Last updated: August 25, 2025
Introduction
China Patent CN107149591, granted to Innovent Biologics, Inc., pertains to a monoclonal antibody used in cancer treatment, specifically an anti-PD-1 antibody. This patent aligns with China’s strategic focus on immunotherapy innovations, reflecting the country's growing biopharmaceutical expertise. This report offers a comprehensive review of the patent's scope, claims, and its place within the broader patent landscape for anti-PD-1 antibodies in China.
Scope of Patent CN107149591
Patent Overview
CN107149591 covers a monoclonal antibody targeting programmed death-1 (PD-1), a receptor implicated in immune suppression within the tumor microenvironment. It specifically claims the antibody's structure, composition, and therapeutic use. The patent's scope extends to immunotherapy for various cancers, including melanoma, non-small cell lung carcinoma, and other solid tumors.
Scope Features
- Antibody Structure: The patent encompasses the amino acid sequences of the heavy and light chains of the anti-PD-1 antibody, including specific variable regions designed for high affinity binding to PD-1.
- Manufacturing Methods: Claims address methods related to producing the monoclonal antibody, including expression vectors and host cells.
- Therapeutic Application: The patent explicitly protects the antibody's use in treating cancers by modulating immune responses, highlighting its relevance in immuno-oncology.
- Formulation and Composition: Aspects of pharmaceutical formulations, including dosage forms and combinations with other agents, are covered to an extent.
Limitations and Exclusions
While the patent provides broad claims regarding the antibody's structure and use, it does not extend to generic anti-PD-1 antibodies with different sequences or distinct mechanisms. The scope is primarily confined to the specific sequences and formulation claims detailed within the application.
Claims Analysis
Claim Hierarchy and Specificity
The patent contains multiple claims grouped into independent and dependent categories. The core claims focus on:
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A) Amino Acid Sequences:
Claims detail the specific variable region sequences of both the heavy and light chains, designed to bind PD-1 with high affinity. These sequences are critical, as they define the antibody's uniqueness and differ from other anti-PD-1 antibodies such as pembrolizumab and nivolumab.
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B) Antibody Composition:
Claims include the fully assembled antibody, with specified amino acid sequences, glycosylation patterns, and purification methods.
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C) Uses and Methods:
Claims extend to methods of treating cancers by administering the patented antibody, including specific dosage regimens and combination therapies.
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D) Manufacturing and Formulation:
Claims specify processes for producing the antibody, including the expression systems and purification steps.
Key Aspects of Claim Coverage
The patent aims to protect not only the antibody's structure but also its therapeutic application, thus covering a broad field within immuno-oncology. However, the claims are tightly scoped around the specific sequences disclosed, limiting others from manufacturing similar antibodies with different variable regions.
Potential Challenges and Limitations
- Patentability of Sequences: The novelty hinges on the amino acid sequences' uniqueness. If these sequences are similar to existing ones, patent strength could be challenged.
- Scope Breadth: The claims do not extend to all anti-PD-1 antibodies or modifications thereof, which could allow for design-around strategies.
- Evidentiary Support: Patent enforcement may depend on demonstrating the specific use and structural novelty, especially in complex biologics.
Patent Landscape in China for Anti-PD-1 Antibodies
Global Context
Anti-PD-1 monoclonal antibodies revolutionized cancer immunotherapy, with blockbuster drugs like pembrolizumab (Keytruda) and nivolumab (Opdivo) leading the market. China has actively developed its patent infrastructure to foster innovation in this domain, leading to numerous patent filings.
Major Players and Patent Filings
- Innovent Biologics: CN107149591 is part of a strategic suite of patents issued to Innovent, which also includes other anti-PD-1 antibodies and their variants.
- Other Chinese Biotech Entities: Shanghai Junshi Biosciences, Zai Labs, and others hold patents for their anti-PD-1/PD-L1 antibodies, often focusing on novel sequences, formulations, or combination therapies.
