When do biologic drug patents expire and when will biosimilars launch?

What does US Patent 7,276,480 cover, and how crowded is the US landscape around it?

Which invention does US 7,276,480 claim (and what does the claims set look like)?

US 7,276,480 is a granted US patent for “Compositions and methods for preparing stabilized peptide formulations” and related stabilized peptide composition and formulation subject matter. The patent’s focus is on stabilizing peptides in liquid or reconstitutable pharmaceutical formats by controlling formulation conditions and excipients so the peptide retains its integrity during storage and handling. (USPTO patent record, US 7,276,480) [1].

A useful way to read the patent landscape is to separate:

Claim scope anchored to “stabilized peptide formulations” (formulation composition and/or process of preparation)
Claim scope anchored to “preparing stabilized peptide formulations” (method of making/handling conditions)

Because the claims drive enforceability and licensing value, the landscape assessment below is organized around how this patent’s formulation logic fits into broader and later US disclosure streams for peptide stabilization.

What are the core claim themes you should map to the US patent landscape?

Based on the patent’s title and typical claim construction for this class of peptide-stabilization patents, the enforceable hooks typically include:

Peptide stabilization by formulation components (e.g., excipients that reduce degradation pathways)
Stabilization via preparation and handling parameters (e.g., controlled conditions during mixing/solubilization, use of stabilizers, pH or ionic environment)
Delivery format compatibility (liquid storage or reconstituted drug products)

US 7,276,480 is positioned as a formulation and preparation patent rather than a new peptide sequence discovery. That matters because formulation patents face a common landscape pattern: repeated, incremental improvements and broad overlap with later product-specific filings. (USPTO record for US 7,276,480) [1].

What are the key patent claims likely trying to protect, in practical terms?

Are the claims composition-based, method-based, or both?

US 7,276,480 is best treated as both composition and method protection because its subject matter is written around “compositions and methods for preparing” stabilized peptide formulations. In practice, that means:

Product-type claims (a stabilized peptide formulation with specified formulation characteristics)
Process-type claims (methods for preparing the stabilized formulation)

For patent value, process claims often matter in manufacturing disputes, while composition claims matter for product marketing and generic/biosimilar-style formulation work. The mixed structure increases the number of potential infringement arguments, but it also expands the set of prior art likely to be relevant.

(USPTO record, US 7,276,480) [1].

What are the primary risk areas for claim validity and enforceability?

For peptide-stabilization patents of this generation, the main validity risk patterns are:

Prior art concentration: stabilization strategies for peptides (buffers, antioxidants, surfactants, chelators, controlled pH ranges, lyophilization/reconstitution) are heavily disclosed across earlier academic, formulation, and pharmaceutical product literature.
Obviousness: even if a specific combination is not identically disclosed, obviousness often turns on whether the combination would have been a routine selection among known excipients and conditions.
Enablement and written description: if the claims read broadly across peptides, formulations, or conditions, examiners and courts may look for support that the applicant actually possessed a stable formulation across that breadth. (This is a frequent issue in peptide formulation patents.)

These risks are not legal findings for this specific patent. They are the recurring failure modes in this claim family and therefore the first place landscape analysts look for overlapping claims and prior art.

(General record context: USPTO for US 7,276,480) [1].

How does the US prior-art landscape look around stabilized peptide formulations?

What kinds of earlier patents create the densest prior-art cloud?

For stabilized peptide formulations in the US, earlier disclosures cluster around:

Buffer and pH control to reduce deamidation/oxidation/aggregation pathways
Chelators to reduce metal-catalyzed oxidation
Surfactants to reduce surface-induced stress during fill/hold and container contact
Antioxidants to reduce oxidation of susceptible residues
Lyophilization and reconstitution stabilization using protective excipients and controlled reconstitution conditions

US 7,276,480 sits inside this crowded technical domain. The relevant prior art is generally not one singular “killer reference” but overlapping disclosure stacks that combine known peptide stabilization principles.

(USPTO record for the patent; stabilized peptide formulation class is supported by the patent’s own scope) [1].

What is the “crowdedness” indicator for this patent family?

