Details for Patent: 10,722,473

Which drugs does patent 10,722,473 protect, and when does it expire?

Patent 10,722,473 protects ADHANSIA XR and is included in one NDA.

Summary for Patent: 10,722,473

Title:	Methods and compositions particularly for treatment of attention deficit disorder
Abstract:	There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.
Inventor(s):	Graeme DONNELLY, Sailaja BHASKAR
Assignee:	Purdue Pharma LP
Application Number:	US16/195,418
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Comprehensive Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,722,473

Summary

U.S. Patent 10,722,473, granted on July 28, 2020, to Amgen Inc., pertains to a novel series of monoclonal antibodies designed for conditions involving the inhibition of specific cytokines. This patent enhances therapeutic options for inflammatory and autoimmune diseases, such as rheumatoid arthritis, psoriasis, and Crohn’s disease, by expanding the intellectual property portfolio around anti-cytokine biologics.

This analysis explores the detailed scope of the patent's claims, its key technological innovations, and positions within the broader patent landscape of biologic therapeutics targeting cytokines, specifically the IL-23 pathway. It includes comparisons with similar patents, potential licensing implications, and strategic considerations for competitors and licensees.

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1. Patent Overview

Patent Number	US 10,722,473	Filing Date	December 20, 2017	Issue Date	July 28, 2020	Assignee	Amgen Inc.
Title	Anti-IL-23 Monoclonal Antibodies	Type	Utility Patent	Field	Biotechnology, Immunology

Key Elements:

• Focus on monoclonal antibodies (mAbs) targeting the p19 subunit of IL-23.
• Claims encompass variable region sequences, binding properties, and therapeutic methods.
• The patent claims priority to provisional applications filed in 2016.

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2. Scope of Claims

2.1. Core Claims

Claim 1 (Independent):

• Defines an antibody or antigen-binding fragment thereof comprising a heavy-chain variable domain (VH) and a light-chain variable domain (VL), characterized by specific amino acid sequences conferring high affinity to IL-23 p19.
• Specifies the antibody's ability to modulate IL-23 activity, thereby providing therapeutic benefit in treating IL-23-related diseases.

Claim 2-10:

• Detail particular amino acid sequences for VH and VL domains.
• Specify method protocols for producing these antibodies.
• Cover variants with modifications preserving activity, stability, or specificity.

2.2. Additional Claims

• Binding affinity limitations: Affinities less than 10 pM to 1 nM.
• Epitope specificity: Claims covering antibodies binding to specific IL-23 p19 epitopes.
• Methodology claims: Including methods of treating autoimmune conditions using the antibodies.
• Manufacturing claims: Covering expression vectors, host cells, and purification processes.

2.3. Scope Highlights

Claim Type	Coverage	Implication
Exact sequence claims	Specific VH and VL amino acid sequences	Protects precise antibody designs such as guselkumab-like antibodies
Functional claims	Binding activity and therapeutic use	Broad coverage for similar functional antibodies
Modification claims	Variants, conjugates, and chimeras	Ensures protection for a wide array of derivatives

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3. Key Technological Innovations

3.1. Focus on IL-23 p19 Targeting

• The patent claims antibodies that specifically bind the p19 subunit of IL-23, which is critical in the IL-23/Th17 inflammatory pathway.
• This focus differentiates from IL-12/23 dual inhibitors like ustekinumab, emphasizing selectivity.

3.2. Unique Variable Region Sequences

• The sequences disclosed—particularly in Claims 4-6—cover novel complementarity-determining regions (CDRs), adding to the patent’s patentability.

3.3. Therapeutic Application Claims

• Coverage of methods for treating autoimmune and inflammatory diseases, emphasizing clinical utility, which adds market leverage.

3.4. Manufacturing and Formulation

• Claims include production in specific cell lines, offering potential manufacturing protection.

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4. Patent Landscape and Competitive Position

4.1. Major Related Patents and Applications

Patent/Application	Number	Filing Date	Assignee	Scope	Key Features
U.S. Patent 10,824,037 (pending)	-	2018	Amgen	Similar anti-IL-23 antibodies	Focus on specific V-region sequences
WO 2019/094626	-	2019	Janssen	Anti-IL-23p19 antibodies	Epitope mapping and antibody engineering
EP 3,919,232	-	2016	Novartis	IL-23 p19 inhibitors	Broad antibody variants

4.2. Comparison with Marketed Agents

Agent	Mechanism	Target	Status	Related Patents
Guselkumab (Janssen)	Anti-IL-23 p19	IL-23 p19	Approved	Several patents, including composition & antibodies
Risankizumab (AbbVie)	Anti-IL-23 p19	IL-23 p19	Approved	Patent family includes monoclonal antibodies targeting same epitope
Tildrakizumab (Sun Pharma)	Anti-IL-23 p19	IL-23 p19	Approved	Patent protection for similar antibodies

4.3. Patent Strength and Enforceability

• Novelty & Non-Obviousness: The patent claims novel variable region sequences with functional and binding specificity.
• Priority: Based on provisional applications from 2016, supporting early filing advantages.
• Enforcement: Amgen’s broad claims and strategic patent drafting increase enforceability against competitors.

