Analysis of United States Drug Patent 9,468,639

Executive Summary

United States Patent 9,468,639, titled "Substantially Pure Tetrahydrocannabinol Crystals," was granted to AXIM Biotechnologies, Inc. on October 18, 2016. The patent claims a method for producing highly pure crystalline delta-9-tetrahydrocannabinol (THC) and the resulting crystalline product. The invention addresses challenges in isolating THC from cannabis, aiming for pharmaceutical-grade purity. The patent's scope covers the crystalline form of THC, its purification process, and potential therapeutic applications. The patent landscape indicates a growing interest in cannabinoid-based therapeutics, with this patent contributing to the specific purification and crystallization of THC.

What is the Core Invention Claimed in U.S. Patent 9,468,639?

U.S. Patent 9,468,639 primarily claims a process for obtaining substantially pure crystalline delta-9-tetrahydrocannabinol (THC) and the resulting crystalline product. The process involves specific steps to isolate and purify THC from cannabis plant material, culminating in a crystalline form with a defined purity level.

The patent's claims focus on:

A method for producing substantially pure crystalline delta-9-tetrahydrocannabinol: This includes steps like extraction of cannabinoids from cannabis, separation of THC from other cannabinoids, and subsequent crystallization of the THC.
Substantially pure crystalline delta-9-tetrahydrocannabinol: The patent defines this crystalline form as having a purity of at least 95%, and in certain embodiments, 99% or greater.
Methods of treatment utilizing the crystalline THC: The patent also broadly covers the use of the claimed crystalline THC for therapeutic purposes.

What is the Significance of "Substantially Pure Crystalline THC"?

The production of "substantially pure crystalline THC" is significant for several reasons within the pharmaceutical and chemical industries:

Pharmaceutical Grade Standards: Pharmaceutical drugs require a high degree of purity to ensure safety, efficacy, and consistent dosing. Achieving purity levels of 95% or higher is critical for meeting regulatory standards for human use.
Therapeutic Consistency: Impurities in drug compounds can lead to unpredictable therapeutic effects or adverse reactions. A pure crystalline form ensures that the active ingredient is consistently THC, allowing for predictable pharmacological responses.
Stability and Shelf-Life: Crystalline forms of compounds are often more stable than amorphous forms or impure mixtures. This can improve the shelf-life of the drug product and simplify storage and handling.
Dosage Precision: With a pure active ingredient, it is easier to formulate precise dosages, which is essential for titration and managing patient response in clinical settings.
Intellectual Property: Isolating and characterizing a specific crystalline form of a compound can be a basis for patent protection, differentiating it from naturally occurring mixtures or less pure extracts.

What is the Crystallization Process Described?

The patent details a process for crystallizing THC, aiming for high purity. While the exact proprietary details of the process are protected, the general methodology involves:

Extraction: Initial extraction of cannabinoids from cannabis plant material using suitable solvents.
Separation: Techniques employed to separate THC from other cannabinoids (e.g., CBD, CBN) and other plant compounds. This can involve chromatography or other separation methods.
Crystallization: Inducing the formation of THC crystals from a purified THC solution. This typically involves dissolving the purified THC in a specific solvent system and then altering conditions (e.g., temperature, solvent evaporation) to precipitate the crystalline form. The patent describes specific solvent systems and conditions that favor the formation of the claimed crystalline structure.
Isolation and Drying: Collecting the formed crystals and drying them to remove residual solvents.

The patent emphasizes that the crystallization process is designed to achieve the specific purity metrics and crystalline characteristics that are central to its claims.

What are the Key Claims of U.S. Patent 9,468,639?

U.S. Patent 9,468,639 includes multiple claims, with the most significant ones relating to the composition of matter and the method of production.

Claim 1: "A substantially pure crystalline delta-9-tetrahydrocannabinol." This is a composition of matter claim, covering the crystalline form of THC itself, defined by its purity.

