Patent 11,975,047 Scope and US Patent Landscape for Sterile Corticotropin Storage-and-Warming in Cross-Linked Silicone Rubber Multiple-Dose Vials
US Patent 11,975,047 claims a tightly bounded method of storing and warming a sterile corticotropin composition using a multiple-dose vial with a cross-linked silicone-coated rubber stopper, with specific concentration, temperature ranges, and multiple optional constraints on formulation composition and physical stability. The core enforceable concept is the combination of (1) sterile corticotropin composition with 80 USP units/mL, (2) storage at 2°–8°C and warming to 18°–26°C, and (3) container/stopper surface treatment (cross-linked silicones; coatings with silicone oils of differing molecular weights including PDMS). Downstream claim coverage adds constraints tied to gel-to-liquid behavior, rolling warmth method, preservative/vehicle system (gelatin, phenol; acidified WFI), particle limits, and acceptance constraints on vasopressin impurity relative to corticotropin.
What does US Patent 11,975,047 claim for storing and warming sterile corticotropin compositions in the US?
Core claim theme (independent claim 1; dependent claim 22 is a formulation-variant independent structure). The patent is written as a process claim focused on what happens to a specific sterile corticotropin composition in a specific multiple-dose vial system. It is not a claim to corticotropin itself as a chemical entity, but to handling conditions that affect readiness for injection.
Independent claim 1: claim 1 elements mapped
Claim 1 requires all of the following in combination:
- Composition: a “sterile corticotropin composition” having:
- Corticotropin composition defined as comprising amino acids 1–39 of SEQ ID NO: 1, or
- The sterile composition has not more than 0.05 USP Vasopressin Units / USP Corticotropin Units.
- Vial type: a multiple-dose vial that comprises:
- a rubber stopper coated with cross-linked silicones.
- the vial is associated with a corticotropin concentration of 80 USP units/mL.
- Storage condition: storing at 2° to 8° C.
- Warming condition: warming to 18° to 26° C.
Claim 1 therefore ties together (i) dose strength and impurity or sequence definition, (ii) cold-chain storage temperature range, (iii) specific warm-up range, and (iv) silicone-modified container/stopper surface.
Independent claim 22: claim 22 elements mapped
Claim 22 reads as a second independent method in which the warm-up is the same, but the vehicle detail is narrower:
- Composition concentration: 80 USP units/mL.
- Container/stopper: rubber stopper coated with cross-linked silicones.
- Storage: 2°–8°C.
- Warming: 18°–26°C.
- Formulation requirement: the sterile corticotropin composition comprises acidified WFI with pH 2.8 to 3.2.
So claim 22 locks in the acidified WFI pH window as the formulation-defining feature.
What is the scope of the stopper and silicone coating limitations in 11,975,047?
The strongest “container” hooks are the stopper coating limitations.
Cross-linked silicone coating and PDMS-style material scope
- Claim 1 requires a rubber stopper coated with cross-linked silicones.
- Claim 8 specifies the coating includes silicone oils of different molecular weights including polydimethylsiloxane.
- Claim 24 allows a stopper comprising a coating with silicone oils of different molecular weights (without necessarily naming PDMS in that dependent clause).
Practical litigation implication: infringement risk concentrates on whether the accused vial uses:
- rubber stoppers (vs. alternative elastomers),
- a silicone oil coating that is cross-linked (vs. non-cross-linked silicone),
- and, in broader dependent variations, whether silicone oils are multi-molecular-weight and may include PDMS.
Other vial-structure dependent limitations
Claims narrow further to:
- 5 mL multiple-dose vial (claim 9).
- a removable cap covering the stopper (claim 10).
- an aluminum seal (claim 11).
- borosilicate glass (claim 12).
These are dependent add-ons: they increase factual specificity for an accused product design but do not reduce the baseline independent requirement on the cross-linked silicone rubber stopper.
What temperature ranges and handling steps are protected in 11,975,047?
Temperature windows
- Storage: 2°–8°C (claims 1 and 22).
- Warming: 18°–26°C (claims 1 and 22).
These are classic label-like temperature windows but here are part of the method-of-use handling claim.
Warming technique limitation
- Claim 3 adds: step b) includes rolling the vial between two hands for at least two minutes.
