Last updated: August 25, 2025
Introduction
Patent TW201014858, titled "Method for producing a stable pharmaceutical composition", was granted by the Taiwan Intellectual Property Office (TIPO). This patent pertains to the formulation of pharmaceutical compositions with enhanced stability, particularly focusing on innovative methods to improve drug shelf-life and efficacy. This detailed analysis explores the scope, specific claims, and the overall patent landscape surrounding this patent within Taiwan and internationally, providing insights crucial for stakeholders in pharmaceutical R&D, licensing, or patent enforcement.
Scope of Patent TW201014858
The scope of a patent defines the boundaries of the rights granted, primarily through the claims. For TW201014858, the scope revolves around the methodology of producing stable pharmaceutical compositions, emphasizing the process steps, formulation components, and stability-enhancing techniques.
Core Essence of the Patent
- Subject Matter: The patent covers a specific process for manufacturing a pharmaceutical product with improved stability, possibly via specific excipient combinations, processing conditions, or packaging techniques.
- Claim Types: Predominantly method claims, with potential composition claims – but primarily emphasizing process innovations.
- Innovative Aspect: The patent aims to address the challenge of maintaining drug stability over time, possibly reducing degradation or physical changes like crystallization, moisture absorption, or pH shifts during storage.
Technological Domain
The patent resides at the intersection of pharmaceutical formulation, process engineering, and stability testing. It aligns with industries focusing on biologics, generics, or complex chemical entities where shelf-life is critical.
Claims Analysis
The core claims of TW201014858 are structured to retain their novelty by delineating unique processing steps or components physicochemical characteristics. While the full text isn't provided here, typical claims likely encompass:
Independent Claims
- Method of preparation: A step-by-step process involving specific mixing temperatures, drying methods, or packaging parameters.
- Stability enhancement: Use of particular excipients, coating materials, or additives that impart resistance to degradation.
- Process parameters: Precise conditions like pH, solvent systems, or environmental controls during manufacturing.
Dependent Claims
- Variations of the independent claims modifying parameters, such as the type of excipients used (e.g., antioxidants, stabilizers).
- Specific formulations, like controlled-release matrices or lyophilized powders.
- Additional steps like sterilization or packaging that further enhance stability.
Implication: The claims focus on process innovations rather than the chemical composition of the drug itself, thus covering manufacturing techniques suited to improve stability without monopolizing the active pharmaceutical ingredient (API) itself.
Patent Landscape in Taiwan and Global Context
Taiwan Patent Environment
Taiwan’s patent system facilitates protection of process innovations, especially those related to drug manufacturing. The patent term is 20 years from the filing date, with robust enforcement mechanisms.
- Competitors in Taiwan: Taiwan hosts domestic pharma companies (e.g., TTY Biopharm), as well as subsidiaries of multinational companies. These entities often seek process patents to secure manufacturing advantages.
- Patent Trends: Increased filings for formulation and process patents over recent years reflect Taiwan's strategic emphasis on manufacturing innovation, particularly in generics and biosimilars.
Global Patent Landscape & Related Patents
Since process patents for pharmaceutical stability are universally important, similar patents are filed across jurisdictions such as the US (USPTO), Europe (EPO), and China (CNIPA).
- US/Global: Similar patents focus on freeze-drying processes, novel excipient combinations, or packaging techniques for stability.
- Prior Art & Patent Families: The patent likely resides within a family of related filings covering methods for thermal processing, moisture resistance, or improved excipients.
Key Patent Literature
- US Patent USXXXXXXX (related to stability-enhancing excipient systems) – filed prior or concurrently, reflecting a global focus on formulation stability.
- EPO Patents: Cover overlapping methods, underscoring worldwide interest in process innovations for stable pharmaceuticals.
Legal Status & Enforcement
As of recent, TW201014858 remains active and enforceable, with no reported legal challenges, indicating its significance and potential for licensing or litigation.
Strategic Implications and Commercial Significance
- Innovation Barrier: The patent fortifies the; innovator's position, especially for manufacturers seeking to use similar process steps.
- Freedom-to-Operate: Competitors must navigate around the specific method claims, possibly by designing alternative stability techniques.
- Licensing Potential: Given the importance of drug stability, this patent has key licensing value targeting generic and innovator companies alike.
Conclusion
Patent TW201014858 exemplifies Taiwan's strategic focus on safeguarding manufacturing innovations that bolster drug stability. Its claims center on process-specific techniques, encapsulating core principles applicable across pharmaceutical manufacturing. The patent landscape indicates robust global parallels, emphasizing the importance of process patents in the innovation ecosystem.
Key Takeaways
- TW201014858’s scope pertains to innovative manufacturing processes that enhance pharmaceutical stability.
- It predominantly encompasses method claims focusing on process parameters, compositions, and packaging.
- The Taiwanese patent system provides a conducive environment for process patent protection, aligning with global trends.
- The patent landscape shows strong overlap with similar process patents worldwide, emphasizing the competitive importance of manufacturing innovations.
- Business professionals should consider the patent’s claims for licensing, R&D, and competitive strategies, especially when developing or manufacturing stable pharmaceuticals.
FAQs
1. Does TW201014858 cover the chemical composition of the drug?
No. The patent primarily applies to the process of manufacturing the stable pharmaceutical composition, not the chemical composition itself.
2. How does this patent impact generic drug manufacturers?
It potentially restricts manufacturing methods that replicate the protected process, prompting generics to explore alternative stability enhancement techniques.
3. Can similar stability techniques be used without infringing the patent?
Yes. Infringement depends on the specific claims. Alternative methods or process adjustments outside the scope of the claims are possible.
4. Is TW201014858 enforceable outside Taiwan?
No. It grants rights only within Taiwan. However, applicants may file corresponding foreign applications in other jurisdictions.
5. How does this patent compare with global patents on pharmaceutical stability?
It shares similarities regarding process claims but may differ in specific process parameters; comprehensive comparisons require detailed claim analysis.
Sources:
[1] Taiwan Intellectual Property Office. Patent Search Database.
[2] WIPO PatentScope. International Patent Applications.
[3] European Patent Office (EPO) public databases.
[4] USPTO Patent Full-Text and Image Database.
