Details for Patent: 7,462,645

Summary for Patent: 7,462,645

Title:	Bronchodilating beta-agonist compositions and methods
Abstract:	Bronchodilating compositions and methods are provided. The compositions are intended for administration as a nebulized aerosol. In certain embodiments, the compositions contain formoterol, or a derivative thereof. Methods for treatment, prevention, or amelioration of one or more symptoms of bronchoconstrictive disorders using the compositions provided herein are also provided.
Inventor(s):	Imtiaz A. Chaudry, Stephen Pham, Partha S. Banerjee
Assignee:	JPMorgan Chase Bank NA , Mylan Specialty LP
Application Number:	US11/688,429
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

United States Patent 7,462,645: Scope, Claim Coverage, and US Patent Landscape for Nebulized Formoterol Bronchoconstriction Treatment

US Patent 7,462,645 claims a specific unit-dose, propellant-free nebulizer delivery method for formoterol (or salts) in narrow concentration, pH, buffer type, and buffer concentration ranges, with direct administration without dilution/other modification. The practical enforcement leverage is highest against products or clinical methods that replicate (i) the nebulizer-ready packaged unit dose, (ii) formoterol concentration in the claimed range, (iii) buffer and pH window, and (iv) shelf-life performance (claim 2) and nebulized volume (claim 3/9). Claim breadth is moderate-to-high on method framing, but narrower on formulation parameters.

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What does US 7,462,645 claim cover for nebulized formoterol?

Core claim theme: delivering a ready-to-use nebulizer solution containing formoterol at 0.08 to 43 μg/mL (formoterol free base basis) in water + a defined buffer system, at pH 4.5 to 5.5, using 1 to 3 mL (with specific embodiments), taken from a propellant-free sterile unit dose packaging, and administered directly without dilution/modification.

How claims map to enforceable product attributes

Because the claims are method claims, infringement typically hinges on whether a defendant’s product or labeling induces the patented steps. The steps are tightly tethered to the composition and packaging form.

Key technical levers:

• Propellant-free, sterile unit dose packaging
• Neubulizer addition volume: ~1 to 3 mL (and ~2.0 mL in claim 9)
• Formoterol concentration: 0.08 to 43 μg/mL
• Buffer identity: citric acid/phosphate buffer, acetate, citrate, phosphate buffers
• Buffer concentration: 1 to 50 mM (with narrower 1 to 20 mM in claim 6)
• pH: 4.5 to 5.5 (with a “pH about 5” embodiment in claim 3)
• Shelf-life performance: claim 2 requires >90% remaining after 3 months at 25°C and after 3 years at 5°C
• Direct administration: no dilution/modification before dosing
• Therapeutic target: asthma or COPD bronchoconstriction symptoms (claims 4-5)
• Packaging types: broad list of container formats (claim 7), plus a narrower “vial overwrapped with laminate” (claim 8)

Claim set coverage summary

• Claims 1 and 4-8: protect composition/pH/buffer/packaging/nebulizer-ready method, with disease indication scope via dependent claims.
• Claim 2: adds shelf-life acceptance requirements.
• Claim 3: adds a tighter citrate buffer concentration (1-20 mM) and pH about 5 with explicit stability thresholds.
• Claim 9: adds about 2.0 mL nebulized.

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What specific numerical ranges narrow or expand US 7,462,645 infringement risk?

Formoterol concentration (free base basis)

• 0.08 μg/mL to 43 μg/mL (claims 1-3, and dependent breadth via “as in any one”) This is the largest numeric discriminator. Products using different dose strengths outside the window should have reduced literal overlap.

Nebulizer fill volume

• About 1 to about 3 mL (claims 1-3)
• About 2.0 mL nebulized (claim 9) Method designs that require reconstitution, premixed multi-dose, or different fill volumes can avoid literal steps if they depart from claimed volume and “without dilution or other modification” procedures.

pH window

• 4.5 to 5.5 (claim 1)
• about 5 (claim 3 embodiment) A formulation with pH outside this window can avoid literal coverage if it does not meet “about” boundaries.

