United States Patent 12,268,724 Scope and Claims Analysis: Barth Syndrome Mitochondrial Organization Using D-Arg-2′6′-Dmt-Lys-Phe-NH2

US 12,268,724 is a US-method-of-treatment patent with claim scope built around (i) a specific peptide identity, (ii) a specific clinical indication tied to Barth syndrome mitochondrial ultrastructure, and (iii) optional route, dosing duration, combination therapy with cardiovascular agents, and specific salt forms. The center of gravity is Claim 1’s method using D-Arg-2′6′-Dmt-Lys-Phe-NH2 (or a salt) to reduce abnormal mitochondrial ultrastructure, reduce the number of mitochondria with abnormal ultrastructure, ameliorate ultrastructure, or maintain mitochondrial organization in subjects with Barth syndrome.

The claim set is narrower than a broad composition claim because it is method-of-use anchored to Barth syndrome and to this peptide (or salts). It also creates multiple infringement “hooks” via treatment duration (6 and 12 weeks), patient type (human), administration route, and co-administration with a broad cardiovascular-agent list.

What does US 12,268,724 claim cover in Barth syndrome patients treated with the peptide?

Answer: The patent claims a method of treating Barth syndrome by administering the peptide D-Arg-2′6′-Dmt-Lys-Phe-NH2 (or a pharmaceutically acceptable salt) in a therapeutically effective amount to achieve one or more mitochondrial-organization endpoints (reduce mitochondria with abnormal ultrastructure, ameliorate ultrastructure, or maintain mitochondrial organization).

Claim 1: Core independent claim scope

Claim 1 recites a method comprising administering a therapeutically effective amount of:

Peptide: D-Arg-2′6′-Dmt-Lys-Phe-NH2, or
Pharmaceutically acceptable salt thereof,

to a subject having Barth Syndrome, for at least one of the following functional outcomes:

Reducing the number of mitochondria with abnormal mitochondrial ultrastructure
Ameliorating abnormal mitochondrial ultrastructure
Maintaining mitochondrial organization

Key structural aspects:

Indication limitation: “in a subject having Barth Syndrome.” This is the gating condition for infringement.
Mechanistic/functional endpoints: the mitochondria ultrastructure/organization language is both a therapeutic purpose and a measurable functional target. In practice, infringement arguments can lean on efficacy evidence showing ultrastructure improvement or normalization.
No dosing requirement in Claim 1: duration, frequency, and route are pushed into dependent claims (Claims 2–5) and into salt identity (Claim 8).

Claim 1’s infringement-relevant boundaries

If a product uses a different peptide (even close analogs) or a different active sequence, it does not fall within Claim 1 as written.
If the therapy is used outside Barth syndrome, Claim 1 likely does not read on it, even if mitochondrial organization is affected.
If the product is used in Barth syndrome but the asserted functional outcome is not met, infringement may become evidence-driven. The claim does not require a specific biomarker measurement in the text, but enforcement typically needs linkage to the claimed functional outcomes.

How narrow is the patent because it is limited to D-Arg-2′6′-Dmt-Lys-Phe-NH2 and salts?

Answer: The claim is narrow on active identity (this exact peptide or a salt) and indication (Barth syndrome). It does not cover generic mitochondrial stabilizers absent this peptide, and it does not cover other D-amino acid peptides unless they are construed to be within “the peptide” as claimed.

“Peptide identity” scope: exact sequence and stereochemistry

The claim specifies:

D-Arg
2′6′-Dmt
Lys
Phe
NH2 C-terminus

This level of precision typically limits coverage to that exact stereochemical/positional arrangement. Salts expand coverage only to “pharmaceutically acceptable salt thereof” and do not expand to different peptide sequences.

Salt scope (Claim 8) tightens fallback

Claim 8 limits to a pharmaceutically acceptable salt comprising acetate or trifluoroacetate.
Even if Claim 1 covers any acceptable salt, Claim 8 is a narrower dependent layer useful for sales/labeling/CMC and for proving narrower claim overlap when a specific salt is used.

Practical implication: If a drug substance is marketed in acetate or trifluoroacetate salt form, it can support a cleaner dependent-claim infringement path (Claims 8 layered on top of Claim 1).

When does US 12,268,724 require treatment duration, and how does that affect generic or biosimilar design?

