US Patent 8,933,127: What Is Claimed, What the Scope Covers, and How the Landscape Looks
What is US 8,933,127 actually about?
US Patent 8,933,127 claims a once-daily ophthalmic formulation for lowering intraocular pressure (IOP) in glaucoma or ocular hypertension, centered on a specific reduction of bimatoprost concentration paired with an adjusted benzalkonium chloride (BAK) concentration to maintain IOP-lowering while improving ocular tolerability (hyperemia and related adverse events).
Core formulation pair in the independent-claim set (verbatim composition targets):
- “First composition”: 0.01% w/v bimatoprost + 0.02% w/v benzalkonium chloride
- “Second composition” (comparison/control in claims): 0.03% w/v bimatoprost + 0.005% w/v benzalkonium chloride
The claims repeatedly frame the invention as: lower IOP-lowering dose of bimatoprost with less hyperemia/ocular adverse events while keeping IOP reduction non-inferior (or “without substantial reduction” / “equivalent” in efficacy time windows).
How do the independent claims define claim scope?
Independent-claim structure (based on the claim text provided) uses composition + regimen + comparative performance. This matters because it limits literal infringement to products that meet both the formula and the clinical/performance benchmark relative to the “second composition.”
Claim 1 (baseline independent)
Claim 1 is directed to:
- Regimen: administered once daily
- Indication: person with glaucoma or ocular hypertension
- Composition: 0.01% bimatoprost + 0.02% BAK
- Performance limitation: lowers IOP and results in less conjunctival hyperemia or less severe macroscopic hyperemia than the once-daily administration of the comparator 0.03% bimatoprost + 0.005% BAK
Scope implications
- Literal claim coverage hinges on (i) matching the exact formulation concentrations and (ii) showing the hyperemia advantage vs the specific comparator.
Claim 5 (second independent; broader administration frequency)
Claim 5 recites:
- Regimen: “administered at least once daily”
- Composition: about 0.01% bimatoprost + about 0.02% BAK
- Performance limitations:
- decreases at least one ocular-related adverse event selected from:
- macroscopic hyperemia
- conjunctival hyperemia
- punctate keratitis
- corneal abnormalities
- and lowers IOP “without a substantial reduction” in IOP-lowering benefit vs the comparator formulation (0.03% bimatoprost + 0.005% BAK)
Scope implications
- “At least once daily” can encompass once daily and multiple daily dosing, expanding potential infringement scenarios if a product is used more frequently.
- The adverse event limitation gives the patentee multiple pathways: proof that the product reduces any one of the listed events can satisfy that portion.
Claim 11 (use to reduce bimatoprost amount)
Claim 11 is framed as:
- a composition for reducing the amount of bimatoprost administered in a once daily treatment for glaucoma/ocular hypertension
- composition: 0.01% bimatoprost + 0.02% BAK
- includes a “remains useful despite a lower concentration” requirement
- ties benefit back to less hyperemia vs 0.03% bimatoprost + 0.005% BAK
Scope implications
- This claim targets the dose-reduction concept packaged as a composition/use.
- It still locks into the same numeric concentrations and comparative hyperemia benefit.
Claim 18 (independent; adverse-event and hyperemia bundle)
Claim 18 recites:
- once daily
- composition: 0.01% bimatoprost + 0.02% BAK
- performance: less adverse events, less hyperemia, and less ocular treatment-related adverse events vs comparator (0.03% bimatoprost + 0.005% BAK)
Scope implications
- Claim 18 reads like a broader “bundle” of tolerance outcomes, but still depends on the comparator and specific formulation concentrations.
What dependent claims add functional and parameter limits?
Dependent claims refine scope using pH, dosing window comparators, equivalence periods, and narrower feature definitions.
pH limitations
- Claim 2 / Claim 6 / Claim 12: first composition has pH of about 7.3
Practical effect
- A product with the same actives concentrations but a meaningfully different pH profile may avoid literal infringement of these dependent claims, though it could still fall under independent claims if pH is not required there (independent claims as provided do not state pH).
Non-inferiority / timepoint requirements
- Claim 4: “non-inferior” at 15/17 timepoints in ocular hypertension vs comparator
Practical effect
- This creates a measurable clinical benchmark. It also means the patentee can argue that products lacking the non-inferiority profile fall outside the claim.
Efficacy / treatment claims
- Claim 3, 9, 10, 19, 20: first composition is effective in treating glaucoma and/or ocular hypertension
Practical effect
- These are standard use/effect dependencies, but because the independent claims already tie to IOP-lowering and tolerance, these dependent clauses typically do not add new numeric thresholds beyond what is inherent in the clinical framing.
