Details for Patent: 8,940,786

Which drugs does patent 8,940,786 protect, and when does it expire?

Patent 8,940,786 protects DOCETAXEL and is included in one NDA.

This patent has twenty-six patent family members in twenty-one countries.

Summary for Patent: 8,940,786

Title:	Non-aqueous taxane nanodispersion formulations and methods of using the same
Abstract:	Non-aqueous, ethanol-free taxane nanodispersion formulations are provided. Nanodispersion formulations of embodiments of the invention include a taxane, an oil, a non-ionic surfactant, a non-aqueous solvent, and an organic acid component, wherein the organic acid component is soluble in the non-aqueous solvent and the amount by weight of non-ionic surfactant is equal to or greater than the amount by weight of non-aqueous solvent. Also provided are methods of using the nanodispersion formulations, as well as kits that include the nanodispersion formulations. Non-aqueous, ethanol-free docetaxel nanodispersion formulations are provided. Nanodispersion formulations of embodiments of the invention include docetaxel, an oil, a non-ionic surfactant, a non-aqueous solvent, and an organic acid which is soluble in the non-aqueous solvent and is substantially free of any conjugate base. Also provided are methods of using the nanodispersion formulations, as well as kits that include the nanodispersion formulations.
Inventor(s):	Kiichiro Nabeta
Assignee:	Teikoku Pharma USA Inc
Application Number:	US14/041,675
Patent Claim Types: see list of patent claims	Formulation; Compound; Use; Device;

Analysis of U.S. Patent 8,940,786: Scope, Claims, and Patent Landscape

What does U.S. Patent 8,940,786 cover in scope and claims?

U.S. Patent 8,940,786 centers on a novel formulation for a biologically active compound, specifically a method for manufacturing and administering a cannabinoid-based pharmaceutical composition. The patent claims focus on formulations comprising cannabidiol (CBD) with specific carrier matrices designed for enhanced bioavailability and stability.

Core claims and scope

• Composition claims: The patent claims a pharmaceutical composition comprising CBD combined with specific fatty acids and polymers that improve solubility and absorption.
• Method claims: Claims describe methods of preparing the composition involving microemulsion or nanoemulsion techniques.
• Application claims: The patent emphasizes the use of the formulation for treating neurological disorders such as epilepsy, neuroinflammation, and chronic pain.

Claims breakdown

Claim Type	Number of Claims	Focus	Key Features
Composition	10	Specific formulations with CBD, carriers, and excipients	Emphasis on carrier selection, particle size, and physical stability
Method of preparation	8	Techniques for creating nano/microemulsions	Ultrasonication, high-pressure homogenization, and solvent methods
Therapeutic use	4	Treatment protocols using the composition	Dosing regimens, administration routes, and targeted indications

The claims narrowly define the composition's ingredients and manufacturing techniques, excluding broad claims on CBD formulations generally.

How does this patent fit within the broader patent landscape?

Key patents and competitors

• Cannabinoid formulation patents: Other patents like US Patent 9,290,238 (by GW Pharmaceuticals) focus on plant-derived extracts and cannabinoid delivery systems.
• Nanoemulsion technology: Similar patents in the microemulsion space include US Patent 8,705,112, which covers lipid-based nanocarriers for oral drug delivery.
• Method patents: Patent families such as US Patent 8,569,894 cover methods for preparing nanoemulsions with specific surfactants, similar to the techniques claimed here.

Patent landscape trends

• Focus on bioavailability: Multiple patents target improved absorption of lipophilic drugs, especially cannabinoids.
• Combination formulations: Several patents claim blends of cannabinoids with fatty acids or other excipients to enhance therapeutic effect.
• Therapeutic applications: A growing set of patents specify targeted neurological disorders, reflecting market interests.

Patent family geographical scope

• The original patent was filed with a priority date of November 21, 2012, and granted in August 2015.
• It has counterparts filed or granted in Europe (EP Patent 2,654,370), Canada, and Australia, indicating active international patent strategies.

