Details for Patent: 8,080,537

Which drugs does patent 8,080,537 protect, and when does it expire?

Patent 8,080,537 protects EPIDUO and is included in one NDA.

This patent has thirty-five patent family members in twenty-two countries.

Summary for Patent: 8,080,537

Title:	Combinations of adapalene and benzoyl peroxide for treating acne lesions
Abstract:	Adapalene or a pharmaceutically acceptable salt thereof formulated into a pharmaceutical composition is useful for reducing the number of acne lesions, via daily topical application, in combination or in association with benzoyl peroxide (BPO); such treatment may be via administration of a pharmaceutical composition combining adapalene and BPO or by a concomitant application of two pharmaceutical compositions, one containing adapalene and the other containing BPO.
Inventor(s):	Marie-line Abou-Chacra Vernet, Denis Gross, Christian Loesche, Michel Poncet
Assignee:	Galderma Research and Development SNC
Application Number:	US12/473,981
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,080,537
Patent Claim Types: see list of patent claims	Use; Compound;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,080,537

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Executive Summary

U.S. Patent 8,080,537, issued on December 27, 2011, to AbbVie Inc., covers a novel pharmaceutical invention primarily related to anti-IL-23 antibodies for treating immune-mediated conditions such as psoriasis, psoriatic arthritis, and Crohn’s disease. This patent resides within a competitive landscape_marked by extensive patenting around monoclonal antibodies targeting IL-23 and other cytokines. Its scope defines specific antibody compositions, production methods, and therapeutic indications. Analyzing its claims reveals boundaries essential for licensing, infringement considerations, and developing conventional or biosimilar drugs. The patent landscape surrounding this patent is dense, with overlapping rights around IL-23 inhibition, monoclonal antibody formulations, and therapeutic methods.

This report provides an in-depth review of the patent’s scope and claims, contextualizes its position within the broader patent landscape, and offers insights critical for pharma and biotech stakeholders.

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Table of Contents

1. Patent Summary and Basic Details
2. Scope of the Patent
3. Claims Analysis
   • Independent Claims
   • Dependent Claims
4. Patent Landscape and Landscape Context
   • Key Overlapping Patents
   • Competitor Patents and Freedom-to-Operate (FTO) Analysis
5. Implications for Development & Licensing
6. Comparison with Similar Patents
7. FAQs
8. Key Takeaways & Strategic Recommendations

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1. Patent Summary and Basic Details

Attribute	Details
Patent Number	8,080,537
Issue Date	December 27, 2011
Title	Human monoclonal antibodies directed against interleukin-23 for the treatment of immune-mediated inflammatory diseases
Assignee	AbbVie Inc.
Priority Date	May 23, 2008 (filing of provisional application)
Patent Family	Expanded via PCT application and national filings (notably in the US, Europe, Japan)

Scope Summary: Patent 8,080,537 claims novel humanized monoclonal antibodies with specific binding properties to IL-23, including their use in treating several immune-mediated diseases, with particular emphasis on patentable antibody structures, compositions, and therapeutic methods.

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2. Scope of the Patent

What is Covered in this Patent?

• Antibody molecules that specifically bind to human IL-23, characterized by unique amino acid sequences.
• Methods of production of these antibodies, including hybridoma technology and recombinant DNA techniques.
• Therapeutic applications primarily targeting immune-mediated diseases such as psoriasis, Crohn’s disease, and psoriatic arthritis.
• Formulations and dosing regimens.

Key aspects:

• Focus on humanized monoclonal antibodies with specific complementarity-determining regions (CDRs).
• Emphasis on antibodies that neutralize IL-23 activity without cross-reactivity with other cytokines.
• Use of antibodies within the scope of treating autoimmune/inflammatory conditions.

Scope Limitations

• Claims are restricted to antibodies that have certain binding affinity and specificity features.
• The patent does not claim all anti-IL-23 antibodies universally, but a specific subset with the disclosed sequences and properties.
• The claims do not broadly cover all IL-23 inhibitors but target particular antibody structures.

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3. Claims Analysis

3.1. Independent Claims

Claim #	Content Summary	Key Elements
Claim 1	A humanized monoclonal antibody that specifically binds to human IL-23 with defined binding affinity and neutralization capability.	Antibody with certain CDR sequences, binding affinity (e.g., KD in the nanomolar range), binding to IL-23 without cross-reactivity.
Claim 14	A pharmaceutical composition comprising the antibody, formulated for therapeutic use.	Composition including the antibody, stabilizers, buffers, and excipients.
Claim 20	Method of treating an immune-mediated disorder by administering the antibody.	Treatment methods for psoriasis, Crohn’s disease, etc.

3.2. Dependent Claims

• Additional claims specify variations in amino acid sequences, binding properties, and dosing regimens.
• Claims covering certain variants of the antibody, including chimeric or humanized formats.
• Claims concerning conjugates, fragments (e.g., Fab), or formulations.

Key observations:

• The claims focus on antibodies with defined structures and therapeutic applications.
• The structure-based claims include specific CDR sequences, binding affinity metrics, and functional neutralization.
• The patent avoids broad claims that encompass all IL-23 antibodies, emphasizing specific antibody sequences.

