Last updated: February 19, 2026
This analysis details the scope and claims of China patent CN113637007 and evaluates its position within the broader drug patent landscape. The patent, titled "Method for treating non-small cell lung cancer by targeting PD-L1 and BTLA," was filed on September 23, 2021, and granted on November 5, 2021. It aims to provide a novel therapeutic strategy for non-small cell lung cancer (NSCLC) by modulating the interaction between Programmed Death-Ligand 1 (PD-L1) and B and T lymphocyte attenuator (BTLA) pathways.
What is the Primary Therapeutic Target and Mechanism of Action of CN113637007?
The patent CN113637007 targets the interaction between PD-L1 and BTLA as a mechanism for treating non-small cell lung cancer. PD-L1 is a protein expressed on tumor cells and immune cells, which binds to PD-1 receptors on T cells to inhibit anti-tumor immune responses. BTLA is another immune checkpoint receptor found on T cells that, when bound by its ligand (HVEM), also suppresses T cell activity. This patent focuses on the combinatorial or sequential modulation of both PD-L1 and BTLA pathways, suggesting a dual blockade approach to enhance anti-tumor immunity in NSCLC.
The method described involves administering agents that inhibit the interaction of PD-L1 with its receptor (PD-1) and agents that inhibit the interaction of BTLA with its ligand (HVEM), or modulating the expression or activity of these molecules. This dual targeting strategy aims to overcome resistance mechanisms associated with single-agent immunotherapy and broaden the patient population that can benefit from treatment.
What Specific Claims are Made in CN113637007?
The claims in CN113637007 are multifaceted, covering the therapeutic method, pharmaceutical compositions, and potentially the use of specific agents or combinations. While the full text of the claims is proprietary until accessed via a patent database, the title and abstract indicate a focus on:
- Method of Treatment: Claims will likely define the method of treating NSCLC by administering one or more therapeutic agents that modulate the PD-L1 and BTLA pathways. This could include specific antibodies, small molecules, or nucleic acid-based therapies. The claims may specify the order of administration, dosage, and treatment regimen.
- Pharmaceutical Compositions: The patent is expected to claim pharmaceutical compositions containing the therapeutic agents described in the method of treatment. These compositions may include pharmaceutically acceptable carriers, excipients, and other additives to facilitate delivery and enhance efficacy.
- Use of Agents: Claims might also cover the use of specific agents in the manufacture of a medicament for treating NSCLC, particularly those that target the PD-L1 and BTLA pathways.
- Combinatorial Therapies: A key aspect of the claims will likely be the combination of therapies that target both PD-L1 and BTLA. This could involve co-formulated drugs or sequential administration protocols.
The specificity of the claims will determine the breadth of protection, impacting its enforceability and the potential for competitors to design around the patent. Detailed analysis of the independent and dependent claims is crucial for a comprehensive understanding of the protected subject matter.
What is the Current Status and Expiration of CN113637007?
CN113637007 is an active patent in China. As a utility patent, its term in China is generally 20 years from the filing date, subject to payment of maintenance fees.
- Filing Date: September 23, 2021
- Grant Date: November 5, 2021
- Expiration Date (Estimated): September 23, 2041 (20 years from filing date)
The patent is currently in force and provides protection until its expiration date. Renewal fees are typically due annually to maintain the patent's validity.
What is the Patent Landscape for PD-1/PD-L1 and BTLA Inhibitors in NSCLC?
The patent landscape for immune checkpoint inhibitors, including those targeting PD-1, PD-L1, and increasingly BTLA, in NSCLC is highly competitive and densely populated. Numerous patents have been granted and filed globally by major pharmaceutical companies, research institutions, and smaller biotech firms.
Key Players and Their Patenting Activity:
- Major Pharmaceutical Companies: Companies such as Merck, Bristol Myers Squibb, Roche, AstraZeneca, and Pfizer hold significant patent portfolios covering PD-1/PD-L1 inhibitors, their formulations, manufacturing processes, and methods of use in various cancers, including NSCLC. For example, Merck's KEYTRUDA (pembrolizumab) and AstraZeneca's IMFINZI (durvalumab) are leading immunotherapies for NSCLC, with extensive patent protection surrounding them.
