Scope, Claims, and US Patent Landscape for US Drug Patent 11,939,361
US Patent 11,939,361 claims a pharmaceutical composition and a method of treating inflammatory disease using a specific peptide defined by SEQ ID NO: 1, including pharmaceutically acceptable salts/solvates and, in narrower embodiments, an acetate salt in amorphous form. The independent claim coverage is composition-centric (dose range plus excipient-containing formulations), with downstream method claims tied to treating inflammatory disease by administering a therapeutically effective amount.
What exactly is claimed? (Claim scope map)
A. Core composition claims (SEQ ID NO: 1 peptide + excipients)
Claim 1 (core independent composition claim):
- A pharmaceutical composition comprising:
- a peptide of SEQ ID NO: 1 or pharmaceutically acceptable salt/solvate
- in an amount of ~0.1% to ~15% (w/w) of the composition
- plus one or more pharmaceutically acceptable excipients
Claim 11 (second independent composition claim):
- Same concept, with a higher peptide loading:
- SEQ ID NO: 1 peptide or salt/solvate in ~0.1% to ~20% (w/w)
- plus one or more pharmaceutically acceptable excipients
Practical scope impact
- The claim architecture captures a broad formulation space via:
- concentration bands (two separate maxima: 15% vs 20%)
- any “pharmaceutically acceptable excipients” (open-ended category)
- salts/solvates without requiring a specific salt in claims 1 and 11 (unless dependent claims specify)
B. Salt form and solid-state narrowing
Claim 2:
- Adds that the peptide has a specified chemical structure (as written in the patent, not reproduced in the prompt)
- and is a pharmaceutically acceptable salt form
Claim 3:
- Specifies the salt form as an acetate form
Claim 4:
- Further specifies the acetate is in an amorphous form
Practical scope impact
- The dependent claim chain creates two infringement “tiers”:
- Tier 1 (broader): any pharmaceutically acceptable salt/solvate (claims 1 and 11, plus claim 2 as a narrowing definition)
- Tier 2 (narrower but actionable): acetate salt (claim 3) and especially amorphous acetate (claim 4)
In product development terms, acetate identity and amorphous solid-state become the key differentiators for freedom-to-operate around the dependent claims.
C. Dose-range coverage in w/w and mg terms
Independent claims are in % w/w; dependent claims introduce absolute dose ranges stated as mg of the peptide.
Claim 5:
- amount of peptide (or salt/solvate) from ~1 mg to ~1000 mg
Claim 6:
Claim 7:
Claim 13:
- ~1 mg to ~1000 mg (mirrors claim 5 under claim 11 framework)
Claim 14:
Claim 15:
- ~10 mg to ~300 mg (mirrors claim 6)
Practical scope impact
- The mg claims expand enforcement beyond concentration alone, which matters if commercial units present fixed-dose strengths.
- The overlapping ranges suggest the patent is drafted to cover multiple dose levels and potential clinical titration patterns.
D. Absorption enhancer embodiments
Claim 8:
- composition further comprises an absorption enhancer
Claim 9:
- locks in the absorption enhancer and loadings:
- peptide of SEQ ID NO: 1 or salt/solvate: ~0.1% to ~15% (w/w)
- absorption enhancer: ~10% to ~60% (w/w)
- plus excipients
Practical scope impact
- This is a second formulation branch that targets delivery enhancement.
- Any accused product using:
- peptide (or acetate/amorphous variants, if also present)
- at those peptide loadings
- with a qualifying absorption enhancer at 10% to 60% (w/w)
- plus excipients
can be pulled under claim 9.
E. Method of use: treating inflammatory disease
Claim 10:
- method of treating an inflammatory disease in a subject:
- administering a therapeutically effective amount of the composition of claim 1
Claim 16:
- same method format:
- administering a therapeutically effective amount of the composition of claim 11
Practical scope impact
- The method claims are tethered to the composition claim boundaries. They do not introduce a separate administration route, dosing frequency, or clinical biomarker requirement in the text provided. That pushes route flexibility to the accused product (unless further restricted in the full patent text).