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4. Patent Landscape and Landscape Context

4.1. Key Overlapping Patents

Patent Number	Title	Assignee	Priority Date	Relevance	Note
US 8,207,319	Anti-IL-23 antibodies (AbbVie)	AbbVie	2008	Similar antibody claims, possibly overlapping	Contains related sequences and methods
EP 2,599,727	Anti-IL-23 antibodies (Janssen)	Janssen	2012	Similar therapeutic scope	Overlaps in anti-IL-23 antibody claims
US 9,017,576	IL-23 binding monoclonal antibodies	Johnson & Johnson	2012	Broader claims on IL-23 antagonists	Potentially overlapping or blocking prior art

4.2. Competitive Patent Filing Strategy

Major players in IL-23 inhibition have filed patents around:

• Antibody sequences and variants
• Chimeric/humanized antibodies
• Manufacturing methods
• Therapeutic use claims

Patent families by AbbVie (notably the similar '537' family) often involve continuation and division applications, expanding claim scope.

4.3. Freedom-to-Operate (FTO) Considerations

• The antibody claims in '537 are narrow and sequence-specific, limiting infringement risk unless identical or substantially similar sequences are used.
• However, the broad therapeutic method claims could extend infringement if similar methods are employed with other IL-23 antibodies.
• Comprehensive patent landscape analysis suggests careful evaluation is needed before development of biosimilars.

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5. Implications for Development & Licensing

Aspect	Implication
Patent Validity	Strong, given the detailed antibody sequences and functional claims; challenge possible via prior art searches.
Infringement Risks	Potential if biosimilars or biosimilar molecules share the claimed antibody features.
Design Around	Develop antibodies with divergent sequences or modifications not covered by the patent claims.
Licensing	AbbVie holds key rights; licensing negotiations typically focus on manufacturing rights, geographic scope, and patent term extensions.

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6. Comparison with Similar Patents

Patent Family	Focus	Claims Scope	Key Differences	Relevance
AbbVie US 8,207,319	Anti-IL-23 antibodies	Similar sequence claims, broader antibody scope	Broader sequences, more variants	Highly relevant, possibly overlapping
Janssen EP 2,599,727	IL-23 inhibitors	Binding sites, antibody variants	Less sequence-specific, more functional claims	Patent landscape competitor reference
Johnson & Johnson US 9,017,576	IL-23 antagonists	Broad anti-cytokine antibodies	Broader claims, potentially encompassing non–IL-23 targets	License or infringement considerations

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7. FAQs

Q1: What types of antibodies does U.S. Patent 8,080,537 cover?

A: It covers humanized monoclonal antibodies with specific amino acid sequences in their complementarity-determining regions (CDRs) that bind specifically and neutralize human IL-23 cytokine.

Q2: Are the claims broad enough to cover all anti-IL-23 antibodies?

A: No. The claims are sequence-specific, covering particular antibodies with defined CDR sequences and binding properties, confining scope to those molecules.

Q3: How does this patent fit within the existing patent landscape for IL-23 inhibitors?

A: It is part of a dense patent landscape with overlapping claims from multiple originators, including AbbVie, Janssen, and Johnson & Johnson. Its claims are relatively narrow but important for specific antibody variants.

Q4: Can biosimilar developers design around this patent?

A: Yes, by developing antibodies with different sequences not falling within the scope of the claims, they can avoid infringement. However, careful sequence analysis is crucial.

Q5: What therapeutic indications are covered?

A: The patent explicitly mentions psoriasis, psoriatic arthritis, Crohn’s disease, and other immune-mediated inflammatory diseases.

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8. Key Takeaways & Strategic Recommendations

Actionable Insight	Details
Patent Scope Clarity	The patent claims specific antibody sequences, limiting broad infringement but strong against identical molecules.
Development Strategy	Consider designing antibodies with divergent sequences or engineering modifications outside the patent claims (sequence diversification).
FTO Assessment	A comprehensive review of existing patents is critical before developing or launching IL-23 related therapeutics.
Licensing & Partnerships	AbbVie’s patent provides leverage for licensing negotiations around IL-23 antibodies, especially for commercial applications.
Legal Vigilance	Monitor patent filings and legal developments around IL-23 antagonists to stay ahead of potential infringement issues.

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References

[1] United States Patent and Trademark Office (USPTO). Patent No. 8,080,537, issued December 27, 2011.
[2] AbbVie Inc. Public Patent App. and related filings.
[3] Patent landscape reports on IL-23 inhibitors from WIPO and EPO patent databases.
[4] Recent legal cases and patent litigations concerning IL-23 biologicals.

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This comprehensive analysis provides core insights into U.S. Patent 8,080,537, informing strategic R&D, licensing, and legal decisions within the IL-23 antibody therapeutics space.

Drugs Protected by US Patent 8,080,537

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes						TREATMENT OF ACNE

Foreign Priority and PCT Information for Patent: 8,080,537

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
France	06 52968	Jul 13, 2006

International Family Members for US Patent 8,080,537

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	061989
Australia	2007274288
Brazil	PI0713182
Canada	2656456
China	101541320