US Patent 6,926,907: What Is Actually Claimed and How It Shapes the NSAID Plus Acid-Suppression Landscape?
US Patent 6,926,907 is a formulation-and-method patent that claims coordinated oral delivery of (1) an acid inhibitor (raise gastric pH to at least 3.5) and (2) an NSAID (including COX-2 inhibitors), where the NSAID is protected by a pH-responsive barrier that does not release NSAID until gastric pH reaches the target threshold. The core patent architecture combines an acid-control component and a triggered NSAID release component in a single unit dosage form (or via coordinated administration, depending on claim set).
The claim set covers two layers of IP:
- Composition claims (unit dose formulation + coordinated release mechanics).
- Method claims (treating pain/inflammation using acid inhibitor plus pH-limited NSAID release).
The patent also includes compliance-improvement language and dose ranges (notably for famotidine and pantoprazole) that can tighten infringement arguments and narrow prior-art exclusion during prosecution.
What Are the Claim-Defining Technical Elements?
What does the patent require, in combination, for claim scope?
Across independent claim 1 and method claims 22 and 24 (and their dependent descendants), the invention repeatedly requires these elements in combination:
- Acid inhibitor present or administered at a dose effective to raise gastric pH to at least 3.5.
- NSAID present/used for pain or inflammation.
- Coordinated release logic:
- NSAID is surrounded by a coating that prevents release of “essentially any NSAID” unless surrounding medium pH is 3.5 or higher.
- Acid inhibitor is not fully pH-protected by the same enteric mechanism: at least a portion is released regardless of pH (claim 1), or the formulation includes non-enteric release behavior for the acid inhibitor layers (claims 13, 14, 53-55).
That structure defines the patent’s center of gravity: the claim is not just “acid suppression + coated NSAID,” but timed, pH-triggered NSAID release paired with prompt or non-pH-barrier acid delivery to reach the pH threshold before NSAID unprotects.
What is the pH threshold logic and how is it expressed?
The patent sets a hard threshold at pH 3.5. Specific dependent coverage expands the pH dissolution conditions:
- In claim 1: release of essentially any NSAID only when pH is >= 3.5.
- In claim 16 and 17: coating does not dissolve unless pH is >= 4 or >= 5.
- In claim 19 and 20: inner-core NSAID barrier coating dissolves such that NSAID is not released until pH is >= 4 or >= 5.
This matters for both:
- Claim construction: the patent is explicit about the pH point of dissolution.
- Design-around: competitors can try to move thresholds, use different trigger units, or deliver the acid inhibitor in ways that do not meet “at least a portion not surrounded by enteric coating” limitations (composition claims) or “concurrently administering” limitations (method claims 37/38/41 etc.).
What Do the Composition Claims Cover? (Claims 1-21, 51-55, 53-55)
Independent composition claim 1 (unit dose with coordinated release)
Claim 1 claims a pharmaceutical composition in unit dose form suitable for oral administration, comprising:
- Acid inhibitor effective to raise gastric pH to >= 3.5 on administration.
- NSAID effective to reduce or eliminate pain/inflammation.
- Coordinated release / pH-controlled release:
- NSAID is surrounded by a coating that prevents essentially any NSAID release unless pH >= 3.5.
- At least a portion of the acid inhibitor is not surrounded by an enteric coating and releases regardless of whether pH is below or above 3.5.
This language is the key “coordination” feature: the acid inhibitor’s delivery is structured to occur without requiring the same pH condition that gates NSAID release.
Dependent composition claim scope around acid inhibitor type
The patent narrows the acid inhibitor species in multiple claim paths:
-
H2 blockers (claims 2-4, 18, 43-45, 49)
Species list includes: cimetidine, ranitidine, ebrotidine, pabutidine, lafutidine, loxtidine, famotidine (claim 3).
Famotidine dose range: 5 mg to 100 mg (claim 4).
-
Proton pump inhibitors (claims 5-6, 15, 41-43, 48-55)
Species list includes: omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole (claim 5).
Pantoprazole dose range: 10 mg to 200 mg (claim 6).
-
Barrier dissolution variants (claims 16-17, 19-20)
Adds dissolution gating at pH 4 or pH 5 rather than only pH 3.5.
Dependent composition coverage around NSAID classes and exemplars
The patent explicitly covers:
-
COX-2 inhibitors (claims 7-8)
Species list includes: celecoxib; rofecoxib; meloxicam; piroxicam; valdecoxib; parecoxib; etoricoxib; CS-502; JTE-522; L-745,337; NS398.
-
Broader NSAID family (claims 9-11)
Species list includes aspirin, acetaminophen, ibuprofen, flurbiprofen, ketoprofen, lornoxicam, naproxen, oxaprozin, etodolac, indomethacin, ketorolac, nabumetone.
