{"id":3561,"date":"2018-09-07T11:34:48","date_gmt":"2018-09-07T15:34:48","guid":{"rendered":"http:\/\/www.drugpatentwatch.com\/blog\/?p=3561"},"modified":"2026-10-19T22:04:39","modified_gmt":"2026-10-20T02:04:39","slug":"diffusion-convergence-and-influence-of-pharmaceutical-innovations-a-comparative-study-of-chinese-and-u-s-patents","status":"publish","type":"post","link":"https:\/\/www.drugpatentwatch.com\/blog\/diffusion-convergence-and-influence-of-pharmaceutical-innovations-a-comparative-study-of-chinese-and-u-s-patents\/","title":{"rendered":"U.S. vs. China Pharma Patents: The Strategy Gap, Mapped"},"content":{"rendered":"\n
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In 2025, PharmCube counted 157 China out-licensing deals worth a disclosed USD 135.7 billion, up from 94 deals worth USD 51.9 billion in 2024. Only USD 7.0 billion of the 2025 total was upfront cash. [7]<\/p>\n\n\n\n

That gap between headline value and cash is the first reason to treat the two patent systems as separate valuation problems. The second reason is legal. China built its generic-entry linkage rules in 2021. The mechanics look like the U.S. rules on a slide and differ in almost every number that matters: stay length, extension formula, exclusivity period, and challenge route.<\/p>\n\n\n\n

This guide compares the two systems using primary and law-firm sources, then adds calculations that no single source reports. It is written for IP teams, licensing teams, and portfolio analysts who must price a patent in both countries.<\/p>\n\n\n\n

The Short Answer<\/strong><\/h2>\n\n\n\n

What are the biggest differences between U.S. and China drug patent systems?<\/strong><\/h3>\n\n\n\n

The biggest differences are stay length, patent listing scope, exclusivity for biologics, and the way term extension is calculated. China stays generic approval for 9 months after a linkage suit is docketed. [1] The U.S. stays approval for 30 months after a timely suit. [2] That is a 3.3-fold difference (analysis: 30 \/ 9).<\/p>\n\n\n\n

    \n
  • China lists only a narrow set of patent types on its linkage platform. [4]<\/li>\n\n\n\n
  • China gives biologic originators 6 years of data protection. The U.S. gives 12 years of reference product exclusivity. [6]<\/li>\n\n\n\n
  • China’s nine-month stay applies to chemical generics only, not to biosimilars. [6]<\/li>\n\n\n\n
  • China caps patent term extension at 5 years and 14 years of post-approval life. The U.S. uses the same two caps but a different formula. [4][10]<\/li>\n<\/ul>\n\n\n\n

    The Seven Findings That Matter<\/strong><\/h2>\n\n\n\n

    Each finding below can be read alone. Reported facts carry a citation. Calculated figures are labeled as analysis.<\/p>\n\n\n\n

      \n
    1. China’s drug patent linkage system took effect on June 1, 2021, and it stays generic approval for 9 months. [1]<\/li>\n\n\n\n
    2. As of April 9, 2026, China’s platform listed 2,236 drugs: 1,390 chemical drugs, 401 biological products and 445 traditional Chinese medicines. Chemical drugs are 62.2% of the list (analysis). [3]<\/li>\n\n\n\n
    3. About 49% of China’s administrative patent adjudications to April 2026 ended in voluntary withdrawal by the patentee or marketing authorization holder. [3]<\/li>\n\n\n\n
    4. Under the formula reported for China’s term extension and its two caps, a patent gains the full 5 years only if 11 or more years pass between filing and approval (analysis). [4][5]<\/li>\n\n\n\n
    5. Since May 15, 2026, China gives an innovative chemical drug 6 years of data protection, flat. [6]<\/li>\n\n\n\n
    6. In 2025, upfront cash was 5.2% of the disclosed value of China out-licensing deals (analysis: 7.0 \/ 135.7). [7]<\/li>\n\n\n\n
    7. The U.S. Office of Management and Budget must publish its first list of biotechnology companies of concern by December 18, 2026, about two months from the date of this article. [8]<\/li>\n<\/ol>\n\n\n\n

      Methodology: What This Analysis Covers<\/strong><\/h2>\n\n\n\n

      Which sources and time period does this guide use?<\/strong><\/h3>\n\n\n\n

      The guide covers rules and data in force or reported through October 19, 2026. Legal mechanics come from law-firm analyses, FDA and USPTO pages, and the U.S. Code. Market data comes from PharmCube, company announcements, and trade press. I did not use any figure that I could not trace to a named source.<\/p>\n\n\n\n

      DrugPatentWatch organizes U.S. Orange Book patent and exclusivity records and Paragraph IV litigation records. Those records are the U.S. half of any comparison like this one. The China half sits in NMPA and CNIPA systems, and CNIPA’s full dataset is in Chinese only. [15] DrugPatentWatch is context here. It is not a source for any claim in this article.<\/p>\n\n\n\n

      What are the limits of this comparison?<\/strong><\/h3>\n\n\n\n

      Four limits apply. First, several China sources describe rules at the draft stage or are dated 2020 to 2023. Check current CNIPA and NMPA text before you rely on a number for a filing decision. Second, I could not verify case outcomes beyond what the cited sources state. Third, the 2025 deal figures include only disclosed values. Fourth, the DIA\/PharmCube counts cover Mainland China innovative drugs and platforms and exclude generics, biosimilars, vaccines and traditional Chinese medicines. [7]<\/p>\n\n\n\n

