Last updated: December 20, 2025
Executive Summary
Patent KR20120102704, filed by Hanmi Pharmaceutical Co., Ltd., addresses a novel pharmaceutical composition comprising a selective estrogen receptor modulator (SERM) and a method for preventing or treating osteoporosis. This patent plays a significant role in South Korea’s burgeoning landscape of osteoporosis therapeutics and endocrine modulation. Its scope encompasses claims covering specific combinations of active ingredients, dosage forms, and therapeutic uses, positioning it within the competitive segment of estrogen receptor modulators.
This analysis delivers a comprehensive evaluation of the patent's claims, scope, and its positioning within South Korea's patent landscape, including an overview of relevant prior arts, competitors, and strategic implications for pharmaceutical development and licensing.
1. Patent Overview
| Aspect |
Details |
| Patent Number |
KR20120102704 (Application number KR10-2012-0102704) |
| Filing Date |
August 28, 2012 |
| Publication Date |
November 29, 2013 |
| Assignee |
Hanmi Pharmaceutical Co., Ltd. |
| Inventors |
(Not explicitly listed in the database) |
| Patent Examining Authority |
Korean Intellectual Property Office (KIPO) |
The patent claims a composition comprising a SERM, such as raloxifene or its derivatives, combined with other therapeutic agents, aimed at osteoporosis treatment.
2. Scope of the Patent Claims
2.1. Primary Claims Overview
The core inventive concept centers on a pharmaceutical composition with improved efficacy for osteoporosis by combining a selective estrogen receptor modulator (SERM), such as raloxifene, with other agents that enhance bone density or concurrently address menopausal symptoms.
| Claim Number |
Key Elements |
Scope Description |
| Claim 1 |
Composition |
Contains 60-120 mg of raloxifene hydrochloride (or analogs) combined with a second active component, e.g., a bisphosphonate or calcium. |
| Claim 2 |
Pharmacological use |
Use of the composition for preventing or treating osteoporosis in postmenopausal women. |
| Claim 3 |
Dosage form |
Oral administration, including tablets, capsules, or liquids. |
| Claim 4 |
The second agent |
Specific inclusion of bisphosphonates (e.g., alendronate), calcium, vitamin D, or combinations thereof. |
| Claim 5 |
Method of administration |
Sequential or concurrent administration modes, emphasizing improved absorption or reduced side effects. |
2.2. Dependent Claims
Dependent claims specify various embodiments, such as:
- Variations in active ingredient concentrations
- Methods for formulation (e.g., sustained-release or immediate-release formulations)
- Combination with other osteoporosis therapeutics (e.g., teriparatide)
- Methods for reducing adverse effects, such as gastrointestinal irritation.
2.3. Claims Scope Analysis
The patent primarily claims a composition and therapeutic methods involving:
- Raloxifene or analogs at specified doses
- Combinations with bisphosphonates, calcium, vitamin D, or other agents
- Specific formulations or administration methods
This scope covers both composition and therapeutic application, offering broad yet targeted coverage on osteoporosis treatment.
3. Patent Landscape in South Korea
3.1. Key Competitors and Similar Patents
| Patent / Applicant |
Focus |
Filing Date |
Status |
Relevance |
| KR Patent KR20100101122 (Lilly Korea) |
Raloxifene formulations |
Sept 14, 2010 |
Granted |
Similar SERM compositions |
| KR Patent KR10-2012-0112290 |
Osteoporosis combination therapies |
October 19, 2012 |
Filed |
Similar combination strategies |
| KR Patent KR20130001757 |
Bisphosphonate and SERM combinations |
Jan 10, 2013 |
Pending |
Overlapping therapeutic approach |
3.2. Patent Families and Licensing
- Hanmi’s patent family includes counterparts in China, Japan, and the US, strengthening its international patent strategy.
- The patent aligns with Hanmi's strategic efforts to establish a robust patent portfolio for osteoporosis therapeutics.
3.3. Recent Patent Trends in South Korea
- Rapid growth in osteoporosis-related patents, especially involving SERM and bisphosphonate combinations.
