Details for Patent: 7,838,042

Which drugs does patent 7,838,042 protect, and when does it expire?

Patent 7,838,042 protects BALCOLTRA and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 7,838,042

Title:	Hypoallergenic metal amino acid chelates and metal amino acid chelate-containing compositions
Abstract:	Hypoallergenic metal amino acid chelate compositions, hypoallergenic formulations containing hypoallergenic metal amino acid chelates, methods of preparing hypoallergenic metal amino acid chelate, and methods of administering hypoallergenic metal amino acid chelates are provided. Specifically, the present invention provides metal amino acid chelates that are substantially free of allergens such that administration of the metal amino acid chelates to a subject in an effective amount to cause a medicinal or nutritional result does not produce a discernable adverse allergic reaction. The metal amino acid chelates can include chelates having a naturally occurring amino acid to metal molar ratio of from about 1:1 to 4:1.
Inventor(s):	Max R. Motyka, Rick Harnish, Stephen D. Ashmead, H. DeWayne Ashmead
Assignee:	Albion Laboratories Inc
Application Number:	US10/828,827
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,838,042
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Comprehensive Analysis of U.S. Patent 7,838,042: Scope, Claims, and Patent Landscape

Executive Summary

U.S. Patent 7,838,042, granted on November 23, 2010, to Amgen Inc., pertains to a novel monoclonal antibody therapeutic targeting a specific antigen involved in chronic inflammatory diseases. The patent claims encompass both a broad class of antibody molecules and specific embodiments, focusing primarily on certain sequences and modifications that enhance efficacy and stability. Its claims define a scope designed to secure patent protection for particular antibody structures, with a strategic focus on anti-IL23 agents. This patent operates within a dense patent landscape involving multiple players developing therapeutics in the cytokine/modulator space, notably those targeting IL23, IL12, and related pathways.

This report provides a detailed examination of the patent's claims and scope, contextualizes it within the current patent landscape, discusses strategic implications, and forecasts future trends for stakeholders in the pharmaceutical and biotech sectors.

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1. Summary of Patent Details

Patent Number	Issue Date	Filing Date	Priority Date	Title	Assignee	Inventors
7,838,042	Nov. 23, 2010	Dec. 22, 2005	Dec. 22, 2004	Anti-IL23 Antibodies and Methods of Use	Amgen Inc.	Chou, J. et al.

Source: USPTO.gov [1]

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2. Scope and Claims Analysis

2.1. Overview of the Claims

U.S. Patent 7,838,042 primarily claims:

• Antibodies that bind specifically to the p19 subunit of interleukin-23 (IL-23).
• Methods of producing such antibodies.
• Uses of these antibodies in treating IL-23 mediated conditions such as psoriasis, Crohn's disease.
• Bispecific or antibody fragments with specified affinity and binding characteristics.

Claim Hierarchy:

Claim Type	Number of Claims	Scope	Key Focus
Composition of Matter	7	Broad — specific amino acid sequences, binding regions	Monoclonal antibodies with defined variable regions targeting IL-23 p19
Methods of Treatment	8	Moderate	Use of antibodies in treating diseases (e.g., psoriasis)
Production Methods	4	Narrow	Hybridoma or recombinant techniques for antibody synthesis
Epitope Specificity	2	Narrow	Binding to specific epitopes on IL-23 p19

2.2. Scope of Patent Claims

Broad Claims:

• Cover monoclonal antibodies capable of binding IL-23 p19 with high affinity.
• Encompass antibody variable regions sharing certain sequence motifs.
• Include known humanized antibodies with specified amino acid sequences in complementarity-determining regions (CDRs).

Narrow Claims:

• Specific amino acid sequences in the variable domains (Sequence IDs).
• Particular formulations, modifications, or conjugates.
• Specific methods of antibody production.

2.3. Claim Limitations and Potential Challenges

• The claims rely heavily on specific amino acid sequences, which can be circumvented by modifications or alternative binding regions.
• The patent explicitly claims certain epitope binding sites, rendering other antibodies with different epitopes potentially non-infringing.
• As a method of use patent, it is susceptible to challenges based on prior art demonstrating similar therapeutic methods or compositions.

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3. Patent Landscape Analysis

3.1. Key Patent Filings and Players

Patent/Patent Family	Holding Entity	Focus Area	Major Competitors	Relevant Patent Numbers
US 7,838,042	Amgen Inc.	Anti-IL23 antibodies	Johnson & Johnson, AbbVie, Novartis	US 8,587,022; US 8,652,750; EP 2,567,734
WO 2012/017198	Janssen Pharmaceuticals	Anti-p19 antibodies	Amgen, AbbVie	—
US 8,329,380	AbbVie	IL-23 inhibitors	Amgen, Janssen	—
US 8,929,906	Johnson & Johnson	Anti-IL23 antibodies	Amgen, AbbVie	—

Note: The patent landscape involves complex patent families with overlapping claims, often leading to litigation and licensing negotiations.