      How are reported and calculated figures separated?<\/strong><\/h4>\n\n\n\n

      A figure with a citation only is reported. A figure marked “analysis” is my arithmetic on reported inputs. You can repeat each one with the inputs shown in the text.<\/p>\n\n\n\n

      How Does Patent Linkage Work in China vs. the U.S. Orange Book System?<\/strong><\/h2>\n\n\n\n

      China: What are Article 76, the platform, and the nine-month stay?<\/strong><\/h3>\n\n\n\n

      China’s National People’s Congress Standing Committee passed the amended Patent Law on October 17, 2020. The law took effect June 1, 2021. Article 76 lets a patent owner or drug approval holder sue before a generic is approved. [1] Before the amendment, filing a generic application was not an infringing act. A patent owner had to wait for market entry to sue. [1]<\/p>\n\n\n\n

      After an Article 76 action is docketed, the NMPA will not approve the generic for 9 months from the docketing date. The patentee can use a civil court or an administrative adjudication at CNIPA. [1] Hogan Lovells notes that the stay applies to chemical generics and has no equivalent for biological products or Chinese herbal drugs. [4]<\/p>\n\n\n\n

      What patents can a brand list in China?<\/strong><\/h4>\n\n\n\n

      For chemical drugs, the platform accepts active ingredient patents, composition patents that contain the active ingredient, and medical use patents. For biological products, it accepts sequence structure and medical use patents. Intermediates, metabolites, crystal forms, preparation methods and detection methods are generally not eligible. Hogan Lovells adds that some process patents with composition or use claims have been registered. [4]<\/p>\n\n\n\n

      This leads to a simple classification, which is my own and not an established industry term. Tier 1 claims are listable: compound, composition and use. Tier 2 claims are not usually listable: crystal form, process, intermediate and metabolite. A brand that holds only Tier 2 claims in China has no linkage stay to rely on. That is a different position from the U.S. Orange Book, where the question is which patents meet the listing rules for the drug. [4]<\/p>\n\n\n\n

      What are the four declarations a China generic applicant must make?<\/strong><\/h4>\n\n\n\n

      The generic applicant must choose one of four declarations. One: no originator patent is registered. Two: the listed patents are invalid or terminated, or the applicant has a license. Three: the patents exist, but the generic will wait for expiry. Four: the patents are invalid (4.1) or do not cover the generic (4.2). [4]<\/p>\n\n\n\n

      IAM reports that about 75% of patent certifications are Type 1, about 5% are Type 4(2), and about 1% are invalidation requests under Type 4(1). [3] The first declaration in Hogan Lovells’ list is the “no registered patent” declaration. [4] If the type numbering matches that list, then three of every four generic certifications met no listed originator patent at all.<\/p>\n\n\n\n

      What are China’s linkage deadlines?<\/strong><\/h4>\n\n\n\n

      Patentees have 45 days from the CDE’s publication of a Type 4 certification to file. Patents must be listed within 30 days of drug approval. The stay lasts nine months. The marketing authorization holder must tell the NMPA within 10 working days of a final decision or judgment. [3]<\/p>\n\n\n\n

      U.S.: How do Paragraph IV certification and the 30-month stay work?<\/strong><\/h3>\n\n\n\n

      A generic applicant that challenges a listed patent sends a Paragraph IV notice letter. The brand has 45 days to file suit, counted from when both the patent owner and the NDA holder receive the notice. A timely suit stays ANDA approval for 30 months. The stay starts on the later date of receipt. The first ANDA filer to challenge the patents earns 180 days of exclusivity. [2]<\/p>\n\n\n\n

      FDA lists the exclusivity types that interact with this process: 5 years for a new chemical entity, 7 years for orphan drugs, 3 years for new clinical investigations, 6 months for pediatric exclusivity added to existing protection, and 180 days for the patent challenge exclusivity. [9]<\/p>\n\n\n\n

      What is NCE-1 filing in the U.S.?<\/strong><\/h4>\n\n\n\n

      A generic applicant can file an ANDA with a Paragraph IV certification four years after approval of a new chemical entity. If the brand sues within 45 days, the stay is extended so that it runs 7.5 years from the NDA approval date. [11] That rule has no direct China counterpart, because China’s data protection period is a separate, flat 6 years. [6]<\/p>\n\n\n\n

      U.S. vs. China patent linkage: side-by-side comparison<\/strong><\/h3>\n\n\n\n
      Feature<\/th>United States<\/th>China<\/th>Source<\/th><\/tr><\/thead>
      Legal start<\/td>Hatch-Waxman framework<\/td>Patent Law Art. 76, effective June 1, 2021<\/td>[1][2]<\/td><\/tr>
      Pre-approval suit window<\/td>45 days after notice letter<\/td>45 days after CDE publication of Type 4 certification<\/td>[2][3]<\/td><\/tr>
      Automatic stay<\/td>30 months<\/td>9 months (chemical generics)<\/td>[2][1][4]<\/td><\/tr>
      Stay for biologic copies<\/td>Not addressed in this guide’s sources<\/td>None<\/td>[4][6]<\/td><\/tr>
      Challenger reward<\/td>180 days for first filer<\/td>12 months for first successful challenger, per Finnegan and Hogan Lovells<\/td>[2][1][4]<\/td><\/tr>
      Typical listable patents<\/td>Patents the NDA holder submits to FDA’s Orange Book<\/td>Active ingredient, composition, medical use (chemical); sequence, medical use (biologic)<\/td>[4]<\/td><\/tr>
      Forums<\/td>Federal district courts<\/td>Courts or CNIPA administrative adjudication<\/td>[1]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

