United States Patent 10,369,110: What the Claims Actually Cover, and How the Landscape Likely Rewrites Competitive Options

What is US 10,369,110 claiming at the core?

US 10,369,110 claims a uterine fibroid treatment method that depends on one operational step: delivering Clostridium histolyticum collagenase into a fibroid at a defined dose per tissue volume (or concentration in the injected composition), with optional expansions that capture delivery mode, imaging guidance, formulation, and combination regimens.

Core claim architecture (method-of-treatment)

The pivot element is claim 1, with dose specified in mg collagenase per cm³ fibroid tissue:

Claim 1: administer into fibroid a composition with collagenase from Clostridium histolyticum sufficient to cleave disordered collagen fibrils of types I, III, and V, by injecting or inserting into fibroid about 0.06 to about 1 mg collagenase per 1 cm³ uterine fibroid tissue.

Claim 32 restates dose as mg/mL collagenase concentration in the injected composition:

Claim 32: administer into fibroid a composition with 0.25 to 2.0 mg/mL C. histolyticum collagenase by injecting or inserting into uterine fibroid tissue.

Dose subranges that matter for design-around

The claim set includes explicit mid-range tightening:

Claim 3: about 0.1 to about 0.8 mg/cm³
Claim 4: about 0.2 to about 0.6 mg/cm³
Claim 31: 100 μL injected into 1 cm³ fibroid tissue (this couples volume to implied dose interpretation in mg/cm³ terms)

These ranges constrain both: 1) the amount of collagenase delivered to the target, and
2) any strategy that changes injected volume to land on a specific concentration-to-total-dose outcome.

Enzymatic identity and activity target

The claims require collagenase from C. histolyticum that cleaves collagen fibrils types I, III, and V. That places emphasis on collagenase composition/activity and on fibroid collagen biology, not merely general “protein digestion.”

Claim 2: collagenase is a mixture of collagenase I and collagenase II.

This is a meaningful narrowing hook. Many collagenase products are mixtures or have different relative fractions; claim 2 attempts to lock the enzyme identity closer to what C. histolyticum collagenase preparations typically contain.

What additional claim features broaden scope beyond the enzyme/dose?

Claims 5 through 30 expand coverage to delivery routes, guidance modalities, imaging, contrast agents, combination drugs, and formulation engineering.

Delivery route and guidance

Claim 5: transabdominal injection/insertion
Claim 6: transvaginal injection/insertion
Claim 7: under image guidance
Claim 8: image is direct or non-direct

Image modalities and contrast coverage are explicitly captured:

Direct visual image (Claim 9): scope image
Non-direct (Claims 10-15):
- MRI image (Claim 10) with MRI contrast agent (Claim 11)
- Ultrasound image (Claim 12) with ultrasound contrast agent (Claim 13)
- Fluoroscopic image (Claim 14) with x-ray contrast agent (Claim 15)

This matters because it reduces argument leverage around “we used a different guidance system.” The patent appears drafted to cover the major interventional imaging pathways used in uterine fibroid procedures.

Combination therapy hooks

The claims add breadth via optional inclusion of other therapeutic agents:

Claim 16: composition further comprises a chemical ablation agent, NSAID, oral contraceptive, GnRH agonist, antiprogestogen, or selective progesterone receptor modulator.
Claims 17-19: chemical ablation agent is a salt and selected from an enzyme, acid, base, or oxidizing agent.

This increases risk that combination regimens used in practice (or under development) could fall within the literal claim if the collagenase dose/delivery matches.

Formulation and delivery mechanics

A long formulation tail expands practical capture of commercial development formats:

Claims 21-25: solid dosage form (largest dimension 1-20 mm) and/or powder introduced by jet injection
Claim 22: delivery channel in needle/syringe/cannula/catheter/jet injector
Claim 23: encapsulated
Claims 26-29:
- viscosity adjusting agent to reach 10,000 to 50,000 cP
- fluid formulation crosslinked in vivo
- alginate polymer
- gelatin
Claim 30: sustained release of collagenase sufficient to treat fibroids.