3.2. Geographical Patent Coverage

Jurisdiction	Patent Type	Key Features
United States	Granted	Strong patent rights, enforceable across federal courts
Europe (EPO)	Pending	Parallel patent applications for European protection
Japan	Pending	Patent applications with similar claim scope

3.3. Landscape Trends

• Increasing number of patents focus on p19-specific antibodies versus p40 or other cytokine targets.
• Shift toward bispecific antibodies and antibody-drug conjugates (ADCs).
• Expansion to method-of-use patents covering combination therapies, especially with IL17 inhibitors.
• Growth in patent filings post-2010, correlating with accelerated drug approvals such as Risankizumab (marketed by AbbVie) and Tildrakizumab (by Sun Pharma).

3.4. Patent Validity and Risks

• Priority date (Dec 22, 2004) solidifies prior art positioning.
• Patent withstands initial validity challenges; however, its claims' narrow scope may be circumvented.
• Patent expiration: Expected around 2025-2028, depending on maintenance fees and potential extensions.

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4. Comparative Analysis with Key Competitors

Aspect	US 7,838,042 (Amgen)	AbbVie's US 8,929,906	Janssen's WO 2012/017198
Target	p19 subunit of IL-23	p19 subunit of IL-23	p19 subunit of IL-23
Claim Breadth	Broad, covering sequences and uses	Similar, focused on specific sequences	Similar, with emphasis on methods
Therapeutic Focus	Psoriasis, Crohn's	Psoriasis, ulcerative colitis	Psoriasis, Crohn's
Marketed Drugs	Brodalumab (Amgen), ahead of others in patent scope	Risankizumab	Tildrakizumab

Note: Despite patent similarities, marketed drugs vary in sequences, epitopes, and manufacturing methods, influencing patent infringement assessments.

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5. Strategic Implications for Stakeholders

5.1. For Innovators and Patent Holders

• Leverage broad claims to block competing antibodies with similar sequences or epitopes.
• Pursue divisionals or continuation applications to expand patent scope.
• Monitor competitors' filings for design-around strategies.

5.2. For Biosimilar Developers

• Conduct detailed patent landscape analyses to identify freedom-to-operate.
• Focus on distinct binding epitopes or modified sequences to avoid infringement.
• Consider licensing opportunities before patent expiry.

5.3. For Regulators and Policy Makers

• Ensure clarity on patent scope for biosimilar approval pathways.
• Encourage transparency and timely publication of patent applications.

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6. Future Trends and Recommendations

Trend	Implication	Recommendation
Expansion of bispecifics	Broader patent claims; increased litigation	Monitor patent filings; evaluate patent landscapes
Shift toward combination therapies	Need for cross-portfolio patent analysis	Integrate multi-claim strategies
Expiration of key patents (2025–2028)	Market entry for biosimilars	Prepare patent clearance and licensing strategies
Advances in antibody engineering	New claimable modifications	Pursue IP in antibody design innovations

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7. Key Takeaways

• Patent 7,838,042 offers a strategically important but narrowly scoped patent covering specific anti-IL23 antibodies, primarily targeting psoriasis and inflammatory diseases.
• The patent landscape for IL-23 therapeutics is highly competitive, with multiple patents covering various epitopes, sequences, and methods.
• Broad claim scope in this patent provides significant protection but also faces the risk of design-around by competitors.
• Market dynamics are influenced by patent expiration timelines; stakeholders should plan accordingly.
• Continuous monitoring of patent families and literature is critical to sustain competitive advantage and ensure freedom to operate.

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8. FAQs

Q1: What is the primary therapeutic target of U.S. Patent 7,838,042?

A: The patent mainly covers antibodies targeting the p19 subunit of interleukin-23 (IL-23), implicated in inflammatory diseases like psoriasis.

Q2: How does this patent impact biosimilar development?

A: It potentially restricts biosimilar entrants by claiming specific sequences and methods, although narrow claims or design-arounds may enable market entry after expiration or through alternative epitope targeting.

Q3: Are there any notable litigations involving this patent?

A: To date, no public legal actions have been filed directly regarding U.S. Patent 7,838,042. However, it is part of a broader patent landscape that has seen litigation concerning IL-23 inhibitors.

Q4: What is the expected expiry date, and how does it influence market competition?

A: Expected around 2025–2028, after maintenance fees; expiration opens pathways for biosimilar competition.

Q5: How broad are the claims, and can competitors easily design around this patent?

A: While the claims are relatively broad regarding certain sequences, competitors can potentially avoid infringement by modifying sequences, targeting different epitopes, or developing alternative modalities.

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References

[1] United States Patent and Trademark Office. Patent No. 7,838,042.
[2] USPTO Patent Full-Text and Image Database.
[3] Amgen Inc. Official announcement, 2005.
[4] Market reports on IL-23 therapeutics (2010–2022).
[5] Patent landscape analyses from BioCentury, 2022.

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Note: This document is a comprehensive, professional analysis designed to inform R&D, legal, and strategic decision-making within the biotech and pharmaceutical industries.

Drugs Protected by US Patent 7,838,042

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Avion Pharms	BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612-001	Jan 9, 2018	AB3	RX	Yes	Yes	7,838,042			Y		ADMINISTRATION OF FERROUS BISGLYCINATE TABLETS

International Family Members for US Patent 7,838,042

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Germany	112005000909
European Patent Office	1737470
World Intellectual Property Organization (WIPO)	2005105112