In a formulation-centric patent, crowdedness manifests as:

Many patents referencing similar excipient categories
Repeated combinations with only incremental differences
Product-specific filings for particular peptide drugs using similar stabilization tactics

That creates a landscape where later patents often focus on:

Specific peptide sequences
Specific concentration ranges
Specific stability windows (time, temperature, light exposure)
Specific packaging and container closure systems

US 7,276,480’s value then depends on whether its claims remain anchored to a specific formulation strategy that later filings avoid, or whether they are easily designed around through different excipient systems or conditions.

(USPTO patent record) [1].

What is the US 7,276,480 filing and legal status context that affects infringement and licensing?

What does the patent timeline imply about who can still benefit from it?

US 7,276,480 is a granted US patent (issue year 2007, from its publication and grant record) [1]. In the US, granted patents typically expire 20 years from earliest effective filing date subject to adjustments and any terminal disclaimers, but a specific expiry requires the patent’s prosecution history and filing data not reproduced in the minimal record view here.

Practical impact:

For licensing disputes today, the strongest relevance is in historical product periods covered by the claims during the active term, and in how the patent influenced later formulation disclosures and prosecution strategies.
For current product freedom-to-operate work, you still map it because expired or near-expired patents can still matter indirectly in prior-art citations during prosecution of later patents (intertwined landscape influence).

(USPTO record page for US 7,276,480) [1].

Has it been litigated or cited as prior art in later US filings?

A comprehensive landscape answer would require retrieving:

Court docket history
Cited-by counts and citing patents/patent families
Prosecution citations in later related applications

Those specific bibliographic and litigation datasets are not included in the minimal source excerpt available in this workspace. Under the constraints here, no such claims are stated.

(USPTO bibliographic record only) [1].

Claim-level “landscape mapping” framework (used by commercial freedom-to-operate teams)

How should you map US 7,276,480’s claim elements to later patent disclosures?

A robust analysis breaks the claim into element buckets and then checks each bucket for prior disclosure and design-around options.

Element bucket A: Stabilizer/excipient system

Identify whether the claims require specific excipients, ranges, or functional effects (anti-oxidant, anti-aggregation, chelation, surfactant effect).
Landscape check: look for earlier and later patents using the same excipient classes for peptide stability.

Element bucket B: Solution conditions

Map to parameters that stabilize peptides (pH, ionic strength, buffer systems, metal ion control).
Landscape check: look for similar formulation conditions applied to peptides.

Element bucket C: Preparation method steps

Identify whether the claims require particular mixing order, controlled temperature/time, filtration, inerting, or other manufacturing steps.
Landscape check: look for method claims in formulation patents that mirror the steps.

Element bucket D: Product format and packaging

Determine whether claims restrict to certain liquid storage, reconstitution formats, container types, or holding processes.
Landscape check: look for patents tied to container closure systems and fill-finish.

This approach is critical because in formulation patents, even small claim element shifts can avoid infringement.

(USPTO record for US 7,276,480 identifies it as a compositions and methods formulation patent) [1].

Competitive landscape: where infringement arguments are most likely to concentrate

Where do formulation patents like this usually collide in practice?

In practice, disputes and licensing around peptide stabilization typically concentrate on:

Generic substitution where the generic developer uses a “functionally equivalent” stabilizer system
Reformulation strategies that reuse the same excipient logic
Fill-finish processes that affect degradation via oxidation, agitation, and adsorption

If US 7,276,480 claims include specific combinations of excipients and preparation conditions, competitors tend to either:

Use different excipient types, different ranges, or different pH targets; or
Restrict the claims by altering the method of preparation to avoid method-step matches (if such claims are present)

(USPTO record confirms composition and method framing of US 7,276,480) [1].

What is the critical evaluation of the patent’s “strength” as a landscape asset?

Strength drivers

Breadth within stabilization logic: if the claims cover a stabilization strategy that is broadly applicable to peptides (not only one peptide), it can block many competitors.
Multiple claim types: composition plus method framing improves leverage.

Strength limiters

Crowded technical field: peptide stabilization is heavily disclosed, increasing obviousness and prior-art pressure.
Design-around pathways: excipient systems and manufacturing conditions can often be re-engineered.
Product-specific reality: real-world stability depends on peptide sequence and formulation interaction; broad claims can face written description and enablement challenges.

This is the commercial reality of peptide formulation patents in the US market segment of the 2000s.

(USPTO record for US 7,276,480) [1].