      What Does China’s Linkage Data Show After Five Years?<\/strong><\/h2>\n\n\n\n

      How many drugs are on China’s patent platform?<\/strong><\/h3>\n\n\n\n

      As of April 9, 2026, the platform listed 2,236 drugs. The split is 1,390 chemical drugs, 401 biological products and 445 traditional Chinese medicines. [3] Those shares are 62.2%, 17.9% and 19.9% (analysis).<\/p>\n\n\n\n

      The traditional Chinese medicine share is worth noting. The nine-month stay does not apply to those products. [4] So about one in five listings sits on a product class where the platform gives no stay (analysis, combining [3] and [4]).<\/p>\n\n\n\n

      What do administrative adjudication outcomes show?<\/strong><\/h3>\n\n\n\n

      IAM reports that, to April 2026, 21% of administrative cases involved generics covered by the patent and 24% involved generics not covered. Withdrawals were 49%. [3] The remaining 6% is not labeled in the source (analysis).<\/p>\n\n\n\n

      The covered-to-not-covered ratio fell from 1.4-fold to 0.8-fold between the May 2024 and April 2026 snapshots. IAM attributes the fall to generic firms reformulating to avoid patents. [3] IAM supports the design-around reading directly. A second reading, that brands now withdraw sooner from weak targets, fits the numbers but the source does not state it (analysis).<\/p>\n\n\n\n

      Chugai v. Wenzhou Haihe: the first Supreme People’s Court linkage decision<\/strong><\/h3>\n\n\n\n

      On August 5, 2022, the Supreme People’s Court decided (2022) Zui Gao Fa Zhi Min Zhong 905. Chugai, the patentee and marketing authorization holder for eldecalcitol soft capsules (0.75 \u03bcg, for osteoporosis), sued the generic applicant Wenzhou Haihe. The Beijing IP Court had dismissed the suit. The Supreme People’s Court upheld that dismissal. [12]<\/p>\n\n\n\n

      The record shows how patent clocks and linkage clocks differ. Chugai’s patent ZL200580009877.6 was filed on February 7, 2005 and granted on December 8, 2010. The drug was approved on December 11, 2020. The patent went on the linkage platform on July 13, 2021. [12]<\/p>\n\n\n\n

      Three derived numbers follow (analysis). A 20-year term from the 2005 filing date ends February 7, 2025, so about 4.2 years of patent life remained at approval. The listing came 214 days after approval. Two generic firms, Sichuan Gowell and Jiangsu Chia Tai-Tianqing, filed invalidation requests against the patent in April and June 2021, before the listing date. [12]<\/p>\n\n\n\n

      What did Chugai v. Haihe not decide?<\/strong><\/h4>\n\n\n\n

      The source excerpt I reviewed does not state the court’s reasoning or the effect on the generic’s approval. I do not state either here. Read the full Bird & Bird note or the judgment before you cite the case for a legal rule. [12]<\/p>\n\n\n\n

      What are the latest Chinese rulings on claim scope?<\/strong><\/h3>\n\n\n\n

      IAM lists several CNIPA administrative decisions with useful holdings. A generic must submit its technical solution even when it files a Type 4(1) declaration with an invalidation request (2025 GUO ZHI YAO CAI 0041). Infringement requires literal infringement, so omitting one claimed feature means no infringement even if the generic performs worse (2024 GUO ZHI YAO CAI 0018). For use patents, the generic’s indications come mainly from its package insert (2024 GUO ZHI YAO CAI 0008). [3]<\/p>\n\n\n\n

      The literal-infringement holding matters most for valuation. A brand cannot assume a doctrine of equivalents will rescue a narrow claim in a CNIPA proceeding. [3]<\/p>\n\n\n\n

      Patent Term Extension: China vs. U.S.<\/strong><\/h2>\n\n\n\n

      How does U.S. patent term extension work under 35 U.S.C. \u00a7 156?<\/strong><\/h3>\n\n\n\n

      The U.S. extension may not exceed 5 years. The total post-approval term may not exceed 14 years. The extension counts one-half of the testing phase and the full approval phase. The application is due within 60 days of marketing permission. [10] USPTO publishes a list of extended patents and updated it through September 8, 2026. [18]<\/p>\n\n\n\n

      How does China’s patent term extension work under Article 42.3?<\/strong><\/h3>\n\n\n\n

      Article 42.3 of the amended Patent Law lets CNIPA extend the term of an invention patent covering a new drug approved in China. [5] The extension can be up to 5 years if the effective term after approval is less than 14 years. [4] The draft rules put the filing deadline at 3 months after approval. They allow only one patent per drug and one drug per patent. [5]<\/p>\n\n\n\n

      The drug must be a new drug, defined as an active ingredient first approved by the NMPA. Medical use patents must be in Swiss-type claim form. [5] Hogan Lovells adds that eligible drugs are limited to Class 1 and certain Class 2 categories. [4] The extension covers the approved new drug and the approved indication only, per the draft. [5]<\/p>\n\n\n\n

