Details for Patent: 8,062,264

« Back to Dashboard

Which drugs does patent 8,062,264 protect, and when does it expire?

Patent 8,062,264 protects FLONASE SENSIMIST ALLERGY RELIEF and is included in one NDA.

This patent has twenty-five patent family members in twenty-two countries.

Summary for Patent: 8,062,264

Title:	Fluid dispensing device
Abstract:	A fluid dispensing device for dispensing a fluid product having a dispensing member mounted for movement along an axis X-X from a first position to a second position which causes a dose of a fluid product to be dispensed, and a finger-operable actuator member movable in an actuating direction generally transverse to the axis to cause at least one cam surface thereof to cam the dispensing member from the first position to the second position. The at least one cam surface has a commitment section, oriented at a first angle to the axis selected such that a minimum actuating force is required to be applied to the actuator member to cause the at least one cam follower surface to ride over the commitment section onto the drive section. The commitment section of the cam surface is arcuate.
Inventor(s):	James William Godfrey, Mark Graham Hedley
Assignee:	Glaxo Group Ltd
Application Number:	US11/911,060
Patent Claim Types: see list of patent claims	Formulation; Device;

US Patent 8,062,264: Claim Scope, Patent Landscape, Exclusivity, and Generic Entry Risk

US Patent 8,062,264 protects a mechanically actuated fluid dispenser that converts transverse or arcuate finger movement into axial movement of a dispensing member through a continuously curved cam profile. The core inventive concept is the cam geometry: a concave commitment section transitions into one or more convex drive sections to establish a threshold actuation force and controlled dispensing motion.

The claims are directed primarily to device architecture and mechanical interaction, not to a particular active pharmaceutical ingredient. The strongest infringement risk arises where a competing nasal spray or other fluid dispenser uses a pivotal finger actuator, an axially movable pump container, and a substantially continuous S-shaped cam surface with defined concave and convex radii.

What does US Patent 8,062,264 protect?

The patent protects a fluid dispensing device having four principal elements:

1. A fluid supply and dispensing outlet.
2. A dispensing member that moves along an axis from a first position to a second position.
3. A finger-operated actuator that moves transversely or along an arcuate path.
4. A cam-and-follower interface that converts actuator movement into dispensing-member movement.

Claim 1 adds the critical geometric limitations. The cam surface must include:

• A concavely arcuate commitment section.
• An adjacent convexly arcuate drive section.
• A continuously curved transition between the sections.
• A configuration in which the cam follower rides sequentially across those sections.
• A commitment section that requires a minimum actuating force before the follower moves onto the drive section.

The claims therefore do not cover every lever-operated dispenser. They target a particular force-displacement profile produced by a continuously curved cam.

What is the claim hierarchy?

Claim	Type	Principal limitation
1	Independent	Fluid dispenser with transverse actuator, cam/follower, concave commitment section, convex drive section, continuous curvature, and threshold-force operation
2	Dependent	Commitment-section radius of about 5-20 mm
3	Dependent	Drive section has an arcuate transition subsection contiguous with the commitment section
4	Dependent	Transition subsection radius of about 1-5 mm
5	Dependent	Transition and remainder of drive section have different radii
6	Dependent	First radius about 1-5 mm; second radius about 15-40 mm
7	Dependent	Minimum actuating force about 10-45 N
8	Dependent	Actuator moves along an arcuate path
9	Dependent	Cam tangent angle remains constant or substantially constant during drive
10	Dependent	Actuator pivots about a first end; cam surface is remote from that end
11	Dependent	Dispensing member is the dispensing container
12	Dependent	Upward dispensing direction and lower actuator pivot
13	Dependent	Cam follower is toward the upper end of the dispensing member
14	Dependent	Dispensing container has a pump
15	Dependent	Nozzle is sized for insertion into a nostril
16	Dependent	Supply contains a fluid medicament formulation
17	Independent	Housing, movable dispensing member, lever, and continuously curved cam with concave and two convex constant-radius surfaces
18	Dependent	Third convex surface has a larger radius than the second
19	Dependent	Rounded cam follower
20	Dependent	Cam surface defines an S-shaped curve

Claims 1 and 17 are the principal enforcement claims. Claims 2-16 narrow claim 1. Claims 18-20 narrow claim 17.

How should claim 1 be construed?

Claim 1 is a combination claim. An accused product must satisfy all material limitations of the claim, either literally or under an applicable doctrine-of-equivalents analysis. The relevant limitations are cumulative rather than optional.

Fluid dispensing architecture

The device must dispense a fluid product from an outlet and contain or access a supply of that product. The claim does not require a specific pump technology, formulation, container volume, or therapeutic indication.

Claim 11 broadens the structural implementation by treating the dispensing container itself as the dispensing member. Claim 14 narrows the structure to a container containing a pump that dispenses a dose when the container moves axially.

