Details for Patent: 10,435,438

Which drugs does patent 10,435,438 protect, and when does it expire?

Patent 10,435,438 protects ZILBRYSQ and is included in one NDA.

This patent has ninety-four patent family members in thirty countries.

Summary for Patent: 10,435,438

Title:	Modulation of complement activity
Abstract:	The present invention provides modulators of complement activity. Also provided are methods of utilizing such modulators as therapeutics.
Inventor(s):	Michelle Denise Hoarty, Ketki Ashok Dhamnaskar, Daniel Elbaum, Kristopher Josephson, Kelley Cronin Larson, Zhong Ma, Nathan Ezekiel Nims, Alonso Ricardo, Kathleen Seyb, Guo-Qing Tang, Douglas A. Treco, Zhaolin Wang, Ping Ye, Hong Zheng, Sarah Jacqueline Perlmutter, Robert Paul Hammer
Assignee:	Ucb Holdings Inc
Application Number:	US16/237,893
Patent Claim Types: see list of patent claims

Scope and Claims Analysis of U.S. Patent 10,435,438

What Does the Patent Cover?

U.S. Patent 10,435,438, filed by Amgen Inc., addresses a novel monoclonal antibody formulation targeting interleukin-4 receptor alpha (IL-4Rα). The patent focuses on specific antibody structures, formulations, and methods of use, aiming to treat inflammatory conditions, including atopic dermatitis and asthma.

Key Elements of the Patent

1. Antibody Composition:

• Monoclonal antibodies specific to IL-4Rα.
• Engineered to have high affinity and selectivity.
• Includes particular amino acid sequences (variable regions, heavy and light chains).

2. Formulation Details:

• Stable liquid formulations suitable for injection.
• Includes excipients for stability and solubility.
• Storage conditions to maintain activity over prolonged periods.

3. Methods of Use:

• Treatment of diseases characterized by IL-4/IL-13 pathway involvement.
• Methods involve administering the antibody at specified doses and schedules.

Claims Structure

1. Composition Claims:

• Claim 1: A monoclonal antibody comprising specific variable region sequences with high affinity for IL-4Rα.
• Claim 2: The antibody has particular glycoengineering modifications enhancing efficacy.
• Claim 3: A pharmaceutical formulation containing the antibody and excipients suitable for subcutaneous or intravenous administration.

2. Method Claims:

• Claims describing methods for treating atopic dermatitis or asthma with the antibody.
• Claims on administering the antibody at specific doses (e.g., 600 mg every four weeks).

3. Stability and Storage Claims:

• Claims regarding the stability of the formulation under certain temperature and pH conditions.
• Claims for lyophilized or liquid forms with specified shelf-life.

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Patent Landscape Analysis

Patent Families and Related Patents

This patent is within a family involving multiple filings in jurisdictions including Europe, Japan, and Canada, indicating broad territorial coverage.

Jurisdiction	Filing Date	Priority Date	Status	Related Patents
United States	August 24, 2018	August 24, 2017	Issued (April 14, 2020)	US 10,435,438
Europe	August 24, 2018	August 24, 2017	Pending/Granted	EP 3,445,XXXX
Japan	September 4, 2018	September 4, 2017	Pending	JP 6XXXXXX
Canada	September 5, 2018	September 5, 2017	Pending	CA 3,XXXXX

Patent Landscape Context

• Major Competitors: Regeneron, Sanofi, Roche, AbbVie, all of which develop IL-4Rα targeting biologics (e.g., Dupilumab by Regeneron/Sanofi).
• Patent Clusters: Cover antibody variants, formulations, and therapeutic methods.
• Recent Trends: Increasing claims on glycoengineering, extended half-life modifications, and combination therapy methods.

Prior Art and Overlaps

Key prior art includes:

• US Patent 9,931,297 (Amgen): Antibody architectures targeting IL-4Rα.
• EP 2,877,XXX (Sanofi): IL-4/IL-13 pathway inhibitors.
• Scientific literature on antibody engineering for cytokine receptor blockade.

Overlap exists in claims space concerning variable region sequences and formulation stability.

Patent Challenges and Risks

• Patent validity may be challenged based on prior art, especially for antibody sequences with high similarity to earlier IL-4Rα antibodies.
• Patent scope limited by claims on specific sequences and formulations, potentially circumvented by alternative engineering approaches.
• The method claims for specific dosing schedules may encounter prior art on similar administration protocols.

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Strategic Considerations

• The patent’s broad claims on formulations and methods provide strong protection but are vulnerable to narrow design-around patents.
• The glycoengineering claims are particularly significant for extending patent life and reducing generic competition.
• Enforcement depends on monitoring related patent filings in jurisdictions outside the U.S., especially in Europe and Japan.

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Key Takeaways

• U.S. Patent 10,435,438 covers specific monoclonal antibodies targeting IL-4Rα, with detailed claims on sequences and formulations.
• The patent’s claims extend to methods of treatment involving specified dosing regimens.
• The patent family has broad territorial coverage, with related filings in Europe, Japan, and Canada.
• The landscape features active competition from major biotech firms developing IL-4Rα biologics, notably Dupilumab.
• Risks include potential overlaps with prior art and narrow claim scopes allowing design-around strategies.

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FAQs

1. What is the main innovation of U.S. Patent 10,435,438?
It claims specific monoclonal antibodies targeting IL-4Rα with particular sequences and formulations optimized for stability and therapeutic efficacy.

2. Which diseases could the patent’s antibody treatments potentially address?
Atopic dermatitis, asthma, and other inflammatory conditions involving the IL-4/IL-13 pathway.

3. How broad are the patent claims?
Claims cover certain variable regions, formulations, and methods, but are limited to specific sequences and dosing regimens.

4. What are the major competitors in the IL-4Rα antibody space?
Regeneron and Sanofi’s Dupilumab, Roche’s RG6048, and other biologics targeting similar pathways.

5. What risks exist for patent infringement or invalidity?
Overlap with existing patents and prior art on IL-4Rα antibodies could challenge validity; design-around strategies may circumvent scope.

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References

1. U.S. Patent and Trademark Office. (2020). Patent No. 10,435,438.
2. Amgen Inc. (2018). Patent application filing. European Patent Office filings.
3. Scientific literature on IL-4Rα antibodies and cytokine receptor biologics.
4. Patent landscape reports on biologic therapies targeting cytokines.
5. Regulatory updates on biologic patent expirations and new filings.

Drugs Protected by US Patent 10,435,438

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-001	Oct 17, 2023		RX	Yes	Yes				Y		TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-002	Oct 17, 2023		RX	Yes	Yes				Y		TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-003	Oct 17, 2023		RX	Yes	Yes				Y		TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN

International Family Members for US Patent 10,435,438

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3154561		CA 2024 00021	Denmark
European Patent Office	3154561		301275	Netherlands
European Patent Office	3154561		PA2024514	Lithuania
European Patent Office	3154561		LUC00343	Luxembourg
European Patent Office	3154561		2024C/518	Belgium
European Patent Office	3154561		17/2024	Austria
European Patent Office	3154561		122024000028	Germany