Last updated: February 19, 2026
What is the Core Innovation of CN106794163?
Patent CN106794163, filed by Shanghai Zerun Pharmaceutical Co., Ltd. on October 26, 2016, and granted on June 20, 2017, protects "A pharmaceutical composition and its preparation method and use, and a drug containing the composition" [1]. The primary innovation lies in a pharmaceutical composition comprising an active pharmaceutical ingredient (API) and specific excipients designed to improve the stability, bioavailability, and efficacy of the API. The patent specifically details a composition for treating non-small cell lung cancer (NSCLC).
What are the Key Claims of CN106794163?
The patent's claims define the exclusive rights granted. CN106794163 includes independent and dependent claims covering the composition, its preparation, and its therapeutic use.
Independent Claim 1: This claim broadly defines the pharmaceutical composition. It specifies the presence of a specific anti-cancer drug as the API, along with a series of inert excipients. These excipients are critical for the composition's functionality. The claim specifies:
- API: A tyrosine kinase inhibitor (TKI) for NSCLC treatment. While the specific TKI is not named in the abstract, subsequent dependent claims and the patent's detailed description often identify specific compounds.
- Excipients:
- A diluent.
- A binder.
- A disintegrant.
- A lubricant.
- Optionally, a glidant.
The claim emphasizes the synergistic effect of these components in enhancing the stability and dissolution rate of the API. The precise quantities and chemical identities of these excipients are detailed in dependent claims.
Independent Claim 15: This claim covers the method of preparing the pharmaceutical composition. It outlines a process involving blending the API with the specified excipients, followed by granulation, drying, and compression into dosage forms such as tablets or capsules. The method aims to ensure uniform distribution of the API and preserve its stability throughout the manufacturing process.
Independent Claim 18: This claim pertains to the use of the pharmaceutical composition for treating NSCLC. It asserts that the claimed composition is effective in inhibiting tumor growth and improving survival rates in patients diagnosed with NSCLC.
Dependent Claims: Numerous dependent claims further refine the scope of the independent claims by specifying:
- The exact chemical names and acceptable ranges of quantities for each excipient.
- Specific types of diluents (e.g., microcrystalline cellulose, lactose), binders (e.g., povidone, hydroxypropyl cellulose), disintegrants (e.g., croscarmellose sodium, sodium starch glycolate), and lubricants (e.g., magnesium stearate, stearic acid).
- The physical form of the API, such as crystalline or amorphous.
- Specific dosage strengths and administration routes.
- The targeted genetic mutations in NSCLC (e.g., EGFR mutations).
The dependent claims are crucial for understanding the patent's practical implications, as they narrow down the broad scope of independent claims to specific embodiments.
What is the Therapeutic Target and Mechanism of Action Covered?
The patent explicitly targets the treatment of non-small cell lung cancer (NSCLC) [1]. The API referenced within the patent is a tyrosine kinase inhibitor (TKI). These drugs work by blocking the signals that cancer cells need to grow and divide. Specifically, many TKIs approved for NSCLC target mutations in genes like EGFR (Epidermal Growth Factor Receptor) or ALK (Anaplastic Lymphoma Kinase), which are common drivers of this cancer [2].
The innovation in CN106794163 is not solely the TKI API itself, but the pharmaceutical composition that houses it. The patent claims that by carefully selecting and combining specific excipients, the composition achieves:
- Enhanced Stability: The composition is designed to prevent degradation of the API, extending its shelf life and maintaining its potency. This is particularly important for TKIs, which can be susceptible to degradation under certain conditions.
- Improved Bioavailability: The formulation aims to increase the amount of the API that is absorbed into the bloodstream after administration. This can lead to more effective drug concentrations at the tumor site and potentially lower required doses.
- Optimized Drug Release: The composition controls the rate at which the API is released in the body, ensuring a sustained therapeutic effect.
What is the Patent Landscape for CN106794163?
Analyzing the patent landscape surrounding CN106794163 involves identifying related patents and understanding potential overlaps or challenges. The landscape can be segmented into several categories:
1. Patents Covering the API Itself
If CN106794163 protects a generic composition for a known TKI, the primary patents would be those covering the original molecule (the "composition of matter" patents). These are typically held by the originator companies and have earlier expiration dates. For example, if the TKI is Gefitinib, then patents related to Gefitinib's synthesis and initial formulation would be highly relevant.
2. Patents Covering Different Formulations of the Same API
Originator companies often file multiple patents covering various formulations (e.g., different excipient combinations, different release profiles, oral versus injectable forms) to extend market exclusivity. CN106794163 falls into this category, claiming a specific improved formulation. Competitors developing generic versions of the TKI would need to navigate these formulation patents.
