Scope of US Patent 10,058,554 (Risperidone LA/GA Implant in N‑Methyl‑2‑pyrrolidone Viscous Gel): claims coverage, design-arounds, and US patent landscape
US Patent 10,058,554 is directed to a method of administering risperidone base by implanting a specific in situ–forming viscous gel depot. The claim set is claim-structure heavy: it narrows to (i) lactide/glycolide copolymer with defined molecular weight and monomer ratio; (ii) N‑methyl‑2‑pyrrolidone (NMP) as the organic solvent (often “consists of” in dependent claims); (iii) weight fractions of polymer and solvent; and (iv) risperidone base in particle form with defined particle size and release duration/lag time.
What is US 10,058,554’s core claim scope?
Independent claim 1 (method claim, not composition claim) requires all of the following in combination:
- Implanting a formulation in a subject to administer risperidone base.
- The formulation contains:
- LA/GA copolymer (lactic acid and glycolic acid copolymer) with number average molecular weight 1,000 to 30,000 Da.
- Organic solvent + copolymer to form a viscous gel, where the organic solvent is NMP.
- Risperidone base in particle form incorporated in the viscous gel.
- Vehicle composition bounds:
- Copolymer is 40% to 55% by weight in the vehicle.
- Organic solvent is 45% to 60% by weight in the vehicle.
- Risperidone base is not constrained in claim 1’s text you provided, but it is constrained in multiple dependent claims (notably 5–40 wt% and 10–30 wt%).
Claim construction posture: the practical “infringement perimeter”
Because claim 1 is a method of administering by implanting a gel-forming LA/GA + NMP matrix with risperidone base particles, infringement generally turns on whether the accused product:
- uses risperidone base (not risperidone salt) in particle form,
- is an implantable depot that matches the gel vehicle system,
- uses NMP specifically (or a substitute only if it avoids “comprising NMP” limitations; dependent claims use “consists of NMP,” which is harder to avoid),
- uses the polymer molecular weight range,
- and hits the copolymer and NMP weight-percent windows in the vehicle.
How do dependent claims narrow the technology into a smaller field?
Polymer chemotype constraints
Multiple dependent claims define polymer specifics:
-
Monomer ratio LA:GA
- Claim 2: 100:0 to 60:40
- Claim 3: 100:0 to 75:25
- Claim 8: LA:GA 100:0 to 60:40 and Mn 5,000–30,000
- Claim 9: LA:GA 100:0 to 75:25 and Mn 5,000–30,000
- Claim 11: LA:GA 100:0 to 75:25, Mn 5,000–30,000, plus NMP-only vehicle
-
Molecular weight
- Claim 4: Mn 5,000–30,000 Da
- Claim 8/9/11/14/15 also recite this together with ratio and solvent restrictions.
These ranges define a polymer window that is typical for PLGA depot tuning (release rate, viscosity, gel behavior). For freedom-to-operate, the main risk is that many PLGA depots will still fall within those broad windows unless the formulation uses different solvent systems or different polymer chemotypes (different copolymer type, different Mn range, different LA:GA ratios outside the disclosed bands).
Solvent constraints: NMP as a dividing line
- Claim 5: “organic solvent consists of N‑methyl‑2‑pyrrolidone”
- Claim 10/11/13/14/15 repeat NMP-only limitation.
The “consists of” language is the strongest handle for design-around: an accused formulation that uses NMP mixed with another solvent (or uses a different solvent entirely) is positioned to avoid those dependent claims. But claim 1 uses “the organic solvent comprising NMP,” which can still capture formulations containing NMP plus additional organic components unless the claim language in the prosecution or the issued claim text is stricter than you provided.
Risperidone base and particle size constraints
-
Risperidone base loading
- Claim 6: 5–40 wt%
- Claim 7: 10–30 wt%
- Claims 12–15 lock in 10–30 wt% plus NMP-only and polymer subranges
-
Particle size
- Claim 17: particle size 0.1–125 μm
- Claim 20: particle size <38 μm
Because these are dependent limitations, they narrow to formulations with the specified particle size distribution. But they matter for generic “drop-in” formulations: a manufacturing change that alters milling/crystallinity could fall outside these bands, avoiding those narrower claims while still potentially falling within broader claim 1 coverage if claim 1 allows broader particle size.
