Details for Patent: 10,688,518

« Back to Dashboard

Which drugs does patent 10,688,518 protect, and when does it expire?

Patent 10,688,518 protects LONHALA MAGNAIR KIT and is included in one NDA.

This patent has seven patent family members in five countries.

Summary for Patent: 10,688,518

Title:	Method of manufacturing a vibratable head for an aerosol generator and vibratable head for an aerosol generator
Abstract:	The invention relates to a method of manufacturing a vibratable head (1) for an aerosol generator (2), the vibratable head (1) comprising a support member (4), a vibratable membrane (6) supported by the support member (4) and a vibrator (8) configured to vibrate the vibratable membrane (6). The method comprises the steps of providing the support member (4), roughening a surface portion (10) of the support member (4) by laser structuring, applying an adhesive (9) to at least a part of the roughened surface portion (10) of the support member (4) and attaching at least one element to the support member (4) by at least a portion of the adhesive (9). Further, the invention relates to a vibratable head (1) manufactured by this method, an aerosol generator (2) comprising such a vibratable head (1) and a method of manufacturing such an aerosol generator (2).
Inventor(s):	Hans-Lukas Anzenberger, Nicole Brune, Durdica Benko
Assignee:	PARI Pharma GmbH
Application Number:	US15/749,847
Patent Claim Types: see list of patent claims	Use;

United States Patent 10,688,518: Claim Scope, Exclusivity, and Aerosol-Generator Patent Landscape

U.S. Patent No. 10,688,518 protects a laser-roughened adhesive interface used to manufacture a vibratable head for an aerosol generator, including vibrating-mesh nebulizers. The patent is directed to device construction and manufacturing, not to an active pharmaceutical ingredient, drug formulation, therapeutic indication, or dosing regimen. Its strongest protection is concentrated in the combination of laser structuring, adhesive bonding, and a vibratable membrane assembly.

The independent claims are claim 1, covering a manufacturing method, and claim 9, covering the resulting vibratable head. Claim 8 extends the manufacturing-method protection to an aerosol generator. Claim 13 covers an aerosol generator containing a head in which adhesive covers the entire laser-roughened support-member surface. [1]

What does U.S. Patent 10,688,518 protect?

The patent protects a specific bonding architecture for a vibratable aerosol-generating head. The required components are:

1. A support member.
2. A vibratable membrane supported by the support member.
3. A vibrator configured to vibrate the membrane.
4. A support-member surface portion roughened by laser structuring.
5. Adhesive applied to at least part of that roughened surface.
6. Attachment of the vibrator and/or membrane to the support member through the adhesive.

The claim does not cover every vibrating-mesh nebulizer. A competing product that uses a smooth support surface, mechanical fixation, welding, brazing, soldering, or a non-laser surface treatment would not satisfy the literal limitations of claim 1 or claim 9.

The core inventive concept is the laser-generated surface topography. The claims connect that topography to adhesive bonding of the vibrator or membrane. A laser-roughened surface used for another purpose, without the claimed adhesive attachment, would fall outside the express combination.

How do the independent claims differ?

Claim	Claim type	Protected subject matter	Principal limitation
1	Method	Manufacturing a vibratable head	Laser roughening followed by adhesive attachment
8	Method	Manufacturing an aerosol generator	Requires manufacture of the head under claim 1 and housing accommodation
9	Product	Vibratable head	Structural head with laser-roughened support surface and adhesive attachment
13	Product	Aerosol generator	Requires the claim 10 head, including adhesive over the entire roughened support surface

Claim 1 is a process claim. It is directed to the steps performed during manufacture, including providing the support, laser roughening, applying adhesive, and attaching the vibrator and/or membrane.

Claim 9 is a product claim. It recites the resulting head using structural and functional language. It does not require proof of every manufacturing step if the accused product itself has the claimed laser-roughened surface and adhesive interface.

Claim 8 is narrower than claim 1 because the method must also include at least partially accommodating the head in a housing.

Claim 13 is narrower than claim 9 because it depends on claim 10. The adhesive must be applied to the entire roughened surface portion, and the completed assembly must be housed as an aerosol generator.

What are the dependent-claim limitations?

Claims 2 and 10: adhesive coverage

Claims 2 and 10 require adhesive across the entire roughened surface portion. These claims may be easier to design around than the broader independent claims because partial adhesive coverage is sufficient for claims 1 and 9.

Their commercial relevance depends on the accused manufacturer’s adhesive-dispensing process. Screen printing, dispensing, spray coating, transfer coating, or automated bead application could produce materially different coverage patterns. Documentation showing full coverage could support infringement of claims 2, 10, and 13.

