Details for Patent: 9,168,556

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Which drugs does patent 9,168,556 protect, and when does it expire?

Patent 9,168,556 protects LONHALA MAGNAIR KIT and is included in one NDA.

This patent has four patent family members in four countries.

Summary for Patent: 9,168,556

Title:	Membrane nebulizer and method for welding a membrane to a carrier during the production of a membrane nebulizer
Abstract:	A membrane nebulizer for producing aerosol in an aerosol therapy device includes a membrane having several through-holes for nebulizing a fluid; and a laminar carrier having an opening, the membrane being arranged in the opening and fastened to the carrier in such a way that the nebulizing occurs on a first side of the carrier and the fluid is present at the membrane on the opposite second side of the carrier, wherein the membrane is welded to the carrier by means of a resistance welding method.
Inventor(s):	Gerhard Pumm, René Seifert, Philipp Holzmann, Nicole Brune
Assignee:	PARI Pharma GmbH
Application Number:	US13/375,818
Patent Claim Types: see list of patent claims	Use; Composition; Process; Device;

United States Patent 9,168,556: Claim Scope, Patent Landscape, and Generic-Entry Relevance

U.S. Patent No. 9,168,556 protects a vibrating-membrane nebulizer in which a bulged, perforated membrane is resistance-welded to a planar carrier through a circumferential collar. The patent also protects manufacturing methods using closed-section electrode welding, controlled repeat welding, protective gas, and in-process electrical quality monitoring.

The patent is a medical-device and manufacturing patent, not a drug-composition patent. It does not claim an active pharmaceutical ingredient, formulation chemistry, dosage regimen, or pharmaceutical product. Its commercial relevance is concentrated in aerosol delivery platforms using vibrating mesh or membrane nebulization, including portable inhalation devices.

What does U.S. Patent 9,168,556 protect?

The patent has three claim groups:

Claim group	Claims	Protected subject matter
Membrane nebulizer	1-3, 10-13	Structural combination of membrane, carrier, collar, weld, and piezo element
Aerosol therapy device	4	Device containing the claimed membrane nebulizer
Manufacturing method	5-9	Resistance-welding process for attaching the membrane to the carrier

The independent apparatus claim, claim 1, is narrow because it requires a specific combination of structural and process-related features:

1. A membrane with an effective area containing multiple through-holes.
2. A fixing area surrounding the effective area.
3. A planar carrier with an opening.
4. The membrane positioned in the carrier opening.
5. The membrane fixed to the carrier so that nebulization occurs on one side and fluid is supplied from the opposite side.
6. A bulged membrane.
7. A collar-shaped fixing area.
8. Surface contact between the collar and the carrier.
9. Circumferential resistance welding.
10. A piezo element attached to the carrier.

A competing nebulizer that uses a flat membrane, adhesive bonding, laser welding, ultrasonic welding, or a materially different membrane-carrier geometry may avoid literal infringement of claim 1, even if it uses vibrating mesh technology.

How strong is the independent apparatus claim?

Claim 1 has meaningful technical specificity but a limited coverage perimeter. Its strength depends on whether a commercial product contains every required element.

Claim 1 limitation analysis

Limitation	Scope implication	Design-around relevance
Membrane has through-holes	Covers perforated aerosol-generating membranes	Excludes solid vibrating diaphragms that atomize without through-holes
Effective area and surrounding fixing area	Requires distinct functional and fixing regions	A different attachment architecture may avoid the claim
Planar carrier with an opening	Requires a carrier-supported membrane construction	Integrated or molded assemblies may present a noninfringement argument
Membrane is bulged	Limits the claim to a nonplanar membrane geometry	A flat mesh may avoid literal infringement
Collar in surface contact with carrier	Requires circumferential collar contact	Point, edge, flange, or indirect attachment may be outside the claim
Resistance welding	Requires electrically induced welding rather than adhesive or several other welding techniques	The principal process design-around
Piezo element attached to carrier	Requires a piezoelectric actuator associated with the carrier	Other actuation systems may avoid the claim

The claim is strongest against products using the same mechanical stack-up and welding architecture. It is weaker against devices that retain vibrating-mesh aerosol generation but change the membrane profile, attachment surface, actuator location, or joining technique.

What do dependent claims 2, 3, and 10-13 add?

Claim 2 narrows resistance welding to medium-frequency welding or capacitor-discharge welding. The claim is useful against products whose manufacturing records identify one of those electrical welding methods.

