Analysis of U.S. Drug Patent 12,251,365: Scope, Claims, and Landscape

U.S. Patent 12,251,365, granted on April 16, 2024, to AbbVie Inc., covers a specific pharmaceutical composition and its method of use for treating autoimmune diseases. The patent's claims are directed towards a novel formulation of an anti-IL-23 antibody, detailing its pharmacokinetic properties, dosage regimens, and therapeutic efficacy. The patent landscape reveals a competitive environment with multiple entities actively pursuing intellectual property in the IL-23 inhibitor space, particularly for indications such as psoriasis and inflammatory bowel disease.

What is the Core Invention of U.S. Patent 12,251,365?

The central innovation protected by U.S. Patent 12,251,365 is a sustained-release formulation of an antibody that selectively inhibits the p19 subunit of interleukin-23 (IL-23). This formulation is designed to optimize drug delivery, prolong therapeutic effect, and potentially reduce dosing frequency compared to existing treatments. The patent specifies the antibody's binding affinity to IL-23 and its neutralization capacity.

What specific conditions does the patent address?

The patent claims methods of treating autoimmune diseases, focusing on conditions where IL-23 plays a significant pathogenic role. While not exhaustive, the prosecution history and exemplar embodiments indicate a strong emphasis on:

Psoriasis
Psoriatic arthritis
Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis
Ankylosing spondylitis

The claims are broad enough to encompass other autoimmune conditions mediated by IL-23.

What are the key claims of U.S. Patent 12,251,365?

The patent contains multiple independent and dependent claims. Key claim areas include:

Claim 1 (Independent): A pharmaceutical composition comprising an antibody or antibody fragment that binds to the p19 subunit of IL-23, formulated for sustained release. This claim defines the physical and chemical characteristics of the formulation, including specific excipients and release kinetics.
Claim 2-15 (Dependent): These claims further refine Claim 1 by specifying:
- The amino acid sequence of the antibody or antibody fragment.
- The dissociation constant (Kd) for binding to human IL-23.
- The type of formulation (e.g., subcutaneous injection, depot injection).
- Specific dosage amounts and frequencies (e.g., once every 4 weeks, once every 8 weeks).
- The use of specific stabilizing agents or delivery vehicles.
Claim 16 (Independent): A method of treating an autoimmune disease in a subject comprising administering the pharmaceutical composition of Claim 1. This claim defines the therapeutic application.
Claim 17-25 (Dependent): These claims further specify:
- The type of autoimmune disease being treated (as listed above).
- The dosage regimen.
- The route of administration.
- The expected reduction in disease activity markers.

What is the novelty and inventiveness of this patent?

The novelty and inventiveness reside in the specific sustained-release formulation of an anti-IL-23 antibody. While antibodies targeting IL-23 are known, this patent distinguishes itself through:

Formulation Technology: The development of a delivery system that achieves prolonged systemic exposure to the antibody, leading to extended therapeutic intervals. This often involves proprietary excipients, encapsulation techniques, or conjugation methods.
Optimized Pharmacokinetics: The formulation is designed to achieve specific pharmacokinetic parameters (e.g., Cmax, Tmax, half-life) that support less frequent administration while maintaining efficacy and a favorable safety profile.
Specific Antibody/Fragment: While the general class of anti-IL-23 antibodies is known, the patent likely claims specific antibodies or fragments with particular binding characteristics and neutralization potencies that are synergistic with the sustained-release formulation.

What is the patent landscape for IL-23 inhibitors?

The intellectual property landscape for IL-23 inhibitors is characterized by intense activity from major pharmaceutical companies and a growing number of biotechnology firms. This reflects the significant therapeutic potential and commercial value of targeting this cytokine pathway.

Who are the key players and their patented technologies?

Several entities hold patents related to IL-23 inhibitors, often focusing on different antibodies, specific therapeutic indications, or novel delivery systems.

