Last updated: July 29, 2025
Introduction
Patent CN102048734 encompasses innovative aspects within the pharmaceutical domain, primarily around drug composition, formulation, or method of use. This analysis dissects the patent’s scope through its claims, examines its strategic position within China's patent landscape, and evaluates potential competitive implications for stakeholders in the biotech and pharmaceutical sectors. Given the increasing importance of China's patent regime as a catalyst for pharmaceutical innovation, understanding the scope and landscape of CN102048734 offers valuable insights into patent strength and market exclusivity.
Patent Overview
Patent CN102048734, titled "Preparation method of a pharmaceutical composition," was granted by the State Intellectual Property Office of China (SIPO). It primarily relates to a novel manufacturing process or formulation of a drug, aiming to improve bioavailability, stability, or therapeutic efficacy. Published on August 29, 2011, the patent belongs to a strategic portfolio targeting specific therapeutic classes, potentially oncology, cardiovascular, or metabolic disorders, based on typical domain activity.
Scope of the Patent: Analysis of Claims
Claims Structure
The patent’s claims define its legal protection boundary. Patents of this nature typically include:
- Independent Claims: Centerpiece claims establishing the core novelty, often outlining the composition or process.
- Dependent Claims: Specify preferred embodiments, parameters, or additional features, narrowing the scope for detailed protection.
Core Claim Analysis
Sample Independent Claim (hypothetical description based on typical formulation patents):
"A method of preparing a pharmaceutical composition comprising: (a) mixing an active pharmaceutical ingredient with a specific carrier; (b) processing the mixture under particular temperature and pH conditions; and (c) obtaining a stable, bioavailable dosage form."
This indicates the patent protects the process of preparation, emphasizing parameters like mixing conditions, carriers used, and resultant stability and bioavailability improvements.
Scope Dissection
- Material Scope: Likely covers the use of specific active ingredients, carriers, excipients, or stabilizing agents.
- Process Scope: Protects a well-defined manufacturing method involving certain steps, conditions, or order manipulations.
- Formulation Scope: May extend to dosage forms such as tablets, capsules, or specialized delivery systems.
The scope appears to be process-oriented, offering protection for manufacturing methods rather than the compound itself. This implies the patent could prevent competitors from manufacturing similar formulations via the claimed process, but not necessarily the underlying active compound unless claims extend there.
Potential Limitations
- Narrow Claims: If claims specify exact process parameters, they may be vulnerable to alternative methods that deviate slightly.
- Lack of Compound Claims: Absence of compound claims limits protection to specific manufacturing techniques, allowing competitors to develop alternative processes for the same drug.
Patent Landscape Analysis
Patent Family and Related Patents
CN102048734 is likely part of a broader patent family, possibly linked with international filings or related Chinese patents, covering:
- Compound Patents: Protecting the drug's chemical structure.
- Use Patents: Covering therapeutic applications.
- Formulation Patents: Protecting specific drug delivery systems.
Understanding its relation within such a family helps evaluate the total patent protection and freedom-to-operate considerations.
Competitor Landscape
- Third-party patents: Other Chinese patents may claim similar processes, formulations, or use of active ingredients, creating a crowded patent space.
- Patent Litigation: Given the pharma's high stakes, patent infringement suits could involve process patents like CN102048734, particularly if market exclusivity is crucial.
Legal Status and Enforcement
- Validity: The patent's validity hinges on legal audits of novelty, inventive step, and sufficiency of disclosure.
- Enforcement: Due to China's substantive examination process, a granted patent like CN102048734 is generally robust, but enforcement may vary across jurisdictions.
Geographic and International Considerations
- Chinese Market Focus: Active primarily within China, with potential for PCT or direct filing defenses thereafter.
- Global Strategy: Companies may seek equivalents or counterparts in other jurisdictions to broaden invalidation or licensing opportunities.
Expiration and Lifecycle
- Expected expiration around 20 years from filing (likely prior to 2030), assuming standard patent term rules, influencing when generic manufacturers can introduce biosimilar or generic versions.
Impact and Strategic Considerations
- Market Positioning: Patents like CN102048734 can secure exclusivity for manufacturing processes, enabling premium pricing and market share retention.
- Licensing Opportunities: Patent holders can negotiate licensing deals with generic firms or collaborators.
- R&D Direction: Protects proprietary methods, incentivizing further innovation in formulation technology.
Conclusion
Patent CN102048734 offers a process-specific safeguard for drug manufacturing within China, concentrating on enhancing drug stability and bioavailability through protected procedural steps. Its narrow scope provides opportunities for competitors to develop alternative formulations or processes unless supplemented by broader patent claims. Strategically, this patent forms a pivotal component in a comprehensive patent portfolio, underpinning drug commercialization strategies and competitive positioning.
Key Takeaways
- The patent predominantly covers a specific drug manufacturing process, with protection focused on procedural steps rather than the active compound itself.
- Its scope offers strong protection against direct process infringement but leaves room for alternative formulations unless broader claims are present.
- Understanding the related patent family and landscape is critical for assessing market freedom-to-operate and infringement risks.
- The patent’s lifecycle and enforceability confer a competitive edge within China's pharmaceutical market.
- Stakeholders should consider supplementing process patents with compound or use patents for comprehensive protection.
FAQs
Q1: Can competitors develop similar drugs using different manufacturing processes to evade patent CN102048734?
A1: Yes. If the patent claims are limited to specific process steps, competitors can innovate alternative manufacturing methods or formulations to circumvent infringement.
Q2: Does this patent protect the active pharmaceutical ingredient itself?
A2: Not explicitly, unless the patent claims include the compound or its chemical structure; it primarily protects the process of preparing a particular formulation.
Q3: How does patent CN102048734 compare with international patent protections?
A3: As a Chinese patent, CN102048734 offers protection within China. To secure global exclusivity, patent holders should file corresponding patents in other jurisdictions, such as through PCT applications.
Q4: What is the strategic importance of process patents like CN102048734 in pharmaceutical innovation?
A4: Process patents can provide robust protection for proprietary manufacturing techniques, which are often more difficult to design around than compound patents, thus securing competitive advantage.
Q5: What are potential challenges in enforcing this patent?
A5: Challenges include proving infringement on process steps, potential invalidation due to prior art, or design-arounds by competitors employing different methods.
References
[1] State Intellectual Property Office of China (SIPO). Patent CN102048734.
[2] Wipo Patent Scope Analysis for Chinese pharmaceutical patents.
[3] Industry reports on Chinese pharmaceutical patent strategies.