      How much extension does a China patent get? (original calculation)<\/strong><\/h3>\n\n\n\n

      The draft formula is: extension = (China approval date minus patent filing date) minus 5 years, capped at 5 years, with total post-approval life capped at 14 years. [5][4] Let E be the years from filing to China approval. The 14-year cap limits the extension to E minus 6. So the extension is the smaller of 5 and E minus 6 (analysis).<\/p>\n\n\n\n

      Years from filing to China approval (E)<\/th>Remaining base term at approval<\/th>Extension (analysis)<\/th>Post-approval protection (analysis)<\/th><\/tr><\/thead>
      6 or less<\/td>14 years or more<\/td>0 years<\/td>14 years or more<\/td><\/tr>
      8<\/td>12 years<\/td>2 years<\/td>14 years<\/td><\/tr>
      9<\/td>11 years<\/td>3 years<\/td>14 years<\/td><\/tr>
      10<\/td>10 years<\/td>4 years<\/td>14 years<\/td><\/tr>
      11<\/td>9 years<\/td>5 years<\/td>14 years<\/td><\/tr>
      12<\/td>8 years<\/td>5 years<\/td>13 years<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

      Table basis: a 20-year base term from filing, no patent term adjustment, and the draft formula. Sources [4][5] describe the rules at the draft stage. Check the final CNIPA implementing text before you use the table.<\/p>\n\n\n\n

      Why does the 14-year cap bind first?<\/strong><\/h4>\n\n\n\n

      The draft formula subtracts 5 years from elapsed time. The cap subtracts 6 years, because it fixes post-approval life at 14 years from a 20-year term. The cap is always the tighter limit until the extension reaches 5 years at E = 11 (analysis). A sponsor with a patent filed early and approved late gets the full 5 years. A sponsor with a faster approval gets less than the nominal 5 years.<\/p>\n\n\n\n

      What is the practical difference between the two formulas?<\/strong><\/h3>\n\n\n\n

      The U.S. formula depends on regulatory time: half of the testing phase plus the approval phase. [10] The China draft formula depends on elapsed time since filing. [5] A U.S. sponsor with a long clinical program gets more credit in the U.S. than a sponsor with a short one. A China sponsor gets credit for any delay between filing and approval, whatever the cause (analysis).<\/p>\n\n\n\n

      Regulatory Exclusivity: China Now Has a Data Protection Stack<\/strong><\/h2>\n\n\n\n

      What changed on May 15, 2026?<\/strong><\/h3>\n\n\n\n

      The revised Implementing Regulations of the Drug Administration Law took effect on May 15, 2026. The NMPA’s Implementing Measures for Drug Trial Data Protection took effect the same day. [6] Greenberg Traurig lists these chemical drug terms: 6 years for an innovative drug not marketed anywhere, 4 years for an improved new drug, 3 years for a domestic generic of an ex-China originator not yet marketed in China, and no protection for a generic of a drug already marketed in China. [6]<\/p>\n\n\n\n

      For vaccines and therapeutic biologics, the terms are 6 years for an innovative product and 4 years for an improved product. Biosimilars and other biologics already marketed in China get none. [6]<\/p>\n\n\n\n

      Data exclusivity: United States vs. European Union vs. China<\/strong><\/h3>\n\n\n\n
      Layer<\/th>United States<\/th>European Union<\/th>China (from May 2026)<\/th><\/tr><\/thead>
      New active substance data protection<\/td>5 years<\/td>8 years plus 2 years market protection, possibly 1 more<\/td>6 years<\/td><\/tr>
      Rare disease<\/td>7 years<\/td>10 years<\/td>Up to 7 years, conditioned on supply<\/td><\/tr>
      Pediatric<\/td>6 months added to existing protection<\/td>6-month SPC extension<\/td>Up to 2 years, standalone<\/td><\/tr>
      Biologics<\/td>12 years<\/td>Same framework as small molecules<\/td>6 years; no linkage stay for biosimilars<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

      Source for all table cells: Greenberg Traurig. [6] The EU column reflects the framework as it stands now. Greenberg Traurig notes the 2026 EU reform restructures it, with most provisions expected from around 2028. [6]<\/p>\n\n\n\n

      What does the new regime mean for biologic originators?<\/strong><\/h3>\n\n\n\n

      A biologic originator in China gets half the data protection of a U.S. reference product (analysis: 6 years versus 12 years). [6] Greenberg Traurig notes that for biologics the 6-year term is the only approval-blocking layer, since the nine-month stay applies only to chemical generics. [6] A China biologic portfolio therefore depends more on patent validity and on commercial lead time than a U.S. one does (analysis).<\/p>\n\n\n\n

      What is still undefined in China’s pediatric and rare disease exclusivity?<\/strong><\/h4>\n\n\n\n

      The implementing measures for market exclusivity are pending. The source sets only maximum periods, leaves qualifying criteria undefined, and does not say whether assets approved between May 15, 2026 and the issue of those measures can claim exclusivity. [6] Do not model these two layers as certain revenue.<\/p>\n\n\n\n

      Validity Risk: What the Gilead Sofosbuvir Case Shows About China<\/strong><\/h2>\n\n\n\n

