Details for Patent: 9,789,270

Which drugs does patent 9,789,270 protect, and when does it expire?

Patent 9,789,270 protects LONHALA MAGNAIR KIT and is included in one NDA.

This patent has fourteen patent family members in ten countries.

Summary for Patent: 9,789,270

Title:	Inhalation therapy device comprising an ampoule for storing a medicament to be nebulized
Abstract:	An inhalation therapy device includes an atomizer for atomizing a drug which is advantageously present in the form of a fluid into an atomization chamber so that an aerosol or mist is provided in the atomization chamber. The patient or user can inhale the aerosol produced by the atomizer from the atomization chamber via a mouthpiece. The ampoule is inserted into an ampoule holder holding the fluid-containing ampoule. The inhalation therapy device also includes an opening unit for opening the fluid-containing ampoule. The ampoule holder advantageously includes a first part, disposed displaceably in relation to the opening unit, thereby allowing an ampoule present in the ampoule holder to be displaced in the direction of the opening unit.
Inventor(s):	Uwe Hetzer, Thomas Gallem
Assignee:	PARI Pharma GmbH
Application Number:	US11/990,474
Patent Claim Types: see list of patent claims	Device;

Patent 9,789,270 Scope and Claims Analysis for Inhalation Device with Lid-Triggered Ampoule Opening and Nebulizer Fluid Path

United States Patent No. 9,789,270 is an apparatus-focused patent that claims inhalation therapy devices where a fluid-filled ampoule is retained in an ampoule holder in the lid, then opened by an opening element (opening means) when the lid closes on the device body. The core claim architecture ties together (i) relative displacement of the ampoule holder versus the lid-opening element, (ii) an opening element (needle or cutter-like structure) positioned at the first end of the ampoule holder adjacent the nebulizer, (iii) a conduit that carries substantially all fluid from the ampoule into the nebulizer chamber, and (iv) optional mechanisms for sealing, pressure control, and ampoule structure (sealing surfaces, bellows/resilient element). The narrowest claim features are the lid-triggered displacement-opening sequence and the specific spatial arrangement (opening means and nebulizer at the first end of the ampoule holder with a conduit through the opening means).

Below is a claim-by-claim scope map and a litigation and design-around view of the likely US patent landscape, including what such claims typically overlap with in device patents and what tends to remain outside scope.

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What is US Patent 9,789,270 about and what is the practical claim “center of gravity”?

Featured snippet answer: The patent claims inhalation therapy devices that open a fluid ampoule during lid closure, using an opening means (needle or cutter) positioned at one end of a displaceable ampoule holder so that substantially all ampoule fluid reaches a nebulizer via a conduit.

Core technical bundle (what the claims consistently require)

1. Body + nebulizer device + nebulizer chamber
   • The claims require a nebulizer device nebulizing fluid in a nebulizer chamber.
2. Lid-triggered mechanism
   • A lid closes on a body, triggering relative motion.
3. Ampoule holder inside the lid
   • The ampoule holder is arranged in the lid.
4. Relative displacement of ampoule holder (or its parts) vs lid opening element
   • In response to lid closing, at least one part of the ampoule holder is configured to be displaced relative to the lid.
5. Opening means at the first end + conduit path to nebulizer
   • The opening means and nebulizer device are located at the first end of the ampoule holder; opening means has a conduit through which fluid from the ampoule reaches the nebulizer device.
6. “Substantially all” fluid reaches nebulizer
   • The claims expressly include functional language tied to opening geometry and fluid communication.

Claim scope character

• Apparatus claims, not drug claims. This patent covers device structure and operation, not a specific drug molecule or formulation.
• Functional-to-structural linkage. Although “substantially all the fluid” is functional, the claim ties that outcome to the spatial arrangement and opening/conduit configuration.
• Multiple dependent claim hooks for common design features:
  • sealing device,
  • positive/negative pressure via squeezing means or internal relative displacement,
  • ampoule sealing surfaces,
  • bellows or resilient element between ampoule portions,
  • membrane nebulizer.

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What does independent claim 1 cover, including element-by-element limitations?

Featured snippet answer: Claim 1 covers a lid-and-body inhalation device where an ampoule retained in a lid-mounted holder is moved toward an opening element when the lid closes, opening the ampoule so a conduit in the opening means delivers substantially all fluid to a nebulizer.

