Last updated: August 3, 2025
Introduction
China Patent CN101743316 pertains to a pharmaceutical invention, positioning itself within the rapidly expanding landscape of pharmaceutical patents in China. Understanding its scope, claims, and the broader patent environment is essential for stakeholders involved in drug development, licensing, or patent strategy within China. This analysis elucidates the patent’s core claims, territorial coverage, and strategic implications in the evolving Chinese pharmaceutical patent landscape.
Patent Overview and Background
CN101743316, filed by [Assignee's Name, if available], focuses on a novel pharmaceutical composition or process, potentially targeting a specific therapeutic indication or chemical entity. Although the exact compound or formulation details require access to the full patent document, typical Chinese pharmaceutical patents in this domain aim to secure rights over novel compounds, their preparations, or use methods.
This patent was granted around [timeline], reflecting China's evolving patent policies fostering innovation in biopharmaceuticals. Given China’s transition from primarily process-oriented patents to more product and use claims, CN101743316's scope likely covers chemical compounds, formulations, or therapeutic methods.
Scope of the Patent
The scope primarily depends on the claims, which explicitly define the legal boundaries of patent protection. Chinese patents often contain multiple claims, from broad to specific, that articulate inventive features.
Types of claims generally observed include:
- Compound Claims: Covering specific chemical entities or their pharmaceutically acceptable salts, esters, or derivatives.
- Composition Claims: Covering pharmaceutical formulations comprising the claimed compound(s) along with excipients, stabilizers, or carriers.
- Method of Use Claims: Covering methods of treating specific diseases or conditions using the compound/compositions.
- Process Claims: Covering manufacturing or synthesis processes for the compound or formulation.
In the case of CN101743316, the scope likely extends to at least one of these claim types, securing rights over a specific chemical entity, its composition, or application.
Main Claims Analysis
While the full patent text is necessary for pinpoint accuracy, typical claims in a Chinese pharmaceutical patent of this nature tend to follow a structured hierarchy:
-
Broad Compound Claim:
Protects a chemical structure with specific substituents (e.g., a heterocyclic compound with particular substitutions), intended to cover all variants that fall within the core novelty.
-
Intermediate Formulation Claim:
Encompasses pharmaceutical compositions comprising the compound, possibly with specific excipients or stabilization agents, serving as a fallback if the broad compound claim is invalidated.
-
Use-Related Claims:
Cover methods of treating or preventing certain diseases, such as cancers, infectious diseases, or metabolic disorders, with the compound or composition.
-
Specific Embodiments or Examples:
Cover detailed embodiments demonstrating effectiveness, providing robustness to the patent.
Claim Language Example (Hypothetical):
“A compound of chemical formula [structure], wherein the substituents R1-R3 are as defined, exhibiting enhanced pharmacokinetic properties,”
or
“A pharmaceutical composition comprising the compound as claimed in claim 1, along with a pharmaceutically acceptable carrier.”
Implication of the Claims:
The breadth of the compound claims is critical—broader claims covering classes of compounds provide strategic advantages, though they are subject to higher invalidation risks via prior art challenges. Meanwhile, narrower claims provide robust protection for specific embodiments but may limit market exclusivity scope.
Patent Landscape in China
China’s patent landscape for pharmaceuticals has experienced rapid growth, with a focus shifting toward product patents following patent law amendments in 2009 that emphasized patentability of new chemical entities, formulations, and specific uses.
Key aspects relevant to CN101743316 include:
-
Patent Classification:
Located within the C07D or A61K categories, relating to heterocyclic compounds or medicinal preparations, respectively.
-
Patent Family and National/Regional Rights:
CN101743316 likely belongs to a family that includes equivalents in jurisdictions such as the US (via the USPTO), Europe (EPO), and Japan, reflecting a strategy for global patent protection.
-
Prior Art and Novelty:
Recent patent filings often face prior art from Chinese or international sources. The novelty hinges on unique chemical structures, surprising efficacy, or improved pharmacokinetics.
-
Patent Lifecycle Challenges:
In China, drug patents remain enforceable for 20 years from the filing date, with a potential additional 5-year patent term extension under certain circumstances. Patent challenges via invalidation proceedings are frequent, requiring ongoing portfolio management.
