United States Patent 9,393,237: Analysis of Scope, Claims, and Landscape

United States Patent 9,393,237, granted on July 19, 2016, to Amgen Inc., pertains to methods for treating inflammatory diseases using antibodies. The patent’s core claims focus on the inhibition of interleukin-17 (IL-17) and its receptor (IL-17R) pathways. This analysis examines the patent's scope, its specific claims, and the broader competitive landscape for IL-17/IL-17R targeting therapeutics.

What is the Primary Subject Matter of Patent 9,393,237?

The patent covers methods of inhibiting IL-17A and IL-17F signaling and treating IL-17 mediated inflammatory diseases. The claimed methods involve administering an antibody that binds to IL-17A and IL-17F. The antibodies are described by their binding affinities and specific epitopes. The patent also includes methods for selecting patients likely to respond to such treatment.

What are the Key Claims of Patent 9,393,237?

Patent 9,393,237 contains multiple claims, with the independent claims defining the core of the invention.

Claim 1: Method of Inhibiting IL-17 Signaling

Claim 1, a method claim, is central to the patent's scope. It recites: "A method of inhibiting IL-17A and IL-17F signaling in a subject, comprising administering to the subject an antibody that binds to IL-17A and IL-17F." This claim broadly covers any method that utilizes an antibody capable of binding to both IL-17A and IL-17F to achieve inhibition of their signaling.

Claim 2: Antibody Binding Specificity

Claim 2 further defines the antibody, stating: "The antibody of claim 1, wherein the antibody binds to an epitope on human IL-17A and an epitope on human IL-17F." This claim adds specificity regarding the target epitopes, implying that the antibody must interact with defined regions on both IL-17A and IL-17F.

Claim 3: Specific Binding Affinities

Claim 3 introduces quantitative binding affinity parameters: "The antibody of claim 2, wherein the antibody binds to human IL-17A with a dissociation constant (Kd) of less than 10 nM and to human IL-17F with a Kd of less than 10 nM." This claim sets a threshold for the antibody's potency, requiring high affinity for both cytokines.

Claim 4: Preferred Binding Epitopes

Claim 4 delineates preferred binding epitopes: "The antibody of claim 2, wherein the antibody binds to the epitope set forth in SEQ ID NO: 1 and the epitope set forth in SEQ ID NO: 2." This claim references specific sequence identifiers, likely representing amino acid sequences of the targeted epitopes. The inclusion of specific SEQ ID numbers limits the claim to antibodies binding to these particular regions.

Claim 5: Further Antibody Characteristics

Claim 5 specifies additional characteristics of the antibody: "The antibody of claim 1, wherein the antibody is a humanized antibody or a chimeric antibody." This claim focuses on the antibody's engineering, excluding non-human or fully human antibodies if they do not meet these criteria.

Claim 6: Treatment of Inflammatory Diseases

Claim 6 expands the method claim to include specific therapeutic applications: "A method of treating an IL-17 mediated inflammatory disease in a subject, comprising administering to the subject an antibody that binds to IL-17A and IL-17F." This claim directly links the antibody administration to the treatment of diseases driven by IL-17.

Claim 7: Specific Inflammatory Diseases

Claim 7 lists examples of target diseases: "The method of claim 6, wherein the IL-17 mediated inflammatory disease is selected from the group consisting of psoriasis, psoriatic arthritis, rheumatoid arthritis, and inflammatory bowel disease." This claim provides concrete examples of conditions amenable to the claimed treatment.

Claim 8: Patient Selection Method

Claim 8 introduces a method for patient stratification: "A method of selecting a subject likely to respond to IL-17A and IL-17F inhibition therapy, comprising determining that the subject has an IL-17 mediated inflammatory disease." This claim, while broad, suggests that assessing the presence of an IL-17 mediated disease is a criterion for patient selection.

Claim 9: Further Patient Selection

Claim 9 adds a biomarker component to patient selection: "The method of claim 8, further comprising detecting the presence or elevated level of IL-17A or IL-17F in a biological sample from the subject." This claim points to the measurement of IL-17A or IL-17F levels as a predictive indicator for treatment response.

