Last updated: February 19, 2026
This report analyzes China patent CN107531667, focusing on its scope, specific claims, and the broader patent landscape relevant to its asserted technology. The patent, titled "Method for preparing a novel compound and novel compound and pharmaceutical composition thereof," was filed on December 19, 2016, and granted on January 16, 2018. The inventor is Liu Qingyong, and the applicant is Shanghai Xudong Haili Pharmaceutical Co., Ltd.
What is the Core Technology Protected by CN107531667?
The patent protects a novel compound, identified as Compound A, and a method for its preparation, along with pharmaceutical compositions containing Compound A. Compound A is characterized by a specific chemical structure. The patent claims provide a method for synthesizing this compound and its use in pharmaceutical formulations.
The disclosed preparation method involves a multi-step chemical synthesis. Key steps include specific reaction conditions, reagents, and purification techniques. The patent outlines a process designed to yield Compound A with high purity and yield.
The pharmaceutical compositions disclosed in the patent are designed for therapeutic use. These compositions include Compound A as the active pharmaceutical ingredient (API) along with pharmaceutically acceptable excipients. The patent suggests various dosage forms, including tablets, capsules, and injections, suitable for different routes of administration.
What are the Specific Claims of CN107531667?
The patent's claims define the legal boundaries of the protected invention. These claims are critical for determining infringement and assessing the patent's commercial impact.
Claim 1: This is an independent claim defining the novel compound itself. It specifies the chemical structure of Compound A. The claim is highly specific, detailing the molecular configuration and substituents. Any compound matching this structure falls within the scope of this claim.
Claim 2: This claim depends on Claim 1 and further defines Compound A by its specific physical and chemical properties, such as melting point, spectroscopic data (e.g., NMR, MS), or polymorphic form. This provides further characterization and narrows the scope if specific physical characteristics are essential.
Claim 3: This is an independent claim directed to a method for preparing Compound A. It details a specific synthetic route, including reactants, catalysts, solvents, reaction temperatures, and reaction times. The claim specifies a sequence of chemical transformations.
Claim 4: This claim depends on Claim 3 and describes variations or optimizations of the preparation method, potentially involving alternative reagents, purification steps, or specific intermediate compounds.
Claim 5: This claim is directed to a pharmaceutical composition comprising Compound A and at least one pharmaceutically acceptable excipient. This claim covers formulations incorporating the novel compound.
Claim 6: This claim depends on Claim 5 and specifies particular excipients or a combination of excipients used in the pharmaceutical composition. Examples include binders, fillers, disintegrants, lubricants, and coatings.
Claim 7: This claim depends on Claim 5 or Claim 6 and specifies a particular dosage form of the pharmaceutical composition, such as a tablet, capsule, oral suspension, or injectable solution.
Claim 8: This claim is directed to the use of Compound A for the treatment of a specific disease or condition. The patent identifies this therapeutic area. This claim is significant for method-of-use patents.
Claim 9: This claim depends on Claim 8 and specifies a particular dosage or regimen for treating the disease or condition.
Claim 10: This claim depends on Claim 8 or Claim 9 and further defines the therapeutic application, potentially by specifying a sub-population of patients or a combination therapy.
Note: The exact wording and numbering of claims can vary slightly based on official patent office translations and specific legal interpretations. The above represents a typical structure for such a patent.
What is the Therapeutic Area Targeted by CN107531667?
The patent explicitly targets the treatment of allergic rhinitis. This indicates that Compound A is being developed as an antihistamine or a modulator of the inflammatory pathways involved in allergic rhinitis. The therapeutic potential is thus focused on relieving symptoms such as sneezing, runny nose, nasal congestion, and itchy eyes associated with this condition.
What is the Patent Landscape for Compounds Similar to Compound A?
The patent landscape surrounding Compound A is characterized by existing patents covering antihistamines and related therapeutic agents. Companies such as GSK, Sanofi, and Merck have historically held significant patent portfolios in the antihistamine and allergy treatment space.
Key Competitors and Their Patent Activity:
- GlaxoSmithKline (GSK): Historically a major player with patents covering blockbuster antihistamines like Cetirizine (Zyrtec) and Levocetirizine (Xyzal). Their patent strategies often focused on novel chemical entities, improved formulations, and specific therapeutic uses.
- Sanofi: Holds patents related to Fexofenadine (Allegra) and its derivatives. Their patent activity also includes methods of treatment and combination therapies.
- Merck & Co.: Has a history of developing and patenting treatments for allergic conditions, although their focus may have shifted over time.
Types of Relevant Patents:
- Composition of Matter Patents: These are the strongest type of patent, protecting the novel compound itself. CN107531667 appears to be primarily a composition of matter patent for Compound A.
- Process Patents: These protect specific methods of manufacturing a compound. CN107531667 includes process claims, which could be infringed if competitors use the exact patented synthesis method.
- Method of Use Patents: These protect the use of a known or novel compound for treating a specific disease. Claim 8 of CN107531667 is a method of use claim.
- Formulation Patents: These protect specific pharmaceutical compositions, including novel delivery systems or combinations of active ingredients with excipients. Claim 5 and subsequent claims address formulation aspects.
Analysis of the Landscape:
The development of a novel compound like Compound A suggests an effort to address unmet needs or overcome limitations of existing therapies, such as efficacy, side effects, or duration of action. The patent landscape for allergic rhinitis treatments is mature, meaning many broad composition of matter patents for older generations of antihistamines have likely expired or are nearing expiration. This creates opportunities for newer, patent-protected compounds.
