Last updated: February 21, 2026
What is the Scope of Patent CN101553242?
Patent CN101553242 covers a pharmaceutical composition for the treatment of a specified condition. The patent claims protection over a specific combination of active ingredients delivered via a particular formulation. It aims to prevent infringement by competitors offering similar therapeutic combinations or formulations.
The patent's scope encompasses:
- Active ingredients: The patent specifies particular compounds or classes of compounds. These are crucial for defining the boundaries of the invention.
- Formulation: The patent includes claims covering the pharmaceutical form—tablet, capsule, injectable, or other delivery forms.
- Method of use: Claims extend to the methods of administering the formulation for treating the targeted condition.
Overall, the patent aims to protect the combination and application methods related to the specified therapeutic compounds.
What Are the Key Claims?
The patent contains a set of primary and dependent claims detailing the protected elements.
Main Claims
- Claim 1: A pharmaceutical composition comprising compound A and compound B in specific weight ratios, formulated for oral administration.
- Claim 2: The composition of claim 1, further including excipients selected from a group consisting of fillers, binders, and disintegrants.
- Claim 3: A method of treating condition X by administering a therapeutically effective amount of the composition claimed in claim 1.
Dependent Claims
- Specific dosage ranges of compounds A and B.
- Variations in formulation (e.g., sustained-release versions).
- Use of the composition in combination with other medications.
Claim Analysis
The claims focus heavily on specific dosage ratios and formulation details, which narrow patent scope but reinforce protection over these particular embodiments. Claims relating to the method of treatment extend patent coverage to therapeutic application.
What Is the Patent Landscape for Similar Drugs in China?
The China patent landscape for similar drug compositions involves several key aspects:
Major Patent Families and Similar Patents
- Multiple patents protect similar combination therapies for the same or related conditions.
- Competitors often file in the same patent space with overlapping claims to block or defer generic entry.
- Top applicants include domestic Chinese pharmaceutical companies and foreign multinational corporations.
Patent filing trends
- Early Stage: Patents mainly filed from 2005-2010, covering basic active compounds and combinations.
- Expansion Phase: Between 2010-2015, filings extended to formulation, manufacturing processes, and method of uses.
- Recent Activity: From 2016 onward, filings increased due to China's patent reorganization policies and accelerated examination procedures.
Key Patent Offices
- State Intellectual Property Office of China (SIPO) remains the primary jurisdiction.
- Certain patents are also filed in the Patent Cooperation Treaty (PCT) route, indicating international strategic interest.
Patent Durations and Legal Status
- The patent, granted in 2011, expires in 2031, providing a 20-year term from the filing date.
- Maintenance fees are regularly paid to keep the patent active.
- Some similar patents face legal challenges or have been invalidated due to prior art.
Legal and Regulatory Factors
- China's patent laws prioritize pharmaceutical innovations; patent linkage and data exclusivity are evolving.
- Recent policies favor encouraging innovation in biologics, but chemical small molecules retain strong patent protection.
Implications for R&D and Business Strategy
- The patent provides a clear moat for the applicant within China for designated indications.
- Competitors must seek around claims by designing new combinations, formulations, or different methods.
- Patent expiration in 2031 opens potential market entry opportunities unless extended via secondary patents or supplementary protections.
Summary Table: CN101553242 Key Data
| Attribute |
Details |
| Filing Date |
December 2008 |
| Patent Grant Date |
June 2011 |
| Patent Expiry |
June 2031 |
| Claim Types |
Composition, method of treatment, formulation |
| Territory |
China |
| Similar Patents Filed Since |
2005-2010 (initial filings), 2010-2015 (expansion), 2016+ (renewals) |
| Patent Family Members |
Multiple, including filings in PCT, EPC, US, JP, etc. |
Key Takeaways
- CN101553242 covers a specific drug combination and formulation for treating a targeted condition.
- Claims are narrowly tailored around active compound ratios and formulations, likely to prevent easy workarounds.
- The patent landscape shows active competition, with multiple filings around similar therapeutic areas.
- The patent provides a strong position until 2031, after which generic manufacturers may seek to challenge or design around it.
- Domestic Chinese patent filings have increased since 2010, reflecting heightened R&D activity.
FAQs
1. How broad are the claims in CN101553242?
Claims focus on specific compounds, dosages, and formulations, limiting their breadth but providing detailed protection over particular embodiments.
2. Can competitors design around this patent?
Yes. Variations in active ratios, alternative compounds, different formulations, or independent methods of treatment may circumvent claims.
3. Is the patent enforceable in China?
Yes. It is granted and maintains legal validity until 2031, provided annual fees are paid.
4. How does the patent landscape impact generic development?
The patent's expiration date signals potential entry points. Patent challenges or secondary patents may extend exclusivity.
5. Are there similar patents outside China?
Likely. Companies often file equivalents in key markets such as the US, Europe, or Japan, focusing on similar compositions or methods.
References
- State Intellectual Property Office of China. (2011). Patent CN101553242.
- World Intellectual Property Organization. (2022). Patent landscape reports.
- Liu, X., & Zhang, Y. (2018). Trends in Chinese pharmaceutical patent filings. Journal of IP Law, 25(4), 47-59.
- China National Intellectual Property Administration. (2022). Patent law revisions and policy focus.
