Scope, Claims, and US Patent Landscape for Drug Patent 10,925,866 (1-Deoxygalactonojirimycin for Fabry Disease)

Executive summary: US Patent 10,925,866 covers a method of treating Fabry disease with 1-deoxygalactonojirimycin (DGJ) or a pharmaceutically acceptable salt, dosed every other day, with exposure targets anchored to Cmax ~9 μM, Tmax ~3 hours, and/or plasma half-life ~3 hours. The claims also cover oral dosing forms and mechanism via α-galactosidase A activity enhancement, with additional claim sets reciting exposure similarity to migalastat HCl 150 mg every other day (via AUC equivalence). The operative enforcement risk for generics and competitors is not “DGJ for Fabry” in the abstract, but DGJ dosing/exposure and administration frequency that fall within the claimed pharmacokinetic windows and oral every-other-day regimen, plus the AUC-to-migalastat equivalence variant.

What does US Patent 10,925,866 claim for Fabry disease treatment with 1-deoxygalactonojirimycin?

Short answer: The patent claims a treatment method for Fabry disease using DGJ at a dose and schedule that yields specific PK exposure metrics in humans, with the additional option of proving similar AUC to migalastat 150 mg every other day. It also limits the “how” to oral dosing in dependent claims and ties the effect to α-galactosidase A activity enhancement.

Core claim structure: what is actually “the invention”

Across independent claims (claim 1 and claim 10), the key limitations are:

Indication and patient class
- “method for treatment of Fabry disease in a human patient in need thereof”
Active ingredient
- “1-deoxygalactonojirimycin or a salt thereof”
Dosing frequency
- “administered every other day”
Pharmacokinetic/exposure target
- Claim 1: one or more of Cmax ~9 μM, Tmax ~3 hours, t1/2 ~3 hours
- Claim 10: similar mean AUC to migalastat HCl 150 mg every other day
Oral formulation and mechanism hooks (dependent)
- Oral dosage forms: tablet/capsule/solution (claims 2-3, 11-12)
- Mechanism: enhances α-galactosidase A activity (claims 4, 14)
Sex-limited variants (dependent)
- Male/female recitals (claims 5-6, 15-16)

Claim-by-claim scope map (practical constraints)

Claim	Independent/dependent	Main scope limiter(s)	What design-arounds usually target
1	Independent	Fabry + DGJ/salt + every other day + PK target(s): Cmax ~9 μM and/or Tmax ~3 hr and/or t1/2 ~3 hr	Avoid matching exposure metrics; change dosing interval; use different route/formulation affecting Cmax/Tmax/half-life
2	Dependent of 1	Oral dosage form	Non-oral route (if feasible) or formulation PK shift
3	Dependent of 2	Tablet/capsule/solution	Dosage form not listed (if allowed by patent interpretation)
4	Dependent of 1	Enhances α-galactosidase A activity	Use alternative therapeutic mechanism (unlikely if product is DGJ)
5-6	Dependent of 1	Patient is male or female	Usually not a design-around in manufacturing strategy; more relevant to infringement coverage
7-9	Dependent of 1	Specifically recite Cmax ~9 μM or Tmax ~3 hr or t1/2 ~3 hr	Same as above, tighter to each metric
10	Independent	Fabry + DGJ/salt + every other day + AUC similarity to migalastat 150 mg HCl every other day	Shift exposure distribution (AUC), dosing interval, or route affecting AUC
11-12	Dependent of 10	Oral; dosage form tablet/capsule/solution	Change route or dosage form class
13	Dependent of 10	Every-other-day administration repeated	Change dosing frequency
14	Dependent of 10	Enhances α-galactosidase A activity	Unlikely with DGJ
15-16	Dependent of 10	Patient sex variants	Not usually strategic
17-19	Dependent of 10	Specifically recite Cmax ~9 μM, Tmax ~3 hr, t1/2 ~3 hr for claim 10 variant	Same PK design-around risk

How “about” and mean exposure metrics affect infringement risk

The claims are anchored to mean PK parameters (mean Cmax, mean Tmax, mean t1/2) with thresholds expressed as “about”. That typically gives some tolerance for assay variability and study design, but the legal center of gravity remains near the recited numeric targets:

Cmax ~9 μM
Tmax ~3 hours
t1/2 ~3 hours
AUC similar to migalastat 150 mg HCl every other day

For enforcement planning, the risk is highest when a competitor’s clinical PK profile is engineered to match or is expected to converge on those exposure values.

Does US 10,925,866 cover oral DGJ formulations, or only dosing regimens?

Short answer: The patent is fundamentally a method-of-treatment claim, but it includes dependent claims that constrain administration as an oral dosage form and further constrain the oral dosage form to tablet, capsule, or solution.

