United States Patent 10,654,844 Scope, Claims, and Patent Landscape for Salt/Topical Ophthalmic Formulations
Executive summary: US 10,654,844 is an ophthalmic-purposed patent that claims (i) a pharmaceutically acceptable salt (Claim 1), (ii) a composition containing that salt (Claim 2), (iii) formulation compositions with pharmaceutically acceptable carriers (Claim 3), (iv) a buffered saline carrier at pH ~5.5 to ~6.5 (Claim 4), and (v) broad therapeutic method-of-use claims covering administration for glaucoma, age-related macular degeneration (wet/dry), diabetic macular edema, dry eye, and ocular hypertension, with topical ocular administration (Claims 5-28). The claim set is structured to create multiple infringement “entry points” across salt selection, composition/formulation composition, and method-of-use, with the tightest formulation limitation located in the buffer pH window.
What is US Drug Patent 10,654,844 claiming: salt, composition, and pH-buffered ophthalmic formulation?
Core claim architecture (independent claims):
- Claim 1: A pharmaceutically acceptable salt of the recited salt component (the drug identity is not provided in the excerpt you provided).
- Claim 2: A composition comprising the salt of Claim 1.
- Claim 3: A pharmaceutical composition comprising the salt plus a pharmaceutically acceptable carrier.
- Claim 4 (formulation-tight): Claim 3’s composition where the carrier is saline buffered to pH about 5.5 to about 6.5.
Practical scope reading:
- Claims 1-3 are composition/salt broad and can cover a wide set of carriers and excipient blends as long as they include the claimed salt and qualify as “pharmaceutically acceptable.”
- Claim 4 is the most specific formulation claim because it locks carrier identity to a saline buffer and constrains pH to a narrow band (about 5.5 to about 6.5). This can materially affect design-around strategies for challengers using different buffering systems (citric acid/phosphate blends, borate, HEPES, tromethamine, different ionic strengths) or different pH settings (even modest drift outside the band can matter).
Claim strength implications:
- If the active salt has multiple known pharmaceutically acceptable salt forms, Claim 1 typically anchors infringement to that specific salt identity (or any salts encompassed by the claim language).
- If manufacturing uses that salt but changes carrier systems, Claims 1-3 are still implicated; the tightest constraints sit in Claim 4.
How does the pH ~5.5 to ~6.5 limit affect design-around risk?
Claim 4 sets up a clear fork:
- In-range pH (5.5-6.5) + saline buffered carrier: higher risk of direct infringement for products matching Claim 4’s formulation structure.
- Outside range or non-saline buffering: potential to avoid Claim 4 while still risking Claims 1-3 and method-of-use claims 5-28 (depending on the product’s carrier presence and the therapeutic claim being asserted).
Because Claims 5-28 are method-of-use, a challenger cannot rely solely on formulation differences if the same therapeutic use and topical administration are at issue.
Which therapeutic areas are covered: glaucoma, AMD, diabetic macular edema, dry eye, and ocular hypertension?
Method-of-use claim set (Claims 5-28):
- Claims 5-10: Method using the salt (Claim 1) for eye diseases.
- Claims 11-16: Method using the composition (Claim 2).
- Claims 17-22: Method using the pharmaceutical composition (Claim 3).
- Claims 23-28: Method using the pH-buffered pharmaceutical composition (Claim 4).
Each block repeats the same disease and administration limitations, with the main difference being the “administered subject” component:
- Eye diseases (the same across the blocks):
- Glaucoma (Claims 6/12/18/24)
- Wet AMD, dry AMD, or diabetic macular edema (Claims 7/13/19/25)
- Dry eye (Claims 8/14/20/26)
- Ocular hypertension (Claims 9/15/21/27)
- Route: “topical administration to an eye” (Claims 10/16/22/28)
Scope breadth note:
- The therapeutic list is broad across major ophthalmic disease categories. This increases the number of plausible FDA label alignments and off-label prescribing contexts.
- The claims are not limited by dosage amount, regimen duration, frequency, or specific patient subpopulation in your excerpt. That broadens both infringement surface area and potential invalidity arguments (if the underlying specification does not support all listed indications).
