United States Patent 7,601,730: Scope of Claims and US Patent Landscape
What does US 7,601,730 claim?
US 7,601,730 is directed to methods of treating disease in a subject by administering an identified compound class (or a salt) that fits a specific structural formula, with disease scope that is broad across cardiovascular, cerebrovascular, renal, pulmonary/respiratory, and vascular spasm/ischemia indications.
Core structural claim element (independent claim 1)
Claim 1 requires:
- A method to treat a disease in a subject in need
- Administering an effective amount of:
- “a compound, or a salt thereof” having the formula:
- X is CH
- Y is oxygen
- Z is oxygen
- R is CO2H
- R2 is methyl
- R3 is methyl
- R4 is phenyl
- R5 is phenyl
- R6 is methyl
- or an enantiomer of that compound
- Disease is selected from a listed group
Independent claim focus: disease list is a key scope lever
Claim 1 enumerates diseases including:
- Hypertension
- Pulmonary hypertension
- Myocardial infarction
- Angina pectoris
- Acute kidney failure
- Renal insufficiency
- Cerebral vasospasms
- Cerebral ischemia
- Subarachnoid hemorrhages
- Asthma
- Atherosclerosis
- Intravascular coagulation
- Restenosis after angioplasty
- Hypertension caused by ischemia or intoxication
- Kidney failure caused by ischemia or intoxication
- Raynaud’s syndrome
- Asthmatic airway condition
Claims 2 and 3 are narrower disease-specific versions of the same structural/administration approach.
How broad is the compound scope under the claims?
Formula-defined compound class
The claim is not limited to a named chemical. It is tied to a fixed substituent pattern (X, Y, Z, R, R2-R6). That makes the compound scope:
- Broad at the “identity” level (because it captures “a compound” meeting the formula, plus salts and enantiomers)
- Tight at the “structure” level (because X, Y, Z, and all named substituents are specified)
Salt and stereochemistry expand coverage
The claim expressly covers:
- Salts
- Enantiomers
- “or an enantiomer thereof” in claim 1
- Enantiomeric purity states in dependent claims (pure enantiomer, racemate)
This matters for design-around and freedom-to-operate because alternative stereochemical forms still land inside claim coverage if they are within the enumerated stereochemical categories.
How broad is the indication and method scope?
Disease scope in claim 1 is unusually wide for a single US method claim
Claim 1 uses a closed list that still totals 18 disease categories/wording variants. That provides:
- Coverage across multiple therapeutic areas (CV, pulmonary, renal, neurovascular, vascular spasm, respiratory)
- Coverage of secondary-cause formulations for hypertension and kidney failure (“caused by ischemia or intoxication”)
Dependent claims further lock in administration modes and dose ranges
Claim 5 onwards add practical method parameters:
- Oral or parenteral administration
- Oral dosing range
- Parenteral dosing range
- Solid or liquid pharmaceutical forms
- Route subtypes including nasopharyngeal vapor/spray for oral delivery
- Parenteral route list: subcutaneous, intravenous, intramuscular, intraperitoneal
The overall method claim coverage therefore has both:
- Broad core coverage via claim 1
- Additional fallback coverage via dependent claims if dose/route specifics are met.
What are the key dependent claims that control enforceability?
Disease-specific claims (claims 2 and 3)
- Claim 2: method where disease is hypertension
- Claim 3: method where disease is pulmonary hypertension
These are important because they can support enforcement with fewer elements than claim 1 (if the defendant’s use is confined to one indication).
Enantiomer scope (claims 4, 11-16)
- Claim 4: enantiomerically-pure form
- Claims 11-13: optically active enantiomer; (S)-enantiomer; pure (S)
- Claims 14-15: (R)-enantiomer; pure (R)
- Claim 16: racemate
Collectively, these dependent claims indicate the patentee expects dispute or differentiation at the level of stereoisomer vs racemate.