Claim 1 required elements (scope-critical)

• Inhalation therapy device
• Body
  • includes a nebuliser device,
  • includes a nebuliser chamber where fluid is nebulized,
  • includes an opening means.
• Lid
• Ampoule holder mounted in/arranged in the lid
  • retains an ampoule containing the fluid
  • the ampoule holder has at least one part displaceable relative to the lid in response to lid closing
  • arranged so that ampoule moves in a direction of the opening means
  • opened by the opening means in response to lid closure
• Substantially all fluid reaches nebuliser device
  • requires the opening means opens the ampoule and fluid reaches the nebulizer
• Ampoule holder geometry
  • has a first end and second end
• Spatial arrangement
  • opening means and nebuliser device are located at the first end of the ampoule holder
• Conduit requirement
  • opening means has a conduit through which fluid from ampoule reaches nebuliser device

Claim 1 likely interpretation pressure points

• “Ampoule holder arranged in the lid”: A design using an ampoule tray fixed to the body rather than in the lid may try to avoid this.
• “Configured to be displaced relative to the lid in response to lid closing”: A mechanism where the opening means moves into the ampoule without the holder displacement may be attacked under literal scope or pushed to equivalency fights.
• “Opening means and nebuliser device located at first end of ampoule holder”: A different axial layout could be a strong design-around.
• “Conduit through which fluid from the ampoule reaches the nebuliser device”: If fluid path is via another channel not part of the opening means, scope may narrow.

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How does dependent claim 2 narrow the mechanism path between lid and ampoule holder?

Featured snippet answer: Claim 2 limits devices where the opening means and ampoule holder are displaceable relative to each other along a substantially straight, circular, or helical path.

Scope impact

• Adds a motion-trajectory limitation.
• Design alternatives that use linear motion only in a non-straight curved profile, or that rely on multi-stage compound motion, can be argued to fall outside the “substantially straight/circular/helical” categories.

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What does claim 3 add about a cutter-based ampoule opening element?

Featured snippet answer: Claim 3 requires an opening means with a cutter designed to cut into an ampoule wall area intended for opening when displacement occurs.

Scope impact

• Narrows from “opening means opens ampoule” to cutting mechanics.
• Needle puncture designs may not satisfy this unless they include a cutter-like cutting edge.

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What does claim 4 require about an integral opening means/conduit construction?

Featured snippet answer: Claim 4 requires the opening means and the conduit to be integrally connected.

Scope impact

• A strong engineering distinction: if the conduit is a separate tube/channel connected downstream from the opening element, an accused device may argue non-integration.

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What does claim 5 add about sealing the ampoule against opening means?

Featured snippet answer: Claim 5 adds a sealing device that seals the ampoule against the opening means.

Scope impact

• Helps enforce against leakage and contamination designs.
• A competitor could attempt to avoid literal infringement by using different sealing geometries, but equivalency risk remains if the function-way-result aligns.

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What does claim 6 add about sealing the ampoule opening to the opening means?

Featured snippet answer: Claim 6 requires the opening means be configured to seal an opening of the ampoule to the opening means.

Scope impact

• Tighter: seal is at/around the ampoule opening created by opening means.
• Distinguish from general sealing of the ampoule exterior.

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How do claims 7 and 8 cover pressure creation during opening?

Featured snippet answer: Claim 7 adds squeezing means that creates positive pressure in the ampoule to hold it squeezed in the displaced position; claim 8 further requires the ampoule holder comprises the squeezing means formed to squeeze the ampoule during opening.

Scope impact

• This is a pressure-control hook tied to displacement and retention of ampoule in the opened/squeezed state.
• Design-around: purely gravity-fed flow or passive capillary delivery could reduce risk, but the independent claim 1 already requires fluid delivery “substantially all”; pressure-control claims may be irrelevant if claim 1 is met.

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What do claims 9 and 10 cover about multi-part ampoule holder designs and pressure development?

Featured snippet answer: Claim 9 splits the ampoule holder into first part that engages the ampoule and second part that holds it; claim 10 requires relative movement between these parts during lid displacement to develop negative or positive pressure in the ampoule.

Scope impact

• Captures internal actuation concepts: the ampoule can be squeezed or decompressed via multi-part mechanics.
• If a competitor uses a single rigid holder with no internal relative movement, claims 9-10 become harder to satisfy.

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What does claim 11 add about the ampoule itself?

Featured snippet answer: Claim 11 requires an ampoule included in the device with a first area for opening by the opening means and a second area for holding by the ampoule holder.

Scope impact

• Introduces a claim that includes ampoule structure/segmentation, not just the external holder.
• A competitor using an ampoule without a distinct first opening zone could challenge literal fit.

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What does claim 12 add about sealing surfaces on the ampoule?

Featured snippet answer: Claim 12 adds a sealing surface on the ampoule designed to seal the ampoule against the opening means or conduit.

Scope impact

• If the ampoule lacks a sealing surface (or uses a different sealing interface), claim 12 is avoided.

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What does claim 13 add about relative movability of ampoule regions?

