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Section 01 / Executive Briefing
- NMPA launches China's first comprehensive drug data exclusivity regime — effective immediately, May 15. The new Regulatory Data Protection framework grants up to six years of data exclusivity for innovative drugs, establishing a "dual-moat" strategy alongside patent protection. Critical transitional deadlines fall within days: May 30 and June 5 filing windows apply to many already-approved products.
- SPC's Draft Patent Infringement Judicial Interpretation (III) nears finalisation after extended comment period. The 31-article draft — addressing jurisdiction, claim construction, prosecution history estoppel, and malicious litigation — closed public comment in February. Practitioner analysis this week signals the final text is approaching release, with significant implications for litigation strategy.
- SAMR Trade Secret Protection Regulations: two weeks to effectiveness. June 1 is now imminent. Companies still finalising trade secret identification and confidentiality audits have a narrowing window.
- CNIPA and Russia's Rospatent sign cooperation MOU, deepening Belt and Road IP partnerships. The agreement, expected to be formalised May 20 in Beijing, extends China's expanding network of bilateral IP cooperation agreements beyond the 99 overseas dispute-response platforms already established across 30 provinces.
- FIFA World Cup 2026 IP enforcement intensifies as tournament approaches. CNIPA's "What's New" channel highlights Chinese companies' growing role as official partners and licensees, alongside sustained customs enforcement against counterfeit merchandise documented in April's typical case release.
- Nintendo awarded only RMB 200,000 despite 500,000+ infringing consoles sold — modest damages draw renewed scrutiny. The case, surfaced in practitioner commentary this week, illustrates that even after Fa Shi [2026] No. 7's effectiveness, damages calculation methodology and evidentiary proof of scale remain decisive variables in outcome — not all cases reach headline-scale awards.
6
Mainland China
1
Hong Kong SAR
1
Taiwan
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Macau SAR
02
Legislation & Policy
Mainland China
⭐ Landmark
Pharma · Data Exclusivity
Effective May 15, 2026
In Force Immediately — NMPA Regulatory Data Protection Regime
NMPA Launches China's First Comprehensive Drug Trial Data Protection Regime — Up to Six Years of Exclusivity, Effective Immediately
6 yrs
Max data exclusivity — innovative drugs (Category 1)
May 30
Deadline for already-approved Class 1 chemical drugs
Jun 5
Deadline for pending-review/approval applicants
On May 15, 2026, China's National Medical Products Administration (NMPA) released the Implementation Regulations for Drug Trial Data Exclusivity (No. 47 [2026]), together with an official policy interpretation and accompanying CDE work procedures — all effective the same day. This launches China's first comprehensive Regulatory Data Protection (RDP) regime, representing the second pillar of the country's pharmaceutical IP framework alongside the patent linkage system established in 2021.
Tiered protection periods. The Measures establish three exclusivity tiers based on NMPA approval category: six years for innovative drugs (Category 1) and overseas-marketed originator drugs first launched domestically; four years for improved new drugs; and three years for other qualifying categories. Imported and domestically manufactured drugs receive equal protection terms — a notable equal-treatment commitment given longstanding foreign industry concerns about discriminatory treatment.
Mechanism. During the protection period, NMPA will not approve marketing authorisation applications or supplemental applications for improved new drugs, generic chemical drugs, or biosimilars submitted by other applicants without the data holder's consent, where those applications rely on the protected data. Applicants must request data protection concurrently with their drug registration application.
Urgent transitional deadlines. For products already approved, under technical review, or in administrative approval before May 15, 2026: Class 1 chemical drugs approved between May 15, 2020 and May 14, 2026 must submit data protection applications to the CDE by June 5, 2026, with CDE review and determination due by June 26. Other already-approved or pending products generally face a May 30, 2026 filing deadline. Failure to file within these windows constitutes a definitive waiver of data protection rights — there is no extension mechanism described in the Measures.
Notably, the Measures explicitly encourage foreign companies to transfer original drug technology for domestic production in China — with the original drug holder's consent, domestically produced drugs can block generic applications relying on the protected data, creating a structural incentive for technology transfer arrangements.
