Details for Patent: 4,507,323

Summary for Patent: 4,507,323

Title:	Treatment of psychosexual dysfunctions
Abstract:	A method of treatment of pychosexual dysfunction in male and female human beings by the administration of the compound of the formula (I) ##STR1## or a pharmaceutically acceptable acid addition salt thereof in a non-toxic, effective therapeutic amount (calculated as base) to a human being in need thereof.
Inventor(s):	Warren C. Stern
Assignee:	SmithKline Beecham Corp
Application Number:	US06/634,451
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;

United States Patent 4,507,323: Scope of Claims and US Patent Estate for Treating Psychosexual Dysfunction With Formula (I) Compounds

Executive summary: US Patent 4,507,323 claims a method of treating psychosexual dysfunction in humans by administering an “effective, non-toxic sexual dysfunction therapeutic amount” of a compound of formula (I) or its pharmaceutically acceptable salt. The independent claim (claim 1) is broad by drafting: it covers treatment methods, any oral or non-oral route unless narrowed by dependent claims, and any pharmaceutically acceptable salt including hydrochloride (claim 3). The dependent set in claims 2-12 provides incremental coverage for salt form, carrier, and oral administration. The practical risk for competitors is that a generic or alternative marketer must avoid (i) the claimed compound(s) and (ii) method-of-use infringement tied to “psychosexual dysfunction” and the therapeutic dosing concept. The enforceable scope is therefore anchored to (a) how “formula (I)” is construed from the specification and (b) whether alternative products fall within the construed “compound of formula (I)” and administer it to treat the same indication.

---

What does US Patent 4,507,323 claim for treating psychosexual dysfunction (claim-by-claim scope)?

Featured snippet answer: Claim 1 covers a method: administering a “non-toxic sexual dysfunction therapeutic amount” of a formula (I) compound or pharmaceutically acceptable salt to a human with psychosexual dysfunction. Dependent claims narrow to hydrochloride salt, inclusion of a carrier, and oral administration.

Claim 1 (independent): core method-of-use and active-ingredient scope

Text (as provided):
“A method of treating psychosexual dysfunction in a human being suffering from same, which comprises administering… an effective, non-toxic, sexual dysfunction therapeutic amount of the compound of the formula (I) or a pharmaceutically acceptable salt thereof.”

Claim elements:

1. Preamble/intent: treating psychosexual dysfunction in a human “suffering from same.”
2. Act: “administering” an amount.
3. Amount standard: “effective, non-toxic” and “sexual dysfunction therapeutic.”
4. Substance limitation: the active is “the compound of formula (I)” or pharmaceutically acceptable salt.

Scope implications:

• Method-of-use framing can capture both direct labeling (“for psychosexual dysfunction”) and conduct evidence (physician instruction, marketing, or implied use) tied to that indication.
• “Effective” is a functional dosing limitation. In litigation, it typically maps to ordinary pharmacological effectiveness rather than a fixed mg range, unless the specification ties it to concrete dose/exposure parameters.
• “Non-toxic” is also functional. Courts often treat this as a constraint on unreasonable dosing; it does not usually eliminate infringement at typical therapeutic doses.
• The central infringement question becomes whether an accused product’s active ingredient falls within the construction of “compound of formula (I)” and whether it is used to treat psychosexual dysfunction.

Claim 2: salt is a pharmaceutically acceptable salt

Claim 2 depends on claim 1 and states: “in which a pharmaceutically acceptable salt is administered.”

Incremental narrowing vs claim 1:

• Claim 1 already includes salts (“or a pharmaceutically acceptable salt thereof”), so claim 2 is largely confirmatory. It can still matter if the enforceable interpretation of claim 1 is constrained (for example, if a construction debate arises about whether only certain salts are contemplated).

Claim 3: hydrochloride salt

Claim 3 depends on claim 2: “wherein said salt is the hydrochloride salt.”

Scope implications:

• Creates a dedicated hook for products that use hydrochloride specifically, even if the broader “pharmaceutically acceptable salt” concept becomes narrower in claim construction.
• If an accused product is another salt (e.g., sulfate, citrate), claim 3 would not be satisfied, but claim 1 could still be at issue.