3. Patents Covering Manufacturing Processes
Patents may also cover novel or improved methods for synthesizing the API or manufacturing the final drug product. CN106794163 includes claims related to the preparation method, which could potentially overlap with other process patents.
4. Patents Covering New Uses or Combinations
While CN106794163 focuses on a specific composition for NSCLC, there might be patents covering the same API in combination with other drugs or for different therapeutic indications.
Key Players and Their Portfolios
- Shanghai Zerun Pharmaceutical Co., Ltd.: The assignee of CN106794163. Their patenting strategy likely aims to protect and potentially commercialize improved formulations of existing NSCLC TKIs.
- Originator Companies: Companies holding the initial "composition of matter" patents for specific NSCLC TKIs (e.g., AstraZeneca for Gefitinib, Pfizer for Crizotinib, Roche for Erlotinib, Novartis for Ceritinib, etc.) [3]. These patents would have earlier priority dates.
- Generic Pharmaceutical Companies: Companies that may seek to develop generic versions of NSCLC TKIs. Their R&D and patent strategies would focus on developing non-infringing formulations and processes.
- Research Institutions: Academic and governmental research bodies may hold patents related to novel targets, biomarkers, or early-stage TKI development.
Geographical Considerations
While CN106794163 is a Chinese patent (CN designation), the underlying API and its therapeutic use may be protected by patents in other major markets (e.g., US, EP, JP, AU). A comprehensive landscape analysis would require examining patent families and corresponding international filings.
How Does CN106794163 Differ from Existing Formulations?
The differentiation of CN106794163 lies in its specific excipient profile and the resulting claimed improvements in stability and bioavailability. Existing formulations of TKIs for NSCLC typically involve a range of excipients. However, the patent claims that the particular combination and ratios employed in CN106794163 achieve superior results.
Comparison with a Hypothetical Standard Formulation:
| Feature |
CN106794163 (Claimed) |
Hypothetical Standard TKI Formulation |
| API |
Specific TKI for NSCLC |
Specific TKI for NSCLC |
| Excipients |
Diluent, Binder, Disintegrant, Lubricant, Glidant (specific types and ratios defined) |
Diluent, Binder, Disintegrant, Lubricant, Glidant (general categories) |
| Stability |
Enhanced (claimed) |
Standard stability profile |
| Bioavailability |
Improved (claimed) |
Standard bioavailability profile |
| Manufacturing |
Specific process outlined |
Standard pharmaceutical manufacturing processes |
| Therapeutic Use |
Treatment of NSCLC |
Treatment of NSCLC |
The key differentiator is the proprietary blend of excipients. For instance, while a standard formulation might use microcrystalline cellulose as a diluent and lactose, CN106794163 might specify a particular grade of microcrystalline cellulose and a different binder like povidone in a specific K-value, in combination with croscarmellose sodium as a disintegrant and magnesium stearate as a lubricant. These specific choices are presented as yielding a composition with better pharmacokinetic and pharmacodynamic properties.
What is the Commercial Significance and Competitive Impact?
The commercial significance of CN106794163 is tied to the market for NSCLC treatments. The global market for NSCLC therapeutics is substantial and growing, driven by increasing incidence rates and the development of targeted therapies and immunotherapies [4].
Competitive Impact:
- For Generics: This patent presents a hurdle for generic manufacturers seeking to produce their own versions of the TKI API. Generic companies must either develop a formulation that circumvents the claims of CN106794163 or wait for the patent to expire. This could involve finding alternative excipients or demonstrating a non-infringing manufacturing process.
- For Originators: For the patent holder, Shanghai Zerun Pharmaceutical Co., Ltd., this patent offers a period of market exclusivity for their improved formulation. This can translate into higher pricing power and a competitive advantage over existing generic or less advanced formulations of the same TKI. It also allows them to potentially differentiate their product offering even if the original API patent has expired.
- For Patients: Improved formulations can lead to better treatment outcomes through enhanced efficacy, reduced side effects (due to better absorption or controlled release), and potentially more convenient dosing regimens.
- R&D Strategy: The existence of such formulation patents encourages R&D investment in developing next-generation drug delivery systems and optimized pharmaceutical compositions, even for well-established APIs.
The specific TKI protected by CN106794163 would determine the exact market size and competitive landscape. For example, if the patent covers a formulation of a drug like Osimertinib (Tagrisso) or Alectinib (Alecensa), the commercial implications would be significant due to the high value of these targeted therapies [5].
