Details for Patent: 7,576,061

Which drugs does patent 7,576,061 protect, and when does it expire?

Patent 7,576,061 protects FORZINITY and is included in one NDA.

This patent has forty-nine patent family members in thirteen countries.

Summary for Patent: 7,576,061

Title:	Methods for preventing mitochondrial permeability transition
Abstract:	The invention provides a method of reducing or preventing mitochondrial permeability transitioning. The method comprises administering an effective amount of an aromatic-cationic peptide having at least one net positive charge; a minimum of four amino acids; a maximum of about twenty amino acids; a relationship between the minimum number of net positive charges (pm) and the total number of amino acid residues (r) wherein 3pm is the largest number that is less than or equal to r+1; and a relationship between the minimum number of aromatic groups (a) and the total number of net positive charges (pt) wherein 2a is the largest number that is less than or equal to pt+1, except that when a is 1, pt may also be 1.
Inventor(s):	Hazel H. Szeto, Kesheng Zhao, Peter W. Schiller
Assignee:	Institut de Recherches Cliniques de Montreal IRCM , Cornell Research Foundation Inc
Application Number:	US10/771,232
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;

US Patent 7,576,061 claims scope and US patent landscape for mitochondrial permeability transition (MPT) reducing peptides

US Drug Patent 7,576,061 is a US composition-and-method-of-use patent focused on reducing or preventing mitochondrial permeability transition (MPT, also described as mitochondrial permeability transitioning) by administering specific D-amino-acid–rich peptide sequences to a mammal (or to a removed organ). The claim set is broad on (i) therapeutic intent (ischemia, reperfusion, hypoxia, drug-induced MPT), (ii) route of administration (oral, topical, intranasal, multiple systemic routes, intrathecal/intracerebroventricular, transdermal/iontophoresis), and (iii) target setting (in vivo mammal vs ex vivo/removed organ). The primary claim scope is pegged to a defined set of peptide formulas and stereochemical “D” residue patterns, plus carrier/composition embodiments.

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What does US 7,576,061 claim cover for mitochondrial permeability transition peptide therapies?

Core claim theme (Claim 1): A method of reducing the number of mitochondria undergoing MPT, or preventing MPT in a mammal, by administering an “effective amount” of a peptide with one of the enumerated C-terminal amidated peptide formulas (all terminate in “-NH2”), including D-Arg, Dmt (a D-amino acid, typically shorthand for a D-methyl-tyrosine–like residue in this patent family’s naming conventions), and Lys/Phe combinations and other D-residue variants.

Claim 1 breadth dimensions

• Biological target: MPT (mitochondrial permeability transition) reduction/prevention.
• Mammal population: includes “a human” (Claim 25).
• Disease/clinical contexts: ischemia, reperfusion, hypoxia, and “drug-induced MPT.”
• Route of administration: oral; topical; intranasal; systemic; intravenous; subcutaneous; intramuscular; intracerebroventricular; intrathecal; transdermal (including iontophoresis).
• Tissue examples: ischemia “due to stroke,” “intestinal ischemia,” muscle tissue (cardiac/skeletal/smooth muscle).

Claim 2 and others narrow to a lead embodiment

• Claim 2: peptide has the specific formula D-Arg-Dmt-Lys-Phe-NH2.
• Other claims similarly “center” around specific exemplars while preserving route and disease breadth.

Ex vivo extension (Claims 32-39):

• Methods apply not only to the mammal but also to “a removed organ of a mammal,” where the effective amount is administered to the removed organ.

Composition embodiments (Claims 26, 27, 29, 34, 35, 37, 39, 42-45):

• Several claims recast the method to specify administration as a composition comprising a pharmaceutically acceptable carrier.
• Additional claims cover a peptide and a composition comprising a peptide plus carrier for specific peptide formulas (not only methods).

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Which peptides (exact formulas) are covered by US 7,576,061, and how broad is the genus?

