United States Patent RE42096: Scope, Claim Structure, and Competitive Patent Landscape

What is RE42096 and what does its claim set cover?

United States Reissue Patent RE42096 claims a pharmaceutical oral composition designed to deliver mixed amphetamine salts with a dual release profile:

Immediate release (IR) fraction: amphetamine salts are coated with an immediate release coating.
Delayed pulsed enteric release (D-PER) fraction: amphetamine salts are coated with an enteric release coating that is delayed and then releases in a pulse.
The enteric coating releases essentially all of the enteric-coated dose within about 60 minutes after initiation of the delayed pulsed enteric release.
Dependent claims add enteric coating thickness (≥ 25 µm), protective layers, single-core vs multi-core presentation, non-pH dependent enteric coating, and timing ranges for delayed pulse (including a delayed interval and a release window after initiation).

The claims also tightly tether the enteric system to mixed amphetamine salts in both IR and enteric fractions, and in several claim groupings the IR and enteric-coated fractions are explicitly arranged either on a single core or on different cores.

What is the independent claim theme and how is the scope drafted?

The claim architecture is built around one core technical concept: (i) IR-coated mixed amphetamine salts combined with (ii) enteric-coated mixed amphetamine salts that release “essentially all” within a defined pulse window after “initiation.”

Across the independent claim set, the following structural elements appear repeatedly:

Core elements (common across the broadest scope)

Dosage form type
- “A pharmaceutical composition for delivery … amphetamine salts”
Two populations of drug-coated particles
- (a) One or more pharmaceutically active amphetamine salts covered with an immediate release coating
- (b) One or more pharmaceutically active amphetamine salts covered with an enteric release coating that provides delayed pulsed enteric release
Pulse release constraint
- The enteric coating releases essentially all of the enteric-coated salts within about 60 minutes after initiation of delayed pulsed enteric release.
Salt identity constraint
- The IR and enteric populations comprise mixed amphetamine salts.

Independent claim-by-claim synopsis (based on the text provided)

The text you provided includes multiple claim sets that are effectively independent-like compositions with different additional structural constraints.

Claim 1: Dual-coated system; enteric releases essentially all within ~60 min after initiation; mixed amphetamine salts in both IR and enteric fractions.
Claim 2: Adds enteric coating thickness ≥ 25 µm (in addition to Claim 1 features).
Claim 8: Similar to Claim 1 but explicitly defines a blood level relationship: IR creates a first blood level, then the delayed enteric pulse creates a second blood level greater than the first; enteric releases essentially all within ~60 min; mixed amphetamine salts in both fractions.
Claim 13: Adds a protective layer over the enteric release coating.
Claim 18: Similar to Claim 13 but specifies a protective layer between the amphetamine salt and the enteric coating and includes additional timing dependents.

What are the key claim limitations that set the infringement boundary?

The infringement-relevant constraints are the ones that define the coating system behavior and drug identity rather than generic “enteric coating” language.

1) “Delayed pulsed enteric release” with a quantified pulse window

The enteric coating must provide delayed and pulsed enteric release.
It must release “essentially all” of the enteric-coated amphetamine salts within about 60 minutes after initiation of delayed pulsed enteric release.

This creates two enforceable attack surfaces for competitors:

whether their enteric system produces a pulse (vs continuous enteric release), and
whether release is essentially complete within ~60 minutes after initiation (vs a slower spread).

2) “Mixed amphetamine salts” in both IR and enteric fractions

The claims specify:

IR-coated fraction includes mixed amphetamine salts.
Enteric-coated fraction includes mixed amphetamine salts.

A design-around that uses single-salt amphetamine (e.g., dextroamphetamine only) in either fraction would miss this requirement. A design-around that uses different salt mixes in each fraction also risks missing the “comprise mixed amphetamine salts” language depending on how “mixed” is interpreted.

3) Coating thickness and layer placement (dependent claim boosters)

Dependent claims expand enforceable scope:

Claim 2: enteric release coating thickness at least 25 µm.
Claim 13: protective layer over the enteric release coating.
Claim 18: protective layer between the amphetamine salt and the enteric coating.
Claims 16-17, 23-24, 21-22: arrangement either on a single core or different cores, and whether salts are coated onto or incorporated into a core.

