Patent: 7,476,652

Summary for Patent: 7,476,652

Title:	Acidic insulin preparations having improved stability
Abstract:	The invention relates to a pharmaceutical formulation comprising a polypeptide selected from the group consisting of insulin, an insulin metabolite, an insulin analog, an insulin derivative and combinations thereof; a surfactant or combinations of two or more surfactants; optionally a preservative or combinations of two or more preservatives; and optionally an isotonicizing agent, buffers or further excipients or combinations thereof, the pharmaceutical formulation having a pH in the acidic range.
Inventor(s):	Anette Brunner-Schwarz, Norbert Lill
Assignee:	Sanofi Aventis Deutschland GmbH
Application Number:	US11/089,777
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,476,652
Patent Claims:	see list of patent claims

United States Patent 7,476,652: Claim Scope, Priority, Expiration, and US Patent Landscape Impact

Executive summary: US Patent 7,476,652’s enforceable value in the US hinges on the exact claim language (independent claim elements and their limiting terms), the prosecution record that shaped those elements, and the continuing patent family activity in the Orange Book and litigation databases. This analysis identifies the claim architecture, maps likely legal vulnerabilities (subject-matter clarity, anticipation/obviousness angles, and design-around space), and places the patent into a practical US freedom-to-operate context.

What does US Patent 7,476,652 claim and what is the scope of protection?

Short answer (claim scope): A patent’s real perimeter is set by its independent claims and the specific dependencies of those claims. Without the claim text, statement of invention, and priority details, the enforceable subject matter cannot be determined in a way that would support licensing, litigation, or design-around decisions.

Which independent claims define the invention?

The analysis starts with:

• Independent claim(s): identify the core product/process/method elements and any functional limitations
• Claim structure: whether dependent claims narrow to specific embodiments (e.g., dosage form, formulation components, process steps, parameters)
• Claim breadth: whether terms are generic (“comprising”) or tightly constrained (“consisting of,” numerical ranges, specific classes)

What dependent claims narrow (and what that means for enforcement)

For enforcement and infringement mapping, dependent claims often create narrower “entry points”:

• Composition limitations (specific excipients, ratios, particle sizes, stabilizers)
• Process limitations (order of steps, temperature/pressure/time parameters)
• Use limitations (therapeutic indications, patient populations, dosing regimens)
• Apparatus or system limitations (if present)

Critical analysis lens: where independent claims are broad but dependent claims are narrow, challengers target the broad elements through prior art; patentees often argue that infringement is easier under narrower dependent claims if the accused product/process falls within them.

What claim interpretation risks exist

Claim construction risk typically comes from:

• Undefined terms that invite intrinsic evidence reliance (specification, prosecution history)
• Functional language that may be attacked under written description and enablement
• Numerical ranges that can be attacked via overlap with prior art ranges

When does US Patent 7,476,652 expire in the US and how does PTA/PTE change exclusivity?

Short answer (expiration): US expiration is generally driven by the earliest effective non-provisional filing date plus 20 years, adjusted for PTA (Patent Term Adjustment) and PTE (for certain FDA-regulated products). Precise dates require the filing date(s), priority chain, and whether PTA/PTE applies.

How to compute baseline expiration

• Earliest effective filing date (including priority) determines the 20-year term
• Maintenance fees can terminate early if unpaid

How PTA can extend term

PTA can extend expiration based on USPTO delays. The net expiration should be taken from USPTO term data, not from statutory “20 years from filing” alone.

How PTE can extend term (if FDA-regulated product)

If the patent covers an FDA-approved product, PTE can add up to 5 years (with caps). Determination requires product association and regulatory review history.

Terminal disclaimer and family filing effects

Terminal disclaimers can align the patent’s expiration to a related earlier-expiring patent, reducing practical term.

What is the prior art exposure for the claims of US 7,476,652?

Short answer: The litigation-grade assessment of invalidity (anticipation/obviousness) requires (1) the exact claim elements, (2) the earliest priority date, and (3) a prior art search scoped to those elements. Without the claim text, a credible anticipation mapping is not possible.

Anticipation (35 USC §102) attack paths

For each independent claim element, a typical anticipation analysis seeks:

• A single prior art reference disclosing every element (explicitly or inherently)
• Overlapping disclosures where only one missing feature is argued as inherent

Obviousness (35 USC §103) attack paths

Obviousness analysis usually combines:

• One primary reference for the core concept
• Secondary references for missing features (ranges, substituents, process parameters)
• Motivation to combine supported by teachings or common design incentives

Written description and enablement vulnerabilities

If claims include:

• Broad genus language with limited examples
• Functional genuses without sufficient disclosure across the full scope then challengers pursue 35 USC §112 attacks.

Which other US patents in the same family cover related subject matter?

Short answer: Patent families often split into:

• Broad generic concept claims (earlier)
• Composition/formulation variants (later)
• Method-of-use variants (later)
• Process variants (later)

To map the landscape, you must identify:

• The earliest priority application
• Continuations/divisionals
• Continuation-in-part relationships
• Terminal disclaimers and co-pending status

Without family identifiers and patent text, the US landscape cannot be enumerated in a way that supports licensing or FTO.

How to count “how many patents cover” the same invention

A practical count for diligence is:

• Number of US family members still in force
• Number expired
• Number disclaimed
• Number subject to litigation or reexamination

What is the Orange Book status of US Patent 7,476,652?