Answer: The duration limitations appear only in dependent claims: daily for 6 weeks or more (Claim 2) and daily for 12 weeks or more (Claim 3). A challenger using shorter dosing windows could aim to avoid those dependent claims, but Claim 1 still targets therapeutically effective administration without a duration minimum.

Dependent timing claims

Claim 2: peptide administered daily for 6 weeks or more
Claim 3: peptide administered daily for 12 weeks or more

Design-around dynamics

A manufacturer could attempt to market a shorter-duration regimen to reduce exposure to Claims 2 and 3. This does not remove Claim 1 risk because Claim 1 does not require a duration.
Duration may still matter for infringement proof. Even if only Claim 1 is asserted, demonstrating “therapeutically effective” dosing that produces the claimed mitochondrial outcomes may still require longer treatment in clinical practice.

What patient population and route-of-administration options expand infringement risk?

Answer: Claim 4 limits to human. Claim 5 expands to essentially any common administration route: oral, topical, systemic, IV, subcutaneous, intraperitoneal, and intramuscular.

Claim 4: Human limitation

Claim 4: subject is human This narrows enforcement against animal-use studies and preclinical-only administration.

Claim 5: Route coverage breadth

Claim 5 includes:

orally
topically
systemically
intravenously
subcutaneously
intraperitoneally
intramuscularly

For pipeline strategy, this limits route-based design-around. A company cannot easily avoid coverage by switching from IV to SC or to oral. If the same peptide is used for Barth syndrome with therapeutically effective dosing, Claim 5 can read across most delivery formats.

What does the cardiovascular co-administration claim add, and how broad is the agent list?

Answer: Claim 6 adds a combination-therapy limitation. Claim 7 provides a large, enumerated list of cardiovascular agents, making the combination claim relatively easy to satisfy for typical Barth syndrome supportive care that includes cardiovascular drugs.

Claim 6: combination framework

Claim 6: further comprising separately, sequentially or simultaneously administering a cardiovascular agent.

This is a typical claim strategy to capture:

fixed-dose combination products,
combination regimens with separate dosing schedules,
sequential initiation or add-on therapy.

Claim 7: broad cardiovascular agent taxonomy

The cardiovascular agent is selected from:

anti-arrhythmia agent
vasodilator
anti-anginal agent
corticosteroid
cardioglycoside
diuretic
sedative
ACE inhibitor
angiotensin II antagonist
thrombolytic agent
calcium channel blocker
thromboxane receptor antagonist
radical scavenger
anti-platelet drug
β-adrenaline receptor blocking drug
α-receptor blocking drug
sympathetic nerve inhibitor
digitalis formulation
inotrope
antihyperlipidemic drug

Scope implication: Because the list is not limited to one or two drug classes, it creates strong coverage probability if a treated Barth syndrome patient receives standard cardiovascular/supportive medications.

Evidence and enforcement angle

Combination claims often face questions about whether the co-administered drug is “cardiovascular” and whether it qualifies under the enumerated selection. Here, the list is extensive and includes broadly recognized cardiovascular classes (ACE inhibitors, beta blockers, calcium channel blockers, etc.). The “separately, sequentially or simultaneously” language also reduces scheduling-based design-around.

What is the likely claim construction strategy for “mitochondria with abnormal mitochondrial ultrastructure” and “therapeutically effective”?

Answer: The claim’s functional language is built to tether peptide administration to a mitochondrial ultrastructure endpoint in Barth syndrome. Enforcement typically depends on interpreting those terms through the patent specification and prosecution history, and then mapping clinical or preclinical data to the functional endpoints.

Functional endpoint mapping risk

“abnormal mitochondrial ultrastructure” and “mitochondrial organization” invite argument about what qualifies as abnormal and how it is measured (e.g., electron microscopy ultrastructure, marker-based readouts, or functional mitochondrial organization metrics).
“reduce the number of mitochondria with abnormal mitochondrial ultrastructure” implies quantification at ultrastructural level.
“ameliorating” and “maintaining” are softer terms but still imply improvement or normalization compared with baseline or untreated control.

“Therapeutically effective amount” is an open-texture phrase

It is likely to be construed to mean an amount sufficient to achieve at least one of the claimed functional outcomes. For infringement, the key question becomes whether the administered dose in Barth syndrome produces ultrastructural or organizational effects contemplated by the claim.

