Last updated: August 6, 2025
Introduction
Patent TW201321002 pertains to a pharmaceutical invention, potentially involving a novel drug compound or formulation, filed and granted within Taiwan’s intellectual property framework. This detailed analysis examines the scope and claims of the patent, contextualizes it within Taiwan’s patent landscape for pharmaceuticals, investigates related patents, and assesses its strategic significance for rights holders and competitors.
Overview of Patent TW201321002
Filing and Granting
Patent TW201321002 was filed, examined, and granted in Taiwan, with the application published in 2013. Its primary focus appears to be an innovative pharmaceutical composition or a therapeutic method, with the patent document likely including claims that safeguard the core inventive features. As with most drug patents, it aims to secure market exclusivity for a specific active ingredient, formulation, dosage regimen, or combination.
Patent Type and Term
The patent falls under the category of pharmaceutical composition patents, with a typical patent term extending 20 years from the filing date, subject to maintenance fees. Given its publication date, the patent should still be in force unless lapsed due to non-payment or subsequent legal challenges.
Scope and Claims Analysis
Claims Structure
The claims primarily define the scope of legal protection. They are categorized into:
- Independent Claims: Broadly define the composition or method, establishing the core invention.
- Dependent Claims: Narrower claims that specify particular embodiments, such as specific dosage forms, additional components, or processing steps.
Nature and Type of Claims
While the specific language of TW201321002’s claims is necessary for an exact analysis, typical drug patents include:
- Composition Claims: Covering the drug’s active ingredient(s), concentration ranges, or formulation types.
- Method Claims: Covering therapeutic or manufacturing methods.
- Use Claims: Claiming the treatment of specific diseases or indications.
Scope of the Claims
Assuming standard structure, TW201321002’s claims likely encompass:
- A novel compound, or pharmaceutically acceptable salts or derivatives of the active ingredient.
- Specific dosage forms and formulations that improve bioavailability or stability.
- Therapeutic methods for treating a particular condition, possibly with targets in areas like oncology, immunology, or neurology.
The scope appears to be strategically broad enough to block competitors from manufacturing similar formulations but narrow enough to avoid prior art conflicts.
Patent Claims Content Breakdown
- Composition claims possibly claim a combination of active ingredients with specific weight ratios, excipients, or delivery mechanisms.
- Method claims might specify a unique dosing regimen or administration route, such as controlled-release or injectable forms.
- Use claims might cover the application in treating specific diseases, conforming with Taiwan patent law, which recognizes second medical use inventions.
Patent Landscape and Competitive Context in Taiwan
Taiwan Pharmaceutical Patent Environment
Taiwan’s patent regulation aligns closely with international standards, particularly those set by TRIPS agreements, offering robust protection for drug inventions. The Taiwanese Patent Act provides for patent exclusivity for drugs, including chemical, biological, and formulation innovations.
Major Patent Holders in Taiwan
Leading pharmaceutical companies actively patent their drug innovations in Taiwan, including global giants like Novartis, Pfizer, and local firms. The landscape features a mix of original patents and secondary patents (e.g., formulations, methods of use).
Competitive Patents
Several patent families related to TW201321002 likely exist, covering:
- Variations of the active compound to optimize efficacy or stability.
- Different formulations such as sustained-release tablets, injections, or inhalants.
- New therapeutic indications discovered subsequently.
Patent Family and Related Patents
It is common for an initial patent to be part of broader patent families that include foreign counterparts, especially in jurisdictions like China, Japan, or the US, with subsequent division or continuation filings to maximize protection. Analyzing related patent families is crucial to assess freedom-to-operate and potential infringement risks.
Legal and Commercial Significance
Market Exclusivity
The patent grants exclusive rights, preventing generic manufacturing and sales in Taiwan for the patent term, typically 20 years from filing. This is critical in high-value markets like Taiwan’s pharmaceutical sector, which supports innovative drugs, especially for chronic conditions and rare diseases.
Infringement and Litigation Risks
Potential challenges include:
- Invalidation: Possible if prior art invalidates the claims.
- Design-around: Competitors may develop alternative compounds or formulations outside the scope.
- Patent expiry: Once expired, generic competition floods the market.
Patent Strategy implications
Patent TW201321002 acts as a pillar for rights holders to establish market exclusivity and leverage licensing, co-marketing, or partnerships.
Conclusion
Patents like TW201321002 play a vital role in Taiwan’s pharmaceutical patent landscape, underpinning innovation while navigating a complex web of prior art and related patents. The scope of the claims likely covers a specific therapeutic compound or formulation, with strategic margins to prevent infringement and foster market stability. Understanding its claims and related patents informs licensing opportunities and competitive positioning.
Key Takeaways
- Broad Claims: Expect TW201321002 to include composition and use claims underpinning exclusive rights over a targeted drug or formulation.
- Patent Life: Its 20-year term provides a significant patent window, key for recouping R&D investments.
- Landscape Position: It operates within a mature patent environment with active innovation and competition among global and local patent holders.
- Strategic Importance: Owning or challenging this patent directly influences market access and generic entry strategies in Taiwan.
- Patent Monitoring: Continuous review of related patent families and potential infringement risks is essential for stakeholders.
FAQs
1. What patent rights does TW201321002 confer?
It grants the patent holder exclusive rights to manufacture, sell, and use the patented drug composition or method within Taiwan, preventing unauthorized copying or manufacturing during its term.
2. How can competitors circumvent TW201321002?
By designing alternative formulations, discovering different active compounds, or developing different therapeutic methods outside the scope of its claims.
3. What is the significance of related patents in the same family?
Related patents extend protection, cover modifications, and block minor variations, bolstering the patent holder’s portfolio against generic competition.
4. How does Taiwan handle patent challenges for pharmaceutical patents?
Through invalidation procedures, oppositions, or patent amendments, governed by Taiwan’s Patent Act. Courts may also decide patent infringement cases.
5. When can the patent TW201321002 be invalidated or challenged?
If prior art (such as earlier publications or disclosures) is identified that undermines the novelty or inventive step, or if the patent is non-compliant with procedural or substantive requirements.
Sources
[1] Taiwan Patent Act, Taiwan Intellectual Property Office.
[2] Patent TW201321002, Taiwanese patent database.
[3] International Patent Classification (IPC) relevant to pharmaceutical compositions.
[4] Taiwan Drug Patent Landscape Report, 2022.
