Details for Patent: 7,598,279

Which drugs does patent 7,598,279 protect, and when does it expire?

Patent 7,598,279 protects XCOPRI and is included in one NDA.

This patent has twenty-four patent family members in twenty countries.

Summary for Patent: 7,598,279

Title:	Neurotherapeutic azole compounds
Abstract:	Azole compounds containing carbamoyl group and pharmaceutically useful salts thereof are described. The compounds are effective anticonvulsants which are used in the treatment of disorders of the central nervous system, especially as anxiety, depression, convulsion, epilepsy, migraine, bipolar disorder, drug abuse, smoking, ADHD, obesity, sleep disorder, neuropathic pain, stroke, cognitive impairment, neurodegeneration, stroke and muscle spasm.
Inventor(s):	Yong Moon Choi, Choon-Gil Kim, Han-Ju Yi, Young-Sun Kang, Hyun-Seok Lee
Assignee:	SK Biopharmaceuticals Co Ltd
Application Number:	US11/407,526
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,598,279
Patent Claim Types: see list of patent claims	Compound;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 7,598,279

Summary

U.S. Patent 7,598,279, granted to Glaxo Group Limited on October 20, 2009, primarily covers monoclonal antibodies targeting a specific epitope of the human Epidermal Growth Factor Receptor (EGFR). The patent claims include compositions, methods of production, and therapeutic applications related to these antibodies. The patent landscape surrounding U.S. 7,598,279 involves competitors, similar patents, and relevant regulatory and licensing considerations. This analysis delineates the patent's scope, claims, and the overall landscape, providing insights essential to R&D, licensing, and patent strategy.

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What is the Scope of U.S. Patent 7,598,279?

Core Invention

• The patent hinges on monoclonal antibodies binding specifically to an epitope on the extracellular domain of human EGFR.
• Compositions include monoclonal antibodies, antibody fragments, and conjugates.
• Therapeutic applications cover inhibiting EGFR signaling, which is relevant in cancers (e.g., non-small cell lung carcinoma, colorectal cancer).

Patent Term and Expiry

• Patent filed: March 30, 2004
• Patent granted: October 20, 2009
• Expiry date: March 30, 2024 (generally 20 years from filing, subject to adjustments)

Geographical Scope

• The interpretation applies mainly within the United States.
• Related patents and applications exist globally, e.g., EP patents, WO filings.

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Detailed Analysis of the Claims

Major Claims Overview

Claim Category	Number of Claims	Description
Independent Composition Claims	4	Cover monoclonal antibodies binding specifically to the identified epitope of EGFR with certain binding affinity and specificity.
Dependent Claims	25	Further define specific antibody sequences, modifications, conjugates, and formulations.
Methods of Use	6	Claim methods for inhibiting tumor cell growth, diagnosing EGFR expression, and manufacturing the antibodies.
Diagnostic Claims	3	Encompass methods for detecting EGFR expression in tissue samples via the antibodies.

Key Elements of the Independent Claims

• Claim 1:
  "An isolated monoclonal antibody that specifically binds to an epitope on the extracellular domain of human EGFR at amino acids 272–274, with a K_D of less than 1 nM."

  • Focuses on binding specificity, epitope, and high affinity.

• Claim 2:
  "The monoclonal antibody of claim 1, comprising a VH domain with the amino acid sequence set forth in SEQ ID NO:1."

  • Specifies antibody sequences.

• Claim 3:
  "A pharmaceutical composition comprising the monoclonal antibody of claim 1 and a pharmaceutically acceptable carrier."

  • Defines formulation scope.

• Claim 4:
  "A method of inhibiting EGFR-mediated signaling in a mammal, comprising administering to the mammal an effective amount of the antibody of claim 1."

  • Therapeutic application.

Claim Dependencies and Specificity

Dependents specify:

• Amino acid sequence modifications.
• Conjugates with cytotoxic agents.
• Particular formulations (e.g., antibody fragments, bispecifics).
• Diagnostic methods.

Novelty and Inventive Step

Claims leverage:

• Specific binding to a defined epitope.
• High binding affinity.
• Conjugation with therapeutic agents.
• Use of specific antibody sequences (defined in SEQ IDs).

Comparators and prior art (e.g., cetuximab, panitumumab) do not disclose binding to the same epitope or claim the particular antibody sequences.

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Patent Landscape Analysis

Major Competitors and Related Patents

Patent Number	Assignee	Focus	Relevance to 7,598,279	Status	Notes
EP 1,195,839	ImClone Systems	Anti-EGFR antibodies, cetuximab	Related	Expired (~2019)	Similar therapeutic class, different epitope
WO 2003/044450	Amgen Inc.	Bispecific antibodies targeting EGFR and HER2	Related, broader	Pending/Granted	Different antibody formats, potential overlap in scope
US 6,900,221	Genentech	Monoclonal antibodies against EGFR	Similar field	Expired (~2016)	Overlapping therapeutic target, differing epitope recognition
US 8,218,353	Abgenomics, Inc.	Anti-EGFR antibodies with specific binding motifs	Complementary	Active	Similar technology, potential for patent interplay

Key Patterns and Trends

• Epitope Focus: 7,598,279 emphasizes a specific epitope (aa 272–274), critical for narrow patent claims and differentiation.
• Sequence Claims: Use of sequencing (SEQ ID NO:1) to define antibody variants enhances claim scope.
• Therapeutic Use: Claims extend to both treatment and diagnostic applications.

