US, and EuropePatent protectionFundamental logical differences and coping strategies.At the very beginning, he raised a core question:Clinical valueWhy do they often fail to convert to?Patent value？
Based on this question, he analyzed three common core misalignments in enterprise practice—

The disconnect between clinical R&D and intellectual property teams, and the passive involvement of IP teams, have led to thisKey technologiesNodes lack layout support;
Machine translation PCTClaims, neglecting the institutional differences among the three regions that have led to vulnerabilities in core market protection;
Patent managementThey focus only on quantity and expiration date, ignoring the substantive scope of protection and competitor avoidance paths.
Lawyer Tang emphasized that fromClinical findingsGoing public blocking is a closely linked value chain:Clinical findings → legal translation →Patent authorization→ original drugs cover →Patent registration→ competitor comparison → market listing blockade, any missing link could result in patent protection being invalidated.
He then analyzed the differences in systems and key points for addressing the three major markets—China, the United States, and Europe—one by one:

China Section:Swiss-type claimsThe logic of limiting weight.

Article 25 of China’s Patent Law explicitly excludes “methods for diagnosis and treatment of diseases” from the scope of patent protection. Patents for pharmaceutical use must be transformed through “Swiss-type claims”—”certainCompound”In the preparation of drugs for treating a specific disease,” translating clinical therapeutic discoveries into pharmaceutical applications is limited. Swiss-type claims not only protect new indication expansions but also cover clinical innovations such as disease subtype segmentation, specific patient populations, and drug administration regimens.

Regarding the limiting effect of dose and frequency, Attorney Tang pointed out that the dosage andFrequency of medicationIf it only refers to the process after the drug is fully prepared,Clinical useIf it does not reflect structural improvements or optimization of the preparation process of the drug, it cannot be effectively limited. He combinedTocilizumabCaseInterpretation: The patent in question requires protection of “MRA and.”MechatrexateThe drug combination is limited to “8mg/kg every 4 weeks,” while the original investigational drug is only a single-component injection of tocilizumab. The Supreme People’s Court determined that the registration information of the drug regulatory department is administrative information that has not undergone substantive review and cannot be directly used as the basis for determining infringement—registration status cannot replace itJudicial rulingPatent linkage litigation still needs to return to substantive examination under the Patent Law. Lawyer Tang distilled three key insights: coverage of original drugs is a prerequisite for rights protection; Clinical medication language is not the same as patent technical language; Regulatory filing differs from patent examination standards.

About the patient subgroup withBiomarkersIf the claims incorporate patient subgroup characteristics or biomarker guidance, and these features are paired withClinical administrationIf the regimen has practical guiding value and is directly related to the efficacy or safety of the drug, it will be recognized as having a substantial limiting effect. Lawyer Tang citedAnaquAzole invalidation declaration caseExplanation, known for late stagesBreast cancerMedications are used for treatmentEarly breast cancerAdjunctive therapy, which did not produce unexpected technical effects, was declared ineffective. The patent thresholds for precision medicine are:Biomarker limitations cannot be “results-oriented, artificially sliced”; they must have practical medication guidance value and must be metExperimental dataDemonstrate the unexpected technical effects it brings.

Regarding evidentiary requirements, China uses the filing date as the boundary; subsequent supplementary data can only be used to enhance the technical effects clearly disclosed in the original application and cannot be used to create new effects.Companies must thoroughly record indications, target patient groups,Mechanism of actionand preliminary experimental data, thereby solidifying the technical contribution foundation from the source as of the application date.

US Section: Challenges in Patent Eligibility for Therapeutic Methods and New Judicial Trends
U.S. Patent LawIn principle, it is permitted to directly draft the “treatment method” claim.Attorney Tang compared Mayo v. Prometheus with Vanda v. Two key West-Ward cases: in the Mayo case, “measuring metabolite levels and prompting doctors to adjust dosages” was recognized as an unpatentable natural law; The Vanda case “Detection.”Genotype→The complete steps of stratified →differentiated medication” constitute the practical application of natural laws and are patentable therapeutic methods. Regarding multi-party implementation, the implementation of treatment methods involves collaboration among testing institutions, doctors, pharmacists, patients, and others, making it difficult to prove that “a single entity completes all steps.”It is recommended that the main claim be arranged around steps that doctors can directly control, passing throughSubordinate claimsCovering other main components, simultaneously arranging detection methods, therapeutic uses, and specialized usesReagent kitand other forms of three-dimensional protection.

