United States Patent 6,653,286: Scope, Claims, and US Patent Landscape (Ganirelix + FSH to Attenuate LH Rise in COH)
US Drug Patent 6,653,286 claims a specific combination regimen used in controlled ovarian hyperstimulation (COH): exogenous follicle-stimulating hormone (FSH) administered with ganirelix (a GnRH antagonist) to attenuate the LH rise in women undergoing COH. The independent claim is limited by (i) the biological objective (attenuating the LH rise), (ii) co-administration modality (FSH conjointly with parenteral ganirelix), and (iii) a ganirelix daily dose window of 0.125 mg to 0.5 mg, including a dependent claim that pins 0.25 mg. Secondary limitations narrow administration route and treatment duration.
What is the claimed invention in plain scope terms?
The patent claims a method of preventing or reducing an LH surge-like rise during COH by using FSH plus ganirelix. The claimed regimen is defined by three practical parameters that drive both infringement risk and design-around options: dose, route, and treatment length.
What do the claims cover and how broad is the independent claim?
Independent Claim 1
Claim 1:
“A method for attenuating LH rise in women undergoing controlled ovarian hyperstimulation by administering exogenous FSH, said method comprising administering cojointly FSH and parenterally administering ganirelix in a daily dose of between 0.125 mg and 0.5 mg.”
Core elements (all required):
- Patient population and clinical context
- “women undergoing controlled ovarian hyperstimulation” (COH)
- Biological/clinical target
- FSH component
- “administering exogenous FSH” and “administering cojointly FSH”
- Ganirelix component
- “parenterally administering ganirelix”
- Daily dose range: 0.125 mg to 0.5 mg
Claim construction implications for breadth:
- The claim is a use-method claim (clinical objective tied to a dosing/composition regimen).
- It is broad on the FSH itself: it does not require a specific FSH brand, formulation, IU dose, or purity in the text provided. It requires “exogenous FSH” and co-administration.
- It is narrow on ganirelix dosing because it requires a daily dose within a defined mg window. That dosing window is the key quantitative limitation.
- It is open on parenteral route in claim 1 (parenteral is broader than subcutaneous). Dependent claims narrow route.
Dependent Claims 2-4
- Claim 2 (dose fixed):
“wherein the daily dose is 0.25 mg.”
- Claim 3 (route):
“wherein said parenteral administration is subcutaneous.”
- Claim 4 (duration):
“wherein said ganirelix is is administered cojointly with FSH for 2-14 days.”
Breadth impact:
- Claim 2 is narrower than claim 1 (subset within the dose window).
- Claim 3 narrows route but still stays within “parenteral” in claim 1.
- Claim 4 adds a dosing duration boundary (2 to 14 days of coadministration with FSH).
How does the claim map to typical COH protocols and what parts are enforceable?
Enforceable regimen definition
The patent enforces a regimen defined by the intersection of:
- COH context in women
- coadministration of exogenous FSH with ganirelix
- parenteral administration of ganirelix at 0.125 to 0.5 mg/day
- clinical function: attenuating LH rise
Where the scope is likely easiest to prove
From an evidentiary standpoint, method claims tied to dosing schedules tend to be simplest to support when the regimen is already used in routine care or is captured in clinical documentation. The dose and duration boundaries are concrete, and route narrowing is explicit in claim 3.
Most evidentiary anchors in this set:
- Ganirelix daily dose (0.125 to 0.5 mg; specifically 0.25 mg in claim 2)
- Administration route (subcutaneous in claim 3)
- Co-administration period with FSH (2 to 14 days in claim 4)
Where scope can become disputed
- “Attenuating LH rise” can become a contested element if clinical records are insufficiently detailed about LH measurements or if LH rise is defined inconsistently across trial protocols. The claim ties “attenuating LH rise” to the method result, but it also depends on how that physiological outcome is measured in practice.
What design-around options exist within the claim language?
Design-around analysis is constrained to the claim text provided.
Dose window design-around (claim 1)
- To avoid claim 1 as written, a regimen would need to use ganirelix daily dose outside 0.125 mg to 0.5 mg.
- Claim 2 (0.25 mg) creates a specific risk point even if a regimen is within the broader window.
Practical boundary risk:
- If ganirelix is administered within 0.125-0.5 mg/day, claim 1 exposure exists if the method is used in COH with the claimed intent/result.
- If a regimen uses exactly 0.25 mg/day, claim 2 exposure is direct (if other claim elements are met).
Route design-around (claim 3)
- Claim 3 explicitly requires subcutaneous administration for parenteral route.
- If a regimen uses a different parenteral route (while still “parenterally administering ganirelix”), claim 3 may be avoided, but claim 1 may still be implicated because claim 1 only requires “parenterally.”
Duration design-around (claim 4)
- Claim 4 requires coadministration duration between 2-14 days.
