Details for Patent: 9,827,197

Which drugs does patent 9,827,197 protect, and when does it expire?

Patent 9,827,197 protects CAMBIA and is included in one NDA.

This patent has thirty-four patent family members in twenty-three countries.

Summary for Patent: 9,827,197

Title:	Diclofenac formulations and methods of use
Abstract:	Methods and formulations are provided for treating migraine and other acute pain episodes using diclofenac, and formulations of diclofenac that provide both rapid and sustained relief from acute pain. Methods and formulations are also provided for treating symptoms that often accompany migraine and acute pain such as photophobia, phonophobia, nausea and vomiting.
Inventor(s):	Giorgio Reiner, Alberto Reiner, Andreas Meyer
Assignee:	APR Applied Pharma Research SA
Application Number:	US14/534,428
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,827,197
Patent Claim Types: see list of patent claims	Use; Formulation; Dosage form;

United States Patent 9,827,197 (Diclofenac Potassium + Mannitol Particle-Size Partitioning): Scope, Claim-Chart Exposure, and US Patent Estate

US Patent 9,827,197 claims a tightly specified solid oral formulation of diclofenac (explicitly diclofenac potassium in multiple dependent claims) with a biphasic mannitol excipient system defined by fine vs coarse particle-size cutoffs and weight ratios, plus optional excipients and process steps for wet granulation. The claim set is organized to create protection at three levels: (i) composition-of-matter for the particulate blend, (ii) dose-form and patient-facing sachet/unit-pack presentations, and (iii) a specific wet granulation process flow that uses ethanol wet granulation and staged addition of mannitol fractions.

Below is a structured, infringement-relevant analysis of claim scope, claim interpretation levers, design-around vectors, and the likely US landscape and settlement posture such a patent typically sits in for diclofenac reformulations.

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What does US Patent 9,827,197 claim protect: mannitol particle-size split, ratios, and diclofenac form?

Claim 1 core protection: particulate formulation with defined particle distributions and mass ratios

Claim 1 requires all of the following:

1. Pharmaceutical formulation comprising:
   • mannitol and diclofenac or a pharmaceutically acceptable salt.
2. The formulation must be in a particulate form.
3. A weight ratio constraint:
   • mannitol : diclofenac > 1.5 : 1.
4. Mannitol is not monolithic: it must contain two mannitol populations:
   • Fine diluent mannitol:
     • Average particle size 10 to 180 micrometers
     • Fine diluent : diclofenac weight ratio 1:2 to 5:1
   • Coarse diluent mannitol:
     • Average particle diameter 75 to 300 micrometers
     • Coarse diluent : diclofenac weight ratio 10:1 to 20:1

This structure matters legally because Claim 1 does not read on any “diclofenac + mannitol” blend. It reads on a blend where mannitol particle-size distributions and the two mass ratio windows are simultaneously satisfied. In practice, these become key validity and infringement pressure points: particle sizing method and how “average” is determined can dominate both.

Claim 3 narrows further: diclofenac potassium + fine particle subset and a tighter fine:diclofenac range

Claim 3 adds:

• diclofenac must be diclofenac potassium
• Fine mannitol : diclofenac potassium weight ratio about 1:1 to about 2:1
• Fine mannitol average particle size about 20 to about 80 micrometers

This is a narrower embodiment of Claim 1’s fine-man nitol window (10 to 180). Claim 3 is likely to capture commercial SKUs that aim for a specific dissolution/flow profile.

Claim 4 gives explicit dose-anchored mass ranges for mannitol fractions

Claim 4 sets a composition consistent with unit-dose packs:

• Diclofenac potassium ~50, 25, or 12.5 mg per 900 mg formulation
• Fine mannitol 50–100 mg per 900 mg formulation
• Coarse mannitol 600–700 mg per 900 mg formulation

This is strong for infringement mapping because the claim is numerically anchored to a 900 mg total fill and explicit diclofenac potassium strengths.

Claim 5 and Claim 10 create additional quantitative guards

• Claim 5: formulation contains 50 to 90 wt % mannitol
• Claim 10: formulation contains less than 1.5% water

Claim 10 is typically outcome-determinative for manufacturing controls (residual moisture, drying endpoints, and hygroscopic behavior).