      What happened to Gilead’s sofosbuvir patent in China?<\/strong><\/h3>\n\n\n\n

      In August 2018, the Initiative for Medicines, Access and Knowledge (I-MAK) challenged Gilead’s sofosbuvir base compound patent before China’s patent office. Gilead withdrew its key claims on the base compound. Four of 16 claims remained, and they cover sofosbuvir’s metabolites. [13]<\/p>\n\n\n\n

      The same release states that the patent office rejected Gilead’s sofosbuvir prodrug patent in June 2015. It also states that a similar base-patent challenge by Idenix in China was unsuccessful. [13] The base compound patent was granted in China in 2009 and was set to expire in 2024. [13]<\/p>\n\n\n\n

      The claim arithmetic is simple (analysis). Gilead withdrew 12 of 16 claims, or 75%. A challenger does not need to win a full invalidation to change a patent’s value. A forced claim withdrawal does the same work.<\/p>\n\n\n\n

      What does a claim withdrawal do to patent value?<\/strong><\/h4>\n\n\n\n

      It narrows what a brand can assert. The remaining 4 claims in the Gilead case cover metabolites. I-MAK argues those claims should not block generic competitors. [13] Treat that as the challenger’s position, not as a court ruling.<\/p>\n\n\n\n

      Who can attack a Chinese pharma patent, and where?<\/strong><\/h3>\n\n\n\n

      Third parties can ask CNIPA to invalidate a granted term extension. A decision can be appealed to court. [5] Generic firms can also file invalidation requests against a patent, as Sichuan Gowell and Jiangsu Chia Tai-Tianqing did against Chugai’s patent. [12] Under the linkage system, a Type 4(1) declaration pairs with an invalidation request. [3]<\/p>\n\n\n\n

      Enforcement and Damages: What Changed in 2021?<\/strong><\/h2>\n\n\n\n

      How large can damages be in a China patent case?<\/strong><\/h3>\n\n\n\n

      The 2020 amendment raised the statutory damages cap from 1 million yuan to 5 million yuan. Courts may increase damages for intentional infringement by more than one time and less than five times the amount determined. [14] The cap rose five-fold (analysis: 5 \/ 1).<\/p>\n\n\n\n

      The source states both numbers and does not describe how courts apply them. [14] I did not find a source in this research that gives average awards in pharma cases. I do not give one.<\/p>\n\n\n\n

      Valuation: How Do You Price a Patent Asset Across Both Systems?<\/strong><\/h2>\n\n\n\n

      What did China out-licensing look like in 2025?<\/strong><\/h3>\n\n\n\n
      \n

      In 2025, China’s out-licensing deals totaled 157, with a disclosed value of USD 135.7 billion and USD 7.0 billion in upfront payments, versus 94 deals and USD 51.9 billion in 2024. (PharmCube, via DIA Global Forum, March 2026) [7]<\/p>\n<\/blockquote>\n\n\n\n

      Metric<\/th>2024<\/th>2025<\/th>Change (analysis)<\/th><\/tr><\/thead>
      Deals<\/td>94<\/td>157<\/td>+67.0%<\/td><\/tr>
      Disclosed value<\/td>USD 51.9B<\/td>USD 135.7B<\/td>+161.5%<\/td><\/tr>
      Average disclosed value per deal<\/td>USD 552M<\/td>USD 864M<\/td>+56.6%<\/td><\/tr>
      Upfront payments<\/td>Not reported in source<\/td>USD 7.0B<\/td>5.2% of 2025 value<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

      Source for 2024 and 2025 inputs: DIA Global Forum. [7] The derived columns are my arithmetic. Disclosed values rely on public data only, and the count excludes generics, biosimilars and vaccines. [7]<\/p>\n\n\n\n

      Why is the upfront share low?<\/strong><\/h4>\n\n\n\n

      Milestones carry most of the headline. A milestone is paid only if a drug reaches a trial, approval or sales target. The 5.2% figure means a buyer shows USD 19 of contingent value for each USD 1 of upfront cash (analysis: 135.7 \/ 7.0 is about 19.4 total value per upfront dollar). Treat headline value as a ceiling, not an expected value.<\/p>\n\n\n\n

      Case study: Summit Therapeutics and Akeso (ivonescimab)<\/strong><\/h3>\n\n\n\n

      On December 6, 2022, Summit announced a license to ivonescimab, a PD-1\/VEGF bispecific antibody, from Akeso. Summit paid USD 500 million upfront. Akeso can earn up to USD 4.5 billion in milestones and low double-digit royalties on net sales. [17]<\/p>\n\n\n\n

      The territory split is the strategy point. Summit holds the U.S., Canada, Europe and Japan. Akeso keeps China and all other regions. [17] The patent position in each territory therefore belongs to a different company. A U.S. validity ruling does not bind China, and a China ruling does not bind the U.S.<\/p>\n\n\n\n

      Case study: Pfizer and 3SBio (SSGJ-707)<\/strong><\/h3>\n\n\n\n

      On May 19, 2025, Pfizer announced a deal for SSGJ-707, a PD-1xVEGF bispecific from 3SBio. Pfizer got ex-China rights. It paid USD 1.25 billion upfront and committed up to USD 4.8 billion in milestones. Pfizer also invested USD 100 million in 3SBio and agreed to tiered double-digit royalties if the drug is approved. [16]<\/p>\n\n\n\n