Naproxen dose range: 50 mg to 1500 mg (claim 10), tightened to 200 mg to 600 mg (claim 11).
These lists matter because they define literal coverage. A design-around is less about the mechanism (pH-triggered delivery) and more about whether the NSAID falls outside the explicitly listed candidates or whether the capsule/tablet mechanics escape the “coating prevents release unless pH >= X” and acid inhibitor release structure.
Dosage form geometry: multilayer vs bilayer vs capsule
The patent covers multiple unit dosage architectures:
What Do the Method Claims Cover? (Claims 22-51)
Independent method claim 22
Claim 22 is a treatment method for pain or inflammation that administers the pharmaceutical composition of claims 1-14.
Independent method claim 24 (two-part dosing with coordinated gating)
Claim 24 claims:
- Orally administer an acid inhibitor at a dose effective to raise gastric pH to >= 3.5.
- Concurrently administer an NSAID coated in a polymer that dissolves only at pH >= 3.5.
This claim is broader than the “single unit dosage form” limitation found in claim 1. It can cover scenarios where acid inhibitor and NSAID are not in the same physical dosage unit, so long as the clinical timing and functional trigger match.
Dependent method claims around acid inhibitor and NSAID specifics
- H2 blockers and species list (claims 25-27)
- PPIs and species list (claims 28-30)
- COX-2 inhibitors list (claim 31)
- NSAID list including naproxen dose ranges (claims 32-34)
Concurrent administration + single dosage form claims
- Claim 35: acid inhibitor and NSAID delivered as part of a single dosage form providing coordinated release.
- Claim 36: bilayer tablet geometry with outer layer H2 blocker and inner core NSAID.
Alternative concurrent formulation method claim 37
Claim 37 is a method with:
- Orally administer acid inhibitor raising pH to >= 3.5.
- Concurrently administer an NSAID coated polymer that dissolves so NSAID is not released until pH is >= 3.5.
This is a functional method claim parallel to claim 24 but written with slightly different conjunction and coverage positioning, then narrowed via dependent claim series 38-49.
Compliance improvement (claim 50)
Claim 50 claims a method of improving patient compliance for frequent daily dosages of an acid inhibitor and NSAID by administering them in a coordinated unit dosage form in accordance with claim 1.
This can extend commercial value even where clinical benefit is framed as adherence rather than mechanism.
Osteoarthritis and rheumatoid arthritis
Claims 23 and 52 specify therapeutic indication: pain/inflammation due to osteoarthritis or rheumatoid arthritis.
What Is the Practical Infringement Core? (How claims map to product design)
Literal infringement “must-haves”
For a product to fall within claim 1’s composition core, it must satisfy:
- NSAID pH-threshold gating: the formulation prevents “essentially any” NSAID release unless pH is >= 3.5.
- Acid inhibitor release behavior: at least a portion of the acid inhibitor is not enteric-coated in the sense required by the claim and releases regardless of pH.
- pH target: the acid inhibitor is dosed to raise gastric pH to >= 3.5 upon administration.
For method claim 24 and parallel claims, a product does not need the same physical unit-dose architecture, but must still deliver:
- effective acid raising to >= 3.5; and
- a coated NSAID polymer dissolving only at pH >= 3.5 under the circumstances of administration.
Where product differentiation is likely to succeed
Design-around levers implied by the claim text:
- Change the trigger from pH 3.5 to a different threshold (or a non-pH trigger).
- Ensure the NSAID coating releases at pH values below 3.5 (or fails the “prevents essentially any NSAID” standard).
- Structure the acid inhibitor so it is also gated by enteric or pH conditions rather than releasing regardless of pH.
- Use NSAIDs not within the explicit enumerated lists (though many could still be argued by broader NSAID terms if claim language in the granted patent supports it, but the provided claim text uses lists).
Patent Landscape: Where This Patent Sits in the Competition Map
Technology cluster: “acid suppression plus pH-protected NSAID”
US 6,926,907 is part of a broader field where inventors combine:
- gastric acid suppression (H2 blockers or PPIs) and
- gastro-resistant or pH-responsive coatings for drugs with gastric irritation risk.
The patent’s differentiator is the coordination requirement (acid inhibitor release not gated by the same threshold as NSAID release) plus the explicit pH target at 3.5.
How claim specificity affects landscape read-through
This patent has narrow “hard points” that competitors can use for portfolio planning:
- Acid inhibitor species include specific H2 blocker and PPI exemplars, and include explicit dose ranges for famotidine and pantoprazole.
- NSAID scope includes explicit lists for COX-2 inhibitors and for broader NSAID options, including naproxen dose ranges.
In a landscape sense:
- If a competitor’s candidate is built around famotidine 5-100 mg or pantoprazole 10-200 mg plus a pH-triggered NSAID coating, the probability of overlapping these claims rises sharply.
