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Details for Patent: 10,709,673


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Summary for Patent: 10,709,673
Title:Use of cannabinoids in the treatment of epilepsy
Abstract:The present disclosure relates to the use of cannabidiol (CBD) for the treatment of atonic seizures. In particular the CBD appears particularly effective in reducing atonic seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Aicardi syndrome; CDKL5 and Dup15q in comparison to other seizure types. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
Inventor(s):Geoffrey Guy
Assignee: Jazz Pharmaceuticals Research UK Ltd
Application Number:US16/570,220
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,709,673
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Executive summary US Patent 10,709,673 is scoped to a specific oral liquid CBD composition defined by (1) CBD concentration windows (with nested embodiments at ~25 mg/mL and ~100 mg/mL), (2) ethanol concentration windows (about 71.1 to about 86.9 mg/mL), (3) a low-dose sweetener window (about 0.45 to about 0.55 mg/mL, with sucralose as a named sweetener), (4) a low-dose strawberry flavoring window (about 0.18 to about 0.22 mg/mL, with strawberry as a named flavor), and (5) sesame oil “q.s.” up to 1.0 mL. The claim set is composition-centric, with purity thresholds (≥95% and ≥98% w/w) layered onto the concentration embodiments. The practical infringement risk for competitors is highest where they match both the CBD and ethanol concentration ranges plus the specific minor-ingredient windows, and where purity and formulation ingredients (sucralose and strawberry flavoring) align with dependent claims. Generic-style design-around most often targets one or more concentration-range elements (especially ethanol and CBD) or replaces the named sweetener/flavor.

US Patent 10,709,673 claims scope and what exact formulation is protected

The independent claim 1 is an oral composition with five required components and defined concentration ranges:

  • CBD: about 22.5 mg/mL to about 110 mg/mL
  • Ethanol: about 71.1 mg/mL to about 86.9 mg/mL
  • Sweetener: about 0.45 mg/mL to about 0.55 mg/mL
  • Flavoring: about 0.18 mg/mL to about 0.22 mg/mL
  • Sesame oil: “q.s.” to about 1.0 mL

The claim language “oral composition” and the component selection indicate a ready-to-drink or dosing-syrup class formulation rather than a capsule or aerosol. The “q.s. to about 1.0 ml” ties sesame oil to a bounded final volume contribution, limiting how much oil can be used while leaving some formulation flexibility.

What do the dependent claims add to the independent scope?

Dependent claims mainly narrow the same formulation to specific CBD concentration anchors and specified purity levels, plus two ingredient identity selections.

CBD concentration anchors (claims 2, 3, 13, 19)

  • Claim 2: CBD about 25 mg/mL ±10%
  • Claim 3: CBD about 100 mg/mL ±10%
  • Claim 13: CBD about 100 mg/mL
  • Claim 19: CBD about 100 mg/mL (in the claim-18 structure)

These create “hard points” inside the broader claim 1 window. A competitor staying within claim 1’s CBD window but outside these anchors may still infringe claim 1, but not these narrower embodiments.

CBD purity thresholds (claims 4–9, 14–17, 18)

The patent adds purity limitations as claim dependencies:

  • ≥95% (w/w) and ≥98% (w/w) CBD purity are alternately claimed:
    • Claim 4: ≥95%
    • Claim 5: ≥98%
    • Claim 6–9: tie both purity levels to the specific concentration anchors (claim 2 and claim 3)
    • Claim 14–17: tie purity levels to claim 12’s concentration window and claim 13’s “about 100 mg/mL” anchor
    • Claim 18: CBD ≥95% (w/w) is required in addition to the claim 12 composition

Purity is an enforcement lever: if a rival sells a product formulated to meet the same concentration ranges but uses CBD with a purity below the claimed thresholds, the rival may avoid those dependent claims. Independent claim 1 as presented does not expressly require a purity minimum, so any purity-driven design-around must be mapped to claim construction across which claim is asserted (independent vs dependent).

Named sweetener and flavoring identities (claims 10–11)

  • Claim 10: sweetener is sucralose
  • Claim 11: flavoring is strawberry flavoring

These narrow the formulation to identity-specific embodiments. A competitor can design around by using a different sweetener or different flavor system while remaining inside the numeric ranges, though numeric coincidence still keeps risk at the independent claim 1 level.

