Patent 10,722,516 landscape: what United States claim scope covers for landiolol hydrochloride dosing in supraventricular tachycardia (SVT)
Executive summary
US Drug Patent 10,722,516 claims a specific parenteral administration regimen of landiolol hydrochloride for supraventricular tachycardia, centered on a constant infusion dose window and time-on-drug parameters, with dependent claim layers that add dose-floor levels, response metrics, post-infusion “no overshoot,” recovery timing, solution concentration/pH, local tolerability, route/concentration, preparation by reconstitution, and special patient contexts. The core claim is tightly tied to infusion behavior (constant dose, duration 2 to 20 hours, >20 and ≤40 μg/kg/min). The dependent claims broaden coverage through measurable outcomes (heart rate reduction magnitude, recovery speed, overshoot avoidance) and formulation/handling features (solution concentration ranges, pH up to 6.5, local tissue tolerability, lyophilized powder reconstitution), creating multiple infringement “entry points” for a would-be generic or competitor using different device/method-of-manufacture assumptions.
What the claims cover in one line
A clinician “reduces heart rate in SVT” by administering landiolol hydrochloride parenterally as a constant-dose infusion at >20 up to 40 μg/kg/min for 2 to 20 hours, with multiple claim add-ons covering dose floors, durability, pharmacodynamic response, post-infusion kinetics, and specific solution/formulation characteristics.
What exactly does US Patent 10,722,516 claim for landiolol hydrochloride dosing in SVT?
Featured snippet answer: The independent claim (claim 1) covers a method of reducing heart rate in a SVT subject by giving parenteral landiolol hydrochloride as a constant dose of >20 to ≤40 μg/kg/min for 2 to 20 hours.
Independent claim 1: core scope and how it is delimited
Claim 1 structure
- Disease/indication: subject suffering from supraventricular tachycardia
- Act: administering landiolol hydrochloride parenterally
- Dosing mode: constant dose
- Dose range: more than 20 μg/kg/min and not higher than 40 μg/kg/min
- Duration: 2 to 20 hours
Key legal/technical delimiters
- “Constant dose” is a functional constraint. A dosing scheme that ramps up/down, or uses intermittent dosing, can avoid literal reading if it is not “constant.”
- The dose boundary is open on the low end (>20) and closed on the high end (≤40). Infringers using 20 μg/kg/min exactly or >40 μg/kg/min can design around.
- Duration is bounded by 2 to 20 hours, inclusive per typical patent claim interpretation unless otherwise stated.
Dependent claim 2: dose “floors” inside the independent window
Claim 2 covers claim 1 methods where the constant dose is:
- at least 25 μg/kg/min, or
- at least 30 μg/kg/min, or
- at least 35 μg/kg/min
This layers on because it carves out narrower sub-ranges within the independent claim’s >20 to ≤40 band:
- 25 to 40
- 30 to 40
- 35 to 40
Dependent claim 3: minimum infusion durations
Claim 3 covers claim 1 where infusion is:
- at least 4 hours, or
- at least 6 hours, or
- at least 12 hours
This creates overlapping coverage for longer infusions (4+, 6+, 12+). A competitor using shorter than 4 hours can avoid those dependent claims, but still potentially fall into claim 1 if they are still within 2 to 20 hours.
Dependent claim 4: pharmacodynamic thresholds
Claim 4 requires heart rate reduction:
- at least 5%, or
- between 10% and 50% compared to pre-administration.
This supports infringement in a setting where dosing and time fall inside claim 1, but also makes outcome a potential lever for defense. If a regimen reduces by less than 5%, it can be argued not to meet the dependent limitation (though claim 1 may still be infringed).
Dependent claim 5: “no overshoot effect”
Claim 5 requires that no overshoot effect occurs after termination of infusion.
This is a post-therapy kinetic requirement. It is not just that heart rate decreases. It must avoid a rebound or overshoot phenomenon after stopping.
Dependent claim 6: recovery timing after termination
Claim 6 requires:
- the subject’s heart reaches a normal rate within 5 to 20 minutes after termination.
This provides a second post-infusion kinetic metric (overshoot behavior plus time-to-normal). It supports a clinical argument around landiolol’s rapid reversibility but also gives design-around pathways (for example, protocols affecting rebound kinetics or using different stopping dynamics).
Dependent claim 7: infusion solution concentration ranges
Claim 7 limits claim 1 by specifying landiolol hydrochloride concentration in the solution:
- about 1 mg/mL to 30 mg/mL, or
- about 5 to 15 mg/mL
This is formulation-dependent, and it interacts with constant-dose infusion. A protocol that changes concentration while maintaining μg/kg/min could avoid if its concentration falls outside the claimed ranges.
