Details for Patent: 9,078,814

Summary for Patent: 9,078,814

Title:	Intranasal spray device containing pharmaceutical composition
Abstract:	An intrasnal spray device contains a composition for the intranasal delivery of fentanyl or a pharmaceutically acceptable salt thereof to an animal includes an aqueous solution of fentanyl or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive selected from (i) a pectin and (ii) a poloxamer and chitosan or a salt or derivative thereof; provided that when the composition comprises a pectin it is substantially free of divalent metal ions; and which, in comparison to a simple aqueous solution of fentanyl administered intranasally at the same dose, provides a peak plasma concentration of fentanyl (Cmax) that is from 10 to 80% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose. A method for treating or managing pain by intranasally administering the composition is also disclosed.
Inventor(s):	Peter James Watts, Jonathan David Castile, William Columbus Ian Lafferty, Alan Smith
Assignee:	Btcp Pharma LLC
Application Number:	US13/541,325
Patent Claim Types: see list of patent claims	Composition; Formulation; Delivery; Device;

United States Patent 9,078,814: Fentanyl Pectin Nasal Spray Scope, Validity, and Patent Landscape

U.S. Patent No. 9,078,814 protects an intranasal fentanyl spray device containing a low-esterification pectin formulation designed to moderate fentanyl absorption. The independent claims require a combination of formulation composition, device architecture, dose delivery, and pharmacokinetic performance. The patent is narrower than a general fentanyl nasal-spray patent because infringement requires the claimed pectin, divalent-metal-ion restriction, delivery parameters, and Cmax/Tmax profile.

The patent was issued July 14, 2015, to Archimedes Development Limited. Its claimed priority traces to December 2006. The nominal patent-term endpoint is December 2027, subject to any applicable patent-term adjustment or disclaimer recorded by the USPTO.[1]

What does U.S. Patent 9,078,814 protect?

The patent protects a fentanyl nasal-spray device containing an aqueous pectin formulation that produces controlled intranasal fentanyl exposure.

Claim 1 requires all of the following:

Claim element	Required scope
Product type	Intranasal spray device
Active ingredient	Fentanyl or pharmaceutically acceptable salt, expressed as fentanyl base
Fentanyl concentration	0.05 mg/mL to 30 mg/mL
Polymer	Pectin with a degree of esterification below 30%
Metal-ion limitation	Composition substantially free of divalent metal ions
Comparator	Simple aqueous fentanyl solution at the same fentanyl dose
Cmax limitation	10% to 80% of comparator Cmax
Tmax limitation	5 to 30 minutes
Therapeutic use	Single dosage regimen effective to treat or manage pain

The claim is a combination claim. A product that satisfies only the fentanyl concentration and pectin limitations does not necessarily infringe. It must also satisfy the device, divalent-metal-ion, dose-performance, and pharmacokinetic limitations.

How many patents cover the core technology?

The core technology is covered by a patent family rather than by U.S. Patent 9,078,814 alone. The family relates to fentanyl delivery using low-methoxyl or low-esterification pectin to control absorption after nasal administration.

The relevant protection layers are:

1. Composition claims, covering aqueous fentanyl and pectin formulations.
2. Device claims, covering unit-dose and multidose spray systems.
3. Dose-volume claims, covering delivery of 0.01 mL to 0.15 mL per actuation.
4. Dose-strength claims, covering 10 micrograms to 5,000 micrograms of fentanyl per dosage unit.
5. Formulation-window claims, covering pectin concentration, pH, osmolality, fentanyl concentration, and low divalent-metal-ion content.
6. Pharmacokinetic claims, covering the claimed Cmax reduction and Tmax range.
7. Foreign counterpart claims, which may differ materially in scope because of prosecution amendments and national claim practice.

The patent should therefore be evaluated with its related applications and issued counterparts. A freedom-to-operate analysis limited to U.S. Patent 9,078,814 could miss composition, manufacturing, device, or method-of-use patents in the same family.

What are the independent claims in U.S. Patent 9,078,814?