That means a competitor using the same vial and formula but warming by other means could avoid claim 3 while still potentially implicating claim 1/22 if warming occurs within 18°–26°C.
What formulation compositional limits are included in 11,975,047 (gelatin, phenol, pH, WFI, preservative status)?
Claim 1 is permissive on some formulation aspects (it is framed around the corticotropin identity/impurity constraint plus vial and temperature handling), but the dependent claims add multiple formulation constraints that can become important for narrow design-around and non-infringement.
Gelatin and phenol concentration and functional requirements
- Claim 4: composition further comprises 0.5% w/w phenol and 15% w/w gelatin, plus water, HCl, and NaOH.
- Claim 13–14: gelatin at 10–20% w/w (claim 13) or about 15% w/w (claim 14).
- Claim 15–16: phenol at 0.1–1% w/w (claim 15) or about 0.5% w/w (claim 16).
- Claim 21: gelatin is pyrogen-free.
- Claim 23 and 18–19 specify combinations:
- claim 18: WFI + gelatin + phenol
- claim 19: WFI + 15% gelatin + 0.5% phenol
- Claim 5: pH 3.0–7.0 (broad pH window).
- Claim 22: acidified WFI with pH 2.8–3.2 (narrow pH window tied to an independent claim).
Preservative and antimicrobial status
- Claim 27: composition is preservative-free, antimicrobial-free, or both.
Acetic acid exclusion
- Claim 26: composition is free of acetic acid.
Net scope effect: The patent covers multiple formulation regimes depending on the dependent claim invoked. Claim 22 is the most stringent on pH and WFI acidification.
What corticotropin identity and impurity constraints are protected (sequence vs vasopressin ratio)?
Two alternative definitional constraints are offered in claim 1:
- Sequence/segment constraint: corticotropin comprises amino acids 1–39 of SEQ ID NO: 1 (claims 1 and 6).
- Impurity/ratio constraint: sterile composition has ≤ 0.05 USP Vasopressin Units per USP Corticotropin Units (claims 1 and 20).
Scope consequence: A formulation can fall within claim 1 either by meeting the sequence-based definition or by meeting the impurity ratio. A competitor can attempt to avoid by:
- using corticotropin with a different sequence/definition, or
- increasing vasopressin units relative to corticotropin beyond the limit (not always feasible from a quality perspective).
What physical property, particle, and gel-to-liquid behavior claims expand coverage?
Gel state switch at specified temperatures
- Claim 2 adds physical-property limitation: at 2°–8°C the composition is a solid gel, and at 18°–26°C it is a liquid gel.
This limitation is material for infringement because a formulation that does not undergo the described state transition may fall outside claim 2 even if it meets claim 1.
Particle limits
- Claim 25: less than 6000 particles ≥10 µm and/or less than 600 particles ≥25 µm.
This is another narrow design point, likely measured by a particle size distribution assay.
How broad is infringement exposure: what combination of claims likely maps to a real product?
This patent is best read as a product-handling + container surface protection suite. For a product to infringe the independent claims, the accused system must match:
- Corticotropin strength: 80 USP units/mL
- Storage and warming: 2°–8°C then 18°–26°C
- Vial: multiple-dose vial with rubber stopper coated with cross-linked silicones
- Corticotropin identity/impurity: either amino acids 1–39 of SEQ ID NO: 1 or vasopressin ratio ≤ 0.05
From there, infringement probability for additional features rises if the competitor also includes one or more dependent features:
- gelatin and phenol amounts,
- pH windows,
- acidified WFI,
- rolling warming method,
- particle limits,
- acetic-acid-free,
- preservative-free/antimicrobial-free,
- specific vial geometry (5 mL), and secondary packaging (aluminum seal).
What does the patent landscape for US corticotropin formulation storage/warming likely look like around this claim theme?
Given only the claim text for US 11,975,047, a complete landscape must be limited to what can be concluded from the claim architecture: this patent is concentrated in container/stopper surface engineering plus temperature-handling for a sterile corticotropin composition. That positions it at the intersection of:
- device-like process patents (handling instructions),
- container-closure system patents (stopper coating characteristics, silicone cross-linking),
- and formulation-quality patents (pH windows, gelatin/phenol ranges, impurity ratio, particles).
A realistic portfolio around it typically clusters into:
- Formulation patents: gelatin/phenol systems, pH adjustments (including acidified WFI), impurity controls, particle specs.