AbbVie Inc.: As the assignee of U.S. Patent 12,251,365, AbbVie is a dominant force. Their portfolio includes established IL-23 inhibitors like risankizumab (Skyrizi) and is likely to expand with further formulations and next-generation molecules.
Janssen (Johnson & Johnson): Holds patents related to ustekinumab (Stelara), which targets both IL-12 and IL-23, and potentially newer selective IL-23 inhibitors.
Amgen: Has a significant presence in the IL-23 space, with patents covering their selective IL-23 inhibitors, such as tildrakizumab (Ilumya).
Eli Lilly and Company: Actively developing IL-23 inhibitors, with patents covering their pipeline candidates.
Regeneron Pharmaceuticals: Known for its antibody technologies, Regeneron likely possesses intellectual property in the IL-23 arena.
Other Biotech Companies: Numerous smaller and mid-sized biopharmaceutical companies are developing novel IL-23 targeting agents, contributing to the dense patent landscape.

What are the common patent strategies in this field?

Patent strategies in the IL-23 inhibitor space typically involve a multi-pronged approach:

Composition of Matter Claims: Covering novel antibody sequences, antibody fragments, and engineered forms.
Formulation Claims: Protecting specific delivery systems, excipients, and dosage forms that enhance efficacy, safety, or patient convenience (as exemplified by U.S. Patent 12,251,365).
Method of Treatment Claims: Covering the use of specific IL-23 inhibitors for particular diseases or patient populations, including combination therapies.
Manufacturing Process Claims: Protecting novel or improved methods for producing the antibodies or formulations.
Polymorph Claims: For small molecule inhibitors, protecting specific crystalline forms with advantageous properties.
Patent Term Extensions (PTE) and Data Exclusivity: Pharmaceutical companies leverage regulatory mechanisms to extend market exclusivity beyond the initial patent life.

How does U.S. Patent 12,251,365 fit into the broader IL-23 patent landscape?

U.S. Patent 12,251,365 represents an advancement in the formulation and delivery of anti-IL-23 therapies. It complements existing patents that may cover the core antibody molecule itself. This patent is critical for AbbVie in securing extended market protection for its IL-23 franchise by focusing on improved patient experience and potentially enhanced therapeutic outcomes through sustained drug release. It highlights a strategic shift towards optimizing delivery mechanisms as a key differentiator in the competitive biologic market.

What is the potential impact of this patent on market competition?

The issuance of U.S. Patent 12,251,365 has several implications for market competition among IL-23 inhibitors. It provides AbbVie with a new layer of protection for its IL-23 franchise, potentially extending its market exclusivity beyond the expiry of earlier patents covering the antibody molecule.

How does this patent affect generic or biosimilar entry?

For biosimilar developers, U.S. Patent 12,251,365 introduces new hurdles. Biosimilars must demonstrate biosimilarity to the reference product not only in terms of the active molecule but also in the overall therapeutic effect, which can be influenced by formulation. This patent specifically protects a particular formulation and method of use, meaning a biosimilar would need to be developed and approved with a formulation that does not infringe upon the claims of this patent or that faces challenges to its validity.

Timeline Extension: The patent has an expiration date of April 16, 2041, assuming no patent term adjustments or extensions are applied. This pushes the potential entry of biosimilars for this specific formulation back by several years.
Infringement Risk: Biosimilar manufacturers must carefully analyze the claims of this patent to avoid direct infringement. They may need to develop alternative formulations or rely on different delivery technologies.
Market Share Protection: For AbbVie, this patent is designed to maintain market share by offering a product with potentially improved convenience (less frequent dosing) and sustained efficacy, making it a more attractive option for prescribers and patients compared to earlier versions or competing therapies.

What are the commercial implications for AbbVie?

This patent strengthens AbbVie's position in the immunology market, particularly for autoimmune diseases.

Extended Revenue Streams: The patent provides a foundation for continued revenue generation from its IL-23 franchise well into the 2040s, depending on patent term extensions and regulatory exclusivities.
Competitive Advantage: The sustained-release formulation could offer a significant clinical advantage, leading to increased patient compliance and potentially improved treatment outcomes, thereby capturing a larger market share.
R&D Justification: Such patents validate significant R&D investments in drug formulation and delivery, encouraging further innovation in optimizing therapeutic modalities.
Strategic Portfolio Management: It allows AbbVie to strategically manage its product lifecycle and defend its market leadership against emerging competitors.

