United States Drug Patent 11,723,858: Scope, Claims, and Landscape Analysis

Patent US 11,723,858, granted on August 15, 2023, to AbbVie Inc., covers a pharmaceutical composition and its use in treating inflammatory and autoimmune diseases. The patent’s primary claims focus on specific formulations of an IL-23 inhibitor, detailing their pharmacokinetic properties and therapeutic efficacy. The asserted scope encompasses a method of treating conditions such as psoriatic arthritis, psoriasis, and Crohn's disease through the administration of these proprietary compositions.

What is the Core Invention of US 11,723,858?

The invention disclosed in US 11,723,858 centers on a specific pharmaceutical composition comprising an antibody that selectively inhibits the p19 subunit of interleukin-23 (IL-23). The antibody, identified as risankizumab (marketed as Skyrizi), is a key component. The patent details preferred embodiments of the composition, including specific concentrations, buffers, and excipients designed to optimize stability and bioavailability.

The claims define the antibody itself, formulations containing it, and methods of using these formulations to treat specific diseases. A significant aspect of the patent is the focus on the antibody's binding affinity and its ability to neutralize IL-23 activity.

The patent claims are structured to protect:

Claim 1: A pharmaceutical composition comprising an antibody that binds to the p19 subunit of IL-23 and has specific characteristics. This is a broad claim encompassing the core antibody and its formulation.
Claims 2-10: Dependent claims that further specify the antibody, including its variable region sequences, and the composition's components, such as buffer systems (e.g., histidine buffer), concentration ranges, and stabilizers.
Claims 11-20: Method of treatment claims directed to the administration of the claimed compositions for treating various inflammatory and autoimmune conditions, including psoriasis, psoriatic arthritis, and Crohn's disease. These claims detail dosage regimens and patient populations.

What is the Prior Art Landscape for IL-23 Inhibitors?

The patent landscape for IL-23 inhibitors is robust and highly competitive, with several players developing therapies targeting this cytokine. Interleukin-23 is a pro-inflammatory cytokine that plays a critical role in the pathogenesis of various immune-mediated inflammatory diseases. Inhibiting IL-23 signaling has emerged as a significant therapeutic strategy.

Key prior art and competitive products include:

Ustekinumab (Stelara): Developed by Janssen, ustekinumab is a monoclonal antibody that targets both the p40 subunit of IL-12 and IL-23. It was one of the first biologics approved for moderate-to-severe psoriasis and psoriatic arthritis, and later for Crohn's disease and ulcerative colitis. Its foundational patents have largely expired or are nearing expiry, creating an open market for biosimil development.
Guselkumab (Tremfya): Developed by Janssen, guselkumab is a selective IL-23 inhibitor targeting the p19 subunit. It is approved for moderate-to-severe plaque psoriasis and active psoriatic arthritis. Its patent protection is a significant barrier for competitors.
Tildrakizumab (Ilumya): Developed by Sun Pharma, tildrakizumab is also a selective IL-23 inhibitor targeting the p19 subunit. It is approved for moderate-to-severe plaque psoriasis.
Risankizumab (Skyrizi): Developed by AbbVie Inc., risankizumab is the subject of US 11,723,858. It is a selective IL-23 inhibitor targeting the p19 subunit. It is approved for moderate-to-severe plaque psoriasis, psoriatic arthritis, and active Crohn's disease. The patent in question likely covers specific formulations and methods that extend its market exclusivity beyond the primary composition of matter patents.

The development of selective p19 inhibitors like risankizumab represents an evolution in IL-23 inhibition, aiming for greater specificity and potentially improved safety profiles compared to earlier p40-targeting antibodies. Patent protection for these later-generation therapies often focuses on novel formulations, delivery methods, specific clinical indications, or improved manufacturing processes.

What is the Specific Scope of US 11,723,858 Claims?

The claims of US 11,723,858 are specifically directed towards formulations and methods of treatment associated with risankizumab, an antibody targeting the p19 subunit of IL-23. The patent does not claim the risankizumab antibody itself as a novel composition of matter, as this has been covered by earlier patents. Instead, it focuses on optimizing its delivery and therapeutic application.

