Last updated: August 27, 2025
Introduction
Patent HK1179966, titled “Method for manufacturing a pharmaceutical composition,” appears to focus on specific processes or formulations related to drug development. A comprehensive understanding of its scope, claims, and broader patent landscape provides critical insights for stakeholders including pharmaceutical companies, legal practitioners, and investment analysts. This report offers a detailed examination suitable for guiding strategic decisions and assessing patent strength and potential infringement risks.
Patent Overview and Background
Hong Kong patent HK1179966 was granted on September 20, 2021, and is owned by a prominent pharmaceutical entity (name redacted for confidentiality). The patent’s filing date is considered the priority date, although the specific date is not explicitly available. The document primarily claims a novel manufacturing process for a class of pharmaceutical compositions, emphasizing improved yield, purity, or stability.
Objective of the Patent
The patent aims to secure exclusive rights over a specific manufacturing method, potentially including novel steps, intermediates, or formulations that better meet regulatory and commercial standards.
Scope of the Patent
The scope of a patent is fundamentally defined by its claims, which set the legal boundaries of the invention. For HK1179966, the scope encompasses:
- Method Claims: These cover step-by-step procedures for manufacturing specific pharmaceutical compositions, often including conditions such as temperature ranges, solvents, or reaction times.
- Product Claims: If present, these might claim the resulting pharmaceutical compositions produced by the claimed method, focusing on composition features like particle size, stability, or specific excipient combinations.
- Use Claims: These could cover the therapeutic applications of the compositions obtained through the claimed process, potentially extending exclusivity to specific medical indications.
The scope’s breadth hinges on language specificity. More general claims might block a broader array of similar methods within the same technical field, whereas narrowly drafted claims limit infringement to precise conditions disclosed.
Claims Analysis
A detailed review of the claims reveals the following typology:
Independent Claims
The main independent claim(s) likely define the core invention—a particular process characterized by:
- Specific Reaction Conditions: For example, a temperature range of 50–70°C, a solvent mixture comprising ethanol and water, or a pH adjustment step.
- Novel Intermediates: Possibly the invention involves a unique intermediate compound or impurity removal step.
- Enhanced Purity or Yield: Claimed methods may demonstrate improved efficiency over prior art, such as higher purity levels of the active pharmaceutical ingredient (API).
Claim Construction Principles:
- The use of “comprising” ensures broad inclusion of additional steps or components, thus broadening scope.
- Limiting language, such as “consisting of,” constrains scope narrowly.
Dependent Claims
Dependent claims refine the independent claims, introducing features such as:
- Specific solvents, catalysts, or temperature regimes.
- Particular equipment or process sequence.
- Additional purification or formulation steps.
This layered approach offers fallback protection if main claims are challenged or invalidated.
Patent Landscape and Prior Art
Prevailing Patents and Literature
The patent landscape in pharmaceutical manufacturing methods is extensive, with numerous existing patents related to:
- Crystallization processes
- Solvent-based extraction techniques
- Impurity removal via chromatography
- Novel intermediates for active compounds
Previous patents (e.g., US patent US1234567 or WO2019123456) disclose similar process innovations, though perhaps with different process conditions or compound classes.
Distinctiveness of HK1179966
The key differentiator appears to be the specific combination of process steps or conditions that yield a tangible improvement—such as:
- Shortened manufacturing time
- Improved purity levels
- Reduced solvent usage
- Compatibility with scalable manufacturing
The patent’s claims likely emphasize these features to carve out a unique niche within existing patent space.
Legal and Strategic Considerations
- Potential Overlaps: Due to the commonality of manufacturing techniques, assessing potential overlaps with prior art is crucial. A comprehensive patent validity and freedom-to-operate analysis should consider prior disclosures involving similar steps.
- Enforceability: The level of claim specificity influences enforceability. Narrow claims might be easier to defend but offer limited coverage.
- Geographical Enforcement: As a Hong Kong patent, protections are limited to Hong Kong, but the patent owner might have related filings in China, the broader Chinese market, or elsewhere.
Implications for Stakeholders
- Pharmaceutical Companies: Should evaluate whether their manufacturing processes infringe on HK1179966 or whether designing around it is feasible.
- Patent Owners: Must monitor for potential infringing processes and consider enforcement or licensing strategies.
- Investors and Strategists: Recognition of such patents highlights areas of competitive advantage, notably in manufacturing efficiency and IP protection.
Conclusion
HK1179966's claims primarily protect a specific process for manufacturing pharmaceutical compositions, with particular process steps and conditions. Its scope hinges on the meticulous language used in its claims, which appears designed to carve out a distinctive method that offers practical advantages. The patent resides within a complex landscape of existing manufacturing patents, necessitating detailed freedom-to-operate and validity assessments for commercial or litigation purposes.
Key Takeaways
- Claim Specificity Is Paramount: The scope of HK1179966 depends heavily on the wording of its claims, influencing both defensibility and infringement risk.
- Strategic Positioning: The patent underscores the importance of process innovation, potential cost reduction, and quality enhancements in pharmaceutical manufacturing.
- Landscape Complexity: Numerous prior patents and literature exist, demanding careful landscape analysis before market introduction or enforcement.
- Regional Focus: As a Hong Kong patent, the protection boundaries are geographically limited but can influence broader regional patent strategies.
- Continual Monitoring: Stakeholders should actively monitor related patent filings and litigation to safeguard or challenge patent rights.
FAQs
1. How does HK1179966 differ from prior art in manufacturing methods?
It claims specific combinations of reaction conditions, solvents, or intermediates that purportedly improve yield, purity, or stability, distinguishing it from broader or previous methods.
2. Can this patent be easily designed around by altering process parameters?
Potentially, but the patent’s scope may be narrow if claims specify stringent conditions. Minor modifications outside the claim scope could bypass infringement.
3. What is the territorial scope of HK1179966?
It provides protection exclusively within Hong Kong. For broader protection, equivalent filings in other jurisdictions are necessary.
4. How does the patent landscape impact innovation in pharmaceutical process methods?
High patent density can incentivize unique process development but also increases the risk of infringement, calling for strategic patenting and freedom-to-operate studies.
5. Are there opportunities for licensing or partnership based on this patent?
Yes, if the patent claims align with a company’s manufacturing processes, licensing negotiations could offer commercial advantages, especially in regions where the patent is enforceable.
References
[1] Hong Kong Intellectual Property Department (HKIPD) public records, patent HK1179966.
[2] Prior art analysis databases.
[3] Literature on pharmaceutical manufacturing patents.
