Patent 7,271,238 (US) scope map: des-1Lys25Pro26Val28,29Pro-h-amylin amylin agonist analogs, salt forms, and diabetes treatment claims

What patents protect US 7,271,238 amylin agonist analogs and their salts?

US 7,271,238 is directed to a specific amylin agonist analog defined by (i) a named peptide (“des-1Lys25Pro26Val28,29Pro-h-amylin (SEQ ID NO: 40)”) and, in broader dependent coverage, (ii) additional peptide sequences claimed via a variable-position Markush framework (SEQ ID NO: 44 with defined allowable substitutions), plus (iii) salt forms (acetate, hydrochloride; and salts generally for the Markush family), and (iv) diabetes treatment methods, including combinations with insulin and routes of administration.

Core “protection unit” is the peptide composition itself, then extended to salts, then to therapeutic uses.

Claim scope by subject matter (high level)

Claim	Subject matter protected	What is actually covered
1	Chemical entity (specific analog)	Agonist analog of amylin: des-1Lys25Pro26Val28,29Pro-h-amylin (SEQ ID NO: 40)
2	Chemical entity (salt)	Claim 1 peptide as acetate salt
3	Use	Administering claim 2 peptide to treat diabetes mellitus
4	Chemical entity (salt)	Claim 1 peptide as hydrochloride salt
5	Use	Administering claim 1 peptide to treat diabetes mellitus
6	Use (combo)	Claim 5 method with further insulin administration
7	Chemical entity (broader peptide family)	Agonist analog with sequence of “SEQ ID NO: 44” plus variable-position constraints; includes special proviso about D-amino acids and Z not amino for certain enumerated embodiments (SEQ ID NOs 45-50 used as concrete examples of allowable sub-families)
8	Chemical entity (salt)	Claim 7 peptide as acetate salt
9	Use	Administering claim 8 peptide to treat diabetes mellitus
10	Use subset	Claim 9 diabetes is type I
11	Use subset	Claim 9 diabetes is insulin-requiring type II
12	Use	Administering claim 7 peptide to treat diabetes mellitus
13	Use (combo)	Claim 12 further comprising insulin
14	Use subset	Claim 12 diabetes is type I
15	Use subset	Claim 12 diabetes is insulin-requiring type II
16	Use (route)	Claim 12 route includes IV, IM, nasal, oral, or transdermal
17	Composition	Therapeutically effective amount of claim 7 peptide and insulin
18	Use (combo composition)	Administering claim 17 composition
19	Use (route)	Claim 18 route includes IV, IM, nasal, oral, or transdermal

What exactly is the peptide claim coverage?

Claim 1: “des-1Lys25Pro26Val28,29Pro-h-amylin (SEQ ID NO: 40)”

This claim is a single, defined sequence identity. It is not a Markush family; it is a fixed analog identified by SEQ ID NO: 40 and by a descriptive mutation/positional naming.

Practical implication for infringement: if an accused peptide has the same sequence as SEQ ID NO: 40 (including the “des-1” N-terminal deletion and the specified substitutions at positions 25-29), the entity claim is directly implicated.

Claims 7-8: “agonist analog of amylin” with a variable sequence scaffold (SEQ ID NO: 44 with positional rules)

Claim 7 expands beyond SEQ ID NO: 40. It uses a long Markush-style variable residue framework with:

Fixed-length architecture tied to the numbering implied by the sequence template and the “provided that” constraints.
Variable positions A1 through M1 with explicit allowable residue sets.
X and Y are residues whose side chains are chemically linked to form an intramolecular linkage.
Z defines a substituent at the linkage-containing segment and is limited to a list of functional groups (hydroxy, amino, alkylamino, dialkylamino, cycloalkylamino, arylamino, aralkylamino, alkyloxy, aryloxy, or aralkyloxy).
A conditional proviso tied to specific instantiations (SEQ ID NOs 45-50): in those enumerated embodiments, one or more of A1 to M1 are D-amino acids, and Z is not amino.

How the “provided that” clause changes the claim boundaries

The final portion of claim 7 is not free-form. It is an enumerated list of specific A1-M1 combinations (SEQ ID NO: 45 through SEQ ID NO: 50) that trigger the special D-amino-acid / Z restriction.

Practical consequence: infringement analysis has to check whether the accused structure maps to the described variable scaffold and whether it lands in the enumerated subsets that invoke the D-amino-acid and “Z is not amino” limits.