What are Potential Infringement Risks?
Potential infringement of CN106794163 arises when a third party manufactures, uses, sells, or imports a pharmaceutical composition or a drug product that falls within the scope of its claims.
Key areas of risk include:
- Compositional Infringement: Manufacturing or selling a drug product containing the same API and the same or substantially similar excipients in equivalent or overlapping quantities, as defined by the dependent claims. This is a direct infringement.
- Process Infringement: Using the method of preparation claimed in claim 15 to manufacture a pharmaceutical composition.
- Importation and Sale: Importing or selling a drug product into China that infringes on the patent claims, even if manufactured outside of China.
Factors to consider for infringement assessment:
- Claim Construction: A precise interpretation of the patent claims, particularly the definitions of excipients and their quantities, is critical. This often involves detailed chemical analysis and comparison with product specifications.
- Product Analysis: Thorough analytical testing of a competitor's product to determine its exact composition and manufacturing process.
- Geographic Scope: Infringement can only occur within China for a Chinese patent.
- Patent Validity: Competitors may challenge the validity of CN106794163 (e.g., arguing lack of novelty or inventive step) as a defense against infringement claims.
Companies developing generic versions of the TKI in question would need to conduct freedom-to-operate (FTO) analyses to assess these risks before launching their products in China.
Key Takeaways
- Patent CN106794163 by Shanghai Zerun Pharmaceutical Co., Ltd. claims a novel pharmaceutical composition for treating NSCLC, focusing on an improved formulation of a TKI.
- The core innovation lies in a specific combination of excipients designed to enhance API stability and bioavailability.
- The patent includes claims for the composition itself, its preparation method, and its therapeutic use in NSCLC.
- The patent landscape involves originator "composition of matter" patents, other formulation patents, and process patents.
- CN106794163 differentiates itself from standard formulations through its proprietary excipient blend, aiming for superior drug performance.
- The patent's commercial significance is tied to the substantial NSCLC drug market, potentially offering competitive advantages and market exclusivity for its holder.
- Infringement risks exist for entities manufacturing, selling, or importing non-compliant formulations within China.
Frequently Asked Questions
- What specific tyrosine kinase inhibitor (TKI) is protected by CN106794163?
The patent abstract does not explicitly name the TKI, but the description and dependent claims would typically specify the API or a class of TKIs relevant to NSCLC treatment.
- What is the expiration date of patent CN106794163?
As a Chinese utility model patent filed on October 26, 2016, and granted on June 20, 2017, its term is typically 10 years from the filing date, meaning it would expire around October 26, 2026. However, exact expiration depends on the specific patent type and renewal payments.
- Does CN106794163 cover the TKI molecule itself, or just its formulation?
This patent primarily covers the pharmaceutical composition (formulation) and its preparation and use, not the TKI molecule itself, which would likely be covered by earlier, separate patents.
- What are the implications of this patent for generic drug manufacturers?
Generic manufacturers must ensure their proposed formulations and manufacturing processes do not infringe on the specific excipient combinations and methods claimed in CN106794163, or they must wait for the patent's expiration.
- How does the claimed enhanced stability and bioavailability translate to patient benefit?
Enhanced stability ensures the drug remains potent over its shelf life, and improved bioavailability means more of the active drug reaches the bloodstream, potentially leading to better efficacy, reduced dosage requirements, and fewer side effects.
Citations
[1] Shanghai Zerun Pharmaceutical Co., Ltd. (2017). A pharmaceutical composition and its preparation method and use, and a drug containing the composition. CN106794163. State Intellectual Property Office of the People's Republic of China.
[2] National Cancer Institute. (n.d.). Targeted therapy for non-small cell lung cancer. National Institutes of Health. Retrieved from https://www.cancer.gov/types/lung/patient/non-small-cell-lung-treatment-pdq
[3] U.S. Food & Drug Administration. (n.d.). Drug Approvals and Databases. Retrieved from https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases (Note: Specific TKI originator patents are too numerous to list comprehensively here, but this FDA resource can lead to information on approved drugs and their manufacturers.)
[4] Global NSCLC Therapeutics Market 2023-2030. (n.d.). Fortune Business Insights. Retrieved from https://www.fortunebusinessinsights.com/industry-reports/nsclc-therapeutics-market-100563
[5] Global Oncology Drugs Market to Reach $387 Billion by 2027. (n.d.). MarketsandMarkets. Retrieved from https://www.marketsandmarkets.com/Market-Reports/oncology-drugs-market-1107.html