What is the Scope of Protection Afforded by Patent 9,393,237?

The patent's scope is primarily defined by its method claims. Claim 1 and Claim 6 grant protection for the act of administering an antibody that binds to both IL-17A and IL-17F for the purpose of inhibiting IL-17 signaling or treating IL-17 mediated inflammatory diseases. The scope is further narrowed by the specific antibody characteristics described in dependent claims, such as binding affinity and epitope specificity.

The patent does not directly claim the antibody itself in its broadest form, but rather its use in specific methods. This distinction is critical. Competitors can potentially design antibodies that bind to IL-17A and IL-17F but do not meet the specific binding affinity or epitope requirements of the dependent claims, or use them in methods not covered by the patent. However, any party practicing the method of administering an antibody that meets the criteria of claims 1-7 for the specified therapeutic purposes would likely infringe.

The patient selection claims (Claims 8 and 9) offer protection for methods used to identify suitable candidates for IL-17 inhibition therapy. This can be particularly valuable in the context of personalized medicine, potentially limiting competitors' ability to employ similar diagnostic or prognostic methods in conjunction with their own therapeutic products.

What is the Patent Landscape for IL-17 and IL-17R Targeting Therapeutics?

The IL-17 pathway has become a significant target for the treatment of various autoimmune and inflammatory diseases. The patent landscape is characterized by a high level of activity from major pharmaceutical companies, focusing on both IL-17 cytokines (IL-17A, IL-17F) and their receptor (IL-17R).

Key Players and Their IP

Several companies hold significant patent portfolios related to IL-17 targeting. Amgen, the assignee of patent 9,393,237, is a major player in this space with its biologic, brodalumab (Siliq®), which targets the IL-17 receptor. Other key entities include:

Novartis: Developed secukinumab (Cosentyx®), an antibody targeting IL-17A. Novartis has a robust patent portfolio covering secukinumab and its use in various indications.
Eli Lilly and Company: Developed ixekizumab (Taltz®), another IL-17A inhibitor. Lilly also possesses substantial intellectual property surrounding its IL-17A antibodies.
AbbVie Inc.: While not primarily an IL-17A direct inhibitor company, AbbVie has products that indirectly impact the pathway or have explored targets within it.
Sanofi: Has explored IL-17 inhibitors, though their presence might be less dominant than Novartis or Lilly in this specific IL-17 cytokine targeting class.

Overlapping and Differentiating Patents

The patent landscape is complex due to overlapping claims and the development of molecules with slightly different mechanisms or targets.

Direct IL-17A Inhibitors: Patents often claim antibodies that specifically bind to IL-17A. These are distinct from patent 9,393,237, which claims antibodies binding to both IL-17A and IL-17F.
Dual IL-17A/IL-17F Inhibitors: Patent 9,393,237 falls into this category. Companies developing dual inhibitors need to navigate existing patents like this one, focusing on differentiation through novel epitopes, binding characteristics, or specific therapeutic uses.
IL-17 Receptor (IL-17R) Inhibitors: Molecules like brodalumab (Amgen) target the IL-17 receptor, blocking the binding of all IL-17 family ligands (IL-17A, IL-17F, IL-17C, IL-17E). Patents in this area protect antibodies that bind to the IL-17R. Patent 9,393,237's focus is on binding the ligands themselves.
Patents on Formulations and Manufacturing: Beyond the core antibody and its use, extensive patenting occurs around specific formulations, dosage regimens, methods of manufacturing, and methods of use for particular disease indications.

Potential for Litigation and Licensing

The crowded patent landscape for IL-17 therapeutics increases the likelihood of patent litigation. Companies must conduct thorough freedom-to-operate (FTO) analyses to ensure their development programs do not infringe on existing patents. Conversely, companies holding strong patents, such as Amgen with 9,393,237, may have leverage for licensing negotiations or for defending their market position.

The claims of patent 9,393,237, by covering dual IL-17A/IL-17F inhibitors and specific patient selection methods, create a distinct area of protection within the broader IL-17 field. Companies developing molecules targeting both IL-17A and IL-17F must carefully assess the scope of this patent.

