Patent 9,180,096 (US 9,180,096): What is claimed about diclofenac solid oral unit doses, and how broad is the US patent estate around particle size (D(90)) and fast dissolution release profiles
What claims are in US Patent 9,180,096 and what does each claim scope cover?
Core invention (claims 1 and 16). US 9,180,096 claims a solid oral unit dose of diclofenac acid with two coupled technical constraints:
- Particle size constraint
- Claim 1: diclofenac acid D(90) < 5000 nm
- Dependent claims tighten that to <3000 nm, <2000 nm, <1900 nm, <1800 nm (claims 2, 6, 10, 11).
- Fast dissolution constraint in a specific USP Apparatus I test
- Claim 1: 94% by weight released by 75 minutes using:
- USP Apparatus I (Basket)
- 100 rpm, 37°C
- 900 mL of 0.05% sodium lauryl sulfate in citric acid buffered to pH 5.75
- Dependent claims define “faster” release windows:
- 94% by 60 min (claim 3)
- 94% by 45 min (claim 4)
- 94% by 30 min (claim 5)
- and similarly for claims 6/7/8/9 under the tighter D(90) regimes.
- Claim 16 mirrors the same framework but with higher dissolution release:
- 35 mg diclofenac acid, D(90) < 5000 nm, and 95% by weight released by 75 min
- with dependent claims specifying 95% by 60/45/30 min and D(90) thresholds below 3000/2000/1900/1800 nm.
- Indication / pain-relief statement (method-leaning use claim)
- Claim 15: “single dose provides perceptible pain relief… acute pain” (94%/D(90)<5000 nm family)
- Claim 30: same concept for the 35 mg / 95% family.
Claim-by-claim scope map
| Claim(s) |
Dose (diclofenac acid) |
Particle size (D(90), volume basis) |
Dissolution requirement in USP I basket |
Practical read-across |
| 1 |
18 mg |
< 5000 nm |
94% by weight released by 75 min |
Broadest composition in the 18 mg family |
| 2 |
18 mg |
< 3000 nm |
94% by 75 min |
Tightens only D(90); dissolution time unchanged |
| 3-5 |
18 mg |
< 3000 nm |
94% by 60 / 45 / 30 min |
Accelerates release while holding D(90) <3000 nm |
| 6-9 |
18 mg |
< 2000 nm |
94% by 60 / 45 / 30 min |
Accelerates release under smaller D(90) |
| 10-11 |
18 mg |
< 1900 nm / <1800 nm |
94% by 75 min |
Further tightens D(90) with no change to 75 min release requirement |
| 12-14 |
18 mg |
< 5000 nm |
94% by 60 / 45 / 30 min |
Tightens only dissolution speed; D(90) remains <5000 nm |
| 15 |
18 mg |
< 5000 nm |
94% by 75 min (by dependency on claim 1) |
Use language tied to “single dose” acute pain relief |
| 16 |
35 mg |
< 5000 nm |
95% by 75 min |
Parallel family with higher dose and release spec |
| 17-20 |
35 mg |
< 3000 nm |
95% by 60 / 45 / 30 min |
Accelerates release under smaller D(90) |
| 21-24 |
35 mg |
< 2000 nm |
95% by 60 / 45 / 30 min |
Accelerates release under smaller D(90) |
| 25-26 |
35 mg |
< 1900 nm / <1800 nm |
95% by 75 min |
Further tightens D(90) only |
| 27-29 |
35 mg |
< 5000 nm |
95% by 60 / 45 / 30 min |
Tightens dissolution speed only |
| 30 |
35 mg |
< 5000 nm |
95% by 75 min (by dependency on claim 16) |
Use language tied to “single dose” acute pain relief |
How is the claim scope limited by the dissolution test conditions (USP Apparatus I specifics)?
The test is part of the claim. The dissolution limitation is not generic. It is anchored to a particular compendial setup and medium:
- Apparatus: USP Apparatus I (Basket)
- Rotation: 100 rpm
- Temperature: 37° C.
- Volume: 900 mL
- Medium: 0.05% sodium lauryl sulfate in citric acid solution buffered to pH 5.75
This matters for infringement and design-around:
- A competitor formulates so that it meets target dissolution under different pH/media or apparatus parameters but fails under the exact claimed test conditions, reducing direct claim reading.
- Conversely, if the competitor’s product is highly soluble and fast across conditions, it becomes harder to design around because the claimed constraints are narrow but test-specific rather than outcome-agnostic.
Where the claim is “tight” vs “loose”
- Tight: the dissolution metric is outcome-based (94% or 95% released) but the experimental conditions are fixed.
- Loosening route (for competitors): change the formulation to alter dissolution in that medium test (SLS + pH 5.75 + 900 mL + basket at 100 rpm), even if dissolution in other environments remains fast.
How broad is US 9,180,096: does it cover any diclofenac nanoparticle formulation or only specific particle size/dissolution targets?
It is narrow-to-medium by numeric thresholds: it does not claim a method of producing a particle size distribution; it claims a finished solid oral unit dose with:
- a specified D(90) cutoff (substantially all dependent claims are stricter than the independent ones), and
- a specified dissolution release profile under an exact USP test.
Likely infringement trigger logic (practical)
A product infringes if, when tested exactly as claimed:
- the active is diclofenac acid (not a salt form, not an alternative active), and
- the particle size distribution meets D(90) < the recited nm threshold (substantially controlled in formulation), and
- dissolution in the claimed medium achieves the recited release percentage by the recited time.
What is excluded by claim structure
- Products with diclofenac sodium as the active, or other prodrugs, are outside the claim literal language if they are not “diclofenac acid.”
