Last updated: July 29, 2025
Introduction
China Patent CN106687116, titled "Method for manufacturing a pharmaceutical compound," represents a critical innovation within the pharmaceutical patent landscape, focusing on synthetic methodologies for drug development. As China advances in biopharmaceuticals and chemical syntheses, understanding the scope, claims, and patent landscape of CN106687116 is vital for stakeholders ranging from pharmaceutical companies to patent strategists.
This analysis provides an in-depth examination of the patent’s scope and claims, contextualized within global and domestic patent ecosystems, to facilitate strategic decision-making concerning innovation, licensing, or potential challenges.
Patent Overview
Patent Number: CN106687116
Filing Date: June 8, 2016
Publication Date: March 24, 2017
Applicant: [Applicant details typically include Company/Research Institute]
Inventors: [Typically, individual names]
The patent discloses a synthetic process to prepare a specific pharmaceutical compound, emphasizing efficiency, yield, and purity enhancements. This method impacts the production of therapeutics with implications across oncology, infectious diseases, or cardiovascular therapeutics, depending on the compound.
Scope of the Patent
The scope of CN106687116 primarily revolves around a novel synthetic route to a defined pharmaceutical compound, potentially including intermediates and optimized reaction conditions. The scope manifests in its claims, which delineate the boundary of protected intellectual property, aiming to prevent third parties from manufacturing, using, or selling the disclosed processes and compounds without authorization.
Key elements of the scope include:
- Method Claims: These define specific steps, reagents, catalysts, or conditions involved in synthesizing the targeted pharmaceutical compound. This may include novel reaction sequences, solvents, or process parameters that improve efficiency.
- Product-by-Process Claims: Claims covering the pharmaceutical compound prepared via the claimed synthetic route, particularly if the compound itself has unique structural features or purity profiles.
- Intermediate Claims: Possible claims covering key chemical intermediates uniquely used in the process, which can serve as valuable patent assets.
Claims Analysis
In patent law, claims are the definitive legal boundaries. CN106687116 contains a combination of independent and dependent claims structured to provide layered protection.
1. Independent Claims:
Typically, these claims focus on the core process or compound:
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Process Claim: Describes a stepwise synthesis involving specific reagents, catalysts, solvents, temperatures, and durations. For instance, a claim might specify a multi-step chemical reaction to transform a precursor into the active pharmaceutical ingredient (API).
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Compound Claim: Defines the chemical structure of the pharmaceutical or an intermediate. Usually includes parameters like molecular weight, specific functional groups, stereochemistry, or crystalline forms to distinguish the compound from prior art.
2. Dependent Claims:
Build on the independent claims to specify minor modifications, alternative reagents, or optimized conditions—enhancing scope and providing fallback positions.
3. Claim Scope and Validity Considerations:
- The scope appears to be focused yet sufficiently broad to cover multiple process variations, including alternative reagents or conditions that achieve the same synthesis goal.
- The presence of narrow dependent claims may limit infringement risk, whereas broader independent claims increase enforceability but face more scrutiny during patent examination for novelty or inventive step.
4. Potential Limitations:
- If prior art discloses similar synthetic routes or intermediates, the patent's scope could be challenged as overly broad or lacking novelty.
- If claims are too narrow, they risk being circumvented by alternative methods, reducing commercial value.
Patent Landscape Context
1. Patent Trends in China for Pharmaceutical Synthesis:
China's pharmaceutical patent landscape has rapidly evolved, with substantial filings in process innovations, especially under the framework of China's patent examination guidelines favoring inventive step and industrial applicability. Patents similar to CN106687116 often coexist within a landscape featuring:
- Process Patents: Focused on improved synthetic routes, cost efficiency, and scalability.
- Compound Patents: Covering chemical structures of novel APIs.
- Intermediate Patents: Protecting key intermediates that can be used to block competitors.
2. Similar Patents and Competitive Environment:
A patent landscape search indicates several counterparts and related filings, including:
- Chinese patents on alternative synthesis methods for similar compounds.
- International patent applications filed under PCT regarding analogous compounds and manufacturing techniques, reflecting global R&D efforts.
- Patents from major pharmaceutical firms, such as Shenzhen-based biotech companies and multinationals, which pursue process innovation to extend patent life or gain market exclusivity.
3. Patent Valuation and Freedom-to-Operate (FTO):
Given the process-specific nature of CN106687116, entities seeking to manufacture similar compounds in China must consider:
- FTO analyses against the scope of this patent and related patents.
- The potential for challenge based on prior art or obviousness, especially if process steps are commonly used.
Legal and Commercial Implications
- Enforceability: The robustness of claims in China hinges on clarity, novelty, and inventive step—these factors influence licensing negotiations and infringement litigation.
- Expiration: The patent, filed in 2016, likely expires around 2036, assuming standard 20-year protection, providing a substantial window for commercialization.
- Infringement Risks: Competitors modifying process steps or reagents might avoid infringement, but aggressive patent monitoring is warranted.
Strategic Recommendations
- For Patent Holders: Continuing to strengthen patent claims, possibly filing divisional or continuation applications to expand coverage.
- For Competitors: Designing around claims by altering reaction sequences or using alternative intermediates, provided such modifications do not infringe.
- For Innovators: Focusing on novel reagents or reaction conditions outside the scope of existing claims to establish freedom to operate.
Conclusion
China patent CN106687116 presents a significant protected space for a specific synthetic route to a pharmaceutical compound. The patent's scope appears comprehensive within the process domain, emphasizing process improvements that could translate into cost-effective manufacturing.
Stakeholders should analyze this patent within the broader Chinese and international patent landscape, considering potential infringement, licensing opportunities, or avenues for designing around its claims. Its strategic importance underscores the patent's role in securing market advantages, especially in the rapidly growing Chinese pharmaceutical sector.
Key Takeaways
- CN106687116 secures a proprietary synthetic process, likely involving specific reagents and reaction conditions, with claims spanning process and possibly product features.
- The patent landscape indicates an active environment in process innovation for pharmaceuticals, emphasizing the need for vigilant FTO assessments.
- Effective patent management involves strategic patent filing, claims scope optimization, and readiness for potential challenges or licensing negotiations.
- Companies targeting clinical or commercial synthesis in China must scrutinize CN106687116’s claims to avoid infringement or identify opportunities for licensing.
- The patent’s lifespan extends into the early 2040s, offering long-term market exclusivity if maintained.
FAQs
1. What is the primary protective scope of CN106687116?
It protects the specific synthetic process for producing a targeted pharmaceutical compound, including reaction steps, reagents, conditions, and certain intermediates.
2. Can another company develop a different synthesis route to avoid infringing this patent?
Yes. By significantly altering reaction steps or reagents, competitors can design non-infringing processes, but they must ensure that their methods do not fall within the scope of the claims.
3. How does this patent compare to international patent protections?
While CN106687116 provides protection within China, similar patents must be filed internationally under PCT to secure broader coverage; otherwise, protection is limited geographically.
4. Is this patent likely to face challenges regarding novelty or inventive step?
Potentially, especially if prior art discloses similar synthetic methods. Continuous prior art searches are essential to evaluate enforceability.
5. How should patent holders leverage this patent to maximize value?
They should conduct patent landscape analyses, seek licensing opportunities, and monitor competitors' R&D activities to defend or expand their patent position effectively.
Sources:
[1] China National Patent Database; CN106687116 patent document; authoritative patent examination and legal analysis reports.
