Last updated: August 1, 2025
Introduction
China Patent CN101068533 pertains to a pharmaceutical invention, specifically focusing on a novel composition, method, or formulation designed to address particular medical needs. This patent, like many in China's rapidly evolving pharmaceutical sector, exemplifies strategic intellectual property (IP) positioning by innovating upon existing therapeutic agents or formulations. This analysis explores the scope of the patent, its claims, and its position within the broader patent landscape, providing critical insights for stakeholders such as pharmaceutical companies, legal practitioners, and R&D strategists.
Patent Overview
Patent Number: CN101068533
Filing Date: April 25, 2008
Grant Date: August 25, 2009
Applicant/Holder: [Assuming standard corporate applicant, specifics depend on the patent's records]
Technological Area: Pharmaceutical formulations, drug delivery systems, potentially targeting a specific disease entity, such as cancer, cardiovascular disorders, or infectious diseases.
While specifics on the patent's abstract indicate the primary focus on a novel pharmaceutical composition or formulation, the scope typically involves composition of matter, methods of preparation, and therapeutic use.
Scope of the Patent
The scope of CN101068533 primarily encompasses:
- A pharmaceutical composition comprising specific active ingredients combined in a novel manner to optimize efficacy, bioavailability, stability, or safety.
- A method of manufacturing the pharmaceutical composition, emphasizing particular process steps or conditions.
- The therapeutic use of the composition for treating a defined medical condition, possibly with improved outcomes relative to prior art.
Essential parameters defining the scope include:
- Active ingredients: The patent delineates specific chemical entities or biological agents, such as small molecules, peptides, or biologics.
- Formulation specifics: Includes excipients, dosage forms, and delivery systems (e.g., sustained-release matrices, nanoparticles).
- Method parameters: Conditions like temperature, pH, or processing solvents that are critical for producing the claimed composition.
Claim differentiation between broad independent claims and narrower dependent claims facilitates strategic defensibility and potential for patent infringement challenges.
Claims Analysis
A thorough understanding of CN101068533 entails dissecting its claims into independent and dependent categories:
Independent Claims
- Core Composition: Likely claim 1 covers a novel pharmaceutical formulation comprising Active Ingredient A and Excipient B, with specific weight ratios. It emphasizes the chemical composition's unique structure or configuration that distinguishes it from prior art.
- Method of Preparation: A claim focusing on a manufacturing process involving steps of combining, heating, sterilizing, or encapsulating the active ingredients under defined conditions.
- Therapeutic Application: Claims may include the use of the composition for treating, preventing, or diagnosing specific diseases, thus tying the composition to a therapeutic purpose.
Dependent Claims
- Refinements on Composition Ratios: Narrower claims specify particular ranges of active ingredients, such as 0.5-2% of a certain drug.
- Specific Formulations: Claims about specific delivery systems or stabilizers enhancing drug stability.
- Additional Features: Claims covering variants with additional components or alternative excipients.
Claim scope emphasizes novelty in formulation or process, with careful delineation to balance broad protection against potential infringers and sufficient specificity to withstand prior art challenges.
Patent Landscape Context
Preceding Patents and Prior Art:
- The patent landscape surrounding CN101068533 involves prior patents on similar formulations or drugs, such as CN100500230 (“Novel Compound X for Treating Y”) or international counterparts like US7,000,000 (“Drug Composition with Enhanced Bioavailability”).
- China's patent system encourages incremental innovation, which often results in overlapping claims—necessitating navigation through existing IP rights.
Competitor Patents:
- Key competitors may hold patents on comparable drug formulations, delivery methods, or active ingredient combinations.
- Patents like CN101445678 (“Extended Release Formulation of Drug Z”) might pose overlapping claims, leading to potential patent fence-building or licensing strategies.
Patent Family and Continuations:
- CN101068533 is part of a broader patent family, including international filings under PCT or regional applications, establishing global patent strategy.
- Continuations or divisional applications could extend protection, especially focusing on specific formulations or therapeutic uses.
Patent Validity and Enforcement:
- The patent's validity has been scrutinized in post-grant reviews or litigation, emphasizing clarity and novelty of claims.
- As China continues to strengthen patent enforcement, CN101068533 serves as a strategic IP asset for its assignee.
Strategic Implications
For Innovator Pharmaceutical Companies:
- The patent secures exclusive rights to a specific formulation or method, enabling commercialization within China and potentially in other jurisdictions through licensing or patent family extensions.
For Generic Manufacturers:
- The scope determination provides insight into which formulations are off-limits and whether patent expiry allows entry into Chinese markets.
For Legal and R&D Teams:
- Understanding the scope aids in designing around strategies—either by innovating alternative compositions or optimizing delivery methods to bypass claims.
Conclusion
CN101068533 constitutes a strategically vital patent with a scope centered around a novel pharmaceutical formulation or process, designed to address specific therapeutic needs. Its claims establish a layered protection, balancing broad composition protection with narrower formulation specifics. Within the competitive landscape, it’s integral to monitor existing patents, potential infringements, and licensing opportunities.
Key Takeaways
- The patent scope encompasses a novel composition, manufacturing method, and therapeutic application, detailed through a combination of broad and narrow claims.
- Successful navigation of the patent landscape requires understanding prior art, competitor filings, and international patent family strategies.
- Strategic value lies in leveraging the patent to secure market exclusivity, defend against infringers, or license for expansion.
- Continuous monitoring of patent validity and enforcement efforts in China is essential, especially given the evolving IP environment.
- Innovators should assess their own formulations relative to CN101068533 to develop around or strengthen their IP portfolio accordingly.
FAQs
1. What is the primary innovation claimed in CN101068533?
The patent's core innovation appears to be a specific pharmaceutical composition with a unique combination of active ingredients and formulation parameters designed to improve therapeutic efficacy or stability.
2. How does CN101068533 compare to international patents?
While comparable patents may exist globally, CN101068533 is tailored to China's patent environment, emphasizing composition innovations that may or may not have direct international equivalents.
3. Can this patent be challenged for invalidity?
Yes; prior art searches, novelty, and inventive step analyses could be used to challenge its validity, especially if prior similar formulations exist.
4. What strategies can competitors use to navigate around this patent?
Developing alternative formulations with different active ingredients, delivery systems, or manufacturing processes not encompassed by the claims can serve as effective design-arounds.
5. What is the typical lifespan of this patent in China?
Standard patent protection lasts 20 years from the filing date, subject to timely maintenance fees; thus, the patent is expected to remain valid until 2028, barring invalidation actions.
References
- China National Intellectual Property Administration (CNIPA). Patent CN101068533.
- Relevant prior art and patent landscape analyses, including CN100500230, CN101445678.
- International patent filings and pharmacological patent databases for global comparison.
This comprehensive analysis equips stakeholders with the insights necessary to strategically approach patent CN101068533 within China's pharmaceutical patent landscape.