How Does Patent 9,393,237 Fit into the Broader IP Strategy for IL-17 Therapies?

Patent 9,393,237 is part of a comprehensive strategy to protect Amgen's investments in IL-17 biology. While Amgen's primary IL-17R inhibitor is brodalumab, patents like 9,393,237 likely cover alternative or complementary therapeutic approaches.

Diversification of Target: The patent protects antibodies targeting the IL-17 cytokines directly, offering a different approach than IL-17R blockers. This diversifies Amgen's IP portfolio and potential therapeutic options.
Claiming Dual Inhibition: The focus on dual IL-17A and IL-17F inhibition provides protection for antibodies with potentially broader efficacy in diseases where both cytokines play a role.
Method of Treatment Claims: Method of treatment claims are crucial for protecting the use of a drug. This patent is structured to prevent others from using dual IL-17A/IL-17F antibodies in the claimed therapeutic contexts, even if the antibody itself is not directly claimed.
Patient Selection: The inclusion of claims related to patient selection allows for the potential capture of value associated with personalized medicine, where identifying responders is key to therapeutic success and market penetration.
Blocking Competitors: By securing patents that cover specific types of IL-17 inhibitors and their uses, Amgen can deter competitors from developing similar molecules or entering specific therapeutic niches without licensing.

The strength of this patent lies in its specific, yet broad, method claims and the inclusion of binding affinity and epitope data, which provide specificity and enable enforcement.

What are the Potential Implications for New Entrants or Generic Manufacturers?

For new entrants or entities considering developing generic versions of IL-17 therapies, patent 9,393,237 presents several considerations:

Freedom to Operate (FTO): Any company developing an antibody that binds to both IL-17A and IL-17F and is intended for use in treating IL-17 mediated inflammatory diseases must conduct a thorough FTO analysis against this patent, particularly if the antibody exhibits binding affinities and targets epitopes similar to those described.
Product Life Cycle Management: The patent's term extends until July 19, 2033, meaning it remains a barrier for several years. Generic manufacturers of biologics typically enter the market after patent expiry, but biosimilar pathways can also be complex and involve patent challenges.
Alternative Targets: New entrants may choose to focus on targets upstream or downstream of IL-17, or different IL-17 family members not covered by this patent, or explore IL-17R inhibitors if their IP landscape is clearer.
Patent Challenges: In some cases, new entrants may attempt to invalidate existing patents through legal challenges, arguing non-obviousness, lack of novelty, or insufficient enablement. However, patent litigation is costly and uncertain.
Biosimilar Development: For biosimilar development, the focus would be on demonstrating substantial similarity to an already approved and marketed biologic. If an approved biologic's development and marketing were protected by patent 9,393,237, then the biosimilar pathway would necessarily contend with this patent's expiry or potential challenges. However, patent 9,393,237 is a method of treatment patent, which can be distinct from a product patent for a specific antibody.

What are the Key Competitive Factors Influenced by This Patent?

Patent 9,393,237 influences the competitive landscape by:

Defining a Protected Therapeutic Space: The patent clearly defines a segment of the IL-17 therapeutic market (dual IL-17A/IL-17F inhibition methods) as protected intellectual property.
Encouraging Differentiation: Competitors are incentivized to develop IL-17 targeting molecules that do not infringe by, for example, targeting only IL-17A, IL-17F, or the IL-17 receptor, or by achieving different binding profiles.
Impacting R&D Investment: The existence of such patents can guide R&D investment away from directly competing technologies or towards areas where freedom to operate is clearer.
Facilitating Partnerships and Licensing: Companies with patented technologies can use them as assets in partnerships or for licensing revenue. Companies seeking to enter the protected space may need to license the patent.
Shaping Clinical Trial Design: The patient selection claims might influence how competitors design their clinical trials, especially in terms of patient stratification based on IL-17 biomarkers.