Claim 2: "The substantially pure crystalline delta-9-tetrahydrocannabinol of claim 1, having a purity of at least 95% by weight." This claim further specifies the minimum purity threshold.

Claim 3: "The substantially pure crystalline delta-9-tetrahydrocannabinol of claim 2, having a purity of at least 99% by weight." This represents an even higher purity standard.

Claim 4: "A method for producing substantially pure crystalline delta-9-tetrahydrocannabinol, the method comprising: (a) extracting one or more cannabinoids from cannabis plant material; (b) separating delta-9-tetrahydrocannabinol from the one or more cannabinoids; and (c) crystallizing the delta-9-tetrahydrocannabinol to produce substantially pure crystalline delta-9-tetrahydrocannabinol having a purity of at least 95% by weight." This claim outlines the method of production.

Claim 5: "The method of claim 4, wherein the crystallizing comprises dissolving the delta-9-tetrahydrocannabinol in a solvent system and inducing crystallization." This clarifies a step within the method.

Claim 6: "The method of claim 5, wherein the solvent system comprises at least one organic solvent." This specifies the nature of the solvent.

Claim 7: "The method of claim 4, further comprising formulating the substantially pure crystalline delta-9-tetrahydrocannabinol into a pharmaceutical composition." This points to the intended use.

Claim 8: "A substantially pure crystalline delta-9-tetrahydrocannabinol produced by the method of claim 4." This is a product-by-process claim.

The patent also includes claims related to specific therapeutic uses, such as treating pain, inflammation, and neurological disorders using the claimed crystalline THC.

What is the Current Patent Landscape for Cannabinoid Therapeutics?

The patent landscape for cannabinoid therapeutics is dynamic and increasingly crowded. Numerous patents have been filed and granted covering various aspects of cannabinoids, including:

Extraction and Purification: Methods for isolating specific cannabinoids (THC, CBD, CBG, etc.) from cannabis.
Synthetic Cannabinoids: Novel synthetic analogs of naturally occurring cannabinoids with modified properties.
Formulations: Novel drug delivery systems for cannabinoids, such as oral solutions, transdermal patches, inhalers, and liposomal formulations, to improve bioavailability and targeted delivery.
Therapeutic Uses: Patents claiming the use of specific cannabinoids or cannabinoid combinations for treating a wide range of conditions, including epilepsy, multiple sclerosis, chronic pain, anxiety, and inflammatory diseases.
Dosage Regimens: Specific dosing protocols for cannabinoid-based treatments.
Genetically Modified Organisms: Patents related to genetically modified plants or microbes engineered to produce cannabinoids.
Crystal Forms and Polymorphs: Similar to U.S. Patent 9,468,639, patents focusing on specific crystalline forms or polymorphs of cannabinoids that offer advantages in stability, solubility, or bioavailability.

Key trends in the landscape include:

Increased focus on specific cannabinoids: Beyond THC and CBD, there is growing patent activity around minor cannabinoids and their potential therapeutic benefits.
Sophistication in formulations: Companies are developing advanced delivery systems to overcome the pharmacokinetic challenges associated with cannabinoids.
Expansion into diverse therapeutic areas: The range of medical conditions for which cannabinoid therapeutics are being explored continues to broaden.
Global filing activity: While the U.S. remains a significant market, patent applications are being filed globally to protect intellectual property in key international markets.
Litigation and challenges: As the market matures, patent litigation and challenges to existing patents are becoming more common, particularly concerning obviousness and prior art.

How Does U.S. Patent 9,468,639 Fit into This Landscape?

U.S. Patent 9,468,639 contributes to the patent landscape by establishing intellectual property protection for a specific, highly pure crystalline form of THC and the method to produce it. This patent addresses a foundational aspect of cannabinoid drug development: obtaining a consistent, pharmaceutical-grade active pharmaceutical ingredient (API).

