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Patent landscape, scope, and claims: |
US Patent 6,693,115: Scope, Claims Dissection, and US Patent Landscape
What does US 6,693,115 claim, in scope terms?
US 6,693,115 claims a specific hydrochloride or maleate salt of a defined small-molecule active, plus second-layer coverage for pharmaceutical compositions and therapeutic methods aimed at thrombus- or embolism-related indications in warm-blooded animals (with human embodiments in dependent claims).
Core chemical claim scope
The patent’s claim set is built around two salts of the same base compound:
| Claim |
Subject matter |
Salt form |
Scope effect |
| 1 |
2-Acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine |
Hydrochloride |
Locks in “salt identity” as a requirement for literal infringement |
| 2 |
Same named base compound |
Maleate |
Provides an alternative literal infringement path using a different counterion |
Formulation scope
Claims 3-4 cover compositions that use the claimed salt as the active with a pharmaceutically acceptable carrier.
| Claim |
Type |
Active ingredient requirement |
Composition breadth |
| 3 |
Composition |
Claim 1 salt (hydrochloride) |
Any carrier-based formulation with that salt |
| 4 |
Composition |
Claim 2 salt (maleate) |
Any carrier-based formulation with that salt |
Indication scope
Claims 5-7 focus on prevention or treatment of thrombus formation-induced or embolization-induced diseases, first broadly across warm-blooded animals, then specifically for humans, and then specifically for treatment.
| Claim |
Animal scope |
Disease framing |
Treatment stage |
| 5 |
Warm-blooded animal |
“thrombus formation-induced or embolization-induced disease” |
Prevention or treatment |
| 6 |
Human |
“thrombosis or embolism” |
Prevention or treatment |
| 7 |
Human |
“thrombosis or embolism” |
Treatment |
Method scope
Claims 8-15 cover administration of the salt for prevention or treatment, again split between warm-blooded animals and then human, and then thrombosis vs embolism.
| Claims |
Method substrate |
Animal |
Indication |
| 8-11 |
Claim 1 salt |
Warm-blooded |
Prevention/treatment; human sub-limits; thrombosis vs embolism |
| 12-15 |
Claim 2 salt |
Warm-blooded |
Same structure but tied to maleate |
How tightly are the claims constrained (where design-arounds tend to land)?
The claim architecture is “chemical identity first,” then “salt-based formulation,” then “use-based method.” That structure makes the patent enforceable when competitors use one of the two claimed salts in the claimed way, and it creates clear design-around levers.
Design-around levers
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Counterion/salt substitution
- Literal infringement for the chemical claims requires the hydrochloride (Claim 1) or maleate (Claim 2) salt.
- A competitor using a different salt form of the same base compound can avoid literal coverage unless the patent’s specification and claim construction are interpreted broadly enough for salt equivalents (the claims as provided read as strict salt recitations).
-
Base compound substitution
- All claims are anchored to the named tetrahydrothieno[3,2-c]pyridine scaffold with the exact substituent pattern (2-acetoxy, α-cyclopropylcarbonyl, 2-fluorobenzyl). Changing the substituent pattern avoids literal scope.
-
Indication carve-outs
- The method claims are tied to thrombus/embolism contexts.
- If a competitor targets a different therapeutic area, literal infringement on the method claims may fail even if the same salt is used.
-
Administration vs. formulation
- The patent separates “medicament composition” from “method of prevention/treatment.”
- A product could potentially be marketed as a formulation without practicing a claimed method (or vice versa), which affects enforcement strategy and proof requirements.
What is the effective “claim stack” for infringement risk?
US 6,693,115 has multiple independent claim entry points: two product-type chemical claims (1-2), two composition claims (3-4), and two method claim families (8-15). From a portfolio perspective, enforcement can proceed through any stack that matches the competitor’s product attributes.
Risk mapping by product type
| Competitor product attribute |
Matches claim family |
Direct risk |
| Uses the same hydrochloride salt |
1, 3, 8-11 |
High for chemical/composition/method |
| Uses the same maleate salt |
2, 4, 12-15 |
High for chemical/composition/method |
| Uses same base compound but different salt |
Not 1 or 2; 3-4 also miss; 8-15 also miss |
Reduced to non-literal theories (if any) |
| Different base compound |
Misses 1 and 2 |
Mostly out of literal scope |
| Same salts but different therapeutic indication |
Can miss 5-7 and 10-11/14-15 method use |
Composition risk may remain; method risk drops |
What does the patent landscape look like in the US for this chemical and use class?
Landscape structure you should expect for this family
Even without expanding beyond the claims text you provided, the US patent landscape for a specific salt-form drug typically clusters into:
- Primary composition of matter: the base compound and/or particular salts (here, hydrochloride and maleate).
- Formulation patents: dosage forms, release profiles, and excipient systems.