Claims 1 and 26 are the principal independent claims.

Claim 1: broad combination claim

Claim 1 covers a spray device containing:

• fentanyl or a fentanyl salt in an aqueous solution;
• 0.05 mg/mL to 30 mg/mL fentanyl, expressed as base;
• pectin with a DE value below 30%;
• substantially no divalent metal ions;
• a practical dose volume;
• Cmax equal to 10% to 80% of a simple aqueous fentanyl comparator; and
• Tmax from 5 to 30 minutes.

The claim also requires that the single dose treat or manage pain.

Claim 26: narrower formulation claim

Claim 26 narrows the formulation to:

Parameter	Claim 26 range
Fentanyl concentration	0.05 mg/mL to 20 mg/mL
Pectin concentration	5 mg/mL to 25 mg/mL
Pectin DE	10% to 25%
pH	3.4 to 5.0
Osmolality	0.20 to 0.40 osmol/kg
Divalent metal ions	Substantially absent
Cmax	10% to 80% of simple aqueous comparator
Tmax	5 to 30 minutes

Claim 26 is commercially important because it consolidates the likely product-development formulation space into a single claim. A competing product within these ranges faces greater literal-infringement exposure than a product that falls outside at least one of the required formulation parameters.

What formulations are protected by the patent?

The dependent claims define a formulation platform with several cumulative and alternative limitations.

Claim group	Protected feature
Claims 9-11	Pectin DE of 7%-30%, 10%-25%, or 15%-25%
Claims 12-13	Fentanyl salt, specifically fentanyl citrate
Claim 14	Pectin concentration of 5-25 mg/mL
Claim 15	At least 99% free of divalent metal ions
Claims 16-18	Osmolality of 0.2-0.8, 0.2-0.4, or 0.25-0.35 osmol/kg
Claims 19-20	Non-metal osmolality adjusters, including mannitol, sorbitol, dextrose, sucrose, and trehalose
Claims 21-23	pH of 3-6, 3.2-5.5, or 3.4-5.0
Claims 24-25	Fentanyl concentration of 0.1-20 or 0.2-16 mg/mL
Claims 27-28	Narrower fentanyl concentration ranges within claim 26

The patent is particularly directed to low-methoxyl pectin systems. Low DE pectin can interact with ions and form gels or structured matrices. The claims exclude, or materially limit, divalent-metal-ion content because calcium and other divalent ions can alter pectin behavior and potentially change spray performance and fentanyl release.

Does the patent cover fentanyl citrate nasal spray?

Yes. Claim 13 expressly covers fentanyl citrate when used in a device otherwise satisfying claim 12 and the limitations inherited from claim 1.

The patent does not cover every fentanyl citrate nasal spray. A competing product would need to meet the relevant pectin, concentration, metal-ion, device, and pharmacokinetic limitations. Fentanyl citrate alone is insufficient for infringement.

The patent also does not require fentanyl citrate in the independent claims. Claims 1 and 26 cover fentanyl or a pharmaceutically acceptable salt. The citrate limitation is a dependent narrowing feature.

What device configurations are protected?

Claims 2 through 8 cover device and dosing configurations.

Claims	Device or delivery limitation
2-3	Unit-dose device, including bottle, pump, and actuator
4-5	Multidose device, including bottle, pump, and actuator
6	0.01 mL to 0.15 mL per actuation
7	10 micrograms to 5,000 micrograms fentanyl per dose
8	10 micrograms to 3,000 micrograms fentanyl per dose

The independent claims are not limited to a particular pump architecture. The dependent claims create additional protection for conventional bottle-pump-actuator arrangements, but claim 1 can reach other intranasal spray-device configurations if all claim elements are present.

A product using a metered pump outside the 0.01 mL to 0.15 mL volume range could avoid claim 6 while remaining exposed under claim 1 or claim 26.

How important are the Cmax and Tmax limitations?

The pharmacokinetic limitations are central to the patent’s scope and its enforcement risk.

The product must provide:

• a Cmax from 10% to 80% of the Cmax achieved by a simple aqueous fentanyl solution at the identical fentanyl dose; and
• a Tmax from 5 to 30 minutes.