Salt coverage (claims 2 and 4 plus salt language in claim 7 family)

Claim 2: SEQ ID NO: 40 as an acetate salt.
Claim 4: SEQ ID NO: 40 as a hydrochloride salt.
Claim 8: claim 7 peptide as an acetate salt.
Claim 7 includes “as a salt” at the end; the claim text you provided does not enumerate all possible salts for the family, but it does establish that salt forms are contemplated.

Practical implication: even if an accused peptide corresponds to the core sequence, the salt form can determine which claims read on. For SEQ ID NO: 40, acetate and hydrochloride are explicitly claimed; for claim 7 family members, at least acetate is explicit (claim 8) and salts are broadly recited (claim 7).

How are method-of-use claims drafted, and what do they cover?

Diabetes treatment (broad)

Claim 3: administer acetate-salt (claim 2) peptide to treat diabetes.
Claim 5: administer peptide (claim 1) to treat diabetes.
Claim 9: administer acetate-salt (claim 8) peptide to treat diabetes.
Claim 12: administer claim 7 peptide to treat diabetes.

These are classic “administration for a therapeutic effect” method claims. They do not tie to a dose regimen, titration schedule, treatment duration, or patient baseline metrics in the excerpted language.

Diabetes subtype narrowing

Claims 10 and 11: for claim 9 method, diabetes is type I or insulin-requiring type II.
Claims 14 and 15: for claim 12 method, diabetes is type I or insulin-requiring type II.

Practical implication: these subtype dependent claims are narrower. If the accused conduct targets non-specified diabetes or uses only for type 2 (non-insulin-requiring), then the dependent claims may not read even if the broad “treat diabetes mellitus” claims do.

Combination with insulin

Claim 6: claim 5 further comprises administration of insulin.
Claim 13: claim 12 further comprises administration of insulin.

Composition claim: peptide + insulin

Claim 17: composition with therapeutically effective amount of claim 7 peptide and insulin.
Claims 18 and 19: administration of that composition for diabetes, including routes.

Infringement posture: a composition claim can be triggered by the product format (co-formulated or packaged combination where the claim language is satisfied). Method claims are triggered by the act of administering the peptide (with or without insulin, depending on the claim).

Route-of-administration expansion (route-agnostic in some claims; explicit in others)

Claim 16: claim 12 route includes IV, IM, nasal, oral, or transdermal.
Claim 19: claim 18 route includes IV, IM, nasal, oral, or transdermal.

Other method claims in the provided excerpt (3, 5, 9, 12 without route limitation) are not route-limited based on the text you provided, so route selection may not be a limiting factor unless the route limitation is part of the asserted claim.

What generic entry risks exist for peptide analogs covered by US 7,271,238?

Chemical entity and composition coverage creates “active ingredient” entry risk

If a generic or biosimilar (not applicable here because this is not a biologic in the excerpt; it is a peptide small-molecule/biopolymer type but still treated as a drug substance) replicates the peptide sequence and salts, it risks both:

entity claims (1, 7), salt claims (2, 4, 8), and
method claims (3, 5, 6, 9, 10-15, 12-16, 17-19) depending on intended use and co-therapy.

The largest “freedom to operate” hinge is whether the accused peptide maps to SEQ ID NO: 40 or the claim 7 variable scaffold

A narrow design-around that changes the sequence away from SEQ ID NO: 40 may avoid claim 1-6, but may still fall within claim 7 if it fits the Markush scaffold and constraints.
A reformulation that uses a different salt could avoid the explicitly stated acetate/hydrochloride claims for SEQ ID NO: 40, but claim 7’s “as a salt” language and claim 8’s acetate dependence still leave salt design-around narrower than it first appears.

“Route” and “insulin combination” can reduce exposure but not eliminate the core entity risk

Even if an accused product avoids insulin co-administration or avoids certain routes, the broad diabetes method claims remain relevant where route is not recited as a limitation.

When does US 7,271,238 lose exclusivity?

You did not provide:

the filing date, priority date, prosecution history, patent term adjustment (PTA), patent term extension (PTE), or any related FDA exclusivity determinations tied to the drug product.

Without those dates and statutory adjustments, a correct exclusivity timeline cannot be produced.

What is the Orange Book status of US 7,271,238-covered drugs?

You did not provide:

the approved drug name(s), NDA/BLA number(s), or Orange Book listing identifiers.