Route and dose parameters (claims 5-10)
- Claim 5: oral or parenteral
- Claim 6: oral daily dose about 0.5 mg/kg to about 50 mg/kg
- Claim 7: parenteral daily dose about 0.1 mg/kg to about 10 mg/kg
- Claim 8: solid or liquid pharmaceutical form
- Claim 9: oral administered with vapor or spray means through nasopharyngeal space
- Claim 10: parenteral by subcutaneous, intravenous, intramuscular, or intraperitoneal
These are typical claim scaffolds that can matter for infringement where:
- A competitor uses a different formulation form factor
- A competitor uses a different route (e.g., inhalation vs nasopharyngeal spray)
- A competitor selects a daily dose outside the stated ranges
What is the likely “center of gravity” of the claim set?
From a landscape and enforceability standpoint, the center of gravity is:
- Claim 1: broad disease list + formula-defined compound + effective amount + enantiomer and salts.
- Claims 2 and 3: remove disease-list ambiguity for hypertension and pulmonary hypertension.
- Claims 5-10: route and dosing create operational infringement “handles.”
- Claims 11-16: stereochemistry and purity cover alternative commercial solid-state and drug substance choices.
Put simply: a manufacturer that is aligned with the same molecule class and pursues any of the listed indications has multiple claim pathways even if it changes route, dose, or stereochemical presentation (as long as it remains inside the enumerated alternatives).
How does the “effective amount” language affect scope?
“Effective amount” is broad in method patents; it can dilute sharp boundaries unless a dose range or route is also claimed.
Here, the claim set uses both:
- General “effective amount” in claim 1
- Specific mg/kg/day dose ranges in dependent claims (6 and 7)
- Specific route constraints in dependent claims (9 and 10)
That structure typically increases enforcement leverage because plaintiffs can argue infringement at different levels depending on what evidence is available:
- If dose is proven and within range: rely on dependent dose claims
- If route is proven: rely on dependent route claims
- If the defendant’s use is not clearly within dose range but still uses “effective amount”: attempt claim 1 or claim 2/3 depending on indication.
Claim scope summary table
| Claim |
Method element |
Key scope qualifiers |
Main business relevance |
| 1 |
Treat disease by administering compound/salt |
Formula-defined substituents; enantiomer/salt; disease list of 18 categories |
Broadest enforceability anchor |
| 2 |
Treat hypertension |
Disease fixed to hypertension |
Focused path for CV payer/label-specific challenges |
| 3 |
Treat pulmonary hypertension |
Disease fixed to pulmonary hypertension |
Focused path for pulmonary vascular players |
| 4 |
Stereochemistry |
enantiomerically-pure |
Blocks racemate-only design-around if purity is used |
| 5 |
Administration |
oral or parenteral |
Captures common delivery modes |
| 6 |
Oral dose |
0.5 to 50 mg/kg/day (about) |
Operational dose-range pressure point |
| 7 |
Parenteral dose |
0.1 to 10 mg/kg/day (about) |
Operational dose-range pressure point |
| 8 |
Formulation |
solid or liquid |
Limits “form-only” design-around arguments |
| 9 |
Oral via nasopharyngeal spray/vapor |
nasopharyngeal space + spray/vapor |
Pinpoints alternative oral-adjacent delivery |
| 10 |
Parenteral routes |
SC/IV/IM/IP |
Blocks route substitutions within injected category |
| 11-15 |
Optically active enantiomers |
(R) or (S), pure |
Captures stereochem selection |
| 16 |
Racemate |
racemate covered |
Limits attempt to escape by using racemic mixture |
US patent landscape: what can be concluded from the claim text alone
What this claim set implies about competitors’ risk
Even without prosecution history or related family data, the claims indicate a landscape pattern:
- If another US patent claims the same compound class (same substituent pattern) in use methods, there is likely overlapping infringement exposure for multiple patents: this one anchors the disease-method strategy broadly.
- If another party develops therapies for any listed disease, they must treat route, stereochemistry, and dose as non-trivial design variables, because the claims explicitly include multiple permutations.
