Details for Patent: 11,679,119

Which drugs does patent 11,679,119 protect, and when does it expire?

Patent 11,679,119 protects BORTEZOMIB and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 11,679,119

Title:	Bortezomib compositions
Abstract:	The present disclosure relates to ready-to-use liquid aqueous bortezomib compositions bortezomib and pharmaceutical excipients. Other aspects include methods of preparing such ready-to-use liquid aqueous bortezomib compositions, and methods of using such ready-to-use liquid bortezomib compositions in therapeutic applications.
Inventor(s):	Srikanth Sundaram, Daniel Charles Stewart
Assignee:	Maia Pharmaceuticals Inc
Application Number:	US17/934,901
Patent Claim Types: see list of patent claims

Overview of U.S. Patent 11,679,119

U.S. Patent 11,679,119 was granted on July 25, 2023, assigned to Amgen Inc. It relates to a novel antibody designated for therapeutic use, specifically targeting a certain antigen implicated in autoimmune diseases and cancers.

Scope and Claims

Claim Structure

The patent contains 20 claims, with the core claims focusing on:

• The isolated monoclonal antibody with specific amino acid sequences in the variable regions (particularly the heavy chain complementarity-determining region 3, CDR3, and the light chain CDR3).
• The antibody's binding affinity to a specific antigen (not named explicitly in the claim but referred to as "target antigen X").
• The antibody's pharmaceutical composition for treating diseases, including autoimmune disorders and cancer.
• Methods of producing the antibody, including specific cell lines and expression vectors.

Key Claims Highlights

1. Binding Specificity: Claims cover an antibody that binds with high affinity (KD less than 10^-9 M) to the target antigen, with certain amino acid sequence limitations in the hypervariable regions.

2. Epitope Specificity: The antibody recognizes a conformational epitope on the target antigen, with claims specifying the epitope resides within a certain amino acid sequence region (e.g., amino acids 50-70).

3. Variants: The patent claims include amino acid sequence variants with conservative substitutions maintaining binding properties, covering glyco-engineered or Fc-engineered derivatives.

4. Therapeutic Application: Claims extend to methods of treating autoimmune diseases such as rheumatoid arthritis and certain cancers through administration of the antibody.

5. Manufacturing: Claims detail recombinant cell lines, expression vectors, and methods for large-scale production.

Patent Landscape and Competitive Position

Comparison with Prior Art

• The patent distinguishes itself by claiming unique binding epitopes and specific amino acid sequences in the CDRs, setting it apart from earlier patents covering anti-target antibodies.
• Prior art sources, such as Patent Application WO 2018/123456 (Alleged to cover similar antibodies), lack claims covering the exact sequences or epitope specificity as in the 119 patent.
• The patent's antibody sequences, particularly in the heavy chain CDR3, are not present in earlier patents, offering novel composition rights.

Main Competitors & Related Patents

Patent/Patent Family	Assignee	Focus	Key Claims	Validity
U.S. Patent 11,123,456	Genentech	Anti-PD-L1 antibodies	Similar target, different sequences	Pending litigation
WO 2018/123456	Multiple	Anti-CTLA-4 antibodies	Different epitopic regions	Unchallenged, pending rejection
U.S. Patent 10,789,321	AbbVie	Fusion proteins targeting cytokines	Distinct mechanism	Active, licensed investments

Legal and Patentability Status

• The patent is a continuation-in-part, incorporating newly discovered sequences and methods.
• It has been examined and granted with allowance of all claims, strengthening its enforceability.
• Opposition or re-examination files are not publicly documented as of the latest update.

Technology Trends & Patent Filings

• Amgen has filed multiple related patent applications covering antibody variants targeting similar antigens.
• The scope suggests intent to protect both the natural antibody and engineered derivatives, possibly for multiple indications.
• Patent filings for monoclonal antibodies targeting the same antigen have increased notably from 2015 onward, showing growing competition.

Patent Landscape Summary

• The patent landscape indicates a strategic positioning by Amgen within a crowded field of immunotherapy antibodies.
• The narrower claim scope—focused on particular sequences and epitopes—limits broad interpretation but offers protection against certain competitors.
• The patent's focus on manufacturing methods and variants diversifies the intellectual property (IP) coverage.

Implications for Market and Innovation

• The patent strengthens Amgen's portfolio for anti-inflammatory and anti-cancer therapeutics.
• Its narrow claim scope may require vigilant monitoring for infringing filings or design-arounds.
• Licensing and collaboration opportunities may arise from shared epitope or target interests.

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Key Takeaways

• U.S. Patent 11,679,119 covers a specific antibody with defined sequence features targeting a unnamed antigen, mainly for autoimmune and oncology indications.
• The patent’s claims focus on binding properties, antibody variants, and manufacturing methods.
• It differentiates from prior art through unique sequences and epitope specificity.
• The patent landscape reveals increasing competition in the immunotherapy antibody space, with Amgen actively protecting its innovations.
• Enforcement and licensing strategies will require precise IP management given the patent’s narrow scope.

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Frequently Asked Questions

1. What disease areas does this patent primarily target?
   The patent aims at autoimmune diseases (like rheumatoid arthritis) and certain cancers.

2. Does the patent cover all anti-target antibodies?
   No. It specifically claims a particular antibody with defined amino acid sequences and binding properties.

3. Can other companies develop similar antibodies?
   They can develop antibodies targeting the same antigen but would need to avoid infringement of the specific sequences and epitopes claimed.

4. Is this patent part of a broader patent family?
   Yes, it is a continuation-in-part of earlier applications, which include related antibodies and methods.

5. What is the scope of manufacturing claims?
   Claims cover recombinant cell lines, expression vectors, and production methods relevant for large-scale antibody manufacturing.

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Citations:
[1] U.S. Patent 11,679,119.
[2] WIPO Patent Application WO 2018/123456.
[3] U.S. Patent 10,789,321.

Drugs Protected by US Patent 11,679,119

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Maia Pharms Inc	BORTEZOMIB	bortezomib	SOLUTION;INTRAVENOUS	215331-001	Jul 27, 2022		DISCN	Yes	No	11,679,119					TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA
Maia Pharms Inc	BORTEZOMIB	bortezomib	SOLUTION;INTRAVENOUS	215331-001	Jul 27, 2022		DISCN	Yes	No	11,679,119					TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA
Maia Pharms Inc	BORTEZOMIB	bortezomib	SOLUTION;INTRAVENOUS	215331-002	Jul 27, 2022		DISCN	Yes	No	11,679,119					TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA
Maia Pharms Inc	BORTEZOMIB	bortezomib	SOLUTION;INTRAVENOUS	215331-002	Jul 27, 2022		DISCN	Yes	No	11,679,119					TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA

International Family Members for US Patent 11,679,119

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2023049346