United States Patent 7,314,883: Claim Scope, Expiration, and CGRP Antagonist Patent Landscape

U.S. Patent No. 7,314,883 is a method-of-treatment patent directed to pharmaceutical compositions containing a broad genus of calcitonin gene-related peptide, or CGRP, receptor antagonist compounds. The claims cover treatment of migraine and other headache disorders, pain, circulatory shock, menopausal flushing, and airway inflammatory diseases such as asthma. The patent does not claim a single marketed active ingredient in the independent claims. It claims administration of structurally defined compounds within an extensive Markush formula.

The principal commercial value lies in claims 30-36, which narrow the genus to specific quinazolinone, indazole, benzotriazole, benzooxazolone, piperidine, piperazine, and related compounds. The patent’s nominal U.S. term is likely exhausted because the patent issued in 2008 from an earlier priority chain. Exact enforceability requires confirmation of the complete USPTO prosecution record, terminal disclaimers, patent-term adjustment, and any patent-term extension.

What does U.S. Patent 7,314,883 cover?

The patent covers methods of treating specified disorders by administering a pharmaceutical composition containing a compound according to Formula (I), or a pharmaceutically acceptable salt.

The covered indications are:

Claimed indication	Scope
Headache	Broadly claimed in claims 1-35
Migraine	Expressly narrowed in claim 36
Pain	Included in claim 1
Circulatory shock	Included in claim 1
Menopausal flushing	Included in claim 1
Airway inflammatory disease	Included in claim 1
Asthma	Expressly narrowed in claim 36

The claim set is a classic genus-to-species structure:

Claim 1 establishes a broad chemical and therapeutic genus.
Claims 2-29 narrow substituent classes and ring systems.
Claims 30-32 identify specific structural combinations.
Claim 33 lists a large group of individual compounds.
Claims 34 and 35 claim two specific compounds.
Claim 36 narrows the indication to migraine and asthma.

The independent claims are method claims. They require administration to a patient in need of treatment, an effective amount, and a pharmaceutical composition containing the claimed compound.

How broad is claim 1 of U.S. Patent 7,314,883?

Claim 1 is exceptionally broad in chemical breadth but narrower in legal form because it is limited to therapeutic administration.

The claim permits two major alternatives at the V position:

V is OR4; or
V is N(R1)(R2).

The R1/R2 options include hydrogen, alkyl, alkenyl, alkynyl, cycloalkyl, phenyl, adamantyl, azetidinyl, piperidinyl, piperazinyl, morpholino, thiomorpholino, and numerous nitrogen-, oxygen-, and sulfur-containing heterocycles.

R1 and R2 may also combine with the attached nitrogen to form a cyclic amine, including:

Azetidine
Pyrrolidine
Imidazolidine
Piperidine
Piperazine
Morpholine
Thiomorpholine
Diazepine and azepine systems

The claim permits substantial substitution of these groups, including halogen, cyano, alkyl, haloalkyl, alkoxy, hydroxy, amino, cycloalkyl, phenyl, benzyl, ureido, and dialkylamino substituents. It also allows spirocyclic structures and interruption by linker groups such as urea, carbamate, amino, alkylene, and alkenylene units.

The Q substituent introduces another large branch of scope. Q may be:

Q′, where Q′ is (Sy)sR3; or
Q″, where Q″ includes amine, urea, carbamate, carbonate, ether, amide, and related linkages.

R3 is divided into R3a and R3b. R3a covers a wide set of fused and non-fused heterocycles, carbazole, fluorene, phenyl, naphthyl, cycloalkyl, alkyl, alkenyl, alkynyl, esters, ketones, and related groups. R3b substantially tracks R3a but excludes a list of specific aromatic groups.

The core scaffold also requires:

D is O, NCN, or NSO2C1-3alkyl;
A is CH;
m and n are each 1;
p is 1;
G, J, and E form a fused heterocycle;
Ax contains two fused rings with five to seven members per ring;
Ax contains one to four heteroatoms and may contain carbonyl groups.

This combination creates a large but chemically coherent genus. It is directed to compounds containing a substituted fused heterocyclic pharmacophore linked through a central urea, amide, or related polar framework to basic cyclic amines and aromatic heterocycles.

What compounds are specifically protected by claims 30 through 35?

Claims 30-35 are more commercially relevant than claim 1 because they identify narrower structural embodiments.

Claim	Principal structural limitations
30	Piperazine substituted with piperidine; methylene-linked benzooxazolinone; fused diazine-containing quinazolinone system
31	Piperazine substituted with piperidine; methylene-linked benzotriazole; fused diazine-containing quinazolinone system
32	Piperazine substituted with piperidine; alkyl-substituted indazole; fused heterocycle containing one nitrogen and one carbonyl
33	Large list of individually named compounds and close analogues
34	Specific R enantiomer containing a quinazolinone-piperidine group, bipiperidine group, and benzooxazolinone substituent
35	Specific methyl ester containing benzotriazole, quinazolinone, and piperidine structural elements
36	Migraine and asthma as the specified treatment indications

Claim 34 is the strongest species claim from a product-identification perspective. It covers:

A defined R stereoisomer;
A quinazolinone-piperidine fragment;
A bipiperidine amine;
A benzooxazolinone aromatic group;
A carboxamide linkage;
Use for headache, circulatory shock, pain, menopausal flushing, or airway inflammatory disease.