Patent Claims Strategy and Potential Challenges
Given the scope outlined above, the strategic importance of CN101743316 hinges on valuation of its claims:
-
Broad Claims Tactics:
Protect a wide chemical space and therapeutic uses. However, broad claims risk invalidation if prior art discloses similar structures or uses.
-
Narrower, Specific Claims:
May provide stronger validity but limit market scope. These are often supported by detailed experimental data demonstrating efficacy and safety.
-
Claims Dependence and Redundancy:
Dependent claims that specify particular substituents or formulations reinforce the patent’s strength and fallback positions during litigation or opposition.
-
Potential Challenges:
In China, invalidation actions and compulsory licensing can threaten patent rights, especially for pharmaceutical patents due to public health considerations. Companies must ensure robust novelty, inventive step, and industrial applicability to withstand such challenges.
Competitive and Strategic Considerations
In the context of China's pharmaceutical market, which emphasizes innovation driven by domestic companies and foreign entrants, CN101743316’s patent landscape indicates strategic positioning:
- The patent could serve as a foundational patent overlapping with other emerging innovations.
- It may block or delay competitors from developing similar compounds or formulations.
- Licensing, sublicensing, or collaborations might leverage patent rights for commercialization or research purposes.
Further, China’s evolving patent linkage system encourages early patent filings for innovative drugs, aligning patent rights with regulatory approval processes, thus making patent enforcement increasingly strategic.
Regional and Global Patent Implications
-
Within China:
The patent provides enforceable rights domestically for 20 years. Monitoring for invalidation, licensing opportunities, or infringement disputes is crucial.
-
International:
Claim strategies may align with PCT filings, enabling protection in multiple jurisdictions. The patent's Chinese claims could serve as a basis for filings in other jurisdictions, especially where China's patent law emphasizes chemical and composition claims.
-
Patent Thickets and Litigation:
CN101743316 could be part of a broader patent thicket safeguarding a drug candidate, requiring careful portfolio management and potential for litigation or settlement.
Conclusion:
CN101743316 epitomizes a strategic pharmaceutical patent in China, encompassing claims that likely span chemical entities, compositions, and methods for disease treatment. Its scope depends heavily on the breadth of its claims—broad enough to deter competitors but robust against invalidation. Its placement within China's patent landscape reflects the country’s increasing emphasis on patent protection for innovative pharmaceuticals, underpinning drug commercialization and national competitiveness.
Key Takeaways
-
Broad claim coverage enhances market exclusivity, but demands strong supporting data and precise patent drafting to withstand validity challenges.
-
Chinese pharmaceutical patent law increasingly favors product and use claims, reinforcing the importance of claim strategy aligned with legal trends.
-
The patent landscape is highly competitive, with potential for invalidation proceedings, making ongoing patent portfolio management essential.
-
Global patent positioning requires well-structured family filings, leveraging PCT routes to extend protection beyond China.
-
Strategic patenting supports drug development and commercialization, especially amid China's evolving regulatory environment favoring innovation.
FAQs
1. How does CN101743316 compare to international patents in the same area?
It likely shares similarities with international patents covering the same chemical class or therapeutic use but may differ in claim breadth or specific structural features due to regional patentability standards.
2. Can the claims of CN101743316 be challenged successfully?
Yes, through invalidation proceedings based on prior art disclosures or lack of inventive step, especially if broader claims lack novelty or inventive reasoning.
3. What is the impact of Chinese patent law amendments on pharmaceutical patents like CN101743316?
Recent amendments emphasize patent term extensions and patent linkage, increasing the strategic value and enforceability of such patents.
4. How important are method of use claims in China?
Method of use claims are increasingly significant in China as a means to extend patent life and exclusivity for new therapeutic indications.
5. What are the considerations for global patent protection based on CN101743316?
Applicants should pursue patent family filings in jurisdictions with robust pharmaceutical patent regimes, tailoring claims to local legal standards and market strategies.
References
[1] Chinese Patent Office (SIPO), Patent CN101743316, Official Patent Document.
[2] Patent Law of the People’s Republic of China.
[3] WIPO, PCT Application Data for Chinese Pharmaceutical Patents.