      Upfront share in the two named deals (original comparison)<\/strong><\/h3>\n\n\n\n
      Deal<\/th>Upfront<\/th>Total potential (excl. equity)<\/th>Upfront share (analysis)<\/th>Rights<\/th>Source<\/th><\/tr><\/thead>
      Summit \/ Akeso, Dec. 2022<\/td>USD 500M<\/td>USD 5.0B<\/td>10.0%<\/td>U.S., Canada, Europe, Japan<\/td>[17]<\/td><\/tr>
      Pfizer \/ 3SBio, May 2025<\/td>USD 1.25B<\/td>USD 6.05B (1.25 + 4.8)<\/td>20.7%<\/td>Ex-China<\/td>[16]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

      Both deals sit above the 5.2% market-wide upfront share (analysis, comparing [16], [17] and [7]). Two deals do not make a trend. They show that named late-stage assets can command larger upfront shares than the market-wide average.<\/p>\n\n\n\n

      Scenario analysis: what if the licensee’s territory has a weaker patent?<\/strong><\/h3>\n\n\n\n

      This scenario uses stated assumptions, not data. Assume a license splits rights as in the Summit and Akeso deal: the licensee holds ex-China rights, and the licensor keeps China. Assume the core composition patent is narrowed in China, as happened with Gilead’s sofosbuvir base claims. [13] The licensee’s ex-China rights are unchanged, because a China decision does not change a U.S. or EU patent. The licensor’s China value falls.<\/p>\n\n\n\n

      The reverse case matters for the licensee. If a U.S. court or the USPTO invalidates a core claim, the licensor can still hold China exclusivity, and the licensee has no China rights to offset the loss. Price each territory with its own validity risk, and check whether the deal terms tie milestones to territory-specific patent outcomes (analysis).<\/p>\n\n\n\n

      Filing Trends: What Did CNIPA Report for 2025?<\/strong><\/h2>\n\n\n\n

      How many invention patents did China grant in 2025?<\/strong><\/h3>\n\n\n\n

      CNIPA granted 971,930 invention patents in 2025. That is 72,847 fewer than the 1,044,777 granted in 2024, a fall the source reports as 7.00%. Total patent grants were 3,099,544, down 16.18% from 3,697,752. [15] Invention patents were 31.4% of 2025 grants (analysis: 971,930 \/ 3,099,544). My own division of 72,847 by 1,044,777 gives 6.97%, so I round to about 7%.<\/p>\n\n\n\n

      The source offers a possible link between the fall and a crackdown on irregular applications, which it says made up roughly 10% of 2025 filings. It gives no official reason and no pharma breakdown. [15] Do not read the aggregate as a pharma trend.<\/p>\n\n\n\n

      Policy Risk: What Does the BIOSECURE Act Do?<\/strong><\/h2>\n\n\n\n

      When did BIOSECURE become law, and whom does it cover?<\/strong><\/h3>\n\n\n\n

      President Trump signed the BIOSECURE Act on December 18, 2025, as section 851 of the National Defense Authorization Act for Fiscal Year 2026. The Act does not name companies. An entity becomes a biotechnology company of concern if it is on the Defense Department’s 1260H list and is involved in biotechnology equipment or services, or if the OMB Director designates it. [8]<\/p>\n\n\n\n

      Ropes & Gray states that the current 1260H list includes BGI Group, BGI Genomics, Forensic Genomics International and MGI Tech. WuXi AppTec, WuXi Biologics and Complete Genomics are not on that list. [8]<\/p>\n\n\n\n

      What happens next?<\/strong><\/h3>\n\n\n\n

      OMB must publish the company list no later than one year after December 18, 2025. [8] From today, October 19, 2026, that is 60 days (analysis). Effective dates run 60 days after the Federal Acquisition Regulation is revised for 1260H companies and 90 days after for OMB-designated or affiliated companies. Contracts entered before a company’s effective date get a five-year grandfathering period that starts once the regulation is amended. [8]<\/p>\n\n\n\n

      For patent strategy, the point is licensing and manufacturing partner selection. A China-originated asset licensed to a U.S. or EU buyer can sit in a supply chain that touches a designated company. That is a contract term, not a patent term. Add it to diligence next to freedom to operate (analysis).<\/p>\n\n\n\n

      What This Means for Each Party<\/strong><\/h2>\n\n\n\n

      What this means for brand manufacturers<\/strong><\/h3>\n\n\n\n

      File claims in the Tier 1 classes (compound, composition, use) if you want a China linkage stay. Add crystal form and process claims for commercial coverage, but do not count on them for the stay. [4] Plan for a 9-month stay, not a 30-month one. [1][2] For biologics, plan on 6 years of data protection and no linkage stay against biosimilars. [6]<\/p>\n\n\n\n

      What this means for generic and biosimilar developers<\/strong><\/h3>\n\n\n\n

      Check the platform for listed patents before you choose a declaration. If Type 1 is the no-listed-patent declaration, about three in four certifications faced no listed patent. [3][4] If a listed patent exists, a Type 4 declaration starts a 45-day clock for the patentee. [3] CNIPA’s literal-infringement approach helps a design-around strategy. [3] A first successful challenger can earn 12 months of exclusivity. [1][4]<\/p>\n\n\n\n

