Details for Patent: 8,978,647

Which drugs does patent 8,978,647 protect, and when does it expire?

Patent 8,978,647 protects ONZETRA XSAIL and is included in one NDA.

This patent has nine patent family members in six countries.

Summary for Patent: 8,978,647

Title:	Nasal delivery
Abstract:	A nasal delivery device for and method of delivering substance to a nasal cavity of a subject, the delivery device comprising: a nosepiece for fitting to a nostril of a subject, wherein the nosepiece comprises a tip element which includes a delivery aperture from which substance is in use delivered into the nasal cavity, and the tip element is at least in part tapered such as to be inclined to a longitudinal axis of the nosepiece, with the delivery aperture extending both laterally across the tip element and along a longitudinal extent of the tip element; a nozzle through which substance is in use delivered, preferably substantially axially to a longitudinal axis of the nosepiece, to the respective nasal cavity; and a delivery unit for delivering substance through the nozzle of the nosepiece.
Inventor(s):	Per Gisle Djupesland, Colin David Sheldrake
Assignee:	Optinose Inc
Application Number:	US12/594,361
Patent Claim Types: see list of patent claims	Delivery; Device;

US Patent 8,978,647: Scope, Claims, Expiration, and Nasal-Device Patent Landscape

US Patent 8,978,647 protects a nasal delivery device and a corresponding nosepiece with a geometrically asymmetric tip and delivery aperture. The core inventive concept is a nosepiece that expands or engages the nasal cavity in the sagittal plane while delivering a liquid, powder, aerosol, or exhalation-driven substance through an aperture extending both laterally and longitudinally across the tip. The patent is directed to device architecture, not a pharmaceutical active ingredient.

The strongest enforceable scope is concentrated in independent claims 1 and 48. Claims 2-47 and 49-51 add alternative structural features involving expansion, inflation, aperture geometry, spray profile, mouthpiece-assisted exhalation, and nasal-valve positioning.

What does US Patent 8,978,647 cover?

US 8,978,647 covers two related subject-matter groups:

1. A complete nasal delivery device under claim 1.
2. A standalone nosepiece under claim 48.

The patent does not require a specific drug, formulation, therapeutic indication, or active pharmaceutical ingredient. It can apply to devices delivering liquid sprays, powder sprays, aerosol sprays, or single jets if the claimed structural limitations are present.

Core elements of claim 1

Claim 1 requires all of the following:

Claim element	Technical scope
Nasal delivery device	A device for delivering a substance into a nasal cavity
Nosepiece	Fits into a nostril
Tip element	Includes the delivery aperture
Tapered or inclined tip	At least part of the tip is inclined relative to the longitudinal axis
Extended delivery aperture	The aperture extends laterally across the tip and along the tip's longitudinal extent
Differential tip lengths	Forwardmost and rearwardmost sections have different lengths
Nozzle	A nozzle delivers the substance
Delivery unit	A unit delivers the substance through the nozzle

The independent claim is therefore a combination claim. A competing product must satisfy the entire combination to literally infringe claim 1. A device with a conventional circular nasal nozzle, a symmetric tip, or an aperture that does not extend along the longitudinal tip direction may avoid literal infringement of the independent claim.

Core elements of claim 48

Claim 48 is narrower in some respects and broader in others. It claims a nosepiece rather than the complete delivery device. It requires:

• A tip element;
• A delivery aperture;
• A tip inclined relative to the nosepiece axis;
• An aperture extending laterally and longitudinally across the tip; and
• A forwardmost tip section longer than the rearwardmost section.

Claim 48 does not expressly require the delivery unit recited in claim 1. This creates potential importance for interchangeable nosepieces, disposable interfaces, and third-party delivery platforms.

How do claims 1 and 48 differ?

Claim 1 is directed to a complete nasal delivery device. Claim 48 is directed to the nosepiece itself.

Issue	Claim 1	Claim 48
Complete device required	Yes	No
Nosepiece required	Yes	Yes
Delivery unit required	Yes	No express requirement
Differential forward/rearward tip length	Yes, but alternatives appear in dependent claims	Yes
Forward section expressly longer	Not in claim 1 itself	Yes
Potential target	Integrated device manufacturers	Nosepiece and component suppliers
Main vulnerability	Multiple limitations create design-around opportunities	Geometry is narrower but component-focused

Claim 48 may create greater component-level exposure because a nosepiece supplier could be accused without supplying the entire delivery platform. Its scope remains limited by the specific aperture and tip geometry.

What dependent claims add to the patent scope?

How do claims 2-8 protect nasal-cavity engagement?

Claims 2-8 cover an elongate lateral section configured to engage the upper and lower surfaces of the nasal cavity. The tip may expand the nasal cavity in the sagittal plane and may be:

• Elliptical;
• Rectangular;
• Rigid;
• Semi-rigid; or
• Flexible.