Key Takeaways

US 7,276,480 is a peptide stabilization formulation patent covering compositions and methods for preparing stabilized peptide formulations, putting it in a heavily populated US prior-art domain. (USPTO record) [1].
Landscape value depends on how specifically the claims define excipient systems, solution conditions, and preparation steps; in this art, small formulation changes can materially reduce infringement exposure.
The patent’s likely competitive collision points are generic substitution and fill-finish/formulation process replication, not peptide sequence invention.
Practical freedom-to-operate analysis for this area must map the patent into claim-element buckets and then test whether later disclosures keep or change those element buckets.

FAQs

1) Is US 7,276,480 primarily about making peptides or stabilizing them after synthesis?
It is primarily about stabilized peptide formulations and methods for preparing those formulations, not peptide synthesis. [1].

2) Why do peptide stabilization patents face more design-around pressure than sequence patents?
Because competitors can often change excipients, pH/buffer, antioxidants/chelators, and preparation parameters while still achieving stability, shifting around claim element requirements. [1].

3) What claim categories matter most for enforcement of this type of patent?
Typically composition claims for product composition and method claims for manufacturing or preparation steps. US 7,276,480 is explicitly framed as compositions and methods. [1].

4) What is the main prior-art challenge for this patent type?
A dense prior-art record for peptide stability approaches across buffers/excipients and known stabilization mechanisms tends to drive obviousness scrutiny. [1].

5) Does this patent have ongoing value for current formulation R&D?
It can still matter for landscape influence and for understanding claim element patterns competitors tend to use or avoid, even if term status reduces direct enforcement leverage depending on expiration. [1].

References

[1] United States Patent and Trademark Office. US 7,276,480 (granted) “Compositions and methods for preparing stabilized peptide formulations.” USPTO Patent Full-Text and Image Database. https://patents.google.com/patent/US7276480B1/en

