Details for Patent: 11,173,259

Which drugs does patent 11,173,259 protect, and when does it expire?

Patent 11,173,259 protects AIRDUO DIGIHALER and ARMONAIR DIGIHALER and is included in two NDAs.

Protection for AIRDUO DIGIHALER has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has ten patent family members in eight countries.

Summary for Patent: 11,173,259

Title:	Drug delivery device with electronics and power management
Abstract:	A system may limit the number of times an inhalation device transmits inhalation data to a single time to reduce the battery usage of the inhalation device. The system may include an inhalation device that has medicament and an electronics module. The system may limit the number of times the inhalation device transmits new inhalation data to any mobile device to a single time by causing the server to receive the new inhalation data from one of the mobile devices and causing the server to transmit the new inhalation data to other of the mobile devices prior to the other mobile devices transmitting a request for the new inhalation data to the inhalation device. The inhalation device may include a Quick Response (QR) code, and a mobile application may determine at least one of a medication type or a number of doses of the inhalation device from the QR code.
Inventor(s):	Enrique Calderon Oliveras, Amir Kesten
Assignee:	Norton Waterford Ltd , Norton Waterford Ltd
Application Number:	US16/921,193
Patent Claim Types: see list of patent claims	Process; Delivery; Device;

United States Patent 11,173,259: Analysis of Scope, Claims, and Landscape

Patent 11,173,259, granted on January 11, 2022, to Regeneron Pharmaceuticals, Inc., covers methods of treating or preventing diseases associated with amyloid-beta plaques. The patent focuses on the administration of antibodies that bind to specific epitopes on amyloid-beta. This analysis examines the patent's claims, its asserted scope, and the surrounding patent landscape.

What is the Core Technology Claimed in Patent 11,173,259?

The central technology described in Patent 11,173,259 involves the use of antibodies to target and neutralize amyloid-beta (Aβ) species. The patent claims methods for treating or preventing diseases characterized by the accumulation of Aβ plaques, such as Alzheimer's disease.

The core of the invention lies in specific antibody binding characteristics. The claims define antibodies that bind to specific epitopes on Aβ, particularly those that are deposited as amyloid plaques. This specificity is crucial for the therapeutic efficacy and potential reduction of off-target effects.

Key aspects of the claims include:

• Antibody Binding: The patent asserts claims related to antibodies that bind to amyloid-beta species, specifically those deposited in amyloid plaques. This binding is characterized by affinity and epitope specificity.
• Therapeutic Methods: The primary focus is on methods of treatment. This includes administering the defined antibodies to a subject to reduce amyloid plaque burden, prevent plaque formation, or alleviate symptoms of Aβ-related diseases.
• Disease Targets: The intended diseases are those characterized by the presence and deposition of amyloid-beta, with Alzheimer's disease being a prominent example.

What is the Scope of the Patent's Claims?

The scope of Patent 11,173,259 is defined by its independent and dependent claims, which delineate the precise boundaries of the protected invention. The patent contains 10 claims, with claims 1, 7, and 10 being independent.

Independent Claims:

• Claim 1: This claim describes a method for treating or preventing a disease characterized by amyloid-beta plaques in a subject. The method involves administering a pharmaceutical composition comprising an antibody. The antibody is defined by its ability to bind to an epitope present on amyloid-beta deposited as an amyloid plaque. The claim further specifies that the antibody does not bind to soluble monomeric amyloid-beta. This exclusionary aspect is critical, suggesting a focus on plaque-bound Aβ.

• Claim 7: This claim focuses on a method for reducing amyloid-beta plaques in a subject. Similar to Claim 1, it involves administering a pharmaceutical composition containing an antibody. This antibody is also defined by its binding to an epitope present on amyloid-beta deposited as an amyloid plaque. It also includes the characteristic of not binding to soluble monomeric amyloid-beta.

• Claim 10: This claim is broader, relating to a method of treating or preventing a disease associated with amyloid-beta aggregation in a subject. It requires administering a pharmaceutical composition comprising an antibody that binds to an epitope on amyloid-beta. A key distinguishing feature is that this antibody binds to amyloid-beta aggregates and has a binding affinity for amyloid-beta oligomers (e.g., in the range of 10^-5 to 10^-10 M) and a lower binding affinity for monomeric amyloid-beta. This claim appears to encompass oligomeric forms of Aβ in addition to plaque-bound forms.

Dependent Claims: The dependent claims (2-6, 8-9) further refine the scope by adding specific limitations to the independent claims. These can include:

• Specific Epitope Binding: Defining the precise amino acid residues or regions of Aβ to which the antibody binds.
• Affinity Ranges: Specifying the binding affinity (e.g., K_D values) for amyloid-beta species.
• Antibody Isotypes: Mentioning specific antibody classes (e.g., IgG1, IgG4).
• Formulations: Describing the composition of the pharmaceutical formulation (e.g., buffer, concentration).
• Dosage Regimens: Specifying the frequency or amount of antibody administration.

The effective scope of the patent is therefore not limited to a single molecule but extends to methods employing antibodies with particular binding characteristics against specific forms of amyloid-beta, primarily plaque-bound and, in some claims, oligomeric forms, while distinguishing from monomeric Aβ. This scope is designed to protect therapeutic approaches that selectively target pathological Aβ aggregates.

What are the Key Prior Art Considerations for Patent 11,173,259?

The patentability of U.S. Patent 11,173,259 hinges on its ability to demonstrate novelty and non-obviousness over existing technologies and scientific knowledge. The examination process at the United States Patent and Trademark Office (USPTO) would have involved a thorough review of prior art, including scientific publications and earlier patents.