Is the method-of-use scope limited to topical administration only?
Yes in the excerpt: every method claim includes topical administration to an eye. A product using systemic administration would not fit these claims as written, but for ophthalmics most competitors will be topical anyway.
How many ways can a competitor infringe US 10,654,844: salt vs formulation vs method-of-use?
Three infringement “layers” in the claim text:
- Salt-level (Claim 1)
- Composition/formulation-level (Claims 2-4)
- Method-of-use (Claims 5-28)
Total method claims: 24 distinct method claims (5-28, exclusive by disease and route variants), though they are structurally repetitive.
- Practical result: even if a competitor argues non-infringement for the formulation claims (carrier/pH differences), the method-of-use pathway can remain.
What is the likely claim construction outcome for key terms: “pharmaceutically acceptable salt,” “pharmaceutically acceptable carrier,” and “saline buffered to pH 5.5 to 6.5”?
Likely construction themes (driven by claim language):
- “Pharmaceutically acceptable salt”: typically construed to cover salts that are tolerated in the pharmaceutical context and meet functional acceptability criteria. If the patent specification ties to specific counterions or an explicit salt identity, that constrains scope more than generic salt “acceptability.”
- “Pharmaceutically acceptable carrier”: broad and typically includes excipients/excipients blends compatible with topical ocular use.
- “Saline buffered to a pH of about 5.5 to about 6.5”: this is a measurable formulation limitation. In litigation, typical focus is on:
- what buffer species is present,
- whether it is “saline buffered,”
- pH measurement methodology (as-supplied vs equilibrium after mixing, acceptable measurement range for “about”).
Commercial implication:
- A competitor trying to avoid Claim 4 must focus on both buffer type (“saline buffered”) and pH.
How does US 10,654,844 compare with typical ophthalmic patent estates: formulation + method-of-use bundling?
US 10,654,844 has the classic bundled structure:
- Salt/composition claims (often used to anchor generic product risk even when excipients differ)
- Formulation claim with a tight pH window
- Multiple method-of-use claims spanning major ophthalmic indications and requiring topical administration
In most ophthalmic patent estates, method-of-use claims are the leverage point against “carve-outs” from formulation differences, while pH/buffer claims are used to narrow the formulation match for a specific approved product.
What patent landscape should be expected around a salt-based ophthalmic patent like US 10,654,844?
Given only the excerpted claims and no salt identity, the landscape can only be mapped by claim-type clusters and typical prosecution patterns:
A. Salt and crystalline/form solid claims (upstream/adjacent)
Typical families include:
- salt formation and selection claims
- polymorph/crystal form claims
- solvates/hydrates claims
- amorphous composition claims
If US 10,654,844 is itself salt-centric, it likely sits near or after salt discovery and may be built to cover formulation-ready salt forms.
B. Vehicle/carrier and pH-buffering claims (formulation/downstream)
- buffered saline claims with specific pH windows are commonly used to differentiate from earlier generic or competitor formulations
- viscosity system, tonicity agents, stabilizers, surfactants, preservatives, and osmolarity are often claimed in related continuations, even if not present in your excerpt
Claim 4 indicates that buffer chemistry and pH are a key differentiator in this estate.
C. Method-of-use and indication-expansion claims
- Repetitive method claim blocks across multiple ophthalmic indications often reflect either:
- a single broad mechanistic therapy statement that spans indications, or
- continuation filings as clinical evidence expanded
Because your claim list includes five major disease buckets, it suggests a strategy to reach any potential label or litigation theory matching topical ophthalmic administration.
When does US 10,654,844 expire?
No expiration date can be computed from the claim text provided. The patent expiry depends on:
- the filing date and claimed priority,
- potential PTA (patent term adjustment),
- continuation or divisional filing history.
No reliable expiry computation is possible from the excerpt alone.
What would Orange Book status be for US 10,654,844?
No Orange Book entry can be identified from the excerpt alone. Orange Book listings depend on:
- the approved NDA or ANDA product,
- the specific drug (active ingredient/salt form) and dosage form,
- which patents are listed for that product and NDA.