Featured snippet answer: Claim 13 requires the first area to be movable relative to the second area of the ampoule.

Scope impact

• This is a structural flexibility requirement. Fixed ampoule wall designs likely avoid.

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What does claim 14 add about resilient elements or bellows between ampoule areas?

Featured snippet answer: Claim 14 requires a resilient element or bellows connecting first and second areas of the ampoule.

Scope impact

• Narrow dependent claim likely to be asserted only when competitors use flexure/bellow designs to maintain sealing while opening occurs.

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What does claim 15 add about the nebulizer being membrane-based?

Featured snippet answer: Claim 15 specifies that the nebuliser device comprises a membrane nebuliser.

Scope impact

• Narrows to membrane nebulization.
• If an accused device uses jet nebulization or ultrasonic nebulization, claim 15 is avoided, while claim 1 may still apply.

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How does claim 16 differ from claim 1 (needle variant)?

Featured snippet answer: Claim 16 is similar to claim 1 but defines the body as having a needle as the opening means, with needle and nebuliser device at the first end and the needle having a conduit.

Scope impact

• Converts “opening means” into a specific element type: needle.
• Cutter-only devices may not satisfy claim 16, but could still be captured under claim 1 if claim 1’s broader “opening means” reads on cutters.

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How does claim 17 differ (broader opening means with closing-triggered relative movement)?

Featured snippet answer: Claim 17 is another independent-like claim variant requiring the ampoule holder to move relative to the lid so that opening means opens the ampoule when lid closes, with opening means and nebuliser device at the first end and conduit through opening means.

Scope impact

• Claim 17 reads more like a structural restatement of claim 1 but can affect infringement arguments where the exact “displacement relative to lid” mechanism differs.

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What does this claim set imply about likely infringement theories?

Strongest literal infringement path

A competitor device is most exposed if it has:

• a lid-mounted ampoule holder where the ampoule is driven toward a body-mounted opening element during closure,
• the opening element itself includes a conduit to deliver fluid to the nebulizer,
• opening and nebulizer are co-located at one end of the holder,
• substantially all ampoule fluid is delivered after opening.

Where accused devices commonly fight scope

• Which part moves during closure: whether the ampoule holder moves relative to lid, or the opening means moves relative to holder.
• Where the conduit is: whether the conduit is part of the opening means or in a separate fluid path.
• Spatial arrangement: whether the opening element and nebulizer are at the first end of the ampoule holder.
• Ampoule design: whether the ampoule has sealing surfaces or movable regions (relevant mainly to dependent claims).

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How strong is the patent estate for this technology class (device mechanics) vs drug patents?

Featured snippet answer: For a device-ampoule opening mechanism, this patent is likely to be one of multiple interlocking device patents rather than a single “catch-all” for inhalation systems. Its strength is in the lid-triggered, end-positioned opening means with conduit delivering substantially all fluid, and in dependent features that track pressure-control and sealing/bellows ampoules.

What this patent likely overlaps with in the broader US device landscape

Without asserting specific unrelated claim numbers, this type of mechanism commonly overlaps across US filings covering:

• ampoule-based nebulizers with single-use vials,
• needle or pierce-and-feed opening systems,
• membrane nebulizers integrated into hand-held inhalers,
• latching lid mechanisms that trigger puncture/valving,
• sealing interfaces between a pierce element and a disposable ampoule.

Those families often split between:

• disposable ampoule patents,
• disposable interface/valve patents,
• device shell and lid motion patents,
• nebulizer technology patents (membrane vs jet).

Litigation relevance pattern

Apparatus patents in this area typically generate disputes around:

• whether the device performs the same actuation sequence (lid closure triggers piercing/pumping),
• whether the conduit is structurally part of the piercing element,
• whether the sealing interfaces match the claimed sealing device configurations.

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When does exclusivity end and can generics/biosimilars enter?

This patent is a device patent on an inhalation therapy device. It does not create drug exclusivity in the way biologics exclusivity or small-molecule patent exclusivity does. Generic/biosimilar entry is governed by the product’s drug/device regulatory status and any drug substance/formulation patents, not by this device apparatus patent alone.

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What generic entry risks exist for an inhalation drug product under this patent?

Featured snippet answer: Entry risk under this patent applies mainly to competitors marketing a competing inhalation therapy device that uses a lid-triggered displaceable ampoule holder and an opening means with conduit delivering substantially all fluid to the nebulizer.

Typical scenarios

1. New ampoule device, same nebulized drug
   • Device design can trigger infringement; drug generic entry can still proceed regulatory-wise, but device availability may be constrained.
2. Different device architecture
   • If the mechanism avoids conduit-in-opening element or avoids lid-mounted displaceable holder arrangement, infringement risk declines.
3. Same device, different ampoule format
   • Dependent claims about sealing surfaces and movable ampoule regions can become decisive.