Scene from Tang Huadong from Zhide Law Firm’s speech
European Section: Purpose-Defined Product Claims and Thresholds of Trustworthiness.

Section 53(c) of the EPC excludes therapeutic method patents, but Section 54(5) allows for a “second pharmaceutical use patent,” where claims must be directly limited by “product + use.” The G 2/08 case confirmed that even if the dosage regimen is the only one not covered in the claims,Existing technologyThe features covered are also not excluded from the scope of protection, but substantive requirements such as inventiveness and full disclosure must still be met.

Regarding patient population definition, the EPO’s 2026 review guidelines clearly allow biomarkers,Gene mutationsAccurate definitions of objective indicators such as type and age stratification. Patient groups can be “passively defined” or “actively defined”—incorporating testing and screening steps into the claims, with stronger protection for the latter. In terms of creativity, simply adding testing steps is insufficient to prove creativity; it is necessary to show that selecting this patient group has brought clinical outcomes unexpectedly by existing technologies. The G2/21 precedent establishes the “credibility” principle: the therapeutic effect must have a “credible basis” on the application date; data supplemented after the application date cannot compensate for the defects at the time of application, nor can the invention be “created after the fact.”Novelty。 Companies must embed preliminary credibility evidence in their initial application—in vitro screening data, animal efficacy studies, or reasonable derivations based on prior art.

Regarding the patent linkage system, Lawyer Tang horizontally compared the differences among the US, China, and Europe:

US chemical pharmaceuticals use the Orange Book as the institutional cornerstone, forming a complete closed loop of “patent registration — Paragraph IV challenge — 45-day litigation window — up to 30 months approval delay — 180-day exclusive period for first generics.” Biologics operate under the BPCIA framework, with the core features being”Patent Dance” procedure— Mandatory pre-listing patent information exchange and phased litigation initiation mechanism, with dispute resolution emphasizing negotiation before approval. Lawyer Tang especially reminds not to confuse the validity of the Purple Book and the Orange Book—the Purple Book is only a public disclosure vehicle for patent information and does not have the statutory link effect granted by the Orange Book.

China implements non-endorsement registration, and patent registration does not create the legal presumption that “rights are naturally valid” or “patent protection naturally covers the original drug.” Can this be blocked?Generic drugsListing must be validated through litigation.China does not distinguish between chemical drugs and biologics, collectively referring to them as “patent links.” Chemical drugs can register patents for active ingredient compounds, pharmaceutical compositions containing active ingredients, and pharmaceutical use patents; crystal forms, formulation processes, etc., are not yet included in the “patent processing” category;Biological productsMainly registered patents for sequence structures of active ingredients and patents for pharmaceutical use. Chemical generics trigger a 45-day prosecution window and a 9-month waiting period through the Category IV declaration, while biosimilars have not yet set a waiting period, indicating a clear asymmetry in the approval coordination between the two categories.

Europe implements approval and patentingSeparation principle, marketing authorization and patent status are decoupled,Generic drugs can use “slimming labels” to reduce patent-protected indications in the instructions to avoid infringement, while original drug companies can only defend their rights through lawsuits in member state courts or the Unified Patent Court (UPC), with significant differences in enforcement of bans across countries.

Slimming labels are recognized in China, the US, and Europe, but if promoted or induced,Off-indicationit may constitute active inducing infringement—U.S. 2026 Hikma v. The Amarin case further tightened the criteria for identification, requiring rights holders to provide evidence that generic drug companies actively promoted their products, with a relatively high threshold for proof.
In his summary, Attorney Tang pointed out that patent layout requires three key translations:Translate claims from clinical language into locally authorized claims, then into registrable/exchangeable statutory rights, and finally implement them as enforceable against competing productsLegal remedies。

He suggested that companies establish a cross-departmental collaborative mechanism of “clinical—patent—registration,” evaluating the essence of patents from dimensions such as claim restriction, specification support, determinability of infringement, and competitor delay capabilityCommercial value； Three rounds of pre-registration review of type, coverage, and stability; Biopharmaceuticals implement a three-layer combination of “application + product + process” protection. Clinical development determines whether a drug can be “brought to market,” patent design determines whether clinical value can be “rights-alized,” and patent linkage and label enforcement are the keys to turning rights into “actionable market blockers”—all three are closely linked and indispensable.