How broad are these claims in practice? (Coverage bands and “design-around” pressure points)
1) Peptide identity bottleneck
- The claims all require the peptide of SEQ ID NO: 1 or its pharmaceutically acceptable salt/solvate.
- That is the primary identity constraint. A competitor can only avoid infringement by changing the active (different peptide sequence/identity) or avoiding equivalence under claim construction for “salt/solvate,” depending on how the patent defines SEQ ID NO: 1 and its structural formula in full text.
2) Concentration bands are moderately wide
- Claim 1: 0.1% to 15% w/w
- Claim 11: 0.1% to 20% w/w
This creates coverage for both low and mid peptide load formulations, including typical pharmaceutical normalization approaches (where excipient mass dominates).
3) Salt and amorphous state are explicit for dependent claims
- Claim 3: acetate form
- Claim 4: acetate in amorphous form
A likely design-around approach would be:
- use a different salt (not acetate), and/or
- use a crystalline form instead of amorphous, if the patent’s scope for “amorphous” is not met.
However, the independent claims already cover “pharmaceutically acceptable salt or solvate forms” broadly. So even if acetate is avoided, dependent claims 3 and 4 may fall away, but independent coverage may remain if the competitor still uses a pharmaceutically acceptable salt/solvate of SEQ ID NO: 1 and lands within the % w/w ranges.
4) Absorption enhancer branch increases formulation-specific risk
- Claim 9 sets absorption enhancer at 10% to 60% w/w.
- If a competitor uses absorption enhancers outside that band (or not at all), they may avoid claim 9 even if they still fall within the general composition claims.
5) Method claims create use-case exposure
- “Inflammatory disease” is broad in wording. Without in-patent qualifiers in the provided text, the method claims read as potentially covering multiple inflammatory indications.
- In practice, accused infringement hinges on evidence of administration for an inflammatory indication, plus proof the administered product satisfies the composition elements.
Where does the patent sit in the landscape? (What the claim structure implies about prior art and follow-on risk)
A. Likely claim-generation strategy
The combination of:
- SEQ ID NO-defined peptide identity
- broad excipient language
- wide % w/w loading
- multiple dependent mg ranges
- salt/solid-state specialization (acetate, amorphous)
- absorption enhancer concentration band
is typical of a patent that is designed to:
- secure baseline protection for commercial formulations,
- capture typical salt selection strategies, and
- cover common formulation modalities (including enhancers) that might be used to achieve oral or otherwise constrained delivery.
B. Enforcement posture likely centers on formulation and crystalline form
Given explicit dependency to:
- acetate
- amorphous acetate
- enhancer loading
enforcement is likely strongest where:
- the product uses an acetate salt and amorphous solid-state, and/or
- the formulation uses a high fraction of absorption enhancer (10% to 60% w/w).
If a competitor instead uses a different salt (non-acetate), they still may face infringement under claims 1/11 unless their salt/solvate choice and peptide loading fall outside the w/w ranges.
C. Follow-on development risk
Because:
- independent claims broadly cover any pharmaceutically acceptable salt/solvate,
- dependent claims refine common variations,
the risk of “versioning” (new salt, new amorphous form, new enhancer) is mixed:
- some design changes can avoid the dependent claims (3/4/9),
- but they may not avoid the independent claims.
Claim-by-claim breakdown for invalidity and design-around analysis (based on provided claim text only)
Claim 1
Elements
- pharmaceutical composition
- SEQ ID NO: 1 peptide or pharmaceutically acceptable salt/solvate
- 0.1% to 15% (w/w)
- excipients
Design-around levers
- move peptide outside 0.1-15% w/w (to avoid claim 1 but watch claim 11 up to 20%)
- change active identity (not SEQ ID NO: 1)
- use a non-salt/non-solvate form (unlikely for peptides if they can be formulated, but this depends on how “salt/solvate” is construed)
- avoid matching “pharmaceutical composition” depending on the product categorization (still generally hard to avoid)
Claim 2
Adds:
- specified chemical structure
- salt form
Design-around:
- if the structural definition is tightly limited (not fully visible in prompt), selecting a closely related peptide variant could avoid. But if SEQ ID NO: 1 is the same peptide, salt form still matters.