Buffer type and concentration

• Buffer types: citric acid/phosphate, acetate, citrate, phosphate (claims 1,2)
• Buffer concentration: 1 to 50 mM (claims 1-2)
• Narrower concentration: 1 to 20 mM (claims 3 and 6) Buffer choice is a classic design-around lever. However, because claim 1 lists multiple buffer classes, switching among these listed buffers does not eliminate infringement.

Stability/shelf-life requirements

• Claim 2: >90% remaining after 3 months at 25°C and 3 years at 5°C
• Claim 3: >94% after 3 months at 25°C and >96% after 3 months at 5°C (as stated) These “performance” limitations increase the importance of defendant’s stability data, manufacturing process control, and product-specific release specifications.

Disease scope

• Asthma (claim 4)
• COPD (claim 5) If a product’s labeled use excludes these indications, method infringement risk can depend on:
• promotional/labeling inducement,
• off-label administration facts,
• and whether the “undesired bronchoconstriction” language is interpreted broadly in litigation.

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Which dependent claim features create the most design-around space?

1) Shelf-life limitations (claim 2)

Design-around strategy: show that the product’s stability does not meet the “estimated shelf life” thresholds tied to specific storage conditions. If a defendant product does not satisfy the claimed shelf-life performance, literal infringement of claim 2 drops. Claims 1 and 3 still remain potential targets, but stability claims often create settlement leverage in litigation.

2) Citrate buffer + pH about 5 (claim 3)

Claim 3 is a “profile” claim. Avoidance can be achieved by:

• using a buffer outside “citrate buffer” (but claim 1 still covers other buffers),
• using pH not “about 5,”
• or missing the citrate concentration range.

3) Nebulized volume about 2.0 mL (claim 9)

If a defendant’s method uses a nebulizer volume outside “about 2.0 mL,” claim 9 becomes harder to assert, though it does not negate coverage under claims 1-3.

4) Packaging format (claims 7-8)

Claim 7 is broad: blister packs, bottles, tubes, inhalers, pumps, bags, vials, containers, syringes. Claim 8 narrows: vial overwrapped with a laminate. For litigation, packaging format becomes relevant mainly if the claimed product uses a distinctly different sterile unit-dose arrangement.

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What patents typically surround US 7,462,645: formulation, device, and method-of-use clusters?

A patent landscape for this kind of claim usually clusters around four families in the US:

1. Formoterol formulation patents (aqueous solutions, buffers, pH control, stability/shelf-life)
2. Nebulizer-ready unit dose and packaging patents (sterile unit doses, propellant-free delivery, volumes)
3. Method-of-use patents for bronchoconstriction (asthma/COPD)
4. Process/manufacturing patents (filtering, aseptic fill, stability-improving steps)

However, without the publication record and assignee context for US 7,462,645, the only accurate landscape characterization is claim-structure-based: the enforceability rests on formulation parameters + unit-dose nebulizer administration protocol.

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How strong is the patent estate for this claim scope under US infringement standards?

Strength drivers

• Tight alignment between method steps and formulation parameters. Courts often treat claims that couple “what the product is” with “what the user does” as easier to map to real-world administration and labeling.
• Multiple independent constraints. Even if a defendant matches one element (e.g., buffer type), they must match the pH, formoterol concentration, unit-dose sterile, volume, and no dilution to get full overlap.
• Shelf-life/performance limitation in claim 2 and stability in claim 3. Performance claims can increase litigation cost for defendants because they must generate or rely on stability and degradation data.

Key litigation vulnerability

• “Without dilution or other modification” and “directly administering” language may require fact development on actual user/clinical instructions. If the market product’s method is “dilute before nebulizing” or uses a different reconstitution regime, literal method infringement can be contested.
• “About” terms (pH about 5, about 2.0 mL) create interpretive range issues that can reduce certainty.

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What generic entry risks exist for companies launching nebulized formoterol using different formulation strategies?

Risk remains high when competitors keep the same delivery concept

Competitors face direct risk if their marketed product:

• is propellant-free,
• is supplied as sterile unit doses,
• is intended for direct nebulizer administration without dilution,
• uses a formoterol concentration within 0.08 to 43 μg/mL,
• uses one of the claimed buffer systems and pH window, and
• meets the claimed stability for claim 2/3 variants.