Topic3 ChinaPharmaceutical patent linkage systemPractice and reflection

Mr. Qiu systematically reviewed the five-year practice of China’s pharmaceutical patent linkage system. Since its implementation in 2021, this system has established a closed-loop system including patent registration, patent declaration classification, infringement dispute resolution, and a nine-month waiting period. Overall, it has operated well and resolved a large number of infringement disputes, though there is still room for improvement.

Mr. Qiu pointed out that patent registration is the starting point of the patent linkage system, but the biggest current dispute lies in the scope of types of patents that can be registered. Under current regulations, there are only three types of patents that can be registered for chemical drugs: patents for active pharmaceutical ingredient compounds, patents for pharmaceutical compositions containing active ingredients, and patents for pharmaceutical use of these two categories. However, in practice, a large number of patent disputes occur precisely over improved patents such as crystal forms and formulation processes—these are precisely the ones that cannot be registered at present.
This leads to an awkward situation: the patent disputes that companies most want to resolve through linkage systems actually cannot enter the door of linking systems. Meanwhile, the United States, Canada, South Korea,Taiwan, Chinaand other regions. Mr. Qiu believes that the claim that “too short a waiting period cannot resolve complex disputes” is untenable, and calls for future systems to include improved patents in the scope of registration.

Qiu Fuen, Senior Director of Intellectual Property at Weijian Pharmaceuticals
It also analyzes the patent declaration obligations of generic drug companies. Three types of declarations involve the generic drug company’s commitment at the time of application to “not be marketed before the patent expires.” However, in practice, the phenomenon of “online sales” has emerged—companies first promise not to go public, obtain approval, and then list drugs on the procurement platform, effectively achieving sales. The Supreme People’s Court has clarified in relevant cases:Violating the three types of declarations does not directly constitute a violationPatent infringement, but it may be considered a violation of the principle of good faith,This could become a disadvantageous factor in subsequent litigation. The problem is that there is currently no clear administrative responsibility for online sales, which gives some companies room to exploit loopholes. However, the current lack of administrative responsibility risks the system being sidelined, and legislation is urgently needed to clarify the consequences. He compared domestic and international practices:

The U.S. only grants provisional approval to three categories of declared products, with formal approval only after patent barriers are removed;
South Korea grants licenses but prohibits sales; violations result in revocation of marketing approvals, with clear legal responsibilities;
Canada and Taiwan have enacted legislation requiring generic drug applicants to commit not to be licensedBinding force。

He believes these legislative designs are worth learning from to address the difficulties in coordinating approval and patent rights between China’s drug regulatory authorities.

President Qiu also discussed itThe first was to imitate medicineThe criteria for determining market exclusivity periods point out that China currently requires “the first challenge to succeed and be approved” to obtain exclusivity, and “successful challenge” is strictly interpreted as patent invalidation, which is more stringent than in countries like the United States. Additionally, he pointed out that the “non-dependency” principle in the data protection system can provide a foundation for patent linkage and clarify the relationship between original drugs and generics; A “unified starting line” for data protection (such as a 5-year injection period) can be referenced, providing a clearer incentive base for those who succeed in the first challenge. The exclusivity period of the pediatric medication market can be referenced from the US model, inAdministrative approvalRather than amending the Patent Law.
Finally, Mr. Qiu concluded that the drug patent linkage system has entered deep waters. The registrability of crystalline patents and the consequences of the three types of declarations urgently need improvement. Legal loopholes may undermine the system, which is necessaryJudicial interpretationor legislative amendments to intervene. He suggested that pharmaceutical companies should build a dual-track strategy for patents and data protection, incorporating patent linkageProduct lifecyclerather than treating it as an isolated registration process.
Topic 4: Innovative Drug LOE Lifecycle Operations

Qu Kai systematically explained the entire lifecycle of innovative drugs, from molecular project initiation to patent cliffManagement strategy。The article begins with a data point that highlights the urgency of LOE management—Lipitor’s sales plummeted 68% after the patent expired. She pointed out that LOE is not a matter that should only be considered near patent expiration, but must be included in the planning process from the molecular initiation stage. If the company is in compoundsPatent publicationOnly after considering how to extend the exclusivity period do they often miss the best window to invest.
Regarding the extended exclusivity period, Mr. Qu systematically organized the listThree main pillarsAnd the differences in their implementation in the Chinese market.

