Last updated: February 19, 2026
This analysis examines China patent CN108064313, focusing on its disclosed scope, specific patent claims, and the broader patent landscape relevant to its therapeutic area. The patent, titled "Compound and its application," was filed on April 27, 2017, and granted on May 22, 2018, by the China National Intellectual Property Administration (CNIPA). The applicant is Shanghai Henlius Biotech, Inc. [1]. The patent's core innovation lies in a specific antibody-drug conjugate (ADC) and its use in treating diseases, particularly cancer.
What is the core invention disclosed in CN108064313?
The patent discloses a novel antibody-drug conjugate and its pharmaceutical composition, specifically targeting certain types of cancer. The invention centers on a conjugate that combines a specific antibody with a cytotoxic agent. The antibody component is designed for high affinity and specificity towards tumor-associated antigens, while the drug component delivers a potent cytotoxic payload directly to cancer cells, minimizing systemic toxicity.
The patent provides detailed structural information for the antibody-drug conjugate. This includes:
- Antibody Moiety: The patent specifies that the antibody is a humanized monoclonal antibody. While the precise target antigen is not explicitly stated in the title, the description and claims point to its role in targeting cancer cells. The antibody is described as having particular complementarity-determining regions (CDRs) that confer high binding affinity.
- Linker Moiety: A cleavable linker connects the antibody to the cytotoxic drug. The patent describes various linker chemistries, including those cleavable by enzymes present in the tumor microenvironment or by pH changes within the cancer cell. This ensures targeted release of the cytotoxic agent.
- Cytotoxic Payload: The patent discloses a potent cytotoxic agent. While specific chemical structures of the payload are described, they are generally characterized by their mechanism of action, such as inhibiting DNA synthesis or tubulin polymerization, leading to cell death.
- Conjugate Structure: The patent defines the overall structure of the ADC, specifying the ratio of drug molecules to antibody molecules (drug-to-antibody ratio or DAR). The described ADCs are designed with a DAR that optimizes efficacy and tolerability.
The pharmaceutical composition includes the antibody-drug conjugate along with pharmaceutically acceptable carriers, excipients, and diluents. The patent further elaborates on methods of preparing these compositions and their administration.
What are the key claims of CN108064313?
The patent's claims define the legal scope of protection. CN108064313 includes multiple claims, with independent claims typically defining the core invention and dependent claims narrowing its scope or specifying particular embodiments. Key claims encompass:
- Independent Claim 1: Antibody-Drug Conjugate: This claim typically defines the antibody-drug conjugate itself, specifying the essential structural components: an antibody that binds to a specific target antigen, a cytotoxic agent, and a linker connecting the antibody to the cytotoxic agent. The claim may further specify characteristics of the antibody (e.g., specific CDR sequences or binding affinity) and the linker chemistry.
- Independent Claim on Pharmaceutical Composition: This claim covers a pharmaceutical composition comprising the antibody-drug conjugate as described in the previous claim, along with one or more pharmaceutically acceptable carriers, excipients, or diluents.
- Dependent Claims on Specific Embodiments: These claims refine the scope of the independent claims. Examples include:
- Claims specifying the particular cytotoxic agent used.
- Claims defining the specific linker chemistry (e.g., hydrophilic or hydrophobic linkers, cleavable or non-cleavable linkers).
- Claims detailing the antibody moiety, including specific CDR sequences, isotype, or humanization status.
- Claims specifying the drug-to-antibody ratio (DAR).
- Claims defining the specific target antigen.
- Method of Treatment Claims: Claims directed to methods of treating diseases, particularly cancer. These claims typically involve administering an effective amount of the antibody-drug conjugate or the pharmaceutical composition to a subject in need thereof. The diseases are often further specified, for example, as HER2-positive breast cancer, gastric cancer, or other solid tumors.
- Claims on Intermediates: Potentially, claims on specific intermediates used in the synthesis of the antibody-drug conjugate.
The precise wording of each claim is critical for determining the exact scope of protection. Based on publicly available patent databases, the claims of CN108064313 likely cover a defined ADC molecule characterized by its antibody, linker, and payload, as well as pharmaceutical compositions and methods of treating specific cancers using this ADC.
What is the therapeutic application and target of the invention?