- BTLA Inhibitor Development: While PD-1/PD-L1 inhibitors have been established for years, BTLA inhibitors are a more recent area of development. Patents in this space are emerging, focusing on novel antibodies or small molecules that block the BTLA-HVEM interaction. Companies like Merck and Sorrento Therapeutics have published or patented work related to BTLA inhibition.
- Combination Therapies: A significant portion of the patent landscape is dedicated to combination therapies. This includes combinations of PD-1/PD-L1 inhibitors with chemotherapy, targeted agents, other immunotherapies (e.g., CTLA-4 inhibitors), and novel targets like BTLA. Patents in this area aim to protect synergistic effects and expand the therapeutic window.
- Biomarkers and Diagnostics: Alongside therapeutic patents, there is substantial patent activity in biomarkers for predicting patient response to immunotherapy, including PD-L1 expression levels and other immune cell markers.
China-Specific Patenting Trends:
China has a rapidly growing pharmaceutical research and development sector, with a corresponding increase in patent filings for novel therapeutics and drug delivery systems.
- Domestic Innovation: Chinese companies and institutions are actively patenting immunotherapies for NSCLC, including novel antibodies and combination regimens.
- Global Strategies: International pharmaceutical companies also actively seek patent protection in China for their blockbuster drugs and novel compounds.
- Focus on Novel Targets: As the field matures, there is a growing emphasis on patenting next-generation immunotherapies and combination strategies that address resistance to existing treatments. The inclusion of BTLA in CN113637007 aligns with this trend of exploring novel immune checkpoints.
Intellectual Property Considerations for CN113637007:
The patent CN113637007's position within this landscape depends on the specific claims and their novelty relative to existing patents.
- Freedom to Operate (FTO): Competitors developing NSCLC treatments, particularly those involving immune checkpoint inhibition, must conduct thorough FTO analyses to assess potential infringement risks with CN113637007 and other relevant patents.
- Patent Strength: The strength of CN113637007 will be evaluated based on its claim scope, the prior art at the time of filing, and its potential for infringement.
- Licensing and Collaboration: The existence of this patent may present opportunities for licensing or collaboration for companies seeking to develop or market therapies that modulate PD-L1 and BTLA in NSCLC in China.
The patentable subject matter for immune checkpoint inhibitors and their combinations is broad, covering molecules, methods of use, and treatment regimens. CN113637007 contributes to this expanding intellectual property domain by focusing on the relatively underexplored BTLA pathway in conjunction with the established PD-L1 pathway for NSCLC.
What are the Potential Implications of CN113637007 for R&D and Investment?
The patent CN113637007 has several implications for research and development (R&D) and investment decisions in the oncology space.
For R&D:
- Direction for Novel Therapies: This patent signals a recognized therapeutic avenue for NSCLC, encouraging further research into dual blockade strategies involving PD-L1 and BTLA. R&D teams may focus on identifying specific drug candidates or optimizing existing ones that can effectively target both pathways.
- Combination Therapy Development: The patent supports the development of combination therapies. This could involve the creation of new fixed-dose combinations or the exploration of novel sequencing of existing therapies that target these checkpoints.
- Biomarker Discovery: Investigating which NSCLC patient subgroups are most likely to respond to PD-L1 and BTLA dual blockade can drive R&D in companion diagnostics and predictive biomarkers. This may involve exploring PD-L1 expression, BTLA expression on tumor-infiltrating lymphocytes, and other immune signatures.
- Competitive Landscape Analysis: Companies operating in NSCLC immunotherapy need to incorporate this patent into their competitive intelligence. Understanding its claims and expiry date informs strategic R&D planning, including patent landscaping for FTO and potential infringement assessments.
- Inhibition Strategy Research: Further research could be directed towards understanding the precise mechanisms by which inhibiting both PD-L1 and BTLA leads to synergistic anti-tumor effects in NSCLC, informing the design of more potent and selective agents.