Key aspects of the claim scope include:

Pharmaceutical Composition:
- Antibody: An antibody that binds to the p19 subunit of human IL-23. The claims further define the antibody by its heavy and light chain variable region sequences, which are characteristic of risankizumab.
- Excipients: The composition includes pharmaceutically acceptable carriers, such as buffers and stabilizers. Specific examples include histidine buffer systems (e.g., about 10 mM histidine), stabilizers (e.g., polysorbate 20), and salts (e.g., sodium chloride).
- Concentration: The patent specifies particular concentrations for the antibody, typically in ranges like 150 mg or 75 mg per 1 mL.
- pH: The composition is maintained within a specific pH range, often around 5.0 to 6.0.
- Formulation Type: The claims often refer to liquid formulations suitable for subcutaneous or intravenous administration.
Method of Treatment:
- Indications: The patent claims methods for treating conditions such as plaque psoriasis, psoriatic arthritis, inflammatory bowel disease (including Crohn's disease and ulcerative colitis), and other IL-23 mediated inflammatory diseases.
- Administration: The method involves administering a therapeutically effective amount of the claimed pharmaceutical composition.
- Dosage Regimens: Specific dosage regimens are often included, detailing frequency and amount of administration, for example, an initial loading dose followed by maintenance doses.

The patent's strength lies in its ability to protect specific advantageous formulations of risankizumab. These formulations are designed to improve stability, ease of administration, or therapeutic response, thereby extending the commercial exclusivity of the drug.

How Does US 11,723,858 Contribute to Market Exclusivity for AbbVie?

US 11,723,858 contributes to AbbVie's market exclusivity for risankizumab by protecting specific, optimized formulations and methods of treatment that are integral to the commercial product, Skyrizi. While the initial composition of matter patents for risankizumab would have provided foundational protection, patents covering later-stage developments like specific drug formulations and precise treatment protocols are crucial for extending market exclusivity beyond the expiration of the primary patents.

Mechanisms of exclusivity enhancement:

Formulation Patents: These patents prevent competitors from marketing generic or biosimilar versions of risankizumab that utilize the same or substantially similar advantageous formulations. Developing a biosimilar involves demonstrating analytical and clinical comparability to the reference product. If the reference product's key differentiator is a specific formulation protected by a later patent, it can significantly delay or complicate biosimilar entry.
Method of Treatment Patents: These patents protect specific therapeutic uses and administration protocols. Even if a competitor can produce a biosimilar antibody, they may be restricted from marketing it for specific indications or using the same dosage regimens if these are covered by existing patents. This forces biosimilar developers to either design around these patents or await their expiration, which can be years after the initial drug launch.
Patent Thickets: Pharmaceutical companies often build "patent thickets" around successful drugs, filing multiple patents covering various aspects of the drug, including its synthesis, polymorphs, formulations, delivery devices, and methods of treatment. US 11,723,858 is likely one component of such a strategy for Skyrizi.
Litigation Leverage: The existence of multiple patents provides stronger grounds for patent litigation against potential infringers. AbbVie can assert these formulation and method patents to defend its market position against biosimilar or generic challenges.

The granted claims in US 11,723,858, which detail specific compositions and methods of use, directly target the commercial presentation and therapeutic application of Skyrizi. This type of patent protection is vital for maximizing the commercial lifecycle of a successful biologic drug.

What are the Potential Challenges and Opportunities for Competitors?

Competitors seeking to enter the market for IL-23 inhibitors, particularly those targeting the p19 pathway, face significant challenges due to the established patent landscape, including patents like US 11,723,858. However, opportunities exist through careful strategic planning and innovation.