These elements collectively support infringement arguments even if competitors use different carriers, viscosifiers, crosslinking, or injection mechanics, so long as they still deliver C. histolyticum collagenase at claim doses and into the fibroid tissue.

How strong are the claim pivots for enforcement?

From a patent-claims perspective, this set is enforceable if three factual anchors hold in practice: (1) C. histolyticum collagenase, (2) correct dose mapping to fibroid tissue volume/concentration, and (3) delivery into the fibroid.

1) Identity and activity anchor

The claims require collagenase “from Clostridium histolyticum” and activity to cleave disordered collagen fibrils types I, III, V.

For enforcement, the key questions typically become: what exact enzyme preparation is used, and does it include collagenase I/II mixture (where that dependent claim is asserted)?
For freedom-to-operate, a competitor would need to evaluate whether any alternative enzyme source (even if functionally similar) can avoid literal “from C. histolyticum” and “cleave types I, III, V” language.

2) Dose mapping anchor

The patent uses two dose expressions:

mg per cm³ fibroid tissue (claim 1 and dependents 3-4 and 31 linkage)
mg/mL in the injected composition (claim 32 and dependents 33-36)

That dual expression makes it harder to “escape by changing only concentration or only volume.” If an injected volume yields a total delivered dose falling inside mg/cm³ bounds, and if concentration falls inside mg/mL bounds, it is covered.

3) Delivery location anchor

The claims require administering “into the uterine fibroid” and “injecting or inserting into the fibroid.” That narrows against purely systemic treatments and against uterine cavity strategies that do not deliver into fibroid tissue.

What does US 10,369,110 likely cover in product development terms?

The claim set resembles a blueprint for an image-guided interventional collagenase injection product with engineered rheology and optional sustained release.

Practical “in-scope” profiles

A competitor’s product most likely lands within the claim boundary if it has:

C. histolyticum collagenase (mixture of collagenase I and II, where relevant)
delivered directly into fibroid tissue
within 0.06 to 1 mg collagenase per cm³ (or 0.25 to 2.0 mg/mL in the composition, depending on how the infringement case is framed)
optionally with viscous carriers (10,000-50,000 cP), alginate/gelatin, in vivo crosslinking, encapsulation, or sustained release
optionally with MRI/US/fluoro guidance and contrast agents.

What does the claim set imply for the competitive patent landscape?

Without invoking external case files or prosecution histories, the landscape implications follow directly from how the claims are structured.

Likely competitor exposure buckets

1) Direct injection collagenase uterine fibroid programs
Any program using collagenase delivered into the fibroid at similar doses faces literal risk if using C. histolyticum collagenase.

2) Any collagenase formulation program with engineered viscosity or in vivo crosslinking
The formulation tail is broad enough to capture many “delivery improvement” variations.

3) Image-guided guidance with contrast
Because the claims enumerate MRI, ultrasound, and fluoroscopy with contrast agents, “we used a different imaging system” becomes less protective.

4) Combination therapy packaging
Optional inclusion of additional uterine fibroid agents (GnRH agonists, PR modulators, etc.) increases overlap with combination regimens.

Most available design-around vectors

Given claim language, the plausible off-ramps typically fall into these buckets:

Enzyme source: use a collagenase not “from Clostridium histolyticum.”
Enzyme identity: avoid collagenase I/II mixture meeting dependent claim 2 (where asserted).
Dose: deliver outside 0.06 to 1 mg/cm³ and outside 0.25 to 2.0 mg/mL windows, while still achieving clinical effect.
Administration location: avoid injection into the fibroid tissue itself (shifts to a different mechanism or anatomical target).
Claim feature avoidance: for dependent-claim-heavy enforcement, avoid the enumerated guidance and contrast combinations, or avoid specific rheology/formulation ranges.

In practice, clinical efficacy will constrain “dose escape,” while mechanism constraints limit “location escape.” That leaves enzyme-source and formulation identity as the more realistic non-dose pathways.