Tiered protection periods. The Measures establish three exclusivity tiers based on NMPA approval category: six years for innovative drugs (Category 1) and overseas-marketed originator drugs first launched domestically; four years for improved new drugs; and three years for other qualifying categories. Imported and domestically manufactured drugs receive equal protection terms — a notable equal-treatment commitment given longstanding foreign industry concerns about discriminatory treatment.
Mechanism. During the protection period, NMPA will not approve marketing authorisation applications or supplemental applications for improved new drugs, generic chemical drugs, or biosimilars submitted by other applicants without the data holder's consent, where those applications rely on the protected data. Applicants must request data protection concurrently with their drug registration application.
Urgent transitional deadlines. For products already approved, under technical review, or in administrative approval before May 15, 2026: Class 1 chemical drugs approved between May 15, 2020 and May 14, 2026 must submit data protection applications to the CDE by June 5, 2026, with CDE review and determination due by June 26. Other already-approved or pending products generally face a May 30, 2026 filing deadline. Failure to file within these windows constitutes a definitive waiver of data protection rights — there is no extension mechanism described in the Measures.
Notably, the Measures explicitly encourage foreign companies to transfer original drug technology for domestic production in China — with the original drug holder's consent, domestically produced drugs can block generic applications relying on the protected data, creating a structural incentive for technology transfer arrangements.
This is a drop-everything deadline for pharmaceutical companies with China-marketed products. Any company with a Class 1 chemical drug, biologic, or innovative product approved in China within the past six years should confirm with regulatory counsel within days whether a data protection filing is required by May 30 or June 5 — missing these dates forfeits the right permanently. Companies should also evaluate whether the "dual-moat" strategy of layering data exclusivity atop existing patent protection changes their China lifecycle management approach, particularly for products approaching patent cliffs.
Mainland China
SPC · Pending Interpretation
Patent Litigation
Comment period closed; finalisation pending
SPC Draft Judicial Interpretation (III) on Patent Infringement Disputes Nears Finalisation — 31 Articles Reshaping Litigation Strategy
The Supreme People's Court's Judicial Interpretation (III) on Several Issues Concerning the Application of Law in the Adjudication of Patent Infringement Disputes, released for public comment on December 20, 2025, with the comment period closing February 2, 2026, continues to draw close practitioner attention as finalisation approaches. The draft would be the SPC's third major interpretation in this area, following Interpretation (I) (2009) and Interpretation (II) (2016, amended 2020).
The 31-article draft spans jurisdiction, standing to sue, claim construction, infringement comparison, non-infringement defences, change of circumstances, malicious litigation, and damages calculation. Several provisions carry significant strategic implications. Article 3 targets forum shopping by closing loopholes around shipping goods to favourable jurisdictions to manufacture venue. Articles 10–12 meaningfully expand the doctrine of prosecution history estoppel — for the first time incorporating "technical effect" into the estoppel analysis, meaning that where an accused technical solution possesses a defect the patent specification claims to overcome, courts shall find non-infringement. This extends estoppel beyond its traditional confinement to formal prosecution and validation statements. Article 25 defines malicious patent litigation to specifically include scenarios involving company IPO registration — addressing concerns about patent assertion timed to coincide with public listing processes.
The 31-article draft spans jurisdiction, standing to sue, claim construction, infringement comparison, non-infringement defences, change of circumstances, malicious litigation, and damages calculation. Several provisions carry significant strategic implications. Article 3 targets forum shopping by closing loopholes around shipping goods to favourable jurisdictions to manufacture venue. Articles 10–12 meaningfully expand the doctrine of prosecution history estoppel — for the first time incorporating "technical effect" into the estoppel analysis, meaning that where an accused technical solution possesses a defect the patent specification claims to overcome, courts shall find non-infringement. This extends estoppel beyond its traditional confinement to formal prosecution and validation statements. Article 25 defines malicious patent litigation to specifically include scenarios involving company IPO registration — addressing concerns about patent assertion timed to coincide with public listing processes.