Where are the patent’s main vulnerability points for challenges or design-arounds?

Answer: The patent’s main vulnerability points are tied to (i) active identity substitution, (ii) indication mismatch, and (iii) functional outcome proof, not to route or combination scheduling.

1) Active identity substitution

Because the independent claim requires the exact peptide (or salt), substitution with:

a different peptide sequence,
different stereochemical configuration,
or a materially different structure is the cleanest design-around if feasible.

2) Indication mismatch

If the therapy is used for a different mitochondrial disorder or a general mitochondrial-targeting indication, it may not satisfy the “subject having Barth Syndrome” limitation.

3) Functional outcome and purpose

If evidence does not show reduction/amelioration/maintenance of mitochondrial organization as claimed, a challenger can contest whether the accused regimen is within the “method” defined.

4) Duration-dependent claims

Claims 2 and 3 are conditional on daily dosing duration. Switching to shorter courses can reduce exposure under those dependent claims, but Claim 1 risk persists.

What formulations are covered by the claims and how does that interact with salt selection in CMC and labeling?

Answer: The claim is formulation-light except for salt specificity in Claim 8. It is primarily an active-and-method claim. Salt form can matter for Claim 8 and for whether the product is “a pharmaceutically acceptable salt.”

Covered formulation dimensions

“pharmaceutically acceptable salt thereof” in Claim 1: broad salt class coverage
acetate or trifluoroacetate salt in Claim 8: specific fallback

Practical impact

If the commercial formulation uses acetate or trifluoroacetate, claim overlap increases because Claim 8 supplies a narrow additional layer. If a different salt is used, Claim 8 may not be triggered, but Claim 1 still may apply if the salt is pharmaceutically acceptable and the actives are otherwise identical.

What generic or licensing strategy best reduces infringement exposure under US 12,268,724?

Answer: Licensing and development strategies that reduce infringement exposure focus on breaking one of the essential limitations: the exact peptide identity, Barth syndrome indication, or the claimed therapeutic method (including the claimed mitochondrial-functional outcomes).

Strategy set

Use a different peptide or peptide analog not falling within the literal “D-Arg-2′6′-Dmt-Lys-Phe-NH2” definition.
Target a different indication than Barth syndrome.
Avoid daily administration regimens that meet the dependent duration claims, while recognizing Claim 1 still lacks a duration minimum.
For combination-therapy exposure, manage whether cardiovascular co-administration occurs, though Claim 6 is dependent and does not affect Claim 1.

Because Claim 5 broadly covers many routes and Claim 6 includes combination regimens even when separately dosed, route and dosing schedule are weaker levers than active identity and indication.

What Orange Book status or Paragraph IV exposure applies to a method patent like US 12,268,724?

Answer: A US method-of-treatment patent like this typically drives ANDA Paragraph IV risk only if the product is eligible for Orange Book listing under relevant FDA patent listing practices and if an applicable “drug product” is listed against the method patent. Without the Orange Book listing record and the associated reference product NDA/ANDAs, Orange Book status cannot be determined from the claim text alone.

Litigation posture expected for method claims

If the peptide drug is developed and listed, Paragraph IV notice letters can assert non-infringement or invalidity as to method-of-use claims (including functional endpoints and therapeutic purpose). Settlements often convert to branded exclusivity or time-limited launches contingent on permitted carve-outs (e.g., different dosing regimen, different indication, or different active form).

What patent landscape issues typically cluster around US 12,268,724 claim types?

Answer: For a peptide method patent anchored to Barth syndrome mitochondrial ultrastructure, the broader landscape usually includes:

composition-of-matter patents covering peptide sequences, stereochemistry, and manufacturing,
formulation/solubility and salt patents (including acetate/trifluoroacetate forms),
method-of-treatment patents for Barth syndrome and related mitochondrial disorders,
combination regimen patents (supportive care or pathway adjuncts),
and manufacturing/process patents.

This patent’s claims are already positioned to reinforce enforcement across multiple real-world dosing scenarios because route and combination are widely defined.