Oral dosage form limitations

Claim 2: DGJ/salt administered as an oral dosage form
Claim 3: oral dosage form comprises tablet/capsule/solution
Claim 11 and 12: parallel oral limitations in the AUC-based independent claim structure

Practical implications for product development

If a competing product uses DGJ but changes route (parenteral delivery) it may attempt to avoid the “oral” dependent limitations.
If it remains oral, changing from tablet/capsule/solution to a different oral format (e.g., chewable, oral film) may or may not avoid literal infringement depending on claim construction of “comprises” and what is considered a “solution” or equivalent dosage format. The safest read from a freedom-to-operate perspective is that competitors should assume oral conventional dosage forms will be captured unless a compelling non-infringing format is developed.

What is the mechanistic scope: does the patent require α-galactosidase A activity enhancement?

Short answer: Mechanistic language appears in dependent claims. Independent claims do not expressly require α-galactosidase A activity enhancement, but dependent claims do.

Mechanism-related dependent claims

Claim 4: “enhances α-galactosidase A activity”
Claim 14: same mechanism tied to the AUC-based independent claim

Infringement and evidence

Mechanistic dependent claims tend to be satisfied by pharmacology already expected for the claimed compound and route. For litigation posture, mechanism is usually easier to establish than exposure metrics, which are sensitive to PK variability. The hard limiter for many competitors remains the every-other-day schedule and specific exposure targets.

How do the Cmax/Tmax/half-life limitations operate in claim 1?

Short answer: Claim 1 captures DGJ every other day when the dosing produces mean exposure metrics around:

Cmax ~9 μM
Tmax ~3 hours
t1/2 ~3 hours and it requires one or more of those metrics to be met.

Exposure mapping to claim 1

Claim 1 is written with an “or” among pharmacokinetic targets:

“provides one or more of: a. Cmax ~9 μM; b. Tmax ~3 hours; c. t1/2 ~3 hours”

So, the claim is not limited to all three simultaneously. Dependent claims 7, 8, 9 each narrow to each individual parameter.

Design-around logic

Competitors typically try to avoid:

matching Cmax near the 9 μM level,
producing a Tmax around 3 hours,
having t1/2 around 3 hours,
while still achieving therapeutic effect in Fabry disease.

If a competitor’s PK profile is shifted (e.g., delayed absorption or altered exposure), it may fall outside literal scope. However, “about” and “mean” can preserve overlap, so the closer a competitor’s expected PK is to the recited values, the more it resembles infringement risk.

What does the AUC “similar exposure” claim add in claim 10?

Short answer: Claim 10 anchors infringement to AUC similarity to a defined reference regimen: migalastat hydrochloride 150 mg every other day, while retaining the DGJ every-other-day schedule.

Claim 10’s defining limitation

“therapeutically effective dose provides a similar mean drug exposure (AUC) as orally administering 150 mg of migalastat hydrochloride every other day”

This creates a distinct infringement pathway separate from matching Cmax/Tmax/t1/2.

Why AUC similarity matters

AUC is often less sensitive than Cmax to absorption rate changes, but it can still be influenced by dose strength and bioavailability. A competitor may attempt to deviate from the Cmax/Tmax/half-life windows while still matching AUC; claim 10 can still be triggered if “similar AUC” is met.

When does a competitor face the highest infringement risk: at Phase 3, launch, or post-approval?

Short answer: The claim is enforceable against commercial use and manufacturing/labeling activities, but the practical risk period for a Paragraph IV-style strategy typically starts when a competitor’s clinical PK package predicts that its regimen will satisfy the claimed “about” exposure targets.

Risk timeline framing (business-useful)

Pre-IND/IND strategy: avoid developing a regimen expected to hit Cmax ~9 μM, Tmax ~3 hours, t1/2 ~3 hours, and/or a “similar AUC” to migalastat 150 mg QOD.
Phase 1 PK bridging/Phase 2 dose finding: this is when exposure will be characterized. If the PK profile tracks the claim targets, the litigation risk is signaled early.
BLA/NDA and label: if the label indicates a QOD oral regimen intended to match those exposure metrics, it increases the evidentiary footprint for method-of-treatment infringement.
Post-launch: damages exposure concentrates on actual sales and prescribing patterns.

What patent landscape issues commonly surround DGJ and migalastat for Fabry disease in the US?

Short answer: US Fabry therapy IP typically includes a dense mix of:

composition/formulation patents,
method-of-treatment patents,
and dosing regimen/pharmacokinetic strategy patents, often spanning small-molecule analogs and comparable “PK target” approaches.

For US Patent 10,925,866, the claim language shows the patent is aimed at a dosing regimen with human PK targets and a comparative AUC linkage to migalastat. That makes it part of the “regimen optimization” layer rather than pure chemistry.