Claims 3 and 11: pulsed laser beam

These claims limit the laser structuring process to a pulsed laser beam. A continuous-wave laser process may avoid these limitations, although it could remain within claim 1 or claim 9 if the other limitations are met.

The pulsed-laser limitation is useful for narrowing prosecution and validity disputes. It also creates a technical diligence point: a buyer or competitor would need to identify the laser source, pulse mode, wavelength, power, and processing records.

Claim 4: relative speed of 500 to 10,000 mm/s

Claim 4 specifies relative movement between the support member and laser beam at 500 to 10,000 mm/s. This is a process parameter, not a product limitation. It is therefore more relevant to direct process infringement than to examination of a finished nebulizer.

A production line operating below 500 mm/s or above 10,000 mm/s may avoid claim 4 while remaining exposed under claim 1. The range also creates potential prosecution-history and enablement issues if the patent specification does not adequately support the full operating interval.

Claim 5: metal, preferably stainless steel

Claim 5 requires a metal support member, with stainless steel identified as the preferred material. “Preferably” does not ordinarily convert stainless steel into a mandatory limitation. A metal support made from aluminum, titanium, nickel alloy, or another conductive material could fall within claim 5 if the claim construction treats the limitation as “metal.”

A polymer support would generally avoid claim 5 but could still fall within claims 1 or 9, which do not require metal.

Claims 6 and 11: laser-roughened membrane

These claims require laser structuring of a surface portion of the vibratable membrane in addition to the laser-roughened support member. They target a more complex bonding interface and may be particularly relevant where the membrane is separately attached to a metal ring or frame.

Claims 7 and 12: integral membrane and support

These claims require the vibratable membrane to be formed integrally with the support member. An integral construction may reduce exposure to these claims if the membrane and support are separate parts joined by adhesive. It may also increase exposure where the assembly uses a one-piece metal membrane-support structure.

How strong is the patent estate for the claimed technology?

The identified patent provides focused protection rather than broad platform protection.

Strength factor	Assessment
Technical specificity	High
Breadth of independent claims	Moderate
Dependence on laser processing	Creates a clear design-around path
Dependence on adhesive bonding	Excludes many mechanical and metallurgical joining methods
Product-claim value	Significant for imported or sold finished heads
Process-claim value	Dependent on access to manufacturing evidence
Pharmaceutical composition coverage	None
Method-of-use coverage	None
Manufacturing know-how relevance	High
Risk to conventional drug-generic manufacturers	Low
Risk to vibrating-mesh nebulizer manufacturers	Potentially material

The patent does not claim aerosolized drug particles, drug-device combinations, inhalation treatment, aerosol droplet size, dosage, active ingredients, or pharmaceutical formulations. Its value is concentrated in the hardware supply chain.

The use of “and/or” in claims 1 and 9 broadens the attachment requirement. Attachment of the vibrator alone, the membrane alone, or both components can satisfy the language, assuming the remaining limitations are met.

What manufacturing processes create infringement risk?

A manufacturer faces the highest risk when its process has all of the following characteristics:

• A metal support member, particularly stainless steel.
• Laser texturing or laser roughening of a bonding surface.
• Adhesive applied after laser treatment.
• Attachment of a piezoelectric vibrator or vibratable membrane.
• A separate mesh membrane bonded to a support ring.
• A finished head placed into a nebulizer housing.

The relevant evidence may exist in manufacturing work instructions, laser recipes, equipment logs, adhesive specifications, supplier drawings, quality-control records, and process-validation reports.

A product-only infringement theory may be stronger than a method theory where the defendant imports or sells a completed head. A process claim may require evidence that the claimed steps were performed in the United States. U.S. patent law separately addresses making, using, offering for sale, selling, and importing patented inventions, as well as induced and contributory infringement. [2]

What design-around options exist?

Potential design-around routes include:

1. Replacing laser roughening with chemical etching, abrasive blasting, plasma treatment, anodizing, knurling, or micro-machining.
2. Using a smooth surface with a primer or adhesion promoter.
3. Attaching the vibrator or membrane by welding, soldering, brazing, crimping, clamping, or interference fit.
4. Using a polymer support member where the relevant dependent claims require metal.
5. Applying adhesive only to a smooth region.
6. Using a continuous-wave laser rather than a pulsed laser to avoid claims 3 and 11.
7. Operating outside the 500 to 10,000 mm/s range to avoid claim 4.
8. Forming the membrane and support as a unitary structure or using a different assembly architecture.