Genus concept in this claim set The patent largely uses a genus defined by enumerated peptide formulas (rather than a simple free-form sequence definition). The genus is therefore broad across the enumerated list, but bounded to those exact residue orderings and the named variants that appear in the claims.

A. Primary peptide genus: D-Arg/Dmt/Lys/Phe–type formulas (Claims 1, 32, 40)

The claims enumerate multiple peptides, including:

• D-Arg-Dmt-Lys-Phe-NH2
• D-Arg-Dmt-Phe-Lys-NH2
• D-Arg-Phe-Lys-Dmt-NH2
• D-Arg-Phe-Dmt-Lys-NH2
• D-Arg-Lys-Dmt-Phe-NH2
• D-Arg-Lys-Phe-Dmt-NH2
• Phe-Lys-Dmt-D-Arg-NH2
• Phe-Lys-D-Arg-Dmt-NH2
• Phe-D-Arg-Dmt-Lys-NH2
• Phe-D-Arg-Lys-Dmt-NH2
• Phe-Dmt-D-Arg-Lys-NH2
• Phe-Dmt-Lys-D-Arg-NH2
• Lys-Phe-Dmt-D-Arg-NH2
• Lys-Dmt-D-Arg-Phe-NH2
• Lys-Dmt-Phe-D-Arg-NH2
• Lys-D-Arg-Phe-Dmt-NH2
• D-Arg-Dmt-D-Arg-Phe-NH2
• D-Arg-Dmt-D-Arg-Dmt-NH2
• D-Arg-Dmt-D-Arg-Tyr-NH2
• D-Arg-Dmt-D-Arg-Trp-NH2
• Trp-D-Arg-Phe-Lys-NH2
• Trp-D-Arg-Tyr-Lys-NH2
• Trp-D-Arg-Trp-Lys-NH2
• Trp-D-Arg-Dmt-Lys-NH2
• D-Arg-Trp-Lys-Phe-NH2
• D-Arg-Trp-Phe-Lys-NH2
• D-Arg-Trp-Lys-Dmt-NH2
• D-Arg-Trp-Dmt-Lys-NH2
• D-Arg-Lys-Trp-Phe-NH2
• D-Arg-Lys-Trp-Dmt-NH2
• Cyclohexyl-D-Arg-Phe-Lys-NH2
• Ala-D-Arg-Phe-Lys-NH2

Claim 28/29 focus narrower genus: Phe-D-Arg-Phe-Lys-NH2 and Dmp-D-Arg-Phe-Lys-NH2

• Claim 28: Phe-D-Arg-Phe-Lys-NH2 OR Dmp-D-Arg-Phe-Lys-NH2
• Claim 29: same peptide options but explicitly “as a composition comprising a pharmaceutically acceptable carrier.”

Claim 30/31 expanded alternative genus: longer D-peptide sequences (SEQ ID NOs 3-26) Claims 30 and 31 enumerate an additional set of longer sequences with SEQ ID NOs (3 through 26), including:

• SEQ ID NO: 3 corresponds to Tyr-D-Arg-Phe-Lys-Glu-NH2
• SEQ ID NO: 4 corresponds to Met-Tyr-D-Lys-Phe-Arg
• SEQ ID NO: 5 corresponds to D-His-Glu-Lys-Tyr-D-Phe-Arg
• … continuing through SEQ ID NO 26, with multiple residue variations (His, Asp, Glu, Cys, Gly, Val, Trp, Tyr, Thr, Ile, Pro, Leu, etc.)

Practical IP implication: the patent has multiple “islands” of sequence scope:

1. short four/four-plus D-residue peptides ending in amidation,
2. a two-alternative motif peptide (Phe-D-Arg-Phe-Lys-NH2 / Dmp-D-Arg-Phe-Lys-NH2),
3. a larger collection of longer D-peptide sequences defined by explicit strings and SEQ IDs.