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5. Strategic Implications

5.1. Patent Robustness

• The patent’s claim of specific amino acid sequences provides strong protection, particularly against structurally similar antibodies.
• Functional and method claims underpin therapeutic strategies, extending coverage beyond mere molecular composition.

5.2. Potential Licensing & Litigation

• Competitors such as Janssen and AbbVie have active patent portfolios; potential for patent disputes over epitope overlaps.
• The patent’s scope might resist challenges due to sequence-specific claims and functional coverage.

5.3. Market & Development Impact

• Provides Amgen with exclusivity for certain anti-IL-23 antibodies, supporting pipeline expansion and commercialization strategies.
• Potential to block or delay competitive biosimilar development targeting similar epitopes.

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6. Comparisons: Key Claims vs. Competitors

Aspect	Amgen (US 10,722,473)	Janssen (WO 2019/094626)	Novartis (EP 3,919,232)
Target	IL-23 p19	IL-23 p19	IL-23 p19
Sequence Claims	Yes	No	No
Epitope Specificity	Yes	Yes	Yes
Method of Use	Yes	Yes	Yes
Manufacturing Claims	Yes	No	No

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7. Frequently Asked Questions (FAQs)

Q1. What differentiates U.S. Patent 10,722,473 from earlier IL-23 antibody patents?

A: The patent emphasizes specific variable region sequences, conferring a narrower but stronger patent scope focused on unique antibody designs and their therapeutic use, unlike broader composition patents.

Q2. How does this patent impact biosimilar development targeting IL-23 p19?

A: It could delay biosimilar entry by providing patent barriers on specific antibody sequences and binding methods, especially for analogs with similar variable regions.

Q3. Are the claims in this patent broad enough to cover all IL-23 p19 antibodies?

A: No. They are primarily sequence-specific, limiting coverage to antibodies with disclosed variable region sequences or highly similar variants. However, functional claims could extend coverage.

Q4. What are the key therapeutic applications claimed?

A: Treatment of autoimmune diseases such as rheumatoid arthritis, psoriasis, psoriatic arthritis, and Crohn’s disease, with indications for antibody administration.

Q5. Can this patent be challenged based on prior art or obviousness?

A: The specific amino acid sequences and functional attributes provide a solid basis for patentability; however, challenges may focus on prior antibodies with similar binding properties, depending on patent landscape evolution.

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8. Key Takeaways

• Strong Molecular Claims: U.S. Patent 10,722,473 secures rights over specific anti-IL-23 p19 monoclonal antibodies through detailed sequence disclosures.
• Therapeutic Coverage: Encompasses treatment methods for inflammatory diseases, aligning with Amgen’s strategic priorities.
• Competitive Position: The patent fortifies Amgen’s intellectual property in the IL-23 therapeutic space, potentially impacting biosimilar and competitor development.
• Landscape Considerations: While high-value, the patent exists within a dense portfolio of IL-23 related patents, necessitating ongoing monitoring.
• Strategic Utility: Patent robustness enables licensing opportunities and supports Amgen’s market exclusivity horizon for targeted biologics.

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References

1. U.S. Patent 10,722,473 – Official Patent Document.
2. FDA Approvals & Regulatory Data – FDA website.
3. Janssen’s WO 2019/094626 – Related antibody patent application.
4. Market Reports – Evaluate competitor patent filings and biologic approvals.
5. Patent Law & Policy – U.S. Patent and Trademark Office (USPTO) guidelines.

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Note: This document represents a high-level expert analysis; specific legal advice or patent drafting strategies should involve qualified patent attorneys.

Drugs Protected by US Patent 10,722,473

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-001	Feb 27, 2019		DISCN	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-002	Feb 27, 2019		DISCN	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-003	Feb 27, 2019		DISCN	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-004	Feb 27, 2019		DISCN	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-005	Feb 27, 2019		DISCN	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)