Transverse actuator movement

The actuator must move in an actuating direction generally transverse to the dispensing axis. Claim 8 expressly covers arcuate actuator movement, and claim 10 identifies a pivotal actuator mounted at one end.

A purely axial push button would present a substantial non-infringement position under the literal language of claim 1 unless it also operates through an equivalent transverse cam arrangement. A rotary knob, sliding button, or flexible membrane would require a separate element-by-element analysis.

Cam and follower interaction

The actuator has the cam surface, while the dispensing member has the cam follower surface. The claim requires the follower to ride on the cam surface as the actuator moves.

This limitation distinguishes a simple linkage, rack-and-pinion mechanism, or direct lever contact unless the relevant contact surfaces perform the claimed camming function. The location of the cam and follower is also significant. Reversing those components may avoid literal infringement, subject to equivalence analysis.

Continuous curvature

The cam must be continuously curved across the commitment and drive sections. A sharp corner, discontinuous step, or flat-to-curve transition may provide a non-infringement argument if the accused geometry does not meet the claimed continuous-curvature limitation.

The specification and prosecution history would control the precise meaning of "continuously curved." The phrase could be litigated over whether it requires geometric continuity only, continuity of tangent direction, or a smoother engineering profile. Claim 17 is more specific because it requires adjoining constant-radius surfaces.

Commitment and drive sections

The commitment section is the initial portion encountered by the follower. Its function is to require a threshold or minimum force before the follower proceeds onto the drive section. The drive section then produces the principal dispensing movement.

The claim does not merely require a cam with any two radii. It requires a functional relationship between geometry and actuation force. A design using a concave region but no threshold-force behavior would be vulnerable to a claim-construction or factual attack on this limitation.

What additional limitations do claims 2 through 16 impose?

The dependent claims create narrower positions that may be important if the broad claims are challenged.

Radius limitations

Claims 2, 4, and 6 impose dimensional ranges:

Feature	Claimed radius
Commitment section	About 5-20 mm
Transition subsection	About 1-5 mm
Remainder of drive section	About 15-40 mm

These ranges may create design-around opportunities. A competitor could alter one or more radii outside the claimed ranges, although that strategy would not avoid claim 1 unless the underlying claim 1 geometry or force relationship is also avoided.

The words "about" introduce tolerance questions. Courts generally assess such terms in light of the specification, prosecution history, measurement method, and technical context. A radius of 20.5 mm cannot automatically be treated as outside the claim.

Force limitation

Claim 7 requires a minimum actuating force of about 10-45 N. Force is likely to depend on:

• Cam geometry.
• Spring rate.
• Pump resistance.
• Friction.
• Container dimensions.
• Temperature.
• Measurement position and speed.
• Whether the device is loaded or empty.

A party evaluating infringement would need a defined test protocol. Different test conditions could materially change the measured force.

Constant-angle drive limitation

Claim 9 requires the tangent at the cam contact point to maintain a constant or substantially constant angle to the dispensing axis while the follower is on the drive section.

This is a functional geometric limitation. It may be difficult to establish from marketing materials alone and may require CAD data, metrology, teardown analysis, or instrumented testing.

Nasal delivery limitation

Claim 15 narrows the device to a nozzle sized and shaped for insertion into a human nostril. This limitation connects the mechanical platform to nasal spray products but does not require a particular drug.

Claim 16 further requires a fluid medicament formulation. Claims 15 and 16 may be relevant to nasal drug-delivery products, while claims 1 and 17 can reach nonmedicated or nonnasal products if their mechanical elements are present.

How does claim 17 differ from claim 1?

Claim 17 is an independent claim with a more structured cam definition. It requires a continuously curved cam having:

1. A first surface of concave constant radius.
2. An adjoining second surface of constant convex radius.
3. An adjoining third surface of constant convex radius.

The follower must ride sequentially across the first, second, and third surfaces. Claim 18 requires the third convex radius to be greater than the second convex radius. Claim 20 characterizes the overall profile as S-shaped.

Claim 17 is narrower in geometric detail but may be stronger against a specific product that uses the claimed three-stage profile. Claim 1 is broader because it refers generally to a concave commitment section and convex drive section without expressly requiring three constant-radius surfaces.

Issue	Claim 1	Claim 17
Number of cam sections	At least commitment and drive sections	Three sequential surfaces
Radius requirement	Ranges appear only in dependent claims	Each named surface has constant radius
Overall shape	Continuous curvature	S-shaped curve under claim 20
Force limitation	Minimum force expressly stated	Threshold force required for transition
Best use	Broad platform claim	More specific geometry claim
Design-around exposure	Higher claim breadth, but more functional disputes	Easier to test geometrically, but narrower

What formulations and products are protected?