These approaches do not automatically avoid claims 1 and 9. The key distinction is whether the surface was “roughened by laser structuring.” A process using laser ablation, laser texturing, laser cleaning, or laser activation could present claim-construction issues if the resulting surface is intentionally roughened for adhesive bonding.

What is the patent expiration date and exclusivity timeline?

U.S. Patent No. 10,688,518 was granted on June 23, 2020. [1] A U.S. utility patent generally has a term of 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, terminal disclaimers, and applicable patent-term extensions. [3]

The grant date alone does not establish the expiration date. The claims supplied do not identify the earliest effective U.S. filing date, any international filing date relied upon for priority, patent-term adjustment, or a terminal disclaimer. No reliable exact expiration date can therefore be calculated from the claim text alone.

Because the patent claims an aerosol-generator component rather than an approved drug, FDA drug exclusivity is not the relevant exclusivity framework. The commercial exclusion period is controlled primarily by the patent term and any enforceable continuation, divisional, or related family rights.

What is the Orange Book status of U.S. Patent 10,688,518?

U.S. Patent 10,688,518 is not the type of patent ordinarily listed in the FDA Orange Book. Orange Book patent listings concern approved drug products and patents claiming the drug substance, drug product, or approved method of use. [4]

This patent claims:

• Manufacturing a vibratable aerosol-generator head.
• The vibratable head itself.
• An aerosol generator containing that head.

It does not claim a drug substance, pharmaceutical composition, dosage form, or method of treating a disease. It therefore does not create a conventional Orange Book Paragraph IV pathway.

Are Paragraph IV challenges or biosimilar challenges relevant?

A Paragraph IV certification is generally used when an abbreviated new drug application applicant challenges a listed patent for a reference drug. [5] That mechanism does not ordinarily apply to a device-manufacturing patent that is not listed against an approved drug product.

Biosimilar litigation is also not directly relevant. Biosimilar applications concern biological products and their reference products. U.S. Patent 10,688,518 is directed to an aerosol-generator structure and manufacturing process, not a biologic molecule or biologic manufacturing method.

A company commercializing an inhaled drug through this type of nebulizer could face separate drug, formulation, device, or combination-product patents. The supplied claims alone do not establish such additional rights.

What FDA regulatory issues affect the patent?

The claimed product is an aerosol generator or nebulizer component. FDA treatment would generally focus on the device classification, substantial equivalence or other applicable pathway, electrical and mechanical safety, biocompatibility, aerosol performance, reliability, and combination-product considerations.

FDA clearance or approval does not eliminate patent infringement risk. Conversely, the patent does not establish FDA approval, clearance, or authorization. Patent rights and regulatory status are separate systems.

A manufacturer could obtain FDA clearance for a nebulizer while still infringing a privately owned device patent. A patent owner could also enforce the patent without having any FDA-listed drug product.

Which companies are likely to be exposed?

Exposure is concentrated among manufacturers and suppliers of vibrating-mesh or vibrating-membrane aerosol systems. Relevant commercial categories include:

• Nebulizer manufacturers.
• Piezoelectric actuator suppliers.
• Mesh-membrane suppliers.
• Contract manufacturers of inhalation devices.
• Companies supplying drug-device combination products.
• Original equipment manufacturers incorporating aerosol heads into portable housings.

Conventional tablet, capsule, injectable, and small-molecule generic manufacturers have little direct exposure unless they control or source the claimed aerosol hardware.

The claims may affect both branded and generic inhalation-device programs. A generic drug developer using a third-party nebulizer should allocate patent diligence to the device supplier, not only to the active ingredient and formulation.

What litigation, licensing, and settlement issues should be assessed?

The claim text does not establish any litigation, license, assignment, covenant not to sue, or settlement agreement. Those rights must be assessed from the current assignment record, family prosecution history, court dockets, and commercial agreements.

The main litigation issues would likely be:

• Whether the accused surface is roughened by laser structuring.
• Whether the adhesive attaches the vibrator, the membrane, or both.
• Whether a product claim can be proven from the finished head.
• Whether the asserted claim requires a separate membrane and support.
• Whether the accused process falls within the pulsed-laser or speed-range limitations.
• Whether prior art discloses laser-textured bonding surfaces in aerosol generators.
• Whether the claims are enabled across the full range of lasers, materials, adhesives, and geometries.

Licensing negotiations would likely focus on field of use, geographic scope, component sales, finished-device sales, minimum royalties, audit rights, and rights to improvements. A license limited to aerosol generators may not cover unrelated laser-roughened adhesive assemblies.