Dependent claims 8–11: “solution” definition, route, pH, local tissue tolerability
Claim 8: landiolol is provided as a solution
Claim 9: solution pH is up to 6.5
Claim 10: route selected from:
- subcutaneous
- intravenous
- intraarterial
- intracoronary
Claim 11: solution is local tissue tolerant at the infusion site, preventing local venous irritation or skin necrosis
These are meaningful because they extend beyond “dose” into physicochemical and tolerability constraints. A competitor could attempt to maintain the dosing regimen while changing pH, concentration, or excipient package and argue it falls outside claims 9–11.
Dependent claim 12: special patient context (intoxication)
Claim 12 covers SVT method steps where the subject’s SVT context is:
- intoxication due to a positive intotropic drug or a sympathomimetic drug
This may be targeted to particular clinical use cases. It can also affect how prescribing data is collected and how “subject suffering from…” is proven.
Dependent claim 13: reconstituting from lyophilized powder
Claim 13 requires the solution is prepared by reconstituting a lyophilized powder comprising landiolol hydrochloride.
This ties infringement to a specific product form/handling process. If a competitor supplies landiolol as a different intermediate form (for example, different commercial presentation) and does not reconstitute from lyophilized powder, it may avoid this dependent claim while still potentially reading on claim 1.
Dependent claim 14: continuous intravenous infusion
Claim 14 narrows route to:
- continuous intravenous infusion.
Depending on how claim 10 route is interpreted, claim 14 creates a stronger literal foothold for IV protocols.
Dependent claim 15: “provided for a period of up to 4 hours”
Claim 15 states:
- landiolol is provided for a period of up to 4 hours.
This is notable because it partially overlaps with claim 3’s at least 4 hours tiers. Claim 15 can cover exactly 4 hours as well as shorter durations (subject to claim 1’s 2–20 hour boundary). A competitor using 4+ hours could still fall into claim 15 if “up to 4 hours” includes 4 exactly; whether it includes any duration above 4 depends on strict claim construction. The practical read is that claim 15 is designed to capture short-course infusion protocols.
How could an accused regimen avoid infringement of US 10,722,516?
Featured snippet answer: Avoiding literal infringement is most feasible by departing from the constant-dose window (>20 to ≤40 μg/kg/min), the 2 to 20 hour infusion duration, the dose concentration ranges (about 1 to 30 mg/mL or about 5 to 15 mg/mL), and/or the solution properties (pH up to 6.5 and local tissue tolerability), plus avoiding the post-stop overshoot/no overshoot and time-to-normal limitations.
Dosing design-arounds (most direct)
- Use ≤20 μg/kg/min or >40 μg/kg/min. Claim 1 is the gatekeeper; missing it can eliminate all dependent claim readings.
- Stop infusion outside 2 to 20 hours.
- Use non-constant dose strategies that are not “constant dose” (dose titration up/down may create a literal non-infringement argument).
Clinical/outcome design-arounds (dependent claim risk)
- If a protocol produces an overshoot effect, it can defeat claim 5.
- If “normal rate within 5 to 20 minutes after termination” is not met, claim 6 can be avoided (though claim 1 and other dependent claims might still apply).
Formulation and administration design-arounds
- Use concentration outside about 1–30 mg/mL or about 5–15 mg/mL.
- Adjust pH beyond 6.5.
- Use a formulation that does not qualify as local tissue tolerant in the claim’s sense (though “local tissue tolerant” is an evidentiary fight, it is still a claimed limitation).
- Use delivery/preparation paths that do not involve reconstituting a lyophilized powder comprising landiolol.
What is the practical claim “stack” for infringement: which limitations are gatekeepers?
Featured snippet answer: For infringement of the independent claim, the gatekeepers are: SVT, parenteral landiolol hydrochloride, constant dose, >20 and ≤40 μg/kg/min, and 2 to 20 hours. Dependent claims then add layers that narrow to specific sub-sets defined by dose floor, duration floor, pharmacodynamic magnitude, overshoot behavior, recovery time, concentration, pH/tolerability, route, patient context, lyophilized reconstitution, and continuous IV infusion.
Gatekeeper map
- Must satisfy for all coverage: Claim 1 elements
- Further narrowed subsets:
- Dose floors (claim 2)
- Duration floors (claim 3)
- HR reduction magnitude (claim 4)
- Post-stop overshoot absence (claim 5)
- Post-stop time-to-normal (claim 6)
- Solution concentration windows (claim 7)
- Solution form/pH/tissue tolerability (claims 8–11)
- Patient context (claim 12)
- Lyophilized reconstitution (claim 13)
- Route as continuous IV (claim 14)
- Up-to-4-hour provided periods (claim 15)
How does US 10,722,516 compare with typical landiolol SVT patent strategies (dose regimen vs formulation vs method-of-use)?
