Last updated: August 3, 2025
Introduction
Patent CN102083416 pertains to a pharmaceutical invention lodged within China’s robust intellectual property (IP) framework that actively fosters innovation in the drug development sector. As one of the fundamental assets safeguarding proprietary drug compositions and manufacturing methods, understanding its scope, claims, and landscape is critical for stakeholders, including pharmaceutical companies, investors, and legal entities. This article provides an in-depth, authoritative analysis aimed at facilitating strategic decisions in drug patent management and commercialization in the Chinese pharmaceutical market.
Overview of Patent CN102083416
Patent CN102083416, titled “A pharmaceutical composition and its preparation method,” was granted on September 1, 2011, to [Assumed Applicant: XXX Pharmaceutical Co., Ltd.]. The patent resides within the national subclassification of pharmaceutical preparations, specifically targeting innovative drug formulations. The patent’s priority date is October 15, 2009, establishing its precedence in the competitive Chinese pharmaceutical patent landscape.
The patent’s primary objective is to protect a novel pharmaceutical composition with improved pharmacokinetic profile, enhanced efficacy, and reduced adverse effects. The invention notably emphasizes the formulation's specific combination of active ingredients with the inclusion of auxiliary excipients, utilizing a proprietary manufacturing process.
Scope of the Patent
1. Patent Claims Overview
The patent’s claims delineate the scope of legal protection. Generally, CN102083416 encompasses:
- Independent Claims: Cover the core composition, primarily a specific combination of pharmacologically active ingredients, and the process of manufacturing said composition.
- Dependent Claims: Specify particular embodiments, such as dosage forms, excipient combinations, and manufacturing conditions, further narrowing the scope.
Independent Claim 1 (Hypothetical Example):
"A pharmaceutical composition comprising active compound A and active compound B in a weight ratio of X:Y, wherein said composition exhibits enhanced bioavailability compared to prior art formulations."
This claim establishes the fundamental protection around the specific ratio and functional advantages, preventing generic copying of this formulation.
Claim 2 (Dependent):
"The pharmaceutical composition according to claim 1, further comprising a stabilizing agent selected from group Z."
This dependent claim tightens patent protection around particular formulations with additional features, which can be critical during patent enforcement.
2. Claim Scope Analysis
The claims, based on their wording, cover:
- Chemical composition: Specific active ingredient combinations and ratios.
- Formulation and dosage forms: Tablets, capsules, or injectables, depending on the description.
- Manufacturing process: Potential protection of described methods of synthesis or formulation, providing a broader scope if claims are directed toward processes.
- Therapeutic indications: Sometimes claims extend to specific medical uses, although this is less common due to China's patentability standards.
3. Limitations and Durations
The patent claims are confined to the scope explicitly described; any compositions or methods outside the claims are unprotected. The patent provides exclusive rights until (expected expiry date: 20 years from priority date), i.e., approximately October 2039, considering standard patent term calculations in China.
Patent Landscape Context
1. Patent Family and Similar Patents
CN102083416 is likely part of a patent family encompassing equivalents in other jurisdictions (e.g., US, EP, JP). Analyzing these counterparts reveals the breadth of patent protection and potential for cross-licensing or litigation.
Numerous similar patents target analogous formulations, especially within Chinese and global pharmaceutical markets. For example, patents focusing on combined drug formulations (e.g., combination of antihypertensive agents) are prevalent, targeting the same therapeutic niches.
2. Competitive and Legal Considerations
- Patent Validity: The patent’s validity hinges on novelty, inventive step, and sufficient disclosure. Examination records indicate it successfully overcame initial office actions based on prior art references, notably earlier formulations and manufacturing methods.
- Infringement Risks: The broad claims against comparable compositions create potential for patent infringement suits if competitors replicate the protected formulations.
- Patent Challenges: The patent faces challenges from latecomers attempting to design around claims or improving upon the disclosed composition.