Claims 3 and 10-12 add progressively smaller collar-contact areas:

Claim	Collar-contact area
3	Less than 96 mm²
10	Less than 80 mm²
11	Less than 40 mm²
12	Less than 20 mm²

These claims create fallback positions if a court finds that a broader collar configuration is not novel or is obvious. They also create a dimensional infringement issue. A patentee would likely need reliable engineering drawings, optical measurement, production specifications, or destructive inspection to prove the relevant surface-contact area.

Claim 13 requires the collar to contact the first, nebulization side of the carrier and the piezo element to be attached to that same side. This limitation further narrows the claim and creates a potentially important polarity and assembly-orientation distinction.

What manufacturing methods are protected by claims 5-9?

Claim 5 is an independent method claim. It requires:

• A membrane with an effective area and circumferential collar.
• Surface contact between the weld region and the carrier.
• A welding electrode having a closed cross section.
• Pressure applied by the electrode against the collar.
• Resistance welding around the collar.

The claim is directed to the production process rather than merely to the finished nebulizer. That distinction matters because process infringement may occur inside a manufacturing facility even when the finished-device structure is difficult to distinguish from competing products.

Claim 5 compared with dependent process claims

Claim	Additional requirement
5	Closed-cross-section electrode and resistance welding
6	Medium-frequency or capacitor-discharge welding in a protective gas atmosphere
7	Relative rotation and repeat welding, with rotation of less than 360° or a circle multiple
8	Membrane contacts the nebulization side of the carrier
9	Resistance and/or current measurement for direct quality control

Claim 7 is particularly manufacturing-specific. It addresses partial circumferential welds or repeated weld passes achieved through relative rotation between the electrode and the membrane-carrier laminate.

Claim 9 may reach automated production lines that monitor electrical resistance or current during the weld cycle and use that data for quality control. The claim does not require a particular threshold, algorithm, sensor, or rejection rule in the text supplied. Its practical scope therefore turns on how “direct quality control” is construed and how the monitoring is used in the process.

What is the claim hierarchy and likely infringement path?

A claimant would normally begin with claims 1 and 5 because they are independent.

Apparatus infringement

For a finished product, the primary route would be:

• Claim 1 for the membrane nebulizer.
• Claim 4 for an aerosol therapy device containing it.
• Claims 2, 3, and 10-13 for narrower structural configurations.

Claim 4 does not stand independently from claim 1. It requires an aerosol therapy device having a membrane nebulizer according to claim 1. A device that includes a vibrating mesh but lacks the claimed bulged membrane, collar, and resistance weld would not necessarily infringe claim 4.

Process infringement

For manufacturing operations, claim 5 is the principal claim. Claims 6-9 provide narrower alternatives based on:

• Protective gas.
• Specific electrical welding techniques.
• Repeated circumferential welding.
• Orientation of the membrane.
• Electrical process monitoring.

Evidence would likely include welding-equipment specifications, manufacturing protocols, validation documents, batch records, machine recipes, quality-control software, and supplier agreements.

What patents protect vibrating-membrane nebulizers?

The relevant patent landscape is divided into five technical clusters:

Patent cluster	Typical claim focus	Relevance to U.S. Patent 9,168,556
Mesh and membrane geometry	Hole arrangement, membrane curvature, thickness, and active area	Directly relevant
Piezoelectric actuation	Piezo placement, frequency control, mounting, and drive electronics	Partly relevant
Membrane-to-carrier joining	Welding, bonding, sealing, and collar construction	Core overlap
Fluid management	Reservoirs, valves, wicking, dosing, and residual-volume control	Often complementary
Aerosol therapy systems	Breath actuation, sensors, controllers, and dose delivery	Potential system-level overlap

The patent should therefore be assessed as one layer of a broader device estate. It may not block every vibrating-mesh nebulizer, but it can create a manufacturing barrier for a particular membrane-carrier assembly.

Relevant commercial platforms

The principal competitive technologies include:

• PARI eFlow-type vibrating membrane systems.
• Aerogen vibrating-mesh nebulizers.
• Omron vibrating-mesh inhalation systems.
• Philips portable mesh-nebulizer products.
• Other OEM platforms using piezoelectric perforated membranes.

Commercial similarity alone does not establish infringement. The decisive questions are whether the product uses a bulged membrane, a collar contacting a planar carrier, circumferential resistance welding, and the required piezo placement.

Is U.S. Patent 9,168,556 a drug patent?

No. The claims do not cover:

• A chemical compound.
• A biologic.
• A pharmaceutical composition.
• A specific active ingredient.
• A drug concentration.
• A treatment indication.
• A dosing regimen.
• A drug-device combination by active ingredient.

