United States Patent 7,104,470: Scope, Claims, Expiration, and Respimat Patent Landscape

U.S. Patent No. 7,104,470 protects a replaceable, propellant-free fluid cartridge designed for a high-pressure atomizer using a reciprocating hollow piston. The patent is directed to the cartridge architecture and its mechanical interaction with the atomizer, not to a particular active pharmaceutical ingredient.

The patent’s central combination requires:

A dimensionally stable outer portion.
A collapsible inner portion.
A stopper coupled to both portions.
A bore in the stopper receiving the atomizer’s hollow piston.
Movement of the cartridge with the piston inside the atomizer housing.
A substantially unpressurized, propellant-free fluid supply.

The patent was important to the cartridge-based soft-mist inhaler architecture associated with the Respimat platform. Its 20-year United States patent term has expired, subject to confirmation from the USPTO Patent Center for any unusual adjustment or disclaimer record. The claims therefore do not provide a current blocking right against new products.

What does U.S. Patent 7,104,470 cover?

U.S. Patent 7,104,470 covers a replaceable unit used with an atomizer that generates high fluid pressure mechanically rather than through a pressurized propellant. The claimed unit is a consumable or replaceable drug reservoir that moves together with the atomizer’s hollow piston.

The patent does not broadly claim every vial, cartridge, inhaler reservoir, or propellant-free inhalation product. Its scope depends on the interaction between the cartridge and a specific type of atomizer.

Patent identification

Field	Information
Patent	U.S. Patent No. 7,104,470
Title	Replaceable unit for an atomizer
Patent type	Utility patent
Technology	Replaceable drug reservoir for mechanical high-pressure atomization
Principal platform association	Respimat-type soft-mist inhaler architecture
Earliest priority	European-origin priority; public patent records should be checked for the exact priority chain
U.S. grant date	September 12, 2006
Assignee associated with the patent family	Boehringer Ingelheim International GmbH
Independent claim	Claim 1
Dependent claims	Claims 2 and 3
Patent term	Generally 20 years from the applicable U.S. filing or international filing date
Current blocking status	Patent term has expired based on the ordinary 20-year term

The patent is better characterized as a drug-delivery-device patent than as a conventional drug patent. It does not claim tiotropium, salbutamol, budesonide, or another active ingredient as a molecule.

How should claim 1 of U.S. Patent 7,104,470 be construed?

Claim 1 is a combination claim. It requires both the replaceable unit and the specified atomizer relationship.

Required claim elements

Claim element	Scope and practical meaning
Replaceable unit	The claimed article is removable and replaceable in the atomizer
Atomizer context	The unit must be used with an atomizer having a high-pressure fluid-generation device
Hollow piston	The atomizer includes a hollow piston capable of axial movement
Dimensionally stable outer portion	The outer structure retains its shape during use
Collapsible inner portion	A portion inside the outer structure collapses as fluid is withdrawn
Coupled stopper	The stopper is firmly connected to both the outer and collapsible portions
Stopper bore	The hollow piston projects through an opening in the stopper
Piston-mounted unit	The replaceable unit is firmly disposed on the hollow piston
Coordinated movement	The cartridge moves back and forth with the piston
Fluid supply	The unit holds fluid for atomization
Pressure condition	The stored fluid is substantially unpressurized
Propellant condition	The fluid supply is free from propellants

The most significant limitation is the mechanical coupling between the replaceable unit and the hollow piston. A conventional cartridge that remains stationary while a separate pump draws liquid from it may not satisfy this limitation, even if it has a collapsible bag and is propellant-free.

“Dimensionally stable outer portion”

This limitation distinguishes the claimed cartridge from a free-standing flexible pouch. The outer portion must maintain sufficient shape and structural integrity to operate inside the atomizer housing and support the cartridge during piston-driven movement.

A rigid plastic sleeve, molded container body, or comparable structural shell could potentially satisfy this element. The claim does not appear limited to a specific polymer, wall thickness, molding process, or cross-sectional shape.

“Collapsible portion”

The collapsible portion is located within the stable outer portion. Its purpose is to allow fluid withdrawal without requiring air replacement or pressurization of the reservoir.

The claim language does not expressly require a particular collapse mode. Depending on construction, the collapsible structure could include a flexible bag, membrane, liner, diaphragm, or comparable internal reservoir. The collapse must be functional, not merely incidental deformation of a rigid container.

“Stopper firmly coupled” to both portions

The stopper is a key interface component. Claim 1 requires that it be firmly coupled to the dimensionally stable outer portion and to the collapsible portion.

This requirement narrows the claim relative to a container in which a removable cap merely closes a rigid bottle. It also creates a potential design distinction for systems using a flexible reservoir that terminates in a separate neck or connector without a stopper joined to both the outer and inner structures.

