Details for Patent: 8,491,524

Summary for Patent: 8,491,524

Title:	Needleless injector drug capsule and a method for filling thereof
Abstract:	A method for tilling needleless injector capsules with liquid drug, whereby dissolved gas within the drug is replaced by a less soluble gas in order to reduce the inclusion of gas bubbles, or to prevent the growth of bubbles during storage and thereby prevent breakage of the capsules.
Inventor(s):	William Henry, Andrew Lewis
Assignee:	Aradigm Corp , Zogenix Inc
Application Number:	US13/495,390
Patent Claim Types: see list of patent claims	Formulation; Compound; Dosage form;

Patent 8,491,524 (US) Scope & Claims Map for Needle-Free Injector Drug Capsules Using Ion-Exchange Strengthened Glass and Inert-Gas Purged Liquid Formulations

US Drug Patent 8,491,524 covers needle-free injector “drug capsule” systems where (i) the drug is contained in an ion-exchange strengthened glass container (with borosilicate glass called out), and (ii) the liquid formulation is purged with an inert gas in a manner that prevents gas coming out of solution across a 0°C to 30°C storage range, with dependent claims narrowing inert gas species (including helium/non-helium). The claim set is tightly centered on the container material/process feature and the inert-gas solubility/temperature-stability feature rather than the injector mechanics.

What patents protect needle-free injector drug capsule systems with ion-exchange glass and inert-gas purging in the US?

Direct coverage in US 8,491,524 is limited to capsule-like containers and formulation handling features: ion-exchange strengthened glass (borosilicate strengthened with ion exchange in independent claims), and a liquid drug formulation purged by an inert gas such that inert gas does not come out of solution during storage/temperature cycling from 0°C to 30°C.

How broad are the independent claim concepts?

US 8,491,524 has at least two independent claim groupings as provided in the claim text you supplied:

• Claim 1: Needle-free injector drug capsule with:
  • Container: borosilicate glass strengthened with ion exchange
  • Drug liquid formulation in container
  • Liquid purged by an inert gas
  • Inert gas solubility specified as 0.5 cm³ to 25 cm³ per 100 cm³ of liquid
  • Condition: gas does not come out of solution during storage across 0°C to 30°C
• Claim 5: Similar capsule but less specific on the inert-gas solubility numeric range and borosilicate callout; still requires:
  • Container: glass strengthened with ion exchange
  • Purged liquid formulation by inert gas soluble in liquid formulation
  • Condition: inert gas solubility such that no gas comes out during temperature cycling (0°C to 30°C)

Practical reading: the enforceable “center of gravity” is (a) ion-exchanged glass container and (b) inert-gas solubility/temperature behavior requirement for the purged liquid drug.

What are the specific claim elements and how do they break down into enforceable limitations?

US 8,491,524 can be reduced into a “claim element matrix” for FTO, licensing, and design-around planning.

Claim 1 element map

1. Product form: “needle free injector drug capsule”
2. Container: borosilicate glass strengthened with ion exchange
3. Liquid formulation: drug in the container
4. Inert gas purging: formulation purged by an inert gas
5. Quantified solubility: inert gas solubility 0.5 cm³ to 25 cm³ per 100 cm³ of formulation
6. Temperature stability condition: gas does not come out of solution during storage over 0°C to 30°C

Enforcement leverage: a claimant can aim to prove the accused system has both (i) ion-exchange strengthened borosilicate glass and (ii) a specific inert-gas solubility behavior that maintains dissolved gas across the defined temperature window.

Claim 5 element map

1. Needle-free injector drug capsule
2. Glass strengthened with ion exchange
3. Liquid formulation includes drug
4. Purged by inert gas soluble in liquid formulation
5. Inert gas solubility is such that gas does not come out during temperature cycling 0°C to 30°C

Key difference vs Claim 1: Claim 5 removes (at least as provided) the explicit numeric solubility range “0.5–25 cm³ per 100 cm³” and keeps the “does not come out of solution” temperature performance requirement.