Release profile constraints (lag and duration)
- Claim 16: lag time < 0.2 (units not provided in your excerpt; infringement will turn on the patent’s defined lag-time measurement in the specification)
- Claim 18: release for one week
- Claim 19: release for one month
These dependent claims can create a time-dependent infringement question even when the chemistry is similar. A product with a different release schedule may avoid claims tied to one-week or one-month release, but it may still satisfy claim 1 unless those release limitations are additionally required in the independent claim (they are not in claim 1).
What formulations are protected by US 10,058,554?
From your claim text alone, the protected formulation is a PLGA-like LA/GA copolymer matrix depot formed with NMP to make a viscous gel, containing risperidone base particles. Protected formulation features:
- Polymer: LA/GA copolymer; Mn 1,000–30,000 (claim 1) and narrowed to Mn 5,000–30,000 (dependent claims).
- Polymer composition: LA:GA ratio bands up to 100:0 to 60:40 or 75:25 depending on dependent claim.
- Vehicle: polymer + NMP; vehicle composition windows:
- polymer 40–55 wt%
- NMP 45–60 wt%
- Drug form: risperidone base in particle form.
- Particle size: 0.1–125 μm in one dependent claim; <38 μm in another.
- Release profile: lag time threshold; one-week or one-month dependent releases.
Likely “claim 1 design envelope” (derived from your provided numbers)
| Parameter |
Independent claim 1 |
Dependent claim narrowing |
| LA/GA copolymer Mn |
1,000–30,000 Da |
Mn 5,000–30,000 (claims 4, 8, 9, 11, 14, 15) |
| LA:GA monomer ratio |
(not set in claim 1) |
100:0 to 60:40 (claims 2, 8, 10, 13) or 100:0 to 75:25 (claims 3, 9, 11, 14, 15) |
| Organic solvent |
NMP (comprising NMP) |
“Consists of NMP” (claims 5, 10–15) |
| Copolymer in vehicle |
40–55 wt% |
same as claim 1 |
| NMP in vehicle |
45–60 wt% |
same as claim 1 |
| Risperidone base wt% |
not specified in claim 1 excerpt |
5–40 wt% (claim 6) and 10–30 wt% (claims 7, 12–15) |
| Particle size |
not specified in claim 1 excerpt |
0.1–125 μm (claim 17); <38 μm (claim 20) |
| Lag time |
not specified in claim 1 excerpt |
<0.2 (claim 16) |
| Release duration |
not specified in claim 1 excerpt |
one week (claim 18), one month (claim 19) |
How strong is the patent estate logic for risperidone LA/GA depots in the US?
US 10,058,554 is strong in “chemistry + composition + process timing” coverage in the sense that claim 1 covers the combined vehicle and drug particle system, while dependents tighten specific polymer chemistries, solvent exclusivity, loading, particle size, and release outcomes.
However, strength in litigation depends on the actual issued specification definitions and prosecution history, which are not provided here. Claim validity, enablement, and written description leverage will hinge on whether the specification supports the numeric bands (Mn, wt%, ratios, particle size, lag time units) and whether the patent’s priority document is compatible with those ranges.
What are the highest-probability design-arounds based on the claim language?
These are the clearest levers in your claim set.
1) Break the NMP requirement
- Avoid “consists of NMP” limitations by using NMP plus another solvent in dependent-claim-targeted designs.
- More robust: replace NMP entirely with another solvent/vehicle former so you avoid both “comprising NMP” and “consists of NMP” limitations, if claim 1 is strictly interpreted to require NMP as the organic solvent.
2) Move polymer molecular weight outside the bands
- Claim 1 permits 1,000–30,000 Da.
- Dependent claims focus on 5,000–30,000.
- A product with polymer Mn below 1,000 or above 30,000 can avoid claim 1 if the polymer used is not within 1,000–30,000.
3) Move LA:GA monomer ratio out of all dependent windows
- Claim 2/3/8/9/10/11/13–15 specify particular ratio ranges.
- If you pick ratios that avoid 100:0 to 60:40 and 100:0 to 75:25, you can avoid those dependent claims.
- Claim 1 itself does not specify ratio in your excerpt, so this is not a complete escape from claim 1 unless claim 1 in the actual issued text includes ratio.
4) Alter risperidone base form or particle size distribution
- If you use a non-particle form or particle size outside 0.1–125 μm and <38 μm targets, you can avoid claims 17/20.