These limitations create several legal and technical issues.

Comparator definition

“Simple aqueous solution” must be construed and applied consistently. The comparator may require analysis of:

• fentanyl concentration;
• administration volume;
• spray device;
• dose;
• subject population;
• fasting or fed conditions;
• sampling schedule; and
• pharmacokinetic calculation method.

Differences in the comparator can materially change whether the accused product falls within the 10%-80% Cmax range.

Experimental variability

Cmax and Tmax are subject to intersubject variability and study design. A patent enforcement case would likely require validated pharmacokinetic evidence rather than reliance on formulation composition alone.

Product-by-performance scope

The claims use pharmacokinetic performance as a limitation of the device. A product can have the claimed formulation ingredients but avoid infringement if it does not produce the specified Cmax and Tmax profile. Conversely, a developer cannot safely assume noninfringement solely because its formulation differs in an ingredient that does not change the measured pharmacokinetic result.

When does U.S. Patent 9,078,814 lose exclusivity?

The nominal expiration date is December 2027, based on the earliest claimed priority date in December 2006 and the standard 20-year U.S. patent term.[1] The effective endpoint should be confirmed in the USPTO Patent Center record because patent-term adjustment, terminal disclaimers, disclaimers, or other recorded events can affect the enforceable term.

Milestone	Date
Earliest claimed priority	December 2006
U.S. patent issued	July 14, 2015
Nominal 20-year term endpoint	December 2027
Post-expiration status	Claims no longer enforceable, subject to applicable term adjustments

Patent expiration does not automatically authorize a product launch if separate patents cover the same product, its formulation, delivery device, manufacturing process, or approved indication.

What is the FDA regulatory and Orange Book status?

U.S. Patent 9,078,814 is a patent directed to a fentanyl pectin nasal-spray device. The patent does not establish FDA approval of a product embodying the claims.

PecFent, the principal product associated with the fentanyl-pectin technology, received regulatory approvals outside the United States. The FDA-approved U.S. fentanyl nasal-spray product is Lazanda, which uses fentanyl citrate but is not the same as the claimed pectin platform.[2]

The Orange Book analysis is product-specific:

Question	Assessment
Is U.S. Patent 9,078,814 automatically an Orange Book patent?	No
Does patent issuance create FDA exclusivity?	No
Is an NDA required for Orange Book listing?	Yes
Does a patent covering an unapproved product create a Paragraph IV pathway?	No, unless listed against an approved NDA
Does generic fentanyl nasal spray automatically infringe?	No

A patent may be Orange Book-listed only against the NDA holder’s approved drug and only if it meets the statutory listing requirements. A patent covering a development-stage or non-U.S.-approved product does not independently create an Orange Book barrier.

Which companies are challenging the patent?

A Paragraph IV challenge is tied to an Orange Book-listed patent and an abbreviated new drug application. No Paragraph IV challenge can be inferred from the patent claims alone.

For U.S. Patent 9,078,814, the relevant questions are:

1. Whether the patent is listed against a specific approved NDA.
2. Whether a generic applicant has filed an ANDA referencing that NDA.
3. Whether the applicant submitted a Paragraph IV certification.
4. Whether the patent owner filed an infringement action within 45 days.
5. Whether a 30-month stay was triggered.
6. Whether the dispute ended in litigation, settlement, or a consent judgment.

The patent’s association with a fentanyl pectin product does not establish that a generic applicant is challenging it. FDA Orange Book records and federal court filings are required to identify any named challenger and litigation status.[3][4]

What patent litigation affects U.S. Patent 9,078,814?

Patent litigation risk is concentrated in three areas:

Literal infringement

A claimant would need to show that the accused spray device contains the claimed formulation and meets the device and pharmacokinetic limitations. Claims 1 and 26 provide the principal litigation targets.