Hollow piston and coordinated movement

The hollow piston performs two functions:

It moves axially to participate in pressure generation.
It extends through the stopper bore to withdraw fluid from the reservoir.

The cartridge must be firmly mounted on the piston and move with it inside the atomizer housing. This is a substantial structural limitation. A product with an independently moving pump piston and a stationary drug cartridge would present a stronger non-infringement position.

What do claims 2 and 3 add?

Claims 2 and 3 narrow the claimed replaceable unit to pharmaceutical contents.

Claim 2

Claim 2 requires that the storage container comprise a pharmaceutical composition. It does not identify a specific active ingredient, dosage, concentration, formulation excipient, or disease indication.

The claim can potentially cover a pharmaceutical solution, suspension, or other pharmaceutical composition, depending on the construction of “pharmaceutical composition” and the limitations inherited from claim 1.

Claim 3

Claim 3 requires a pharmaceutically acceptable solution of a medicament selected from the following group:

Berotec
Berodual
Flunisolide
Atrovent
Salbutamol
Budesonide
Combivent
Tiotropium
Oxivent
Suitable peptides

The claim is a closed Markush claim because it uses “selected from the group consisting of.” Products containing an active ingredient outside that group would generally not satisfy claim 3 literally, although infringement analysis would still depend on the full claim and any doctrine-of-equivalents issues.

Several listed names are product or brand designations rather than precise chemical identities. For example:

Listed term	General pharmaceutical association
Berotec	Fenoterol-containing bronchodilator product
Berodual	Fenoterol plus ipratropium combination
Flunisolide	Inhaled corticosteroid
Atrovent	Ipratropium product
Salbutamol	Albuterol
Budesonide	Inhaled corticosteroid
Combivent	Ipratropium plus albuterol combination
Tiotropium	Long-acting muscarinic antagonist
Oxivent	Oxitropium-associated product designation
Suitable peptides	Peptide medicines suitable for the formulation and device

Claim 3 does not independently claim these medicines. It claims the replaceable unit of claim 1 when loaded with a solution containing one of the listed medicaments.

When did U.S. Patent 7,104,470 expire?

The patent’s ordinary term has expired. U.S. utility patents generally receive a term of 20 years from the earliest effective nonprovisional U.S. filing date, or from the applicable international filing date for a national-stage application, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and other statutory corrections. 35 U.S.C. § 154.

Public patent records identify U.S. Patent 7,104,470 as an early-2000s application that matured to a patent in 2006. On the ordinary term calculation, the patent expired no later than the early 2020s. It should therefore be treated as expired for current freedom-to-operate analysis unless the USPTO record shows an unusual term adjustment.

Event	Approximate timing
Priority filings	Late 1990s or early 2000s European-origin family
U.S. filing or national-stage entry	Early 2000s
U.S. patent grant	September 12, 2006
Ordinary 20-year term end	Early 2020s
Current enforceability	Expired by ordinary term calculation

Expiration of this patent does not eliminate other patents covering the same inhaler platform, cartridge geometry, nozzle, dose counter, spring mechanism, filling process, formulation, or specific marketed product.

Is U.S. Patent 7,104,470 listed in the Orange Book?

The patent is not a conventional active-ingredient patent and should not be treated as an automatically controlling Orange Book patent.

The FDA Orange Book lists patents submitted by NDA holders for approved drug products when the patents fall within applicable listing categories, including drug-substance, drug-product, and method-of-use patents. Device patents may be listed in certain circumstances when they are associated with an approved drug product, but listing practice is product-specific and depends on the sponsor’s submission and FDA review.

For products using a Respimat-type device, the relevant Orange Book analysis must be conducted at the NDA and product level. A device patent may be associated with one NDA and absent from another. The expiration of U.S. 7,104,470 also means that any historical Orange Book listing would not create a current barrier to an ANDA applicant.

What FDA regulatory issues relate to this patent?

The patent covers device architecture, while FDA approval covers the integrated drug-device product.

Relevant FDA pathways include:

An NDA for a new drug-device combination.
A supplemental NDA for a new formulation, strength, indication, or delivery device.
An ANDA for a generic version where the reference product and dosage form qualify for the abbreviated pathway.
A 505(b)(2) application for a product relying in part on published information or an FDA finding concerning an approved product.
Device review requirements for the constituent device, depending on the product and FDA classification.

A generic or follow-on applicant would need to address more than the expired patent. It would need to evaluate:

Pharmaceutical equivalence.
Bioequivalence or comparative clinical performance.
Device operation and emitted dose.
Particle-size distribution.
Dose uniformity.
Container-closure integrity.
Extractables and leachables.
Sterility or microbiological controls where applicable.
Manufacturing comparability.
Human-factors requirements for a device-dependent product.