Patent litigation teams with active or contemplated Chinese infringement matters should treat the finalisation of Interpretation (III) as imminent and review pending case strategy against the draft provisions now, particularly the expanded estoppel doctrine in Articles 10–12 and the malicious litigation provisions in Article 25. Patentees should exercise particular caution regarding statements made during invalidation proceedings, as these may now have broader estoppel consequences than under prior practice.
03
Enforcement & Administration
Mainland China
International Cooperation
Expected May 20, 2026
CNIPA and Rospatent Sign Cooperation MOU — Belt and Road IP Network Continues to Expand
CNIPA Commissioner Shen Changyu met with Rospatent head Yury Zubov in Beijing this week ahead of a planned Memorandum of Understanding on IP cooperation, expected to be formally signed around May 20 and witnessed at head-of-state level. The agreement extends China's growing bilateral IP cooperation network, which already includes 99 overseas IP dispute response guidance platforms across 30 provinces and six industry-specific platforms covering sectors such as automotive and photovoltaics. CNIPA officials have indicated that in 2025 these platforms provided guidance and consulting services more than 4,800 times on issues including cross-border e-commerce IP disputes and overseas trademark squatting, recovering an estimated RMB 2.75 billion in losses for Chinese enterprises. CNIPA Deputy Director Rui Wenbiao has also recently led delegations to Egypt and Seychelles, underscoring the breadth of China's outbound IP diplomacy as Belt and Road cooperation deepens across multiple regions simultaneously.
Mainland China
Copyright Damages
Reported this week
Nintendo Awarded Only RMB 200,000 in Console Piracy Case Despite 500,000+ Infringing Units Sold — A Reminder That Damages Outcomes Still Vary Widely
In a copyright infringement case involving more than 500,000 infringing game consoles sold in China, Nintendo was awarded compensation of only RMB 200,000 — a striking outcome given the scale of the alleged infringement and a useful counterpoint to the headline-grabbing punitive damages awards profiled in recent issues (the CNC machine-tool RMB 380 million case, the NP01154 plant variety RMB 53 million case). The case illustrates that despite the elevated damages environment created by Fa Shi [2026] No. 7 and the broader judicial trend toward higher awards, actual outcomes remain highly dependent on the quality and completeness of damages evidence presented at trial — including proof of unit sales volume, profit margins, and the causal connection between the infringement and the claimed loss.
Rights holders should not assume that the current punitive damages environment guarantees large awards. Evidentiary preparation — particularly documented proof of infringement scale, sales data (including from third-party platforms or distributor records), and a clear damages calculation methodology — remains the decisive factor separating modest awards from landmark ones, even under the more favourable Fa Shi [2026] No. 7 framework.
04
Courts & Key Decisions
Mainland China
SPC · Procedural
Patent
Reported this week
SPC Fines Patentee for Failure to Report Claim Amendment During Invalidation Proceedings to Trial Court — Procedural Discipline Tightens
In a recently reported ruling, the Supreme People's Court imposed a fine on a patentee who failed to report an amendment to patent claims made during concurrent invalidation proceedings to the court hearing the corresponding infringement trial. The case reflects the SPC's increasing emphasis on procedural coordination between parallel administrative (CNIPA invalidation) and judicial (infringement) proceedings — a theme that runs through both the new punitive damages interpretation and the draft Interpretation (III) discussed in Section 02, both of which tighten the relationship between invalidation outcomes and infringement litigation.
The ruling sends a clear signal: parties cannot treat invalidation and infringement proceedings as separate, uncoordinated tracks. Claim amendments made during invalidation can materially affect the scope of protection at issue in a parallel infringement trial, and courts now expect timely, proactive disclosure rather than allowing the trial court to be the last to learn of changes that affect its own proceedings.
The ruling sends a clear signal: parties cannot treat invalidation and infringement proceedings as separate, uncoordinated tracks. Claim amendments made during invalidation can materially affect the scope of protection at issue in a parallel infringement trial, and courts now expect timely, proactive disclosure rather than allowing the trial court to be the last to learn of changes that affect its own proceedings.