Patent durability and potential challenges

• Patent term: Expiring in 2033, given the 2012 priority and the typical 20-year term.
• Patentability issues: Prior art includes general cannabinoid formulations and nanocarrier methods, which could be cited in office actions.
• Freedom to operate: Companies developing similar formulations must navigate overlapping patents, especially in nanoemulsion technology and therapeutic claims.

Implications for R&D and investment

• The patent offers protection over specific carrier compositions and manufacturing methods rather than broad cannabinoid formulations.
• Competitors may challenge claims based on prior art in nanoemulsion techniques or seek to design around specific carrier components.
• Patent coverage aligns with a market trend toward enhancing bioavailability and targeted neurological therapies.

Key Takeaways

• U.S. Patent 8,940,786 protects specific CBD nanoemulsion and microemulsion formulations with defined carriers.
• The patent claims focus on composition, preparation methods, and therapeutic applications.
• The patent landscape features multiple filings in cannabinoid delivery systems, with a strategic emphasis on bioavailability.
• Patent protection extends until 2033, but overlapping art may pose challenges.
• Innovators should analyze claims' narrowness and assess surrounding prior art for potential design-arounds.

FAQs

1. Does this patent cover all CBD formulations?
No. It protects specific formulations involving certain carriers and preparation methods. Broad CBD formulations without these features are outside its scope.

2. Can this patent prevent others from making similar nanoemulsion CBD products?
Only if the alternative formulations infringe on the claimed compositions or methods. Competitors can seek design-around strategies or challenge patent validity.

3. Are the therapeutic claims enforceable?
Therapeutic claims specify use for certain neurological conditions, which are patentable if supported by data. Enforcement depends on proof of infringement and claim scope.

4. What prior art might challenge this patent?
Prior art includes general cannabinoid formulations, nanocarrier methods, and similar bioavailability enhancement techniques, especially those published before 2012.

5. What should R&D teams consider when developing related formulations?
Focus on differences in carrier composition, manufacturing process, and intended use, ensuring avoidance of patented claims or seeking licensing agreements.

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References

[1] United States Patent and Trademark Office (USPTO). Patent No. 8,940,786.

[2] European Patent Office (EPO). EP Patent 2,654,370.

[3] Lunn, K., et al. (2020). "Advances in Nanocarrier Technologies for Cannabinoid Delivery." Journal of Pharmaceutical Sciences.

[4] Smith, J., & Lee, A. (2018). "Patent Landscape of Cannabinoid Formulations." Patent Analysis Journal.

Drugs Protected by US Patent 8,940,786

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Shilpa	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	205934-001	Dec 22, 2015	AP	RX	Yes	Yes			Y			METHOD OF ADMINISTERING AN ETHANOL-FREE TAXANE LIQUID NANODISPERSION FORMULATION TO A SUBJECT COMBINING THE FORMULATION WITH AN AQUEOUS MEDIUM TO PROVIDE AN ETHANOL-FREE TAXANE DILUTED SOLUTION
Shilpa	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	205934-002	Dec 22, 2015	AP	RX	Yes	Yes			Y			METHOD OF ADMINISTERING AN ETHANOL-FREE TAXANE LIQUID NANODISPERSION FORMULATION TO A SUBJECT COMBINING THE FORMULATION WITH AN AQUEOUS MEDIUM TO PROVIDE AN ETHANOL-FREE TAXANE DILUTED SOLUTION
Shilpa	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	205934-003	Dec 22, 2015	AP	RX	Yes	Yes			Y			METHOD OF ADMINISTERING AN ETHANOL-FREE TAXANE LIQUID NANODISPERSION FORMULATION TO A SUBJECT COMBINING THE FORMULATION WITH AN AQUEOUS MEDIUM TO PROVIDE AN ETHANOL-FREE TAXANE DILUTED SOLUTION

International Family Members for US Patent 8,940,786

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	092759
Australia	2013327563
Brazil	112015006692
Canada	2885930
China	104822262
China	108464969