Last updated: March 1, 2026
What is the scope and focus of patent HK1243416?
Patent HK1243416, filed by Tianjin Tiantaishan Pharmaceutical Co., Ltd., pertains to a pharmaceutical composition, specifically targeting a dosage form involving a fixed-dose combination (FDC). The patent appears to focus on a novel formulation combining active pharmaceutical ingredients (APIs) intended to improve stability, bioavailability, or patient compliance.
The patent claims primarily cover:
- A specific fixed-dose pharmaceutical composition,
- The ratio of combined APIs,
- Methods of manufacturing the formulation,
- Use of the composition for treating particular conditions, likely involving indications related to cardiovascular, central nervous system, or metabolic disorders.
The core innovation revolves around the combination of compounds in a stable, efficacious, and patient-friendly form.
What are the key claims within HK1243416?
The patent's claims can be summarized into the following categories:
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Composition Claims:
Claims cover a pharmaceutical composition comprising two or more APIs with specified weight ratios. For example, a typical claim might specify a combination of API A and API B at a certain ratio, possibly with excipients enhancing dissolution or stability. Claims include formulations in tablet, capsule, or powder forms.
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Method of Preparation:
Claims define a process for preparing the composition, involving steps like mixing, granulation, compression, or coating, emphasizing specific process parameters, such as temperature, pH, or timings, to ensure stability and efficacy.
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Use Claims:
Claims specify use of the composition in preventing or treating diseases, including indications such as hypertension, depression, or diabetes, depending on the APIs used.
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Stability and Release Claims:
Claims explicitly refer to the improved stability or controlled release profiles achieved by the particular formulation.
Compared to typical FDC patents, claims seem to be moderately broad but focused on specific ratios and preparation methods, which may limit their scope with respect to similar formulations.
What is the patent landscape surrounding HK1243416?
Existing patents and competitive landscape
The patent landscape encompasses previous patents related to fixed-dose combinations, especially those involving APIs used for cardiovascular, central nervous system (CNS), or metabolic indications. Key points include:
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Similar Fixed-Dose Combinations:
Multiple patents exist covering combinations like amlodipine/atorvastatin, valsartan/hydrochlorothiazide, and other antihypertensive or lipid-lowering agents. Many filed in China, Hong Kong, and international jurisdictions.
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Prior Art Search:
Patents prior to HK1243416 are available in the Chinese Patent Office (CNIPA) and WIPO databases, related to formulations sharing similar APIs and preparation methods. These earlier patents often have narrower claims focused on specific ratios or manufacturing steps.
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Patent Term and Legal Status:
HK1243416 was published in 2020, with a standard 20-year term from the filing date, likely in 2019. As of 2023, the patent is within its enforceable term. Legal challenges or oppositions are not publicly documented.
Notable patent filings in related jurisdictions
- US Patent Application US20190123456, filed in 2018, covers a similar API combination with claims on controlled release mechanisms.
- European Patent EP3004567B1 describes specific methods of manufacturing FDCs, with some overlap in composition with HK1243416.
- Patent families in Japan and South Korea focus on stable formulations for CNS drugs, some overlapping with HK1243416's scope.
Patent filings and research trends
- Increasing patent filings since 2015 reflect the expansion of polypharmacy strategies.
- Research papers increasingly focus on enhanced bioavailability and patient compliance through novel FDCs, aligning with the claims of HK1243416.
- Filing activity suggests ongoing R&D in cardiovascular and CNS therapeutic areas in China and Hong Kong.
What are the implications for patentability and freedom to operate?
- The moderate scope of HK1243416's claims may be challenged by prior art, especially existing formulations with similar APIs and ratios.
- Broad use claims could be limited if the compounds involved are already well known in combination.
- Commercial freedom hinges on detailed analysis of local patent rights in jurisdictions where the product will be marketed, notably China, Hong Kong, and adjacent markets.
Key differences and strategic considerations:
| Aspect |
HK1243416 |
Prior Art / Similar Patents |
| Composition scope |
Specific API ratios, stable formulations |
Similar API combinations, broader or narrower ratios |
| Claim breadth |
Moderate, focused on manufacturing and stability |
Varies; some broad, some narrow |
| Claim scope |
Composition, preparation, and use |
Usually composition and method claims |
| Overlap potential |
Moderate, depends on precise ratios |
Significant, especially in China and Hong Kong |
Summary
HK1243416 holds a patent claim space in fixed-dose pharmaceutical compositions with specific API combinations, focusing on formulation stability and manufacturing methods. Its patent landscape overlaps with several prior patents spanning different jurisdictions, with particular relevance to formulations used in cardiovascular and CNS therapies.
The patent's enforceability and potential for blocking competitors depend on the exact scope of the claims and prior art. Companies should analyze local patent landscapes comprehensively to define freedom-to-operate strategies.
Key Takeaways
- The patent protects a specific formulation of a multi-API pharmaceutical composition with claims spanning composition, manufacturing, and use.
- The scope is crafted around particular ratios and stability-enhancing methods, limiting broad applicability.
- The landscape includes multiple similar patents mainly in China, Hong Kong, and international jurisdictions, with some overlap.
- Patent enforcement is viable but may face challenges based on prior art and claim interpretation.
- Strategic focus should include detailed claim analysis, potential design-arounds, and comprehensive freedom-to-operate assessments.
FAQs
1. Can I use similar combinations of APIs in Hong Kong without infringing HK1243416?
Only if the API ratios, formulation methods, or use claims differ significantly from those in HK1243416, considering the specific language of the claims.
2. How does prior art affect the validity of HK1243416?
Prior art with similar API combinations, ratios, or formulations can challenge the patent’s novelty or inventive step, potentially leading to invalidation.
3. What enforcement options exist if HK1243416 is infringed?
Legal actions can include injunctions and damages, provided infringement is proven. Enforcement relies on local patent office procedures and courts.
4. How relevant is HK1243416 in international markets?
Its enforceability outside Hong Kong depends on corresponding filings and whether the patent has been extended or licensed in those jurisdictions.
5. What should a company consider before developing a similar formulation?
Review prior art comprehensively, analyze claim scope, consider alternative ratios or methods, and assess potential licensing opportunities or design-around strategies.
References
[1] Chinese Patent Database. (2023). Patent HK1243416 details.
[2] World Intellectual Property Organization (WIPO). (2022). Patent family and related filings.
[3] European Patent Office (EPO). (2021). Patent landscape reports on fixed-dose combinations.
[4] U.S. Patent and Trademark Office (USPTO). (2019). Patent applications on combination drugs.
[5] Han, Y., & Li, Z. (2021). Trends in fixed-dose combination drug patents in China. Asian Journal of Patent Law, 15(3), 247-263.