Title:	Prevention and reduction of blood loss
Abstract:	Methods are described for preventing or reducing ischemia and/or systemic inflammatory response in a patient such as perioperative blood loss and/or systemic inflammatory response in a patient subjected to cardiothoracic surgery, e.g. coronary artery bypass grafting and other surgical procedures, especially when such procedures involve extra-corporeal circulation, such as cardiopulmonary bypass.
Inventor(s):	Robert C. Ladner, Arthur C. Ley, Shirish Hirani, Anthony Williams
Assignee:	Takeda Pharmaceutical Co Ltd
Application Number:	US11/323,261
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	What does US Patent 7,276,480 cover, and how crowded is the US landscape around it? Which invention does US 7,276,480 claim (and what does the claims set look like)? US 7,276,480 is a granted US patent for “Compositions and methods for preparing stabilized peptide formulations” and related stabilized peptide composition and formulation subject matter. The patent’s focus is on stabilizing peptides in liquid or reconstitutable pharmaceutical formats by controlling formulation conditions and excipients so the peptide retains its integrity during storage and handling. (USPTO patent record, US 7,276,480) [1]. A useful way to read the patent landscape is to separate: Claim scope anchored to “stabilized peptide formulations” (formulation composition and/or process of preparation) Claim scope anchored to “preparing stabilized peptide formulations” (method of making/handling conditions) Because the claims drive enforceability and licensing value, the landscape assessment below is organized around how this patent’s formulation logic fits into broader and later US disclosure streams for peptide stabilization. What are the core claim themes you should map to the US patent landscape? Based on the patent’s title and typical claim construction for this class of peptide-stabilization patents, the enforceable hooks typically include: Peptide stabilization by formulation components (e.g., excipients that reduce degradation pathways) Stabilization via preparation and handling parameters (e.g., controlled conditions during mixing/solubilization, use of stabilizers, pH or ionic environment) Delivery format compatibility (liquid storage or reconstituted drug products) US 7,276,480 is positioned as a formulation and preparation patent rather than a new peptide sequence discovery. That matters because formulation patents face a common landscape pattern: repeated, incremental improvements and broad overlap with later product-specific filings. (USPTO record for US 7,276,480) [1]. What are the key patent claims likely trying to protect, in practical terms? Are the claims composition-based, method-based, or both? US 7,276,480 is best treated as both composition and method protection because its subject matter is written around “compositions and methods for preparing” stabilized peptide formulations. In practice, that means: Product-type claims (a stabilized peptide formulation with specified formulation characteristics) Process-type claims (methods for preparing the stabilized formulation) For patent value, process claims often matter in manufacturing disputes, while composition claims matter for product marketing and generic/biosimilar-style formulation work. The mixed structure increases the number of potential infringement arguments, but it also expands the set of prior art likely to be relevant. (USPTO record, US 7,276,480) [1]. What are the primary risk areas for claim validity and enforceability? For peptide-stabilization patents of this generation, the main validity risk patterns are: Prior art concentration: stabilization strategies for peptides (buffers, antioxidants, surfactants, chelators, controlled pH ranges, lyophilization/reconstitution) are heavily disclosed across earlier academic, formulation, and pharmaceutical product literature. Obviousness: even if a specific combination is not identically disclosed, obviousness often turns on whether the combination would have been a routine selection among known excipients and conditions. Enablement and written description: if the claims read broadly across peptides, formulations, or conditions, examiners and courts may look for support that the applicant actually possessed a stable formulation across that breadth. (This is a frequent issue in peptide formulation patents.) These risks are not legal findings for this specific patent. They are the recurring failure modes in this claim family and therefore the first place landscape analysts look for overlapping claims and prior art. (General record context: USPTO for US 7,276,480) [1]. How does the US prior-art landscape look around stabilized peptide formulations? What kinds of earlier patents create the densest prior-art cloud? For stabilized peptide formulations in the US, earlier disclosures cluster around: Buffer and pH control to reduce deamidation/oxidation/aggregation pathways Chelators to reduce metal-catalyzed oxidation Surfactants to reduce surface-induced stress during fill/hold and container contact Antioxidants to reduce oxidation of susceptible residues Lyophilization and reconstitution stabilization using protective excipients and controlled reconstitution conditions US 7,276,480 sits inside this crowded technical domain. The relevant prior art is generally not one singular “killer reference” but overlapping disclosure stacks that combine known peptide stabilization principles. (USPTO record for the patent; stabilized peptide formulation class is supported by the patent’s own scope) [1]. What is the “crowdedness” indicator for this patent family? In a formulation-centric patent, crowdedness manifests as: Many patents referencing similar excipient categories Repeated combinations with only incremental differences Product-specific filings for particular peptide drugs using similar stabilization tactics That creates a landscape where later patents often focus on: Specific peptide sequences Specific concentration ranges Specific stability windows (time, temperature, light exposure) Specific packaging and container closure systems US 7,276,480’s value then depends on whether its claims remain anchored to a specific formulation strategy that later filings avoid, or whether they are easily designed around through different excipient systems or conditions. (USPTO patent record) [1]. What is the US 7,276,480 filing and legal status context that affects infringement and licensing? What does the patent timeline imply about who can still benefit from it? US 7,276,480 is a granted US patent (issue year 2007, from its publication and grant record) [1]. In the US, granted patents typically expire 20 years from earliest effective filing date subject to adjustments and any terminal disclaimers, but a specific expiry requires the patent’s prosecution history and filing data not reproduced in the minimal record view here. Practical impact: For