Key Takeaways

Claim 1 is the main asset: administer D-Arg-2′6′-Dmt-Lys-Phe-NH2 (or pharmaceutically acceptable salt) to human Barth syndrome subjects to reduce abnormal mitochondrial ultrastructure/mitochondrial abnormality or maintain mitochondrial organization.
Dependent claims expand enforcement leverage: daily dosing for ≥6 weeks (Claim 2) and ≥12 weeks (Claim 3), broad route coverage (Claim 5), and cardiovascular co-administration (Claims 6–7).
Salt form matters at the margin: Claim 8 specifically captures acetate and trifluoroacetate salt forms.
Design-around is mostly active/indication driven: because route and combination scheduling are broad, the strongest avoidance lever is using a different active peptide identity and/or not treating Barth syndrome.

FAQs

1) Does US 12,268,724 cover oral administration of the peptide for Barth syndrome?
Yes. Claim 5 includes oral administration among covered routes.

2) Is the cardiovascular agent optional or required for infringement?
Required only for Claim 6 and Claim 7. Claim 1 does not require cardiovascular co-administration.

3) If a regimen is given for less than 6 weeks, does it avoid the patent?
It may avoid Claims 2 and 3, but it does not avoid Claim 1, which has no minimum duration requirement in the text.

4) Are acetate and trifluoroacetate the only salt forms covered?
No. Claim 1 covers pharmaceutically acceptable salts broadly, while Claim 8 adds specific coverage for acetate and trifluoroacetate.

5) Can the patent be infringed if used for a non-Barth mitochondrial disease?
The claims are tied to “subject having Barth Syndrome,” so non-Barth indications do not fall within the claimed method as written.

References

United States Patent 12,268,724. “Method for reducing the number of mitochondria with abnormal mitochondrial ultrastructure…in Barth Syndrome” (claims provided in prompt).

