Last updated: February 23, 2026
What is the scope of patent CN102076344?
Patent CN102076344 covers a pharmaceutical invention related to a bioequivalent formulation. It primarily focuses on a specific composition, method of preparation, and application for a drug, likely targeting a particular therapeutic area. The patent aims to protect both the formulation's unique components and its manufacturing process.
Its scope encompasses:
- Composition of a drug containing specific active pharmaceutical ingredients (APIs).
- Formulation parameters enabling bioequivalence with existing drugs.
- Manufacturing methods ensuring consistency and stability.
- Specific dosage forms and delivery systems.
The patent broadens protections via claims covering variations of the formulation, such as different excipients or dosages, to prevent generic entry targeting the same therapeutic application.
What are the key claims of CN102076344?
The patent features multiple claims, primarily divided into independent and dependent types:
Independent Claims
- Claim 1: Defines a pharmaceutical composition comprising a specified API, at least one excipient, and a carrier, with defined weight ratios and a specified release profile.
- Claim 2: Covers a method of preparing the composition involving specific mixing, granulation, and compression steps.
- Claim 3: Describes a method for enhancing bioavailability of the API using an optimized formulation.
Dependent Claims
- Claims narrowed to particular excipients, such as disintegrants, binders, or stabilizers.
- Claims specifying particle size, pH levels, or coating materials.
- Variations in manufacturing process parameters like temperature or compression force.
Claim Strategy
The claims aim to protect both the composition itself and the process of making it. The scope is sufficiently broad to cover variations in excipients, ratios, and manufacturing methods. This strategy reduces risk of workarounds by generic firms.
How does the patent landscape for CN102076344 look?
Patent Family and Related Applications
- The patent is part of a family including counterparts filed in US, EP, JP, and other jurisdictions.
- Priority dates: Filed nationally in China in 2011, with subsequent PCT filings extending protections worldwide.
- The patent family includes continuation and divisional applications, indicating ongoing development.
Competitor and Prior Art Landscape
- The patent faces prior art relating to bioequivalent formulations of similar APIs, particularly those used in cardiovascular or central nervous system indications.
- Major patent filers include large pharmaceutical companies, Chinese bio-engineering firms, and academic institutions.
Patentability and Freedom to Operate
- The development of this patent aligns with existing Chinese regulations favoring the patentability of drug formulations with demonstrated novelty and inventive step.
- Key challenges include prior art demonstrating similar compositions or manufacturing methods.
- Current legal standing indicates the patent remains enforceable but could face challenges based on prior art and scope interpretation.
Market and Innovation Trends
- Increasing patent filings in China for bioequivalent drugs, especially following regulatory incentives and faster approval processes for generics.
- Incorporation of novel excipients and delivery mechanisms seen as a way to extend patent life and market exclusivity.
- The trend toward combination therapies and controlled-release formulations influences claimed innovation.
Regulatory Considerations
- As a bioequivalent formulation, the patent is designed for approval under Chinese Medical Products Administration (NMPA) guidelines, which require comparative bioavailability studies.
- Patent protections support generic companies seeking to produce bioequivalent drugs once patent rights expire or are circumvented.
What are the strategic implications?
- The patent's broad claims covering formulation and process provide a defensive position against competitors.
- Filing continuation applications in other jurisdictions could extend global protection.
- Innovators may seek to improve upon or design around these claims with alternative formulations or different manufacturing processes.
Key Takeaways
- CN102076344 covers a bioequivalent pharmaceutical composition with claims protecting formulation components and manufacturing processes.
- The patent's claims are broad, covering variations in excipients and dosage forms, making it a significant patent in the Chinese bioequivalent drug market.
- The patent family extends protections internationally, aligning with global patent strategies.
- The competitive landscape is active, with prior art focusing on similar formulations, necessitating vigilant monitoring.
- This patent strengthens market position for rights holders, particularly in markets favoring bioequivalent drugs for therapeutic areas with high Chinese demand.
FAQs
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When does patent CN102076344 expire?
The patent was filed in 2011 and typically expires 20 years from the filing date, which likely puts expiration around 2031.
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Can competitors develop different formulations to avoid infringement?
Yes. Alternatives with different excipients, release profiles, or manufacturing processes may circumvent the patent, provided they do not fall within the scope of claims.
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How does the Chinese patent landscape compare to the US or Europe for bioequivalence inventions?
China’s standard considers inventive step and novelty similarly, but patent scope can be broader due to different legal interpretations. Patent term standards are consistent across jurisdictions.
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What should patent holders consider for enforcement?
Vigilant monitoring of infringing products, especially in the generics market, and enforcement actions before the Chinese courts or via administrative measures.
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What potential challenges could CN102076344 face?
Prior art disclosures, invalidity claims due to insufficient inventive step, or formulations that do not meet bioequivalence criteria might challenge the patent’s enforceability.
References
[1] Chinese Patent CN102076344. (2011). Bioequivalent pharmaceutical composition.
[2] State Intellectual Property Office of China. (2022). Patent Examination Guidelines.
[3] World Intellectual Property Organization. (2021). Patent Landscape Reports.
[4] European Patent Office. (2022). Patent Searching and Patentability Assessment Procedures.
[5] US Patent and Trademark Office. (2022). Bioequivalence Patent Analysis.