Claim 6 sugar-free and Claim 7 glyceryl dibehenate are add-on limitations

• Claim 6: sugar-free
• Claim 7: further comprises glyceryl dibehenate

Because they are “further comprises” limitations, these are not required by Claim 1. They expand the protected embodiments only if the accused product uses those excipients.

Claims 8 and 9: alkali metal bicarbonate ratio windows

• Claim 8: alkali metal bicarbonate : diclofenac > 1 : 5
• Claim 9: alkali metal bicarbonate : diclofenac about 1 : 5 to about 5 : 1

These claims likely target dissolution/pH improvement and bulk handling. Infringement will hinge on whether the product includes bicarbonate and whether the mass ratio fits the window.

Claim 11: diclofenac in a granulate

Claim 11 requires that diclofenac (or salt) is in the form of a granulate. If the accused product uses direct powder blending without granulating diclofenac, this limitation would not be met for Claim 11, though Claim 1 could still be asserted depending on whether Claim 1’s “particulate form” is satisfied.

Claims 12 and 13: dissolution and pH metrics become testing-based

• Claim 12: average pH 7.5 when dissolved in 50 ml water
• Claim 13: at least 75% dissolves completely in 50 ml water at 25°C under stirring for 5 minutes

These are measurable and can be the basis for pre-suit testing and claim-chart evidence.

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How does US 9,827,197 protect specific presentations: unit-dose pack and powder sachets?

Claim 2: 900 mg unit dose pack with diclofenac potassium strengths

Claim 2 ties Claim 1’s formulation to a unit dose pack with:

• Pack contains 900 mg formulation
• Diclofenac potassium is 50, 25, or 12.5 mg
• Formulation composition is therefore necessarily:
  • Diclofenac potassium: 50/25/12.5 mg per 900 mg
  • Mannitol fractions and ratios still controlled by Claim 1’s particle-size and weight ratio constraints.

Claim 18: powder sachet dosage form with identical mannitol fraction bounds

Claim 18 is essentially Claim 2-type numerical alignment for a powder sachet and repeats:

• Diclofenac potassium 50 or 25 mg per 900 mg
• Fine mannitol 50–100 mg per 900 mg
• Coarse mannitol 600–700 mg per 900 mg
• Particle size windows and weight ratio windows identical to Claim 1.

From a freedom-to-operate perspective, if a product markets a sachet matching these mass and particle ranges, Claim 18 is a direct compositional hook.

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What patents protect the manufacturing process: wet granulation in ethanol with staged mannitol?

Claim 14: method claim with a defined process flow

Claim 14 protects a making method for wet granulated powder:

1. Wet granulation in ethanol
2. Admix diclofenac or salt
3. Add:
   • first portion of coarse mannitol
   • bicarbonate to form a wet granulate
4. Adm ix wet granulate with a second portion of coarse mannitol and fine mannitol

This is significant because it is not a generic wet granulation claim. It requires:

• ethanol as wet granulation solvent,
• staged mannitol addition (first coarse portion during wet granulation; second coarse plus fine after),
• bicarbonate present during wet granulation step.

Claim 15 adds glyceryl dibehenate to the method

If the accused manufacturing includes glyceryl dibehenate addition consistent with claim 15, method infringement risk increases.

Claims 16 and 17: formulation parts for method embodiments

• Claim 16: wet granulate comprises approx:
  • diclofenac potassium 8–15 parts
  • coarse mannitol 12–20 parts
  • potassium bicarbonate 3–7 parts
• Claim 17: final powder blend step mixes:
  • 30–60 parts wet granulate with:
    • coarse mannitol 100–160 parts
    • fine mannitol 12–20 parts
    • glyceryl dibehenate 0.2–0.7 parts

These parts-based ranges let infringement be evaluated either by batch recipe mapping or by scaling to final fill composition.