Dependent claims narrowing inert-gas identity

• Claim 2 / 7 / 13: inert gas selected from helium, argon, neon, krypton, xenon, nitrogen, and certain halogenated/fluorinated gases (chlorofluorocarbons and hydrofluorocarbons), including mixtures
• Claim 3: inert gas excludes helium
• Claim 4 / 8 / 14: inert gas is helium
• Claim 6 / 9 / 12 / 15: temperature cycling language and borosilicate glass restatement tied to the solubility behavior condition

Enforcement leverage: claim subsets create distinct “identity hooks” for different inert gases. If an accused formulation uses a non-helium inert gas, the helium-specific dependents become irrelevant, but broad dependents (2/7/13) still cover if the gas falls within the listed group.

How do Claims 1–15 differentiate coverage between solubility range, temperature cycling, and container glass?

1) Container limitation: borosilicate vs generic ion-exchange glass

• Bor osilicate explicitly + ion exchange: Claim 1, Claim 9 (and by incorporation Claim 15)
• Ion-exchange glass generally (not borosilicate required): Claim 5 and downstream dependents

Design-around implication: Switching away from borosilicate while keeping ion-exchanged glass may still fall under Claim 5, depending on how the “glass strengthened with ion exchange” is characterized in the accused product.

2) Solubility quantification: numeric window vs functional condition

• Numeric inert-gas solubility range appears in Claim 1 (0.5 to 25 cm³ per 100 cm³).
• Functional temperature cycling condition appears in Claim 1 and Claim 5 group.

Design-around implication: A formulation developer may try to avoid the exact numeric range while still achieving no gas comes out of solution, or vice versa. Claim strategy can pull either (or both) types of limitations into the infringement argument depending on which claim is asserted.

3) Temperature: storage vs temperature cycling

• Claim 1: “storage over a range of temperatures of 0°C to 30°C.”
• Claims 6/9/12/15: “does not come out of solution during temperature cycling.”

Practical litigation implication: temperature cycling language may be used to argue robustness across repeated thermal stress cycles, but both claim groupings still anchor on 0°C to 30°C.

What is the claim strength around inert gas selection (helium vs non-helium)?

Helium coverage

• Explicit helium dependent claims are present: Claim 4, Claim 8, Claim 14.

If accused uses helium: helium-specific dependents provide a narrower path for infringement, but broader claims (Claim 1/5 and 2/7/13) still apply if helium is within the inert gas group and meets the solubility/temperature requirements.

Non-helium coverage

• Claim 3 excludes helium.
• Claims 2/7/13 include helium among the enumerated gases, so non-helium systems still can infringe Claims 1/2/5/7/13 when inert gas falls into the listed group and meets functional solubility/temp conditions.

What does US 8,491,524 likely exclude from its own scope?

Based on the provided claims alone, the patent’s scope does not automatically extend to:

• needle-free injector designs that do not use an ion-exchange strengthened glass container (borosilicate strengthened with ion exchange for Claim 1)
• liquid formulations that are not purged to achieve “gas does not come out of solution” behavior across the 0°C to 30°C window
• inert gas types not covered by the enumerated group in the dependent claims, although the independent claims as provided use “inert gas” more broadly (the dependents list specific gases)

How many patents cover the same needle-free injector glass and inert-gas purging theme?

No complete US patent family or citation set is provided in your prompt. A complete landscape (family members, continuation filings, related US publications, and NP/EP equivalents) cannot be constructed from the claims alone.

Orange Book status: is US 8,491,524 listed for any FDA-approved drug?

No Orange Book listing information is present in your prompt. Without the linked NDA/BLA/Reference Listed Drug, the Orange Book status cannot be determined here.

When does US 8,491,524 lose exclusivity?

Expiration date cannot be computed from the prompt because filing date, priority date, and term adjustments (if any) are not included. The claim text provided is insufficient to infer term.

What Paragraph IV or generic entry risks exist for products using ion-exchange glass capsules and inert-gas purging?

Risk assessment requires identifying the FDA-approved reference product and any Orange Book patents tied to it. The prompt provides only the US patent number and the provided claim text, not the FDA product linkage, listed claims, or relevant litigation history.

What patent litigation affects US 8,491,524?

No litigation docket, venue, asserted claims, or settlement terms are provided in the prompt. A litigation landscape cannot be produced from claim text alone.

Which generic or biosimilar programs would most likely implicate US 8,491,524?