Without the specific reference listed drug (RLD) and product identifiers, Orange Book status cannot be mapped to US 7,271,238 with accuracy.

How strong is the patent estate for amylin analog diabetes therapy?

This analysis is limited to the single patent provided and its claim set excerpt. A full “patent estate” strength evaluation requires identification of:

related continuation/divisional family members,
other US patents covering the same peptide analogs,
formulation patents (delivery systems, excipients, stabilization),
device and combination patents, and
regulatory exclusivities.

No such landscape data is included in the prompt.

What patent litigation affects US 7,271,238?

No litigation docket numbers, parties, jurisdictions, or court filings are included in the prompt. Without case identifiers, litigation impact cannot be asserted.

Key claim construction takeaways (what will control infringement and validity)

1) Claim 1 is a tight sequence identity claim

It is directly tied to SEQ ID NO: 40.
Any accused peptide with an identical amino acid sequence is within the claim’s center of gravity.

2) Claims 7 and 17 rely on a complex Markush scaffold

A-mapped residues (A1-M1), the X-Y intramolecular linkage, and Z are all limiting.
The “provided that” clause adds specific constraints for certain enumerated embodiments, including D-amino-acid presence and Z not amino.

3) Salt forms matter, but for claim 7 family there is broader salt language

SEQ ID NO: 40 salts are explicitly claimed as acetate and hydrochloride.
Claim 7 includes “as a salt,” and claim 8 explicitly covers acetate for the family.

4) Method claims are triggered by therapeutic intent and act of administration

Diabetes treatment method claims are broad and depend mainly on whether the administered compound matches the claimed peptide (and salt where required).
Subtype dependent claims narrow to type I and insulin-requiring type II.
Combination-dependent claims add insulin.

5) Route limitations appear only in specific dependents

Claim 16 and 19 include a route basket (IV, IM, nasal, oral, transdermal).
If asserted, route selection can become a gating issue for those dependent claims; independent diabetes-treatment dependents do not appear route-limited in your excerpt.

Key Takeaways

US 7,271,238 protects an amylin agonist analog defined by SEQ ID NO: 40 (claim 1), plus acetate and hydrochloride salts (claims 2 and 4), and diabetes treatment by administration (claims 3, 5).
The patent also protects a broader peptide family under a Markush scaffold (claim 7) with defined residue sets (A1-M1), an X-Y intramolecular linkage, and a Z substituent limitation, including special D-amino-acid and Z-not-amino constraints for enumerated embodiments (SEQ ID NOs 45-50).
Insulin combination use and co-therapy are claimed (claims 6, 13) along with a composition of peptide plus insulin (claims 17-19).
Route-of-administration inclusion is expressly stated only in claims 16 and 19.
The strongest infringement risk is a product that contains the exact SEQ ID NO: 40 peptide and the claimed salt, followed by products that map into the broader claim 7 scaffold even if the exact SEQ ID NO: 40 is avoided.

FAQs

Does US 7,271,238 cover both acetate and hydrochloride salts of the same amylin analog?
Yes for SEQ ID NO: 40 via claims 2 (acetate) and 4 (hydrochloride), and for the claim 7 family via claim 8 (acetate).
Do the method claims require insulin co-administration to infringe?
No. Insulin is optional for the broad diabetes treatment claims (claims 3, 5, 9, 12) and required only in the insulin-dependent claims (claims 6, 13) and the composition claims (claims 17-19).
Which claims explicitly list diabetes subtype (type I vs insulin-requiring type II)?
Claims 10-11 for claim 9 methods, and claims 14-15 for claim 12 methods.
Are route-of-administration limitations present across all method claims?
No. Route basket appears in claim 16 and claim 19 (IV, IM, nasal, oral, transdermal) based on the provided claim text.
Can a design-around by changing the salt avoid all protection?
For SEQ ID NO: 40, changing away from acetate/hydrochloride could avoid claims 2 and 4, but claim 5 still covers the peptide entity for diabetes treatment unless the accused product also changes the peptide sequence away from the claimed analogs.

References

No external sources were cited because the prompt did not provide bibliographic identifiers, jurisdictional documents, or any public records to verify/quote beyond the claim text supplied.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	205854	⤷ Start Trial
Australia	1245697	⤷ Start Trial
Australia	3075392	⤷ Start Trial
Australia	673147	⤷ Start Trial
Australia	714439	⤷ Start Trial
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Details for Patent: 7,271,238

Summary for Patent: 7,271,238