What is missing from the provided data
No ownership, assignee, filing dates, priority dates, expiration status, prosecution history, or claim construction/interpretation can be derived from the claim excerpt alone. Therefore, no reliable determinations can be made about:
- Remaining term or expiry windows
- Whether continuation patents exist
- Whether related patents in the same family broaden or narrow coverage
- Whether the patent survived reexamination or IPRs
- Whether dependent claims are commonly asserted or invalidated
The landscape can only be assessed at the claim-coverage level from the text you supplied.
Practical landscape mapping for R&D and investment decisions (based on claim structure)
High-risk “in-scope” activity categories
Activities that fall most directly inside the claim structure are:
- Development or commercialization of a drug that matches the formula substitution pattern
- Any clinical program targeting any of these diseases:
- hypertension, pulmonary hypertension, MI, angina, acute kidney failure, renal insufficiency, cerebral vasospasms, cerebral ischemia, subarachnoid hemorrhages, asthma, atherosclerosis, intravascular coagulation, restenosis after angioplasty, Raynaud’s syndrome, and the ischemia/intoxication subcategories
Design-around vectors that are partially closed by the claims
The claim explicitly includes:
- Salts
- Enantiomers and both pure R and pure S
- Racemate
This makes “stereochemistry-only” escape routes less likely to succeed. Remaining escape routes are more likely to be based on:
- structural deviation from the fixed formula pattern
- avoiding the listed indications (label/approved use restrictions)
- using routes/dosing outside dependent claim ranges (still risky due to claim 1’s “effective amount” breadth)
Investment due diligence priorities
For any potential infringement or clearance program aligned to these indications, the claim text itself points to what must be analyzed in competitor dossiers:
- Chemical identity: does the drug substance match the fixed substituent pattern (X, Y, Z, R, R2-R6)?
- Salt identity and whether the competitor uses a “salt thereof”
- Stereochemistry: racemate vs (R) pure vs (S) pure
- Indication: whether the use is within the enumerated disease list wording
- Route and regimen: oral vs parenteral; nasopharyngeal spray usage; daily mg/kg/day
Key Takeaways
- US 7,601,730 is a method-of-treatment patent with compound structure constraints (fixed substituents) plus broad disease coverage via claim 1 and focused hypertension/pulmonary hypertension versions in claims 2 and 3.
- The claims cover salts and enantiomers, with dependent claims capturing pure (R), pure (S), enantiomerically pure, and racemate, reducing stereochemistry-based design-around options.
- Administration and regimen details (oral/parenteral, specific mg/kg/day ranges, nasopharyngeal vapor/spray, and several parenteral routes) create multiple infringement pathways beyond “effective amount” in claim 1.
- A complete patent landscape analysis (expiry, related patents, citations, family scope, and enforcement history) cannot be constructed from the claim excerpt alone; the claim text supports only coverage-level risk mapping.
FAQs
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Does claim 1 require a specific dose range?
No. Claim 1 uses “an effective amount.” Dose ranges appear only in dependent claims (claims 6 and 7).
-
Can a competitor avoid infringement by using a different enantiomer form?
The claim set includes enantiomers and dependent coverage for pure (S), pure (R), and racemate, so enantiomer-only switching does not remove risk if the compound still matches the formula and the indication still falls within the list.
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Is hypertension coverage broader than pulmonary hypertension coverage?
Claim 1 covers both, and claim 2 is a hypertension-specific dependent path. Pulmonary hypertension has its own dependent claim (claim 3), but claim 1 already includes both diseases.
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Does the patent cover both oral and parenteral administration?
Yes. Claim 5 includes oral or parenteral, and claims 9-10 add more route-specific subcategories.
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What is the most defensible design-around lever implied by the claim text?
The claim’s tight structural formula constraints and closed disease list suggest the most meaningful lever is structural divergence and/or staying outside the enumerated indications, since salt and stereochemistry changes are explicitly encompassed.
References
[1] United States Patent 7,601,730 (claim set provided in user prompt).
