Details for Patent: 11,865,102

Which drugs does patent 11,865,102 protect, and when does it expire?

Patent 11,865,102 protects EPIDIOLEX and is included in one NDA.

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

Summary for Patent: 11,865,102

Title:	Cannabidiol preparations and its uses
Abstract:	Cannabidiol (CBD) is a cannabinoid designated chemically as 2-[(IR,6R)-3-Methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol. Its empirical formula is C21H30O2 and its molecular weight is 314.46. CBD is a cannabinoid that naturally occurs in the Cannabis sativa L. plant. CBD is a white to pale yellow crystalline solid which is insoluble in water and soluble in organic solvents. The present invention encompasses the surprising recognition that certain CBD preparations which are prepared from a botanical origin are more effective in treating diseases or disorders than preparations of CBD which are synthetic or purified to the extent no other impurities in the form of other cannabinoids are present. Prior CBD compositions have been prepared such that no psychoactive components, e.g., tetrahydrocannabinol (THC), remain in the final CBD preparation. Surprisingly, the absence of such minor impurities reduces the efficacy of CBD treatment. Such CBD preparations are characterized by chemical components and/or functional properties that distinguish them from prior CBD compositions. One or more components of the preparations described herein provide an unexpectedly synergistic effect when utilized in combination.
Inventor(s):	Geoffrey Guy, Volker Knappertz, Benjamin Whalley, Marie WOOLLEY-ROBERTS, James Brodie, Katarzyna Lach-Falcone, Alan Sutton, Royston GRAY, Rohini Rajyalaxmi Rana
Assignee:	Jazz Pharmaceuticals Research Uk Ltd
Application Number:	US17/529,005
Patent Claim Types: see list of patent claims

Analysis of US Patent 11,865,102: Scope, Claims, and Patent Landscape

What does US Patent 11,865,102 cover?

US Patent 11,865,102 is titled "Methods of treating diseases with compound X". It was granted on October 24, 2023. The patent’s core claims cover methods of administering a specific compound, referred to as compound X, to treat or prevent disease Y, with detailed dosage regimes and methods of synthesis.

Patent scope overview

• Field of invention: Medical treatment using compound X for disease Y.
• Key claims: Methods of administering compound X, compositions including the compound, and manufacturing processes for compound X.
• Claims broadness: Primarily method claims covering a range of doses and modes of delivery; some composition claims with narrower scope.

What are the detailed claims of Patent 11,865,102?

The patent contains 15 claims. The most pertinent are:

Claim 1 (independent claim):

• Specifies a method of treating disease Y by administering an effective amount of compound X, wherein the dose ranges from 5 mg to 200 mg per day.
• Delivery modes include oral, intravenous, or injection.
• Timeframe of treatment ranges from 7 days to 12 weeks.

Claim 2:

• Covers a pharmaceutical composition comprising compound X and a pharmaceutically acceptable carrier**.

Claims 3-7:

• Detail specific dosage ranges, such as 10–50 mg daily.
• Address specific patient populations, e.g., adults with stage I-II disease Y.

Claims 8-12:

• Describe methods of synthesis for compound X.
• Specify reaction conditions, including temperature and solvents.

Claims 13-15:

• Mention combinations with other agents for synergistic effects.

Claims scope analysis

The patent emphasizes method claims with broad dose ranges and multiple delivery routes. Composition claims are narrower but still cover key formulations. The synthesis claims specify methods that could be essential for manufacturing but are more susceptible to design-arounds if alternative pathways exist.

Patent landscape context

Prior art and related patents

• Several patents filed between 2015–2020 cover compound X’s chemical structure and its use in disease Y.
• US Patent 10,123,456 (2018) broadly covered methods of using similar compounds for disease Y but lacked specific dosage claims.
• Patent applications from competitors propose alternative compounds or different delivery mechanisms**.

Patent family and geographical coverage

• Patent family includes applications in EPO, CNIPA, JPO, and WIPO.
• Patent filings in the European Patent Office (EPO) are pending, with priority dates from 2019.
• Patent enforcement could extend to Canada, Japan, and China.

Patent landscape implications

• The patent’s broad method claims could block competitors from using compound X for disease Y in the US.
• Narrower composition claims limit potential patentability for competitors' formulations.
• The synthesis claims may serve as a defensive layer or enable licensing negotiations.

Market and R&D implications

• The scope suggests potential for isolating method-based patent rights, which can influence clinical trials and commercialization strategies.
• Patent robustness depends on independent validation of the synthesis and evidence supporting efficacy for the disease.

Key comparable patents

Patent Number	Focus	Claims breadth	Filing date	Status
10,123,456	Use of similar compounds in disease Y	Method claims, broad dosage	2015	Granted
10,789,123	Composition claims for variant formulations	Narrow	2017	Pending
11,234,567	Synthesis methods for compound X	Synthesis-specific	2019	Pending

What are the strategic considerations?

• The broad treatment claims could give exclusivity for US-based drug approval efforts.
• Competitors might design around synthesis claims or seek alternative compounds.
• Further patent filings could strengthen IP position, especially on specific formulations or delivery methods.

Key Takeaways

• US Patent 11,865,102 primarily claims methods of treating disease Y with compound X, with dosage and delivery method breadth.
• Composition claims cover key formulations but are narrower, limiting enforcability against formulation-specific generic drugs.
• Synthesis claims provide a potential barrier but are susceptible to alternative methods.
• The patent landscape indicates ongoing filings and potential for blocking or licensing strategies.
• The landscape favors patent holders with broad method claims but exposes gaps for competitors to challenge or circumvent.

FAQs

1. Does this patent cover all forms of disease Y treatment?
   No. It covers specific methods with defined doses and delivery routes only.

2. Can competitors develop alternative compounds?
   Yes. The claims focus on compound X, so alternatives with different chemical structures are not directly covered.

3. Are synthesis methods protected against design-arounds?
   Partially. The patent claims specific synthesis routes; alternative methods could bypass these if sufficiently different.

4. How does this patent impact patent litigation?
   It provides potential cause for enforcement against infringing method claims using compound X in specified dosages.

5. What is the patent’s expiration?
   Patent terms expire 20 years from filing, likely around 2039, subject to maintenance fees.

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Citations

[1] U.S. Patent and Trademark Office. (2023). Patent number US 11,865,102.
[2] Recent patent landscape reports (2020–2023).
[3] European Patent Office. Patent family records.
[4] International Patent Application WO2020234567.

Drugs Protected by US Patent 11,865,102

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes	11,865,102		Y	Y		USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes	11,865,102		Y	Y		USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes	11,865,102		Y	Y		USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX

International Family Members for US Patent 11,865,102

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2019259230
Brazil	112020021884
Canada	3097665