Claim construction

Likely disputes include:

• the meaning of “substantially free” of divalent metal ions;
• the scope of “simple aqueous solution”;
• the meaning of “practical dose volume”;
• whether Cmax and Tmax are inherent product characteristics;
• whether the comparator must use the same device or administration volume; and
• whether “effective to treat or manage pain” imposes a meaningful additional limitation.

Validity

Potential validity challenges could focus on:

• anticipation by prior fentanyl nasal sprays;
• obviousness based on fentanyl delivery and pectin references;
• written-description support for the numerical Cmax and Tmax ranges;
• enablement across the full concentration and pectin ranges;
• indefiniteness of “substantially free,” “practical dose volume,” and the pharmacokinetic comparator.

The functional limitations may help distinguish prior art, but they also create proof and claim-construction burdens.

How strong is the patent estate?

The estate has meaningful commercial relevance but is not a broad monopoly over intranasal fentanyl.

Strength factor	Assessment
Formulation specificity	Strong; pectin DE, pH, osmolality, concentration, and metal-ion limits define a recognizable platform
Device coverage	Moderate; claims cover unit-dose and multidose systems but do not require one exclusive pump design
Pharmacokinetic protection	Potentially strong if reproducible and measurable
Design-around risk	Moderate to high
Product-specific relevance	High for a fentanyl pectin spray; lower for non-pectin products
Regulatory leverage	Limited unless listed against an approved U.S. NDA
Manufacturing barrier	Moderate; low-DE pectin control and ion exclusion may require process controls
Generic substitution risk	Depends on FDA approval pathway and separate Orange Book patents

The strongest commercial position exists where a product uses fentanyl citrate, pectin with a DE of 10%-25%, pectin at 5-25 mg/mL, pH 3.4-5.0, osmolality 0.20-0.40 osmol/kg, and a low-volume metered spray. That profile maps closely to claim 26 and claims 27-28.

What design-arounds could reduce infringement risk?

Potential design-around approaches include:

• using a non-pectin mucoadhesive or absorption-modifying polymer;
• using pectin with a DE of 30% or higher;
• using a delivery composition with divalent metal ions, although this may create stability or performance problems;
• selecting pH or osmolality outside the claimed ranges;
• changing fentanyl concentration outside the relevant claim ranges;
• using a delivery volume outside 0.01 mL to 0.15 mL;
• producing a Tmax outside 5-30 minutes;
• producing a Cmax outside 10%-80% of the specified comparator; or
• using a non-spray intranasal delivery system.

A design-around based only on one numerical parameter may be insufficient because claim 1 has broader ranges than claim 26. The product must be mapped against every asserted claim independently.

What manufacturing and IP barriers exist?

The manufacturing barrier is principally process control rather than raw-material scarcity.

A commercial product would need consistent control of:

• pectin degree of esterification;
• pectin molecular-weight distribution;
• residual calcium and other divalent ions;
• fentanyl concentration;
• pH;
• osmolality;
• viscosity;
• spray plume and droplet-size distribution;
• delivered dose uniformity;
• container-closure compatibility; and
• stability over the proposed shelf life.

The “substantially free” limitation makes raw-material qualification and water-system control relevant. Pectin can contain naturally occurring mineral content, and processing equipment or excipients may introduce divalent ions.

The formulation also requires a device capable of delivering a reproducible low volume. Device patents and regulatory device specifications may create separate barriers even if U.S. Patent 9,078,814 is avoided.

How does this patent compare with Lazanda?

Attribute	U.S. Patent 9,078,814 technology	Lazanda
Active ingredient	Fentanyl or salt	Fentanyl citrate
Delivery route	Intranasal spray	Intranasal spray
Pectin requirement	Yes	Not established by the product description
Low divalent-ion requirement	Yes	Not a defining public product feature
Cmax/Tmax limitations	Yes	Patent-specific analysis required
FDA status	Patent does not establish approval	FDA-approved product
Generic pathway	Depends on listed NDA and patents	ANDA and Orange Book framework applies
Primary differentiation	Pectin-controlled absorption	Fentanyl nasal delivery without the claimed pectin combination

The products compete in the same therapeutic and delivery category but are not interchangeable from a patent-scope perspective. A fentanyl nasal spray modeled on Lazanda is not automatically within the scope of U.S. Patent 9,078,814.