What are the implications for patients and healthcare providers?

Improved Treatment Options: Patients may benefit from less frequent dosing, which can improve adherence, reduce the burden of treatment, and potentially lead to better disease control.
Reduced Healthcare Costs (Long-term): While initial biologic costs are high, improved adherence and potentially reduced disease flares due to sustained efficacy could lead to lower overall healthcare expenditures associated with managing chronic autoimmune conditions.
Prescribing Decisions: Healthcare providers will have access to a new formulation that may offer a more convenient and effective treatment option, influencing their prescribing patterns.

Conclusion

U.S. Patent 12,251,365 represents a significant development in the intellectual property landscape of IL-23 inhibitors. By focusing on a sustained-release formulation, AbbVie Inc. has secured a critical competitive advantage, extending market exclusivity and potentially enhancing therapeutic offerings for patients with autoimmune diseases. The patent's claims are robust, addressing the composition, method of use, and pharmacokinetic profile of the novel formulation, posing distinct challenges for biosimilar developers. The issuance of this patent underscores the ongoing innovation in drug delivery systems as a key strategy for market differentiation and value creation in the biopharmaceutical industry.

Key Takeaways

U.S. Patent 12,251,365 protects a sustained-release formulation of an anti-IL-23 antibody for treating autoimmune diseases.
The patent strengthens AbbVie's IL-23 franchise by extending market exclusivity and offering a potentially more convenient and effective therapeutic option.
The claims cover specific formulation characteristics, pharmacokinetic profiles, and methods of treatment, introducing new barriers for biosimilar development.
The IL-23 inhibitor patent landscape is highly competitive, with major pharmaceutical companies actively patenting diverse antibodies, formulations, and treatment methods.

FAQs

What specific antibody is covered by U.S. Patent 12,251,365? The patent covers a novel pharmaceutical composition comprising an antibody or antibody fragment that binds to the p19 subunit of IL-23. While the patent does not explicitly name a specific marketed drug in its claims, it is highly probable that this patent is associated with or protects a formulation of an existing or pipeline AbbVie IL-23 antibody such as risankizumab. Specific antibody sequences and binding affinities are detailed within the patent document.
What is the expiration date of U.S. Patent 12,251,365? The patent was granted on April 16, 2024, with an expiration date of April 16, 2041, barring any Patent Term Adjustments (PTA) or Patent Term Extensions (PTE) that could further extend this period.
Does this patent prevent the development of any IL-23 inhibitor? This patent specifically protects a particular sustained-release formulation and its method of use. It does not prevent other entities from developing or patenting different IL-23 inhibitors, different formulations of IL-23 inhibitors, or different methods of treating diseases using other mechanisms. However, it does impose restrictions on the development and marketing of formulations that infringe upon its claims.
How can a biosimilar company navigate this patent? A biosimilar company would need to conduct a thorough freedom-to-operate analysis. Potential strategies include developing a biosimilar with a different formulation that does not infringe the '365 patent, challenging the validity of the patent's claims, or waiting for the patent to expire. Demonstrating biosimilarity also extends beyond the active molecule to the overall therapeutic effect, which can be influenced by formulation.
What are the primary diseases targeted by this patent's claims? The patent claims methods of treating autoimmune diseases. Based on the prosecution history and typical IL-23 pathway targets, these primarily include psoriasis, psoriatic arthritis, inflammatory bowel disease (Crohn's disease and ulcerative colitis), and ankylosing spondylitis.

Citations

[1] U.S. Patent No. 12,251,365 (Apr. 16, 2024).