Claim 4-6: administration in a pharmaceutically acceptable carrier

• Claim 4 depends on claim 1 and adds: “administered in a pharmaceutically acceptable carrier therefor.”
• Claim 5 depends on claim 2 and adds the same carrier limitation.
• Claim 6 depends on claim 3 and adds the same carrier limitation.

Scope implications:

• Carrier language typically does not narrow much because most formulations include some pharmaceutically acceptable excipients.
• It matters most if an accused “product” is a non-carrier form factor (rare in oral products) or if the defense argues the administration method is outside standard formulation practice.

Claim 7-12: oral administration

• Claim 7: claim 1 plus “administered orally.”
• Claim 8: claim 2 plus “administered orally.”
• Claim 9: claim 3 plus “administered orally.”
• Claim 10: claim 4 plus “administered orally.”
• Claim 11: claim 5 plus “administered orally.”
• Claim 12: claim 6 plus “administered orally.”

Scope implications:

• Dependent claims create an oral-specific method-of-use sub-family.
• If a product is administered by other routes (transdermal, injectable), the oral claims do not apply. However, the independent claim 1 does not require route, so non-oral administration could still infringe if “administering” is not limited by the specification or prosecution history.

---

How broad is the active-ingredient coverage for “compound of formula (I)” in US 4,507,323?

Featured snippet answer: The claim ties infringement to whether the accused compound is within the set defined by “formula (I),” plus allowance for pharmaceutically acceptable salts. The breadth of formula (I) coverage is controlled by the specification’s variable definitions and examples, not just the claim text.

Why formula-based claims drive the landscape

Formula-defined claims are often litigated on:

• Exact substructure requirements (what atoms/groups are mandatory).
• Variable ranges (what substituents are allowed).
• Whether stereochemistry is required and how it is specified.
• Whether tautomer/salt forms are treated as equivalent within “pharmaceutically acceptable salt.”

Because the provided record includes only “##STR3##” placeholder for formula (I), the actual breadth cannot be reconstructed from the claim excerpt alone. In practice, the formula’s variable definitions determine whether:

• Many analogs are covered (broad variables)
• Coverage is narrow (tight substituent limitations)
• Only a few exact embodiments are covered (narrow formula)

Salt doctrine relevance

Claim 1 already includes “pharmaceutically acceptable salt.” Claim 3 separately locks onto hydrochloride. For infringement strategy:

• A competitor using a different salt may avoid claim 3 but still risk claim 1 and claim 2.
• A competitor using the free base form may still fall within claim 1 if the formula element is satisfied.

---

What constitutes “psychosexual dysfunction” for infringement purposes under this patent?

Featured snippet answer: Claim 1 requires treating “psychosexual dysfunction” in a human “suffering from same.” The claim does not enumerate DSM/ICD categories in the provided text, so the infringement scope depends on the specification’s description of the treated condition(s).

Typical interpretation pressure points

• Plain meaning: “psychosexual dysfunction” can be broad and may include disorders tied to libido, sexual performance, or psychogenic sexual issues.
• Specification anchoring: patents often define what they mean by psychosexual dysfunction via embodiments and examples.
• Indication mapping: for method-of-use claims, the critical question is whether the accused product is used to treat that same clinical concept.

Commercial and litigation risk

For any generic/alternative challenge, the risk is highest where:

• The product label, marketing, or physician instructions tie use to psychosexual dysfunction.
• Dosing is within a range supported by the patent’s described “non-toxic” therapeutic concept for sexual dysfunction.

---

How strong is the claim 1 method-of-use protection versus design-around options?

Featured snippet answer: Strength is driven by the combination of (i) formula (I) active coverage and (ii) indication-specific method-of-use. Design-around is most feasible by stepping outside formula (I) or avoiding use for the claimed indication.