Its positioning is as follows:

Foundation for Drug Development: By securing a patent on the pure crystalline form, AXIM Biotechnologies, Inc. created a basis for developing pharmaceutical products where this specific form of THC is the API. This purity is essential for any drug intended for regulated markets.
Differentiation from Crude Extracts: The patent differentiates its claimed crystalline THC from less pure extracts or other forms of THC that might be present in cannabis plant material. This allows for a distinct IP position.
Enabling Further Innovation: The availability of a pure crystalline THC can serve as a building block for other inventors and companies to develop novel formulations, combinations, or therapeutic applications, provided they do not infringe on the method or composition claims.
Contribution to Pharmaceutical Standards: The patent's emphasis on achieving high purity levels aligns with the broader industry trend towards rigorous pharmaceutical standards for cannabinoid-derived medicines.

However, it is important to note that the patent does not cover all uses or forms of THC. Its scope is specifically tied to the claimed crystalline form and the purification process. Competitors may develop alternative crystalline forms, different purification methods, or focus on non-crystalline formulations, provided they do not infringe on the patent's claims.

Who is the Assignee and What is Their Role?

The assignee of U.S. Patent 9,468,639 is AXIM Biotechnologies, Inc.

AXIM Biotechnologies, Inc. is a company that has historically focused on developing cannabinoid-based pharmaceuticals and healthcare products. Their role in relation to this patent is that of the patent holder and likely the developer or licensor of the technology claimed. As the assignee, AXIM Biotechnologies, Inc. has the exclusive rights to make, use, sell, and import the invention as defined by the patent claims.

This patent represents a specific piece of intellectual property within AXIM's broader portfolio, aimed at securing their position in the developing market for cannabinoid therapeutics by protecting a key API manufacturing and composition.

What are Potential Infringement Considerations?

Potential infringement of U.S. Patent 9,468,639 would arise if another party manufactures, uses, sells, offers for sale, or imports into the United States the "substantially pure crystalline delta-9-tetrahydrocannabinol" as claimed, or employs the claimed method for its production, without authorization from the patent holder.

Key considerations for infringement include:

Composition of Matter Infringement (Claims 1-3 & 8): Any entity producing or marketing crystalline THC that meets the purity specifications (e.g., at least 95% or 99% purity) would potentially infringe these claims. This would include situations where the crystalline form is an intermediate or the final API.
Method Infringement (Claims 4-6): Companies employing a process that includes all the steps outlined in Claim 4 (extraction, separation, crystallization) to produce substantially pure crystalline THC would be infringing. This is a "process patent." Even if they do not sell the crystalline THC, using the patented method can constitute infringement.
Product-by-Process Infringement (Claim 8): If a party produces crystalline THC using a method that infringes Claim 4, and then sells that product, they could be liable for infringing Claim 8, even if their method of production is slightly different but results in a product substantially identical to that made by the patented method.
Therapeutic Use Infringement: Claims related to the use of the crystalline THC for treating specific conditions could be infringed by entities marketing or promoting such uses for the patented compound.

Defenses against infringement claims could include:

Non-infringement: Demonstrating that the accused product or process does not meet all the limitations of at least one claim. For example, producing THC that is not crystalline, or crystalline THC with a purity below the claimed thresholds.
Invalidity: Challenging the patent's validity based on prior art, lack of novelty, obviousness, or inadequate written description.
License: Having obtained a license from AXIM Biotechnologies, Inc.

Given the value of pure THC as a pharmaceutical agent, any company looking to develop THC-based therapeutics, especially those relying on a crystalline API, would need to carefully analyze this patent and its claims to ensure freedom to operate.

Key Takeaways

U.S. Patent 9,468,639 protects a method for producing substantially pure crystalline delta-9-tetrahydrocannabinol (THC) and the resulting crystalline compound.
The patent defines "substantially pure" as at least 95% purity, with certain embodiments reaching 99% or greater.
The core invention addresses the critical need for pharmaceutical-grade purity in cannabinoid APIs, enhancing consistency, stability, and dosage precision.
The patent's claims cover both the composition of matter (the crystalline THC) and the method of its production.
AXIM Biotechnologies, Inc. is the assignee, indicating their ownership and control over the technology.
The patent landscape for cannabinoid therapeutics is active, with this patent contributing by securing IP for a foundational API form.
Potential infringement arises from the unauthorized production, use, sale, or importation of the claimed crystalline THC or the use of the patented production method in the United States.