Non-inferiority/equivalence over duration
- Claim 21: composition is equivalent in efficacy to the second composition over a three month period
Practical effect
- This creates a duration-based proof structure. A product showing non-inferiority only over shorter intervals could be argued to miss this dependent-claim element.
Dosing form constraint
- Claim 14: first composition is a solution
Practical effect
- Non-solution dosage forms (if any) would not match this dependent claim. Ophthalmic bimatoprost formulations in market practice are typically solutions, but the claim language can still matter for alternative dosage forms.
Tolerability comparative claim
- Claim 8: greater ocular surface tolerability than the second composition
- Claim 13: improved ocular surface tolerability as compared to the second composition
Practical effect
- This language expands the tolerance concept beyond a single endpoint, but still relies on “as compared to” the comparator.
Where is the claim “center of gravity” in infringement analysis?
For a US infringement evaluation, the claim set as written is strongest in a three-factor matrix:
-
Exact formulation concentrations
- 0.01% w/v bimatoprost and 0.02% w/v BAK (or “about” versions depending on the claim)
- plus the “second composition” comparison is fixed at 0.03% bimatoprost + 0.005% BAK as the benchmark.
-
Dosing regimen alignment
- once daily (Claims 1, 11, 18)
- at least once daily (Claim 5)
-
Performance framing versus the fixed comparator
- “less conjunctival or macroscopic hyperemia” (Claims 1, 11)
- “decreases at least one ocular-related adverse event” from a defined list (Claim 5)
- “non-inferior at 15/17 timepoints” (Claim 4)
- “equivalent in efficacy over three months” (Claim 21)
- “without substantial reduction” (Claim 5)
The comparative language is key. Even if a competitor reduces hyperemia, the claim set ties benefit to a specific comparator composition and to IOP efficacy maintenance without substantial loss, and several dependent clauses specify clinical benchmark structures.
What does the “about” language likely do to enforceable scope?
Several claims use “about” for the bimatoprost and BAK concentrations (for example, Claim 5). In practice, “about” can expand the literal range beyond the nominal values, but the scope still anchors to the intended formulation relationship:
- lower bimatoprost from 0.03% → 0.01%
- higher BAK from 0.005% → 0.02%
That pairing is part of the claim’s logic: it is not merely “less bimatoprost”; it is “less bimatoprost with a specific BAK level” that preserves IOP reduction while improving hyperemia.
What is the practical “design-around” surface?
Because claims lock to both formulation and comparative performance, design-around approaches usually fall into these buckets:
1) Avoid matching the formulation pair
- Change either bimatoprost concentration away from ~0.01%
- Change BAK concentration away from ~0.02%
This is the cleanest route because formulation is the most direct claim anchor.
2) Avoid meeting the comparator-performance limitation
Even if the formulation is close, the claim set requires comparative outcomes:
- less conjunctival/macroscopic hyperemia vs the fixed comparator
- reduction in at least one of listed adverse events
- non-inferiority/equivalence benchmarks in dependent claims
A product that does not meet the proof structure may still avoid literal infringement even if formulation is close, though doctrine-of-equivalents theories can complicate non-literal issues.
3) Change dosing frequency
- Move away from once daily for claims that require it
- Note Claim 5 covers “at least once daily,” so simply using more frequent dosing may not avoid Claim 5 if formulation matches.
4) Change dosage form
- Claim 14 limits to a solution (dependent). Non-solution dosage forms could avoid this dependency.
How does this patent fit into the broader bimatoprost/glaucoma landscape?
Even without file wrapper history or specification details, the claim architecture signals the patent’s position in a familiar treatment evolution path:
- Known active: bimatoprost as an IOP-lowering prostaglandin analog.
- Known preservative issue: BAK is linked to ocular surface toxicity and hyperemia.
- Known clinical trade-off: higher bimatoprost concentrations can increase hyperemia, so dose reduction is attractive if IOP efficacy can be preserved.
- Claim-crafted solution: reduce bimatoprost concentration while adjusting BAK to produce a tolerability and adverse-event advantage while maintaining IOP lowering.
In market terms, this kind of formulation patent typically targets competitors seeking a lower-dose bimatoprost product with improved ocular comfort while still hitting pressure control benchmarks.