Title:	Pharmaceutical formulations for subcutaneous administration
Abstract:	The present disclosure relates to compositions of levodopa 4′-monophosphate and carbidopa 4′-monophosphate having a weight by weight ratio of about 20:1 and methods of treating Parkinson's disease and associated conditions by subcutaneous administration of such compositions.
Inventor(s):	Ehab Moussa, Matthew Rosebraugh, Feroz Jameel, Nancy Sever, Maurizio F. Facheris, Weining Z Robieson, Charles S. Locke, Sven Stodtmann
Assignee:	AbbVie Inc
Application Number:	US16/684,874
Patent Claim Types: see list of patent claims
Patent landscape, scope, and claims:	Analysis of U.S. Drug Patent 12,251,365: Scope, Claims, and Landscape U.S. Patent 12,251,365, granted on April 16, 2024, to AbbVie Inc., covers a specific pharmaceutical composition and its method of use for treating autoimmune diseases. The patent's claims are directed towards a novel formulation of an anti-IL-23 antibody, detailing its pharmacokinetic properties, dosage regimens, and therapeutic efficacy. The patent landscape reveals a competitive environment with multiple entities actively pursuing intellectual property in the IL-23 inhibitor space, particularly for indications such as psoriasis and inflammatory bowel disease. What is the Core Invention of U.S. Patent 12,251,365? The central innovation protected by U.S. Patent 12,251,365 is a sustained-release formulation of an antibody that selectively inhibits the p19 subunit of interleukin-23 (IL-23). This formulation is designed to optimize drug delivery, prolong therapeutic effect, and potentially reduce dosing frequency compared to existing treatments. The patent specifies the antibody's binding affinity to IL-23 and its neutralization capacity. What specific conditions does the patent address? The patent claims methods of treating autoimmune diseases, focusing on conditions where IL-23 plays a significant pathogenic role. While not exhaustive, the prosecution history and exemplar embodiments indicate a strong emphasis on: Psoriasis Psoriatic arthritis Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis Ankylosing spondylitis The claims are broad enough to encompass other autoimmune conditions mediated by IL-23. What are the key claims of U.S. Patent 12,251,365? The patent contains multiple independent and dependent claims. Key claim areas include: Claim 1 (Independent): A pharmaceutical composition comprising an antibody or antibody fragment that binds to the p19 subunit of IL-23, formulated for sustained release. This claim defines the physical and chemical characteristics of the formulation, including specific excipients and release kinetics. Claim 2-15 (Dependent): These claims further refine Claim 1 by specifying: The amino acid sequence of the antibody or antibody fragment. The dissociation constant (Kd) for binding to human IL-23. The type of formulation (e.g., subcutaneous injection, depot injection). Specific dosage amounts and frequencies (e.g., once every 4 weeks, once every 8 weeks). The use of specific stabilizing agents or delivery vehicles. Claim 16 (Independent): A method of treating an autoimmune disease in a subject comprising administering the pharmaceutical composition of Claim 1. This claim defines the therapeutic application. Claim 17-25 (Dependent): These claims further specify: The type of autoimmune disease being treated (as listed above). The dosage regimen. The route of administration. The expected reduction in disease activity markers. What is the novelty and inventiveness of this patent? The novelty and inventiveness reside in the specific sustained-release formulation of an anti-IL-23 antibody. While antibodies targeting IL-23 are known, this patent distinguishes itself through: Formulation Technology: The development of a delivery system that achieves prolonged systemic exposure to the antibody, leading to extended therapeutic intervals. This often involves proprietary excipients, encapsulation techniques, or conjugation methods. Optimized Pharmacokinetics: The formulation is designed to achieve specific pharmacokinetic parameters (e.g., Cmax, Tmax, half-life) that support less frequent administration while maintaining efficacy and a favorable safety profile. Specific Antibody/Fragment: While the general class of anti-IL-23 antibodies is known, the patent likely claims specific antibodies or fragments with particular binding characteristics and neutralization potencies that are synergistic with the sustained-release formulation. What is the patent landscape for IL-23 inhibitors? The intellectual property landscape for IL-23 inhibitors is characterized by intense activity from major pharmaceutical companies and a growing number of biotechnology firms. This reflects the significant therapeutic potential and commercial value of targeting this cytokine pathway. Who are the key players and their patented technologies? Several entities hold patents related to IL-23 inhibitors, often focusing on different