How does this patent compare with drug and formulation patents?

Patent category	Relevance to U.S. 10,688,518
Active-ingredient patent	No overlap
Salt, polymorph, or crystal-form patent	No overlap
Drug-formulation patent	No overlap in the supplied claims
Method-of-use patent	No overlap
Device patent	Direct overlap
Manufacturing-process patent	Direct overlap
Combination-product patent	Possible commercial interaction, but not shown by these claims
Biosimilar patent	Not relevant to the supplied claims
Orange Book-listed patent	Not indicated

The patent may be commercially important even without drug claims because a protected nebulizer head can be a necessary component of a drug-delivery system. Its economic value depends on whether the claimed interface is used by high-volume device suppliers and whether alternative bonding processes meet performance, yield, durability, and regulatory requirements.

What is the geographic coverage?

The supplied patent is a United States patent. Its enforceable scope is limited to the United States. Foreign protection would depend on related national applications in jurisdictions such as Europe, Japan, China, South Korea, Canada, and Australia.

A U.S. claim may affect imported finished aerosol generators or heads because importing a patented product can constitute infringement under Section 271. [2] Foreign manufacture alone does not establish U.S. infringement, but importation, U.S. sale, or U.S. use can create exposure.

A complete global landscape requires review of the patent family and corresponding national grants. The claims supplied do not identify those foreign applications.

Key Takeaways

• U.S. 10,688,518 is a device and manufacturing patent, not a conventional drug patent.
• The central limitation is laser roughening of a support-member surface followed by adhesive attachment of a vibrator and/or vibratable membrane.
• Claims 1 and 9 provide the principal protection.
• Claims 2 through 7 and 10 through 13 narrow the scope through adhesive coverage, pulsed lasers, processing speed, metal supports, laser-treated membranes, integral construction, and housing.
• The patent does not create Orange Book, Paragraph IV, or biosimilar litigation exposure by itself.
• The highest risk falls on vibrating-mesh nebulizer manufacturers, component suppliers, contract manufacturers, and drug-device combination-product developers.
• The most direct design-around strategies replace laser roughening or adhesive bonding with a different surface treatment or joining method.
• The exact expiration date cannot be determined from the supplied claims because patent-term variables and the earliest effective filing date are not stated.
• Foreign patent protection, licensing, assignments, and litigation require family-level and public-record review beyond the claim text.

FAQs

Does U.S. Patent 10,688,518 cover all vibrating-mesh nebulizers?

No. It covers heads and manufacturing methods that use the claimed combination of laser-roughened surfaces and adhesive attachment. A vibrating-mesh nebulizer using another bonding or surface-treatment method may fall outside the claims.

Can a nebulizer avoid infringement by using a nonmetal support?

Possibly. A nonmetal support may avoid dependent claim 5, but claims 1 and 9 do not expressly require metal. The complete structure and manufacturing process must be compared with the independent claims.

Does use of laser cleaning create infringement risk?

It can. If laser cleaning intentionally produces a roughened bonding surface, an argument may arise that the surface was “roughened by laser structuring.” The result, purpose, process parameters, and prosecution history would be important.

Can a company sell the aerosol head without selling the drug?

Yes, but the absence of a drug sale does not eliminate device-patent risk. The patent claims the head and aerosol generator independently of any pharmaceutical composition.

Is a third-party nebulizer license enough for an inhaled-drug developer?

Not necessarily. License scope may be limited to a particular supplier, territory, product family, or field of use. The commercial agreement must cover the relevant patent, component, finished device, and intended market.

References

1. United States Patent and Trademark Office. (2020). U.S. Patent No. 10,688,518, Vibratable head for an aerosol generator and methods of manufacture [Patent claims supplied in the request].
2. United States Code, Title 35, §§ 271, 281-285.
3. United States Code, Title 35, § 154.
4. U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations: Orange Book, 43rd edition.
5. U.S. Food and Drug Administration. (2024). Abbreviated new drug application submissions: Patent certifications and the 30-month stay under the Hatch-Waxman Amendments.

Drugs Protected by US Patent 10,688,518

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			Y

Foreign Priority and PCT Information for Patent: 10,688,518

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	15179487	Aug 3, 2015

PCT Information
PCT Filed	August 03, 2016	PCT Application Number:	PCT/EP2016/068523
PCT Publication Date:	February 09, 2017	PCT Publication Number:	WO2017/021441

International Family Members for US Patent 10,688,518

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2994491
European Patent Office	3127616
European Patent Office	3331650
Spain	2654803
Spain	2828024
Japan	2018525094