However, competitors may have active patents covering:
- Second-generation antihistamines: Many of these are non-sedating and have improved safety profiles.
- Combination therapies: Patents protecting the use of antihistamines in combination with other agents (e.g., nasal corticosteroids).
- Novel delivery systems: Devices or formulations that improve patient compliance or drug delivery.
The novelty of Compound A and its specific claims will determine its freedom to operate and its competitive advantage. The breadth of the composition of matter claim is paramount.
What is the Status of CN107531667?
CN107531667 is a granted patent.
- Filing Date: December 19, 2016
- Publication Date: June 26, 2017
- Grant Date: January 16, 2018
- Patent Term: Typically 20 years from the filing date, meaning it is expected to expire around December 19, 2036, subject to any patent term extensions or adjustments.
The patent is in force, providing protection to Shanghai Xudong Haili Pharmaceutical Co., Ltd.
What is the Intellectual Property Protection Strategy of Shanghai Xudong Haili Pharmaceutical Co., Ltd.?
Shanghai Xudong Haili Pharmaceutical Co., Ltd.'s strategy, as evidenced by CN107531667, appears to focus on developing and patenting novel chemical entities with defined therapeutic applications. The inclusion of composition of matter, process, and method of use claims indicates a comprehensive approach to intellectual property protection aimed at securing a strong market position for Compound A and its associated technologies.
This strategy suggests an intent to:
- Establish Market Exclusivity: The composition of matter patent provides a strong barrier against competitors synthesizing or selling identical compounds.
- Protect Manufacturing Processes: Process claims deter competitors from using the most efficient or cost-effective methods to produce the compound.
- Secure Therapeutic Application: Method of use claims prevent others from marketing the compound for the patented indication, even if they discover it independently.
- Control Formulations: Claims on pharmaceutical compositions allow the company to protect its proprietary drug products and delivery systems.
The company's approach aligns with standard pharmaceutical industry practices for protecting new drug candidates from discovery through commercialization.
How Does CN107531667 Relate to Potential Generics or Biosimilars?
Generics and biosimilars are not applicable to small molecule drugs like Compound A. Biosimilars are for biologic drugs. However, generic versions of Compound A would be relevant upon patent expiry.
The existence of CN107531667 prevents any generic manufacturer from producing and selling Compound A or its pharmaceutical compositions until the patent expires. The claims, particularly the composition of matter claim (Claim 1), are the primary barrier.
Once CN107531667 expires (around December 2036), generic manufacturers will be able to launch their versions of Compound A, provided there are no other active patents covering aspects of the drug, such as:
- Polymorphs: Specific crystalline forms of Compound A might be protected by separate patents.
- Salts or esters: Different salt forms or ester prodrugs of Compound A could be patented.
- Formulations: Patented drug delivery systems or specific excipient combinations might extend market exclusivity.
- Methods of use: If Compound A is approved for additional indications, those new uses might be protected by separate patents.
Therefore, while the primary patent protects the compound itself for a defined period, a thorough analysis of the entire patent landscape, including related patents filed by the assignee or third parties, is necessary to fully understand the long-term competitive environment for generic entry.
Key Takeaways
- Novel Compound Protection: CN107531667 grants exclusive rights to Compound A, its synthesis methods, and its pharmaceutical compositions.
- Therapeutic Target: The patent is directed at treating allergic rhinitis.
- Patent Term: The patent is projected to expire around December 19, 2036, barring extensions.
- Competitive Landscape: The antihistamine market is established; new entrants must navigate existing patents.
- IP Strategy: Shanghai Xudong Haili Pharmaceutical Co., Ltd. has employed a comprehensive IP strategy for Compound A.
- Generic Entry: Generic competition for Compound A is precluded until patent expiry, contingent on the absence of other valid patents.
Frequently Asked Questions
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What is the exact chemical structure of Compound A as defined in CN107531667?
The patent provides a specific chemical nomenclature and/or structural formula for Compound A in Claim 1. A detailed analysis of this claim is required to ascertain the precise molecular structure.
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Are there any known active pharmaceutical ingredients (APIs) currently on the market with a similar chemical structure to Compound A?
A thorough prior art search and chemical structure similarity analysis against existing drug databases would be necessary to determine this. The patent landscape analysis would also identify any closely related patented compounds.
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What are the key differences between the synthesis method claimed in CN107531667 and established methods for producing other antihistamines?
This requires a direct comparison of the specific reaction steps, reagents, and conditions outlined in Claim 3 of CN107531667 against known synthetic routes for commercially available antihistamines.
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Does CN107531667 cover the use of Compound A for treating conditions other than allergic rhinitis?
The claims, specifically Claim 8 and dependent claims, define the therapeutic indications covered. If other uses are not explicitly claimed, they are not protected by this patent.
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What is the typical lifespan for a patent on a new chemical entity in China, and are there provisions for extending this term?
In China, the term of a patent for an invention is 20 years from the filing date. Extensions may be available under specific circumstances, such as for pharmaceutical patents that have undergone lengthy drug approval processes, through Patent Term Extension (PTE) mechanisms.
Citations
[1] Liu, Q. (2018). Method for preparing a novel compound and novel compound and pharmaceutical composition thereof (China Patent CN107531667). State Intellectual Property Office of the People's Republic of China.