B. Single-value “lead” peptide emphasized repeatedly

• D-Arg-Dmt-Lys-Phe-NH2 appears in multiple independent and dependent claims:
  • Claim 2 (specific formula)
  • Claim 27 (composition/method claim with carrier)
  • Claim 33/35 and the ex vivo variants (32-37)
  • Claim 41/43/45 composition claims around the same peptide.

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How does claim structure shift protection between method-of-treatment and composition-of-matter?

US 7,576,061 is not a pure composition patent; it is a hybrid protection package built around multiple claim types:

1) Method claims anchored to route and patient condition

• Claims 1-25:
  • method reducing/preventing MPT
  • administration routes (oral/topical/intranasal/systemic including IV/SC/IM/intrathecal/intracerebroventricular/transdermal by iontophoresis)
  • clinical conditions (ischemia due to stroke, intestinal ischemia, hypoxia, reperfusion, drug-induced MPT)
  • tissue contexts (cardiac/skeletal/smooth muscle; also ex vivo removed organ analogs later)

2) Method claims anchored to carriers

• Claim 26 is the method that includes “as a composition comprising a pharmaceutically acceptable carrier.”
• Claim 29 is similar for the Phe-D-Arg-Phe-Lys / Dmp-D-Arg-Phe-Lys variant with carrier.
• Claims 34, 37, 39 are ex vivo with carrier. This matters because it can force a challenger attempting “un-carrier” administration into infringement arguments against the literal carrier language, while still leaving other method claims without carrier limitations to cover active administration.

3) Peptide and composition claims

• Claim 40 defines a peptide genus subset (the D-Arg-Dmt/Lys/Phe–type list).
• Claim 41 narrows to D-Arg-Dmt-Lys-Phe-NH2.
• Claim 42 defines a composition of a listed peptide plus pharmaceutically acceptable carrier.
• Claim 43 narrows to the D-Arg-Dmt-Lys-Phe-NH2 composition.
• Claim 44 covers peptide Phe-D-Arg-Phe-Lys-NH2 or Dmp-D-Arg-Phe-Lys-NH2.
• Claim 45 covers the same peptides in a composition with carrier.

IP implication: Even if a generic tries to “design around” a method claim by targeting a route or condition not covered, composition and peptide claims remain a separate infringement lane.

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What legal/claim scope issues matter most for freedom-to-operate around US 7,576,061?

A. “MPT” reduction/prevention standard is broad in wording

The independent method claims are written as:

• reducing the number of mitochondria undergoing MPT, or
• preventing MPT.

That language typically does not require a specific biomarker threshold in the claim text, so infringement arguments can be based on observed MPT modulation in assays or in disease models.

B. “Effective amount” and route choices are permissive

Because the claims:

• use “effective amount,” and
• enumerate many routes including very invasive CNS routes, the patent reduces the ability to design around by changing delivery.

C. Ex vivo “removed organ” creates additional non-obvious coverage

If a sponsor uses organ perfusion systems (ischemia-reperfusion in transplantation models), the “removed organ” claims can attach even if patient administration is not performed.

D. Enumerated sequences limit design-around options but also define clear infringement targets

Because peptides are explicitly listed (and longer sequences are tied to explicit residue strings and SEQ IDs), a competitor can attempt to choose sequences not enumerated. The practical risk depends on whether the competitor’s peptide sequence falls within any enumerated exact match.

E. Carrier language can create a split between formulation and administration strategies

Claims that explicitly require “as a composition comprising a pharmaceutically acceptable carrier” create a potential non-infringement path for a party that administers the peptide in a manner that arguably falls outside “composition comprising carrier.” However:

• other method claims do not necessarily impose the carrier requirement (e.g., Claim 1),
• and composition/peptide claims still create infringement exposure independent of administration narrative.

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How many distinct claim categories exist inside US 7,576,061, based on the claim text provided?