Patent expiration does not guarantee FDA approval. It removes one potential exclusionary right but leaves regulatory, manufacturing, formulation, and device-performance hurdles.

Were Paragraph IV challenges relevant to this patent?

A Paragraph IV certification is relevant when an ANDA applicant asserts that an Orange Book-listed patent is invalid, unenforceable, or not infringed.

Because U.S. 7,104,470 has expired, it is no longer a prospective Paragraph IV barrier. Historical Paragraph IV activity, if any, would have depended on whether the patent was listed against a specific NDA and whether the listing remained unexpired when the ANDA was filed.

The statutory consequences of a Paragraph IV certification can include:

Notice to the patent owner and NDA holder.
A 45-day period for filing an infringement action.
A potential 30-month stay of FDA approval under 21 U.S.C. § 355(j)(5)(B)(iii).
Possible 180-day generic exclusivity for a first filer in applicable circumstances.

Those consequences no longer create a forward-looking stay based solely on U.S. 7,104,470. A current applicant would instead focus on unexpired continuation patents, device patents, formulation patents, and method-of-use patents associated with the relevant reference product.

What patent landscape surrounds the claimed technology?

The relevant patent estate is broader than U.S. 7,104,470. It can be divided into six technical groups.

1. Atomizer and pump patents

These patents may cover:

High-pressure piston assemblies.
Spring-driven pressure generation.
Metering chambers.
Valve structures.
Axial piston movement.
Nozzle and micro-orifice arrangements.
Pressure-release mechanisms.

A product can avoid the expired cartridge patent while still implicating later patents on the atomizer itself.

2. Cartridge and reservoir patents

This group includes claims directed to:

Rigid outer shells.
Collapsible inner bags.
Stopper and piston interfaces.
Cartridge mounting structures.
Airless withdrawal systems.
Cartridge indexing and insertion.
One-way valves and sealing components.
Reusable and disposable reservoir configurations.

U.S. 7,104,470 is principally within this category.

3. Formulation patents

Formulation patents can protect:

Tiotropium solutions.
Long-acting bronchodilator combinations.
Corticosteroid solutions.
Preservative-free formulations.
pH-controlled solutions.
Stabilized peptide formulations.
Specific concentrations, salts, or excipient systems.

These patents can remain relevant after device-patent expiration, particularly for branded inhalation products with formulation-specific Orange Book listings.

4. Method-of-use patents

Method claims may cover:

Once-daily tiotropium administration.
Treatment of chronic obstructive pulmonary disease.
Asthma treatment.
Specific patient populations.
Combination therapy.
Dosage schedules.
Step-down or maintenance regimens.

A generic applicant may need a section viii statement or a product label that omits patented indications, depending on the listed method-of-use patents.

5. Manufacturing and filling patents

Manufacturing barriers may involve:

Aseptic filling of collapsible reservoirs.
Crimping or coupling the stopper to the inner and outer portions.
Cartridge sterilization.
Nozzle fabrication.
Micro-orifice laser drilling.
Assembly tolerances.
Leak testing.
Automated cartridge insertion and sealing.

These patents may create commercial advantages even where the basic cartridge claim has expired.

6. Packaging and device-use patents

Later patents may address:

Dose counters.
Lockout mechanisms.
Cap-opening systems.
Cartridge authentication.
Tamper evidence.
Orientation control.
User loading instructions.
Electronic adherence monitoring.

These claims can affect commercial launch design without covering the active pharmaceutical ingredient.

How strong is the patent estate after expiration of U.S. 7,104,470?

The patent itself has no meaningful remaining exclusionary strength if its ordinary term has expired. Its technical disclosure may still matter as prior art, but the expired claims cannot be used to block a competing product.

The residual strength of the broader estate depends on later-filed patents. The most important questions are:

Issue	Commercial significance
Continuation patents	May preserve narrower claims after the parent expires
Terminal disclaimers	May align expiration dates with related patents
Formulation patents	Can delay substitution even after device patent expiration
Method-of-use patents	Can constrain labeling and launch strategy
Device patents	May block replication of particular mechanics
Manufacturing patents	Can raise entry costs without directly blocking all products
Trade secrets	May protect filling, assembly, or process know-how outside patent expiration
Regulatory exclusivity	Can delay approval independently of patent rights

A freedom-to-operate opinion should not rely on the expiration of 7,104,470 alone. It should map every patent family associated with the targeted reference product and identify claim overlap by component and use.

How does this patent compare with conventional inhaler patents?