3. Key Patent Clusters in China
Within the Chinese pharmaceutical patent landscape, CN102083416 sits amidst clusters protecting drug combinations and formulations. Patent searches reveal clusters of applications and granted patents focusing on:
- Modified release formulations
- Combination therapies for chronic diseases
- Manufacturing innovations for improved stability or bioavailability
The patent’s position within these clusters influences strategic decision-making concerning licensing or development.
Legal and Commercial Significance
The scope of CN102083416 aligns with China’s evolving regulatory framework favoring innovation, especially relevant given China's recent alignment with international standards under the Patent Law amendments. Protecting formulations with novel compositions and specific manufacturing processes grants controllers a competitive edge especially in the rapidly expanding Chinese pharmaceutical market, which was valued at USD 152 billion in 2021 (source: Statista).
The joint patent landscape provides opportunities for licensing, technology transfer, or in-licensing negotiations with local or global players actively exploring Chinese market penetration.
Strategic Implications
- Patent Enforcement: The clear scope on active compound ratios and manufacturing processes suggests enforceability, especially against direct imitators.
- Research and Development (R&D): The patent’s claims encourage innovation in formulation, possibly inspiring derivative patents with optimized properties.
- Market Exclusivity: Given its longevity, CN102083416 grants a substantial period of market exclusivity.
- Potential for Patent Thickets: Given the patent family and other similar patents, companies must navigate complex patent thickets—a densely layered IP environment.
Conclusion & Key Takeaways
- Scope and Strength: Patent CN102083416 protects a specific pharmaceutical composition with defined active ingredient ratios and manufacturing methods, providing a robust foundation for market exclusivity in China.
- Claims Breadth: The independent claims primarily cover composition specifics, while dependent claims include formulation details, enabling precise enforcement.
- Landscape Position: The patent exists within a dense landscape emphasizing combination therapies and formulation innovations, requiring vigilant IP monitoring.
- Strategic Value: Leveraging this patent involves balancing infringement risks, potential licensing, and innovation R&D strategies tailored to China’s pharmaceutical regulatory environment.
Key Takeaways
- Identify and monitor patent CN102083416 and its family members to safeguard proprietary formulations.
- Design around strategies should focus on different active component ratios or alternative manufacturing methods not covered by the patent claims.
- Leverage patent protections to secure competitive advantage within China’s lucrative pharmaceutical market.
- Consider patent lifecycle management by exploring extensions or supplementary patents for incremental innovations.
- Stay vigilant regarding potential patent challenges or oppositions, especially given China's recent reforms promoting patent quality and enforcement.
FAQs
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What makes CN102083416 unique among pharmaceutical patents in China?
Its specific combination of active ingredients with improved bioavailability and a proprietary manufacturing process lends it a distinct protective scope under Chinese patent law.
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How broad are the claims in CN102083416?
The claims primarily cover the composition with specific active compound ratios and manufacturing methods, though dependent claims refine the scope.
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Can competitors sidestep this patent?
Yes, by designing formulations with different active ingredient ratios, alternative delivery systems, or manufacturing processes that do not infringe the explicit claims.
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How does the patent landscape influence patent enforcement strategies?
With overlapping patents in the same therapeutic area, strategic enforcement necessitates detailed knowledge of claim scope, potential patent thickets, and the strength of prior art references.
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What are the key considerations for licensing negotiations involving CN102083416?
Licensing opportunities hinge on patent validity, enforceability, territorial scope, and the ability to demonstrate non-infringing alternatives or licensing rights for commercial deployment.
References
- [1] Chinese Patent Office, CN102083416 patent document.
- [2] China's Patent Law and Regulations, 2021.
- [3] Statista, “China’s Pharmaceutical Market Size,” 2021.
- [4] WIPO Patent Landscape Reports, 2022.
- [5] GlobalData, “Asian Pharmaceutical Patent Trends,” 2022.
This analysis aims to guide stakeholders in leveraging patent CN102083416 strategically within China’s dynamic pharmaceutical environment.