- Again, claim 1 requires “particle form” in your excerpt; avoiding “particle form” may be a full escape if feasible.
5) Alter release profile to avoid dependent release-timing claims
- For designs that match chemistry, release tuning can avoid claims 16–19.
- This generally does not evade claim 1 because release duration is only in dependents.
What other US patents likely exist around this technology cluster?
A full “patent landscape” requires the complete US patent record for US 10,058,554’s family, related continuations, and nearby inventions from the same assignee(s) and competitors. Your prompt provides only the claim text. Without the prosecution record, family members, and cited art, a complete landscape cannot be produced while meeting the requirement for hard data.
Given only the claim text, the most defensible landscape assertions are limited to scope-based inference: this patent targets LA/GA + NMP gel implant approaches for risperidone base. The broader field includes other long-acting injectable/implant systems for risperidone (microspheres, in situ forming depots, salt forms, other solvents), but listing specific US patent numbers, expiration dates, or assignees would require external bibliographic verification not present in your input.
So the analysis below remains restricted to the only patent you specified.
Key interpretation points for enforcement on US 10,058,554
Claim is a method claim tied to “implanting”
Infringement risk is higher for products that are marketed or manufactured with an implant administration mechanism matching the claim. A purely injectable system that is not implanted (or not implantable as claimed) can create a non-trivial non-infringement path.
“Vehicle” weight fractions are central
Claim 1’s vehicle ratio constraints (copolymer 40–55 wt%, NMP 45–60 wt%) are numeric barriers. If an accused formulation changes vehicle composition, even while keeping the same polymer and solvent, it can be outside claim 1.
Dependent claims add stacked filters
Claims 5, 10–15 combine:
- NMP-only solvent,
- narrower polymer Mn and/or LA:GA ratio,
- and fixed risperidone base loading (10–30 wt%).
This stacked structure can create “partial infringement” scenarios where an accused product matches core claim 1 but avoids all dependents, or matches some dependents but not claim 1.
What is the litigation and regulatory posture of US 10,058,554?
A litigation/regulatory landscape requires docket-level and FDA labeling/orange-book linkage data, none of which is included in your input. That information cannot be accurately stated here.
Key Takeaways
- US 10,058,554 protects a risperidone base implant depot formed from LA/GA copolymer + NMP viscous gel, with defined vehicle wt% windows (polymer 40–55%, NMP 45–60%).
- Dependent claims narrow to specific polymer Mn bands (5,000–30,000) and LA:GA ratios (100:0 to 60:40 or 75:25), plus NMP-only solvent (“consists of”).
- Additional dependent claims constrain risperidone base loading (5–40 wt% and 10–30 wt%), particle size (0.1–125 μm and <38 μm), and release profile (lag time <0.2; one-week and one-month releases).
- The strongest practical design-arounds based purely on claim language are: change solvent away from NMP or add non-NMP solvents, move polymer Mn outside the claim windows, or alter drug form/particle size and release profile to avoid the most specific dependents.
FAQs
1) Does US 10,058,554 require a specific LA:GA monomer ratio in claim 1?
Not from the excerpted claim 1 text you provided. The monomer ratio limitations appear in dependent claims (claims 2, 3, 8, 9, 10, 11, 13–15).
2) Can a formulation still infringe if it uses NMP plus another solvent?
It depends on whether it meets claim 1’s “organic solvent comprising NMP” requirement and whether any asserted dependent claims require “consists of NMP.” Claims using “consists of NMP” are the tighter barrier.
3) Which dependent claims are most useful for narrowing infringement to a specific product target?
Claims 5 and 10–15 (NMP-only), claims 12–15 (fixed 10–30 wt% risperidone base plus NMP-only plus polymer constraints), and claims 16–20 (lag time and release duration and particle size).
4) What parameter change is most likely to avoid the narrowest composition claims?
Particle size and risperidone base wt% are clear numeric levers, but the biggest “litigation lever” is the solvent exclusivity in “consists of NMP” dependents.
5) How does the release timing language affect infringement analysis?
Release duration and lag time appear only in dependent claims (claims 16–19). Matching chemistry may still trigger claim 1 even if release timing avoids those dependents.
References (APA)
No external sources cited because only the claim text provided by you was used.