Lower risk when competitors change one or more “hard” constraints

Risk can drop if they move outside any of the following:

• formoterol concentration range
• pH range
• buffer concentration range (especially 1-20 mM citrate)
• unit-dose / no-dilution protocol
• volume (particularly around the claim 9 embodiment)
• stability profile required for claim 2

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What is the US exclusivity and FDA regulatory relevance of US 7,462,645 (Orange Book impact)?

US 7,462,645 is a US drug patent that typically would appear in FDA’s Orange Book if it is listed for an approved drug product and meets listing requirements. However, Orange Book status, listed formulation linkage, and the specific associated NDC(s) cannot be determined from the claim text provided.

Practically, if US 7,462,645 is listed against an approved nebulized formoterol NDA/ANDA product, FDA would require Paragraph IV or other certifications in generic/biosimilar-related submissions, creating a litigation and settlement pathway common to this patent class.

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How does US 7,462,645 compare to typical nebules and inhaled LABA formulation patents?

Differentiation from broader inhaled delivery patents

Many formoterol patents claim:

• inhalers (metered-dose, DPI),
• different salt forms,
• different dose regimens,
• or general aqueous formulations without the specific pH + buffer + concentration + unit-dose nebulizer fill combination.

US 7,462,645 is narrower by requiring:

• nebulizer addition of 1-3 mL
• unit-dose sterile packaged supply
• no dilution/other modification prior to administration
• and specific buffer/pH/stability constraints.

This combination is often less crowded than general formoterol composition-of-matter claims, because it binds to a particular “ready-to-nebulize” product format and usability constraints.

Differentiation within nebulized LABA patents

Some nebulizer patents focus on delivery devices, aerosol characteristics, or excipient sets not limited to the cited buffer families. This claim’s explicit buffer list and pH range make it more directly “formulation-map-able” than device-only claims.

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What patent claim coverage remains if a competitor uses a different buffer system?

Claim 1 expressly covers four buffer categories:

• citric acid/phosphate buffer
• acetate buffer
• citrate buffer
• phosphate buffer

Switching to another buffer outside these categories can reduce literal infringement risk. But if the competitor uses a “phosphate” or “citrate” system under the claimed concentrations and pH window, the substitution does not provide avoidance.

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Key Takeaways

• US 7,462,645 is a method-of-use + formulation + unit-dose delivery patent for propellant-free nebulized formoterol.
• Independent claim 1 is anchored to: formoterol 0.08–43 μg/mL, 1–3 mL nebulizer fill, pH 4.5–5.5, water + one of four buffer types, buffer 1–50 mM, sterile unit dose, and direct administration without dilution/modification.
• Dependent claims add litigation leverage via: stability thresholds (claim 2), citrate buffer concentration and pH about 5 (claim 3), asthma/COPD indications (claims 4–5), 1–20 mM buffer concentration (claim 6), and ~2.0 mL nebulized volume (claim 9).
• Design-arounds with the greatest immediate impact are changing formoterol concentration, pH, buffer concentration, no-dilution protocol, nebulizer fill volume, or stability profile tied to claim 2/3.

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FAQs

1. Do US 7,462,645 claims cover nebulizer administration with dilution steps?
   The claims require direct administration without dilution or other modification prior to dosing.

2. What is the most critical numeric limiter in US 7,462,645?
   The formoterol concentration range (0.08–43 μg/mL) and the pH window (4.5–5.5) are the most determinative for literal overlap.

3. Can a competitor avoid claim 2 by failing the shelf-life threshold while still matching the formulation?
   Yes for claim 2, because the shelf-life performance limitations are integral to that claim’s coverage.

4. Does using a citrate buffer at 1–20 mM automatically fall within the patent?
   It satisfies only one subset constraint. Coverage also requires pH about 5 (claim 3), the formoterol concentration, unit-dose sterile format, and direct nebulizer administration without dilution.

5. How do asthma and COPD dependent claims affect infringement analysis?
   If a product is used solely outside those indications, method infringement risk depends on labeling, inducement, and how “undesired bronchoconstriction” is interpreted in the relevant factual record.

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References

1. US Patent No. 7,462,645.

Drugs Protected by US Patent 7,462,645

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 7,462,645

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1660035
Taiwan	200507830
Taiwan	I359675
World Intellectual Property Organization (WIPO)	2005007142