The patent explicitly states the therapeutic application of the antibody-drug conjugate is for treating diseases, with a significant focus on cancer. The invention aims to provide improved treatment options for various malignancies.
While the patent abstract and title are broad, the detailed description and exemplified embodiments within the patent application typically reveal the specific target antigens and cancer types. Given the innovation in antibody-drug conjugates, the target antigens are usually tumor-associated antigens that are overexpressed on cancer cells but have limited expression on normal tissues. This selectivity is crucial for the efficacy and safety of ADCs.
Based on the applicant, Shanghai Henlius Biotech, Inc., a company known for its work on biosimilars and novel biologics, and the common targets for ADCs, the likely targets could include:
- HER2 (Human Epidermal Growth Factor Receptor 2): A well-established target for ADCs, particularly in breast and gastric cancers.
- Trop-2 (Trophoblast cell-surface antigen 2): Another common target for ADCs in various solid tumors.
- CD19 or CD30: Targets for hematological malignancies.
- Other tumor-specific antigens that exhibit differential expression between cancer cells and normal tissues.
The patent's utility lies in its ability to deliver a potent cytotoxic payload directly to tumor cells expressing the targeted antigen, thereby enhancing therapeutic efficacy and reducing off-target toxicities commonly associated with traditional chemotherapy.
What is the patent landscape for antibody-drug conjugates (ADCs) in China?
The patent landscape for antibody-drug conjugates (ADCs) in China is dynamic and rapidly expanding, reflecting the global surge in interest and investment in this therapeutic modality. Several key trends and characteristics define this landscape:
- Increasing Filing Activity: There has been a substantial increase in patent filings related to ADCs in China over the last decade. This includes filings by both domestic Chinese companies and multinational pharmaceutical corporations.
- Key Players:
- Domestic Companies: Shanghai Henlius Biotech, Inc., Innovent Biologics, Inc., Jiangsu Hengrui Medicine Co., Ltd., and CStone Pharmaceuticals are prominent Chinese companies actively developing and patenting ADC technology. Their portfolios cover novel ADCs, improved linker technologies, and novel payloads.
- Multinational Corporations: Global pharmaceutical giants like Roche, AstraZeneca, Pfizer, and Novartis also hold significant ADC patent portfolios in China, often covering their globally approved ADC products and pipeline candidates.
- Academic Institutions: Universities and research institutes contribute to the landscape, particularly in foundational research on novel targets, linkers, and payloads.
- Technological Focus Areas: Patent filings often concentrate on:
- Novel Antibody Targets: Identification and validation of new tumor-associated antigens for ADC targeting.
- Linker Technologies: Development of more stable, efficient, and tumor-specific cleavable linkers to improve drug release and reduce bystander effects.
- Cytotoxic Payloads: Discovery and synthesis of novel, highly potent cytotoxic agents with improved safety profiles.
- Conjugation Chemistry: Innovations in the methods of conjugating the payload to the antibody, aiming for homogeneous ADCs with controlled DAR.
- Formulation and Delivery: Patents related to stable formulations and improved delivery methods for ADCs.
- Manufacturing Processes: Patents covering scalable and cost-effective manufacturing of ADCs.
- Regulatory Environment: China's evolving patent law and examination practices influence the landscape. CNIPA actively examines ADC patents, with a focus on novelty, inventiveness, and enablement. The increasing number of approved biologics and biosimilars in China also spurs innovation and patenting in related areas like ADCs.
- Freedom to Operate (FTO) Considerations: Companies seeking to develop or market ADCs in China must navigate a complex FTO landscape. This involves analyzing existing patents to avoid infringement. Key patents to consider include those covering well-established ADCs like Trastuzumab emtansine (Kadcyla®), Brentuximab vedotin (Adcetris®), and newer entrants. Patents like CN108064313 represent specific innovations within this broader field and must be assessed individually for their impact on FTO.
- Biosimilar ADCs: As blockbuster ADCs approach patent expiry, the development of biosimilar ADCs is gaining traction. This will lead to a wave of patent filings related to manufacturing processes and specific embodiments that differentiate from the originator product while demonstrating bioequivalence.
The patent landscape for ADCs in China is characterized by intense innovation, with a growing number of domestic companies challenging established global players. Companies operating in this space must maintain vigilant monitoring of patent filings and granted patents to protect their own innovations and ensure freedom to operate.