Claim 35 covers a different specific compound, retaining the quinazolinone-piperidine core but replacing the benzooxazolone-containing side chain with a benzotriazole-substituted amino acid methyl ester.

Claim 33 is broad as a list of species but may present claim-construction and written-description issues if the listed compounds are not consistently supported by the specification or if typographical defects affect structural identity.

What formulations are protected by U.S. Patent 7,314,883?

The patent does not claim a specific tablet, capsule, injectable formulation, dosage strength, release profile, excipient system, particle size, polymorph, or salt form as an independent formulation invention.

The relevant formulation limitation is functional and generic: the compound must be present in a pharmaceutical composition and administered in an effective amount.

A composition containing a covered compound could therefore include:

Oral tablets;
Capsules;
Solutions;
Suspensions;
Injectable preparations;
Pharmaceutically acceptable salts;
Conventional pharmaceutical excipients.

The claims do not appear to require a particular route of administration. A generic company could avoid a formulation-specific patent only if the product does not contain a compound within the claimed chemical scope or if its use does not meet the method limitations. Changing excipients, tablet coating, dosage strength, or release profile would not ordinarily avoid infringement if the underlying compound and claimed use remain covered.

Does the patent claim a method of use, a compound, or a composition?

The issued claims primarily claim methods of treatment.

Potential activity	Directly claimed by the supplied claims?
Making the compound	No, not independently
Selling the compound as a raw material	No, not independently
Selling a pharmaceutical composition	Not as a standalone composition claim
Administering the composition for a listed indication	Yes
Using the compound for migraine	Yes, through claim 36 and broader claims
Using the compound for asthma	Yes, through claim 36 and broader claims
Manufacturing a specific polymorph	No
Manufacturing a specific salt	Only insofar as the salt is a pharmaceutically acceptable salt in the treatment method

A generic applicant would face a method-of-use issue if its proposed labeling directs use for a claimed indication. A section viii “skinny label” strategy may reduce risk where the generic label omits patented indications, but the outcome depends on the actual label, promotional conduct, prescribing context, and whether the claimed use is an inherent or encouraged use.

When does U.S. Patent 7,314,883 lose exclusivity?

The patent’s term is calculated from the applicable nonprovisional filing or priority framework, not from the 2008 grant date. The ordinary term is 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, terminal disclaimers, patent-term extension, and statutory exclusions under 35 U.S.C. §§ 154 and 156.

The relevant timeline is:

Event	Date or status
U.S. patent application	Filed before grant; exact filing and priority chain control term
Patent publication	Published before grant
Patent grant	January 1, 2008
Nominal expiration	Likely in the 2021-2023 period, depending on the earliest effective filing date
Current enforceability	Requires confirmation from USPTO Patent Center and the patent’s term calculation

The patent should not be treated as enforceable solely because it appears in patent databases. A current freedom-to-operate assessment must confirm:

Patent-term adjustment;
Patent-term extension;
Reexamination or post-grant certificates;
Terminal disclaimers;
Continuation or divisional relationships;
Whether related family patents remain active.

What is the Orange Book status of U.S. Patent 7,314,883?

A patent number alone does not establish Orange Book listing status. Orange Book listing is tied to an approved new drug application and the drug product identified by the NDA holder.

The supplied claims do not identify:

An FDA-approved active ingredient;
An NDA number;
A product trade name;
A listed dosage form;
An Orange Book patent-use code;
A current NDA holder.

Because the patent claims a broad research-stage CGRP antagonist genus and numerous unmarketed compounds, it cannot be assumed to have an Orange Book listing. The FDA Orange Book must be checked by active ingredient and NDA, not only by patent number. FDA regulations require listed patents to meet the applicable drug-substance, drug-product, or method-of-use listing requirements under 21 C.F.R. § 314.53.

What Paragraph IV challenges could arise?

A Paragraph IV certification could target this patent if an ANDA applicant seeks approval for a product containing an active ingredient that falls within claims 1 or 30-36 and the reference listed drug’s labeling includes a claimed use.

Potential challenge theories include:

Invalidity for lack of written description.
Lack of enablement across the full Markush genus.
Anticipation by earlier CGRP antagonist disclosures.
Obviousness based on known CGRP receptor antagonist scaffolds.
Indefiniteness arising from structural definitions, inconsistent nomenclature, or typographical errors.
Non-infringement because the proposed compound falls outside the claimed substituent definitions.
Non-infringement based on an unclaimed indication or labeling strategy.
Failure to satisfy the “effective amount” or “patient in need” limitations.

Claims 34 and 35 would generally be more difficult to invalidate through a purely genus-based argument if the specification provides specific preparation and biological examples. They may, however, face conventional anticipation or obviousness attacks based on earlier disclosure of the exact species, close stereoisomers, or predictable analogues.