Based on the claim text you supplied, the scope clusters into at least five distinct categories:

1. Short enumerated D-peptide formulas for in vivo method reducing/preventing MPT (Claim 1; Claim 32 for removed organ).
2. A lead short peptide (D-Arg-Dmt-Lys-Phe-NH2) as a specific dependent confirmation (Claims 2, 27, 33, 35, 41, 43).
3. Specific motif peptide genus: Phe-D-Arg-Phe-Lys-NH2 / Dmp-D-Arg-Phe-Lys-NH2 (Claims 28-29, 36-37, 44-45).
4. Long enumerated D-peptide sequences with SEQ IDs (Claims 30-31, 38-39).
5. Peptide and composition claims (Claims 40-45) that function as a separate “object of infringement” beyond method-of-use.

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What is the likely infringement surface: peptides, formulations, and delivery modes?

1) Direct infringement risk highest for peptide manufacture and sale

If any entity sells or distributes the exact peptide molecules enumerated in:

• Claim 40 (listed short peptides),
• Claim 41 (D-Arg-Dmt-Lys-Phe-NH2),
• Claim 44 (Phe-D-Arg-Phe-Lys-NH2 / Dmp-D-Arg-Phe-Lys-NH2), then the patent creates a composition/peptide infringement lane even before method-of-treatment facts arise.

2) Formulation risk depends on whether carrier is required

For entities preparing a “composition comprising pharmaceutically acceptable carrier,” Claims 26, 29, 42, 43, 45 are direct hooks.

3) Delivery mode is less useful as a design-around

Claim 1 enumerates route choices widely, including oral and invasive CNS routes. A route change is therefore unlikely to avoid infringement under Claim 1 unless the route used falls outside the explicitly listed options and the claim interpretation is constrained to those options (while many jurisdictions treat such dependencies as specific limitations only for dependent claims).

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How does the claim set compare to typical mitochondrial permeability transition patents (broad vs narrow)?

Compared with very broad “MPT inhibition” patents:

• This patent is narrower than generic “any MPT modulator” claims because it ties protection to a specific peptide genus with exact sequences.

Compared with very narrow patents that cover only one sequence and one indication:

• This patent is broader because it covers:
  • many routes of administration,
  • multiple pathophysiology triggers (ischemia/reperfusion/hypoxia/drug-induced MPT),
  • multiple tissue contexts (including intestinal ischemia and multiple muscle tissue types),
  • in vivo mammal and removed organ settings,
  • and multiple sequence islands (short peptides, specific motif peptides, and SEQ ID longer peptides).

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What generic/biotech entry risks exist for competitors targeting MPT with D-peptides?

High-risk entry conditions

A competitor faces high risk if it does any of the following:

• uses an enumerated peptide sequence exactly as written;
• prepares a carrier-containing pharmaceutical composition of those exact peptides;
• targets clinical scenarios that map to ischemia/reperfusion/hypoxia/drug-induced MPT in a mammal, including humans;
• uses CNS delivery modes or transdermal iontophoresis, which appear explicitly in Claim 1.

Lower-risk entry conditions

Risk falls materially if a competitor:

• uses an MPT-modulating peptide that is not in the enumerated claim lists, or
• does not practice the method with the claimed active peptide (even if the therapy concept is similar).

Because the patent uses explicit peptide formula lists, sequence-level design-around can be effective. The tradeoff is that it may require significant development and clinical validation.

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Is there anything in the claim text that creates internal redundancy or reinforces key coverage?

Yes. The claim set repeats key anchors:

• MPT reducing/preventing appears in every method cluster.
• D-Arg-Dmt-Lys-Phe-NH2 is singled out repeatedly.
• Carrier-based embodiments appear across multiple method types and are echoed by direct composition claims.
• Removed organ appears as a separate method cluster, adding an ex vivo lane.

This redundancy supports enforcement because a challenger may not be able to avoid infringement by attacking one dependent feature if other independent claims remain aligned.

