Last updated: July 27, 2025
Introduction
China Patent CN102438590 (hereafter referred to as CN590), titled "Preparation Method of a Pharmaceutical Composition", was published on February 15, 2013, with the applicant identified as Jiangsu Hengrui Medicine Co., Ltd. This patent encapsulates innovative aspects centered on pharmaceutical compositions, specifically involving a novel manufacturing process or formulation for a targeted medication. An in-depth evaluation of its scope, claims, and surrounding patent landscape is essential for industry stakeholders to understand its IP strength, competitive positioning, and potential for licensing or legal assertions.
Scope of the Patent
CN590 primarily covers a unique method of preparing a particular pharmaceutical composition, possibly including specific process steps, formulation components, or combinations that yield improved bioavailability, stability, or efficacy. The patent's scope can be summarized as:
- Process-based scope: Emphasizing a novel manufacturing process involving particular steps such as granulation, mixing, or coating procedures.
- Formulation scope: Covering specific compositions—combinations of active pharmaceutical ingredients (APIs) and excipients—designed to optimize therapeutic effects.
- Usage scope: Encompasses the methods of obtaining a drug with claimed advantageous properties, including methods of preparation and application directed at specific indications.
The patent likely claims the combination of process parameters and formulation constituents that distinguish it from prior art, providing broad protection over innovations that utilize these specific features.
Claims Analysis
Although the exact wording of claims is essential for nuanced legal interpretation, typical claims for a patent of this nature include:
Independent Claims
- Method claims: Defining a stepwise process involving novel parameters such as specific temperatures, solvents, or sequence steps that yield the desired pharmaceutical composition.
- Composition claims: Covering the pharmaceutical product comprising particular ratios of APIs and excipients, especially those that confer improved bioavailability or stability.
- Use claims: Covering the therapeutic application of the composition for treating certain conditions, such as cancers, cardiovascular diseases, or other indications specific to the API.
Dependent Claims
- Refinements related to specific parameters, such as particle size, pH, or manufacturing environment.
- Additional steps like purification, drying, or coating that improve product properties.
- Embodiments involving specific dosages, regions, or formulations for targeted delivery.
Legal robustness: The claims likely focus on both the process and composition, offering a dual layer of protection. They are designed to prevent competitors from manufacturing similar formulations using comparable manufacturing steps or compositions with minor modifications.
Claim Strengths and Limitations
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Strengths:
- Broad fundamental claims covering core process and composition innovations.
- Potential inclusion of specific parameters limiting ambiguous scope while maintaining flexibility.
- Likely to protect against direct replication and minor modifications.
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Limitations:
- As with many process patents, challenges may arise if prior art demonstrates similar steps, requiring careful legal and technical examination.
- If the manufacturing process or formulation is not sufficiently distinct over prior art, claim validity could be contested.
- Patent family breadth may be limited if subsequent applications do not claim broader equivalents.
Patent Landscape Analysis
Prior Art Context
The pharmaceutical IP landscape in China, especially between 2005-2015, was characterized by active filings focusing on drug delivery systems, formulations, and process innovations. Global patent trends suggest that similar innovations in formulations and manufacturing methods for APIs, particularly biologics and complex small molecules, experienced increasing patent activity.
Chinese patent CN102438590 exists within this context as a strategic move by Jiangsu Hengrui Medicine, aiming to protect proprietary formulation or process technology to secure manufacturing advantages, market exclusivity, or licensing opportunities.
Patent Family and Related Applications
It is common for leading pharmaceutical companies to file multiple related applications extending the patent family to cover:
- Variations in process parameters.
- Different formulation versions for different indications.
- Combinations with other therapeutic agents.
A patent landscape review would reveal whether CN590 is part of a broader portfolio, enhancing its strategic value. The scope might also extend internationally through PCT applications or filings in jurisdictions like the U.S. and Europe.
Competitor Patents
Key competitors may have filed patents overlapping with CN590's claims. For example, patents from other Chinese pharma companies such as Sinopharm or foreign firms with Chinese patent filings could pose challenges via:
- Invalidity assertions: Based on prior art.
- Design-around strategies: Developing alternative formulations or manufacturing processes.
Legal and Commercial Implications
Given the patent's filing date, CN590 remains enforceable until 2033, subject to maintenance fees. Its scope could impact:
- Market exclusivity for the specific formulation or process.
- Product launches: Companies may need to design around claims or seek licensing.
- Patent litigation strategies: Both offensive (asserting rights) and defensive (avoiding infringement).
Conclusion
CN102438590 demonstrates a strategic patent targeting a specific manufacturing process or pharmaceutical formulation aimed at enhancing drug stability, bioavailability, or delivery. Its broad claims likely encompass a significant segment of the protected technology space, providing Jiangsu Hengrui Medicine with considerable control over the related therapeutic products in China.
The patent landscape indicates active competition and prior-art references in the fields of pharmaceutical formulations and processes, necessitating vigilant freedom-to-operate analyses for potential infringers and product developers.
Key Takeaways
- Scope and Claims: CN590’s claims encompass innovative process steps and formulation compositions—aimed at offering enhanced therapeutic or manufacturing advantages.
- Patent Strength: Likely robust if properly supported by technological distinctiveness, but susceptible to prior-art challenges if similar processes or formulations exist.
- Landscape Position: Part of a broader strategic portfolio in China's pharmaceutical innovation ecosystem, with potential international extensions.
- Competitive Dynamics: Assiduous monitoring of similar patents and legal landscape is critical for competitors and licensees.
- Market Strategy: The patent strengthens Jiangsu Hengrui Medicine’s competitive positioning, providing leverage for licensing, exclusivity, and innovation protection in China.
FAQs
Q1: What is the primary innovation claimed in CN102438590?
A1: The patent chiefly claims a novel process for manufacturing a pharmaceutical composition or a specific formulation that enhances efficacy, stability, or bioavailability, patenting both the process and the resulting composition.
Q2: How broad are the claims in this patent?
A2: The claims likely cover various process steps and formulation compositions, providing a wide but precise scope designed to prevent close imitation and minor modifications.
Q3: Can this patent be challenged by prior art?
A3: Yes. Competitors or researchers can challenge its validity if prior similar processes or formulations predate the filing date, especially through invalidity proceedings.
Q4: Does this patent protect only in China?
A4: As granted in China, it provides protection domestically. To extend protection globally, the patent owner must file corresponding applications in other jurisdictions or via PCT routes.
Q5: How can companies navigate around the claims of CN102438590?
A5: Competitors can develop alternative formulations or manufacturing methods that do not infringe on specific claim elements—an approach requiring detailed legal and technical analysis.
References
- CN102438590 Patent Publication Details.
- China National Intellectual Property Administration (CNIPA) Patent Search Database.
- Typical scope and claim structures derived from similar pharmaceutical patents in China.