Short answer: Orange Book status depends on whether the patent is listed for an FDA-approved drug product as of Orange Book listings and the associated NDA/ANDA label. That requires linkage to a specific FDA application and drug product.

What to check in Orange Book for enforcement

• NDA/ANDA product code associated with the patent
• Patent type: drug substance, drug product, method of use
• Expiration listed in the Orange Book
• Whether the patent is listed as “withdrawn” or “expired”

Are there any Paragraph IV certifications tied to US 7,476,652?

Short answer: Paragraph IV challenges depend on a generic/authorized generic seeking FDA approval with a certification that the listed patent is invalid, unenforceable, or not infringed. Identifying ties requires ANDA litigation data mapped to the patent number and its Orange Book listing.

What settlement terms usually reveal in these cases

Where available, settlements commonly include:

• Launch-date design: covenants not to market until a specific date
• Section 271(e)(8) timing and triggers
• “Reserve” patents clauses for later follow-on patents
• Non-infringement and dismissal provisions

What patent litigation affects US Patent 7,476,652?

Short answer: Litigation relevance depends on:

• Parties sued (brand vs generic/affiliate)
• Alleged infringing product(s)
• Venue, judge, and key claim construction orders
• Timing and status (stayed, tried, appealed, dismissed)

Without litigation docket identifiers and claim text, a reliable litigation map cannot be produced.

How strong is the patent estate around US 7,476,652 for validity and enforcement?

Short answer: Strength is a function of claim construction outcomes, surviving independent claim elements, and the closeness of prior art. A defensible strength rating requires:

• Exact claim elements
• The prosecution history (especially arguments distinguishing prior art)
• Prior art similarity metrics

What typically determines whether the estate holds up

• Narrow, specific limitations tied to the specification usually survive better
• Overly broad genus claims without full written description support are vulnerable
• If the independent claim hinges on a single critical element, invalidity risk rises if that element is taught by prior art

What typically determines whether infringement can be proven

• Whether the accused product/process satisfies every limitation
• Whether “comprising” language allows partial overlap
• Whether accused design around changes a non-essential element versus a claim-critical element

How could competitors design around US 7,476,652?

Short answer: Design-around space is controlled by which limitations are critical. In general, challengers target:

• Substituting different classes of components outside claimed ranges or definitions
• Changing process steps or parameters outside claimed intervals
• Avoiding specific functional outcomes if the claim requires both structure and function tightly coupled

A credible design-around analysis requires the claim text.

Which companies are likely competing for market entry under the same technical space?

Short answer: Competitive pressure depends on the drug product linked to the patent and the market segment. Without the patent’s technical domain and Orange Book linkage, company mapping would be speculative.

What generic or biosimilar entry risks exist for products implicated by US 7,476,652?

Short answer: Generic risk exists when:

• A listed patent is approaching expiration or can be challenged via Paragraph IV
• The ANDA pathway enables design-around infringement
• The method-of-use claims (if any) have label-carveability and enforceability limits

Biosimilar risk depends on biologic linkage, 351(k) pathway status, and whether claims are method-of-use or formulation/process.

How does US 7,476,652 compare with nearby patents for the same drug or technology?

Short answer: Comparison requires the set of adjacent patents within the same therapeutic and formulation/process space, including claims and expiration sequencing. Without family and technology identification, the comparison cannot be made without error.

What manufacturing or formulation patents commonly co-exist with this kind of claim?

Short answer: In many US pharmaceutical estates, patents co-exist across:

• Drug substance synthesis or purification
• Drug product formulation (excipients, stabilizers, particle engineering)
• Dosage form (capsules/tablets/sterile injectables)
• Process for manufacturing (mixing, milling, sterilization, lyophilization)
• Method-of-use (indications, dosing regimens)

This section cannot be anchored to US 7,476,652 without knowing what its claims cover.

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Key Takeaways

• US 7,476,652’s enforceable scope and legal strength depend on its actual claim language, priority chain, and any Orange Book and litigation links.
• A validity and design-around analysis must be anchored to the independent claim elements and their limiting terms.
• Expiration and exclusivity exposure require earliest effective filing date plus PTA/PTE/terminal disclaimer status, and any FDA regulatory linkage for Orange Book.
• Mapping Paragraph IV risk and litigation outcomes requires Orange Book association to NDA/ANDA and docket data keyed to the specific patent.

FAQs

1. How do dependent claim limitations change infringement proof for US 7,476,652?
2. What is the difference between drug substance, drug product, and method-of-use patent coverage for enforcement against generics?
3. How do PTA and terminal disclaimers alter the real US litigation launch-date risk around a patent?
4. How do label carve-outs impact method-of-use patent infringement after generic approval?
5. What prosecution history estoppel theories most often narrow claim construction in pharmaceutical patents?

References (APA)

No sources were provided or retrievable within the information available in this request to cite US Patent 7,476,652 claim text, family members, Orange Book listings, litigation, or regulatory linkages.

Details for Patent 7,476,652

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629	April 16, 2004	7,476,652	2025-03-25
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629	December 20, 2005	7,476,652	2025-03-25
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629	February 24, 2009	7,476,652	2025-03-25
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	December 16, 2015	7,476,652	2025-03-25