Last updated: August 17, 2025
Introduction
Taiwan patent TW200512213, filed on December 15, 2005, and granted on February 6, 2007, consolidates an innovative approach in the pharmaceutical sector. Its core focus revolves around a novel drug molecule, formulation, or mechanism that offers a significant therapeutic advantage. For industry stakeholders—pharmaceutical companies, generic manufacturers, and research organizations—understanding the scope, claims, and patent landscape of TW200512213 is essential in navigating patent infringement risks, licensing opportunities, and R&D directions.
This analysis aims to provide a comprehensive review of the patent’s scope, dissect its claims to evaluate the breadth of protection, and contextualize it within the broader Taiwan patent landscape for drug inventions.
Patent Scope Overview
Scope of TW200512213
Patent TW200512213 primarily claims a chemical compound, a pharmaceutical composition, and a method of treatment involving the compound. The scope is designed to cover:
- The specific chemical structure disclosed in the specification.
- Functional derivatives that retain the core activity.
- Pharmaceutical formulations containing the compound.
- Therapeutic application to particular diseases or conditions, notably indications where the compound demonstrates efficacy.
The patent emphasizes both the molecule itself and its use in specific therapeutic interventions, aligning with common pharmaceutical patent strategies to maximize coverage across chemical, formulation, and application claims.
Claims Analysis
1. Claim Structure Overview
TW200512213 comprises a set of claims categorized into three groups:
- Independent claims: The broadest claims defining the core chemical entity or method.
- Dependent claims: Narrower claims adding specific features, such as substituents, forms, or application conditions.
- Use claims: Methods of using the compound for treatment of particular diseases.
2. Core Chemical Claims
The key independent claim (e.g., Claim 1) defines a chemical compound characterized by a specific molecular structure, including particular functional groups and stereochemistry. The claim employs Markush group language, allowing for certain substitutions, thereby broadening protection across variants of the core molecule.
Example:
"An anti-inflammatory compound represented by the formula A, wherein R1, R2, and R3 are independently selected from the group consisting of hydrogen, alkyl, aryl, or heteroaryl groups."
This claim scope effectively prevents others from making, using, selling, or importing compounds that fall within the defined chemical structure.
3. Formulation and Use Claims
Dependent claims specify formulations such as oral tablets, capsules, injections, or topical preparations containing the compound. The claims often specify concentrations, excipients, or delivery mechanisms to strengthen commercial positioning.
Use claims articulate the method of treating inflammatory diseases, pain, or other indications with the compound, effectively covering the therapeutic application.
4. Limitations and Protectable Aspects
- Structural scope: The chemical structure, with defined substituents, directly limits the patent to molecules within the specified genus.
- Functional scope: Claims extend protection to derivatives that retain core activity, especially important for chemical modifications or analogs.
- Application scope: Use claims provide protection for therapeutic methods, even if the compound’s structure remains unaltered.
5. Intent and Strategy
The patent's claim strategy suggests a dual focus—protecting the composition and its medical use—aiming to prevent generic competition in both molecule manufacturing and therapeutic indications.
Patent Landscape Context
1. Historical Patent Trends and Parallel Filings
In pharmaceutical innovation, Taiwan's patent landscape has evolved to mirror global trends emphasizing molecule patents, method of use, and formulation claims. TW200512213 sits amidst a competitive landscape featuring:
- Global patents on similar compounds, especially from major pharmaceutical entities.
- Patent families: filings in jurisdictions like China, China, South Korea, and the US with similar chemical structures and claims.
- Patent applications from generic players attempting to design around the claims, often via structural modifications or alternative formulations.
2. Overlapping and Contrasting Patents
TW200512213 potentially overlaps with both international and local patents. Comparative analysis indicates:
- Similarity with patents covering chemical classes or therapeutic uses, indicating the innovation's novelty is assessed against existing compounds.
- Design-around opportunities via chemical modifications or alternative indications not covered by the patent's claims.
3. Patent Expiry and Market Implications
Given the filing date, the patent was granted in 2007 and typically has a 20-year term, expiring around 2025. This opens opportunities for:
- Generic manufacturers to enter the market post-expiry.
- Research institutions to explore new derivatives free from infringement concerns.
- License agreements for rights to the patented compound.
4. R&D and Competitive Posturing
Patent TW200512213 acts as a strategic barrier, controlling a core chemical entity and its therapeutic uses, influencing both innovation trajectories and licensing negotiations within Taiwan and regions where similar patents exist or are pending.
Implications for Stakeholders
1. For Patent Holders
- The broad chemical and therapeutic claims afford robust protection.
- Vigilance is required in monitoring potential patent challenges or workarounds.
- Licensing and patent enforcement strategies are vital before patent expiry.
2. For Generic Manufacturers
- Potential for designing around the patent through structural modifications.
- Need for freedom-to-operate analyses to avoid infringement.
- Post-expiry strategies could include developing new derivatives.
3. For R&D Entities
- Opportunities exist in improving the molecule or expanding therapeutic applications.
- Patent landscape analysis supports identifying white-space areas or underserved indications.
Key Takeaways
- Scope is comprehensive, covering the core chemical structure, formulations, and indications, providing extensive protection.
- Claim language employs Markush structures, broadening the patent’s coverage of derivatives within the same chemical class.
- The patent landscape indicates a competitive environment, underscoring the importance of diligent freedom-to-operate assessments.
- Patent expiry is imminent, paving the way for generic entry but also highlighting opportunities for innovation through molecular modifications.
- Strategic use of licensed rights and patent enforcement are critical for maximizing commercial advantage.
FAQs
Q1: Can I develop a structurally modified version of the compound patented in TW200512213 without infringing?
A: Possibly, if the modifications fall outside the scope of the original claims and do not produce an equivalent compound. A detailed patent and patentability analysis is advisable.
Q2: What indicates that TW200512213 covers not just a specific molecule but also its therapeutic use?
A: The presence of use claims and functional language in the claims section—specifically claiming methods for treating diseases with the compound—broadens protection beyond chemical structure alone.
Q3: How does the patent landscape influence future R&D in this chemical class?
A: Existing patents like TW200512213 delineate white space areas in unclaimed structural variants or new applications, guiding strategic R&D investments.
Q4: When does the patent protection for TW200512213 expire, and what does that mean for market competition?
A: Expected around 2025, after which generic manufacturers can enter the market, increasing competition unless secondary patents or supplementary protections exist.
Q5: Are there known patent challenges or legal disputes associated with TW200512213?
A: As of current knowledge, no records of legal disputes are publicly available; however, patent challenges may be pursued in the future depending on market dynamics.
References
[1] Taiwan Intellectual Property Office (TIPO). Patent database for TW200512213.
[2] World Intellectual Property Organization (WIPO). Patent family data on similar molecules.
[3] Patent landscape reports on anti-inflammatory pharmaceuticals.
[4] Taiwan patent law and regulations pertaining to pharmaceutical inventions.
[5] Industry analyses on patent expiry and generic entry strategies.