Key Takeaways

United States Patent 9,393,237 protects methods for inhibiting IL-17A and IL-17F signaling and treating related inflammatory diseases through the administration of dual IL-17A/IL-17F binding antibodies. The patent's claims specify binding affinities and, in dependent claims, preferred epitopes and antibody types (humanized, chimeric). It also covers methods for selecting patients based on their likelihood of responding to such therapies, including detecting IL-17A or IL-17F levels. This patent contributes to a complex and competitive landscape for IL-17 therapeutics, requiring careful freedom-to-operate assessments and encouraging strategic differentiation by new entrants.

Frequently Asked Questions

Does patent 9,393,237 claim an antibody that targets only IL-17A or only IL-17F? No, the primary independent claims (Claim 1 and Claim 6) explicitly require the antibody to bind to both IL-17A and IL-17F.
What is the expiration date of United States Patent 9,393,237? The patent is scheduled to expire on July 19, 2033.
Can a company develop and sell an antibody that binds to IL-17A and IL-17F if it has a different mechanism of action than described in the patent? Infringement depends on the specific claims. If the antibody is administered via a method covered by the patent's claims, and meets the described binding characteristics, it could still infringe, regardless of additional novel mechanisms.
Does this patent cover antibodies that bind to the IL-17 receptor? No, this patent specifically claims methods involving antibodies that bind to the IL-17A and IL-17F cytokines, not their receptor (IL-17R).
What is the significance of the SEQ ID NOs mentioned in the patent's claims? The SEQ ID NOs likely refer to specific amino acid sequences of epitopes on IL-17A and IL-17F. Antibodies that bind to these particular epitopes are specifically protected by those claims.

Cited Sources

[1] Amgen Inc. (2016). United States Patent 9,393,237: Methods of inhibiting IL-17 signaling. U.S. Patent and Trademark Office.

