| Abstract: | Novel benzoheterocyclic compounds of the formula: wherein R1 is H, halogen, alkyl, optionally substituted amino, alkoxy; R2 is H, halogen, alkoxy, phenylalkoxy, OH, alkyl, optionally substituted amino, carbamoyl-alkoxy, optionally substituted amino-alkoxy, optionally substituted benzoyloxy; R3 is a group: -NR4R5 or -CO-NR11R12; R4 is H, optionally substituted benzoyl, alkyl; R5 is a group: [R16 is halogen, optionally substituted alkyl, OH, alkoxy, alkanoyloxy, alkylthio, alkanoyl, carboxy, alkoxycarbonyl, CN, NO2, optionally substituted amino, phenyl, cycloalkyl, etc., or a group: -O-A-NR6R7; m is 0 to 3], phenyl-alkoxycarbonyl, alkanoyl, phenylalkanoyl, etc.; R11 is H or alkyl; R12 is cycloalkyl or optionally substituted phenyl; and W is a group: -(CH2)p (p is 3 to 5) or -CH=CH-(CH2)q (q is 1 to 3), the carbon atom of these groups begin optionally replaced by O, S, SO, SO2 or a group: -N(R13)- and further these groups having optionally 1 to 3 substituents of alkyl, alkoxycarbonyl, carboxy, OH, O, alkanoyloxy, etc., which have excellent vasopressin antagonistic activities and are useful as vasodilator, hypotensive agent, water diuretics, platelet agglutination inhibitor, and a vasopressin antagonistic composition containing the compound as the active ingredient. |
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Patent landscape, scope, and claims: |
Executive summary
- US Patent 5,258,510 is an issued US drug patent with claims that require construction before assessing scope, enforceability, and freedom-to-operate.
- No claim text or claim set was provided after “The claims are:”, so the patent’s claim boundaries, dependent claim relationships, likely novelty points, and infringement-relevant elements cannot be mapped to current competitors or to Orange Book-protected products.
- With the claim set absent, a complete and accurate “scope and claims” and “patent landscape” analysis cannot be produced.
US Patent 5,258,510 scope and claims: What do the claims cover?
What are the independent claim elements for US 5,258,510?
- Cannot determine claim scope without the actual claim language.
- Construction cannot be performed (for claim terms, antecedent basis, functional limitations, and structural vs. method language) without the claim text.
Which embodiments do dependent claims narrow to?
- Cannot map dependent claim fallbacks, additional limitations, or excluded subject matter without dependent claim text.
Does US 5,258,510 claim a drug composition, method of treatment, or manufacturing step?
- The claim type and therefore the infringement pathway (composition vs. method-of-use vs. method-of-manufacture) cannot be identified without the claim set.
Which products are protected by US 5,258,510?
What is the Orange Book status of US 5,258,510?
- Orange Book protection determination requires:
- the drug name/active ingredient tied to the patent, and
- the Orange Book patent-to-product listing.
- No product identification is provided, so protected drugs and dosage forms cannot be listed.
What dosage forms and strengths are within claim scope?
- Cannot infer dosage form limitations (tablet, capsule, solution), strength ranges, or excipient constraints without claim terms.
How strong is the patent estate around US 5,258,510?
How many related patents cite or are in the same family?
- A family-landscape analysis requires bibliographic data (priority application, continuations/divisionals, related patents).
- No family identifiers (INPADOC/FTO set, assignee, priority number) are provided.
What prosecution history signals are needed to assess claim breadth?
- Claim breadth in litigation depends on file-wrapper record (amendments, arguments, restriction practice).
- No prosecution history inputs are provided.
What patent litigation affects US 5,258,510?
Have there been Hatch-Waxman cases or PTAB challenges involving US 5,258,510?
- Litigation mapping requires docket-level identifiers tied to the patent number and parties.
- No case captions, district courts, or outcomes are provided, so a “what litigation affects” answer cannot be produced.
Which Paragraph IV filings targeted the patent?
- Paragraph IV targeting and settlement terms require linkage to FDA Orange Book listings and FDA litigation records.
- No listing linkage is provided.
When does US 5,258,510 lose exclusivity?
What is the expiration date of US 5,258,510?
- Patent expiration depends on:
- filing date and term calculation,
- PTA/adjustments, and
- any terminal disclaimers.
- No filing and adjustment data is provided, so a precise expiration timeline cannot be stated.
Does patent term extension apply?
- Without jurisdiction-specific TME/PTA data for the patent, exclusivity loss timing cannot be computed.
What generic entry risks exist for products covered by US 5,258,510?
When could ANDA or 505(b)(2) applicants launch?
- Launch timing depends on Orange Book listings, regulatory exclusivities (3-year, 5-year, 7-year), and the patent’s expiration and any litigation stay.
- No drug linkage is provided, so generic entry scenarios cannot be generated.
What design-arounds are implied by claim structure?
- Design-around strategies require claim element identification and coverage mapping.
- Claim text is missing.
How do US 5,258,510 claims compare with competing drugs’ patents?
Do competing products avoid claim elements or use alternative mechanisms?
- Requires knowledge of:
- the active ingredient and claimed composition/method, and
- competitor patent estates.
- None of that is identifiable from the prompt.
Which competitor assignees hold overlapping coverage?
- Cannot be listed without bibliographic and family data and without the claim content.
Formulations and manufacturing: What variants fall within scope?
What are the excipient and process limits in US 5,258,510?
- Scope of formulations (particle size, salt form, polymorph, ratios) and manufacturing steps depends entirely on the claim language.
- Not provided.
Does the patent cover salts, hydrates, solvates, or polymorphs?
- Cannot answer without claim terms specifying chemical forms.
Method-of-use and regimen coverage: What therapeutic indications are claimed?
Does US 5,258,510 claim a specific patient population or dosing regimen?
- Method-of-use scope depends on claimed indications, dose ranges, frequency, and treatment steps.
- Claim text is missing.
Key Takeaways
- A complete scope-and-claims analysis for US 5,258,510 cannot be produced because the claim text was not included.
- Landscape elements that require the patent-to-drug link, family identifiers, litigation record, and prosecution history cannot be compiled from the provided input.
FAQs
- What is the independent claim scope of US 5,258,510?
- Which drug products list US 5,258,510 in the FDA Orange Book?
- What is the exact expiration date for US 5,258,510 including PTA?
- Has US 5,258,510 been asserted in Hatch-Waxman Paragraph IV litigation?
- What claim elements create the largest generic or formulation design-around risk?
References
- (No sources cited because the required claim text and drug/patent linkage information were not provided.)
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