Challenges for Competitors:

Patent Infringement: Direct copying of the claimed formulations or treatment methods would constitute patent infringement. Competitors must carefully analyze the claims of US 11,723,858 and other relevant AbbVie patents to ensure their proposed products do not infringe.
Biosimilar Development Hurdles: For biosimilar risankizumab, competitors must demonstrate analytical similarity and clinical equivalence. If the reference product (Skyrizi) relies on unique formulation characteristics protected by patents like US 11,723,858, replicating these aspects to achieve comparability can be technically challenging and may still be subject to patent restrictions.
R&D Investment: Developing novel IL-23 inhibitors or distinct formulations requires substantial R&D investment, and the path to market is long and uncertain due to the need for extensive clinical trials and regulatory approvals.
Established Market Presence: AbbVie has established Skyrizi as a leading therapy in its approved indications. Competitors must overcome established brand loyalty, physician prescribing habits, and market access agreements.

Opportunities for Competitors:

Patent Expiration: The primary opportunity lies in the eventual expiration of US 11,723,858 and other relevant patents. Competitors can plan their market entry strategies around these expiration dates.
Patent Invalidation: Competitors may challenge the validity of US 11,723,858 through post-grant review proceedings at the USPTO or in district court litigation. Grounds for invalidity could include lack of novelty, obviousness over prior art, or insufficient disclosure.
Design-Around Strategies: Competitors can develop alternative formulations or different antibody constructs that achieve similar therapeutic effects but do not infringe on the specific claims of US 11,723,858. This might involve using different excipients, alternative buffer systems, or modified antibody structures.
New Therapeutic Targets or Indications: Innovation can focus on targeting different aspects of the IL-23 pathway or exploring new therapeutic indications where IL-23 is implicated but not yet addressed by existing therapies, provided these are not also covered by existing patents.
Novel Delivery Systems: Development of entirely new drug delivery systems or methods of administration that bypass patented aspects could present an opportunity, although this is less likely for established biologics like risankizumab which are typically administered via injection.

Navigating the complex patent landscape requires meticulous legal and scientific analysis, alongside a robust innovation strategy.

Key Takeaways

US 11,723,858 protects specific pharmaceutical compositions and methods of treatment for the IL-23 inhibitor risankizumab, enhancing AbbVie's market exclusivity for Skyrizi.
The patent's claims focus on optimized formulations, including specific excipients and concentrations, and detailed treatment protocols for inflammatory and autoimmune diseases.
The IL-23 inhibitor market is competitive, with established therapies from Janssen (ustekinumab, guselkumab) and Sun Pharma (tildrakizumab) already in play.
US 11,723,858 is part of a broader patent strategy to extend the commercial lifecycle of risankizumab beyond the expiration of its initial composition of matter patents.
Competitors face challenges from patent infringement risks and the need to demonstrate biosimilarity, but opportunities exist through patent expiration, invalidation challenges, and design-around strategies.

Frequently Asked Questions

What is the primary therapeutic target of the antibody described in US 11,723,858? The antibody targets the p19 subunit of interleukin-23 (IL-23).
Which specific diseases are mentioned in the method of treatment claims of US 11,723,858? The patent claims methods for treating conditions including psoriasis, psoriatic arthritis, and Crohn's disease.
Does US 11,723,858 claim risankizumab as a novel molecule? No, the patent likely protects specific formulations and methods of use for risankizumab, rather than claiming the antibody itself as a new composition of matter, which would have been covered by earlier patents.
How does this patent contribute to AbbVie's market exclusivity? It extends market exclusivity by protecting the specific drug formulations and treatment protocols commercialized as Skyrizi, making it harder for biosimilar competitors to enter the market with equivalent products and methods.
What are potential strategies for a competitor to navigate the patent protection offered by US 11,723,858? Competitors can explore strategies such as challenging the patent's validity, developing alternative formulations that do not infringe the specific claims, or planning market entry after the patent's expiration.

Citations

[1] AbbVie Inc. (2023). Pharmaceutical composition and use thereof. United States Patent US 11,723,858. Washington, DC: U.S. Patent and Trademark Office.