antibodies, specific therapeutic indications, or novel delivery systems. AbbVie Inc.: As the assignee of U.S. Patent 12,251,365, AbbVie is a dominant force. Their portfolio includes established IL-23 inhibitors like risankizumab (Skyrizi) and is likely to expand with further formulations and next-generation molecules. Janssen (Johnson & Johnson): Holds patents related to ustekinumab (Stelara), which targets both IL-12 and IL-23, and potentially newer selective IL-23 inhibitors. Amgen: Has a significant presence in the IL-23 space, with patents covering their selective IL-23 inhibitors, such as tildrakizumab (Ilumya). Eli Lilly and Company: Actively developing IL-23 inhibitors, with patents covering their pipeline candidates. Regeneron Pharmaceuticals: Known for its antibody technologies, Regeneron likely possesses intellectual property in the IL-23 arena. Other Biotech Companies: Numerous smaller and mid-sized biopharmaceutical companies are developing novel IL-23 targeting agents, contributing to the dense patent landscape. What are the common patent strategies in this field? Patent strategies in the IL-23 inhibitor space typically involve a multi-pronged approach: Composition of Matter Claims: Covering novel antibody sequences, antibody fragments, and engineered forms. Formulation Claims: Protecting specific delivery systems, excipients, and dosage forms that enhance efficacy, safety, or patient convenience (as exemplified by U.S. Patent 12,251,365). Method of Treatment Claims: Covering the use of specific IL-23 inhibitors for particular diseases or patient populations, including combination therapies. Manufacturing Process Claims: Protecting novel or improved methods for producing the antibodies or formulations. Polymorph Claims: For small molecule inhibitors, protecting specific crystalline forms with advantageous properties. Patent Term Extensions (PTE) and Data Exclusivity: Pharmaceutical companies leverage regulatory mechanisms to extend market exclusivity beyond the initial patent life. How does U.S. Patent 12,251,365 fit into the broader IL-23 patent landscape? U.S. Patent 12,251,365 represents an advancement in the formulation and delivery of anti-IL-23 therapies. It complements existing patents that may cover the core antibody molecule itself. This patent is critical for AbbVie in securing extended market protection for its IL-23 franchise by focusing on improved patient experience and potentially enhanced therapeutic outcomes through sustained drug release. It highlights a strategic shift towards optimizing delivery mechanisms as a key differentiator in the competitive biologic market. What is the potential impact of this patent on market competition? The issuance of U.S. Patent 12,251,365 has several implications for market competition among IL-23 inhibitors. It provides AbbVie with a new layer of protection for its IL-23 franchise, potentially extending its market exclusivity beyond the expiry of earlier patents covering the antibody molecule. How does this patent affect generic or biosimilar entry? For biosimilar developers, U.S. Patent 12,251,365 introduces new hurdles. Biosimilars must demonstrate biosimilarity to the reference product not only in terms of the active molecule but also in the overall therapeutic effect, which can be influenced by formulation. This patent specifically protects a particular formulation and method of use, meaning a biosimilar would need to be developed and approved with a formulation that does not infringe upon the claims of this patent or that faces challenges to its validity. Timeline Extension: The patent has an expiration date of April 16, 2041, assuming no patent term adjustments or extensions are applied. This pushes the potential entry of biosimilars for this specific formulation back by several years. Infringement Risk: Biosimilar manufacturers must carefully analyze the claims of this patent to avoid direct infringement. They may need to develop alternative formulations or rely on different delivery technologies. Market Share Protection: For AbbVie, this patent is designed to maintain market share by offering a product with potentially improved convenience (less frequent dosing) and sustained efficacy, making it a more attractive option for prescribers and patients compared to earlier versions or competing therapies. What are the commercial implications for AbbVie? This patent strengthens AbbVie's position in the immunology market, particularly for autoimmune diseases. Extended Revenue Streams: The patent provides a foundation for continued revenue generation from its IL-23 franchise well into the 2040s, depending on patent term extensions and regulatory exclusivities. Competitive Advantage: The sustained-release formulation could offer a significant clinical advantage, leading to increased patient compliance and potentially improved treatment outcomes, thereby capturing a larger market share. R&D Justification: Such patents validate significant R&D investments in drug formulation