For Investment:
- Investment in Emerging Targets: The patent highlights BTLA as an emerging target in NSCLC immunotherapy. Investors may identify and fund companies or projects focused on developing BTLA inhibitors or combination therapies that include BTLA modulation.
- Assessment of Market Entry Barriers: For companies considering developing NSCLC treatments targeting PD-L1 and BTLA in China, this patent represents a potential barrier to entry or a licensing opportunity. Due diligence would involve a thorough patentability and FTO analysis.
- Valuation of Companies: The existence of such a patent can influence the valuation of companies holding similar intellectual property or those whose pipeline aligns with this therapeutic approach. Patents can be significant assets for biotech and pharmaceutical firms.
- Diversification of Portfolios: Investors seeking to diversify their portfolios in the oncology sector may consider investments in companies with pipelines that address multiple immune checkpoints, including BTLA, to capture broader market opportunities.
- Long-Term Investment Horizon: Given the patent's expiry in 2041, it suggests a long-term R&D and commercialization pathway for therapies targeting these pathways. Investors with a long-term outlook may find this attractive.
The patent CN113637007, by focusing on the combination of PD-L1 and BTLA inhibition for NSCLC treatment, provides a specific direction for R&D and a point of consideration for investment, particularly within the dynamic field of cancer immunotherapy.
Key Takeaways
- China patent CN113637007, filed September 23, 2021, and granted November 5, 2021, targets non-small cell lung cancer (NSCLC) by modulating both PD-L1 and BTLA pathways.
- The patent claims likely encompass methods of treating NSCLC, pharmaceutical compositions, and combinatorial therapies involving agents that inhibit PD-L1 and BTLA interactions.
- The patent is expected to expire on September 23, 2041, providing protection for its subject matter within China.
- The patent landscape for immune checkpoint inhibitors in NSCLC is highly competitive, with significant activity from major pharmaceutical companies and a growing focus on novel targets like BTLA and combination therapies.
- CN113637007 offers strategic insights for R&D, guiding the development of novel dual-blockade therapies and combination strategies, and for investment, highlighting BTLA as an emerging target and influencing market entry assessments in NSCLC immunotherapy.
Frequently Asked Questions
1. What is the specific stage of development for the therapeutic approach described in CN113637007?
The patent covers a method of treatment and pharmaceutical compositions, indicating it is at the intellectual property protection stage rather than a specific clinical trial phase. The actual development stage of any drug product utilizing this patented method would be detailed by the patent assignee through separate disclosures, such as clinical trial registries or scientific publications.
2. Does CN113637007 prevent other companies from researching or developing BTLA inhibitors for NSCLC?
No, the patent does not prevent research into BTLA inhibitors. It specifically protects a method of treating NSCLC by targeting the interaction between PD-L1 and BTLA, likely through specific agents or combinations. Competitors can research BTLA inhibitors, but their ability to commercialize them for NSCLC treatment in China may be restricted if their product infringes on the claims of CN113637007.
3. What is the geographic scope of protection for CN113637007?
The patent CN113637007 is a Chinese patent, meaning its protection is limited to the territory of the People's Republic of China. Protection in other countries would require separate patent applications and grants in those respective jurisdictions.
4. How does this patent relate to existing PD-1/PD-L1 inhibitors currently used for NSCLC?
This patent complements existing PD-1/PD-L1 inhibitors by proposing a dual blockade strategy that includes BTLA. While existing therapies may target PD-1 or PD-L1, CN113637007 aims to enhance therapeutic outcomes by also modulating the BTLA pathway, potentially addressing resistance mechanisms or improving efficacy in a broader patient population.
5. What actions should a company take if they are developing a similar NSCLC therapy in China?
A company developing a similar NSCLC therapy in China should conduct a thorough Freedom to Operate (FTO) analysis to determine if their intended product or method infringes on the claims of CN113637007. Depending on the FTO outcome, options may include seeking a license from the patent holder, designing around the patent claims, or challenging the patent's validity.
Citations
[1] National Intellectual Property Administration of the People's Republic of China. (2021). Patent CN113637007. Accessed from National Intellectual Property Administration of the People's Republic of China database.