Title:	Methods and compositions for the prevention or treatment of Barth Syndrome
Abstract:	The disclosure provides methods of preventing or treating Barth Syndrome in a mammalian subject, reducing risk factors associated with Barth Syndrome, and/or reducing the likelihood or severity of Barth Syndrome. The methods comprise administering to the subject an effective amount of an aromatic-cationic peptide to increase expression of TAZ1 in subjects in need thereof.
Inventor(s):	D. Travis Wilson, Mark Bamberger
Assignee:	Stealth Biotherapeutics Inc
Application Number:	US18/454,319
Patent Claim Types: see list of patent claims	Use; Formulation; Delivery;
Patent landscape, scope, and claims:	United States Patent 12,268,724 Scope and Claims Analysis: Barth Syndrome Mitochondrial Organization Using D-Arg-2′6′-Dmt-Lys-Phe-NH2 US 12,268,724 is a US-method-of-treatment patent with claim scope built around (i) a specific peptide identity, (ii) a specific clinical indication tied to Barth syndrome mitochondrial ultrastructure, and (iii) optional route, dosing duration, combination therapy with cardiovascular agents, and specific salt forms. The center of gravity is Claim 1’s method using D-Arg-2′6′-Dmt-Lys-Phe-NH2 (or a salt) to reduce abnormal mitochondrial ultrastructure, reduce the number of mitochondria with abnormal ultrastructure, ameliorate ultrastructure, or maintain mitochondrial organization in subjects with Barth syndrome. The claim set is narrower than a broad composition claim because it is method-of-use anchored to Barth syndrome and to this peptide (or salts). It also creates multiple infringement “hooks” via treatment duration (6 and 12 weeks), patient type (human), administration route, and co-administration with a broad cardiovascular-agent list. What does US 12,268,724 claim cover in Barth syndrome patients treated with the peptide? Answer: The patent claims a method of treating Barth syndrome by administering the peptide D-Arg-2′6′-Dmt-Lys-Phe-NH2 (or a pharmaceutically acceptable salt) in a therapeutically effective amount to achieve one or more mitochondrial-organization endpoints (reduce mitochondria with abnormal ultrastructure, ameliorate ultrastructure, or maintain mitochondrial organization). Claim 1: Core independent claim scope Claim 1 recites a method comprising administering a therapeutically effective amount of: Peptide: D-Arg-2′6′-Dmt-Lys-Phe-NH2, or Pharmaceutically acceptable salt thereof, to a subject having Barth Syndrome, for at least one of the following functional outcomes: Reducing the number of mitochondria with abnormal mitochondrial ultrastructure Ameliorating abnormal mitochondrial ultrastructure Maintaining mitochondrial organization Key structural aspects: Indication limitation: “in a subject having Barth Syndrome.” This is the gating condition for infringement. Mechanistic/functional endpoints: the mitochondria ultrastructure/organization language is both a therapeutic purpose and a measurable functional target. In practice, infringement arguments can lean on efficacy evidence showing ultrastructure improvement or normalization. No dosing requirement in Claim 1: duration, frequency, and route are pushed into dependent claims (Claims 2–5) and into salt identity (Claim 8). Claim 1’s infringement-relevant boundaries If a product uses a different peptide (even close analogs) or a different active sequence, it does not fall within Claim 1 as written. If the therapy is used outside Barth syndrome, Claim 1 likely does not read on it, even if mitochondrial organization is affected. If the product is used in Barth syndrome but the asserted functional outcome is not met, infringement may become evidence-driven. The claim does not require a specific biomarker measurement in the text, but enforcement typically needs linkage to the claimed functional outcomes. How narrow is the patent because it is limited to D-Arg-2′6′-Dmt-Lys-Phe-NH2 and salts? Answer: The claim is narrow on active identity (this exact peptide or a salt) and indication (Barth syndrome). It does not cover generic mitochondrial stabilizers absent this peptide, and it does not cover other D-amino acid peptides unless they are construed to be within “the peptide” as claimed. “Peptide identity” scope: exact sequence and stereochemistry The claim specifies: D-Arg 2′6′-Dmt Lys Phe NH2 C-terminus This level of precision typically limits coverage to that exact stereochemical/positional arrangement. Salts expand coverage only to “pharmaceutically acceptable salt thereof” and do not expand to different peptide sequences. Salt scope (Claim 8) tightens fallback Claim 8 limits to a pharmaceutically acceptable salt comprising acetate or trifluoroacetate. Even if Claim 1 covers any acceptable salt, Claim 8 is a narrower dependent layer useful for sales/labeling/CMC and for proving narrower claim overlap when a specific salt is used. Practical implication: If a drug substance is marketed in acetate or trifluoroacetate salt form, it can support a cleaner dependent-claim infringement path (Claims 8 layered on top of Claim 1). When does US 12,268,724 require treatment duration, and how does that affect generic or biosimilar design? Answer: The duration limitations appear only in dependent claims: daily for 6 weeks or more (Claim 2) and daily for 12 weeks or more (Claim 3). A challenger using shorter dosing windows could aim to avoid those dependent claims, but Claim 1 still targets therapeutically effective administration without a duration minimum. Dependent timing claims Claim 2: peptide administered daily for 6 weeks or more Claim 3: peptide administered daily for 12 weeks or more Design-around dynamics A manufacturer could attempt to market a shorter-duration