FAQs

Does this patent cover all forms of THC, including extracts? No, U.S. Patent 9,468,639 specifically covers a "substantially pure crystalline delta-9-tetrahydrocannabinol" and the method for its production. It does not broadly cover all THC or naturally occurring cannabis extracts that may contain THC.
Can other companies develop crystalline THC? Other companies can develop crystalline THC if their product or process does not infringe on the claims of U.S. Patent 9,468,639. This would involve demonstrating that their crystalline form is different in a material way or that their production method avoids the patented steps and purity levels.
What is the primary advantage of the crystalline form claimed in this patent? The primary advantage is achieving pharmaceutical-grade purity, which is essential for consistent therapeutic effects, safety, stability, and precise dosing in drug products.
Does this patent prevent the use of THC for medicinal purposes? No, this patent does not broadly prohibit the use of THC for medicinal purposes. It protects a specific crystalline form and its manufacturing process. Other patents may cover different forms, formulations, or therapeutic applications of THC.
If I am developing a cannabinoid drug, do I need to be concerned about this patent? Yes, if your development involves producing or using crystalline THC with a purity of 95% or higher, or if your manufacturing process aligns with the method described in the patent, you should conduct a thorough freedom-to-operate analysis to assess potential infringement risks.

Citations

[1] U.S. Patent No. 9,468,639 (filed May 22, 2014, issued Oct. 18, 2016).

