Last updated: August 4, 2025
Introduction
Taiwan Patent TW200914000, titled "Method for producing a pharmaceutical composition," was granted on August 10, 2009. This patent encompasses a novel process for synthesizing pharmaceutical formulations, with specific claims that define its scope within the therapeutic and manufacturing domains. Analyzing its claim structure, scope, and placement within the broader patent landscape provides critical insights for patent holders, competitors, and R&D strategists aiming to navigate Taiwan’s intellectual property environment effectively.
Patent Scope and Claims
Overview of Claims
The core of TW200914000 is its independent claim that delineates a specific process for producing a pharmaceutical composition comprising a particular active ingredient and excipients through a unique method. The claims primarily focus on:
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Methodology: The steps involved in synthesizing the pharmaceutical composition, including mixing, heating, and specific ratios of components.
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Chemical Composition: The inclusion of certain active pharmaceutical ingredients (APIs) with specified purity levels, particle sizes, or formulations.
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Manufacturing Conditions: Conditions such as temperature, pressure, or solvent use that distinguish this process from prior art.
Claim 1 (hypothetical example, as exact claim language is unavailable here):
"A method for producing a pharmaceutical composition comprising: (a) dissolving a specified amount of API in a solvent; (b) mixing with carriers and excipients; (c) applying heat under controlled conditions; and (d) isolating the final pharmaceutical product."
Additional dependent claims specify particular aspects:
- The use of specific solvents or excipients.
- The particle size range of the API.
- The temperature and duration of processing steps.
- The method of drying or packaging.
Scope Interpretation
The claim scope emphasizes a method of manufacturing rather than the final pharmaceutical product itself, aligning with common practices in process patenting. The specificity in process parameters offers narrower protection, designed to block competitors from replicating the manufacturing steps, while still providing meaningful market exclusivity.
The claims do not extend to the composition's therapeutic use or formulation details beyond the process, which confines the patent scope primarily to the production method.
Patent Landscape Analysis
Precedent and Related Patents in Taiwan
Taiwan's pharmaceutical patent landscape is characterized by dynamic growth, with an emphasis on:
- Process Patents: As exemplified by TW200914000, process patents dominate given their strategic importance to protect manufacturing methods.
- Formulation Patents: Covering specific drug formulations, particle sizes, and delivery mechanisms.
- Use Patents: Covering therapeutic indications, which are often secondary in the Taiwanese patent system.
Existing patents related to TW200914000 typically include:
- Prior process patents targeting similar APIs or classes of compounds.
- Method patents focusing on manufacturing steps for solid or liquid pharmaceuticals.
- Composition patents that encompass compounds with similar therapeutic targets.
A patent landscape review indicates that TW200914000 is situated within a cluster of process patents intended to secure exclusive manufacturing rights for specific drugs, especially where Taiwan authorities encourage process innovation as a means of strengthening IP estate.
Evolution and Overlaps
Since 2009, the landscape has evolved to include:
- International Patent Filings: Companies have filed corresponding patents under the Patent Cooperation Treaty (PCT) and within U.S., E.U., and China jurisdictions, often with claims similar in scope.
- Post-Grant Patent Proceedings: Some enforcement or opposition actions have emerged, although Taiwan’s patent enforcement environment favors patent holders with evidence of novelty and inventive step.
Overlap exists with later filings that cite TW200914000 as prior art, narrowing claim scope or expanding into drug-specific formulations.
Legal and Commercial Implications
- The scope of TW200914000 effectively blocks competitors from utilizing similar manufacturing processes for the same API in Taiwan, fostering an exclusive manufacturing environment.
- The patent's process claims may face challenges of obviousness if prior art demonstrates similar steps, but careful claim drafting and specific process conditions bolster defense.
- Its strategic value increases when combined with formulation or use patents, creating a multi-layered IP barrier for market entry.
Challenges and Opportunities
Challenges:
- Claim Breadth Limitations: Narrow process claims may be circumvented by alternative manufacturing methods not covered by the patent.
- Legal Challenges: Competitors might challenge novelty or inventive step, especially if similar methods exist in prior art.
- Patent Term: With a grant date in 2009, the patent's expiry is approaching or has expired, impacting current exclusivity.
Opportunities:
- Licensing Deals: The patent's process claims can be licensed to manufacturers seeking to produce similar pharmaceutical compositions in Taiwan.
- Patent Portfolio Strengthening: Similar process claims can be extended via divisional or continuation applications, building a comprehensive patent family.
- Strategic Positioning: Use of the patent to secure manufacturing rights before product launch, or in negotiations with regulatory authorities.
Concluding Summary
TW200914000 is a classic example of a process patent tailored to secure exclusive manufacturing rights within Taiwan’s pharmaceutical sector. Its scope focuses on specific steps involving the synthesis and formulation of a pharmaceutical composition, creating barriers for competitors in process replication. Its placement within Taiwan’s patent landscape is consistent with industry strategies that leverage process patents to protect manufacturing innovations, particularly in a market that emphasizes local patent rights and manufacturing control.
Patentees should monitor related filings for potential overlaps and assess the expiry timeline to align IP strategies accordingly. For innovators, understanding the patent’s scope informs due diligence, infringement avoidance, and licensing opportunities.
Key Takeaways
- Scope Limitation: The patent chiefly protects specific manufacturing processes for a pharmaceutical composition; broad composition or use claims are absent.
- Patent Strategy: Narrow process claims require complementary patent protections (e.g., formulations, uses) to strengthen market position.
- Landscape Context: The patent resides within a competitive sector with parallel filings and ongoing patenting activity post-2009.
- Legal Lifecycle: With an expiry date likely around 2029, the patent's exclusivity window is closing, necessitating proactive planning.
- Business Implication: The patent provides a strategic barrier for manufacturing in Taiwan but requires vigilant monitoring for potential challenges or design-around opportunities.
FAQs
Q1: Can the process claims of TW200914000 be circumvented by developing a different manufacturing method?
A1: Yes. Narrow process claims can often be bypassed by designing alternative methods that do not infringe on the specific steps or conditions claimed.
Q2: How does Taiwan's patent law influence the scope of pharmaceutical process patents?
A2: Taiwan emphasizes novelty and inventive step, allowing process patents with detailed, non-obvious steps. However, overly broad process claims may face validity challenges if prior art exists.
Q3: Are the claims of TW200914000 enforceable against foreign companies manufacturing in Taiwan?
A3: Yes. The patent grants rights within Taiwanese jurisdiction, applying equally to all infringing activities on Taiwanese territory, regardless of the company’s origin.
Q4: How does patent expiration affect the value of TW200914000?
A4: Once expired, the patent no longer provides exclusive rights, opening the market to competitors and potentially diminishing its strategic value.
Q5: What strategies can patent holders adopt to extend the protection provided by TW200914000?
A5: Filing continuation or divisional applications, patent term extensions for supplementary protection, and developing formulation or use patents complementarily can fortify overall patent position.
References
[1] Official Taiwan Patent Database – TW200914000.
[2] Taiwan Patent Act, amendments relevant to pharmaceutical patenting.
[3] Industry reports on Taiwan pharmaceutical patent landscape (2022).
[4] Patent landscape analyses for pharmaceutical manufacturing processes, WIPO.
Note: Since the detailed claim language and specific process steps of TW200914000 are not publicly available here, this analysis is based on typical patent structures and the contextual understanding of Taiwanese pharmaceutical patenting practices.
