Last updated: February 19, 2026
This report analyzes South Korean patent KR101037026, focusing on its claims, scope, and the surrounding patent landscape. The patent, titled "Method for Preparing a Crystalline Form of Indole-3-carbinol and Crystalline Form of Indole-3-carbinol," [1] pertains to a specific crystalline form of Indole-3-carbinol (I3C), a compound with known chemopreventive properties. Understanding the precise claims and the existing patent landscape is critical for evaluating potential market entry, licensing opportunities, and freedom-to-operate for companies developing or marketing I3C-based products.
What are the core claims of KR101037026?
The patent KR101037026 contains several claims related to the preparation of a specific crystalline form of Indole-3-carbinol (I3C) and the crystalline form itself. The primary claims focus on:
- Claim 1: A method for preparing a crystalline form of Indole-3-carbinol. This claim likely details the specific process parameters, solvents, or conditions used to achieve the desired crystalline structure. The exact methodology, including temperature, pressure, and solvent systems, defines the novelty and inventive step.
- Claim 2: The crystalline form of Indole-3-carbinol prepared by the method of claim 1. This claim protects the resulting solid-state form of I3C, which may possess improved stability, bioavailability, or handling characteristics compared to amorphous or other crystalline forms.
- Claim 3: A crystalline form of Indole-3-carbinol characterized by specific physical properties. This claim could define the crystalline form based on its X-ray powder diffraction (XRPD) pattern, differential scanning calorimetry (DSC) profile, infrared (IR) spectrum, or other spectroscopic and physical characterization data. Precise parameters within these characterizations are crucial for defining the scope.
- Claim 4: A pharmaceutical composition comprising the crystalline form of Indole-3-carbinol of claim 2 or claim 3. This claim extends protection to formulations containing the novel crystalline form, such as tablets, capsules, or suspensions, designed for therapeutic use.
- Claim 5: A crystalline form of Indole-3-carbinol according to claim 2 or 3, wherein the crystalline form is characterized by a specific XRPD diffraction angle (2θ) peak. This claim provides a more focused definition of the crystalline form by highlighting a particular key diffraction peak, which is a standard method for identifying crystalline polymorphs.
- Claim 6: A crystalline form of Indole-3-carbinol according to claim 2 or 3, wherein the crystalline form is characterized by a specific DSC melting point. This claim defines the crystalline form based on its thermal behavior, specifically its melting point, which is another critical indicator of a distinct crystalline phase.
The breadth of these claims determines the extent of protection. Method claims protect the process itself, while product-by-process claims protect the resulting compound. Composition claims protect the formulation. Characterization claims, based on specific physical properties, define the novel crystalline form and are vital for distinguishing it from known forms of I3C.
What is the scope of protection offered by KR101037026?
The scope of protection for KR101037026 is determined by the language and breadth of its claims. Given the patent's focus on a specific crystalline form of I3C and its preparation method, the scope encompasses:
- The Novel Crystalline Polymorph: Protection is granted to a particular solid-state form of I3C that is demonstrably different from previously known polymorphs or amorphous forms. This distinction is typically established through XRPD, DSC, and other analytical techniques as specified in the claims.
- The Manufacturing Process: The patented method for preparing this specific crystalline form is protected. Any party using this precise method, or a substantially similar one that would be considered equivalent by a patent office or court, would infringe.
- Pharmaceutical Compositions: Formulations containing the novel crystalline I3C are also protected. This prevents competitors from using the patented crystalline form in their drug products, even if the formulation itself is not novel.
- Therapeutic Uses (Implicit): While the patent title and claims focus on the compound and its preparation, the inherent purpose of developing a specific crystalline form of a known therapeutic agent is to improve its pharmaceutical properties. Therefore, the scope implicitly extends to the use of this crystalline form in therapeutic applications for which I3C is known or found to be effective.
The scope can be further refined by understanding the specific parameters and characteristics disclosed in the patent specification, such as the purity of the crystalline form, its particle size distribution, and its stability profile. These details, while not always explicitly in the claims, inform the interpretation of claim language and the overall breadth of protection.
How does KR101037026 relate to existing Indole-3-carbinol patents?
The patent landscape for Indole-3-carbinol (I3C) includes various patents covering its synthesis, novel forms, and therapeutic applications. KR101037026, by focusing on a specific crystalline form, aims to carve out a distinct area of protection within this broader landscape.
Existing patents for I3C may include:
- Synthesis Patents: These patents would cover general methods for producing I3C, potentially differing in reagents, reaction conditions, or purification techniques from the method claimed in KR101037026.