The patent is not principally a formulation patent. It does not claim:

• A specific active ingredient.
• A chemical composition.
• A preservative system.
• A particle-size distribution.
• A dosage regimen.
• A therapeutic indication.
• A manufacturing process for the drug substance.

The relevant product claims concern the dispensing device and, in claim 16, a device containing a fluid medicament formulation. The patent can therefore be relevant to nasal sprays, topical dispensers, ophthalmic dispensers, oral liquid dispensers, and other products if the mechanical structure is used.

The strongest product-specific position is the combination of claims 12-16: an upward-moving dispensing container, a lower-end pivotal actuator, an upper cam follower, a pump, and a nostril-insertable nozzle containing a medicament.

What is the Orange Book status of US Patent 8,062,264?

A device patent is not automatically eligible for Orange Book listing. FDA Orange Book listing generally concerns patents submitted by an NDA holder that claim the approved drug substance, drug product, or method of use under the applicable statutory framework. FDA regulations address patent information submitted for approved drug products and associated use patents. [2]

US Patent 8,062,264 appears, based on the supplied claims, to be a mechanical dispensing-device patent rather than a drug-substance, drug-product-composition, or method-of-use patent. Its practical role is more likely to arise through device ownership, supply agreements, product-platform licensing, or separate patent litigation than through a conventional Orange Book patent challenge.

A Paragraph IV certification would generally be relevant only if the patent were listed for the reference listed drug and the proposed generic's product implicated the listed patent. The claims supplied do not establish that this patent is Orange Book listed, tied to a specific NDA, or eligible for a Paragraph IV certification.

When does US Patent 8,062,264 lose exclusivity?

The enforceable term depends on the patent's earliest effective nonprovisional filing date, any priority claims, patent-term adjustment, terminal disclaimer, and other USPTO records. Under 35 U.S.C. § 154, a utility patent generally runs for 20 years from the earliest effective nonprovisional filing date, subject to statutory adjustments. [3]

The patent issued on November 22, 2011. The issuance date does not determine expiration. A reliable expiration assessment must use the official patent bibliographic record and any patent-term-adjustment calculation.

The patent's practical exclusivity has three separate dimensions:

Exclusivity type	Relevance
Patent exclusivity	Depends on enforceable claims and remaining patent term
FDA regulatory exclusivity	Not established by the supplied device claims
Commercial exclusivity	Depends on ownership, licensing, supply contracts, and switching costs

Patent expiration would eliminate ordinary infringement liability for post-expiration practice of the claims, but it would not eliminate trade-secret, trademark, contract, or unrelated patent rights.

What patent litigation and Paragraph IV risks affect the patent?

The supplied material does not establish a specific district-court case, International Trade Commission investigation, Paragraph IV notice, or settlement agreement involving US Patent 8,062,264. Patent litigation cannot be inferred from the existence of the claims.

For an accused competitor, the principal litigation issues would likely include:

• Whether the accused actuator moves generally transverse to the dispensing axis.
• Whether the cam surface is continuously curved.
• Whether the follower rides sequentially across the claimed sections.
• Whether the commitment section creates the required minimum force.
• Whether the accused geometry satisfies the claimed radius ranges.
• Whether "about" and "substantially constant" have measurable boundaries.
• Whether the patent's claims are enabled and adequately described under 35 U.S.C. §§ 112(a) and 112(b). [4]
• Whether the claim limitations are anticipated or rendered obvious by earlier dispenser patents under 35 U.S.C. §§ 102 and 103. [5]

A Paragraph IV challenge would be a regulatory pathway issue only if the patent were properly listed for an NDA product. A device-only dispute would more likely proceed through ordinary patent litigation, an abbreviated new drug application dispute involving a listed patent, or commercial negotiations.

How strong is the patent estate?

The patent estate reflected in the supplied claims is technically focused and potentially valuable where the commercial product uses the same cam architecture. Its strength is mixed.

Strengths

• Claims 1 and 17 cover the central actuator-cam-follower architecture.
• Claims 2-7 provide measurable geometric and force limitations.
• Claims 8-14 capture a practical pump-container implementation.
• Claims 15 and 16 connect the mechanism to nasal medicament delivery.
• Claim 17 defines a recognizable three-surface profile.
• The claims can apply across multiple fluid products if the mechanical structure is reused.

Vulnerabilities

• The claims are limited to a specific mechanical relationship.
• The "continuously curved" and "minimum actuating force" limitations may generate factual disputes.
• Radius and force limitations can create design-around pathways.
• The patent does not protect the active ingredient or formulation.
• A competitor can potentially avoid infringement with a different actuator direction, linkage, follower arrangement, or cam discontinuity.
• Earlier pump and lever dispensers may provide prior-art arguments, especially if they disclose curved cam surfaces and force-control functions.