Claim 8 covers a soft resilient outer body supported by an inner structural body. This reaches a layered nosepiece construction in which a compliant external surface provides patient contact while an internal member provides mechanical support.

These claims are useful against devices that intentionally shape or widen the nasal valve or nasal cavity rather than merely placing a conventional spray nozzle at the nostril entrance.

What do claims 9-16 protect about expandable and inflatable tips?

Claims 9-16 cover mechanisms that change the lateral shape of the nosepiece after insertion.

The principal alternatives are:

1. A flexible tubular tip expanded by axial insertion force;
2. A delivery aperture that remains closed until the tip expands;
3. A coil that changes from a flat configuration to an expanded configuration;
4. Multiple elongate elements that displace relative to one another; and
5. An inflatable tip with an inflation chamber, including an annular chamber surrounding the delivery aperture.

This group is directed to controlled deployment. The delivery aperture may be substantially closed before insertion and opened only after expansion or inflation. That feature can reduce leakage, protect the aperture during handling, and control the position of the spray within the nasal cavity.

A competing device using a permanently open aperture may avoid claims requiring a normally closed and subsequently opened aperture. A device using radial expansion without axial insertion force may also avoid some claims directed to the coil and elongate-element mechanisms.

What do claims 17-26 protect about aperture geometry?

Claims 17-19 cover an asymmetric delivery aperture. The claimed shapes include:

• Teardrop shapes;
• Triangular shapes;
• Narrower forward sections; and
• Wider rearward sections.

Claims 23-25 address the ratio between forwardmost and rearwardmost tip lengths:

• Less than 2:1;
• Greater than 2:1; or
• About 2:1.

Claims 20-22 add a base section and shoulder. The shoulder may seal against the nare and provide a gripping surface for the patient.

Claims 26 and 27 cover a forward aperture section extending substantially orthogonally to the longitudinal axis and a nozzle integrally formed with the tip.

The aperture and tip-ratio claims provide measurable design limitations. They also create a practical freedom-to-operate path because a manufacturer can change the ratio, symmetry, angular orientation, or location of the aperture.

What do claims 28-42 protect about sprays and nasal positioning?

Claims 28-30 cover:

• Single liquid jets;
• Single powder jets; and
• Aerosol sprays.

Claims 31-40 focus on an asymmetric spray profile. The spray must have a greater angle in the vertical or sagittal plane than in the orthogonal plane. The dependent thresholds range from:

Spray characteristic	Claimed threshold
Sagittal-plane angle	Greater than about 35°, 40°, 45°, or 50°
Orthogonal-plane angle	Not more than about 35°, 30°, 25°, 20°, or 15°

These claims are directed to spray-pattern engineering rather than only mechanical shape. In an infringement analysis, spray-angle testing would likely be material. A device could avoid these claims by using a substantially symmetric spray profile, even if its nosepiece geometry is similar.

Claim 42 requires the nosepiece to extend into the nasal valve. This limitation may require anatomical and dimensional evidence, including the intended insertion depth and actual placement during use.

What do claims 43-46 protect about exhalation delivery?

Claims 43 and 44 add a mouthpiece and flow channel. The user exhales through the mouthpiece, causing closure of the oropharyngeal velum, while exhaled air is directed through the nosepiece.

This is the exhalation-driven nasal delivery configuration associated with Optinose's Exhalation Delivery System technology and XHANCE. The claims supplied here do not require a particular drug or treatment indication. They focus on the physical airflow path and patient-operated delivery mechanism.

Claims 45 and 46 add manual actuation and substantially axial delivery.

What is the patent's likely expiration date?

US 8,978,647 was issued on March 17, 2015. The patent's base term depends on the earliest effective nonprovisional filing date in its priority chain, not simply the date of grant or any provisional filing. The patent is part of a nasal-delivery patent family associated with Optinose technology and has an expected ordinary term extending into the late 2020s, subject to the USPTO's recorded patent-term adjustment and any terminal disclaimer.

The controlling records for a transactional expiration analysis are:

• The face of US 8,978,647;
• The continuity and priority data in USPTO Patent Center;
• The patent-term adjustment entry;
• Any terminal disclaimer; and
• Any post-grant legal-status event.

A patent expiration date cannot be calculated reliably from the claim text alone. For licensing, acquisition, or litigation, the USPTO term record should control over third-party patent databases.[1]

What is the Orange Book status of US 8,978,647?

US 8,978,647 is a device patent. It does not claim a drug substance, drug formulation, method of treatment, or therapeutic use.

The patent therefore has no standalone Orange Book status merely because it covers a nasal delivery device. Orange Book listing is product-specific and depends on whether an NDA holder submitted the patent for an approved drug product under FDA patent-listing rules.[2]

Does the patent create Paragraph IV risk?