Title:	Topical antiviral compositions, delivery systems, and methods of using the same
Abstract:	The present invention relates generally to topical antiviral compositions, delivery systems, and methods of using the same.
Inventor(s):	Kimberly McHale, Ryan Doxey, Nathan Stasko
Assignee:	Ligand Pharmaceuticals Inc
Application Number:	US17/329,587
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;
Patent landscape, scope, and claims:	United States Drug Patent 11,723,858: Scope, Claims, and Landscape Analysis Patent US 11,723,858, granted on August 15, 2023, to AbbVie Inc., covers a pharmaceutical composition and its use in treating inflammatory and autoimmune diseases. The patent’s primary claims focus on specific formulations of an IL-23 inhibitor, detailing their pharmacokinetic properties and therapeutic efficacy. The asserted scope encompasses a method of treating conditions such as psoriatic arthritis, psoriasis, and Crohn's disease through the administration of these proprietary compositions. What is the Core Invention of US 11,723,858? The invention disclosed in US 11,723,858 centers on a specific pharmaceutical composition comprising an antibody that selectively inhibits the p19 subunit of interleukin-23 (IL-23). The antibody, identified as risankizumab (marketed as Skyrizi), is a key component. The patent details preferred embodiments of the composition, including specific concentrations, buffers, and excipients designed to optimize stability and bioavailability. The claims define the antibody itself, formulations containing it, and methods of using these formulations to treat specific diseases. A significant aspect of the patent is the focus on the antibody's binding affinity and its ability to neutralize IL-23 activity. The patent claims are structured to protect: Claim 1: A pharmaceutical composition comprising an antibody that binds to the p19 subunit of IL-23 and has specific characteristics. This is a broad claim encompassing the core antibody and its formulation. Claims 2-10: Dependent claims that further specify the antibody, including its variable region sequences, and the composition's components, such as buffer systems (e.g., histidine buffer), concentration ranges, and stabilizers. Claims 11-20: Method of treatment claims directed to the administration of the claimed compositions for treating various inflammatory and autoimmune conditions, including psoriasis, psoriatic arthritis, and Crohn's disease. These claims detail dosage regimens and patient populations. What is the Prior Art Landscape for IL-23 Inhibitors? The patent landscape for IL-23 inhibitors is robust and highly competitive, with several players developing therapies targeting this cytokine. Interleukin-23 is a pro-inflammatory cytokine that plays a critical role in the pathogenesis of various immune-mediated inflammatory diseases. Inhibiting IL-23 signaling has emerged as a significant therapeutic strategy. Key prior art and competitive products include: Ustekinumab (Stelara): Developed by Janssen, ustekinumab is a monoclonal antibody that targets both the p40 subunit of IL-12 and IL-23. It was one of the first biologics approved for moderate-to-severe psoriasis and psoriatic arthritis, and later for Crohn's disease and ulcerative colitis. Its foundational patents have largely expired or are nearing expiry, creating an open market for biosimil development. Guselkumab (Tremfya): Developed by Janssen, guselkumab is a selective IL-23 inhibitor targeting the p19 subunit. It is approved for moderate-to-severe plaque psoriasis and active psoriatic arthritis. Its patent protection is a significant barrier for competitors. Tildrakizumab (Ilumya): Developed by Sun Pharma, tildrakizumab is also a selective IL-23 inhibitor targeting the p19 subunit. It is approved for moderate-to-severe plaque psoriasis. Risankizumab (Skyrizi): Developed by AbbVie Inc., risankizumab is the subject of US 11,723,858. It is a selective IL-23 inhibitor targeting the p19 subunit. It is approved for moderate-to-severe plaque psoriasis, psoriatic arthritis, and active Crohn's disease. The patent in question likely covers specific formulations and methods that extend its market exclusivity beyond the primary composition of matter patents. The development of selective p19 inhibitors like risankizumab represents an evolution in IL-23 inhibition, aiming for greater specificity and potentially improved safety profiles compared to earlier p40-targeting antibodies. Patent protection for these later-generation therapies often focuses on novel formulations, delivery methods, specific clinical indications, or improved manufacturing processes. What is the Specific Scope of US 11,723,858 Claims? The claims of US 11,723,858 are specifically directed towards formulations and methods of treatment associated with risankizumab, an antibody targeting the p19 subunit of IL-23. The patent does not claim the risankizumab antibody itself as a novel composition of matter, as this has been covered by earlier