- Container/closure patents: silicone coatings on rubber stoppers, cross-linking, multi-MW silicone oil mixtures, PDMS inclusion.
- Method-of-use/handling patents: storage and warm-up ranges, and specific warming actions like manual rolling.
- Stability and usability patents: gel state transitions across temperature windows and acceptability after handling.
However, the numbered patent landscape cannot be enumerated from the provided input alone because no application/publication numbers, assignee, priority, family members, or expiration data were supplied for 11,975,047, and no citations to related documents are provided. Under the constraints here, any attempt to list competitor patents would be speculative.
How many claim “design-around levers” exist in 11,975,047?
The patent includes multiple independent “levers” that each can be used to craft a non-infringing product profile.
Levers tied to independent claim coverage
- Stopper coating: remove or change the “cross-linked silicones” feature or use a non-matching silicone system.
- Temperature handling: if warming does not target 18°–26°C after cold storage, claim 1/22 may not be met.
- Concentration: if the product is not 80 USP units/mL, independent claims are not met.
- Corticotropin definition: if the corticotropin does not comprise amino acids 1–39 of SEQ ID NO:1, but also fails the vasopressin ratio constraint, it can fall outside claim 1.
- WFI acidification pH window: for claim 22 specifically, avoid pH 2.8–3.2 acidified WFI.
Levers tied to dependent claim coverage
- gelatin and phenol ranges (10–20% gelatin; ~15%; 0.1–1% phenol; ~0.5%),
- gelatin pyrogen-free status,
- preservative-free/antimicrobial-free designation,
- acetic-acid-free status,
- particle count limits,
- gel state transitions (solid gel at 2–8°C; liquid gel at 18–26°C),
- rolling method duration (≥2 minutes),
- and narrower vial hardware (5 mL; aluminum seal; borosilicate glass).
What is the likely commercial relevance: which patents in this set would matter for launch strategy and regulatory submissions?
The independent claims are written to match the real-world “instructions for use” and “container-closure” facts that are present in:
- product labeling/handling instructions,
- manufacturing fill-finish decisions (stopper coating),
- and quality specifications (particle counts, impurity ratio, pH/acidified WFI).
For a generic or authorized product that uses the same vial system, dose strength, and temperature handling, the patent gives an enforcement hook even if the active ingredient is the same and the formulation is close.
Key Takeaways
- US 11,975,047 protects a sterile corticotropin handling method tied to 80 USP units/mL, storage at 2°–8°C, and warming to 18°–26°C.
- The most central technical lock is the multiple-dose vial rubber stopper coated with cross-linked silicones.
- Claim 1 requires corticotropin to be defined by SEQ ID NO: 1 amino acids 1–39 or by a vasopressin impurity ratio ≤ 0.05.
- Claim 22 narrows to acidified WFI at pH 2.8–3.2 as a formulation-defining feature.
- Dependent claims add coverage for gel-to-liquid behavior, rolling warmth (≥2 minutes), gelatin/phenol composition, particle limits, pH ranges, and vial construction attributes.
FAQs
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If a generic corticotropin uses a silicone-coated stopper that is not cross-linked, does it avoid US 11,975,047?
The independent claims require “rubber stopper coated with cross-linked silicones,” so the cross-linking feature is a direct infringement boundary.
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Does US 11,975,047 cover storage-warming only when rolling is performed?
No. Rolling is only required for claim 3. Claim 1/22 only require warming to 18°–26°C.
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Is claim 22 limited to compositions with acidified WFI at pH 2.8–3.2?
Yes. Claim 22’s independent structure requires acidified WFI with pH 2.8–3.2.
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Can the vasopressin ratio limit substitute for the SEQ ID NO: 1 amino-acid definition?
Yes. Claim 1 provides an “or” framework: either the sequence requirement or the vasopressin ratio limit can satisfy the corticotropin definition.
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What formulation specs could be most important for knock-out non-infringement positions?
For dependent claims: particle limits, gel state behavior, pH windows, gelatin and phenol ranges, and acetic-acid-free status; for independent claims: dose strength (80 USP units/mL), temperature ranges, and cross-linked silicone stopper coating.
References
- United States Patent 11,975,047. Claims as provided in user prompt.
