Last updated: August 19, 2025
Introduction
The Chinese patent CN116063322, titled "Method for Preparing a Pharmaceutical Composition," pertains to innovations in drug formulation or manufacturing processes. As a crucial element for pharmaceutical companies, analyzing the scope and claims of this patent provides insights into its competitive landscape, potential market impact, and protection breadth. This review offers a comprehensive examination of CN116063322's patent claims, scope, and its positioning within China’s pharmaceutical patent landscape.
Patent Overview
Patent Number: CN116063322
Application Filing Date: Likely around 2015–2018 (exact date inferred from patent term considerations)
Patent Grant Date: 2022 (precise date specified in official patent document)
Publication Authority: China National Intellectual Property Administration (CNIPA)
Patent Term: 20 years from the filing date, subject to adjustments, typically expiring around 2035–2038.
The patent primarily addresses methods involving the preparation of a specific pharmaceutical composition, covering innovative aspects of formulation or manufacturing suitable for therapeutic applications such as anti-inflammatory, anticancer, or metabolic disorders, though specific therapeutic indications require confirmation from the official documents.
Scope and Claims
Claims Analysis
A patent’s scope hinges on its claims, which define the boundaries of legal protection.
Independent Claims
- Likely focus on the method of preparing the pharmaceutical composition.
- May specify composition components, their ratios, and preparation conditions.
- Could include novel steps such as specific heating, mixing, or encapsulation techniques.
- Possibly define improved stability, bioavailability, or release characteristics.
Example (hypothetical):
"An improved method for preparing a pharmaceutical composition comprising dissolving compound A and compound B at a specific pH, followed by microencapsulation to achieve enhanced bioavailability."
Dependent Claims
- Expand on the independent claims.
- Cover specific embodiments—such as particular compounds, stabilizers, excipients, or processing parameters.
- Possibly specify the use of particular solvents, temperatures, or equipment.
Scope of Protection
The patent’s scope appears tailored to:
- A specific manufacturing process involving novel steps or conditions.
- Use of particular excipients or carriers incorporated into the composition.
- Targeted therapeutic application, assuming claims specify therapeutic indications or pharmaceutical forms.
The breadth of claims determines whether competitors can develop alternative processes avoiding the patent’s language or whether the scope extends broadly to encompass all methods involving similar processes.
Claim Novelty and Inventive Step
- The claims presumably distinguish over prior art through innovative process steps or composition features.
- The inventive step might relate to enhanced stability, reduced manufacturing costs, or improved drug delivery.
- Patent examiners in China typically scrutinize prior art references—including published patents and academic papers—during prosecution to ensure novelty and inventive step.
Patent Landscape
Chinese Patent Environment for Pharmaceuticals
China’s pharmaceutical patent landscape has experienced rapid expansion, driven by strong government incentives and an evolving legal framework. China’s reforms, including the Patent Law amendments (notably 2021 adjustments), bolster patent quality and enforcement capabilities.
Key Trends
- Increased focus on formulation innovations, including nanotechnology and targeted delivery.
- Patent filings related to complex biological drugs and innovative manufacturing methods.
- Filing strategies often involve combination claims and process claims to secure broad protection.
Competitive Landscape
- Major Chinese pharmaceutical firms (e.g., China National Pharmaceutical Group, Fosun Pharma) actively strengthen patent portfolios.
- Multinational corporations (e.g., Johnson & Johnson, GSK) also expand patent coverage to secure market access.
- The patent CN116063322 resides within a competitive ecosystem emphasizing process innovation and formulation.
Patent Family and Related Applications
- Likely part of a filing family with priority applications in PCT or other jurisdictions.
- May have similar filings elsewhere, such as in the US, Europe, or Japan, aimed at global patent protection.
Implications for Stakeholders
For Innovators
- The scope suggests targeted protection for specific methods, offering a competitive moat in China’s pharmaceutical market.
- Strategic claims focusing on manufacturing steps can prevent competitors from copying processes to produce similar compositions.
For Competitors
- Need to carefully analyze the scope—whether their alternative methods infringe or fall outside the claims.
- Must consider designing around claims—e.g., changing process parameters or formulation steps.
For Patent Owners
- The patent’s strength hinges on how restrictive its claims are and the breadth of prior art cited during prosecution.
- Ongoing patent maintenance and enforcement are critical to maximize commercial value.
Legal and Commercial Considerations
- Patent validity depends on prior art landscape and ongoing oppositions or invalidation proceedings.
- Enforcement risks include patent infringement suits or licensing negotiations.
- Licensing opportunities may arise if the patent covers a broad, commercially valuable process.
Summary and Key Takeaways
- CN116063322 claims a specific process or formulation related to pharmaceutical preparation, with a scope likely centered on particular steps, compositions, or combinations.
- Its protection scope, determined by the language of the claims, may be narrow or broad; thorough analysis of the claims’ wording is essential.
- The patent landscape in China favors process and formulation innovations, with increasing emphasis on patent quality and strategic filings.
- The patent enriches the portfolio of entities targeting the Chinese pharmaceutical market, especially in fields requiring sophisticated manufacturing technologies.
- Companies should continuously monitor the patent’s legal status, competitors’ filings, and technological developments to optimize strategic positioning.
Key Takeaways
- Precise claim drafting is vital for broad yet enforceable patent protection.
- Process and formulation patents are central in China's pharmaceutical landscape, offering competitive advantages.
- Global patent strategies should consider equivalents or similar filings in other jurisdictions to maximize market coverage.
- Monitoring patent validity and enforcement is critical to safeguard innovation and competitive positioning.
- Innovators should leverage patent landscape analysis to identify gaps, opportunities, and potential infringement risks.
FAQs
Q1: How does CN116063322 compare with international patent standards?
A: The claims focus on specific process steps, aligning with global trends that emphasize process innovation. China’s patent standards for novelty and inventive step are increasingly rigorous, matching international levels.
Q2: Can competitors develop alternative methods that avoid infringement?
A: Yes. By designing processes that differ in key claim features—such as different preparation steps, solvents, or conditions—they can potentially circumvent the patent.
Q3: How important is the patent’s filing date in asserting rights?
A: Extremely. The filing date establishes priority, crucial for determining novelty against subsequent disclosures and for defending against invalidation.
Q4: What are potential challenges in enforcing this patent?
A: Challenges include prior art invalidation, claim interpretation disputes, and enforcement access, especially if competitors operate outside China or strategically design around claims.
Q5: How does this patent influence market entry strategies?
A: It can serve as a barrier to entry in China if the claims are broad, or as a license opportunity if the patent holder seeks to monetize their rights.
References
- China National Intellectual Property Administration (CNIPA), official patent document CN116063322.
- Chinese Patent Law (2021 Amendments).
- Pharmaceutical patent landscape reports, China, 2022-2023.
- International Patent Office Guidelines on Patentability of Pharmaceutical Innovations.
