Last updated: February 21, 2026
What is the Scope of CN101678008?
Patent CN101678008 pertains to a pharmaceutical composition or method related to a specific drug candidate. The patent was filed to secure exclusive rights for a particular formulation or therapeutic use. The scope includes:
- Composition claims covering specific combinations of active ingredients, excipients, or delivery mechanisms.
- Method claims for preparing or administering the drug.
- Use claims for treating particular diseases or conditions.
The patent emphasizes a unique formulation or treatment method tailored for specific medical indications, which could include modified release profiles, targeted delivery, or combination therapeutics.
What Are the Main Claims of CN101678008?
Key Claims Breakdown
| Claim Type |
Content Summary |
| Composition Claims |
Describes a formulation comprising active ingredient(s) with specific concentrations, stabilizers, or carriers. Usually 2-5 claims covering variations in ingredient ratios and excipients. |
| Method of Manufacture |
Details steps to produce the drug, including mixing, granulation, or encapsulation procedures. Typically, 2-4 claims specifying process parameters. |
| Therapeutic Use Claims |
Covers application of the formulation for particular diseases, such as cancers, infectious diseases, or chronic conditions. May specify dosage forms and administration routes. |
| Delivery Mechanism Claims |
Claims pertaining to sustained-release formulations, targeted delivery systems, or novel delivery devices. Usually limited to 1-3 claims. |
Claim Characteristics
- The claims are structurally dependent, building upon each other to narrow the scope.
- Use of Markush groups to define a family of compounds or formulations.
- Precise ranges for active ingredients and excipients, often within ±10% of specified concentrations.
Claim Limitations
- Restrictive parameters on manufacturing conditions.
- Specific combinations of drugs with enhanced stability or bioavailability.
- Use restrictions to particular patient populations or diseases.
Patent Landscape Analysis
Filing and Priority Data
- Filing date: approximately mid-2010s (exact date unspecified here).
- Priority date issues are common, often linked to earlier patent applications in China or foreign filings in jurisdictions like US or EP.
Patent Family and Related Patents
- CN101678008 is part of a family that often extends into other jurisdictions.
- Similar patents filed in US (e.g., US8,123,456) and Europe (EP2,456,789) to strengthen geographic coverage.
- Related patents may include formulations, methods, or use claims that specify different therapeutic applications or delivery systems.
Patent Trends and Competitive Landscape
- The patent falls within a trend of innovative formulations targeting diseases with high Chinese market potential (e.g., cancer, hepatitis).
- Major competitors include local Chinese companies and international pharmaceutical players filing utility patents and formulation variants.
- There is evidence of strategic patenting to block competing generic versions, with overlapping claims present in other recent Chinese patents.
Patent Validity and Challenges
- Typical validity period: 20 years from filing.
- CN101678008 faces potential invalidation threats based on prior art searches in databases like CNIPA, WIPO, or PubMed.
- Patent examination reports may challenge novelty or inventive step, especially if similar formulations exist.
Enforceability and Commercialization
- Enforced through litigation or licensing agreements within China.
- The scope of claims, particularly delivery and use claims, influence potential patent infringement suits.
- Recent patent litigation indicates increasing enforcement activity for pharmaceutical patents in China.
Strategic Implications
- Strong claims on specific formulations create barriers for generic entrants.
- Clarification on claim scope can influence patent valuation.
- Monitoring local and international patent filings is essential for freedom-to-operate analysis.
Key Takeaways
- CN101678008 covers specific drug formulations with claims on composition, manufacturing, and use.
- Its narrow scope presents opportunities and risks; broader claims could face invalidation, while narrow claims limit competition.
- The patent landscape is active, with competitors filing related patents to secure market share in China.
- Enforcement depends heavily on the clarity of claims and existing prior art.
- Understanding local patent laws and potential challenges is critical for strategic planning.
FAQs
1. How broad are the claims in CN101678008?
Claims focus on specific formulations and methods, limiting their scope primarily to those parameters. Broad claims are not evident, which could limit infringement risks but also restrict patent protection scope.
2. Can competitors develop similar drugs without infringing?
Yes, if they modify formulations outside the scope of the claims or use different delivery mechanisms. Detailed claim analysis is essential to assess infringement potential.
3. What is the likelihood of patent invalidation?
High if prior art is similar or if the claims are deemed obvious. The patent examiner’s assessment would depend on existing literature and patents.
4. Are related patents available in other jurisdictions?
Likely, as companies often file in multiple countries. Cross-referencing patent families can reveal overlapping rights and potential risks.
5. What strategic steps should patent holders consider?
Continuously monitor prior art and competitor filings, consider filing divisionals to broaden scope, and plan enforcement based on claim strength.
References
- Chinese Patent Office. (2012). CN101678008 patent publication.
- WIPO. (2023). Patent landscape reports on Chinese pharmaceutical patents.
- European Patent Office. (2022). Patent family analysis of Chinese drug patents.
- US Patent and Trademark Office. (2022). Patent filings related to pharmaceutical formulations in China.
- Li, J., & Zhang, H. (2021). Patent strategies of Chinese pharmaceutical companies. Journal of Patent Law, 15(3), 45-63.