How to read the estate logic

A competitor’s freedom-to-operate assessment should treat US 10,925,866 as potentially blocking:

DGJ oral every-other-day regimens that hit the PK numeric targets, and
DGJ oral every-other-day regimens that yield AUC comparable to migalastat 150 mg QOD.

If a competitor can avoid those PK/AUC targets, it may mitigate this specific patent’s risk, but it must still clear other patents covering:

DGJ compositions,
oral dosage forms,
and general Fabry treatment methods with DGJ.

(No additional patent numbers, assignees, or prosecution histories are provided in the input; therefore this analysis does not enumerate other specific US patents.)

What generic or biosimilar entry risks exist for products that use 1-deoxygalactonojirimycin?

Short answer: There is no biosimilar concept for small molecules like DGJ. The entry risk is the generic or “follow-on” drug approach, where the key question is whether the generic’s actual human exposure under its proposed regimen lands inside the claimed PK windows or AUC similarity.

Factual levers that drive risk

Dose strength and formulation affecting bioavailability
Dosing interval (strict every other day requirement)
Absorption rate driving Tmax
Elimination profile driving half-life
Clinical mean PK alignment with “about” values

Launch strategy implications

If a generic product is designed for bioequivalence at the systemic exposure level, it can still match AUC and thereby trigger claim 10 unless it is intentionally designed to land outside “similar AUC” to migalastat’s reference regimen.

How strong is the patent estate behind US 10,925,866 based on claim scope alone?

Short answer: The patent appears broad on regimen concept (Fabry treatment with DGJ every other day with PK target(s)) but narrow on exposure specificity (requires mean PK/AUC alignment to defined numeric and comparative benchmarks). Enforcement strength usually correlates with the likelihood that a reasonable DGJ regimen will converge on those values.

Claim breadth indicators

Broad:
- Applies to DGJ or salts
- Covers both Cmax/Tmax/t1/2-based and AUC similarity-based independent routes
- Covers oral regimens in dependent claims
Narrow:
- Requires every-other-day schedule
- Requires human mean exposure alignment (with “about” tolerance)
- Uses specific numeric anchors tied to defined PK parameters

Key Takeaways

US 10,925,866 is a Fabry method-of-treatment patent covering 1-deoxygalactonojirimycin (DGJ) or salts administered every other day.
The independent claims are built around human mean PK targets: Cmax ~9 μM, Tmax ~3 hours, t1/2 ~3 hours (claim 1) and mean AUC similarity to migalastat HCl 150 mg QOD (claim 10).
Dependent claims add oral dosage forms (tablet/capsule/solution) and α-galactosidase A activity enhancement.
The practical infringement risk for follow-on products is driven less by “DGJ treats Fabry” and more by whether the product’s real-world/clinical PK matches the claimed exposure profile and every-other-day regimen.

FAQs

1) Can a competitor avoid US 10,925,866 by changing DGJ dose but keeping every-other-day dosing?

A competitor would need to ensure its mean Cmax/Tmax/half-life does not fall within the “about” targets and its mean AUC is not “similar” to migalastat 150 mg every other day, while still treating Fabry disease.

2) If a product is oral but not a tablet/capsule/solution, does it escape infringement?

Claims 3 and 12 specifically list tablet, capsule, or solution as dependent limitations. Whether non-listed formats avoid infringement depends on claim construction of those terms, but this is the only explicit formulation escape lever within the provided claim set.

3) Does the patent cover both male and female patients separately?

Yes. Claims include dependent recitals for male (claims 5, 15) and female (claims 6, 16), which can matter in labeling or trial population contexts.

4) Is α-galactosidase A activity enhancement required to infringe claim 1 or only for dependent claims?

It is required in dependent claims 4 (and 14 for the claim 10 line). Claim 1’s independent structure does not expressly require that mechanism language.

5) What matters more for infringement: matching Cmax/Tmax/half-life or matching AUC?

Both are independent pathways. A product matching any of the claim 1 PK targets may fall within claim 1, while a product matching the AUC similarity may fall within claim 10 even if Cmax/Tmax/half-life are not aligned.

References (APA)

No sources were provided in the prompt beyond the claim text of US Patent 10,925,866.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Amicus Therap Us	GALAFOLD	migalastat hydrochloride	CAPSULE;ORAL	208623-001	Aug 10, 2018		RX	Yes	Yes	10,925,866	⤷ Start Trial				THE TREATMENT OF FABRY PATIENTS	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	109103	⤷ Start Trial
Argentina	134835	⤷ Start Trial
Australia	2008245578	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,925,866

Which drugs does patent 10,925,866 protect, and when does it expire?

Summary for Patent: 10,925,866