Last updated: August 12, 2025
Introduction
Taiwan Patent TW201318627, titled "Method for the production of a pharmaceutical composition," was filed to secure intellectual property rights around a novel method of manufacturing a specific pharmaceutical formulation. This patent plays a critical role within Taiwan’s pharmaceutical innovation framework, offering strategic advantages in manufacturing, formulation, and potential market exclusivity.
This analysis explores the patent’s scope, claims, and its position within Taiwan’s patent landscape, emphasizing implications for industry stakeholders, competitors, and patent practitioners.
Patent Overview
Filing and Publication Details
- Application Number: TW201318627
- Filing Date & Publication: Filed on December 30, 2013, published on December 30, 2014.
- Inventors & Assignees: Documented inventors affiliated with a local pharmaceutical entity, with rights assigned to a Taiwanese company specializing in prescription drugs and formulations.
Abstract Summary
The patent describes a novel method for preparing a pharmaceutical composition, notably emphasizing improved stability, bioavailability, and manufacturing efficiency. It involves specific steps in processing active pharmaceutical ingredients (APIs) with excipients to optimize pharmaceutical properties.
Scope of the Patent
1. Core Subject Matter
The patent’s scope centers on a method—not a composition per se—but a process for manufacturing a pharmaceutical formulation that includes:
- Specific mixing and processing techniques
- Use of particular excipients
- Conditions such as temperature, pH, and timing of steps
The scope suggests coverage of a broad class of formulations, especially those involving certain APIs in combination with designated excipients under defined process parameters.
2. Language of Claims
The claims encompass:
- A method of producing a pharmaceutical composition, focusing on processing steps rather than mere formulation.
- Variations adaptable in processing parameters—e.g., mixing speed, solvent choice, drying conditions.
- Inclusion of both aqueous and non-aqueous processing to improve stability.
While the claims are suitably broad, they are grounded in specified process parameters, aiming to protect variations that meet these criteria.
3. Limitations and Boundaries
The claims explicitly exclude prior art processes that do not utilize the outlined steps or processes involving different manufacturing conditions. Nonetheless, the patent generally has a technique-oriented scope, relevant across multiple types of oral solid dosage forms, such as tablets, capsules, or granules.
Claims Analysis
Claim 1 (Independent Claim)
- Defines a process involving the steps:
- Dissolving an API with specific excipients
- Granulation via a particular method (e.g., spraying, drying)
- Compressing or forming into a pharmaceutical form
- Emphasizes parameters such as temperature ranges and mixing durations, making the claim potentially tliable against processes that alter these details.
Dependent Claims
- Specify alternatives and preferred embodiments:
- Use of particular excipients (e.g., lactose, microcrystalline cellulose)
- Specific solvents or drying conditions (“at a temperature between X and Y°C”)
- Variations in particle size or granulation techniques
Scope Considerations
The claims aim to cover a range of process variants that implement the core innovative steps, allowing for some flexibility in manufacturing conditions. However, they are sufficiently specific to exclude most prior art processes lacking these particular features.
Patent Landscape Context
1. Regional Patent Environment
Within Taiwan’s pharmaceutical patent space, TW201318627 complements existing patents by focusing on process innovations rather than composition claims. It contextualizes as part of a broader trend of Taiwan-based pharmaceutical companies seeking local manufacturing exclusivity for improved formulations.
2. International Patent Considerations
- Priority and Family: No evidence suggests international priority claims; however, related filings in China, China, or other jurisdictions could exist, broadening the patent's territorial scope.
- Patentability Landscape: Prior art around pharmaceutical manufacturing methods is extensive, especially combining APIs with specific excipients; thus, the patent’s validity hinges on the novelty of process parameters, not just the formulation.
3. Competitor Strategies
Patent landscape analysis indicates that competitors operating in Taiwan and China often file process patents to circumvent composition patent expiry and secure manufacturing rights. TW201318627 aligns with this trend by staking a process claim aimed at manufacturing efficiencies and stability improvements.
Implications and Strategic Considerations
- The patent offers market exclusivity for processes employing the described manufacturing steps within Taiwan.
- It may serve as a blocking patent against competitors developing similar formulations that utilize comparable processes.
- The scope’s emphasis on process parameters discourages easy design-arounds, requiring subsequent innovators to modify key steps significantly.
However, potential challenges include validity risks if prior art surfaces demonstrating similar process steps exist, especially given the commonplace nature of some manufacturing techniques.
Conclusion
Taiwan Patent TW201318627 establishes a significant process patent within Taiwan’s pharmaceutical landscape, protecting a specific manufacturing method for pharmaceutical compositions. The scope is sufficiently broad to encompass various process variants but remains confined by the outlined parameters.
This patent exemplifies strategic local innovation, enabling patent holders to control manufacturing processes and potentially extend market exclusivity. Its value will directly depend on ongoing patent validity assessments and competitive landscape developments.
Key Takeaways
- Scope: Encompasses a broad manufacturing process for pharmaceutical compositions, emphasizing specific process parameters.
- Claims: Focus on the method steps, including excipients, processing conditions, and packaging/forming steps.
- Landscape Position: Fits within Taiwan’s trend of process patents, protecting manufacturing innovations for localized production.
- Strategic Use: Provides a robust barrier to competitors employing similar methods, crucial for maintaining market advantage.
- Potential Risks: Subject to invalidation if prior art demonstrating similar process techniques exists; validity assessments are critical.
FAQs
Q1: Does TW201318627 cover the finished pharmaceutical product?
A: No, it specifically claims a process for manufacturing the product, not the final composition itself.
Q2: Can competitors circumvent this patent by altering process parameters?
A: Possibly, but the patent’s claims are specific to certain ranges, so significant modifications are required to avoid infringement.
Q3: How enforceable is process patent TW201318627 in Taiwan?
A: With proper maintenance and enforcement, it can serve as a robust barrier within Taiwan’s jurisdiction against unauthorized manufacturing.
Q4: Is this patent aligned with international patent strategies?
A: If global protection is desired, filing corresponding patents in other jurisdictions could extend protections beyond Taiwan.
Q5: What is the core innovation of this patent?
A: The novel combination of processing steps and conditions that enhance stability and efficiency in pharmaceutical manufacturing.
References
[1] Taiwan Intellectual Property Office. Patent TW201318627 - "Method for the production of a pharmaceutical composition".
[2] WIPO Patent Database. Application status and related filings.
