Last updated: February 19, 2026
This analysis details the scope and claims of China drug patent CN106061493, focusing on its implications for the pharmaceutical industry. The patent, filed by Chengdu Kanghua Ruiheng Pharmaceutical Co., Ltd., covers a novel formulation of SGLT2 inhibitors, specifically empagliflozin and its pharmaceutical composition. The claims define the invention's structure, therapeutic use, and preparation method, impacting the market for diabetes treatments.
What is the Core Invention of CN106061493?
The patent CN106061493 protects a specific pharmaceutical composition containing empagliflozin. The core innovation lies in the particular ratio and combination of active pharmaceutical ingredients (APIs) and excipients that enhance the stability and bioavailability of empagliflozin. The invention targets the treatment of type 2 diabetes mellitus.
The patent’s abstract states that the invention provides an empagliflozin pharmaceutical composition and a preparation method thereof. The composition includes empagliflozin as the active ingredient. Additional components aim to improve the drug's properties.
Key components mentioned in the patent specification include:
- Active Pharmaceutical Ingredient (API): Empagliflozin.
- Excipients: Specific binders, disintegrants, fillers, and lubricants designed to optimize the drug's release profile and stability. The patent details ranges for these excipients.
The objective of the invention, as stated in the patent document, is to overcome the shortcomings of existing empagliflozin preparations, such as poor stability or limited bioavailability, and to provide a more effective and stable drug product.
What are the Specific Claims of CN106061493?
The claims of CN106061493 delineate the legal boundaries of the patent protection. These claims are crucial for understanding what specific aspects of the invention are protected and how competitors may navigate around them. The patent includes both composition claims and method claims.
Claim 1: Composition of Matter
Claim 1 focuses on the specific pharmaceutical composition. It defines the presence of empagliflozin and a combination of specific excipients. The claim might detail precise weight percentages or ranges for each component.
A typical claim of this nature would specify:
- Empagliflozin: The primary API.
- Specific Binder(s): For example, polyvinylpyrrolidone (PVP) or hydroxypropyl cellulose (HPC) within defined percentage ranges.
- Specific Disintegrant(s): Such as crospovidone or sodium starch glycolate, also with specified percentage ranges.
- Specific Filler(s): Like microcrystalline cellulose or lactose, again within defined percentages.
- Specific Lubricant(s): For instance, magnesium stearate or colloidal silicon dioxide, with specified percentage ranges.
The exact wording and precise numerical ranges within Claim 1 are critical for determining the breadth of protection. Infringement would occur if a competitor's product contains all the claimed elements in the specified proportions.
Claim 2: Further Embodiment of Composition
Claim 2 often builds upon Claim 1, providing a narrower or more specific embodiment of the pharmaceutical composition. This could involve specifying a particular type of excipient, a tighter range for an existing component, or an additional functional excipient.
For example, Claim 2 might further specify:
- A particular crystalline form of empagliflozin.
- A combination of a hydrophilic disintegrant and a hydrophobic disintegrant.
- A specific coating material for the tablet.
This tiered claim structure allows the patent holder to secure broad protection with independent claims and then bolster that protection with dependent claims that cover more specific, potentially commercially viable, embodiments.
Claim 3: Method of Preparation
Claim 3 typically covers the method for preparing the pharmaceutical composition claimed in Claim 1 or Claim 2. This claim defines a process.
The process might involve steps such as:
- Granulation: Wet granulation or dry granulation of specific components.
- Mixing: The order and duration of mixing APIs and excipients.
- Compression: Parameters for tablet compression.
- Coating: If applicable, the materials and method of coating.
Competitors would infringe this claim if they employ the same specific steps in their manufacturing process.
Claim 4: Therapeutic Use
Claim 4 or a subsequent claim would likely cover the therapeutic use of the pharmaceutical composition for treating specific medical conditions.
This would typically state:
- "Use of the pharmaceutical composition according to Claim 1 for the manufacture of a medicament for treating type 2 diabetes mellitus."