regimen to reduce exposure to Claims 2 and 3. This does not remove Claim 1 risk because Claim 1 does not require a duration. Duration may still matter for infringement proof. Even if only Claim 1 is asserted, demonstrating “therapeutically effective” dosing that produces the claimed mitochondrial outcomes may still require longer treatment in clinical practice. What patient population and route-of-administration options expand infringement risk? Answer: Claim 4 limits to human. Claim 5 expands to essentially any common administration route: oral, topical, systemic, IV, subcutaneous, intraperitoneal, and intramuscular. Claim 4: Human limitation Claim 4: subject is human This narrows enforcement against animal-use studies and preclinical-only administration. Claim 5: Route coverage breadth Claim 5 includes: orally topically systemically intravenously subcutaneously intraperitoneally intramuscularly For pipeline strategy, this limits route-based design-around. A company cannot easily avoid coverage by switching from IV to SC or to oral. If the same peptide is used for Barth syndrome with therapeutically effective dosing, Claim 5 can read across most delivery formats. What does the cardiovascular co-administration claim add, and how broad is the agent list? Answer: Claim 6 adds a combination-therapy limitation. Claim 7 provides a large, enumerated list of cardiovascular agents, making the combination claim relatively easy to satisfy for typical Barth syndrome supportive care that includes cardiovascular drugs. Claim 6: combination framework Claim 6: further comprising separately, sequentially or simultaneously administering a cardiovascular agent. This is a typical claim strategy to capture: fixed-dose combination products, combination regimens with separate dosing schedules, sequential initiation or add-on therapy. Claim 7: broad cardiovascular agent taxonomy The cardiovascular agent is selected from: anti-arrhythmia agent vasodilator anti-anginal agent corticosteroid cardioglycoside diuretic sedative ACE inhibitor angiotensin II antagonist thrombolytic agent calcium channel blocker thromboxane receptor antagonist radical scavenger anti-platelet drug β-adrenaline receptor blocking drug α-receptor blocking drug sympathetic nerve inhibitor digitalis formulation inotrope antihyperlipidemic drug Scope implication: Because the list is not limited to one or two drug classes, it creates strong coverage probability if a treated Barth syndrome patient receives standard cardiovascular/supportive medications. Evidence and enforcement angle Combination claims often face questions about whether the co-administered drug is “cardiovascular” and whether it qualifies under the enumerated selection. Here, the list is extensive and includes broadly recognized cardiovascular classes (ACE inhibitors, beta blockers, calcium channel blockers, etc.). The “separately, sequentially or simultaneously” language also reduces scheduling-based design-around. What is the likely claim construction strategy for “mitochondria with abnormal mitochondrial ultrastructure” and “therapeutically effective”? Answer: The claim’s functional language is built to tether peptide administration to a mitochondrial ultrastructure endpoint in Barth syndrome. Enforcement typically depends on interpreting those terms through the patent specification and prosecution history, and then mapping clinical or preclinical data to the functional endpoints. Functional endpoint mapping risk “abnormal mitochondrial ultrastructure” and “mitochondrial organization” invite argument about what qualifies as abnormal and how it is measured (e.g., electron microscopy ultrastructure, marker-based readouts, or functional mitochondrial organization metrics). “reduce the number of mitochondria with abnormal mitochondrial ultrastructure” implies quantification at ultrastructural level. “ameliorating” and “maintaining” are softer terms but still imply improvement or normalization compared with baseline or untreated control. “Therapeutically effective amount” is an open-texture phrase It is likely to be construed to mean an amount sufficient to achieve at least one of the claimed functional outcomes. For infringement, the key question becomes whether the administered dose in Barth syndrome produces ultrastructural or organizational effects contemplated by the claim. Where are the patent’s main vulnerability points for challenges or design-arounds? Answer: The patent’s main vulnerability points are tied to (i) active identity substitution, (ii) indication mismatch, and (iii) functional outcome proof, not to route or combination scheduling. 1) Active identity substitution Because the independent claim requires the exact peptide (or salt), substitution with: a different peptide sequence, different stereochemical configuration, or a materially different structure is the cleanest design-around if feasible. 2) Indication mismatch If the therapy is used for a different mitochondrial disorder or a general mitochondrial-targeting indication, it may not satisfy the “subject having Barth Syndrome” limitation. 3) Functional outcome and purpose If evidence does not show reduction/amelioration/maintenance of mitochondrial organization as claimed, a challenger can contest whether the accused regimen is within the “method” defined. 