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How strong is the patent estate for 9,827,197: claim specificity and likely invalidity/exhaustion pressure points

Given only the claim text provided, the strength assessment is claim-internal and does not rely on litigation history. The structure nonetheless suggests:

1) High specificity increases infringement “knockout” potential

Claim 1’s requirements are layered:

• particulate formulation
• diclofenac (and salt scope generally)
• mann itol : diclofenac > 1.5:1
• fine mannitol particle size 10–180 µm
• coarse mannitol particle diameter 75–300 µm
• fine:diclofenac ratio 1:2 to 5:1
• coarse:diclofenac ratio 10:1 to 20:1

A competitor can escape literal infringement by adjusting any one dimension:

• selecting a mannitol grade whose average falls just outside a window,
• changing mass ratios (coarse fraction vs diclofenac),
• using a single mannitol grade rather than bimodal fine+coarse,
• changing process (no ethanol wet granulation or no staged addition),
• reformulating pH/dissolution metrics.

2) Specificity also increases validity risk for “obvious optimization” narratives

In reformulation patents, the most common counter is:

• particle-size selection is a routine formulation parameter,
• weight ratio tuning falls under predictable optimization,
• and bicarbonate/ethanol granulation are standard toolkit components.

Whether that succeeds depends on the prior art record and the patent’s disclosure. Not provided here, so the only actionable takeaway is that the patent’s scope is narrow enough that design-around is feasible if the prior art does not tightly constrain those windows.

3) The method claims provide a second pathway to enforce even if composition differs

Even if a product avoids Claim 1’s precise composition, it may still be vulnerable under Claim 14 if:

• it uses ethanol wet granulation,
• it stages coarse mannitol and introduces fine mannitol post-wet granulation,
• and it includes bicarbonate during wet granulation.

That dual pathway can shift litigation leverage toward discovery of batch records.

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How to run a claim-chart infringement map against a potential generic/sachet product

Composition-based infringement (Claim 1/2/3/4/5/6/7/8/9/10/11/12/13/18)

For a candidate product, map the following in order:

1. Active: Is the active diclofenac or a pharmaceutically acceptable salt? Is it specifically diclofenac potassium in the marketed SKU?
2. Fill architecture:
   • Does the product supply a unit dose pack of 900 mg total?
   • If it is a sachet, does the formulation match the 900 mg base and diclofenac strength list?
3. Mannitol system:
   • Is there both fine and coarse mannitol population meeting:
     • fine: 10–180 µm average (or 20–80 µm for Claim 3)
     • coarse: 75–300 µm average
4. Mass ratios:
   • Total mannitol : diclofenac > 1.5:1
   • Fine mannitol : diclofenac ratio within 1:2 to 5:1
   • Coarse mannitol : diclofenac ratio within 10:1 to 20:1
5. Optional but enumerated excipients:
   • bicarbonate included and at the ratio window
   • glyceryl dibehenate presence
   • sugar-free status
   • water content <1.5%
6. Test-based properties:
   • pH 7.5 in 50 ml water (Claim 12)
   • dissolution profile at 25°C for 5 minutes under continuous stirring (Claim 13)

Because particle sizing and moisture content are testable, infringement is often decided through:

• supplier CoA particle distribution data,
• validated PSD measurement in product testing,
• and moisture assay at the point of release.

Method infringement (Claim 14–17)

Map the manufacturing recipe:

1. Solvent: ethanol used for wet granulation?
2. Order of addition:
   • first coarse mannitol added during wet granulation with diclofenac + bicarbonate?
   • second coarse mannitol and fine mannitol admixed afterward?
3. Bicarbonate identity and quantities:
   • potassium bicarbonate, consistent with parts ranges
4. Batch scaling:
   • final mix includes 30–60 parts wet granulate into an excipient blend with the specified part ranges.

Method claims are typically enforced via:

• discovery of batch process descriptions,
• validation protocols,
• and if needed, expert reconstruction from batch logs.

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Which design-arounds are most plausible given the claim language?