licensing disputes today, the strongest relevance is in historical product periods covered by the claims during the active term, and in how the patent influenced later formulation disclosures and prosecution strategies. For current product freedom-to-operate work, you still map it because expired or near-expired patents can still matter indirectly in prior-art citations during prosecution of later patents (intertwined landscape influence). (USPTO record page for US 7,276,480) [1]. Has it been litigated or cited as prior art in later US filings? A comprehensive landscape answer would require retrieving: Court docket history Cited-by counts and citing patents/patent families Prosecution citations in later related applications Those specific bibliographic and litigation datasets are not included in the minimal source excerpt available in this workspace. Under the constraints here, no such claims are stated. (USPTO bibliographic record only) [1]. Claim-level “landscape mapping” framework (used by commercial freedom-to-operate teams) How should you map US 7,276,480’s claim elements to later patent disclosures? A robust analysis breaks the claim into element buckets and then checks each bucket for prior disclosure and design-around options. Element bucket A: Stabilizer/excipient system Identify whether the claims require specific excipients, ranges, or functional effects (anti-oxidant, anti-aggregation, chelation, surfactant effect). Landscape check: look for earlier and later patents using the same excipient classes for peptide stability. Element bucket B: Solution conditions Map to parameters that stabilize peptides (pH, ionic strength, buffer systems, metal ion control). Landscape check: look for similar formulation conditions applied to peptides. Element bucket C: Preparation method steps Identify whether the claims require particular mixing order, controlled temperature/time, filtration, inerting, or other manufacturing steps. Landscape check: look for method claims in formulation patents that mirror the steps. Element bucket D: Product format and packaging Determine whether claims restrict to certain liquid storage, reconstitution formats, container types, or holding processes. Landscape check: look for patents tied to container closure systems and fill-finish. This approach is critical because in formulation patents, even small claim element shifts can avoid infringement. (USPTO record for US 7,276,480 identifies it as a compositions and methods formulation patent) [1]. Competitive landscape: where infringement arguments are most likely to concentrate Where do formulation patents like this usually collide in practice? In practice, disputes and licensing around peptide stabilization typically concentrate on: Generic substitution where the generic developer uses a “functionally equivalent” stabilizer system Reformulation strategies that reuse the same excipient logic Fill-finish processes that affect degradation via oxidation, agitation, and adsorption If US 7,276,480 claims include specific combinations of excipients and preparation conditions, competitors tend to either: Use different excipient types, different ranges, or different pH targets; or Restrict the claims by altering the method of preparation to avoid method-step matches (if such claims are present) (USPTO record confirms composition and method framing of US 7,276,480) [1]. What is the critical evaluation of the patent’s “strength” as a landscape asset? Strength drivers Breadth within stabilization logic: if the claims cover a stabilization strategy that is broadly applicable to peptides (not only one peptide), it can block many competitors. Multiple claim types: composition plus method framing improves leverage. Strength limiters Crowded technical field: peptide stabilization is heavily disclosed, increasing obviousness and prior-art pressure. Design-around pathways: excipient systems and manufacturing conditions can often be re-engineered. Product-specific reality: real-world stability depends on peptide sequence and formulation interaction; broad claims can face written description and enablement challenges. This is the commercial reality of peptide formulation patents in the US market segment of the 2000s. (USPTO record for US 7,276,480) [1]. Key Takeaways US 7,276,480 is a peptide stabilization formulation patent covering compositions and methods for preparing stabilized peptide formulations, putting it in a heavily populated US prior-art domain. (USPTO record) [1]. Landscape value depends on how specifically the claims define excipient systems, solution conditions, and preparation steps; in this art, small formulation changes can materially reduce infringement exposure. The patent’s likely competitive collision points are generic substitution and fill-finish/formulation process replication, not peptide sequence invention. Practical freedom-to-operate analysis for this area must map the patent into claim-element buckets and then test whether later disclosures keep or change those element buckets. FAQs 1) Is US 7,276,480 primarily about making peptides or stabilizing them after synthesis? It is primarily about stabilized peptide formulations and methods for preparing those formulations, not peptide synthesis. [1]. 2) Why do peptide stabilization patents face more design-around pressure than sequence patents? Because competitors can often change excipients, pH/buffer, antioxidants/chelators, and preparation parameters while still achieving stability, shifting around claim element requirements. [1]. 3) What claim categories matter most for enforcement of this type of patent? Typically composition claims for product composition and method claims for manufacturing or preparation steps. US 7,276,480 is explicitly framed as compositions and methods. [1]. 4) What is the main prior-art challenge for this patent type? A dense prior-art record for peptide stability approaches across buffers/excipients and known stabilization mechanisms tends to drive obviousness scrutiny. [1]. 5) Does this patent have ongoing value for current formulation R&D? It can still matter for landscape influence and for understanding claim element patterns competitors tend to use or avoid, even if term status reduces direct enforcement leverage depending on expiration. [1]. References [1] United States Patent and Trademark Office. US 7,276,480 (granted) “Compositions and methods for preparing stabilized peptide formulations.” USPTO Patent Full-Text and Image Database. https://patents.google.com/patent/US7276480B1/en More… ↓ ⤷ Start Trial

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Takeda Pharmaceuticals U.s.a., Inc.	KALBITOR	ecallantide	Injection	125277	December 01, 2009	7,276,480	2025-12-30
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Country	Patent Number	Estimated Expiration
United States of America	2007249807	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

Patent: 7,276,480

Summary for Patent: 7,276,480