The estate is strongest as a platform patent against close mechanical copies. It is weaker as a barrier to independent development of the same therapeutic product using a materially different delivery mechanism.

What generic launch scenarios exist?

Scenario 1: Same nasal device architecture

A generic or follow-on product using the same pivotal lever, upward-moving pump container, and continuous concave-convex cam could face direct infringement risk under claims 1 and 17. Claims 12-16 could provide additional exposure if the product is a nasal medicament dispenser.

Scenario 2: Same function, different cam geometry

A product may preserve the general user experience while changing the cam profile, radii, contact location, or force curve. This approach could avoid dependent claims but may still implicate claim 1 or claim 17.

Scenario 3: Axial or non-camming actuator

A direct axial actuator, screw mechanism, diaphragm, rotary pump, or electronic actuator could avoid the transverse cam limitation if it does not reproduce the claimed interaction.

Scenario 4: Different cam location

Moving the cam surface from the actuator to the housing, or changing the follower arrangement, may avoid literal infringement. The risk would depend on claim construction and whether the accused structure is an equivalent.

Scenario 5: Post-expiration launch

After patent expiration, the claims no longer block practice of the patented mechanical design. Unrelated patents, regulatory requirements, trademarks, and contractual rights could still affect launch timing.

Which companies are challenging the patent?

No challenging company, litigation defendant, Paragraph IV filer, or settlement counterparty is identified in the supplied information. An accurate competitor-specific litigation landscape requires official court, USPTO, FDA, and assignment records. The claims alone do not establish those facts.

What manufacturing and IP barriers remain?

The patent does not claim a specialized chemical manufacturing process. Manufacturing barriers are more likely to arise from:

• Precision molding of the cam profile.
• Control of radius and tangent continuity.
• Dimensional control of the follower.
• Friction and wear at the contact interface.
• Spring and pump-force calibration.
• Consistent actuation force across temperature and fill conditions.
• Assembly tolerances affecting dose delivery.
• Validation of nasal nozzle dimensions and delivered dose.

These engineering constraints can create commercial barriers even where a competing design avoids the patent. They do not, by themselves, create patent rights.

Key Takeaways

• US Patent 8,062,264 is a mechanical fluid-dispenser patent centered on a continuously curved concave-convex cam.
• Claims 1 and 17 are the primary independent claims.
• The patent does not primarily protect a drug, formulation, active ingredient, or method of treatment.
• Claims 2-7 add radius and force limitations that may support enforcement but also create design-around paths.
• Claims 12-16 are particularly relevant to upward-actuated nasal medicament dispensers.
• A simple lever dispenser is not necessarily within scope; the claimed cam geometry and follower sequence are essential.
• Orange Book and Paragraph IV relevance is not established by the supplied device claims.
• Patent expiration cannot be stated reliably without the official priority, patent-term-adjustment, and terminal-disclaimer records.
• The estate is strongest against close mechanical copies and weaker against alternative actuator and pump architectures.
• No specific litigation, settlement, license, or challenging company is established by the supplied information.

FAQs

Does US Patent 8,062,264 cover all nasal spray pumps?

No. It covers nasal spray devices only when they also satisfy the claimed actuator, cam, follower, curvature, and dispensing-motion limitations.

Can a competitor avoid the patent by changing the cam radius?

Possibly. Changing a radius may avoid a dependent claim, but it will not necessarily avoid claim 1 or claim 17 unless the modified profile also falls outside their broader structural and functional limitations.

Is the patent a drug patent or a device patent?

It is principally a device patent. Claim 16 refers to a fluid medicament formulation, but the protected subject matter remains the dispensing-device architecture.

Does a Paragraph IV certification automatically apply to this patent?

No. Paragraph IV applies to a listed patent associated with an approved drug product and an ANDA certification. The supplied claims do not establish Orange Book listing.

What evidence would be needed to test infringement?

A complete analysis would typically require product teardown data, CAD or metrology measurements, cam radii, actuator travel, force-displacement testing, pump configuration, and the patent's prosecution history.

References

1. United States Patent No. 8,062,264, claims 1-20.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.
3. 35 U.S.C. § 154. Patent term.
4. 35 U.S.C. § 112. Specification requirements.
5. 35 U.S.C. §§ 102-103. Novelty and nonobviousness.

Drugs Protected by US Patent 8,062,264

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y

Foreign Priority and PCT Information for Patent: 8,062,264

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0507224.4	Apr 09, 2005

PCT Information
PCT Filed	April 05, 2006	PCT Application Number:	PCT/GB2006/001264
PCT Publication Date:	October 19, 2006	PCT Publication Number:	WO2006/109021

International Family Members for US Patent 8,062,264

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E476260
Australia	2006235671
Brazil	PI0610671