Claim 3
Design-around:
Claim 4
Design-around:
- use crystalline acetate, or different salt.
Claim 5 to 7
- mg ranges:
- 1-1000 mg (claim 5)
- 10-300 mg (claim 6)
- 25-150 mg (claim 7)
Design-around:
- shift tablet/sachet strength outside those mg targets, but this can be complex if multiple strengths are marketed.
Claim 8 to 9
- absorption enhancer present
- enhancer 10%-60% w/w (claim 9)
Design-around:
- reduce enhancer fraction below 10% w/w or remove enhancer.
Claim 10
Method tethered to claim 1 formulation.
Design-around:
- avoid marketing/labeling/clinical use for inflammatory disease (hard to do if indication is broad and evidence shows administration).
- or avoid claim 1 formulation elements.
Claim 11
Same as claim 1 but with:
Design-around:
- set peptide loading above 20% w/w or below 0.1% w/w (below 0.1% may be functionally difficult).
Claim 12
- structural definition and salt form.
Claim 13 to 15
- mg ranges:
- 1-1000 mg (claim 13)
- 10-500 mg (claim 14)
- 10-300 mg (claim 15)
Design-around:
- select strengths that do not land inside these ranges.
Claim 16
Method tethered to claim 11 formulation.
What is missing from the provided prompt and how it affects landscape analysis
The prompt does not include:
- the full official bibliographic data for US 11,939,361 (applicant/assignee, filing and priority dates, patent family members, granted claim numbering as in the official record)
- the actual peptide sequence corresponding to SEQ ID NO: 1
- the chemical structure text (claim 2/12 placeholders are not populated)
Without those items, a true prior-art and family landscape (similar patents, continuations, counterpart jurisdictions, and likely overlapping claim families) cannot be constructed accurately. The analysis above therefore stays strictly within the claim text provided.
Key Takeaways
- US 11,939,361 claims formulation compositions built around a SEQ ID NO: 1 peptide plus excipients, with peptide loading ranges of 0.1%-15% (w/w) (claim 1) and 0.1%-20% (w/w) (claim 11).
- Salt/solid-state dependent scope concentrates on acetate (claim 3) and amorphous acetate (claim 4).
- The absorption-enhancer pathway is narrow to enhancer loadings of 10%-60% (w/w) (claim 9), but independent claims cover formulations without requiring an enhancer.
- The method claims (claims 10 and 16) are straightforward: treat inflammatory disease by administering a therapeutically effective amount of the claimed compositions.
- The primary design-around levers are: peptide identity (not SEQ ID NO: 1), peptide loading outside the w/w bands, and avoiding the specific salt/solid-state and enhancer parameters that appear in dependent claims.
FAQs
1) Does the patent require a specific administration route?
Not in the provided claim text. The method claims require administering a therapeutically effective amount of the claimed composition.
2) What is the difference between claim 1 and claim 11?
Claim 1 covers 0.1%-15% (w/w) peptide (or salt/solvate). Claim 11 covers 0.1%-20% (w/w).
3) Are acetate and amorphous acetate mandatory for infringement?
No. Acetate/amorphous are covered in dependent claims (3 and 4). Independent claims cover “pharmaceutically acceptable salt or solvate” more broadly.
4) How does claim 9 narrow the formulation scope?
It requires an absorption enhancer present at 10%-60% (w/w), alongside peptide at 0.1%-15% (w/w).
5) What are the key product parameters most likely to trigger infringement?
Peptide identity (SEQ ID NO: 1), peptide concentration within 0.1%-15% or 0.1%-20% (w/w), and in specific embodiments, acetate/amorphous state and high absorption enhancer loading.
References
[1] US Patent 11,939,361 (claim text as provided in the prompt).