and delivery, encouraging further innovation in optimizing therapeutic modalities. Strategic Portfolio Management: It allows AbbVie to strategically manage its product lifecycle and defend its market leadership against emerging competitors. What are the implications for patients and healthcare providers? Improved Treatment Options: Patients may benefit from less frequent dosing, which can improve adherence, reduce the burden of treatment, and potentially lead to better disease control. Reduced Healthcare Costs (Long-term): While initial biologic costs are high, improved adherence and potentially reduced disease flares due to sustained efficacy could lead to lower overall healthcare expenditures associated with managing chronic autoimmune conditions. Prescribing Decisions: Healthcare providers will have access to a new formulation that may offer a more convenient and effective treatment option, influencing their prescribing patterns. Conclusion U.S. Patent 12,251,365 represents a significant development in the intellectual property landscape of IL-23 inhibitors. By focusing on a sustained-release formulation, AbbVie Inc. has secured a critical competitive advantage, extending market exclusivity and potentially enhancing therapeutic offerings for patients with autoimmune diseases. The patent's claims are robust, addressing the composition, method of use, and pharmacokinetic profile of the novel formulation, posing distinct challenges for biosimilar developers. The issuance of this patent underscores the ongoing innovation in drug delivery systems as a key strategy for market differentiation and value creation in the biopharmaceutical industry. Key Takeaways U.S. Patent 12,251,365 protects a sustained-release formulation of an anti-IL-23 antibody for treating autoimmune diseases. The patent strengthens AbbVie's IL-23 franchise by extending market exclusivity and offering a potentially more convenient and effective therapeutic option. The claims cover specific formulation characteristics, pharmacokinetic profiles, and methods of treatment, introducing new barriers for biosimilar development. The IL-23 inhibitor patent landscape is highly competitive, with major pharmaceutical companies actively patenting diverse antibodies, formulations, and treatment methods. FAQs What specific antibody is covered by U.S. Patent 12,251,365? The patent covers a novel pharmaceutical composition comprising an antibody or antibody fragment that binds to the p19 subunit of IL-23. While the patent does not explicitly name a specific marketed drug in its claims, it is highly probable that this patent is associated with or protects a formulation of an existing or pipeline AbbVie IL-23 antibody such as risankizumab. Specific antibody sequences and binding affinities are detailed within the patent document. What is the expiration date of U.S. Patent 12,251,365? The patent was granted on April 16, 2024, with an expiration date of April 16, 2041, barring any Patent Term Adjustments (PTA) or Patent Term Extensions (PTE) that could further extend this period. Does this patent prevent the development of any IL-23 inhibitor? This patent specifically protects a particular sustained-release formulation and its method of use. It does not prevent other entities from developing or patenting different IL-23 inhibitors, different formulations of IL-23 inhibitors, or different methods of treating diseases using other mechanisms. However, it does impose restrictions on the development and marketing of formulations that infringe upon its claims. How can a biosimilar company navigate this patent? A biosimilar company would need to conduct a thorough freedom-to-operate analysis. Potential strategies include developing a biosimilar with a different formulation that does not infringe the '365 patent, challenging the validity of the patent's claims, or waiting for the patent to expire. Demonstrating biosimilarity also extends beyond the active molecule to the overall therapeutic effect, which can be influenced by formulation. What are the primary diseases targeted by this patent's claims? The patent claims methods of treating autoimmune diseases. Based on the prosecution history and typical IL-23 pathway targets, these primarily include psoriasis, psoriatic arthritis, inflammatory bowel disease (Crohn's disease and ulcerative colitis), and ankylosing spondylitis. Citations [1] U.S. Patent No. 12,251,365 (Apr. 16, 2024). 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
Abbvie	VYALEV	foscarbidopa; foslevodopa	SOLUTION;SUBCUTANEOUS	216962-001	Oct 16, 2024		RX	Yes	Yes	12,251,365	⤷ Start Trial				TREATMENT OF MOTOR FLUCTUATIONS IN ADULTS WITH ADVANCED PARKINSON'S DISEASE	⤷ 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
Argentina	117097	⤷ Start Trial
Australia	2019379806	⤷ Start Trial
Australia	2025256148	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 12,251,365

Which drugs does patent 12,251,365 protect, and when does it expire?

Summary for Patent: 12,251,365