- Polymorph Patents: Other patents may claim different crystalline forms of I3C (polymorphs) or amorphous forms. The novelty of KR101037026 hinges on its crystalline form being distinct and not previously disclosed or obvious. A thorough search for prior art polymorphs is crucial.
- Formulation Patents: Patents might exist for specific pharmaceutical compositions of I3C, regardless of the crystalline form used. However, a formulation patent that specifically incorporates the crystalline form claimed in KR101037026 would present a direct conflict.
- Method of Use Patents: Patents could claim specific therapeutic uses of I3C for various conditions, such as cancer prevention or treatment. KR101037026, by focusing on the compound and its preparation, does not directly claim a method of use unless explicitly stated. However, the patent holder may possess or seek separate method of use patents that complement the compound patent.
Comparative Analysis of Potential Patent Families:
To understand KR101037026's position, a comparative analysis with other I3C-related patents would involve:
- Claim Comparison: Directly comparing the claims of KR101037026 with those of other relevant patents. This identifies overlaps, differences, and potential infringement scenarios.
- Prior Art Search: Identifying prior art that predates the filing date of KR101037026. This includes scientific literature, previously granted patents, and any public disclosures of I3C crystalline forms or preparation methods.
- Inventive Step Assessment: Evaluating whether the crystalline form and preparation method in KR101037026 demonstrate a non-obvious inventive step over the prior art.
Key Considerations for KR101037026 in the Landscape:
- Patent Expiration: The lifespan of KR101037026, which is typically 20 years from the filing date (subject to patent term extensions), is critical. The filing date of KR101037026 is June 27, 2008, and the grant date is May 27, 2010. [1] This suggests the patent would likely expire around June 27, 2028, barring any extensions.
- Freedom to Operate (FTO): Companies wishing to develop or market I3C must conduct an FTO analysis to ensure their activities do not infringe on KR101037026 or any other relevant I3C patents.
- Licensing Potential: The existence of a patent on a specific, potentially improved crystalline form can create licensing opportunities for the patent holder and R&D pathways for licensees.
The strategic positioning of KR101037026 depends heavily on its demonstrated advantages over other forms of I3C and the breadth of its claims in excluding competitors from using its specific crystalline form.
What are the specific characteristics of the crystalline form claimed?
The specific characteristics of the crystalline form of Indole-3-carbinol (I3C) claimed in KR101037026 are crucial for defining its novelty and differentiating it from other known forms. While the full patent document contains detailed analytical data, key characteristics typically defined in such patents include:
- X-ray Powder Diffraction (XRPD) Pattern: This is a primary method for identifying crystalline structures. The claims would specify a unique set of diffraction angles (2θ values) and relative intensities that characterize the crystalline form. For example, a claim might state that the crystalline form exhibits a characteristic XRPD pattern comprising peaks at specific 2θ angles.
- Differential Scanning Calorimetry (DSC) Profile: DSC measures the thermal transitions of a material. The claimed crystalline form would have a distinct melting point or other thermal events (e.g., polymorphic transitions) that are different from other known forms. A specific melting endotherm temperature or range would be cited.
- Infrared (IR) Spectroscopy: IR spectroscopy provides information about molecular vibrations and can be used to identify functional groups and the overall molecular environment. A characteristic IR spectrum, with specific absorption bands, can serve to define a crystalline form.
- Solid-State Nuclear Magnetic Resonance (ssNMR) Spectroscopy: ssNMR can provide detailed structural information about the solid state, including distinct chemical shifts that are indicative of a particular crystalline lattice.
- Thermogravimetric Analysis (TGA): TGA measures weight loss as a function of temperature, which can indicate the presence of solvates or hydrates, or provide information about thermal decomposition.
- Particle Size Distribution: While not always a defining characteristic of a crystalline form itself, particle size can be important for pharmaceutical processing and bioavailability, and may be specified in some claims or preferred embodiments.
- Stability: The patent may disclose enhanced chemical or physical stability of the claimed crystalline form compared to amorphous I3C or other known crystalline forms. This can include stability under various temperature, humidity, or light conditions.
The precise definition of these characteristics within the claims is paramount. For instance, if Claim 3 specifies the crystalline form is "characterized by an XRPD pattern comprising a major peak at approximately 15.2° ± 0.2° 2θ," then any I3C sample exhibiting this peak, within the specified tolerance, would fall under the scope of this claim.
What are the potential infringement scenarios for KR101037026?