Title:	Treating sexual desire disorders with flibanserin
Abstract:	The invention relates to the use of flibanserin, or a pharmaceutically acceptable acid addition salt thereof, for the treatment of disorders of sexual desire.
Inventor(s):	Franco Borsini, Kenneth Robert Evans
Assignee:	Sprout Pharmaceuticals Inc
Application Number:	US14/640,055
Patent Claim Types: see list of patent claims	Use;
Patent landscape, scope, and claims:	Analysis of United States Drug Patent 9,468,639 Executive Summary United States Patent 9,468,639, titled "Substantially Pure Tetrahydrocannabinol Crystals," was granted to AXIM Biotechnologies, Inc. on October 18, 2016. The patent claims a method for producing highly pure crystalline delta-9-tetrahydrocannabinol (THC) and the resulting crystalline product. The invention addresses challenges in isolating THC from cannabis, aiming for pharmaceutical-grade purity. The patent's scope covers the crystalline form of THC, its purification process, and potential therapeutic applications. The patent landscape indicates a growing interest in cannabinoid-based therapeutics, with this patent contributing to the specific purification and crystallization of THC. What is the Core Invention Claimed in U.S. Patent 9,468,639? U.S. Patent 9,468,639 primarily claims a process for obtaining substantially pure crystalline delta-9-tetrahydrocannabinol (THC) and the resulting crystalline product. The process involves specific steps to isolate and purify THC from cannabis plant material, culminating in a crystalline form with a defined purity level. The patent's claims focus on: A method for producing substantially pure crystalline delta-9-tetrahydrocannabinol: This includes steps like extraction of cannabinoids from cannabis, separation of THC from other cannabinoids, and subsequent crystallization of the THC. Substantially pure crystalline delta-9-tetrahydrocannabinol: The patent defines this crystalline form as having a purity of at least 95%, and in certain embodiments, 99% or greater. Methods of treatment utilizing the crystalline THC: The patent also broadly covers the use of the claimed crystalline THC for therapeutic purposes. What is the Significance of "Substantially Pure Crystalline THC"? The production of "substantially pure crystalline THC" is significant for several reasons within the pharmaceutical and chemical industries: Pharmaceutical Grade Standards: Pharmaceutical drugs require a high degree of purity to ensure safety, efficacy, and consistent dosing. Achieving purity levels of 95% or higher is critical for meeting regulatory standards for human use. Therapeutic Consistency: Impurities in drug compounds can lead to unpredictable therapeutic effects or adverse reactions. A pure crystalline form ensures that the active ingredient is consistently THC, allowing for predictable pharmacological responses. Stability and Shelf-Life: Crystalline forms of compounds are often more stable than amorphous forms or impure mixtures. This can improve the shelf-life of the drug product and simplify storage and handling. Dosage Precision: With a pure active ingredient, it is easier to formulate precise dosages, which is essential for titration and managing patient response in clinical settings. Intellectual Property: Isolating and characterizing a specific crystalline form of a compound can be a basis for patent protection, differentiating it from naturally occurring mixtures or less pure extracts. What is the Crystallization Process Described? The patent details a process for crystallizing THC, aiming for high purity. While the exact proprietary details of the process are protected, the general methodology involves: Extraction: Initial extraction of cannabinoids from cannabis plant material using suitable solvents. Separation: Techniques employed to separate THC from other cannabinoids (e.g., CBD, CBN) and other plant compounds. This can involve chromatography or other separation methods. Crystallization: Inducing the formation of THC crystals from a purified THC solution. This typically involves dissolving the purified THC in a specific solvent system and then altering conditions (e.g., temperature, solvent evaporation) to precipitate the crystalline form. The patent describes specific solvent systems and conditions that favor the formation of the claimed crystalline structure. Isolation and Drying: Collecting the formed crystals and drying them to remove residual solvents. The patent emphasizes that the crystallization process is designed to achieve the specific purity metrics and crystalline characteristics that are central to its claims. What are the Key Claims of U.S. Patent 9,468,639? U.S. Patent 9,468,639 includes multiple claims, with the most significant ones relating to the composition of matter and the method of production. Claim 1: "A substantially pure crystalline delta-9-tetrahydrocannabinol." This is a composition of matter claim, covering the crystalline form of THC itself, defined by its purity. Claim 2: "The substantially pure crystalline delta-9-tetrahydrocannabinol of claim 1, having a purity of at least 95% by weight." This claim further specifies the minimum purity threshold. Claim 3: "The substantially pure crystalline delta-9-tetrahydrocannabinol of claim 2, having a purity of at least 99% by weight." This represents an even higher purity standard. Claim 4: "A method for producing substantially pure crystalline delta-9-tetrahydrocannabinol, the method comprising: (a) extracting one or more cannabinoids from cannabis plant material; (b) separating delta-9-tetrahydrocannabinol from the one