      What this means for licensors and licensees<\/strong><\/h3>\n\n\n\n

      Price headline value and upfront cash separately. The 2025 market ratio was 5.2%. [7] Split diligence by territory. A narrowed China claim and a narrowed U.S. claim are two independent events (analysis). Read BIOSECURE exposure into partner and manufacturing clauses. [8]<\/p>\n\n\n\n

      Key Takeaways<\/strong><\/h2>\n\n\n\n
        \n
      • China’s nine-month linkage stay, effective June 1, 2021, is 3.3 times shorter than the U.S. 30-month stay. [1][2]<\/li>\n\n\n\n
      • China’s platform lists 2,236 drugs, and 49% of administrative adjudications to April 2026 ended in withdrawal. [3]<\/li>\n\n\n\n
      • China’s patent term extension, under the reported formula and caps, gives 2 to 5 years for patents with 8 to 11 or more years between filing and approval. [4][5]<\/li>\n\n\n\n
      • China’s data protection began on May 15, 2026: 6 years for innovative drugs and for biologics, against 12 years for U.S. biologics. [6]<\/li>\n\n\n\n
      • China out-licensing in 2025: 157 deals, USD 135.7 billion disclosed, 5.2% upfront. [7]<\/li>\n\n\n\n
      • OMB must publish its BIOSECURE list by December 18, 2026. [8]<\/li>\n<\/ul>\n\n\n\n

        FAQ<\/strong><\/h2>\n\n\n\n

        Does China have an Orange Book?<\/strong><\/h3>\n\n\n\n

        China has a patent information registration platform for marketed drugs, which plays a similar role to the U.S. Orange Book. [4] The platform listed 2,236 drugs as of April 9, 2026. [3]<\/p>\n\n\n\n

        How long is the generic approval stay in China?<\/strong><\/h3>\n\n\n\n

        The stay is 9 months from the docketing of an Article 76 action. [1] It applies to chemical generics only. [4]<\/p>\n\n\n\n

        Can a China patent be extended like a U.S. patent?<\/strong><\/h3>\n\n\n\n

        Yes, for a new drug approved in China. The extension is up to 5 years, and the total post-approval term cannot exceed 14 years. [4][5]<\/p>\n\n\n\n

        Does China have data exclusivity for biologics?<\/strong><\/h3>\n\n\n\n

        Yes. Since May 15, 2026, an innovative biologic gets 6 years of data protection. [6] A U.S. reference product gets 12 years. [6]<\/p>\n\n\n\n

        What is the first-to-file reward in China?<\/strong><\/h3>\n\n\n\n

        Finnegan and Hogan Lovells report 12 months of exclusivity for the first successful challenger whose generic is approved. [1][4] The U.S. reward is 180 days for the first filer. [2]<\/p>\n\n\n\n

        What is the first Supreme People’s Court linkage ruling?<\/strong><\/h3>\n\n\n\n

        It is Chugai v. Wenzhou Haihe, decided August 5, 2022, which upheld dismissal of Chugai’s suit over an eldecalcitol patent. [12]<\/p>\n\n\n\n

        How large can punitive damages be in China?<\/strong><\/h3>\n\n\n\n

        For intentional infringement, courts may raise damages by more than one time and less than five times. The statutory damages cap is 5 million yuan. [14]<\/p>\n\n\n\n

        Does the BIOSECURE Act name WuXi?<\/strong><\/h3>\n\n\n\n

        No. The Act names no company. The 1260H list, as of the Ropes & Gray analysis, does not include WuXi AppTec or WuXi Biologics. [8]<\/p>\n\n\n\n

        How do I find the U.S. side of this data?<\/strong><\/h3>\n\n\n\n

        Use the FDA Orange Book and the USPTO extension list for official records. [9][18] DrugPatentWatch organizes Orange Book patent and exclusivity data and Paragraph IV litigation records for the same purpose.<\/p>\n\n\n\n

        Why do upfront payments matter more than headline deal value?<\/strong><\/h3>\n\n\n\n

        Upfront cash is certain, and milestones are not. In 2025, upfront payments were 5.2% of the disclosed value of China out-licensing deals (analysis). [7]<\/p>\n\n\n\n