How strong is the patent estate?

The patent has mixed strength.

Strengths

Claim 1 reaches a large number of CGRP antagonist structures.
Claims 30-35 identify narrower, litigation-ready species.
The claims cover multiple therapeutic indications.
Claim 36 expressly addresses migraine and asthma.
The patent includes stereochemically defined compounds, which can support species-level protection.

Weaknesses

The genus is unusually large.
The chemical definitions contain extensive nested alternatives.
The claim text includes apparent drafting irregularities, including inconsistent nomenclature and possible typographical errors.
The method claims require proof of administration for a covered use.
The patent may already be outside its ordinary enforceable term.
There is no apparent formulation, polymorph, manufacturing, or dosage-regimen layer in the supplied claims.

The strongest residual commercial position would have depended on active continuation patents, species patents, formulation patents, or regulatory exclusivity covering a commercial compound. The supplied claims alone do not establish those rights.

What manufacturing and intellectual-property barriers remain?

The patent does not independently create a broad manufacturing barrier because it lacks a standalone process claim in the supplied claim set. A manufacturer could still face risk from:

Separate process patents;
Intermediate patents;
Salt or polymorph patents;
Crystalline-form patents;
Enantiomer patents;
Formulation patents;
Combination-treatment patents;
Regulatory exclusivity;
Trade-secret manufacturing controls.

For a commercial compound within claim 34 or claim 35, the most important diligence issue is whether the patent family includes later-filed continuations or divisionals claiming the compound, salt, process, formulation, or therapeutic indication separately.

Which companies are challenging or commercializing compounds in this landscape?

The supplied patent claims do not identify an approved commercial product, patent owner’s current portfolio, licensee, or litigation defendant. The chemical and therapeutic subject matter is consistent with the broader CGRP antagonist field, which has included pharmaceutical companies developing small-molecule CGRP receptor antagonists for migraine and related disorders.

No reliable conclusion about current challengers, licensing transactions, revenue exposure, or active litigation can be drawn from U.S. Patent 7,314,883 and the quoted claims alone. Those issues depend on the patent family, FDA records, USPTO assignment records, PACER litigation records, and current commercial product data.

What generic launch scenarios exist?

The principal scenarios are:

Scenario	Commercial consequence
Patent expired and no active family member covers the product	Launch may proceed subject to regulatory approval
Patent active but listed only for an omitted indication	Section viii strategy may be available
Patent active and product falls within claim 34 or 35	Paragraph IV litigation risk is high
Product is outside the claimed chemical genus	Non-infringement position improves
Continuation or species patent remains active	Freedom to operate remains constrained despite expiration of 7,314,883
No approved reference product exists	ANDA pathway may not be available; 505(b)(2) or another pathway may be required

Key Takeaways

U.S. Patent 7,314,883 claims therapeutic administration of a broad CGRP antagonist genus.
The covered indications include headache, migraine, pain, circulatory shock, menopausal flushing, and airway inflammatory disease.
Claims 34 and 35 are the most commercially specific claims in the supplied set.
The patent is a method-of-use patent, not a standalone compound, formulation, or manufacturing patent.
The ordinary patent term likely ended between 2021 and 2023, but the exact date requires the complete USPTO term record.
Orange Book status cannot be established from the patent claims alone.
Paragraph IV risk depends on the active ingredient, proposed labeling, patent listing, and any surviving continuation or species patents.
The most important diligence issue is whether related family members remain active after the apparent expiration of the granted patent.

FAQs About U.S. Patent 7,314,883

Is U.S. Patent 7,314,883 a migraine patent?

Yes. The claims cover headache treatment broadly, and claim 36 expressly specifies migraine. The patent is directed to compounds understood from the claim structure to be CGRP receptor antagonists.

Does the patent cover telcagepant?

The quoted claims do not identify telcagepant by name. Coverage would require mapping telcagepant’s exact molecular structure against the limitations of claims 1 and 30-36 and reviewing related patents.

Does the patent cover asthma treatment?

Yes. Claim 36 expressly identifies asthma as the airway inflammatory disease. Claims 1-35 also cover airway inflammatory diseases more generally.

Can a generic avoid the patent by changing the excipients?

Usually not if the generic uses a compound within the claimed genus for a claimed indication. The claims are directed to administration of a pharmaceutical composition containing the covered compound, not to a particular excipient system.

Is the patent still enforceable after its nominal expiration?

Only if a surviving term adjustment, term extension, or related enforceable patent applies. Grant status alone does not establish current enforceability.

References

U.S. Patent No. 7,314,883, “CGRP receptor antagonists.” United States Patent and Trademark Office.
U.S. Patent and Trademark Office. (2024). Patent term adjustment and patent term calculation guidance.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book.
Code of Federal Regulations, 21 C.F.R. § 314.53.
United States Code, 35 U.S.C. §§ 154, 156, 271.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003237255	⤷ Start Trial
Brazil	0311812	⤷ Start Trial
Brazil	PI0311812	⤷ Start Trial
Canada	2487976	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,314,883

Summary for Patent: 7,314,883