Not by itself.

A Paragraph IV certification arises when an ANDA applicant addresses a patent listed for the reference drug in the Orange Book. A device-only patent that is not listed for the reference product does not independently create an ANDA Paragraph IV barrier.

If the patent were listed for a drug-device combination product, an ANDA applicant could potentially address it. The relevant analysis would then depend on:

• The Orange Book listing;
• Whether the ANDA uses the claimed device;
• Whether the listed patent claims the approved product;
• The applicant's certification; and
• Any resulting patent litigation.

The claims supplied do not identify fluticasone, another corticosteroid, or any other active ingredient. They therefore do not independently create pharmaceutical exclusivity.

What drug products and FDA approvals are commercially relevant?

The commercial product most closely associated with the exhalation-driven architecture is XHANCE, fluticasone propionate exhalation delivery system, marketed by Optinose. FDA approved XHANCE in 2017 for the treatment of chronic rhinosinusitis with or without nasal polyps in adults.[3]

US 8,978,647 is broader than XHANCE in one respect because it does not require fluticasone. It is narrower in another respect because it requires particular nosepiece geometry and aperture orientation.

Product or technology	Relevance to US 8,978,647
XHANCE	Closest commercial exhalation-delivery product
Conventional steroid nasal sprays	Usually lack the claimed nosepiece geometry and mouthpiece airflow path
Saline and irrigation devices	May use different flow and nozzle architectures
Powder nasal delivery systems	Could implicate claims 28-29 or 41 if the structural limitations are present
Generic fluticasone sprays	Drug-device equivalence does not automatically establish infringement

Which companies are relevant to the competitive patent landscape?

The relevant competitive groups are:

Exhalation-driven nasal delivery companies

Optinose is the central commercial participant associated with exhalation delivery through a nasal device. Its patent portfolio has included device architecture, airflow control, patient positioning, formulations, and therapeutic-use claims.

Nasal spray device manufacturers

Aptar Pharma, Nemera, Bespak, and other inhalation and nasal-delivery component manufacturers supply pump, actuator, nozzle, and container-closure systems. Their conventional products often use circular or oval nozzles that may avoid the specific asymmetric tip and aperture limitations in US 8,978,647.

Nasal powder and specialty delivery developers

Companies developing intranasal powders, vaccines, peptides, and systemic-delivery products may encounter the patent if they use an elongate, expandable, or asymmetric nasal tip. The risk depends on the physical device rather than the active ingredient.

How strong is the patent estate?

The patent has moderate technical strength and moderate design-around exposure.

Strengths

• Two independent claim formats target both a complete device and a nosepiece.
• The claims identify concrete structural features.
• The aperture extends in two dimensions, which distinguishes ordinary point or circular nozzles.
• The patent covers rigid, flexible, expandable, inflatable, and mechanically deployable tip configurations.
• Spray-pattern claims add measurable performance limitations.
• Claim 48 can reach a nosepiece supplied separately from the delivery unit.

Weaknesses

• Claim 1 contains numerous cumulative limitations.
• The claims rely on relative terms such as "substantially," "about," "at least in part," and "differing lengths."
• Several dependent claims present overlapping or alternative configurations.
• Claims 23-25 cover less than, greater than, and approximately 2:1 ratios, which may create construction and prosecution-history issues.
• A competitor can potentially redesign the tip aperture, spray profile, expansion mechanism, or tip-length ratio.
• The patent does not cover the active pharmaceutical ingredient or the therapeutic indication.

What generic launch scenarios create the greatest risk?

Scenario 1: Conventional nasal spray

Risk is comparatively low if the product uses a standard circular actuator, a permanently open nozzle, and no sagittal expansion. It may not satisfy the claimed tip geometry.

Scenario 2: Generic or follow-on product using the XHANCE device architecture

Risk is high if the product copies the exhalation flow path, mouthpiece, axial delivery, nasal-valve insertion, and asymmetric nosepiece. The applicant would need a claim-by-claim device comparison, not only an active-ingredient comparison.

Scenario 3: Powder delivery device with an asymmetric expandable nosepiece

Risk is potentially significant under claims 28-29 and 41, even though the delivered substance is powder rather than liquid. The patent is substance-agnostic.

Scenario 4: Device using the same nosepiece but a different drug

Changing the drug generally would not avoid claims 1 or 48 because the independent claims do not require a particular active ingredient.

Scenario 5: Device with different spray geometry

A device can reduce risk under claims 31-40 by using a symmetric spray or by remaining outside the claimed sagittal and orthogonal spray-angle thresholds. That change does not necessarily avoid claims 1 or 48 if the nosepiece geometry remains identical.