        References<\/strong><\/h2>\n\n\n\n
          \n
        1. Finnegan. (2021, May 4). Comparative overview of drug patent linkage systems in China and the United States<\/em>. https:\/\/www.finnegan.com\/en\/insights\/articles\/comparative-overview-of-drug-patent-linkage-systems-in-china-and-the-united-states.html<\/li>\n\n\n\n
        2. DLA Piper. (2020, June 29). Hatch-Waxman litigation 101<\/em>. https:\/\/www.dlapiper.com\/en-ma\/insights\/publications\/2020\/06\/ipt-news-q2-2020\/hatch-waxman-litigation-101<\/li>\n\n\n\n
        3. IAM. (2026). Analysing key trends in China’s patent linkage system and their impact on pharmaceutical patent strategies<\/em>. Global Life Sciences 2026. https:\/\/www.iam-media.com\/guide\/global-life-sciences\/2026\/article\/analysing-key-trends-in-chinas-patent-linkage-system-and-their-impact-pharmaceutical-patent-strategies<\/li>\n\n\n\n
        4. Hogan Lovells. (2023, July 27). What China’s new patent linkage and PTE systems mean for foreign pharma<\/em>. https:\/\/www.hlc.com\/en\/publications\/what-chinas-new-patent-linkage-and-pte-systems-mean-for-foreign-pharma<\/li>\n\n\n\n
        5. Mondaq. (n.d.). Patent term extension in China<\/em> (discussing November 2020 draft rules). https:\/\/www.mondaq.com\/china\/patent\/1045602\/patent-term-extension-in-china<\/li>\n\n\n\n
        6. Greenberg Traurig. (2026, August). China on the move: China reprices clinical data, part one: A new exclusivity architecture takes effect<\/em>. https:\/\/www.gtlaw.com\/de\/insights\/2026\/8\/china-on-the-move-china-reprices-clinical-data-part-one-a-new-exclusivity-architecture-takes-effect<\/li>\n\n\n\n
        7. PharmCube (Valencia S., J.). (2026, March). China’s out-licensing deals bear fruit in 2025. DIA Global Forum<\/em>. https:\/\/globalforum.diaglobal.org\/issue\/march-2026\/chinas-out-licensing-deals-bear-fruit-in-2025\/<\/li>\n\n\n\n
        8. Ropes & Gray. (2026, January 15). BIOSECURE Act enacted<\/em>. https:\/\/www.ropesgray.com\/en\/insights\/alerts\/2026\/01\/biosecure-act-enacted<\/li>\n\n\n\n
        9. U.S. Food and Drug Administration. (n.d.). Frequently asked questions on patents and exclusivity<\/em>. https:\/\/www.fda.gov\/drugs\/development-approval-process-drugs\/frequently-asked-questions-patents-and-exclusivity<\/li>\n\n\n\n
        10. 35 U.S.C. \u00a7 156. Extension of patent term<\/em>. Legal Information Institute, Cornell Law School. https:\/\/law.cornell.edu\/uscode\/text\/35\/156<\/li>\n\n\n\n
        11. 21 U.S.C. \u00a7 355. New drugs<\/em> (subsections (j)(5)(B)(iii) and (j)(5)(F)). Legal Information Institute, Cornell Law School. https:\/\/www.law.cornell.edu\/uscode\/text\/21\/355<\/li>\n\n\n\n
        12. Bird & Bird. (2022). China’s first Supreme Court patent linkage decision<\/em>. https:\/\/www.twobirds.com\/en\/insights\/2022\/china\/patent-linkage-decision-the-first-supreme-court-judgment-from-china<\/li>\n\n\n\n
        13. Initiative for Medicines, Access & Knowledge. (2018, August 9). China patent challenge compels Gilead to withdraw key patent claims on sofosbuvir base compound<\/em>. https:\/\/www.i-mak.org\/2018\/08\/09\/china-patent-challenge-compels-gilead-withdraw-key-patent-claims-sofosbuvir-base-compound-opening-life-saving-hepatitis-c-treatment-access-millions\/<\/li>\n\n\n\n
        14. IPWatchdog. (2020, November 3). China legislature approves increases in statutory patent damages maximum, 5x punitive damages for intentional infringement<\/em>. https:\/\/ipwatchdog.com\/2020\/11\/03\/china-legislature-approves-increases-statutory-patent-damages-maximum-5x-punitive-damages-intentional-infringement\/<\/li>\n\n\n\n
        15. China IP Law Update. (2026, January). CNIPA releases 2025 statistics: Total patent grants down 16% YoY<\/em>. https:\/\/www.chinaiplawupdate.com\/2026\/01\/cnipa-releases-2025-statistics-total-patent-grants-down-16-yoy\/<\/li>\n\n\n\n
        16. Fierce Biotech. (2025, May 20). Pfizer pays 3SBio $1.25B for PD-1xVEGF bispecific, joining red-hot race with BioNTech, Merck<\/em>. https:\/\/www.fiercebiotech.com\/biotech\/pfizer-pays-3sbio-125b-pd-1xvegf-bispecific-joining-biontech-merck-and-summit-red-hot-race<\/li>\n\n\n\n
        17. Summit Therapeutics. (2022, December 6). Summit Therapeutics partners with Akeso Inc. in deal for up to $5 billion to in-license ivonescimab<\/em>. BioSpace. https:\/\/www.biospace.com\/summit-therapeutics-partners-with-akeso-inc-in-deal-for-up-to-5-billion-to-in-license-breakthrough-innovative-bispecific-antibody-500-million-upfront-payment-to-activate-the-partnership-for-ivonescimab<\/li>\n\n\n\n
        18. U.S. Patent and Trademark Office. (2026). Applications for patent term extension and patent terms extended under 35 U.S.C. 156<\/em>. https:\/\/www.uspto.gov\/patents\/laws\/patent-term-extension\/patent-terms-extended-under-35-usc-156<\/li>\n<\/ol>\n\n\n\n

          <\/p>\n","protected":false},"excerpt":{"rendered":"

          In 2025, PharmCube counted 157 China out-licensing deals worth a disclosed USD 135.7 billion, up from 94 deals worth USD […]<\/p>\n","protected":false},"author":1,"featured_media":39969,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_lmt_disableupdate":"","_lmt_disable":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[10],"tags":[],"class_list":["post-3561","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-insights"],"modified_by":"DrugPatentWatch","_links":{"self":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/3561","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/comments?post=3561"}],"version-history":[{"count":0,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/3561\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/media\/39969"}],"wp:attachment":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/media?parent=3561"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/categories?post=3561"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/tags?post=3561"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}