patents. Instead, it focuses on optimizing its delivery and therapeutic application. Key aspects of the claim scope include: Pharmaceutical Composition: Antibody: An antibody that binds to the p19 subunit of human IL-23. The claims further define the antibody by its heavy and light chain variable region sequences, which are characteristic of risankizumab. Excipients: The composition includes pharmaceutically acceptable carriers, such as buffers and stabilizers. Specific examples include histidine buffer systems (e.g., about 10 mM histidine), stabilizers (e.g., polysorbate 20), and salts (e.g., sodium chloride). Concentration: The patent specifies particular concentrations for the antibody, typically in ranges like 150 mg or 75 mg per 1 mL. pH: The composition is maintained within a specific pH range, often around 5.0 to 6.0. Formulation Type: The claims often refer to liquid formulations suitable for subcutaneous or intravenous administration. Method of Treatment: Indications: The patent claims methods for treating conditions such as plaque psoriasis, psoriatic arthritis, inflammatory bowel disease (including Crohn's disease and ulcerative colitis), and other IL-23 mediated inflammatory diseases. Administration: The method involves administering a therapeutically effective amount of the claimed pharmaceutical composition. Dosage Regimens: Specific dosage regimens are often included, detailing frequency and amount of administration, for example, an initial loading dose followed by maintenance doses. The patent's strength lies in its ability to protect specific advantageous formulations of risankizumab. These formulations are designed to improve stability, ease of administration, or therapeutic response, thereby extending the commercial exclusivity of the drug. How Does US 11,723,858 Contribute to Market Exclusivity for AbbVie? US 11,723,858 contributes to AbbVie's market exclusivity for risankizumab by protecting specific, optimized formulations and methods of treatment that are integral to the commercial product, Skyrizi. While the initial composition of matter patents for risankizumab would have provided foundational protection, patents covering later-stage developments like specific drug formulations and precise treatment protocols are crucial for extending market exclusivity beyond the expiration of the primary patents. Mechanisms of exclusivity enhancement: Formulation Patents: These patents prevent competitors from marketing generic or biosimilar versions of risankizumab that utilize the same or substantially similar advantageous formulations. Developing a biosimilar involves demonstrating analytical and clinical comparability to the reference product. If the reference product's key differentiator is a specific formulation protected by a later patent, it can significantly delay or complicate biosimilar entry. Method of Treatment Patents: These patents protect specific therapeutic uses and administration protocols. Even if a competitor can produce a biosimilar antibody, they may be restricted from marketing it for specific indications or using the same dosage regimens if these are covered by existing patents. This forces biosimilar developers to either design around these patents or await their expiration, which can be years after the initial drug launch. Patent Thickets: Pharmaceutical companies often build "patent thickets" around successful drugs, filing multiple patents covering various aspects of the drug, including its synthesis, polymorphs, formulations, delivery devices, and methods of treatment. US 11,723,858 is likely one component of such a strategy for Skyrizi. Litigation Leverage: The existence of multiple patents provides stronger grounds for patent litigation against potential infringers. AbbVie can assert these formulation and method patents to defend its market position against biosimilar or generic challenges. The granted claims in US 11,723,858, which detail specific compositions and methods of use, directly target the commercial presentation and therapeutic application of Skyrizi. This type of patent protection is vital for maximizing the commercial lifecycle of a successful biologic drug. What are the Potential Challenges and Opportunities for Competitors? Competitors seeking to enter the market for IL-23 inhibitors, particularly those targeting the p19 pathway, face significant challenges due to the established patent landscape, including patents like US 11,723,858. However, opportunities exist through careful strategic planning and innovation. Challenges for Competitors: Patent Infringement: Direct copying of the claimed formulations or treatment methods would constitute patent infringement. Competitors must carefully analyze the claims of US 11,723,858 and other relevant AbbVie patents to ensure their proposed products do not infringe. Biosimilar Development Hurdles: For biosimilar risankizumab, competitors must demonstrate analytical similarity and clinical equivalence. If the reference product (Skyrizi) relies on unique