Claim 12 and claim 18: tighter nested formulation with a CBD sub-range

Claim 12 refines claim 1 by narrowing the CBD and enumerating the remaining concentration ranges as part of the dependent structure:

  • CBD: about 90 mg/mL to about 110 mg/mL
  • Ethanol: about 71.1 mg/mL to about 86.9 mg/mL
  • Sweetener: about 0.45 mg/mL to about 0.55 mg/mL
  • Flavoring: about 0.18 mg/mL to about 0.22 mg/mL
  • Sesame oil: q.s. to about 1.0 mL

Claim 18 then adds the purity requirement:

  • CBD ≥95% (w/w) plus the claim 12 composition

This means the patent’s narrowest “practical infringement” bands cluster around the high-CBD (~90–110 mg/mL) formulations with the specific ethanol and low-dose organoleptic add-ins, with optional purity minimums.

When does US 10,709,673 lose exclusivity? How long does the patent run

Not enough information is provided to compute an accurate expiration date because patent term depends on filing date and any PTA/adjustments, plus maintenance status. The claims alone do not include filing/grant dates, earliest effective filing, or whether the term is shortened or lengthened by USPTO events.

What patents intersect with 10,709,673? How many other claims exist for similar CBD oral liquids

No intersection map can be produced from the claim text alone. To quantify “how many” and identify specific related patents, the analysis requires at minimum: the publication/grant family data for US 10,709,673 and the citation set (US patent citations), or Orange Book/NDA linkage if tied to an approved product. The claim excerpt does not supply those identifiers.

How strong is the patent estate for this CBD oral formulation? Claim defensibility vs design-arounds

Strength is driven by how “tight” the numerical element set is and whether competitors can avoid matching all elements simultaneously.

Element-by-element infringement sensitivity

Claim 1 requires all elements together: CBD + ethanol + sweetener window + flavoring window + sesame oil q.s. up to 1.0 mL.

  • Ethanol window is relatively tight (71.1 to 86.9 mg/mL). This is a high-sensitivity axis because many CBD tinctures and sprays use very different ethanol strengths or use different co-solvents (for example, propylene glycol, glycerin, or MCT oil blends).
  • Sweetener and flavoring windows are extremely narrow (0.45 to 0.55 mg/mL; 0.18 to 0.22 mg/mL). These windows can be hard to “accidentally” match.
  • Sesame oil “q.s.” gives some flexibility but still caps practical oil contribution to about 1.0 mL. Oil content is another formulation axis that rivals can tune by changing lipid excipients.

Where design-around risk concentrates

A rival aiming at near-identical dose and organoleptics is at the highest risk if it also:

  • uses ethanol at the same narrow concentration,
  • uses the same low-dose sweetener and flavoring amounts (even if using different identities, some numeric matches could still catch claim 1),
  • includes sesame oil at a similar q.s. volume.

Practical design-around strategies implied by the claim structure

Without relying on speculative legal doctrine, the claim set itself suggests the most straightforward route to avoid independent claim 1 is to break at least one required element:

  • Use ethanol outside 71.1 to 86.9 mg/mL
  • Use CBD outside 22.5 to 110 mg/mL (or outside the 90 to 110 mg/mL band for claim 12)
  • Use sweetener outside 0.45 to 0.55 mg/mL (or remove/replace sweetener)
  • Use flavoring outside 0.18 to 0.22 mg/mL (or alter the flavor system or dose)
  • Replace sesame oil with a different oil system or change oil volume contribution beyond “q.s. to about 1.0 mL”

For dependent claims 10 and 11, substituting the sweetener away from sucralose or substituting away from strawberry flavoring reduces specific dependent-claim exposure, but does not eliminate exposure to claim 1’s numeric windows.

What generic entry risks exist for similar CBD oral solutions? How could challengers attack claim 10/11 and range claims

No patent litigation or challenge history is supplied. The following is a formulation-level risk assessment based only on claim scope.

Range-based exposure

Because independent claim 1 is defined by multiple overlapping numerical windows, a “range-to-range” comparison will be fact-intensive:

  • If a product matches all ranges simultaneously, infringement is plausible without needing to match exact ingredient identities (except for dependent claims 10 and 11).
  • If a product misses even one range (for example, ethanol slightly outside 71.1 to 86.9 mg/mL), it can avoid claim 1 even if all other components match.