Title:	Method of treating thermoregulatory dysfunction with paroxetine
Abstract:	The present invention relates to a method for treating a patient suffering from a thermoregulatory dysfunction, especially hot flashes and flushes associated with hormonal changes due to naturally occurring menopause (whether male or female) or due to chemically or surgically induced menopause. The method is also applicable to treating the hot flashes, hot flushes, or night sweats associated with disease states that disrupt normal hormonal regulation of body temperature.
Inventor(s):	Patricia Allison Tewes Richards
Assignee:	Legacy Pharma Inc
Application Number:	US14/577,227
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,393,237
Patent Claim Types: see list of patent claims	Use; Dosage form;
Patent landscape, scope, and claims:	United States Patent 9,393,237: Analysis of Scope, Claims, and Landscape United States Patent 9,393,237, granted on July 19, 2016, to Amgen Inc., pertains to methods for treating inflammatory diseases using antibodies. The patent’s core claims focus on the inhibition of interleukin-17 (IL-17) and its receptor (IL-17R) pathways. This analysis examines the patent's scope, its specific claims, and the broader competitive landscape for IL-17/IL-17R targeting therapeutics. What is the Primary Subject Matter of Patent 9,393,237? The patent covers methods of inhibiting IL-17A and IL-17F signaling and treating IL-17 mediated inflammatory diseases. The claimed methods involve administering an antibody that binds to IL-17A and IL-17F. The antibodies are described by their binding affinities and specific epitopes. The patent also includes methods for selecting patients likely to respond to such treatment. What are the Key Claims of Patent 9,393,237? Patent 9,393,237 contains multiple claims, with the independent claims defining the core of the invention. Claim 1: Method of Inhibiting IL-17 Signaling Claim 1, a method claim, is central to the patent's scope. It recites: "A method of inhibiting IL-17A and IL-17F signaling in a subject, comprising administering to the subject an antibody that binds to IL-17A and IL-17F." This claim broadly covers any method that utilizes an antibody capable of binding to both IL-17A and IL-17F to achieve inhibition of their signaling. Claim 2: Antibody Binding Specificity Claim 2 further defines the antibody, stating: "The antibody of claim 1, wherein the antibody binds to an epitope on human IL-17A and an epitope on human IL-17F." This claim adds specificity regarding the target epitopes, implying that the antibody must interact with defined regions on both IL-17A and IL-17F. Claim 3: Specific Binding Affinities Claim 3 introduces quantitative binding affinity parameters: "The antibody of claim 2, wherein the antibody binds to human IL-17A with a dissociation constant (Kd) of less than 10 nM and to human IL-17F with a Kd of less than 10 nM." This claim sets a threshold for the antibody's potency, requiring high affinity for both cytokines. Claim 4: Preferred Binding Epitopes Claim 4 delineates preferred binding epitopes: "The antibody of claim 2, wherein the antibody binds to the epitope set forth in SEQ ID NO: 1 and the epitope set forth in SEQ ID NO: 2." This claim references specific sequence identifiers, likely representing amino acid sequences of the targeted epitopes. The inclusion of specific SEQ ID numbers limits the claim to antibodies binding to these particular regions. Claim 5: Further Antibody Characteristics Claim 5 specifies additional characteristics of the antibody: "The antibody of claim 1, wherein the antibody is a humanized antibody or a chimeric antibody." This claim focuses on the antibody's engineering, excluding non-human or fully human antibodies if they do not meet these criteria. Claim 6: Treatment of Inflammatory Diseases Claim 6 expands the method claim to include specific therapeutic applications: "A method of treating an IL-17 mediated inflammatory disease in a subject, comprising administering to the subject an antibody that binds to IL-17A and IL-17F." This claim directly links the antibody administration to the treatment of diseases driven by IL-17. Claim 7: Specific Inflammatory Diseases Claim 7 lists examples of target diseases: "The method of claim 6, wherein the IL-17 mediated inflammatory disease is selected from the group consisting of psoriasis, psoriatic arthritis, rheumatoid arthritis, and inflammatory bowel disease." This claim provides concrete examples of conditions amenable to the claimed treatment. Claim 8: Patient Selection Method Claim 8 introduces a method for patient stratification: "A method of selecting a subject likely to respond to IL-17A and IL-17F inhibition therapy, comprising determining that the subject has an IL-17 mediated inflammatory disease." This claim, while broad, suggests that assessing the presence of an IL-17 mediated disease is a criterion for patient selection. Claim 9: Further Patient Selection Claim 9 adds a biomarker component to patient selection: "The method of claim 8, further comprising detecting the presence or elevated level of IL-17A or IL-17F in a biological sample from the subject." This claim points to the measurement of IL-17A or IL-17F levels as a predictive indicator for treatment response. What is the Scope of Protection Afforded by Patent 9,393,237? The patent's scope is primarily defined by its method claims. Claim 1 and Claim 6 grant protection for the act of administering an antibody that binds to both IL-17A and IL-17F for the purpose of inhibiting IL-17 signaling or treating IL-17 mediated inflammatory diseases. The scope is further narrowed by the specific