Patentees involved in parallel invalidation and infringement proceedings should establish a clear internal protocol requiring immediate notification to litigation counsel — and through them, to the trial court — whenever claims are amended during invalidation. Failure to do so now carries a direct risk of judicial sanction, separate from any substantive consequences the amendment itself may have on the infringement analysis.
05
Industry, Market & Emerging Issues
Mainland China
FIFA World Cup 2026
May 2026 (ongoing)
Chinese Companies Expand Role as FIFA World Cup 2026 Partners and Licensees — IP Enforcement Posture Sustained Through Tournament
As the FIFA World Cup 2026 approaches, CNIPA's public communications have highlighted the growing presence of Chinese companies as official tournament partners, sponsors, and licensees — extending a trend already visible in China's "Village Super League" grassroots football phenomenon, which CNIPA has cited as evidence of organic domestic sports IP development. This commercial expansion runs in parallel with the sustained customs enforcement posture documented in April's typical case release, where special border enforcement actions specifically targeting counterfeit World Cup merchandise — jerseys, emblems, mascot products, and sponsor goods — were confirmed to continue through the tournament period. Brand owners and official licensees should expect continued close coordination between Customs, CNIPA, and event organisers on IP protection through the conclusion of the tournament.
Hong Kong SAR
Patent Practice
May 2026
Hong Kong IP Hub Momentum Continues to Build Following April's Con-Con Festival and Budget Commitments
Following the inaugural Con-Con Hong Kong 2026 IP festival and the financial secretary's renewed IP hub commitments earlier this spring, Hong Kong's IP services sector continues to develop the practical infrastructure needed to support the city's ambitions as a regional IP trading and dispute resolution centre. Practitioners continue to emphasise the importance of getting the fundamentals right — including the short-term and standard patent re-registration mechanisms discussed in recent practitioner guidance — as the foundation for more sophisticated IP financing and arbitration services the city is seeking to build. As Mainland China's IP asset base continues to scale (now exceeding 6.3 million valid invention patents per the May 7 white paper), the addressable market for Hong Kong-based IP financial services grows correspondingly, reinforcing the strategic logic behind the city's continued investment in this space.
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Macau SAR
MacauMay 11–17, 2026
No significant IP policy, legislative, or enforcement announcements were issued by Macao's Economic and Technological Development Bureau (DSEDT) during this reporting period. IP registration and enforcement operations continue normally. For Macau-specific IP enquiries, please contact foridom@foridom.com.
📅 Upcoming Dates & Key Deadlines
May 20
CNIPA–Rospatent IP Cooperation MOU expected to be formally signed in Beijing. China
May 30
NMPA data exclusivity transitional filing deadline for most already-approved or pending-review pharmaceutical products. Missing this date forfeits protection rights. ⚠ Urgent
Jun 1
SAMR Trade Secret Protection Regulations take effect. Two weeks remaining — complete internal audits now. ⚠ Urgent
Jun 5
NMPA data exclusivity deadline for Class 1 chemical drugs approved May 15, 2020 – May 14, 2026. CDE determination due by June 26. China
H2 2026
Trademark Law (Amendment) — second NPC Standing Committee reading expected. China
Pending
SPC Judicial Interpretation (III) on Patent Infringement Disputes — finalisation expected following closed comment period. China
Publication
Greater China IP Watch, Issue No. 06
Reporting period: May 11–17, 2026
Published: Monday, May 18, 2026
Reporting period: May 11–17, 2026
Published: Monday, May 18, 2026
Prepared & Proofread by
Foridom IP Law Firm (百一知识产权)
Proofread by: Wiky Wang — Attorney at Law, Patent Attorney & Trademark Attorney
Proofread by: Wiky Wang — Attorney at Law, Patent Attorney & Trademark Attorney
Contact & Subscriptions
foridom@foridom.com
For subscription, feedback, or IP enquiries
For subscription, feedback, or IP enquiries
Coverage & Sources
Mainland China · Hong Kong SAR · Taiwan · Macau SAR
Primary: CNIPA, SPC, NMPA, SAMR, TIPO, IPD, DSEDT
Primary: CNIPA, SPC, NMPA, SAMR, TIPO, IPD, DSEDT