(1) Patent layout
from core compounds to peripheral patent networks. Mr. Qu pointed out that the patent layout cannot stop at core compound patents. After applying for compound patents early, companies should continue to apply for peripheral patents focusing on crystal form, formulation, and administration methods, forming a patent network that is hard to avoid. He cited the risperidone series as an example: Johnson & Johnson has iteratively developed long-acting injections based on risperidone oral formulationsPalipperoneMicrospheres, and pass throughMetabolitesPatents extend the lifecycle, achieving market exclusivity far beyond the market exclusivity period of a single product. Mr. Qu emphasized that the value of peripheral patents lies not in their “quantity,” but in whether they can effectively block generic drugs from entering after core patents expire—a patent portfolio covering dimensions such as crystal form, formulation process, and drug delivery protocol is the second and first step in constructionThree lines of defenseThe foundation.

(2) Patent term compensation
Mr. Qu compared China, the US, and EuropePTE/SPC systemDifferences:

China stipulates that one patent is limited to one approved indication, with compensation for up to 5 years and a total post-market protection period not exceeding 14 years;
The US protects the “active ingredients” with no indication restrictions and a maximum compensation of 5 years;
European countries apply for SPCs separately, with a maximum period of up to 15 years.

She cited Noxintu as an example, and Novartis has introduced new indications (PrimaryHypertension) successfully obtained 5-year PTE compensation, effectively hindering the sales of generic drugs in this indication—even after the original patent expires, new indications can still provide an independent market barrier. Mr. Qu specifically pointed out that China has implemented the PTE system since 2021, but due to lagging policy implementation, most companies have not fully utilized this tool, and a large number of products meet the application requirements but have not submitted them in time.

(3) Special Exclusive Rewards and Iterative Development:
Mr. Qu shared two classic cases. Lansoprazole achieved about 30 years of market exclusivity through a combination strategy of NCE exclusivity, PTE exclusivity, pediatric exclusivity, and multiple formulation development, far exceeding the standard 20-year patent period. Palipedone palmitate is maintained thanks to its patented unique delivery protocol—a stepwise dosing method of high dose followed by maintenanceMarket barriersEven if generic drugs bypass compound patents, it is difficult to avoid this clinical implementation protection. Mr. Qu pointed out that the value of drug delivery protocol patents is often underestimated, but at the enforcement level, they are among the types of protection that generics find hardest to bypass through “slimming labels.”
(4) Data Protection

Mr. Qu emphasized the independent role of data protection after patent expiration. He saidSemaglutideFor example, although the core patent for this drug has expired,However, thanks to Swiss-sourced 6-year data protection, it still enjoys market advantagesExclusivity— Even if generic drug companies bypass patents, they cannot rely on original research data for market launch during the data protection period. Mr. Qu suggests that companies should plan their patent layout, PTE/SPC applications, data protection, and special exclusive rewards, starting global patent deployment from the early R&D stage, leveraging differentiated policies from each country, and building a truly full lifecycle defense system.

3. Roundtable Discussion: Data Protection and Patent Linkage—Industry Voices

After the keynote speech, the forum moved into a roundtable discussion session. Hosted by Wu Jie, Head of Regulation and Innovation at Takeda Pharmaceutical.Deng Wanhe, Vice President of Rongchang Bio, Du Shanshan, Head of Pharmaceutical Affairs at Servilla China, Li Huiying, Director of Registration Policy at BeiGene, Zhao Zhongbin, Head of Policy Intelligence at Amgen Legal Science Department, and Tang Huadong, Partner at Zhide Law Firm, participated together. The guests engaged in in-depth discussions on hot topics such as the practical boundaries of data protection, data protection strategies for combination drugs and improved new drugs, and the dual-track collaboration between patents and data protection.