What patent litigation and settlement issues matter?

A litigation review should focus on:

• Whether US 8,978,647 was asserted against a nasal-device manufacturer;
• Whether the patent was included in a patent-infringement action involving XHANCE;
• Any claim-construction ruling concerning "delivery aperture," "tip element," "forwardmost," "rearwardmost," "sagittal," or "nasal valve";
• Any prosecution disclaimer narrowing the aperture or tip geometry;
• Terminal disclaimers and patent-term adjustments;
• Any settlement or license covering the device family.

The claim text alone does not establish an active infringement case, a Paragraph IV dispute, or a settlement agreement. Device patent litigation also may proceed under a different family member even when the commercial product is associated with the same technology.

What geographic coverage does the patent provide?

US 8,978,647 provides protection only in the United States. International protection would require separate national or regional patents in the relevant family.

The commercial freedom-to-operate analysis should separately review:

• Europe and the European Patent Office;
• The United Kingdom;
• Canada;
• Australia;
• Japan;
• China; and
• Any market where the device is manufactured, assembled, imported, or sold.

Manufacturing outside the United States does not necessarily eliminate US infringement risk if the claimed device is imported into, sold in, or used in the United States.

What manufacturing and IP barriers remain after expiration?

The patent's most important manufacturing barriers are not necessarily patent-based. They include:

• Precision molding of asymmetric tip structures;
• Reliable control of aperture dimensions;
• Biocompatible flexible and resilient materials;
• Repeatable expansion or inflation behavior;
• Spray-angle consistency;
• Device-to-drug compatibility;
• Sterilization and packaging;
• Human-factors validation; and
• FDA combination-product requirements.

A competitor may avoid literal infringement but still face FDA comparability, usability, manufacturing-validation, and supplier qualification hurdles.

Key Takeaways

• US 8,978,647 is a nasal-device and nosepiece patent, not an active-ingredient patent.
• Claims 1 and 48 are the principal independent claims.
• The core combination is an inclined or tapered tip, a laterally and longitudinally extending delivery aperture, and unequal forward and rearward tip lengths.
• Dependent claims cover expandable, inflatable, coil-based, multi-element, and soft-shell nosepieces.
• Other claims address asymmetric aperture shapes, spray angles, nasal-valve insertion, and exhalation through a mouthpiece.
• The patent can apply to liquid, powder, aerosol, and single-jet delivery.
• Orange Book and Paragraph IV relevance is product-specific and does not arise automatically from this device patent.
• The patent is most relevant to products using Optinose-style exhalation delivery or a similarly shaped nasal interface.
• The main design-around routes are changing aperture geometry, tip-length ratios, expansion mechanics, spray profile, and exhalation architecture.
• The expected patent term extends into the late 2020s, with the exact expiration controlled by USPTO term and continuity records.

FAQs

Does US 8,978,647 cover fluticasone propionate?

No. The claims do not recite fluticasone propionate or any other active ingredient. They cover nasal delivery hardware and related mechanical and airflow configurations.

Can a generic nasal spray infringe US 8,978,647 without using a mouthpiece?

Yes. Claims 1 and 48 do not require a mouthpiece. Claims 43 and 44 separately address mouthpiece-assisted exhalation.

Does changing a liquid spray to a powder avoid the patent?

No. Claims 28, 29, and 41 expressly contemplate powder delivery. The device geometry remains the principal issue.

Is an asymmetric spray angle required for all claims?

No. The asymmetric spray-angle limitations appear in claims 31-40. Claims 1 and 48 focus on the nosepiece and aperture geometry and do not require a particular spray-angle profile.

Can a nosepiece supplier face infringement exposure separately from the device manufacturer?

Potentially. Claim 48 is directed to a nosepiece and does not expressly require the complete delivery unit recited in claim 1. Liability would depend on the supplied structure, accused activity, and applicable infringement theory.

References

1. United States Patent and Trademark Office. (2015). U.S. Patent No. 8,978,647, Nasal delivery device.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book.
3. U.S. Food and Drug Administration. (2017). XHANCE (fluticasone propionate) nasal spray prescribing information.
4. United States Patent and Trademark Office. (2024). Manual of Patent Examining Procedure, patent term and patent adjustment provisions.

Drugs Protected by US Patent 8,978,647

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Azurity	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	8,978,647		Y

Foreign Priority and PCT Information for Patent: 8,978,647

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0706863.8	Apr 5, 2007

PCT Information
PCT Filed	April 07, 2008	PCT Application Number:	PCT/GB2008/001217
PCT Publication Date:	October 16, 2008	PCT Publication Number:	WO2008/122791

International Family Members for US Patent 8,978,647

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Denmark	2136865
European Patent Office	2136865
European Patent Office	3777939
Spain	2829915
Spain	2947933