4) Non-pH dependent enteric coating (narrower dependent limitation)

Claim 7: enteric release coating is a non-pH dependent enteric release coating.

5) Timing ranges tied to delayed pulse behavior (dependent limitations)

Claim 19: delayed pulse enteric release is from 4 to 6 hours after administration.
Claim 20: pulse release occurs in about 30 to 60 minutes after initiation.

These dependents become important if the primary infringement theory relies on a timing match in addition to the release window.

What is the claim coverage map (scope by feature)?

The following table organizes the provided claim text into a feature matrix showing what each claim adds or narrows.

Claim	Drug identity	Dual release architecture	Pulse release window	Extra constraint(s)
1	Mixed amphetamine salts in (a) and (b)	IR-coated + delayed pulsed enteric	Enteric releases essentially all within ~60 min after initiation	Core dual-coated structure
2	Mixed amphetamine salts	Same as Claim 1	Same as Claim 1	Enteric coating thickness ≥ 25 µm
3	Same	“Coated onto a core”	Same	Salt coated onto core (not just incorporated)
4	Same	“Incorporated into a core”	Same	Salt incorporated into core
5	Mixed amphetamine salts	IR + enteric on single core	Same	Single-core presentation
6	Mixed amphetamine salts	IR + enteric on different cores	Same	Multi-core presentation
7	Mixed amphetamine salts	Same	Same	Enteric is non-pH dependent
8	Mixed amphetamine salts	IR creates first level; enteric pulse increases to second level	Enteric essentially all within ~60 min after initiation	Blood level relationship
9	Same	Coated onto core	Same	“Coated onto a core”
10	Same	Incorporated into core	Same	“Incorporated into a core”
11	Same	Single core	Same	IR and enteric on single core + blood level framing
12	Same	Different cores	Same	IR and enteric on different cores
13	Mixed amphetamine salts	IR + enteric + protective layer over enteric	Enteric essentially all within ~60 min	Protective layer over enteric
14	Same	Coated onto core	Same	Claim 13 + coated onto core
15	Same	Incorporated into core	Same	Claim 13 + incorporated into core
16	Same	Single core	Same	Claim 13 + single core
17	Same	Different cores	Same	Claim 13 + different cores (text says “On on different cores”)
18	Mixed amphetamine salts	IR + enteric + protective layer between salt and enteric	Enteric within ~60 min	Protective layer placement
19	Same	Same	Same	Delayed pulse at 4 to 6 hours after administration
20	Same	Same	Same	Release in ~30 to 60 minutes after initiation
21	Same	Coated onto core	Same	Claim 18 + coated onto core
22	Same	Incorporated into core	Same	Claim 18 + incorporated into core
23	Same	Single core	Same	Claim 18 + single core
24	Same	Different cores	Same	Claim 18 + different cores
25	Mixed amphetamine salts	Same	Same	Explicitly ties mixed amphetamine salts in (a) and (b) for Claims 2, 13, 18-20

Practical observation: the broadest behavioral constraint is the “essentially all within about 60 minutes after initiation” limitation. The rest of the constraints define when and how the pulse system is built.

What does the landscape likely look like around RE42096’s main differentiators?

Because you provided only the claim text and not bibliographic identifiers (assignee, original patent family, filing dates, reissue history, expiration), the landscape analysis below focuses on the patent risk zones created by the specific limitations in the claim set.

Risk zone A: Dual IR + enteric pulse for amphetamine salts

Any competitor product that uses:

amphetamine salts (not necessarily all mixed),
immediate release fraction, and
enteric delayed pulse fraction faces a first-order risk because the structure is directly claimed.

Risk zone B: Pulse completeness within ~60 minutes after initiation

The claims do not just require “delayed” or “enteric.” They require a pulse that empties the enteric dose quickly after a defined initiation point. Systems that spread release beyond this window can reduce literal risk.

Risk zone C: Non-pH dependent enteric coating implementations

Claim 7 adds a pathway for enforceability against enteric systems that use mechanisms other than pH-triggering. Competitors using classic pH-dependent enteric chemistry can potentially avoid Claim 7 but still be at risk under Claims 1/8/13/18 depending on their pulse behavior.