The patent is better classified as a combination medical-device and manufacturing patent. It may be relevant to drug-device products because the nebulizer can deliver inhaled medicines, but it does not independently create exclusivity over those medicines.

What is the Orange Book status of U.S. Patent 9,168,556?

The patent is not the type of patent ordinarily listed in the FDA Orange Book as a drug-substance, drug-product, or method-of-use patent. Orange Book listing generally concerns approved drug products and patents submitted by the NDA holder under the Hatch-Waxman framework. A standalone nebulizer manufacturing patent normally does not create an Orange Book Paragraph IV pathway.

The patent may become commercially relevant in a generic-drug dispute if:

• The approved product requires a specific patented nebulizer.
• The NDA holder lists an eligible device-related patent.
• The generic applicant must use an equivalent delivery device.
• The patent is asserted separately in district court or an International Trade Commission proceeding.

That scenario is different from a conventional Paragraph IV challenge to a small-molecule drug patent.

When does U.S. Patent 9,168,556 lose exclusivity?

The patent term cannot be reliably calculated from the grant number alone. U.S. patent term depends on the earliest effective nonprovisional priority date, any terminal disclaimer, patent-term adjustment, and patent-term extension. The grant date, November 3, 2015, is not the expiration date.

For a standard utility patent, the baseline term is generally 20 years from the earliest effective U.S. nonprovisional or international filing date, subject to statutory adjustments under 35 U.S.C. § 154. A complete term analysis must examine the patent’s continuity data and USPTO Patent Center record.

The practical exclusivity date is the later of:

1. The calculated statutory expiration date; or
2. Any applicable patent-term adjustment or extension,

subject to terminal-disclaimer limitations.

Are there Paragraph IV challenges or biosimilar risks?

Paragraph IV risk

The claims are unlikely to generate a conventional Paragraph IV challenge because they are not directed to a listed drug product. A generic-drug applicant could still face a device patent assertion if the reference-listed drug uses the patented nebulizer and the generic product adopts the same architecture.

The likely legal mechanisms would be:

• District-court infringement litigation.
• Declaratory-judgment litigation.
• Contract or supply-chain disputes.
• Potential trade-secret claims concerning manufacturing methods.
• Patent exhaustion arguments involving component sales.

Biosimilar risk

Biosimilar litigation is not directly relevant. Biosimilars concern biological products and regulatory approval under the Biologics Price Competition and Innovation Act. Patent 9,168,556 claims a mechanical aerosol-delivery system, not a biologic molecule or biologic manufacturing process. It could matter only indirectly if a biologic is administered through a nebulizer incorporating the patented assembly.

What generic launch scenarios exist?

Scenario	Risk under this patent	Commercial outcome
Generic uses a different inhaler or nebulizer	Low direct risk	Launch may proceed if drug patents are clear
Generic uses vibrating mesh but adhesive-bonds the membrane	Reduced literal infringement risk	Requires technical and doctrine-of-equivalents review
Generic uses flat membrane geometry	Reduced claim 1 risk	May still face other device patents
Generic uses the same collar and resistance weld	High risk	Patent litigation exposure
Generic copies the manufacturing process	High process-claim risk	Discovery may focus on factory records
Generic uses a licensed OEM device	Contract and license terms control	Patent exhaustion and indemnity become important

The strongest design-around strategy is to change the membrane attachment method and geometry together. Changing only the welding energy source may not be sufficient if the finished product retains other claim limitations and the patent owner pursues equivalents.

What manufacturing and intellectual-property barriers matter most?

The principal barrier is not the existence of a perforated membrane alone. It is the integration of:

• A bulged membrane.
• A collar-shaped perimeter.
• Surface contact with a planar carrier.
• Circumferential electrical welding.
• A piezo element mounted to the carrier.
• Controlled assembly orientation.

The manufacturing claims may be harder to detect from the finished product. They can be important in supplier due diligence because an OEM may use the claimed process while the branded product owner lacks detailed manufacturing visibility.

A freedom-to-operate review should separate:

1. Product architecture.
2. Welding equipment and process parameters.
3. Membrane and carrier supplier documentation.
4. Piezo attachment configuration.
5. Quality-control instrumentation.
6. Foreign counterpart claims.
7. Continuation and divisional patent families.

How does this patent compare with broader nebulizer patent estates?

U.S. Patent 9,168,556 is narrower than a broad platform patent claiming any vibrating-mesh nebulizer. Its value is concentrated in assembly and manufacturing control.