Claim-by-claim map (what each adds to the independent base)
| Claim |
Added scope elements (from the text provided) |
Scope impact |
| 1 |
Once daily; 0.01% bimatoprost + 0.02% BAK; less conjunctival or less severe macroscopic hyperemia vs 0.03% bimatoprost + 0.005% BAK |
Strongest direct composition-and-performance anchor |
| 2 |
pH about 7.3 |
Adds parameter-dependent limitation |
| 3 |
Effective treating glaucoma |
Use-effect dependency |
| 4 |
Non-inferior at 15/17 timepoints vs comparator |
Quantified clinical benchmark |
| 5 |
At least once daily; decreases at least one adverse event from a defined list; IOP lowering without substantial reduction vs comparator |
Expands tolerability endpoints; preserves efficacy standard |
| 6 |
pH 7.3 |
Parameter dependency |
| 7 |
comprises 0.01% bimatoprost and 0.02% BAK |
Composition reiteration |
| 8 |
greater ocular surface tolerability |
Comparative tolerability dependency |
| 9 |
effective treating glaucoma |
Use-effect dependency |
| 10 |
effective treating ocular hypertension |
Use-effect dependency |
| 11 |
Once daily; use aimed at reducing bimatoprost amount while maintaining utility; less hyperemia vs comparator |
Dose-reduction framing plus comparative advantage |
| 12 |
pH 7.3 |
Parameter dependency |
| 13 |
improved ocular surface tolerability vs comparator |
Comparative tolerability dependency |
| 14 |
first composition is a solution |
Dosage-form dependency |
| 15 |
effective treating elevated IOP |
Indication/use dependency |
| 16 |
effective treating glaucoma |
Indication/use dependency |
| 17 |
effective treating ocular hypertension |
Indication/use dependency |
| 18 |
Once daily; less adverse events and less ocular treatment-related adverse events vs comparator |
Broad adverse-event framing |
| 19 |
effective treating glaucoma |
Use-effect dependency |
| 20 |
effective treating ocular hypertension |
Use-effect dependency |
| 21 |
Equivalent efficacy over 3 months |
Duration-based efficacy standard |
What is the effective “landscape” risk profile created by this patent?
This patent creates infringement risk for:
- any competitor product that uses 0.01% bimatoprost + 0.02% BAK (or close “about” equivalents, depending on claim construction) and is used once daily (or “at least once daily” for Claim 5) for glaucoma/ocular hypertension; and
- whose clinical outcomes show improved hyperemia and ocular surface tolerability without giving up IOP control vs the fixed comparator benchmark.
Because the claims embed comparator formulations and measurable outcome constructs (hyperemia endpoints, adverse-event list, non-inferiority timepoints, three-month equivalence), risk is highest for applicants that attempt to mirror the claimed formulation and then market it as a tolerability improvement while maintaining pressure control.
Key Takeaways
- US 8,933,127 is a formulation-and-clinical-outcome patent for once-daily or at-least-once-daily glaucoma/ocular hypertension treatment using 0.01% bimatoprost + 0.02% benzalkonium chloride.
- The claims are built around a fixed comparator: 0.03% bimatoprost + 0.005% benzalkonium chloride, tying infringement to reduced hyperemia/adverse events while maintaining IOP lowering.
- Dependent claims tighten scope with pH about 7.3, non-inferiority at 15/17 timepoints, and three-month efficacy equivalence, increasing the evidence burden for both infringement and invalidity defenses.
- The most direct design-around is to change the concentration pair (bimatoprost and/or BAK) or to avoid meeting the comparative clinical performance requirements in the claim language.
FAQs
-
Does the patent claim bimatoprost generally, or only this specific dose?
It is dose- and preservative-specific: the claims center on 0.01% bimatoprost paired with 0.02% BAK, contrasted against 0.03% bimatoprost + 0.005% BAK.
-
Is the key benefit “lower IOP” or “less hyperemia”?
Both are required in the claims. IOP lowering is coupled with reduced conjunctival/macroscopic hyperemia and/or reduced ocular adverse events versus the fixed comparator.
-
What does “non-inferior at 15/17 timepoints” mean for competitors?
It is a measurable clinical benchmark. Products that do not satisfy that profile for ocular hypertension versus the comparator can argue they do not meet the dependent claim limitation.
-
Can a product avoid infringement by changing dosing frequency?
Claims requiring once daily can be avoided if dosing is not once daily, but Claim 5 covers “at least once daily,” so increasing frequency does not automatically remove risk.
-
Which dependent claims impose the tightest formulation constraints?
The pH about 7.3 dependent claims (2, 6, 12) and the solution dependent claim (14) add narrow, parameter-level restrictions beyond the actives concentrations.
References (APA)
[1] US Patent 8,933,127. Claims text provided in user prompt.