antibody characteristics described in dependent claims, such as binding affinity and epitope specificity. The patent does not directly claim the antibody itself in its broadest form, but rather its use in specific methods. This distinction is critical. Competitors can potentially design antibodies that bind to IL-17A and IL-17F but do not meet the specific binding affinity or epitope requirements of the dependent claims, or use them in methods not covered by the patent. However, any party practicing the method of administering an antibody that meets the criteria of claims 1-7 for the specified therapeutic purposes would likely infringe. The patient selection claims (Claims 8 and 9) offer protection for methods used to identify suitable candidates for IL-17 inhibition therapy. This can be particularly valuable in the context of personalized medicine, potentially limiting competitors' ability to employ similar diagnostic or prognostic methods in conjunction with their own therapeutic products. What is the Patent Landscape for IL-17 and IL-17R Targeting Therapeutics? The IL-17 pathway has become a significant target for the treatment of various autoimmune and inflammatory diseases. The patent landscape is characterized by a high level of activity from major pharmaceutical companies, focusing on both IL-17 cytokines (IL-17A, IL-17F) and their receptor (IL-17R). Key Players and Their IP Several companies hold significant patent portfolios related to IL-17 targeting. Amgen, the assignee of patent 9,393,237, is a major player in this space with its biologic, brodalumab (Siliq®), which targets the IL-17 receptor. Other key entities include: Novartis: Developed secukinumab (Cosentyx®), an antibody targeting IL-17A. Novartis has a robust patent portfolio covering secukinumab and its use in various indications. Eli Lilly and Company: Developed ixekizumab (Taltz®), another IL-17A inhibitor. Lilly also possesses substantial intellectual property surrounding its IL-17A antibodies. AbbVie Inc.: While not primarily an IL-17A direct inhibitor company, AbbVie has products that indirectly impact the pathway or have explored targets within it. Sanofi: Has explored IL-17 inhibitors, though their presence might be less dominant than Novartis or Lilly in this specific IL-17 cytokine targeting class. Overlapping and Differentiating Patents The patent landscape is complex due to overlapping claims and the development of molecules with slightly different mechanisms or targets. Direct IL-17A Inhibitors: Patents often claim antibodies that specifically bind to IL-17A. These are distinct from patent 9,393,237, which claims antibodies binding to both IL-17A and IL-17F. Dual IL-17A/IL-17F Inhibitors: Patent 9,393,237 falls into this category. Companies developing dual inhibitors need to navigate existing patents like this one, focusing on differentiation through novel epitopes, binding characteristics, or specific therapeutic uses. IL-17 Receptor (IL-17R) Inhibitors: Molecules like brodalumab (Amgen) target the IL-17 receptor, blocking the binding of all IL-17 family ligands (IL-17A, IL-17F, IL-17C, IL-17E). Patents in this area protect antibodies that bind to the IL-17R. Patent 9,393,237's focus is on binding the ligands themselves. Patents on Formulations and Manufacturing: Beyond the core antibody and its use, extensive patenting occurs around specific formulations, dosage regimens, methods of manufacturing, and methods of use for particular disease indications. Potential for Litigation and Licensing The crowded patent landscape for IL-17 therapeutics increases the likelihood of patent litigation. Companies must conduct thorough freedom-to-operate (FTO) analyses to ensure their development programs do not infringe on existing patents. Conversely, companies holding strong patents, such as Amgen with 9,393,237, may have leverage for licensing negotiations or for defending their market position. The claims of patent 9,393,237, by covering dual IL-17A/IL-17F inhibitors and specific patient selection methods, create a distinct area of protection within the broader IL-17 field. Companies developing molecules targeting both IL-17A and IL-17F must carefully assess the scope of this patent. How Does Patent 9,393,237 Fit into the Broader IP Strategy for IL-17 Therapies? Patent 9,393,237 is part of a comprehensive strategy to protect Amgen's investments in IL-17 biology. While Amgen's primary IL-17R inhibitor is brodalumab, patents like 9,393,237 likely cover alternative or complementary therapeutic approaches. Diversification of Target: The patent protects antibodies targeting the IL-17 cytokines directly, offering a different approach than IL-17R blockers. This diversifies Amgen's IP portfolio and potential therapeutic options. Claiming Dual Inhibition: The focus on dual IL-17A and IL-17F inhibition provides protection for antibodies with potentially broader efficacy in diseases where both cytokines play a role. Method of Treatment Claims: Method of treatment claims are crucial for protecting the use of a drug. This patent is structured to prevent others from using dual IL-17A/IL-17F antibodies in the claimed therapeutic contexts, even if the antibody itself is not directly claimed. Patient Selection: The inclusion of claims related to patient selection allows for the potential capture of value associated with personalized medicine, where identifying responders is key to therapeutic success and market penetration. Blocking Competitors: By securing patents that cover specific types of IL-17 inhibitors and their uses, Amgen can deter competitors from developing similar molecules or entering specific therapeutic niches without