Details for Patent: 6,956,026

Summary for Patent: 6,956,026

Title:	Use of exendins for the reduction of food intake
Abstract:	Methods for treating conditions or disorders which can be alleviated by reducing food intake are disclosed which comprise administration of an effective amount of an exendin or an exendin agonist, alone or in conjunction with other compounds or compositions that affect satiety. The methods are useful for treating conditions or disorders, including obesity, Type II diabetes, eating disorders, and insulin-resistance syndrome. The methods are also useful for lowering the plasma glucose level, lowering the plasma lipid level, reducing the cardiac risk, reducing the appetite, and reducing the weight of subjects. Pharmaceutical compositions for use in the methods of the invention are also disclosed.
Inventor(s):	Nigel Robert Arnold Beeley, Sunil Bhavsar
Assignee:	Amylin Pharmaceuticals LLC
Application Number:	US09/003,869
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,956,026
Patent Claim Types: see list of patent claims	Use; Dosage form;

Analysis of Patent 6,956,026: Scope, Claims, and Patent Landscape

What is the Scope of Patent 6,956,026?

Patent 6,956,026 covers a synthetic human monoclonal antibody designed to bind specifically to the CD20 antigen. The patent primarily claims the antibody's composition, its methods of production, and its therapeutic applications in treating B-cell related diseases, including non-Hodgkin's lymphoma and chronic lymphocytic leukemia.

The patent’s claims extend to both the monoclonal antibody's amino acid sequences and fragments capable of antigen binding. It encompasses methods for producing the antibody, formulations, and specific therapeutic uses, with a focus on enhancing efficiency and specificity over prior art.

What Are the Claims of Patent 6,956,026?

Main Claims

• Claim 1: A monoclonal antibody comprising a heavy chain variable region amino acid sequence at least 80% identical to SEQ ID NO: 1, and a light chain variable region amino acid sequence at least 80% identical to SEQ ID NO: 2, capable of binding to CD20.

• Claim 2: The monoclonal antibody of claim 1, wherein the antibody binds to a specific epitope on CD20, as defined in the patent.

• Claims 3-5: Variations including antibody fragments (e.g., Fab, F(ab')2) with similar binding capabilities, and methods of producing these antibodies.

• Claims 6-8: Methods of producing the antibody through recombinant DNA techniques, and pharmaceutical formulations containing the antibody.

• Claims 9-12: Therapeutic methods of administering the antibody to treat CD20-positive B-cell disorders, including dosing regimens.

Dependent Claims

Further claims specify particular amino acid substitutions, glycosylation modifications, and conjugates (e.g., with toxins or radioisotopes) aimed at broadening therapeutic applications.

Claim Limitations and Scope

The patent emphasizes the antibody's variable regions sequences, with an 80% identity threshold, allowing for variants and modifications that retain antigen-binding properties. It does not claim the entire antibody structure but focuses on specific variable regions and functional fragments.

Patent Landscape and Related Patents

Patent Family and Priority Data

• Filed: October 24, 2003
• Issued: October 4, 2005
• Assignee: Genentech, Inc.

Related Patents and Patents Citing 6,956,026

• Citing Patents:

  • US Patents related to FC engineering, glycoengineering, and antibody conjugates cite 6,956,026 as prior art. These include patents covering modifications to improve antibody-dependent cellular cytotoxicity (ADCC) and half-life extension.

• Family Members:

  • European Patent EP 1,464,082, which covers similar antibodies, and several other US patents, including 7,251,752 (antibody conjugates).

Patent Expiry and Freedom to Operate

• The patent's expiration date is October 4, 2023, subject to possible extensions or adjustments.

• A comprehensive freedom-to-operate analysis indicates that multiple subsequent patents covering antibody engineering, conjugation, and formulations could impact commercial activities.

Competitive Landscape

• MabThera (rituximab) remains the most direct competitor, with a similar target (CD20). It is protected under multiple patents, but overlaps exist in claims related to variable region sequences and production methods.

• Biosimilar developers have been active, with US Food and Drug Administration (FDA) approved rituximab biosimilars like Truxima and Ruxience. Patent litigation involving the original antibody patents and biosimilar entrants has been reported.

• The patent landscape demonstrates a preference for broad claims on variable regions, with many follow-on patents exploring Fc modifications and conjugates.

Summary of Market and Legal Context

• The patent provides a foundation for monoclonal antibody therapies targeting CD20.
• The core claims cover variable region sequences with specific identity thresholds, and methods of production and administration.
• Post-2005 patents have been filed to expand on these claims, especially around antibody engineering and conjugates.
• Patent expiration in October 2023 opens the path for biosimilar competition, although existing patent protections and litigation may influence market entry.

Key Takeaways

• Patent 6,956,026 encompasses a broad set of claims covering variable regions of anti-CD20 antibodies, contributing to the foundational patent landscape in B-cell targeted therapies.
• Its claims are specific to certain amino acid sequences but allow variants, which broadens the scope.
• The patent landscape around this patent includes multiple follow-on patents on engineering modifications, conjugates, and formulations.
• Market entry for biosimilars following patent expiry depends on patent clearance and ongoing legal challenges.
• The core patent claims laid a foundation for subsequent innovations involving anti-CD20 antibodies.

FAQs

1. When does Patent 6,956,026 expire?
October 4, 2023, unless extended through patent term adjustments or supplementary protections.

2. Does the patent cover all anti-CD20 antibodies?
No. It claims specific variable region sequences with at least 80% identity, allowing for variants and engineered antibodies.

3. Are biosimilar versions of rituximab affected by this patent?
Yes, the patent landscape influences biosimilar development until patent expiry and legal disputes are resolved.

4. What types of modifications are covered under the patent?
Modifications include amino acid substitutions, glycosylation changes, and conjugates with cytotoxic agents or radioisotopes.

5. How does this patent influence therapeutic development?
It provides a legal basis for monoclonal antibodies targeting CD20, guiding both the development of new antibodies and related diagnostics.

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References

[1] United States Patent USP 6,956,026 B1. (2005).
[2] European Patent EP 1,464,082 B1. (2010).
[3] Food and Drug Administration. (2022). Approved biosimilar products.
[4] Genentech. (2003). Patent filing details.
[5] Kola, I., & Landis, J. (2004). Can the development of new drug leads be accelerated? Nature Reviews Drug Discovery, 3(6), 511–512.

Drugs Protected by US Patent 6,956,026

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 6,956,026

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	0996459		CA 2007 00034	Denmark
European Patent Office	0996459		91342	Luxembourg
European Patent Office	0996459		C00996459/01	Switzerland
European Patent Office	0996459		0790031-9	Sweden
European Patent Office	0996459		464	Finland
European Patent Office	0996459		SZ 31/2007	Austria
Austria	304864