Design-around levers

1. Change the compound: avoid “compound of formula (I)” by using a structurally distinct active not falling within the formula’s defined scope.
2. Change the indication: avoid prescribing for “psychosexual dysfunction” as framed by the patent’s definition and supporting evidence.
3. Change the route: the dependent oral claims can be avoided by non-oral administration, but claim 1 does not limit route. Non-oral administration alone is not a safe harbor.

Design-around that does not fully avoid risk

• Switching salts: may avoid claim 3 (hydrochloride) but does not avoid claim 1’s inclusion of all “pharmaceutically acceptable salts.”
• Using excipients/carriers: carrier language is not usually a meaningful workaround.

---

What formulations are protected by US 4,507,323 (carrier and oral dosing claims)?

Featured snippet answer: The patent protects method-of-use with formula (I) compounds in pharmaceutically acceptable carriers and explicitly covers oral administration in claims 7-12.

Protected formulation concepts in the claim set

• Carrier-based administration (claims 4-6)
• Oral route (claims 7-12)
• Salt-specific oral (claims 8-9, 11-12)

Practical read-across

Even though the claims are method claims, they function like formulation-protective hooks:

• If the specification only supports oral dosage forms, it can influence whether route and carrier are integral to practicing the invention.
• If non-oral embodiments exist, claim 1 can still be asserted against those routes.

---

What patent estate surrounds US 4,507,323 in the US (and how does that affect freedom to operate)?

Featured snippet answer: A full US estate map requires the complete patent family data, including continuations, divisionals, related salts/polymorphs/formulation patents, and any terminal disclaimers. That information is not contained in the provided excerpt.

Result: No complete, accurate US landscape can be produced from the claim text alone. Per operating constraints, an estate-level map (expiration dates, related application numbers, assignees, and other claim families) cannot be generated here without the underlying bibliographic and family records.

---

When does US 4,507,323 lose exclusivity (expiration, term adjustments, and regulatory extensions)?

Featured snippet answer: Term and any regulatory exclusivity turn on filing date, grant date, possible continuations, and whether any patent term adjustment or extension applies under Hatch-Waxman. Those details are not present in the provided material.

Result: A definitive US exclusivity timeline cannot be produced without the patent’s filing and legal status history.

---

Is US 4,507,323 likely implicated in Paragraph IV or biosimilar-style generic risk scenarios?

Featured snippet answer: The claims are method-of-use tied to a specific chemical formula and its salts. Paragraph IV risk depends on whether the generic’s product contains a compound that falls within formula (I) and whether its proposed label or intended use targets psychosexual dysfunction.

Result: A specific generic challenge or settlement scenario cannot be mapped without Orange Book listing context, FDA approval identifiers, and known litigations for this patent.

---

Key takeaways

• Claim 1 is the main protection: it covers administering formula (I) or pharmaceutically acceptable salts in a therapeutic, non-toxic manner to treat psychosexual dysfunction.
• Dependent claims add targeted coverage for hydrochloride salt, carrier-based administration, and oral administration.
• The practical enforceability hinges on claim construction of formula (I) and on how the specification defines “psychosexual dysfunction.”
• Switching salts does not fully avoid risk because claim 1 already includes “pharmaceutically acceptable salts.”
• Avoiding oral route avoids only the dependent oral claims; claim 1 can still be asserted for non-oral administration.

---

FAQs

1. Does changing from hydrochloride to another pharmaceutically acceptable salt avoid infringement of US 4,507,323?
2. If a product treats sexual dysfunction but the label does not mention “psychosexual dysfunction,” does it still risk method-of-use infringement?
3. Are carrier/excipient details relevant to infringement under this patent’s claims 4-6?
4. How do formula-based claim constructions typically treat stereochemistry or specific substituent ranges for “formula (I)” patents?
5. What design-around is more effective: changing dosing route or changing the chemical scaffold relative to formula (I)?

---

References (APA)

1. United States Patent 4,507,323. (Claim text provided by user).

Drugs Protected by US Patent 4,507,323

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

International Family Members for US Patent 4,507,323

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	38327
Australia	4531585
Australia	583833
Germany	3565934