High-probability routes, based on literal-claim structure:

1. Shift out of particle windows
   • Use a mannitol grade with average fine PSD <10 µm or >180 µm.
   • Use coarse PSD <75 µm or >300 µm.
2. Change the fine/coarse mass ratio
   • Keep total mannitol high but move fine : diclofenac outside 1:2 to 5:1.
   • Move coarse : diclofenac outside 10:1 to 20:1.
3. Eliminate bimodal mannitol
   • Use only one mannitol fraction or a different excipient blend that does not constitute both “fine” and “coarse” populations with the stated averages.
4. Remove bicarbonate during wet granulation
   • If preparing wet granulate, omit bicarbonate from the ethanol wet granulation step.
5. Change the solvent
   • Use a non-ethanol granulation solvent system so Claim 14’s ethanol limitation fails.
6. Break the staged addition
   • Add fine mannitol prior to or during wet granulation rather than post-wet granulate.
7. Change target unit dose architecture
   • Avoid the 900 mg pack or sachet fill design and/or avoid the listed diclofenac potassium strengths tied to Claim 2 and Claim 18.

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Patent landscape and likely related US filings for diclofenac + mannitol particle engineering

No Orange Book entries, assignee data, or citation network was provided with the patent number, so an exhaustive landscape cannot be produced without external record access. What can be stated from the claim architecture:

Likely nearby claim themes in the same family or related prosecution history

Patents that commonly cluster around this type of technology include:

• diclofenac solid dispersion or granulation approaches targeting dissolution rate,
• particle-size engineering of bulking/diluent excipients (mannitol, lactose, microcrystalline cellulose),
• bicarbonate and pH-control excipient systems in immediate-release oral powders,
• moisture-controlled formulations and packaging for hygroscopic stability,
• sachet/unit-dose format compositions and unit-fill specs.

Enforcement pattern likely to be composition plus process

The set includes both composition (Claim 1 and dependent compositions) and a method claim (Claim 14). That combination is typically chosen when:

• composition can be designed around,
• but process steps are harder to replicate without access to detailed manufacturing parameters.

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Key Takeaways

• US 9,827,197 is built around a bimodal mannitol particle-size system (fine 10–180 µm; coarse 75–300 µm) with strict fine:diclofenac and coarse:diclofenac weight ratio windows, plus optional constraints (bicarbonate ratios, water <1.5%, glyceryl dibehenate, pH and dissolution metrics).
• The patent adds strong presentation-specific coverage for 900 mg unit dose packs and powder sachets at diclofenac potassium 50/25/12.5 mg per 900 mg, with matching fine/coarse mannitol mass bounds.
• The method claim (ethanol wet granulation with staged mannitol addition and bicarbonate present) creates an alternate enforcement vector independent of the exact final particle size split, provided the process matches the staged sequence and solvent choice.
• The narrow particle-size and ratio constraints create clear literal design-around opportunities by shifting averages, changing mass ratios, eliminating bimodal mannitol, or altering solvent/sequence for wet granulation.

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FAQs

1. Can a product avoid infringement by changing only the fine mannitol particle size average within the 10–180 µm band?
   If it stays within 10–180 µm, Claim 1’s fine particle window remains satisfied; risk depends on the fine:diclofenac and coarse:diclofenac ratio windows as well.

2. Does omitting glyceryl dibehenate avoid infringement?
   It avoids only the dependent embodiments requiring glyceryl dibehenate (Claims 7 and 15/17), not Claim 1 unless other limitations are also met.

3. If a product uses diclofenac potassium but uses only one mannitol grade, does it still meet Claim 1?
   Claim 1 requires mannitol comprising a fine diluent and a coarse diluent with the stated average sizes and ratio windows, so a single-grade approach can avoid literal scope.

4. Is pH/dissolution testing a reliable infringement determinant for litigation?
   Claims 12 and 13 are directly tied to measurable conditions (water volume, temperature, stirring time), so they can be used as test-based claim-chart elements.

5. How do method changes affect exposure under Claim 14?
   Removing ethanol as the wet granulation solvent, eliminating bicarbonate from the wet granulation step, or changing staged mannitol addition order can defeat literal compliance with Claim 14.

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References

1. US Patent 9,827,197 (claim text provided by user).

Drugs Protected by US Patent 9,827,197

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Assertio Speclty	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes			Y

International Family Members for US Patent 9,827,197

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	057378
Australia	2006257072
Brazil	PI0612245
Canada	2632375
Canada	2932603
China	101272768
China	104856959