Only products using the same combination of features are plausible:

• needle-free injector “drug capsule” systems
• ion-exchange strengthened glass container (borosilicate strengthened with ion exchange at least for Claim 1)
• liquid drug formulation purged with inert gas achieving the specified solubility/temperature behavior

But the identity of those products cannot be determined without linking the patent to specific NDAs/BLAs and marketed injector systems.

How strong is the patent estate for formulation-level protection in needle-free injectors?

On the merits of the claims you supplied, US 8,491,524 is formulation/container-process focused, which usually produces:

• Higher specificity via material and physical-property limitations (borosilicate ion-exchanged glass; inert gas solubility; no exsolution over 0°C to 30°C)
• Potentially narrower scope than broad “needle-free injector” mechanical claims, but stronger factual tethering to measurable formulation properties

Claim construction pressure points likely in litigation

1. What qualifies as “glass strengthened with ion exchange”?
2. How is “inert gas solubility” measured and reported (units and test method)?
3. What does “gas does not come out of solution during storage/temperature cycling” mean operationally
4. Whether the accused product meets the numeric solubility window in Claim 1 (0.5–25 cm³ per 100 cm³)

Which jurisdictions and claim strategies are most relevant to US 8,491,524?

Without the family and priority data, jurisdictional scope beyond the US cannot be determined from the prompt. The enforceability here is US-focused since the provided number is a US drug patent.

FTO and design-around checklist based on the provided claim limitations

High-value variables to change (each maps to an asserted limitation):

• Replace ion-exchange strengthened borosilicate glass (Claim 1) with a different glass treatment approach that does not meet “ion exchange strengthened” characterization.
• If using ion-exchanged glass, adjust formulation such that inert gas comes out of solution at some point within 0°C to 30°C, removing the “no gas exsolution” functional limitation (high risk to product stability/performance).
• Use an inert gas not within the dependent claim enumerations and ensure it fails to satisfy the functional solubility requirement.
• For designs targeted at avoiding Claim 1: ensure inert gas solubility is outside 0.5–25 cm³ per 100 cm³ while also managing the temperature-exsolution condition (still must avoid Claim 5’s functional requirement).

Key Takeaways

• US 8,491,524 covers needle-free injector “drug capsules” where the container is ion-exchange strengthened glass (borosilicate required in Claim 1) and the drug liquid is purged with inert gas engineered so dissolved gas does not exsolve across 0°C to 30°C.
• Claim 1 adds a specific solubility numeric range (0.5 to 25 cm³ per 100 cm³) plus the 0°C–30°C “no come out” condition.
• Dependent claims narrow inert gas identity to listed gases, including explicit coverage for helium and an exclusion path for non-helium via a helium-excluding dependent claim.
• Strength is driven by measurable formulation/physical property limits (solubility and temperature behavior) and the container’s ion-exchange glass treatment.
• A full US patent landscape, Orange Book status, exclusivity timelines, generic entry risk, and litigation mapping cannot be derived from the prompt because the FDA product linkage, family members, and docket data are not included.

FAQs

1. What happens if a needle-free injector capsule uses ion-exchanged glass but the inert gas is not purged?
   It fails the “liquid formulation has been purged by an inert gas” limitation.

2. If the inert gas causes exsolution outside 0°C to 30°C but not inside that range, does it avoid infringement?
   The claim language anchors to the specified range, but “storage over a range of temperatures of 0°C to 30°C” and “temperature cycling” ties the functional limitation to that interval.

3. Does using helium automatically guarantee infringement of US 8,491,524?
   No. Helium identity alone is not sufficient; the claims also require the inert gas solubility/temperature behavior and the ion-exchange glass container.

4. How important is borosilicate glass versus ion-exchange glass generally?
   Borosilicate is required for Claim 1, while Claim 5 covers ion-exchange strengthened glass more generally as provided.

5. Can a competitor avoid US 8,491,524 by targeting a different temperature window?
   The claims as provided are tied to 0°C to 30°C storage/cycling, so changing behavior outside that window does not eliminate the claim’s functional requirement within it.

References (APA)

No external sources were cited because the prompt did not include patent bibliographic data beyond the claim text, nor any FDA/Orange Book, litigation, or family documentation.

Drugs Protected by US Patent 8,491,524

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 8,491,524

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	364417
Australia	2002343045
Canada	2468283
Germany	60220701
European Patent Office	1446177
United Kingdom	0127942
Japan	2005510307