No reliable Orange Book mapping is possible without the drug identity and/or the Orange Book record.
What Paragraph IV or biosimilar risks exist for a salt-based ophthalmic patent?
A precise risk assessment requires knowing:
- whether the salt corresponds to a small-molecule ophthalmic drug or a biologic (the excerpt does not indicate),
- whether any ANDAs exist and which patents are asserted.
However, structurally, US 10,654,844 is well positioned to be listed and asserted because:
- it has independent formulation claims (Claims 1-4), and
- it has multiple method-of-use claims (Claims 5-28), which can be asserted under FDA patent listing and infringement theories tied to labeled indications.
What generic entry risks exist: do pH-buffer and method-of-use create different barriers?
Scenario mapping (based only on claim text):
- A generic that uses the same salt and targets the same labeled indications risks direct infringement via:
- Claim 1 (salt use in product manufacturing if product contains the salt),
- Claims 2-3 (composition and carrier presence),
- Claims 5-28 (topical administration for the listed disease categories).
- Even if the generic changes carrier or buffer formulation:
- Claim 4 may be avoided if pH is not in the 5.5-6.5 saline-buffer band,
- but the generic may still face infringement exposure under Claims 1-3 and the method-of-use claims.
Claim scope summary table
| Claim |
Type |
Limitation focus |
Main infringement hook |
| 1 |
Product (salt) |
“pharmaceutically acceptable salt” |
Same salt identity present in competitor product |
| 2 |
Product (composition) |
composition comprising Claim 1 salt |
Product contains the salt as a composition |
| 3 |
Product (formulation) |
salt + pharmaceutically acceptable carrier |
Carrier differences may not avoid claims |
| 4 |
Product (formulation) |
saline buffered to pH ~5.5 to ~6.5 |
Design-around via buffer system and pH |
| 5-10 |
Method-of-use |
administering effective amount of Claim 1 salt; topical |
Use for glaucoma/AMD/ DME/dry eye/ocular hypertension |
| 11-16 |
Method-of-use |
administering composition of Claim 2 |
Same disease and route coverage |
| 17-22 |
Method-of-use |
administering pharmaceutical composition of Claim 3 |
Same disease and route coverage |
| 23-28 |
Method-of-use |
administering pH-buffered composition of Claim 4 |
Highest formulation-specific method risk |
Key Takeaways
- US 10,654,844 targets an ophthalmic salt and expands protection into composition, formulation, and topical method-of-use.
- The tightest formulation limitation is the saline-buffered pH window (~5.5 to ~6.5) in Claim 4, creating a clear design-around pathway only for that specific formulation element.
- The repeated method-of-use claims (Claims 5-28) cover broad indication categories: glaucoma, wet/dry AMD, diabetic macular edema, dry eye, and ocular hypertension, with topical administration, preserving infringement exposure even when carrier/pH varies.
- Without the drug identity, Orange Book listing, and prosecution history, expiry, competitor-specific litigation posture, and jurisdictional scope cannot be deterministically mapped from the excerpt alone.
FAQs
1) What’s the difference between Claim 1 and Claim 4 in US 10,654,844?
Claim 1 protects the specific pharmaceutically acceptable salt; Claim 4 protects a formulation where that salt is in a saline-buffered carrier with pH about 5.5 to about 6.5.
2) Can a competitor avoid US 10,654,844 by changing the buffer pH?
Changing pH outside ~5.5 to ~6.5 may avoid Claim 4, but it does not eliminate exposure under Claims 1-3 and the method-of-use claims if the salt and topical disease-use coverage remain.
3) Are all indications in US 10,654,844 claimed as topical treatment?
Yes. Every method claim in the excerpt includes “topical administration to an eye.”
4) Which claims are most formulation-specific and therefore most vulnerable to design-around?
Claim 4 is the most formulation-specific due to the explicit saline-buffered pH range.
5) Does US 10,654,844 cover both composition and methods?
Yes. The patent covers product salt/composition/formulation (Claims 1-4) and repeated method-of-use treatments (Claims 5-28) for multiple ophthalmic diseases.
References
- United States Patent 10,654,844. Claims provided in user prompt.