Patent Clusters and Competition
The Chinese patent landscape features clusters around specific antibody sequences, manufacturing methods, and therapeutic combinations. Innovent’s patent CN107149591 contributes to this ecosystem by securing protection for a specific anti-PD-1 antibody, potentially blocking competitors from commercializing similar molecules with identical variable regions within China.
Legal and Regulatory Implications
In China, patent validity is subject to examination for novelty, inventive step, and industrial applicability. The country’s stringent standards have led to a competitive environment where innovative design and detailed disclosures are critical for patent strength.
Patent Strategies and Risks
- Design-Around: Competitors may design antibodies with different sequences to evade patent claims.
- Cross-Licensing and Litigation: Strategic licensing or infringement disputes are common as multiple entities vie for market share.
- Patent Term and Expiry: Patents generally last 20 years from filing, but newer filings could extend protection, particularly with patent term adjustments or pediatric extensions.
Implications for Industry and R&D
The issuance of CN107149591 reflects China’s intent to bolster domestic innovation in immunotherapy. For multinational companies, this patent reinforces the need for comprehensive patent strategies, including sequence diversity, manufacturing methods, and combination therapies. It also signals that Chinese companies like Innovent are formidable competitors capable of securing effective IP rights in a high-value therapeutic space.
Key Takeaways
- Specificity of Claims: CN107149591 protects a particular anti-PD-1 antibody with defined amino acid sequences, conferring exclusivity for that molecular entity within China.
- Strategic Positioning: Innovent’s patent fortifies its market position and may serve as a barrier for generic or biosimilar competitors targeting identical sequences.
- Landscape Dynamics: The Chinese patent landscape for anti-PD-1 antibodies is highly competitive, emphasizing sequence innovation and therapeutic combinations.
- Evolving IP Risks: Competitors may pursue alternative sequences or formulations to circumvent patent claims, highlighting the necessity for continual innovation and IP portfolio expansion.
- Regulatory Timing: As China accelerates approval pathways for biologics, patent protection's importance intensifies for market success.
FAQs
Q1: How does CN107149591 compare with international patents on similar anti-PD-1 antibodies?
This Chinese patent is specific to certain amino acid sequences and therapeutic applications, similar to international patents that focus on antibody structure and uses. However, it may differ in claims scope due to regional patentability standards and theorem-based disclosure.
Q2: Can Innovent expand this patent's scope to cover other anti-PD-1 antibodies?
Potentially, through filing additional patents claiming different sequences, modifications, or novel uses. The current patent’s claims are limited to the specific sequences disclosed.
Q3: What are the challenges in enforcing this patent in China?
Enforcement depends on demonstrating infringement, proof of identical or equivalent sequences, and navigating potential challenges on novelty or inventive step. The evolving legal environment requires strategic IP management.
Q4: How does this patent influence the development of biosimilars or generics in China?
It restricts companies from manufacturing or selling antibodies with identical variable region sequences within China without licensing. Biosimilar developers may need to design around these claims.
Q5: What is the strategic significance of this patent for Innovent?
It secures a robust IP position in Chinese immunotherapy markets, enabling exclusivity, potential licensing revenues, and competitive advantage against local and international rivals.
Conclusion
China patent CN107149591 exemplifies a strategic move by Innovent Biologics to protect a specific anti-PD-1 antibody's structure and use in cancer immunotherapy. Its targeted claims delineate a clear boundary around particular amino acid sequences, deterring direct copying but leaving room for innovation through sequence differentiation. As the Chinese biologics patent landscape matures, such patents will become integral to shaping market dynamics, investment decisions, and R&D strategies in immuno-oncology.
References
- Patent CN107149591. Innovent Biologics, Inc. (2017).
- World Intellectual Property Organization (WIPO). Patent Landscape for Anti-PD-1/PD-L1 Antibodies (2022).
- Chinese Patent Office (CNIPA). Examination Guidelines for Biotech Patents.
- Market reports on China immuno-oncology therapeutics.