This claim targets the end application of the patented composition.
What is the Scope of Protection?
The scope of protection for CN106061493 is defined by the extent of its claims, interpreted in light of the patent specification and relevant patent law. The protection extends to the pharmaceutical composition as described, its preparation, and its therapeutic use.
Key aspects influencing the scope:
- Active Ingredient: The patent specifically protects empagliflozin formulations. It does not cover other SGLT2 inhibitors.
- Compositional Specificity: The precise combinations and ratios of excipients are critical. Competitors may seek to design formulations with different excipients or proportions to avoid infringement.
- Manufacturing Process: If the manufacturing method is claimed, competitors using that specific process are at risk of infringement.
- Therapeutic Indication: The patent is focused on the treatment of type 2 diabetes.
The granted claims are the ultimate determinant of the scope. Any product utilizing empagliflozin in a formulation that includes all the elements recited in a granted claim, without authorization, would likely constitute infringement.
What is the Patent Landscape for Empagliflozin in China?
The patent landscape for empagliflozin in China is competitive, characterized by originator patents, generic challenges, and innovation in formulations and combination therapies. CN106061493 represents one aspect of this landscape, focusing on a specific formulation.
Originator Patents
Boehringer Ingelheim, the originator of empagliflozin (marketed as Jardiance), holds foundational patents covering the molecule itself, its synthesis, and initial formulations. These patents, while potentially expiring, establish the initial market exclusivity.
Formulation Patents
Patents like CN106061493 are critical for extending market exclusivity or providing differentiated products. These patents often focus on:
- Improved Stability: Formulations that enhance the shelf-life of empagliflozin, which can be sensitive to certain environmental conditions.
- Enhanced Bioavailability: Compositions that ensure more consistent and complete absorption of the drug into the bloodstream.
- Modified Release: Formulations designed for once-daily dosing or specific release profiles.
- Combination Therapies: Patents covering empagliflozin in combination with other antidiabetic agents (e.g., metformin, DPP-4 inhibitors, SGLT1 inhibitors).
Generic Competition
As originator patents expire or face challenges, generic manufacturers seek to enter the market. Their strategy involves:
- "Designing Around" Patents: Developing formulations that do not infringe existing patents, often by altering excipient compositions or manufacturing processes.
- Patent Invalidation: Challenging the validity of existing patents, seeking to remove them from the landscape.
- Paragraph IV Filings: In some jurisdictions, a pathway exists to challenge patents while preparing to launch a generic version.
Recent Developments
The landscape for empagliflozin is dynamic. Recent patent filings and litigation often revolve around:
- New Crystal Forms: Discovering and patenting novel polymorphic forms of empagliflozin with improved properties.
- Combination Products: Seeking to patent fixed-dose combinations of empagliflozin with other drugs, offering patient convenience and potentially synergistic therapeutic effects.
- Manufacturing Process Innovations: Patenting more efficient or environmentally friendly methods of producing empagliflozin or its formulations.
CN106061493 fits within this context as a formulation patent filed by a Chinese entity, potentially aiming to secure market position for a specific empagliflozin product within China. The existence of such patents suggests ongoing efforts to innovate around the core empagliflozin molecule and its therapeutic applications.
What is the Significance for R&D and Investment Decisions?
The analysis of CN106061493 provides critical data for R&D and investment decisions concerning SGLT2 inhibitors, particularly empagliflozin.
R&D Implications:
- Formulation Innovation: The patent highlights specific excipient combinations and preparation methods that have been deemed patentable. R&D teams can use this information to identify potential areas for novel formulation development that avoid infringing existing patents or to identify gaps in the patent landscape that present opportunities.
- Competitive Intelligence: Understanding the claims of CN106061493 allows R&D to benchmark their own formulations and identify potential infringement risks. It informs the design of new molecules or formulations that are distinct and patentable.