Featured snippet answer: US 10,722,516 is primarily a dose-regimen method-of-use patent with formulation and administration add-ons that behave like secondary claim anchors.
Dose-regimen focus
The independent claim’s structure is characteristic of patents that pursue clinical practice parameters rather than new chemistry:
- constant-dose infusion window
- bounded treatment duration
- SVT context
Outcome gating
Claims 4–6 use measurable pharmacodynamics and kinetics:
- % reduction magnitude
- overshoot absence
- time to normal
Formulation/handling add-ons
Claims 7–11 and 13 introduce “product-like” features:
- concentration
- pH
- tissue tolerability at infusion site
- reconstituting from lyophilized powder
This hybrid structure increases the number of ways a product label, infusion protocol, or compounding/reconstitution practice can become evidence of infringement.
What patent estate issues matter for freedom-to-operate around landiolol hydrochloride infusion in SVT?
Featured snippet answer: Even if a challenger targets dosing outside the >20 to ≤40 μg/kg/min window, the estate risk remains if other patents cover:
- narrower dose ranges adjacent to the window
- infusion duration subdivisions (including 2–4 hours and ≥4/6/12 hours)
- post-infusion rebound/overshoot kinetics
- specific concentration/pH/tolerability formulations
- specific commercial presentations requiring lyophilized reconstitution
- method-of-use claims tied to SVT subpopulations or intoxication contexts.
Litigation readiness: evidence types
The claim set indicates the most relevant evidence categories for a dispute:
- infusion pump records showing “constant dose” and μg/kg/min calculation
- administration start/stop timestamps to prove duration and time-to-normal windows
- heart-rate measurements before and after for % reduction limits
- post-stop monitoring to confirm or refute “overshoot” and time-to-normal
- concentration preparation records and solution pH testing
- formulation/excipient documentation and reconstitution process documents
- site observations supporting “local venous irritation or skin necrosis” absence.
Orange Book status, FDA labeling, and Paragraph IV risk for US 10,722,516
No Orange Book listing, FDA reference product details, and Paragraph IV litigation posture are provided in the input. Without those, a complete status mapping cannot be produced.
Commercial and regulatory positioning: what dosing-window patents usually do to entry strategy
Featured snippet answer: Patents that tightly claim constant infusion dose ranges and duration windows create “labeling and protocol lock” effects. Generic or competitor strategies tend to focus on (1) avoiding the claimed dose/time window, (2) altering concentration/pH/tolerability practice, or (3) arguing non-constant dosing and non-meeting pharmacodynamic post-stop parameters.
Implementation realities
- Hospitals often standardize infusion protocols. A protocol that maps directly onto claim 1 and typical concentration/pH practice can become high-risk.
- Competitors can sometimes avoid by shifting protocol to a dosing range just outside claim 1, but that can run into clinician adoption barriers and label constraints.
Key Takeaways
- US 10,722,516 is a regimen-driven SVT method-of-use patent that hinges on parenteral landiolol hydrochloride delivered as a constant-dose infusion at >20 and ≤40 μg/kg/min for 2 to 20 hours.
- Dependent claims add layered narrowing: dose floors (25/30/35+), duration floors (4/6/12+), HR reduction magnitude (≥5% or 10–50%), and post-infusion pharmacodynamics (no overshoot; normal rate within 5–20 minutes).
- Formulation and administration features expand the infringement map via solution concentration ranges, pH ≤6.5, local tissue tolerability, reconstituting lyophilized powder, and route constraints including continuous IV infusion.
- Design-around pathways are most feasible by breaking claim 1 (dose, constant dosing, or time bounds). If claim 1 is met, dependent limitations can still be avoided by manipulating concentration/pH/tolerability practice or by producing different post-stop kinetics (overshoot and recovery timing).
- Dispute-proofing requires operational evidence: pump math for constant dose, infusion timing, HR measurement windows, solution concentration/pH documentation, and reconstitution records.
FAQs
- Does US 10,722,516 cover titration regimens if the average dose is within >20 to ≤40 μg/kg/min?
- If a protocol reduces heart rate by >5% but produces overshoot after stopping, which claims are at risk?
- How do the solution concentration and pH limitations change infringement risk for different compounding practices?
- Can a continuous intravenous infusion avoid the lyophilized reconstitution limitation if the drug is supplied in a different finished form?
- Is a 3-hour infusion covered under claim 15, and how does it interact with claim 1’s 2 to 20 hour boundary?
References
- United States Patent 10,722,516 (claims provided in prompt).
