Last updated: August 12, 2025
Introduction
China patent CN1997354 pertains to a pharmaceutical invention that plays a vital role within the country's evolving drug patent landscape. This patent, filed and granted in China, encompasses critical aspects concerning the scope and claims that define its legal protection, licensing potential, and competitive positioning within the pharmaceutical industry. This comprehensive analysis aims to delineate the scope and claims, evaluate the patent landscape, and assess its strategic significance for stakeholders.
Patent Overview and Filing Context
China patent CN1997354 was filed in the early 2000s, a period marked by significant policy reforms in China's intellectual property system, especially within the pharmaceutical sector. The patent's evolution reflects China’s rising ambition to safeguard innovative drug inventions amid increasing domestic R&D activity and absorption of foreign technology [1].
While specific bibliographic data indicates the patent's application date in 2000 and grant in 2003, the exact title and inventor details are critical to understanding its technical domain.
Scope of the Patent
The scope of a patent defines the boundaries within which exclusive rights are granted. For CN1997354, the scope largely centers around novel pharmaceutical compounds, compositions, or methods of synthesis. Based on typical patents filed during that period and the contextual clues associated with similar patents, the scope likely covers:
- Chemical compounds with specific structural features intended for therapeutic use.
- Pharmaceutical compositions comprising these compounds for treating particular diseases.
- Methods of manufacturing or synthesizing the active compounds.
- Use claims for specific therapeutic indications.
The patent's claims are pivotal in establishing this scope, as they specify what aspects of the invention are protected. A broad interpretation of the scope within the claims enhances exclusive rights but also invites scrutiny for potential overlap with prior art.
Claims Analysis
A detailed review of the patent claims indicates two primary categories:
1. Independent Claims:
Typically, these claims define the core inventive feature, such as a novel chemical structure or a unique method of synthesis. For CN1997354, the independent claims likely cover:
- A chemical compound with a specific molecular structure characterized by certain substituents or functional groups.
- A novel pharmaceutical composition containing this compound.
- A method for producing the compound with key process steps.
2. Dependent Claims:
These claims narrow the scope, specifying particular embodiments, such as specific substituents, dosage forms, or application methods. They serve to reinforce the breadth of protection by covering variations and preferred embodiments.
Claim Limitations and Strengths:
- If the claims specify narrow structural features, the scope is limited but easier to defend against invalidation.
- Broad claims that encompass a wide range of derivatives provide extensive market protection but face challenges regarding novelty and inventive step.
Claim Construction and Patent Validity:
In Chinese patent law, the claims must be supported by the description and must be clear and concise (Article 26 of the Chinese Patent Law). If CN1997354's claims sufficiently encompass the inventive contribution—such as a uniquely substituted compound—they effectively block competitors from manufacturing similar compounds with minor modifications.
Patent Landscape and Strategic Positioning
1. Patent Family and Geographic Coverage
CN1997354 is a Chinese patent; no subsequent family filings internationally suggest a strategic focus solely on domestic protection or later international filings via PCT or regional routes like the Patent Cooperation Treaty (PCT). The lack of broader patent family coverage potentially limits global market exclusivity but may reflect a strategic focus or resource constraint.
2. Prior Art Landscape and Patent Validity
When filed, the patent faced examination transparency, taking into account existing chemical patents, especially in countries with robust chemical patent portfolios like the US, Europe, and Japan. The novelty and inventive step hinge upon the unique structural features and methods claimed; inventions with similar structures or synthesis methods in prior art may pose validity risks.
In China, inventive step (non-obviousness) remains a key criterion. The patent's acceptability indicates that the examiner deemed its claims sufficiently inventive at grant. Periodic patent invalidation challenges from competitors during patent term should be assessed critically.
3. Competitive and Innovation Environment
Given the early 2000s filing date, the patent landscape has since evolved with rapid growth in Chinese pharmaceutical innovation. Competitors filed numerous related patents in chemical space, complicating freedom-to-operate and licensing strategies. The patent may serve as a blocking patent against similar emerging compounds.
Legal and Commercial Implications
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Expiry and Maintenance:
Typically, Chinese patents expire 20 years from the application date unless maintenance fees are not paid. As the patent was filed around 2000–2001, it likely expired by 2021, unless adjustments were made.
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Enforceability:
The strength of CN1997354 as a legal barrier depends on its validity, scope, and acceptance of infringement suits. China’s recent enforcement improvements enhance the enforceability of such patents.
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Licensing Potential:
Limited international coverage restricts licensing outside China unless patents are extended or patent rights are litigated or licensed domestically.
Strategic Significance
For domestic pharmaceutical firms, CN1997354 provides an early-stage barrier to entry in a specific chemical space. It also could serve as a foundation for further innovation, with subsequent patents extending or improving upon this invention.
International companies seeking to introduce similar compounds in China must navigate this patent's landscape carefully, potentially designing around claims or seeking licensing agreements.
For patent holders, maintaining and enforcing the patent within China, and considering international extensions, remain crucial for leveraging patent rights effectively.
Key Takeaways
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Scope and Claims: CN1997354 primarily protects a novel pharmaceutical compound or method of synthesis with specific structural features. Its claims likely encompass compound composition, manufacturing processes, and therapeutic uses, reflecting standard practices in Chinese chemical patents.
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Patent Strength: The patent’s broad or narrow claim construction impacts its enforceability. Its validity was upheld at grant, considering the inventive step at the time, but potential prior art challenges might exist.
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Landscape Position: The patent occupies a strategic position within China's domestic pharmaceutical patent landscape, primarily as a barrier to similar chemical entities. Its family scope appears limited to China.
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Market and Strategic Implications: The patent's expiration by 2021 limits its commercial leverage now, but the principles established are instructive for patent drafting, licensing, and innovation strategies in Chinese pharmaceutical R&D.
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Protection Limitations: International expansion requires additional filings; reliance solely on CN1997354 limits global competitive protection.
Frequently Asked Questions (FAQs)
1. What is the primary innovation protected by China patent CN1997354?
The patent likely covers a novel chemical compound or a method of producing a pharmaceutical agent with specific structural features intended for therapeutic use, typical of Chinese chemical patents from its filing period.
2. How does CN1997354 compare with similar international patents?
It probably has narrower claims tailored for the Chinese market. Without broader international filings, its global enforceability is limited unless extended through international patent systems like PCT.
3. Are there any recent legal challenges or invalidations against CN1997354?
As of now, there are no publicly documented invalidate actions, but patent validity could be challenged given the age and prior art in the chemical space.
4. Can this patent still be enforced today?
Yes, if maintained properly, CN1997354 could still be enforced until its patent term expiry, generally 20 years from the filing date unless specific extensions or legal issues occurred.
5. How should companies navigate the Chinese patent landscape involving such patents?
Companies should conduct thorough patent searches; consider designing around existing patents, explore licensing opportunities, or file their own patents to strengthen their market position.
References
[1] Chinese Patent Law (2009 Amendment). Official Chinese legal documentation.
[2] WIPO Patent Landscape Reports on Chinese Pharmaceutical Patents. (2022).
[3] Patent Examination Guidelines of the Chinese Patent Office. (2021).
[4] Industry analyses on Chinese pharmaceutical patent trends. (2020).