licensing. The strength of this patent lies in its specific, yet broad, method claims and the inclusion of binding affinity and epitope data, which provide specificity and enable enforcement. What are the Potential Implications for New Entrants or Generic Manufacturers? For new entrants or entities considering developing generic versions of IL-17 therapies, patent 9,393,237 presents several considerations: Freedom to Operate (FTO): Any company developing an antibody that binds to both IL-17A and IL-17F and is intended for use in treating IL-17 mediated inflammatory diseases must conduct a thorough FTO analysis against this patent, particularly if the antibody exhibits binding affinities and targets epitopes similar to those described. Product Life Cycle Management: The patent's term extends until July 19, 2033, meaning it remains a barrier for several years. Generic manufacturers of biologics typically enter the market after patent expiry, but biosimilar pathways can also be complex and involve patent challenges. Alternative Targets: New entrants may choose to focus on targets upstream or downstream of IL-17, or different IL-17 family members not covered by this patent, or explore IL-17R inhibitors if their IP landscape is clearer. Patent Challenges: In some cases, new entrants may attempt to invalidate existing patents through legal challenges, arguing non-obviousness, lack of novelty, or insufficient enablement. However, patent litigation is costly and uncertain. Biosimilar Development: For biosimilar development, the focus would be on demonstrating substantial similarity to an already approved and marketed biologic. If an approved biologic's development and marketing were protected by patent 9,393,237, then the biosimilar pathway would necessarily contend with this patent's expiry or potential challenges. However, patent 9,393,237 is a method of treatment patent, which can be distinct from a product patent for a specific antibody. What are the Key Competitive Factors Influenced by This Patent? Patent 9,393,237 influences the competitive landscape by: Defining a Protected Therapeutic Space: The patent clearly defines a segment of the IL-17 therapeutic market (dual IL-17A/IL-17F inhibition methods) as protected intellectual property. Encouraging Differentiation: Competitors are incentivized to develop IL-17 targeting molecules that do not infringe by, for example, targeting only IL-17A, IL-17F, or the IL-17 receptor, or by achieving different binding profiles. Impacting R&D Investment: The existence of such patents can guide R&D investment away from directly competing technologies or towards areas where freedom to operate is clearer. Facilitating Partnerships and Licensing: Companies with patented technologies can use them as assets in partnerships or for licensing revenue. Companies seeking to enter the protected space may need to license the patent. Shaping Clinical Trial Design: The patient selection claims might influence how competitors design their clinical trials, especially in terms of patient stratification based on IL-17 biomarkers. Key Takeaways United States Patent 9,393,237 protects methods for inhibiting IL-17A and IL-17F signaling and treating related inflammatory diseases through the administration of dual IL-17A/IL-17F binding antibodies. The patent's claims specify binding affinities and, in dependent claims, preferred epitopes and antibody types (humanized, chimeric). It also covers methods for selecting patients based on their likelihood of responding to such therapies, including detecting IL-17A or IL-17F levels. This patent contributes to a complex and competitive landscape for IL-17 therapeutics, requiring careful freedom-to-operate assessments and encouraging strategic differentiation by new entrants. Frequently Asked Questions Does patent 9,393,237 claim an antibody that targets only IL-17A or only IL-17F? No, the primary independent claims (Claim 1 and Claim 6) explicitly require the antibody to bind to both IL-17A and IL-17F. What is the expiration date of United States Patent 9,393,237? The patent is scheduled to expire on July 19, 2033. Can a company develop and sell an antibody that binds to IL-17A and IL-17F if it has a different mechanism of action than described in the patent? Infringement depends on the specific claims. If the antibody is administered via a method covered by the patent's claims, and meets the described binding characteristics, it could still infringe, regardless of additional novel mechanisms. Does this patent cover antibodies that bind to the IL-17 receptor? No, this patent specifically claims methods involving antibodies that bind to the IL-17A and IL-17F cytokines, not their receptor (IL-17R). What is the significance of the SEQ ID NOs mentioned in the patent's claims? The SEQ ID NOs likely refer to specific amino acid sequences of epitopes on IL-17A and IL-17F. Antibodies that bind to these particular epitopes are specifically protected by those claims. Cited Sources [1] Amgen Inc. (2016). United States Patent 9,393,237: Methods of inhibiting IL-17 signaling. 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
Legacy Pharma	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes	9,393,237	⤷ Start Trial				TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE	⤷ 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	2007282065	⤷ Start Trial
Brazil	PI0715087	⤷ Start Trial
Canada	2659577	⤷ Start Trial
China	101505759	⤷ Start Trial
Cyprus	1120867	⤷ Start Trial
Cyprus	1120902	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,393,237

Which drugs does patent 9,393,237 protect, and when does it expire?

Summary for Patent: 9,393,237