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Where are the best design-around levers suggested by the claim language?

Claim 1 design-around levers (highest impact)

• Remove lid-based ampoule holder displacement
  • Keep ampoule fixed relative to body; move only the opening element, or use a carousel/rotating piercing.
• Change conduit architecture
  • Provide fluid path via a separate channel not “through the opening means” and avoid integral construction (relevant especially to claim 4).
• Move opening means and nebulizer away from “first end” relationship
  • Use a different axial arrangement where opening means and nebulizer are not co-located relative to the holder end definition.
• Avoid “substantially all” delivery
  • This is harder to engineer away because “substantially all” can be argued broadly; competitors typically focus on structural non-correspondence instead.

Dependent claim design-around levers

• No cutter (claim 3) if using puncture-only needle without cutter edge geometry.
• No internal pressure squeezing means (claims 7-8) if delivery is purely valving/gravity-driven.
• No multi-part holder generating internal negative/positive pressure (claims 9-10).
• No sealing surface on ampoule (claim 12).
• No movable ampoule opening region and no bellows/resilient element (claims 13-14).
• Avoid membrane nebulizer (claim 15).

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How does this patent compare with typical needle-based ampoule opening devices?

Featured snippet answer: Compared with many generic “pierce-and-feed” nebulizer concepts, this patent adds a specific structural choreography: the ampoule holder is in the lid, displaces relative to the lid during closure, and the opening element includes a conduit to feed the nebulizer, with opening means and nebulizer located at the same end of the holder.

Practical differentiation

• Devices that pierce a fixed ampoule using a body-mounted needle without a displaceable lid-held holder may avoid claim 1’s specific displacement arrangement.
• Devices that feed via a separate manifold rather than a conduit in the piercing element may avoid the “opening means has a conduit” requirement.

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What commercial products are most at risk?

Featured snippet answer: Any inhalation therapy device that uses lid closure to trigger ampoule piercing while delivering fluid through a conduit integrated into the opening element, especially with membrane nebulization and sealed ampoule interfaces.

Risk concentration

• single-use ampoules and discrete nebulizer chambers
• latch/hinge lids that trigger opening
• needle-pierce assemblies where the needle also acts as a conduit

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Key Takeaways

• US 9,789,270’s claim center of gravity is the lid-triggered displacement-opening sequence for a lid-mounted ampoule holder, with opening means (needle/cutter) having a conduit that delivers fluid to the nebulizer.
• Independent claim 1 is broad on “opening means” but hard on the structural choreography: holder in lid, displacement relative to lid on closure, opening at the first end, and conduit through the opening means.
• Dependent claims add enforceable narrowing hooks on motion path, cutter geometry, integral conduit, sealing interfaces, pressure squeezing, multi-part holder pressure development, and ampoule internal movable regions with bellows/resilient element, plus a membrane nebulizer limitation.
• The best design-arounds are structural: change which component moves, separate the conduit from the opening means, alter end-relative geometry, or eliminate sealing/pressure/bellows features to avoid dependent claims.

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FAQs

1. Does US 9,789,270 cover the drug substance or only the inhalation device?
   Only the inhalation therapy device apparatus and its ampoule-opening delivery mechanics.

2. Can a competitor avoid the patent by using a different piercing mechanism than a needle or cutter?
   A non-needle/non-cutter opening approach may avoid dependent claims like the needle or cutter variants, but claim 1 still looks to “opening means” with conduit-based delivery.

3. If a competitor uses a similar lid action but keeps the ampoule fixed, is it still within claim 1?
   Risk turns on whether the ampoule holder is displaceable in response to lid closing and whether the ampoule moves toward the opening means as claimed.

4. Do claims 7-10 require active pressure generation during opening?
   Yes. They require squeezing means to create positive pressure and/or multi-part holder mechanics to develop positive or negative pressure in the ampoule.

5. How does membrane nebulization affect infringement exposure?
   Claim 15 adds a membrane nebulizer requirement; other claims may still cover non-membrane nebulizers if the independent claim elements are met.

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References

1. United States Patent No. 9,789,270.

Drugs Protected by US Patent 9,789,270

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		DISCN	Yes	No	9,789,270		Y

Foreign Priority and PCT Information for Patent: 9,789,270

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	10 2005 038 619	Aug 16, 2005

PCT Information
PCT Filed	August 16, 2006	PCT Application Number:	PCT/EP2006/008086
PCT Publication Date:	February 22, 2007	PCT Publication Number:	WO2007/020073

International Family Members for US Patent 9,789,270

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006281561
Brazil	PI0614818
Canada	2619605
China	101291699
Germany	102005038619