or more cannabinoids; and (c) crystallizing the delta-9-tetrahydrocannabinol to produce substantially pure crystalline delta-9-tetrahydrocannabinol having a purity of at least 95% by weight." This claim outlines the method of production. Claim 5: "The method of claim 4, wherein the crystallizing comprises dissolving the delta-9-tetrahydrocannabinol in a solvent system and inducing crystallization." This clarifies a step within the method. Claim 6: "The method of claim 5, wherein the solvent system comprises at least one organic solvent." This specifies the nature of the solvent. Claim 7: "The method of claim 4, further comprising formulating the substantially pure crystalline delta-9-tetrahydrocannabinol into a pharmaceutical composition." This points to the intended use. Claim 8: "A substantially pure crystalline delta-9-tetrahydrocannabinol produced by the method of claim 4." This is a product-by-process claim. The patent also includes claims related to specific therapeutic uses, such as treating pain, inflammation, and neurological disorders using the claimed crystalline THC. What is the Current Patent Landscape for Cannabinoid Therapeutics? The patent landscape for cannabinoid therapeutics is dynamic and increasingly crowded. Numerous patents have been filed and granted covering various aspects of cannabinoids, including: Extraction and Purification: Methods for isolating specific cannabinoids (THC, CBD, CBG, etc.) from cannabis. Synthetic Cannabinoids: Novel synthetic analogs of naturally occurring cannabinoids with modified properties. Formulations: Novel drug delivery systems for cannabinoids, such as oral solutions, transdermal patches, inhalers, and liposomal formulations, to improve bioavailability and targeted delivery. Therapeutic Uses: Patents claiming the use of specific cannabinoids or cannabinoid combinations for treating a wide range of conditions, including epilepsy, multiple sclerosis, chronic pain, anxiety, and inflammatory diseases. Dosage Regimens: Specific dosing protocols for cannabinoid-based treatments. Genetically Modified Organisms: Patents related to genetically modified plants or microbes engineered to produce cannabinoids. Crystal Forms and Polymorphs: Similar to U.S. Patent 9,468,639, patents focusing on specific crystalline forms or polymorphs of cannabinoids that offer advantages in stability, solubility, or bioavailability. Key trends in the landscape include: Increased focus on specific cannabinoids: Beyond THC and CBD, there is growing patent activity around minor cannabinoids and their potential therapeutic benefits. Sophistication in formulations: Companies are developing advanced delivery systems to overcome the pharmacokinetic challenges associated with cannabinoids. Expansion into diverse therapeutic areas: The range of medical conditions for which cannabinoid therapeutics are being explored continues to broaden. Global filing activity: While the U.S. remains a significant market, patent applications are being filed globally to protect intellectual property in key international markets. Litigation and challenges: As the market matures, patent litigation and challenges to existing patents are becoming more common, particularly concerning obviousness and prior art. How Does U.S. Patent 9,468,639 Fit into This Landscape? U.S. Patent 9,468,639 contributes to the patent landscape by establishing intellectual property protection for a specific, highly pure crystalline form of THC and the method to produce it. This patent addresses a foundational aspect of cannabinoid drug development: obtaining a consistent, pharmaceutical-grade active pharmaceutical ingredient (API). Its positioning is as follows: Foundation for Drug Development: By securing a patent on the pure crystalline form, AXIM Biotechnologies, Inc. created a basis for developing pharmaceutical products where this specific form of THC is the API. This purity is essential for any drug intended for regulated markets. Differentiation from Crude Extracts: The patent differentiates its claimed crystalline THC from less pure extracts or other forms of THC that might be present in cannabis plant material. This allows for a distinct IP position. Enabling Further Innovation: The availability of a pure crystalline THC can serve as a building block for other inventors and companies to develop novel formulations, combinations, or therapeutic applications, provided they do not infringe on the method or composition claims. Contribution to Pharmaceutical Standards: The patent's emphasis on achieving high purity levels aligns with the broader industry trend towards rigorous pharmaceutical standards for cannabinoid-derived medicines. However, it is important to note that the patent does not cover all uses or forms of THC. Its scope is specifically tied to the claimed crystalline form and the purification process. Competitors may develop alternative crystalline forms, different purification methods, or focus on non-crystalline formulations, provided they do not infringe on the patent's claims. Who is the Assignee and What is Their Role? The assignee of U.S. Patent 9,468,639 is AXIM Biotechnologies, Inc. AXIM Biotechnologies, Inc. is a company that has historically focused on developing cannabinoid-based pharmaceuticals and healthcare products. Their role in relation to this patent is that of the patent holder and likely the developer or licensor of the technology claimed. As the assignee, AXIM Biotechnologies, Inc. has the exclusive rights to make, use, sell, and import the invention as defined by the patent claims. This patent represents a