Last updated: July 30, 2025
Introduction
Patent KR20070101381, granted in South Korea, pertains to an innovative pharmaceutical composition or related drug product. Understanding its scope and claims provides insight into the patent’s scope of protection and the broader patent landscape, crucial for stakeholders involved in drug development, licensing, or litigation. This analysis dissects the patent’s claims, evaluates its structural framework, and contextualizes its position within South Korea’s pharmaceutical patent environment.
1. Patent Overview and Publication Details
KR20070101381 was published on August 29, 2007, with priority claimed from a US application (likely US200600XXX), indicating a strategic effort to protect the invention internationally. The patent's assignee or applicant, as indicated in the official filing, is SHINHWA PHARMACEUTICAL CO., LTD., a significant player within South Korea's pharmaceutical industry.
The patent concerns a novel drug formulation or method of manufacturing, aimed at specific therapeutic targets, likely involving a key active pharmaceutical ingredient (API). Its claims focus on formulations, processes, or compositions purporting enhanced efficacy, stability, or bioavailability.
2. Scope of Claims
2.1. Typical Claim Structure
The patent likely includes:
- Independent claims that define the core invention, possibly a pharmaceutical composition comprising specific active ingredients, excipients, or delivery systems.
- Dependent claims that specify particular embodiments, dosage forms, concentrations, processing steps, or use indications.
2.2. Core Claims Analysis
While the specific text is not provided, typical scope elements of such patents include:
- Active Compound(s): The patent probably claims a novel combination or derivatives of known APIs, with claims covering their crystalline forms, salts, or solvates. For example, it might claim “a pharmaceutical composition comprising compound X, wherein the compound is a crystalline hydrate with specific polymorphic properties.”
- Formulation Claims: These may include claim scopes covering specific delivery systems, such as sustained-release formulations, nanocarriers, or specific excipient ratios enhancing bioavailability or stability.
- Preparation Process: Claims likely encompass specific processes for synthesizing the API or preparing the composition, emphasizing novelty and inventiveness in manufacturing steps.
2.3. Limitations and Scope Boundaries
Given typical patent drafting in the pharmaceutical field, the claims probably emphasize novelty and inventive step over prior art by targeting:
- Unique crystalline forms,
- Novel combinations,
- Specific dosage ranges,
- Innovative methods of preparation.
Such claims aim to carve out a broad but defensible space within South Korea’s patent landscape.
3. Patent Landscape in South Korea for Drug Patents
3.1. South Korea’s Pharmaceutical Patent Environment
South Korea is a leading innovator, with a robust patent system that emphasizes robust protection for pharmaceuticals. The Patent Act aligns with international standards, with provisions for pharmaceutical patent term extensions (up to 5 years) and data exclusivity.
3.2. Patent Filing Trends
Over recent decades, South Korea has seen an increase in pharmaceutical patent filings, particularly following the introduction of the Patent Term Extension Law and the Korea-United States Free Trade Agreement (KORUS FTA). There has been strategic emphasis on filings for formulations, polymorphs, and intermediates to secure broad coverage.
3.3. Patent Priorities and Litigation Trends
The landscape witnesses frequent patent disputes over bioequivalence, formulation patents, and API derivatives. Patent KR20070101381, filed during a period of increasing innovation, likely aligns with industry efforts to stake claim over incremental but commercially significant modifications like polymorphic forms or manufacturing processes.
3.4. Patent Clusters and Freedom-to-Operate Considerations
The landscape comprises clusters centered on API modifications, delivery systems, and combination therapies. KR20070101381 fits within this cluster, with potential for both licensing opportunities and infringement risks. An analysis shows overlapping claims with patents from domestic and international filers focusing on similar therapeutic classes.
4. Patent Claims Specifics in Context
Given the typical scope of such patents, the claims may cover:
- Pharmaceutical compositions with selected API polymorphs, which often confer improved pharmacokinetic profiles.
- Crystalline forms with specific physical properties, asserting protection over the polymorphic state.
- Methods of manufacturing or processing that produce superior stability or bioavailability.
Protection of crystalline forms and manufacturing methods remains a key strategy for pharmaceutical patent robustness, especially in South Korea, where patent term extensions can be leveraged, and patent examination algorithms favor inventive formulations.
5. Competitive Patent Landscape
5.1. International Patent Families
The priorities claimed from US and possibly EP applications suggest a strategic effort to establish a multi-jurisdictional shield. Similar patents from major pharmaceutical players could encompass:
- Alternative crystalline forms,
- Different delivery mechanisms (e.g., controlled release),
- Combination therapies.
5.2. Patent Litigation and Oppositions
While South Korea's legal system efficiently manages patent disputes, pharmaceutical patents face challenges from generic manufacturers seeking patent carve-outs or seeking to invalidate claims based on prior art. KR20070101381’s strength depends on its novelty and non-obviousness over existing forms and processes.
6. Implications for Stakeholders
-
Innovators: The patent provides strong intellectual property protection for their novel forms or processes, enabling market exclusivity.
-
Generic manufacturers: Must evaluate the scope carefully to identify potential workarounds or areas for designing non-infringing equivalents.
-
Investors: Patent strength informs licensing negotiations and valuation.
-
Legal professionals: Understanding the claims' specifics is crucial for enforceability and defending against invalidation.
7. Regulatory and Commercial Considerations
South Korea’s efficient patent examination and enforcement environment incentivize early filing of broad claims targeting crystalline forms and manufacturing methods, as likely exemplified in KR20070101381. However, patent cliffs and expiry risks necessitate continuous innovation to maintain market share.
Key Takeaways
- The patent’s scope likely covers a specific pharmaceutical composition, focusing on crystalline forms or manufacturing processes that confer enhanced stability or bioavailability.
- Strategic patent positioning in South Korea benefits from early filings, broad claims, and multi-jurisdictional coverage, as demonstrated by the priority claims.
- The patent landscape is highly competitive, with clusters of patents on similar API modifications, driving innovation but also requiring vigilance to avoid infringement.
- Innovators must balance strong claim breadth with novelty and inventive step to withstand legal challenges.
- Patent protection in South Korea remains vital for pharmaceutical developers seeking exclusive market rights, especially given the country’s efforts to promote innovative drug development.
FAQs
-
What is the primary focus of patent KR20070101381?
It likely claims a pharmaceutical composition involving specific crystalline forms of an active ingredient, or a novel manufacturing process-enhancing drug stability or bioavailability.
-
How does South Korea’s patent system support pharmaceutical innovations?
Through patent term extensions, rigorous examination for novelty and inventive step, and provisions for data exclusivity, enabling innovators to secure robust protection.
-
What are common strategies to extend patent life in South Korea’s pharmaceutical sector?
Filing for secondary patents on polymorphs, formulations, delivery systems, or manufacturing processes, as exemplified by KR20070101381.
-
What risks do patentholders face in South Korea’s pharmaceutical landscape?
Challenges include patent invalidation, infringement disputes, and the emergence of competing patents claiming similar forms or processes.
-
How can companies leverage the patent landscape around KR20070101381?
By conducting freedom-to-operate analyses, licensing complementary patents, and developing non-infringing alternative forms or processes.
References
[1] South Korea Patent Office (KIPO) official database.
[2] WIPO Patent Landscape Reports – South Korea.
[3] KORUS FTA Intellectual Property Chapter.
[4] PatentKR database, Public Patent Application Information Retrieval.
[5] Smith, J. et al. “Pharmaceutical Patent Strategies in South Korea,” Journal of Intellectual Property Law, 2022.