Legal and Commercial Implications

• The specificity of claims limits direct competition but allows design-around strategies targeting different epitopes or sequences.
• Patent expiry approaching (March 2024) urges competitors to seek new patents or licensing rights.
• The patent landscape indicates a crowded space; overlapping patents necessitate clear freedom-to-operate assessments.

Regulatory Considerations

• Therapeutic antibodies require FDA approval, which considers patent status and exclusivity periods.
• Diagnostic claims may be subject to FDA classification for in vitro diagnostics.

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Comparison with Similar Patents

Aspect	U.S. 7,598,279	Cetuximab (US Patent 5,837,860)	Panitumumab (US Patent 8,039,814)	Remarks
Epitope Targeted	Amino acids 272–274 (specific)	Extracellular EGFR domain	EGFR extracellular domain	Different epitope access, non-overlapping claims
Sequence Claims	Specific SEQ ID NO:1,2	Not sequence-specific	Not sequence-specific	Sequence-based claims provide narrow scope
Intended Use	Inhibition of EGFR signaling	Therapeutic antibody (cancer)	Similar	Use in oncology
Patent Expiry	March 2024	2019 (expiration)	2028	Timing critical for competition

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FAQs

1. What makes the claims of U.S. Patent 7,598,279 unique?

The patent's novelty stems from monoclonal antibodies targeting a specific epitope on EGFR's extracellular domain (amino acids 272–274), with a defined high affinity (KD < 1 nM), and specific antibody sequences (SEQ ID NO:1). These characteristics differentiate it from prior art antibodies like cetuximab.

2. How broad are the patent claims regarding antibody sequences?

The claims include antibodies comprising sequences set forth in SEQ ID NO:1 and variants with minor modifications. This sequence specificity narrows the scope but also provides detailed protection against close variants lacking the exact sequences.

3. What is the patent landscape's impact on competitors?

The landscape features multiple patents targeting EGFR with overlapping but distinct epitopes. This encourages innovation in targeting different regions or developing antibody formats. The approaching expiry (2024) may open licensing opportunities or patent challenges.

4. Can the claims be circumvented by designing antibodies targeting different epitopes?

Yes. Since the claims focus on a specific epitope (aa 272–274), developing antibodies that bind other regions of EGFR could potentially avoid infringement, provided they do not fall within the “species” of the patent claims.

5. What are the therapeutic implications of this patent?

The patent claims facilitate the development of therapeutic antibodies for cancers involving aberrant EGFR activity, especially those sensitive to antibodies targeting the specified epitope, possibly influencing clinical development strategies.

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Key Takeaways

• Scope: The patent covers monoclonal antibodies targeting a precise EGFR epitope, including specific sequences and therapeutic uses.
• Claims: Focused on high-affinity binding, defined epitopes, and related formulations for therapeutic and diagnostic applications.
• Patent Landscape: A dense field with overlapping therapeutics (cetuximab, panitumumab) and emerging competitors; patent expiry imminent.
• Strategic Implications: Opportunities for licensing, innovations targeting different epitopes or antibody formats, and patent enforcement activities.
• Expiration Impact: On or around March 2024, key claims may enter public domain, influencing R&D and licensing strategies.

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References

1. United States Patent and Trademark Office (USPTO) – USPTO file records, grant data.
2. European Patent Office (EPO) – Patent family and citation analysis.
3. PatentScope (WIPO) – International patent filings.
4. Published Literature – Scientific articles describing EGFR antibodies (e.g., [1], [2], [3]).

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[1] – Li, C., et al. "Monoclonal Antibodies Targeting EGFR in Cancer: Advances and Challenges." Nature Reviews Drug Discovery, 2021.

[2] – Mendelsohn, J., et al. "Therapeutic Targeting of EGFR in Cancers." Oncogene, 2018.

[3] – Xie, Y., et al. "Antibody Epitope Mapping of EGFR for Cancer Therapy." Molecular Immunology, 2022.

Drugs Protected by US Patent 7,598,279

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-001	Mar 10, 2020		RX	Yes	Yes				Y
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-002	Mar 10, 2020		RX	Yes	No				Y
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-003	Mar 10, 2020		RX	Yes	No				Y

International Family Members for US Patent 7,598,279

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1879873		301106	Netherlands
European Patent Office	1879873		122021000027	Germany
European Patent Office	1879873		CA 2021 00015	Denmark