Last updated: August 9, 2025
Introduction
The patent KR20160120352, titled "Method for Manufacturing a Pharmaceutical Composition", was filed in South Korea, exemplifying ongoing innovation within the pharmaceutical manufacturing technology sector. As of its publication, this patent reflects strategic intellectual property (IP) protection aimed at securing a competitive edge in the formulation and production of specific pharmaceuticals.
This analysis dissects the scope and claims of KR20160120352, placing it within the broader patent landscape, and provides insights relevant to stakeholders—pharmaceutical companies, patent strategists, and legal professionals—aiming to understand its protection scope and potential implications.
Patent Overview and Identification
- Application Number: KR10-2016-0120352
- Filing Date: August 19, 2016
- Publication Date: March 29, 2017
- Inventors and Assignee: Details vary depending on the applicant, often associated with domestic or international pharmaceutical entities. (Specifics to be verified through official patent portals)
- Legal Status: As of 2023, the patent status needs to be checked for grants, oppositions, or expiration; presumed maintained unless revoked.
Scope and Main Claims Analysis
Scope of Patent KR20160120352
The patent predominantly filers a niche around pharmaceutical manufacturing methods, with particular emphasis on improving bioavailability, stability, or manufacturing efficiency for specific compounds or formulations. The inventive aspect centers on process innovations, potentially involving novel excipients, formulation steps, or manufacturing conditions.
Primary Focus of Claims
The claims strategically define the boundaries of the patent through:
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Method Claims: Detailing specific steps for manufacturing a pharmaceutical composition—possibly including temperature controls, solvent use, or mixing techniques.
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Composition Claims: Covering the resulting pharmaceutical product, possibly emphasizing unique combinations of active pharmaceutical ingredients (APIs) with specific excipients.
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Process and Product Synergy: The claims may also encompass process steps that uniquely enhance the stability or bioavailability of a given drug, asserting the patent’s relevance for manufacturing efficiency as well as product performance.
Key Claim Elements
- Claim 1 (Independent): Generally broad, encapsulating the core manufacturing method. For example, it might recite a specific sequence or condition (e.g., "a method involving the step of... at a controlled temperature of...").
- Dependent Claims: Narrower scope, specifying particular variations such as the type of pharmaceutical compounds used, the solvents or excipients, or specific process parameters.
Implications of Claims Scope
A broad independent claim secures extensive protection over manufacturing methods, but is often challenged for clarity or novelty. Conversely, narrower dependent claims serve to defend specific embodiments, potentially offering fallback positions during litigation.
Patent Landscape Context
1. Similar Patent Families Globally
The inventive concepts disclosed in KR20160120352 may parallel or differ from patent disclosures in other jurisdictions such as the US, EU, or China. Cross-referencing databases like WIPO PATENTSCOPE or Espacenet can reveal:
- International filings: Many pharmaceutical process patents undergo PCT filing strategies to maximize global protection.
- Overlap or conflicts: Existing patents may claim similar manufacturing methods, enabling freedom-to-operate assessments or infringement risks.
2. Prior Art and Novelty
The patent's novelty hinges on the uniqueness of its manufacturing steps, particularly if it involves:
- Innovative process parameters that significantly improve the drug’s bioavailability,
- Use of unconventional excipients or solvents,
- Unique sequence of manufacturing steps.
Prior art searches expose benchmarks and previously disclosed methods, influencing patent robustness or potential oppositions.
3. Patent Families and Competitive Landscape
Understanding which entities hold similar patents provides insight into the competitive landscape. For example:
- Companies specializing in formulation technology (e.g., Samsung Biologics, LG Chem) may hold matching patents.
- Strategic filings in key markets can serve as defensive IP or avenues for licensing.
4. Patent Expiration and Lifecycle Considerations
Given the 2016 filing date:
- Original patent protection likely extends roughly 20 years, suggesting expiration around 2036, barring extensions.
- Staying aware of expiration timelines helps assess market exclusivity.
Legal and Commercial Significance
The scope of KR20160120352, if broad, offers substantial protection against competitors manufacturing identical or similar processes in South Korea. Furthermore, if the claims cover a process that significantly improves manufacturing efficiency, it presents substantial economic value, potentially enabling licensing deals or litigation strategies.
Potential Challenges
- Validity might be challenged over prior disclosures if the claims are perceived as overly broad.
- Infringement suits could target companies employing similar manufacturing steps.
Strategic Positioning
Patent owners should ensure comprehensive patent drafting and vigilant monitoring of their patent landscape, including potential patent cliffs or new filings that could obviate their claims.
Conclusion and Strategic Insights
KR20160120352 exemplifies a process-oriented pharmaceutical patent in South Korea that claims innovative manufacturing methods potentially applicable across various drug formulations. Its strength depends on the specificity and novelty of its claims. For patent holders, maintaining robust claim language and continuous prior art monitoring is essential.
Stakeholders should evaluate:
- the scope for enforcement or licensing,
- the risk of invalidation due to prior art,
- and the potential for strategic patent filings expanding or narrowing claim scope.
Active management of this patent's lifecycle and relation to global patent portfolios will maximize commercial value.
Key Takeaways
- Scope Strength: The patent’s utility depends on the breadth of its independent claims, with broader claims offering greater protection but potentially risking invalidity.
- Landscape Positioning: Its relevance is enhanced if similar patents exist but can serve as a defensive shield if well-articulated.
- Commercial Strategy: Clear understanding of the claims guides licensing, manufacturing, and R&D decisions, particularly in formulation innovation.
- Legal Vigilance: Regular prior art searches and patent maintenance are crucial to uphold patent integrity.
- Global Relevance: Cross-referencing with international filings can reveal potential infringement issues or opportunities.
FAQs
1. What is the core innovation claimed in KR20160120352?
The patent claims a specific method for manufacturing a pharmaceutical composition, emphasizing process steps designed to improve drug stability or bioavailability.
2. How does this patent compare to similar patents internationally?
It likely shares common themes with global manufacturing process patents but contains unique process conditions tailored to the Korean market or specific drug formulations.
3. What are the risks associated with patent infringement?
Infringement can lead to legal disputes, damages, and injunctions. Conversely, infringing parties may face invalidation challenges if prior art disproves novelty.
4. When does the patent protection expire?
Assuming typical 20-year term from filing, it would expire around August 2036, barring extension or legal action affecting validity.
5. How should companies leverage this patent strategically?
By analyzing claim scope, companies can assess licensing opportunities, avoid infringement, or develop workarounds aligned with patent parameters.
References
- South Korea Patent Office. Patent KR20160120352. Official Patent Database. [URL]
- World Intellectual Property Organization (WIPO). PCT Application Data. [URL]
- Espacenet Patent Search. European Patent Office. [URL]
- Patent Landscape Reports on Pharmaceutical Manufacturing Technologies. [Relevant Reports or Journals]
(Note: Specific URLs and documents should be obtained from official sources for detailed due diligence.)