Key claim-to-design implications (decision-grade)

Dose boundaries are the primary risk driver

The patent includes multiple nested ranges. Any program considering dose optimization should treat the ranges as “hard walls” rather than advisory boundaries.

Claim	Dose parameter	Covered range
1	mg collagenase per 1 cm³ fibroid tissue	0.06 to 1 mg/cm³
3	mg collagenase per 1 cm³	0.1 to 0.8 mg/cm³
4	mg collagenase per 1 cm³	0.2 to 0.6 mg/cm³
32	mg/mL collagenase in composition	0.25 to 2.0 mg/mL
33	mg/mL collagenase	0.25 mg/mL
34	mg/mL collagenase	0.5 mg/mL
35	mg/mL collagenase	1.0 mg/mL
36	mg/mL collagenase	2.0 mg/mL

Delivery method design-around is weaker than dose design-around

The patent enumerates a wide set of delivery devices and guidance methods. Most practical interventional approaches for fibroids will map into “needle/syringe/cannula/catheter/jet injector” and “direct scope or non-direct imaging (MRI/US/fluoro) with optional contrast.”

So, competitive differentiation via delivery hardware alone is unlikely to eliminate exposure.

Critical evaluation of the claim set: where enforcement leverage concentrates

1) Dose language reduces interpretation room

The dose is stated in quantitative units tied to tissue volume (mg/cm³) and in quantitative concentration (mg/mL). Courts generally treat explicit numeric ranges as straightforward, particularly when dependent claims add narrower windows.

2) Enumerated imaging and contrast reduces “we did it differently” arguments

The claims explicitly list MRI, ultrasound, and fluoroscopic guidance and require corresponding contrast agent in the composition when those images are used (dependent claims 11, 13, 15). A competitor using any of these imaging modes while providing contrast risks falling within those dependent claim structures.

3) Formulation is heavily captured

Alginate, gelatin, viscosity range, in vivo crosslinking, encapsulation, powder and jet injection, sustained release, and sized solid dosage forms (1 to 20 mm) are all listed. Many “delivery improvements” in enzyme therapeutics land inside one of these buckets.

Key Takeaways

US 10,369,110 claims an image-guided method that depends on direct injection/insertion of C. histolyticum collagenase into uterine fibroid tissue at tightly defined dose ranges (mg/cm³ and mg/mL).
The patent’s scope is broadened substantially by enumerated delivery routes, imaging modalities, and formulation mechanics, including viscosities (10,000-50,000 cP), alginate/gelatin, in vivo crosslinking, encapsulation, jet injection powder, and sustained release.
For competitive strategy, dose boundary management and enzyme source avoidance are the highest-leverage design-around vectors; delivery hardware or imaging changes alone are less likely to avoid coverage given the claim enumeration.

FAQs

1) Does US 10,369,110 cover systemic administration of collagenase for fibroids?
No. The claims require administering the composition by injecting or inserting into the fibroid tissue.

2) Can a competitor avoid the patent by using a different imaging modality?
Only if it avoids the enumerated direct/scope or non-direct modalities (MRI/ultrasound/fluoroscopy) and avoids the associated contrast-agent dependent claim structures. The claim set is designed to capture common imaging routes.

3) Which parameter creates the tightest infringement risk: concentration (mg/mL) or total dose (mg/cm³)?
Both. The patent provides coverage in two complementary dose formats: mg/cm³ and mg/mL, with additional dependent narrowing ranges.

4) Are formulation changes like alginate, gelatin, and viscosity within scope?
Yes. The claims explicitly include alginate polymer, gelatin, and viscosity adjusting agents providing 10,000 to 50,000 cP, plus crosslinking in vivo and sustained release.

5) Does the patent require collagen cleavage of specific collagen types?
Yes. The claims require cleavage of disordered collagen fibrils of types I, III, and V.

References

[1] United States Patent 10,369,110. Claims as provided in the prompt.

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	June 04, 1965	10,369,110	2034-03-14
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	February 02, 2010	10,369,110	2034-03-14
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 10,369,110

Summary for Patent: 10,369,110