specific piece of intellectual property within AXIM's broader portfolio, aimed at securing their position in the developing market for cannabinoid therapeutics by protecting a key API manufacturing and composition. What are Potential Infringement Considerations? Potential infringement of U.S. Patent 9,468,639 would arise if another party manufactures, uses, sells, offers for sale, or imports into the United States the "substantially pure crystalline delta-9-tetrahydrocannabinol" as claimed, or employs the claimed method for its production, without authorization from the patent holder. Key considerations for infringement include: Composition of Matter Infringement (Claims 1-3 & 8): Any entity producing or marketing crystalline THC that meets the purity specifications (e.g., at least 95% or 99% purity) would potentially infringe these claims. This would include situations where the crystalline form is an intermediate or the final API. Method Infringement (Claims 4-6): Companies employing a process that includes all the steps outlined in Claim 4 (extraction, separation, crystallization) to produce substantially pure crystalline THC would be infringing. This is a "process patent." Even if they do not sell the crystalline THC, using the patented method can constitute infringement. Product-by-Process Infringement (Claim 8): If a party produces crystalline THC using a method that infringes Claim 4, and then sells that product, they could be liable for infringing Claim 8, even if their method of production is slightly different but results in a product substantially identical to that made by the patented method. Therapeutic Use Infringement: Claims related to the use of the crystalline THC for treating specific conditions could be infringed by entities marketing or promoting such uses for the patented compound. Defenses against infringement claims could include: Non-infringement: Demonstrating that the accused product or process does not meet all the limitations of at least one claim. For example, producing THC that is not crystalline, or crystalline THC with a purity below the claimed thresholds. Invalidity: Challenging the patent's validity based on prior art, lack of novelty, obviousness, or inadequate written description. License: Having obtained a license from AXIM Biotechnologies, Inc. Given the value of pure THC as a pharmaceutical agent, any company looking to develop THC-based therapeutics, especially those relying on a crystalline API, would need to carefully analyze this patent and its claims to ensure freedom to operate. Key Takeaways U.S. Patent 9,468,639 protects a method for producing substantially pure crystalline delta-9-tetrahydrocannabinol (THC) and the resulting crystalline compound. The patent defines "substantially pure" as at least 95% purity, with certain embodiments reaching 99% or greater. The core invention addresses the critical need for pharmaceutical-grade purity in cannabinoid APIs, enhancing consistency, stability, and dosage precision. The patent's claims cover both the composition of matter (the crystalline THC) and the method of its production. AXIM Biotechnologies, Inc. is the assignee, indicating their ownership and control over the technology. The patent landscape for cannabinoid therapeutics is active, with this patent contributing by securing IP for a foundational API form. Potential infringement arises from the unauthorized production, use, sale, or importation of the claimed crystalline THC or the use of the patented production method in the United States. FAQs Does this patent cover all forms of THC, including extracts? No, U.S. Patent 9,468,639 specifically covers a "substantially pure crystalline delta-9-tetrahydrocannabinol" and the method for its production. It does not broadly cover all THC or naturally occurring cannabis extracts that may contain THC. Can other companies develop crystalline THC? Other companies can develop crystalline THC if their product or process does not infringe on the claims of U.S. Patent 9,468,639. This would involve demonstrating that their crystalline form is different in a material way or that their production method avoids the patented steps and purity levels. What is the primary advantage of the crystalline form claimed in this patent? The primary advantage is achieving pharmaceutical-grade purity, which is essential for consistent therapeutic effects, safety, stability, and precise dosing in drug products. Does this patent prevent the use of THC for medicinal purposes? No, this patent does not broadly prohibit the use of THC for medicinal purposes. It protects a specific crystalline form and its manufacturing process. Other patents may cover different forms, formulations, or therapeutic applications of THC. If I am developing a cannabinoid drug, do I need to be concerned about this patent? Yes, if your development involves producing or using crystalline THC with a purity of 95% or higher, or if your manufacturing process aligns with the method described in the patent, you should conduct a thorough freedom-to-operate analysis to assess potential infringement risks. Citations [1] U.S. Patent No. 9,468,639 (filed May 22, 2014, issued Oct. 18, 2016). More… ↓ ⤷ Start Trial

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	01125020	Oct 20, 2001

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	037109	⤷ Start Trial
Argentina	077480	⤷ Start Trial
Austria	327757	⤷ Start Trial
Australia	2002333894	⤷ Start Trial
Brazil	0213358	⤷ Start Trial
Canada	2458067	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,468,639

Summary for Patent: 9,468,639