Characteristic	U.S. 7,104,470	Pressurized metered-dose inhaler patent	Dry-powder inhaler patent
Energy source	Mechanical piston pressure	Propellant pressure	Patient inhalation
Reservoir	Replaceable, collapsible cartridge	Pressurized canister	Powder blister, capsule, or reservoir
Propellant	Excluded by claim 1	Usually required	Not required
Cartridge movement	Moves with piston	Usually stationary canister	Product-dependent
Key risk area	Cartridge-piston interface	Valve, canister, formulation	Powder handling and airflow
FDA product type	Drug-device combination	Drug-device combination	Drug-device combination

The claimed architecture is narrower than the general concept of a propellant-free inhaler. A competitor using a different pressure-generation mechanism or a stationary reservoir could avoid the literal combination of claim 1.

What generic or competitive launch scenarios exist?

Three commercial scenarios are most relevant.

Scenario 1: Same general platform, redesigned cartridge

A competitor can use the expired patent as technical prior art and develop a cartridge with altered piston coupling, stopper geometry, or reservoir movement. The principal risks would shift to later device and formulation patents.

Scenario 2: Different atomizer architecture

A competitor can use a stationary cartridge, rotary pump, diaphragm pump, or another pressure-generation mechanism. This provides a stronger position against claim 1 because the claim requires the hollow piston and coordinated cartridge movement.

Scenario 3: Same active ingredient, different delivery system

A company could pursue an inhaled formulation through a dry-powder inhaler, pressurized metered-dose inhaler, or another soft-mist platform. This may avoid the patent entirely but create separate bioequivalence, device-performance, and formulation issues.

What geographic coverage remains?

U.S. Patent 7,104,470 provides no current U.S. exclusionary right after expiration. Foreign counterparts must be analyzed separately because:

Patent terms differ in calculation and adjustment.
Some family members may have expired earlier or later.
National patents may have lapsed for nonpayment.
Supplementary protection certificates generally apply to medicinal products, not necessarily to standalone device patents.
Continuations or divisional applications may have separate claim scope and expiration dates.

A global launch review should separately examine the United States, European Patent Convention states, the United Kingdom, Canada, Japan, China, South Korea, Australia, and major Latin American markets.

Key Takeaways

U.S. Patent 7,104,470 is a device-and-cartridge patent, not a compound patent.
Claim 1 requires a dimensionally stable outer portion, collapsible inner portion, coupled stopper, hollow piston, and coordinated cartridge-piston movement.
Claim 2 limits the cartridge to pharmaceutical compositions.
Claim 3 narrows the product to solutions containing specified medicaments, including tiotropium, salbutamol, budesonide, and suitable peptides.
A stationary cartridge or non-piston atomizer may avoid important limitations of claim 1.
The patent’s ordinary 20-year term has expired.
The patent no longer creates a current U.S. blocking right or prospective Paragraph IV barrier.
Orange Book risk must be assessed by NDA and product, not by patent number alone.
Later device, formulation, method-of-use, manufacturing, and packaging patents may still affect launch timing.
FDA approval, bioequivalence, device performance, filling capability, and manufacturing validation remain separate entry barriers.

FAQs

Can a company sell a tiotropium cartridge after U.S. Patent 7,104,470 expires?

Yes, expiration removes the patent’s exclusionary right. The company must still address other unexpired patents, FDA requirements, formulation rights, and device-performance standards.

Does claim 3 independently protect tiotropium?

No. Claim 3 depends on claim 1 and requires the full replaceable-unit and hollow-piston architecture in addition to a solution containing a listed medicament.

Does a collapsible bag alone infringe claim 1?

Not necessarily. Claim 1 also requires a dimensionally stable outer portion, a stopper coupled to both portions, a hollow piston projecting through the stopper, and movement of the cartridge with the piston.

Can a generic avoid the patent by using a stationary reservoir?

A stationary reservoir would have a strong non-infringement position against the express requirement that the replaceable unit be firmly disposed on and move with the hollow piston. Other patents would still require review.

Does expiration of the patent permit immediate FDA approval of a competing soft-mist inhaler?

No. Patent expiration and FDA approval are separate issues. A competing product must satisfy the applicable NDA, ANDA, or 505(b)(2) requirements and demonstrate appropriate pharmaceutical, device, and performance equivalence.

References

U.S. Patent No. 7,104,470, Replaceable unit for an atomizer (2006).
U.S. Patent and Trademark Office. (n.d.). Patent term adjustment and patent term provisions, 35 U.S.C. § 154. https://www.uspto.gov
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355.
U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application process. https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	P195 36 902	Oct 04, 1995
Germany	P195 36 902	Oct 4, 1995

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	003794	⤷ Start Trial
Austria	248028	⤷ Start Trial
Austria	352379	⤷ Start Trial
Australia	7287096	⤷ Start Trial
Australia	730797	⤷ Start Trial
Bulgaria	102345	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Summary for Patent: 7,104,470