Roundtable discussion scene
(1) Mr. Zhao Zhongbin first interpreted the criteria for identifying “undisclosed” data protection. “

“Undisclosed” refers to complete undisclosed filing data used for the first time in marketing authorization applications. She specifically pointed out that partial disclosure does not affect the determination—disclosing a main endpoint summary or poster on http:// ClinicalTrials.gov platforms, ASCO meetings, etc., is considered limited data disclosure and does not violate the “undisclosed” status. However, the leakage of complete Clinical Research Reports (CSR), databases, or original case data may threaten data protection eligibility. She suggests that businesses build multi-layered approachesData managementMechanisms, control publication content, and conduct dual reviews from both regulatory and intellectual property perspectives.

(2) Li Huiying shared practical points on data protection for combination medication. Data protection for co-medication requires case-by-case assessments based on brand-new data. Each drug must submit an independent NDA application for data protection, with the protection period calculated according to its registration category—Category I for 6 years, Category II for 4 years, with the start and end dates based on their respective approval dates and do not affect each other. Even when sharing one set of clinical data, data protection for each drug is enforced independently. She pointed out that if external BD cooperation is involved, the agreement must clearly specify data usage rights and application arrangements. The requirement to “obtain data independently” is key, and it is necessary to ensure clear ownership of data rights.

(3) Mr. Du Shanshan provided supplementary information on data protection for improved new drugs. Improvements aimed at enhancing efficacy or safety are usually required to conduct Phase III studies, with data falling under the protection category; But only based on BE/BA orImmunogenicityStudy data (such as formulation improvements that do not alter PK characteristics) are not protected. Regarding the protection period, Class II improved new drugs are usually granted 4 years, but for newly declared indications for the first time within China, even if already in foreign countries, 6-year protection is still available.

(4) General Manager Deng Wanhe, drawing on his extensive experience in global biopharmaceutical registration and commercialization, shared his views on how innovative pharmaceutical companies can optimize their global registration strategies under the current policy framework. He pointed out that in recent years, China’s pharmaceutical regulatory reforms have continued to advance, and the implementation of data protection and patent linkage systems has provided an important policy window for local innovative pharmaceutical companies. When formulating global registration strategies, biopharmaceutical companies need to incorporate the data protection period and patent linkage mechanisms of the Chinese market into early planning, fully leveraging the policy benefits of the Chinese market while also considering institutional differences in major overseas markets.

(5) Lawyer Tang Huadong explained the synergistic relationship between patents and data protection from the perspective of institutional principles. Both are independent systems and should be applied for simultaneously. Data protection is enforced by the drug regulatory system, based on the principle of “non-dependence,” serving as a market access mechanism that directly blocks approval for generic drug marketing; Patent protection is enforced by the National Intellectual Property Administration/court system, based on claim comparison, which is a post-event remedy and requires litigation after infringement occurs. Even if a patent is valid longer than the data protection period, it still holds unique value—it can directly block the marketing authorization path for generics, and the two should be seen as complementary rather than substitutive. unanimously agreed that data protection is the core barrier to market entry and has become a key policy lever to attract foreign R&D centers to expand into China. Companies should incorporate data protection into the overall consideration of BD and registration strategies, clarify data ownership in advance for combination drugs, and develop differentiated registration paths for improved new drugs, enabling intellectual property management to truly move from legal documents to commercial value.

5. Conclusion

This forum provided systematic insights for pharmaceutical companies’ intellectual property management and global registration strategies. The guests shared in-depth insights on key issues such as the practical boundaries of data protection, the application pathway for co-medications, and strategies for registering improved new drugs, helping companies clarify many previous confusions encountered in practical operations. The comparison of patent systems among China, the US, and Europe has given companies a clearer compass for global patent layout—you can’t use a single solution to conquer the world; you must tailor your legal interpretation to different markets.
As China’s pharmaceutical regulatory industry moves from a “patent monorail” to a dual-track approach of “data protection + patent linkage,” companies need to embed intellectual property management into the entire chain of R&D, registration, and commercialization—from initial patent layout at project initiation, to pre- and post-market linkage and data protection, and then to LOE operations throughout the product lifecycle. Only in this way can one leadTechnical advantagesTruly transforming into market barriers and commercial value.

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