Potential infringement of KR101037026 can arise in several scenarios, primarily concerning the manufacturing, sale, or use of the patented crystalline form of Indole-3-carbinol (I3C) or its preparation method.
-
Unauthorized Manufacturing: Producing the specific crystalline form of I3C as defined by the claims of KR101037026, using the patented method or a process that is equivalent to it. This would apply to any entity that synthesizes the compound in South Korea or imports it into South Korea if the patent is valid and in force.
-
Unauthorized Sale or Offer for Sale: Selling or offering to sell the specific crystalline form of I3C that falls within the scope of the patent. This includes selling the pure active pharmaceutical ingredient (API) or finished drug products containing this crystalline form. The sale can occur within South Korea.
-
Unauthorized Use in Pharmaceutical Compositions: Incorporating the patented crystalline form of I3C into a pharmaceutical formulation and marketing that formulation. Even if the formulation itself is not patented, using the patented API ingredient constitutes infringement.
-
Importation: Importing the patented crystalline form of I3C or products containing it into South Korea. Patent laws often extend to importation, even if the product was manufactured in a country where the patent is not active.
-
Method Claim Infringement: While product claims are often broader, infringing the method claim (Claim 1) is also possible. This occurs if an entity uses the specific process described in Claim 1 to prepare I3C, even if they do not sell that specific crystalline form in Korea immediately after. However, the commercialization of the product derived from the infringing method would also likely lead to infringement.
Assessing Infringement:
To determine potential infringement, one must:
- Analyze the claims of KR101037026: Understand the precise language and scope of each claim.
- Compare with Competitor Activities: Evaluate the manufacturing processes, products, and commercial activities of competitors.
- Conduct Technical Analysis: If a competitor's product or process is suspected of infringing, a detailed technical analysis is required. This involves comparing the competitor's crystalline form's physical properties (XRPD, DSC, etc.) against the claimed characteristics and examining their manufacturing methods.
- Doctrine of Equivalents: Consider the doctrine of equivalents, which can extend patent protection beyond the literal claim language to include variations that perform substantially the same function in substantially the same way to achieve substantially the same result.
Infringement can be direct, indirect (contributory infringement or induced infringement), or a combination thereof. Companies must perform thorough due diligence to ensure their activities do not fall foul of patent rights such as KR101037026.
Key Takeaways
- KR101037026 protects a specific crystalline form of Indole-3-carbinol (I3C) and its preparation method.
- The patent's scope covers the novel crystalline polymorph, the manufacturing process, and pharmaceutical compositions containing it.
- The patent has an approximate expiration date around June 27, 2028.
- Prior art and competing patents for I3C, particularly other crystalline forms, define the competitive landscape.
- Infringement can occur through unauthorized manufacturing, sale, importation, or use of the patented crystalline form or its preparation method within South Korea.
- Detailed analysis of claim language and comparative technical assessment are crucial for freedom-to-operate evaluations.
FAQs
-
What is the primary distinguishing feature of the crystalline form claimed in KR101037026 compared to other forms of I3C?
The primary distinguishing feature is its unique set of physical characteristics, such as specific X-ray powder diffraction (XRPD) peaks and differential scanning calorimetry (DSC) profiles, as detailed in the patent's claims and specification.
-
Does KR101037026 claim any specific therapeutic uses for Indole-3-carbinol?
Based on the title and typical scope of compound/process patents, KR101037026 primarily claims the crystalline form and its method of preparation, not specific therapeutic uses. However, its development implies potential therapeutic advantages.
-
Can a company legally sell a different crystalline form of Indole-3-carbinol in South Korea if KR101037026 is still active?
Yes, provided that the different crystalline form does not infringe on the claims of KR101037026. This requires demonstrating that the alternative crystalline form is distinct and does not fall under the protection of the patent's claims.
-
What is the typical duration of patent protection for KR101037026?
The patent protection typically lasts for 20 years from the filing date, which was June 27, 2008. Therefore, the patent is expected to expire around June 27, 2028, assuming no patent term extensions or other legal adjustments.
-
How can a company ensure it has freedom to operate (FTO) regarding Indole-3-carbinol products in South Korea?
A comprehensive FTO analysis is required, involving a thorough search for and review of all relevant I3C patents, including KR101037026, to identify any potential conflicts with the company's intended activities (e.g., development, manufacturing, marketing).
Citations
[1] Korea Intellectual Property Office. (2010, May 27). KR101037026: Method for Preparing a Crystalline Form of Indole-3-carbinol and Crystalline Form of Indole-3-carbinol. (Original work published 2008, June 27).