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Key tables: “What is claimed?” mapped to claim groups and boundaries

Table 1. Claim scope mapping by peptide and claim category (based on provided claim text)

Claim cluster	Claimed object	Peptide scope (as listed)	Administration/setting limits
Claims 1, 32	Method reducing/preventing MPT	Enumerated short D-peptide formulas (multiple variants incl. D-Arg-Dmt-Lys-Phe-NH2; Trp/Dmt/Tyr/Arg/Lys permutations; cyclohexyl-D-Arg; Ala-D-Arg)	Mammal (Claim 1) or removed organ (Claim 32); route/disease/tissue limitations in Claim 1 dependents
Claims 2, 33	Narrowed method embodiment	D-Arg-Dmt-Lys-Phe-NH2	Specific formula within the genus
Claim 26, 27	Method with carrier	Same short D-peptide list	Administration “as a composition comprising pharmaceutically acceptable carrier”
Claims 28-29, 36-37	Method with specific motif peptides	Phe-D-Arg-Phe-Lys-NH2 OR Dmp-D-Arg-Phe-Lys-NH2	Mammal vs removed organ; carrier-limited in dependent claim 29/37
Claims 30-31, 38-39	Methods using longer SEQ ID peptides	SEQ ID NOs 3-26 peptide strings (multiple D-residue sequences)	Mammal vs removed organ; carrier included in 31/39
Claims 40-41	Peptide (molecule) claims	Enumerated short D-peptide formulas; narrowed to D-Arg-Dmt-Lys-Phe-NH2	No route needed
Claims 42-43	Composition claims	Same short peptides plus pharmaceutically acceptable carrier	No route needed
Claims 44-45	Peptide and composition claims for motif peptides	Phe-D-Arg-Phe-Lys-NH2 or Dmp-D-Arg-Phe-Lys-NH2	Composition requires carrier in Claim 45

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Key Takeaways

• US 7,576,061 protects D-peptide–based MPT modulation with broad clinical and delivery coverage (ischemia, reperfusion, hypoxia, drug-induced MPT; multiple routes including CNS and iontophoresis), and adds ex vivo “removed organ” methods.
• The scope is sequence-enumerated: infringement risk turns on whether a competitor’s peptide matches an enumerated formula (short D-peptides, two specific motif peptides, and longer SEQ ID peptides).
• Enforcement surface is strengthened by redundancy across independent method claims and separate peptide/composition claims.
• For freedom-to-operate, the highest exposure comes from manufacturing/selling exact enumerated peptides and formulating them with pharmaceutically acceptable carriers.

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FAQs

1. Do US 7,576,061 method claims require a specific route to infringe?
   Claim 1 includes explicit route-dependent options (oral, topical, intranasal, systemic, IV/SC/IM, intracerebroventricular, intrathecal, transdermal including iontophoresis), creating multiple literal pathways depending on which dependent claims are asserted.

2. Are removed-organ (ex vivo) uses covered by US 7,576,061?
   Yes. Claims 32-39 extend method coverage to “a removed organ of a mammal,” with versions that include carrier requirements.

3. Which single peptide is repeatedly singled out in US 7,576,061?
   D-Arg-Dmt-Lys-Phe-NH2 appears as the specified formula in multiple dependent and composition embodiments (Claims 2, 27, 33, 35, 41, 43).

4. Does US 7,576,061 include claims directed to peptide molecules and carrier compositions, not only methods?
   Yes. Claims 40-45 cover peptide and composition embodiments tied to enumerated peptide formulas, including carrier-containing compositions.

5. What peptides are covered under the narrower motif genus tied to Phe-D-Arg-Phe-Lys-NH2?
   Claims 28-29 and 36-37 cover methods using Phe-D-Arg-Phe-Lys-NH2 or Dmp-D-Arg-Phe-Lys-NH2, with carrier-required embodiments in the dependent claims; Claims 44-45 also provide peptide and composition coverage for that motif.

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References

1. United States Patent 7,576,061 (claims as provided in user prompt).

Drugs Protected by US Patent 7,576,061

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	7,576,061		Y	Y

International Family Members for US Patent 7,576,061

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004209663
Canada	2515080
China	100536909