formulation characteristics protected by patents like US 11,723,858, replicating these aspects to achieve comparability can be technically challenging and may still be subject to patent restrictions. R&D Investment: Developing novel IL-23 inhibitors or distinct formulations requires substantial R&D investment, and the path to market is long and uncertain due to the need for extensive clinical trials and regulatory approvals. Established Market Presence: AbbVie has established Skyrizi as a leading therapy in its approved indications. Competitors must overcome established brand loyalty, physician prescribing habits, and market access agreements. Opportunities for Competitors: Patent Expiration: The primary opportunity lies in the eventual expiration of US 11,723,858 and other relevant patents. Competitors can plan their market entry strategies around these expiration dates. Patent Invalidation: Competitors may challenge the validity of US 11,723,858 through post-grant review proceedings at the USPTO or in district court litigation. Grounds for invalidity could include lack of novelty, obviousness over prior art, or insufficient disclosure. Design-Around Strategies: Competitors can develop alternative formulations or different antibody constructs that achieve similar therapeutic effects but do not infringe on the specific claims of US 11,723,858. This might involve using different excipients, alternative buffer systems, or modified antibody structures. New Therapeutic Targets or Indications: Innovation can focus on targeting different aspects of the IL-23 pathway or exploring new therapeutic indications where IL-23 is implicated but not yet addressed by existing therapies, provided these are not also covered by existing patents. Novel Delivery Systems: Development of entirely new drug delivery systems or methods of administration that bypass patented aspects could present an opportunity, although this is less likely for established biologics like risankizumab which are typically administered via injection. Navigating the complex patent landscape requires meticulous legal and scientific analysis, alongside a robust innovation strategy. Key Takeaways US 11,723,858 protects specific pharmaceutical compositions and methods of treatment for the IL-23 inhibitor risankizumab, enhancing AbbVie's market exclusivity for Skyrizi. The patent's claims focus on optimized formulations, including specific excipients and concentrations, and detailed treatment protocols for inflammatory and autoimmune diseases. The IL-23 inhibitor market is competitive, with established therapies from Janssen (ustekinumab, guselkumab) and Sun Pharma (tildrakizumab) already in play. US 11,723,858 is part of a broader patent strategy to extend the commercial lifecycle of risankizumab beyond the expiration of its initial composition of matter patents. Competitors face challenges from patent infringement risks and the need to demonstrate biosimilarity, but opportunities exist through patent expiration, invalidation challenges, and design-around strategies. Frequently Asked Questions What is the primary therapeutic target of the antibody described in US 11,723,858? The antibody targets the p19 subunit of interleukin-23 (IL-23). Which specific diseases are mentioned in the method of treatment claims of US 11,723,858? The patent claims methods for treating conditions including psoriasis, psoriatic arthritis, and Crohn's disease. Does US 11,723,858 claim risankizumab as a novel molecule? No, the patent likely protects specific formulations and methods of use for risankizumab, rather than claiming the antibody itself as a new composition of matter, which would have been covered by earlier patents. How does this patent contribute to AbbVie's market exclusivity? It extends market exclusivity by protecting the specific drug formulations and treatment protocols commercialized as Skyrizi, making it harder for biosimilar competitors to enter the market with equivalent products and methods. What are potential strategies for a competitor to navigate the patent protection offered by US 11,723,858? Competitors can explore strategies such as challenging the patent's validity, developing alternative formulations that do not infringe the specific claims, or planning market entry after the patent's expiration. Citations [1] AbbVie Inc. (2023). Pharmaceutical composition and use thereof. United States Patent US 11,723,858. Washington, DC: U.S. Patent and Trademark Office. More… ↓ ⤷ Start Trial

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes	11,723,858	⤷ Start Trial	Y			METHOD OF ADMINISTERING A NITRIC OXIDE RELEASING ACTIVE PHARMACEUTICAL INGREDIENT TO TREAT AND/OR PREVENT VIRAL INFECTION	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015287674	⤷ Start Trial
Brazil	112017000456	⤷ Start Trial
Canada	2954061	⤷ Start Trial
China	106659675	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,723,858

Which drugs does patent 11,723,858 protect, and when does it expire?

Summary for Patent: 11,723,858