- Polymorph/solid-state: crystallinity and process-specific solid forms.
- Therapeutic use: thrombotic/embolic indication patents and related method-of-treatment claims.
- Regulatory linkage: Orange Book listings tied to the relevant NDA/ANDA and patent expiration schedules.
However, a complete US landscape cannot be generated from the claim text alone because it requires verification of:
- the drug’s identity beyond the IUPAC-like chemical name,
- whether US 6,693,115 is tied to a specific INN/brand,
- the existence and status of later continuation patents,
- Orange Book listings and listed patents, and
- citation and family members that define true priority and terminal disclaimers.
Under the provided constraints, no additional database-driven assertions can be made with integrity.
Claim-by-claim scope analysis (what each claim practically covers)
Claims 1-2: Salts as composition of matter
- Claim 1 covers the exact molecule as a hydrochloride salt. Coverage is literal and does not depend on therapeutic use.
- Claim 2 covers the exact molecule as a maleate salt. This is a second, separate composition-of-matter anchor.
Claims 3-4: Medicament compositions
- Claim 3 covers any formulation where the hydrochloride salt (Claim 1) is the active in an amount that is pharmaceutically effective, combined with any pharmaceutically acceptable carrier.
- Claim 4 repeats this for the maleate salt (Claim 2).
In enforcement, these claims typically require showing:
- presence of the claimed salt in the product,
- sufficient “pharmaceutically effective amount” (which is a functional threshold),
- and existence of a pharmaceutically acceptable carrier (broad category).
Claims 5-7: Use in thrombus/embolism disease
- Claim 5 covers prevention or treatment of a thrombus formation-induced or embolization-induced disease in a warm-blooded animal. It is broad on animal category but narrow on disease driver.
- Claim 6 narrows warm-blooded to humans and frames the disease as thrombosis or embolism.
- Claim 7 further limits to treatment in humans.
This claim progression makes the human therapeutic use the most litigation-relevant path for clinical products.
Claims 8-15: Methods of administering
- Claims 8-11: method using the hydrochloride salt.
- Claim 8: warm-blooded animal prevention/treatment.
- Claim 9: warm-blooded animal is human.
- Claims 10-11: treatment of thrombosis vs treatment of embolism.
- Claims 12-15: identical structure but tied to the maleate salt.
These method claims are usually the hinge for clinical and label-aligned enforcement, especially where formulation patents are not strong or where sales-based infringement theories require method practice.
What are the most plausible enforcement targets based on the claims?
Given the breadth of the composition claims (“any pharmaceutically acceptable carrier”), enforcement generally focuses on whether the commercial product uses the same salt form.
High-probability targets
- Branded or generic products marketed in hydrochloride or maleate salt form.
- Clinical dosing regimens for thrombosis or embolism where the salt is administered.
- Labeling and promotional materials that support “treatment” of thrombosis/embolism in humans.
Lower-probability targets
- Products using different salt forms of the same base compound, unless non-literal equivalence arguments are pursued.
- Products aimed at other indications where method claims may not be provably practiced.
Key takeaways
- US 6,693,115 is a salt-anchored patent: it locks onto hydrochloride (Claim 1) and maleate (Claim 2) of the specified tetrahydrothieno[3,2-c]pyridine derivative.
- The claim set extends from composition of matter to pharmaceutical compositions (Claims 3-4) and to therapeutic methods for thrombosis/embolism (Claims 5-7, 8-15), with human limitations in dependent claims.
- The main design-around lever is switching the salt form or changing the substituted core, since the claims explicitly recite the salts.
- A definitive US patent landscape requires database and family/original drug identity checks; the claim text alone is insufficient to map later US continuations, related polymorph filings, or Orange Book-listed patents.
FAQs
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Is US 6,693,115 broader for hydrochloride than maleate, or vice versa?
No. The patent provides parallel chemical, composition, and method coverage for hydrochloride (Claims 1,3,8-11) and maleate (Claims 2,4,12-15).
-
Do the method claims require that the disease is thrombosis or embolism in humans?
Yes. Dependent claims specify human use and then restrict to thrombosis or embolism for treatment (Claims 10-11 and 14-15).
-
Can a competitor avoid all coverage by using a different dosage form?
Not if the product still uses the claimed salt and practices the claimed method/use. Claims 3-4 are carrier-based and do not hinge on a specific dosage form.
-
Are the composition claims dependent on any particular therapeutic regimen?
No. Claims 3-4 cover a medicament composition with the claimed salt and carrier without requiring the thrombus/embolism method limitations.
-
Which claim family is most directly relevant to a marketed thrombolysis/antithrombotic drug product?
The method family (Claims 5-7, 8-15) is typically most aligned to clinical treatment and labeling, while composition claims (3-4) can apply to product formulation regardless of regimen.
References
- United States Patent 6,693,115.
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