4) Duration-dependent claims Claims 2 and 3 are conditional on daily dosing duration. Switching to shorter courses can reduce exposure under those dependent claims, but Claim 1 risk persists. What formulations are covered by the claims and how does that interact with salt selection in CMC and labeling? Answer: The claim is formulation-light except for salt specificity in Claim 8. It is primarily an active-and-method claim. Salt form can matter for Claim 8 and for whether the product is “a pharmaceutically acceptable salt.” Covered formulation dimensions “pharmaceutically acceptable salt thereof” in Claim 1: broad salt class coverage acetate or trifluoroacetate salt in Claim 8: specific fallback Practical impact If the commercial formulation uses acetate or trifluoroacetate, claim overlap increases because Claim 8 supplies a narrow additional layer. If a different salt is used, Claim 8 may not be triggered, but Claim 1 still may apply if the salt is pharmaceutically acceptable and the actives are otherwise identical. What generic or licensing strategy best reduces infringement exposure under US 12,268,724? Answer: Licensing and development strategies that reduce infringement exposure focus on breaking one of the essential limitations: the exact peptide identity, Barth syndrome indication, or the claimed therapeutic method (including the claimed mitochondrial-functional outcomes). Strategy set Use a different peptide or peptide analog not falling within the literal “D-Arg-2′6′-Dmt-Lys-Phe-NH2” definition. Target a different indication than Barth syndrome. Avoid daily administration regimens that meet the dependent duration claims, while recognizing Claim 1 still lacks a duration minimum. For combination-therapy exposure, manage whether cardiovascular co-administration occurs, though Claim 6 is dependent and does not affect Claim 1. Because Claim 5 broadly covers many routes and Claim 6 includes combination regimens even when separately dosed, route and dosing schedule are weaker levers than active identity and indication. What Orange Book status or Paragraph IV exposure applies to a method patent like US 12,268,724? Answer: A US method-of-treatment patent like this typically drives ANDA Paragraph IV risk only if the product is eligible for Orange Book listing under relevant FDA patent listing practices and if an applicable “drug product” is listed against the method patent. Without the Orange Book listing record and the associated reference product NDA/ANDAs, Orange Book status cannot be determined from the claim text alone. Litigation posture expected for method claims If the peptide drug is developed and listed, Paragraph IV notice letters can assert non-infringement or invalidity as to method-of-use claims (including functional endpoints and therapeutic purpose). Settlements often convert to branded exclusivity or time-limited launches contingent on permitted carve-outs (e.g., different dosing regimen, different indication, or different active form). What patent landscape issues typically cluster around US 12,268,724 claim types? Answer: For a peptide method patent anchored to Barth syndrome mitochondrial ultrastructure, the broader landscape usually includes: composition-of-matter patents covering peptide sequences, stereochemistry, and manufacturing, formulation/solubility and salt patents (including acetate/trifluoroacetate forms), method-of-treatment patents for Barth syndrome and related mitochondrial disorders, combination regimen patents (supportive care or pathway adjuncts), and manufacturing/process patents. This patent’s claims are already positioned to reinforce enforcement across multiple real-world dosing scenarios because route and combination are widely defined. Key Takeaways Claim 1 is the main asset: administer D-Arg-2′6′-Dmt-Lys-Phe-NH2 (or pharmaceutically acceptable salt) to human Barth syndrome subjects to reduce abnormal mitochondrial ultrastructure/mitochondrial abnormality or maintain mitochondrial organization. Dependent claims expand enforcement leverage: daily dosing for ≥6 weeks (Claim 2) and ≥12 weeks (Claim 3), broad route coverage (Claim 5), and cardiovascular co-administration (Claims 6–7). Salt form matters at the margin: Claim 8 specifically captures acetate and trifluoroacetate salt forms. Design-around is mostly active/indication driven: because route and combination scheduling are broad, the strongest avoidance lever is using a different active peptide identity and/or not treating Barth syndrome. FAQs 1) Does US 12,268,724 cover oral administration of the peptide for Barth syndrome? Yes. Claim 5 includes oral administration among covered routes. 2) Is the cardiovascular agent optional or required for infringement? Required only for Claim 6 and Claim 7. Claim 1 does not require cardiovascular co-administration. 3) If a regimen is given for less than 6 weeks, does it avoid the patent? It may avoid Claims 2 and 3, but it does not avoid Claim 1, which has no minimum duration requirement in the text. 4) Are acetate and trifluoroacetate the only salt forms covered? No. Claim 1 covers pharmaceutically acceptable salts broadly, while Claim 8 adds specific coverage for acetate and trifluoroacetate. 5) Can the patent be infringed if used for a non-Barth mitochondrial disease? The claims are tied to “subject having Barth Syndrome,” so non-Barth indications do not fall within the claimed method as written. References United States Patent 12,268,724. “Method for reducing the number of mitochondria with abnormal mitochondrial ultrastructure…in Barth Syndrome” (claims provided in prompt). More… ↓ ⤷ 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
Stealth Biotheraps	FORZINITY	elamipretide hydrochloride	SOLUTION;SUBCUTANEOUS	215244-001	Sep 19, 2025		RX	Yes	Yes	12,268,724	⤷ Start Trial				METHOD FOR TREATING BARTH SYNDROME IN ADULT AND PEDIATRIC PATIENTS WEIGHING AT LEAST 30KG	⤷ 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
Canada	2916880	⤷ Start Trial
Canada	2916884	⤷ Start Trial
Canada	2916977	⤷ Start Trial
China	105407906	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Summary for Patent: 12,268,724