Risk zone D: Protective layer architecture

Claims 13 and 18 create specific mechanical layer placement requirements:

protective layer over the enteric coating (Claim 13)
protective layer between drug and enteric coating (Claim 18)

If a competitor uses a barrier layer for stability, its location becomes relevant.

Risk zone E: Single-core versus multi-core architectures

Claims 5-6 and 11-12 and 16-17 and 23-24 indicate explicit embodiments. Many competing designs use multiple populations of coated particles, which can land in either claim set depending on whether IR and enteric fractions are on the same core or different cores.

How competitors may design around (by claim feature rather than generic strategy)

The following design-around levers are derived directly from claim language:

Avoid “mixed amphetamine salts” in either IR or enteric fraction
- If only one fraction contains mixed salts, or if the formulation uses a different drug identity, you risk missing claim coverage.
Change the enteric pulse release profile so “essentially all” is not achieved within ~60 minutes after initiation
- Slower, multi-phase, or broadened release after initiation can avoid literal “within about 60 minutes” if release is not “essentially all” within that window.
Use a different enteric trigger mechanism (to bypass non-pH dependent limitation)
- This mainly reduces risk for Claim 7; it does not necessarily avoid the broader claims that do not require non-pH dependency.
Alter barrier layer placement
- Claim 13 and Claim 18 turn on whether the protective layer is “over” the enteric coating versus “between” drug and enteric coating.
Alter core architecture
- Rebuilding particles so the IR and enteric fractions are not on the claimed configuration (single core vs different cores) can matter for dependent claim coverage, but the independent claim coverage may still exist depending on how “single core” is treated in the broader limitations.

What is the patent strength implication of the claim draft?

Overbreadth vs enforceability

The claims are enforceable primarily because they specify quantitative release behavior (“essentially all within about 60 minutes”) coupled to an amphetamines mixed salts identity and a dual-coated architecture.
They are also structured to capture multiple formulation builds (coated-on core, incorporated core; single core vs different cores; protective layer over vs between).

Claim stacking

The text shows many dependent claims that “stack” structural and timing elements onto the same base dual-coated pulse concept. That supports multiple infringement theories across different product architectures.

Key Takeaways

RE42096 claims an oral dual-release amphetamine formulation with IR-coated mixed amphetamine salts plus delayed pulsed enteric-coated mixed amphetamine salts.
The central behavioral limitation is that the enteric coating releases “essentially all” within about 60 minutes after initiation of delayed pulsed enteric release.
Dependent claims broaden coverage to include enteric thickness ≥ 25 µm, protective layer placement, non-pH dependent enteric, and timing (4-6 hours delayed; ~30-60 minutes after initiation for pulse release).
The main freedom-to-operate risk sits in formulations that match the pulse completeness window and use mixed amphetamine salts in both release populations.

FAQs

1) Does RE42096 require that both IR and enteric fractions contain mixed amphetamine salts?

Yes. The claim text states that the amphetamine salts in (a) and (b) are mixed amphetamine salts.

2) What is the single most important quantitative release limitation in the claim set?

The enteric release coating must release essentially all enteric-coated amphetamine salts within about 60 minutes after initiation of the delayed pulsed enteric release.

3) How do the “single core” and “different cores” dependents affect infringement analysis?

They define embodiments for dependent claims. A formulation where IR and enteric fractions are arranged on the claimed core configuration aligns with those dependents.

4) Can a competitor avoid the enteric part by using a pH-dependent enteric material?

A pH-dependent material may avoid the narrower non-pH dependent enteric dependent claim, but it does not automatically avoid the broader dual-release and pulse-window limitations in claims that do not require non-pH dependency.

5) Is the protective layer required only in some claims?

Yes. Claims 13 and 18 add protective layer requirements and specify placement: over the enteric coating (Claim 13) or between the drug and enteric coating (Claim 18).

References

United States Reissue Patent RE42096, claim text provided by user.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	427101	⤷ Start Trial
Australia	1214500	⤷ Start Trial
Canada	2348090	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: RE42096

Summary for Patent: RE42096