- Duration outside that window can avoid claim 4 but not necessarily claim 1.
FSH coadministration design-around
- Claim 1 requires “administering cojointly FSH” with ganirelix. Regimens that separate dosing in time such that they are no longer “cojointly” may present an argument, but the claim text does not define “cojointly” precisely.
US patent landscape: who else likely owns adjacent COH/antagonist IP?
This section uses the claim’s active and functional features to outline the structural landscape in the US: other patents often clustered around (i) GnRH antagonists in COH, (ii) specific antagonist dosing schedules, (iii) LH suppression endpoints, and (iv) combination regimens with FSH.
Key landscape anchors by technical feature
- Ganirelix itself (API composition and related method-of-use IP)
- Patents covering ganirelix composition, formulation, and initial method-of-use tend to be earlier and more centralized.
- COH method IP for GnRH antagonists
- Separate patent families often cover the use of GnRH antagonists to prevent LH rise/surge in IVF/COH.
- Dose schedule IP
- A dominant axis of differentiation is the antagonist dose and timing relative to FSH initiation and monitoring.
Where 6,653,286 fits
- This patent’s independent claim focuses on a specific dosing range (0.125-0.5 mg/day) for ganirelix combined with FSH to attenuate LH rise in COH.
- That positions it as a regimen-claim that can overlap with:
- broader GnRH antagonist COH claims that do not specify dose in mg windows, and
- narrower claims that specify a particular dose (like 0.25 mg) or route or treatment duration.
Expected claim interaction structure
In practice, the most common landscape outcome is that multiple families create overlapping coverage:
- A broad “GnRH antagonist + COH to suppress LH rise” method claim (often wider, less dose-specific)
- A narrower “ganirelix at X mg/day during COH” method claim (dose-specific)
- Additional dependent claims narrowing route/duration
Because 6,653,286 has both physiological outcome and a dose range, it can act as a “bridge” between broader COH suppression concepts and specific clinical regimens.
How do claims 1 and 4 define the regimen window in enforceable terms?
Dose-interval control: claim 1
- Daily ganirelix dose range: 0.125 mg to 0.5 mg
Time control: claim 4
- Co-administration duration with FSH: 2 to 14 days
Route control: claim 3
- Subcutaneous administration of parenteral ganirelix
Specific dose control: claim 2
- Exact daily dose: 0.25 mg
Together, the set forms a lattice:
- Claim 1 sets the core dose range and regimen objective.
- Claim 2 locks one dose within the core range.
- Claim 3 locks one route method.
- Claim 4 locks the duration.
Potential infringement scenarios (based on claim elements)
These are outcome-based scenarios derived directly from the claim structure.
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Standard COH regimen with ganirelix 0.25 mg/day, subcutaneous, 10 days
- Likely meets claim 1 and claim 2, and likely meets claim 3 and claim 4 if duration falls in 2-14 days.
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COH regimen with ganirelix 0.3 mg/day, subcutaneous, 14 days
- Likely meets claim 1 and claim 3 and claim 4 (duration inclusive if within 2-14).
-
COH regimen with ganirelix 0.2 mg/day, parenteral non-subcutaneous route
- Likely meets claim 1, potentially avoids claim 3 depending on what route is used, and may or may not meet claim 4 depending on duration.
-
COH regimen with ganirelix outside the 0.125-0.5 mg/day range
- Likely avoids claim 1 on dose grounds, even if objective and coadministration are otherwise the same.
Key Takeaways
- US 6,653,286 is a regimen method claim: FSH plus parenteral ganirelix to attenuate LH rise in women undergoing COH.
- Claim 1 is anchored by a ganirelix daily dose window of 0.125 mg to 0.5 mg plus co-administration with FSH and a COH/LH-suppression objective.
- Claim 2-4 narrow the scope through 0.25 mg/day, subcutaneous route, and 2-14 day coadministration duration.
- The most direct design-arounds in claim text are ganirelix dose outside 0.125-0.5 mg/day (for claim 1), and route/duration carveouts for dependent claims.
FAQs
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What is the key limiting element of claim 1?
The ganirelix daily dose range (0.125 mg to 0.5 mg), combined with COH use of FSH + parenteral ganirelix to attenuate LH rise.
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Does claim 1 require subcutaneous administration?
No. Claim 1 requires “parenterally administering” ganirelix; subcutaneous is required only in claim 3.
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Is 0.25 mg/day covered even if dose is within the broader range?
Yes. Claim 2 explicitly covers a daily dose of 0.25 mg.
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What does claim 4 add beyond claim 1?
It limits coadministration duration to 2-14 days.
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What is the strongest design-around based only on these claims?
Use a ganirelix daily dose outside 0.125 mg to 0.5 mg, because that can avoid claim 1 regardless of route and duration.
References
[1] United States Patent 6,653,286 (claims provided in prompt).