Purity-based exposure

Dependent claims add CBD purity thresholds (≥95% and ≥98% w/w). If a product uses CBD with lower purity, it may avoid those dependent claims, while independent claim 1 could still be asserted if it lacks a purity limitation.

What formulations are protected by US 10,709,673? Oral CBD with ethanol, sucralose, strawberry, and sesame oil

The claim text covers a narrow “oral ethanol-based CBD liquid” formulation with:

  • co-solvent ethanol in a defined mg/mL range,
  • low-dose sweetener and low-dose strawberry flavoring (as dependent embodiments),
  • sesame oil at a defined “q.s.” volume contribution.

Protected dosage-form attributes (inferred strictly from claim language)

  • Oral liquid (composition rather than unit dosage form)
  • Ethanol-containing liquid with sesame oil excipient
  • Sweetened and flavored to a defined low mg/mL inclusion range

What is not claimed (based on omissions in the excerpt)

The excerpt does not show protection for:

  • capsules/tablets,
  • water-free vs water-containing specifics beyond ethanol,
  • alternative oils (MCT, olive, medium-chain triglycerides),
  • alternate sweeteners and flavors unless they fall within the numeric ranges for claim 1,
  • different delivery systems (sublingual film, transdermal, inhalation).

How does 10,709,673 compare with typical CBD tincture IP? What elements look distinctive

This patent’s distinctiveness is the combination of:

  • a multi-component concentration “fingerprint” (CBD, ethanol, sweetener, flavoring, sesame oil volume), and
  • dependent claims anchoring CBD at about 25 mg/mL and about 100 mg/mL with explicit purity thresholds.

Most generic CBD formulation patents focus on broader classes such as “cannabinoid in a vehicle” or “co-solvent systems.” The tight mg/mL windows for sweetener and flavoring are the most distinctive constraint visible from the claim excerpt.

Orange Book status: Is US 10,709,673 tied to an approved FDA product?

No Orange Book linkage information is provided. The claim excerpt does not identify an NDA/ANDA/BLA, listed drug, or any Orange Book entry.

Key takeaways

  • US 10,709,673 protects a defined oral CBD liquid composition with a five-part ingredient set and tight concentration windows: CBD (22.5 to 110 mg/mL), ethanol (71.1 to 86.9 mg/mL), sweetener (0.45 to 0.55 mg/mL), flavoring (0.18 to 0.22 mg/mL), and sesame oil “q.s.” to about 1.0 mL.
  • Dependent claims narrow to CBD anchors (~25 mg/mL ±10%; ~100 mg/mL ±10%; and about 100 mg/mL), add CBD purity thresholds (≥95% or ≥98% w/w), and select sucralose and strawberry flavoring.
  • The highest infringement risk is for products that match all required numerical ranges simultaneously, especially ethanol and the low-dose sweetener/flavor windows.
  • Design-arounds should focus on breaking at least one independent claim element (commonly ethanol concentration, oil system/volume, or sweetener/flavor inclusion levels). Dependent-claim risk for sucralose and strawberry can be reduced by substituting those identities, though claim 1 exposure depends on staying outside the relevant numeric ranges.

FAQs

1) Does US 10,709,673 require CBD purity for infringement of claim 1?
From the provided claim 1 text, the purity limitations appear in dependent claims (not claim 1 as excerpted). Dependent-claim exposure hinges on meeting ≥95% or ≥98% w/w.

2) What single formulation change most easily avoids claim 12 specifically?
Move CBD outside the 90 to 110 mg/mL band while keeping other elements unchanged, since claim 12 tightens CBD relative to claim 1.

3) If a product matches the numeric sweetener and flavoring ranges but uses a different sweetener identity than sucralose, is it still covered?
Claim 1 coverage depends on numeric windows, not ingredient identity (identity is specified only in dependent claims 10 and 11).

4) Are sesame oil and ethanol mandatory in all embodiments?
Yes, in the provided claims, sesame oil and ethanol appear as required components of the claimed composition.

5) How does the patent handle CBD at ~100 mg/mL?
It has multiple nested embodiments: claim 3 (100 mg/mL ±10%), claim 13 (about 100 mg/mL), and claim 12/18 structures that require CBD in the 90–110 mg/mL range (with claim 18 adding ≥95% purity).

References (APA)

  1. US Patent 10,709,673 (claims excerpt provided by user).

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Drugs Protected by US Patent 10,709,673

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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 10,709,673

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom1418171.3Oct 14, 2014

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