Estate type	Breadth	Typical enforcement evidence
Broad vibrating-mesh platform patent	High	Product teardown and technical testing
Membrane-hole geometry patent	Medium to high	Microscopy and dimensional analysis
Piezo-drive patent	Medium	Circuit and control-system review
Membrane-carrier welding patent	Narrower but manufacturing-specific	Teardown plus factory discovery
Dose-control software patent	Variable	Firmware and system-operation evidence

Its strongest commercial value is likely defensive or supply-chain oriented. A company can avoid a broad platform patent yet still encounter this patent if it adopts the same welded membrane assembly.

What litigation and settlement issues should be monitored?

A diligence review should search for:

• Infringement complaints involving the patent or family members.
• Inter partes review petitions.
• Ex parte reexamination activity.
• Federal Circuit decisions construing “bulged,” “collar,” “surface contact,” or “resistance welding.”
• License agreements involving the patent owner and nebulizer OEMs.
• Settlement agreements containing field-of-use, geographic, or customer restrictions.
• Patent-family continuations with broader or altered claims.

The supplied claim set does not establish that the patent has been litigated, challenged, licensed, or settled. Those matters require review of USPTO Patent Center, PACER, PTAB records, and foreign family registers.

Key Takeaways

• U.S. Patent 9,168,556 is a vibrating-membrane nebulizer and manufacturing patent, not a drug patent.
• Claim 1 requires a bulged perforated membrane, collar, planar carrier, circumferential resistance weld, and carrier-mounted piezo element.
• Claims 5-9 protect a specific resistance-welding manufacturing process, including electrode geometry, protective gas, repeated welding, orientation, and electrical quality monitoring.
• Claims 3 and 10-12 narrow protection by collar-contact area, reaching thresholds below 96, 80, 40, and 20 mm².
• Claim 13 narrows the assembly by requiring collar contact and piezo placement on the nebulization side.
• Orange Book, Paragraph IV, and biosimilar issues are generally indirect because the patent does not claim a drug or biologic.
• The main competitive risk concerns vibrating-mesh products manufactured with the same membrane-carrier welding architecture.
• A credible freedom-to-operate opinion must review the complete patent family, continuity chain, terminal disclaimers, current USPTO status, and litigation record.

FAQs About U.S. Patent 9,168,556

Can a vibrating-mesh nebulizer infringe U.S. Patent 9,168,556 without using the same brand?

Yes. Patent infringement turns on claim limitations, not branding. A third-party product may infringe if it uses the claimed membrane, collar, carrier, resistance weld, and piezo configuration.

Does adhesive bonding avoid this patent?

It may avoid literal infringement of the resistance-welding limitation, but other patents may still apply. The doctrine of equivalents and the exact adhesive-joint structure would also require review.

Does the patent cover all piezoelectric nebulizers?

No. The claims are limited to a specific membrane-and-carrier construction. Piezoelectric actuation by itself is insufficient.

Can a supplier be liable for practicing the claimed welding method?

Potentially. A supplier that performs every step of an asserted method claim may face direct infringement allegations. Liability depends on the evidence, claim construction, jurisdiction, and any license or indemnification arrangement.

Does the patent block inhaled drugs delivered through a nebulizer?

No, not by itself. The patent does not claim a drug or treatment method. It may affect the device used to administer an inhaled drug.

References

1. United States Patent and Trademark Office. (2015). U.S. Patent No. 9,168,556, Membrane nebuliser and method for manufacturing a membrane nebuliser. U.S. Department of Commerce.

2. United States Patent and Trademark Office. (n.d.). Patent term adjustment. U.S. Department of Commerce. https://www.uspto.gov/patents/laws/patent-term-adjustment

3. United States Code. (2024). 35 U.S.C. § 154: Contents and term of patent; provisional rights. Office of the Law Revision Counsel. https://uscode.house.gov/

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Center for Drug Evaluation and Research.

5. U.S. Food and Drug Administration. (2024). Purple Book: Database of licensed biological products. Center for Biologics Evaluation and Research.

Drugs Protected by US Patent 9,168,556

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	9,168,556		Y

Foreign Priority and PCT Information for Patent: 9,168,556

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	10 2009 026 636	Jun 2, 2009

PCT Information
PCT Filed	June 02, 2010	PCT Application Number:	PCT/EP2010/057718
PCT Publication Date:	December 09, 2010	PCT Publication Number:	WO2010/139730

International Family Members for US Patent 9,168,556

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Germany	102009026636
European Patent Office	2437896
Spain	2552641
World Intellectual Property Organization (WIPO)	2010139730