- Products that use larger particles but reach dissolution targets via matrix effects might still infringe if their D(90) in volume basis meets the nm ceiling and dissolution matches.
Which portions of the claim set create the strongest infringement footholds?
Strongest “objective” hooks are:
- D(90) thresholds: <5000 nm (independent), then <3000 / <2000 / <1900 / <1800
- dissolution timing: 94% or 95% by 75 min (baseline), with dependent claims down to 30 min
- dose amount: 18 mg vs 35 mg (separate families)
Use language (claim 15 and 30) is secondary. It states that “a single dose provides perceptible pain relief to a patient suffering from acute pain.” In infringement analysis, the composition claims drive the outcome because the use claim depends on meeting the underlying composition/dissolution requirements.
What design-around strategies are implied by the claim structure (without changing the active)?
The claim gives three key variables to engineer around:
-
Reduce D(90) but miss dissolution
If a competitor reaches a D(90) below 5000 nm but formulation fails to hit 94% or 95% release by the exact times in the exact medium and apparatus, it may avoid literal infringement.
-
Hit dissolution but keep D(90) above thresholds
If dissolution is fast due to excipients or other mechanisms but particle size distribution measured as D(90) (volume basis) is above the nm cutoff, it may avoid literal infringement.
-
Alter dissolution behavior only in the claimed test medium/conditions
If a product dissolves quickly in other media but not under 0.05% SLS + citric buffer pH 5.75 with USP I basket at 100 rpm, it may avoid meeting the claim’s measured release percentage by the recited time.
How do claim dependencies stratify patent coverage against different product “profiles”?
The claim set functions as a ladder:
- D(90) ladder: <5000 → <3000 → <2000 → <1900 → <1800 nm
- Dissolution ladder: by 75 min (independent) → down to 60 → 45 → 30 min
- Dose ladder: 18 mg (94% family) vs 35 mg (95% family)
Implication for portfolio risk: a generic or OTC challenger that only partially matches targets may still collide with at least one dependent claim if its profile fits any combination.
Is US 9,180,096 likely limited to one embodiment (single product), or can it cover multiple diclofenac fast-dissolution products?
It can cover multiple products because:
- It is defined by compositional and performance parameters rather than a unique excipient system.
- It is not limited to a specific manufacturing method in the claims you provided.
- It covers two dose strengths (18 mg and 35 mg) with different release performance (94% vs 95%).
That said, real-world coverage depends on whether competitors can meet both the D(90) and the time-based dissolution metric in the claimed USP test.
How does US 9,180,096 fit into the broader diclofenac particle-size / dissolution landscape?
US 9,180,096 positions diclofenac acid for fast onset using particle size reduction (nanometer-scale D(90)) and a specific dissolution requirement in an SLS-containing acidic buffer.
In the diclofenac space, typical IP themes around rapid onset include:
- micronization/nanosizing,
- solid-state comminution,
- formulation excipient selection for wettability and surfactant-assisted dissolution,
- use claims tied to acute pain relief after a single dose.
This patent’s distinguishing feature, based on the claim language provided, is the explicit coupling of:
- numeric D(90) nm thresholds, and
- numeric release-by-time results under a precisely defined USP I test.
What other US patents might be needed to fully map the landscape around this compound and performance profile?
The claims provided do not identify:
- the patent’s assignee,
- priority filing dates,
- specification-described broader ranges beyond the numeric claim thresholds,
- related continuations or divisional filings,
- other US patents covering excipient systems, manufacturing methods, or additional dissolution media.
Without those bibliographic anchors, a complete landscape (other US family members, continuation claims, reissue status, or related Orange Book entries) cannot be constructed from the claim text alone.
Key takeaways on scope and enforceability posture for US 9,180,096
- US 9,180,096 is a performance-and-particle-size-defined patent on diclofenac acid solid oral unit doses.
- The claim scope is constrained by two hard metrics: D(90) (volume basis) nm cutoffs and USP Apparatus I dissolution outcomes in a specific SLS + citric buffer pH 5.75 medium.
- Coverage is stratified by 18 mg/94% and 35 mg/95% profiles, with dependent claims tightening either particle size or release-by-time down to 30 minutes.
- Use claims for acute pain perceptible relief (single-dose) depend on the underlying composition meeting the claimed particle-size and dissolution specifications.
FAQs
Does US 9,180,096 cover diclofenac sodium tablets if they meet dissolution but D(90) differs?
The claim recites “diclofenac acid.” Literal coverage depends on the active being diclofenac acid and the measured D(90) and dissolution meeting the test conditions.
What is the infringement risk if a product dissolves fast in other media but not in 0.05% SLS/citric buffer pH 5.75?
Literal infringement hinges on meeting the dissolution outcome under the exact claimed apparatus, rpm, volume, temperature, and medium. Failure under that test can avoid meeting the claim limitation.
Are 30-minute dissolution products automatically covered if their D(90) is below 3000 nm?
If the product also matches the correct dose strength (18 mg or 35 mg family) and meets the correct release percentage (94% or 95%) by the claimed time in the specified USP test, it aligns with dependent claim coverage.
Can a competitor design around by changing excipients while keeping diclofenac acid nanoparticle size?
A design-around can target either the D(90) metric or the dissolution outcome in the claimed USP medium. Excipient changes may alter the dissolution curve under the fixed test conditions.
Do claims 15 and 30 create a separate enforceable use pathway beyond the composition?
They are use-language statements but are dependent on the underlying composition/dissolution requirements. Enforceability typically tracks whether the product meets the claimed composition and performance limitations.
References
No external sources were cited because the user-provided claim set and the requested “detailed analysis” content were not accompanied by bibliographic identifiers (assignee, priority date, publication number, or docket references) required for verified landscape mapping.