What revenue exposure exists?

The direct revenue exposure from this patent depends on whether the patent protects an approved U.S. product with material sales. The patent itself does not establish U.S. product revenue or market exclusivity.

Commercial exposure is highest for:

• a follow-on fentanyl nasal spray using low-DE pectin;
• a licensed product based on the PecSys platform;
• a U.S. product seeking approval through an NDA or 505(b)(2) pathway; and
• a generic or hybrid product referencing a listed fentanyl nasal-spray NDA while using a similar pectin formulation.

Exposure is lower for:

• oral transmucosal fentanyl products;
• injectable fentanyl;
• non-pectin nasal formulations;
• high-DE pectin systems;
• products with materially different pharmacokinetics; and
• products launched after the patent term expires, provided no other enforceable patents apply.

Key Takeaways

• U.S. Patent 9,078,814 is a combination patent for fentanyl pectin intranasal spray devices.
• Claim 1 requires fentanyl, low-DE pectin, substantial absence of divalent metal ions, specified Cmax reduction, and Tmax of 5-30 minutes.
• Claim 26 is the commercially narrow but potentially strongest formulation claim.
• Fentanyl citrate is expressly covered by dependent claim 13.
• Unit-dose, multidose, bottle-pump-actuator, volume, and dose-strength configurations are separately protected.
• The nominal patent expiration is December 2027, subject to the USPTO-recorded patent-term calculation.
• The patent does not automatically create FDA exclusivity or an Orange Book listing.
• Paragraph IV exposure depends on whether the patent is listed against an approved NDA and whether an ANDA references that NDA.
• The main validity pressure points are obviousness, enablement, indefiniteness, and the evidentiary basis for the Cmax/Tmax limitations.
• The most practical design-around routes involve replacing pectin, changing the pectin DE, altering formulation ranges, or producing a materially different pharmacokinetic profile.
• Separate family members, device patents, manufacturing patents, and Orange Book-listed patents must be reviewed before making a launch or licensing decision.

FAQs About U.S. Patent 9,078,814

Does U.S. Patent 9,078,814 cover all fentanyl nasal sprays?

No. It covers devices containing the claimed fentanyl-pectin formulation and meeting the specified device and pharmacokinetic limitations.

Is fentanyl citrate itself patented by U.S. Patent 9,078,814?

No. Fentanyl citrate is covered only as part of the claimed intranasal pectin-device combination.

Can a product avoid infringement by using pectin with a DE of 35%?

That may avoid the low-DE limitations in claims 1 and 26, but the complete claim set and related patents must also be reviewed.

Does a Paragraph IV certification automatically invalidate U.S. Patent 9,078,814?

No. A Paragraph IV certification is an applicant’s legal position that a listed patent is invalid, unenforceable, or not infringed. The patent remains enforceable unless cancelled, disclaimed, held invalid, or expired.

Does patent expiration eliminate all barriers to a fentanyl pectin nasal spray?

No. Separate patents, regulatory exclusivity, device rights, manufacturing know-how, trade secrets, and regulatory requirements may continue to affect launch timing.

References

1. United States Patent and Trademark Office. (2015). U.S. Patent No. 9,078,814, intranasal fentanyl composition and delivery device. https://patents.google.com/patent/US9078814B2/en
2. U.S. Food and Drug Administration. (2011). Lazanda prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022569s000lbl.pdf
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
4. U.S. Food and Drug Administration. (2024). Patent and exclusivity information. https://www.fda.gov/drugs/development-resources/patent-and-exclusivity-information-prd-

Drugs Protected by US Patent 9,078,814

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 9,078,814

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0300531.1	Jan 10, 2003

International Family Members for US Patent 9,078,814

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1635783		C300653	Netherlands
European Patent Office	1635783		CA 2014 00016	Denmark
European Patent Office	1635783		300653	Netherlands
European Patent Office	1635783		122014000024	Germany