- If a competitor relies on the same concept but uses different acid inhibitors, different pH dissolution logic, or different NSAID selections outside the listed exemplars, the overlap probability changes.
Key Claim Text Features That Investors Should Track
- “pH of said patient to at least 3.5” appears as the functional objective, not as a coating label alone.
- NSAID coating must prevent “essentially any NSAID” release below pH threshold.
- Acid inhibitor delivery includes an explicit release qualifier: “at least a portion of said acid inhibitor is not surrounded by an enteric coating” and releases regardless of whether pH is below or above 3.5.
- The patent contains multiple dependent branches that expand coverage to:
- dissolution thresholds at pH 4 and pH 5
- specific acid inhibitor species and dosage ranges
- specific NSAID species and dosage ranges
- unit-dose geometries (multilayer tablet, bilayer tablet, capsule)
- Independent method claims allow coverage beyond one physical product if dosing is “concurrent” and functionally achieves the same pH gating of NSAID release.
Table: Claim Coverage Map (Core Technical Elements → Claimed Scope)
| Element |
Where it appears |
Claim language effect |
| Gastric pH target >= 3.5 |
Claim 1; method claims 24, 37 |
Sets functional requirement for acid inhibitor dose effectiveness |
| Acid inhibitor type: H2 blocker |
Claims 2-4, 18, 25-27, 38-40, 48-49 |
Constrains species and can add famotidine dose window |
| Acid inhibitor type: PPI |
Claims 5-6, 15, 28-30, 41-43, 48-49 |
Constrains species and can add pantoprazole dose window |
| NSAID pH-triggered coating |
Claim 1 (core); method claims 24 and 37 |
Gating on pH >= 3.5; prevents NSAID release below threshold |
| Acid inhibitor not enteric-gated |
Claim 1 (at least a portion released regardless of pH) |
Forces coordination structure within unit-dose mechanics |
| Optional stricter thresholds (pH 4 or 5) |
Claims 16-17 and 19-20 |
Adds fallback coverage for formulations that dissolve at higher pH |
| NSAID scope: COX-2 inhibitors |
Claims 7-8 and 31; 44 |
Enumerated COX-2 list |
| NSAID scope: broader NSAIDs |
Claims 9-11 and 32-34; 45-47 |
Enumerated list and naproxen dose windows |
| Dosage form geometry |
Claims 12-14, 21, 36, 49 |
Coverage by multilayer/bilayer/capsule embodiments |
| Indication |
Claims 23, 22/52 |
OA and RA explicit |
| Compliance method |
Claim 50 |
Adds commercial utility tied to claim 1 unit-dose form |
Key Takeaways
- US 6,926,907 centers on coordinated oral delivery where an acid inhibitor raises gastric pH to >= 3.5 and the NSAID is pH-gated so it does not release unless pH >= 3.5.
- The tightest composition coverage is claim 1, especially the requirement that at least a portion of the acid inhibitor is not enteric-coated and releases regardless of pH while the NSAID remains protected until the pH threshold is met.
- The method claims (notably claims 24 and 37) can extend beyond a single physical unit if acid inhibitor and coated NSAID are concurrently administered in a way that functionally achieves the same gastric pH trigger and NSAID dissolution threshold.
- The patent’s practical freedom-to-operate hinges on matching or escaping these explicit “hard points”: pH threshold (3.5, with dependent 4/5), acid inhibitor release design (non-enteric gating), NSAID coating release suppression (“essentially any”), and enumerated drug species/dose ranges (famotidine, pantoprazole, naproxen).
FAQs
1) What is the invention’s main technical novelty in one sentence?
It is an oral dosing scheme that pairs acid suppression that reaches gastric pH >= 3.5 with a pH-responsive NSAID coating that blocks essentially all NSAID release until that pH threshold is reached.
2) Does the patent require the acid inhibitor and NSAID to be in the same physical dosage form?
Claim 1 requires a single unit dosage form with coordinated release mechanics, while method claim 24 and parallel method claims can cover concurrent administration where the NSAID is separately coated and the acid inhibitor is separately dosed.
3) What pH threshold is most central to infringement arguments?
pH 3.5 is the base threshold across independent claim 1 and method claim 24; dependent claims expand to dissolution behavior at pH 4 and pH 5.
4) Which acid inhibitors and NSAIDs are explicitly enumerated in the claims provided?
Acid inhibitors include listed H2 blockers (including famotidine) and listed PPIs (including pantoprazole). NSAIDs include listed COX-2 inhibitors and a broader NSAID list including naproxen.
5) What dosage ranges are specified that can narrow claim coverage?
The claims provided specify famotidine 5 mg to 100 mg and pantoprazole 10 mg to 200 mg, and naproxen 50 mg to 1500 mg with a narrower 200 mg to 600 mg dependent range.
References
[1] US Patent 6,926,907.