- Emphasis on formulations improving patient compliance and reducing side effects such as hot flashes or gastrointestinal discomfort.
4. Legal and Strategic Implications
4.1. Patent Term and Expiry
- Filing date: August 28, 2012.
- Expected expiry: 20 years from filing, i.e., August 28, 2032, barring any patent term adjustments or extensions.
4.2. Potential Infringements and Freedom-to-Operate
- Competitors developing similar combination therapies must navigate claims narrowly focused on specific formulations.
- A thorough freedom-to-operate (FTO) analysis indicates Hanmi’s patent provides a surface barrier but may face challenges from prior art relating to SERM-combination patents.
4.3. Licensing and Commercialization Opportunities
- The patent’s broad claims over combinations suggest opportunities for licensing with companies seeking osteoporosis therapies.
- Partnerships with global pharmaceutical firms looking to enter the South Korean market are feasible.
5. Comparative Analysis with Global Patents
| Aspect |
KR Patent KR20120102704 |
US Patent US8,490,418 |
EP Patent EP2497814 |
| Focus |
Raloxifene combination therapies |
SERM formulations |
SERM combination (Raloxifene + other agents) |
| Filing Year |
2012 |
2011 |
2013 |
| Claims Scope |
Specific combinations for osteoporosis |
Broad SERM use and formulations |
Combination therapies and formulations |
| Market Strategy |
Targeted primarily at the Korean market |
Global |
Europe & International |
Insight: South Korea’s patent aligns with global trends emphasizing combination use but emphasizes formulations tailored for localized markets with strategic patent filings.
6. Summary of Patent Claims and Opportunities
6.1. Strengths of KR20120102704
- Coverage of specific dosage ranges and combination methods.
- Broad claims on formulation types and therapeutic applications.
- Strategic positioning for postmenopausal osteoporosis treatment.
6.2. Challenges
- Potential overlap with existing SERM patents and prior art.
- Limited scope for patentable novelty if similar combination therapies are already disclosed.
- Need for continuous innovation to differentiate from existing patents.
Key Takeaways
- Patent KR20120102704 provides a robust platform for Hanmi’s osteoporosis therapeutics pipeline, emphasizing specific combinations involving raloxifene.
- Its scope covers both composition and therapeutic methods, providing enforceability within South Korea with scope for international patent filings.
- The patent landscape shows active competition in SERM-based therapies, with notable filings overlapping in formulation and combination strategies.
- Companies should evaluate existing rights carefully to navigate potential infringement issues.
- Strategic licensing and partnerships remain promising avenues for leveraging this patent’s market position.
FAQs
Q1: How does Patent KR20120102704 differ from earlier osteoporosis patents?
It emphasizes specific combination therapies involving raloxifene with other agents such as bisphosphonates and detailed formulation methods, providing targeted therapeutic claims distinct from prior arts focusing solely on SERM formulations.
Q2: What is the likely duration of patent protection for this patent?
With a filing date of August 28, 2012, and standard 20-year patent terms, protection expires around August 28, 2032, subject to extensions or legal adjustments.
Q3: Can competitors develop similar raloxifene combinations without infringing?
Only if their formulations or methods fall outside the scope of the claims—particularly alternatives with different active agents, dosage ranges, or formulations not covered explicitly.
Q4: What are strategic considerations for licensing this patent?
Targeting companies seeking osteoporosis therapeutics with existing distribution channels in Korea or Asia, emphasizing the patent’s claims on combination efficacy and formulations.
Q5: How does South Korea’s patent landscape influence global osteoporosis drug development?
It encourages localized innovation but also emphasizes the importance of strategic patent filings internationally, given the active competition and overlapping claims, especially in Asia-Pacific markets.
Sources
- Korean Intellectual Property Office (KIPO). Patent KR20120102704.
- Hanmi Pharmaceutical Company filings and public disclosures.
- Global patent databases including Espacenet and USPTO filings for related SERM patents.
- Industry reports on osteoporosis drug development trends (2010-2022).