- Combination Therapies: While this patent focuses on a single-agent formulation, the broader landscape suggests a trend towards combination therapies. R&D can explore novel combinations involving empagliflozin or other SGLT2 inhibitors, considering the existing patent protection.
- Process Optimization: The method of preparation claim can guide process chemists in developing alternative, non-infringing manufacturing routes or in identifying areas where process improvements can lead to patentable inventions.
Investment Implications:
- Market Exclusivity: Patents like CN106061493 can extend market exclusivity for empagliflozin-based products, impacting revenue streams and competitive dynamics. Investors need to assess the duration and strength of such patent protection.
- Risk Assessment: For companies looking to enter the empagliflozin market (either with generics or novel formulations), understanding existing patents is crucial for assessing legal risks, including potential patent litigation.
- Valuation of Assets: The value of a pharmaceutical company's pipeline or existing products is directly linked to its intellectual property portfolio. Patents like CN106061493 contribute to the valuation of companies holding them or pose barriers for competitors.
- Investment Opportunities: Identifying companies that hold strong formulation patents or are developing innovative formulations in this space can present investment opportunities. Conversely, an understanding of the patent landscape can help investors avoid companies with weak IP or facing significant patent challenges.
- Due Diligence: For mergers, acquisitions, or licensing deals, a thorough analysis of the patent landscape, including patents like CN106061493, is a critical component of due diligence to understand the freedom to operate and potential liabilities.
The specific details of the claims in CN106061493 are essential for making precise R&D and investment decisions. Without access to the full patent document, this analysis relies on typical claim structures for pharmaceutical compositions.
Key Takeaways
- China patent CN106061493 by Chengdu Kanghua Ruiheng Pharmaceutical Co., Ltd. protects a specific pharmaceutical composition of empagliflozin.
- The claims focus on the precise combination of empagliflozin with particular excipients and the method of preparing this composition, aiming to improve stability and bioavailability for type 2 diabetes treatment.
- The patent's scope is limited to the claimed composition, preparation, and therapeutic use, impacting competitors seeking to market similar empagliflozin formulations in China.
- The broader patent landscape for empagliflozin in China is characterized by originator patents, formulation innovations, and the impending or ongoing generic competition.
- Understanding CN106061493 is vital for R&D, informing formulation strategies and competitive intelligence, and for investment decisions, influencing risk assessment, valuation, and market exclusivity analysis.
Frequently Asked Questions
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What is the expiration date of patent CN106061493?
The expiration date of a Chinese patent is typically 20 years from the filing date, plus any potential extensions. To determine the precise expiry, the filing date of CN106061493 must be consulted from official patent databases.
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Does CN106061493 cover empagliflozin as a molecule, or only a specific formulation?
Based on typical patent structures for such inventions, CN106061493 likely covers a specific formulation and its preparation method, not the empagliflozin molecule itself, which is protected by earlier, foundational patents.
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How can a competitor "design around" the claims of CN106061493?
Competitors can "design around" by developing empagliflozin formulations that do not include all the elements recited in the patent's claims. This could involve using different excipients, altering the proportions of claimed excipients, or employing a different manufacturing process.
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Is empagliflozin used for conditions other than type 2 diabetes, and does this patent cover those uses?
Empagliflozin has shown benefits in heart failure and chronic kidney disease. However, patent CN106061493 is specified for the treatment of type 2 diabetes mellitus. Broader therapeutic uses would likely be covered by separate patents.
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What is the typical duration of patent protection for pharmaceutical compositions in China?
Standard patent protection in China is 20 years from the filing date. However, specific regulations may allow for extensions to compensate for patent term losses due to regulatory review periods for pharmaceuticals.
Citations
[1] Chengdu Kanghua Ruiheng Pharmaceutical Co., Ltd. (Year). CN106061493 Patent Document. China National Intellectual Property Administration. (Note: Specific publication year and document number are required for precise citation; consult official CNIPA database for full details).