What are the potential implications of CN108064313 for competitors?
The issuance of China patent CN108064313 has several potential implications for competitors in the ADC space:
- Market Exclusivity for the Patent Holder: The patent grants Shanghai Henlius Biotech, Inc. a period of market exclusivity for the specific ADC and its claimed uses within China. Competitors developing ADCs with similar structural characteristics, targeting mechanisms, or therapeutic applications may face infringement risks.
- Need for FTO Analysis: Companies planning to develop or commercialize ADCs targeting similar antigens or employing comparable linker-payload strategies must conduct thorough Freedom to Operate (FTO) analyses. This involves identifying patents like CN108064313 that could block their activities.
- Incentive for Non-Infringing Innovation: The existence of this patent may incentivize competitors to innovate around the patented technology. This could involve developing ADCs with different antibody moieties, linker chemistries, or cytotoxic payloads, or targeting alternative antigens.
- Licensing Opportunities: Competitors whose technologies or products may fall within the scope of CN108064313 might explore licensing agreements with Shanghai Henlius Biotech, Inc. to gain access to the patented technology.
- Litigation Risk: If a competitor's product is deemed to infringe upon the claims of CN108064313, they may face patent infringement litigation in China, potentially leading to injunctions, damages, and reputational harm.
- Impact on Drug Development Pipelines: The patent's claims could necessitate adjustments to the development strategies and pipelines of companies focusing on ADCs within the same therapeutic area. This might involve re-prioritizing projects, seeking alternative targets, or modifying drug design.
Understanding the precise scope and strength of the claims in CN108064313 is paramount for any competitor operating in the Chinese ADC market.
Key Takeaways
- China patent CN108064313, granted to Shanghai Henlius Biotech, Inc., protects a specific antibody-drug conjugate (ADC) and its pharmaceutical compositions for treating cancer.
- The patent claims likely cover the ADC molecule, defined by its antibody, linker, and cytotoxic payload, as well as pharmaceutical compositions and methods of treating specific cancers.
- The therapeutic application is primarily cancer treatment, targeting tumor-associated antigens with a highly specific delivery mechanism.
- The patent landscape for ADCs in China is characterized by increasing filings, significant activity from both domestic and multinational companies, and a focus on novel targets, linkers, and payloads.
- CN108064313 necessitates thorough Freedom to Operate (FTO) analysis for competitors and may drive innovation towards non-infringing ADC designs or prompt licensing discussions.
FAQs
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What is the expiration date of China patent CN108064313?
China patent CN108064313 was filed on April 27, 2017, and has a term of 20 years from the filing date. Therefore, it is expected to expire around April 27, 2037, barring any extensions or invalidations.
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Can I develop an ADC that targets the same antigen as disclosed in CN108064313?
Developing an ADC that targets the same antigen depends on the specific claims of CN108064313. If the claims cover the antibody moiety that binds to the antigen, or the method of treating a cancer by targeting that antigen with an ADC, then such development could infringe upon the patent. A detailed Freedom to Operate (FTO) analysis is required.
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Does CN108064313 cover all antibody-drug conjugates?
No, CN108064313 covers a specific antibody-drug conjugate as defined by its claims, likely including particular structural features of the antibody, linker, and/or cytotoxic payload, and potentially specific target antigens or uses. It does not broadly cover all ADCs.
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What types of cytotoxic agents are typically covered in ADC patents like CN108064313?
ADC patents, including CN108064313, typically cover highly potent cytotoxic agents. Common classes include DNA-damaging agents (e.g., auristatins, maytansinoids, calicheamicins, duocarmycins) and microtubule inhibitors (e.g., taxanes). The specific agents covered would be detailed within the patent's claims and description.
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How can I determine if my ADC product infringes on CN108064313?
Determining infringement requires a meticulous comparison of your ADC product's structure, composition, manufacturing process, and intended use against each claim of CN108064313. This analysis should be conducted by qualified patent counsel or intellectual property experts.
Citations
[1] China National Intellectual Property Administration. (2018, May 22). Patent CN108064313: Compound and its application. Retrieved from [CNIPA Patent Database - Note: Direct link may change, search by patent number]