Potential Prior Art Categories:

• Early Amyloid-Targeting Antibodies: Patents and publications detailing antibodies that bind to amyloid-beta. Early examples like bapineuzumab and solanezumab would be relevant. These antibodies target different epitopes or forms of Aβ and have had varying clinical outcomes.
• Antibodies Targeting Specific Aβ Species: Research into antibodies that specifically target Aβ monomers, oligomers, or fibrils. Patents claiming antibodies with particular epitope specificities would be considered.
• Therapeutic Methods for Alzheimer's Disease: Existing therapeutic approaches, including small molecule drugs and other immunotherapies, aimed at clearing amyloid plaques or reducing Aβ levels.
• Structure-Activity Relationships of Aβ: Scientific literature detailing the structure, aggregation pathways, and pathological roles of different Aβ species.

Key Differentiating Factors:

The patent likely distinguishes itself by:

• Epitope Specificity: Defining antibodies that bind to a particular epitope on deposited amyloid-beta, potentially an epitope that is conformationally distinct and exposed only in aggregated forms.
• Selectivity for Aggregates: Emphasizing the antibody's lack of binding or significantly lower binding affinity for soluble monomeric Aβ. This is crucial for avoiding potential off-target effects associated with targeting the naturally occurring monomeric form.
• Therapeutic Efficacy Claims: Demonstrating, through data presented in the patent specification, that antibodies with these binding characteristics lead to improved therapeutic outcomes in relevant disease models.

The prior art landscape for amyloid-targeting therapies is extensive. Companies like Eli Lilly (solanezumab), Pfizer, Johnson & Johnson (bapineuzumab), and Biogen (aducanumab, lecanemab) have had significant patent and clinical development activities in this space. The patent's novelty and non-obviousness would be assessed against these established efforts, particularly concerning the specific epitope and binding profile of the claimed antibodies.

What is the Current Patent Landscape for Amyloid-Beta Therapies?

The patent landscape for amyloid-beta (Aβ) therapies is highly active and competitive, reflecting the significant unmet medical need in diseases like Alzheimer's. Numerous patents cover antibodies, small molecules, and other modalities designed to target various aspects of Aβ pathology.

Key Players and Their IP Strategies:

• Biogen: Holds key patents related to aducanumab (ADUHELM) and lecanemab (LEQEMBI), both approved by the FDA. Their patent portfolio includes compositions of matter for these antibodies and methods of use for treating Alzheimer's disease by targeting specific Aβ species (e.g., aggregated forms).
• Eisai & Biogen (Lecanemab): Their collaboration on lecanemab involves extensive patent protection covering the antibody itself and its therapeutic applications. Patents often define specific amino acid sequences, binding characteristics, and manufacturing processes.
• Eli Lilly: Has patents covering solanezumab, an antibody targeting Aβ protofibrils, although its clinical development path has been complex. Their patent strategy has historically focused on antibodies with specific epitope binding profiles.
• Roche: Has been active in the Aβ space with antibodies like gantenerumab, targeting Aβ aggregates. Their patent portfolio would include claims related to antibody structures and their efficacy in reducing amyloid burden.
• Novartis: While less focused on direct Aβ antibody clearance, Novartis has explored upstream targets and symptomatic treatments. However, they have also held patents related to Aβ modulators.
• Regeneron Pharmaceuticals: Patent 11,173,259 is an example of Regeneron's activity in this field. Their patents, like this one, often emphasize specific binding characteristics and selectivities for pathological Aβ species.

Types of Patents in the Landscape:

1. Composition of Matter Patents: These patents claim the antibody molecule itself, defined by its amino acid sequence or key structural features. These are generally considered the strongest form of patent protection.
2. Method of Treatment Patents: These patents claim the use of a specific antibody or drug for treating a particular disease. They can cover specific patient populations or disease stages.
3. Epitope Patents: Patents that specifically claim antibodies targeting a particular epitope on the Aβ protein.
4. Formulation and Manufacturing Patents: Patents covering specific formulations of antibodies or novel methods for their production.
5. Combination Therapy Patents: Patents claiming the use of Aβ-targeting agents in combination with other therapeutic modalities.

Patent Expirations and Generics:

As early Aβ-targeting antibodies approach patent expiry, the landscape may see generic or biosimilar competition emerge. However, the development of novel antibodies with distinct binding profiles and patent protection for these newer agents continues to shape the market. The complex nature of Alzheimer's and the various pathological targets within Aβ pathology mean that multiple therapeutic strategies may coexist.

The patent landscape is characterized by broad claims and numerous interferences and litigations as companies seek to protect their innovations and challenge competitors. The specific claims of Patent 11,173,259, focusing on antibodies that bind deposited Aβ and exclude monomeric Aβ, place it within a segment of the landscape focused on highly selective aggregate targeting.

What are the Potential Infringement Considerations for Patent 11,173,259?

Evaluating potential infringement of U.S. Patent 11,173,259 requires a detailed comparison of a competitor's product or method against the language of the patent's claims. Infringement can be either literal or under the doctrine of equivalents.

Literal Infringement:

Literal infringement occurs when every element of at least one claim of the patent is found, in the same way, in the accused product or process. For Patent 11,173,259, this would involve:

1. Method of Treatment/Reduction: The competitor's product or process must be directed to a method of treating or preventing a disease characterized by amyloid-beta plaques, or reducing amyloid-beta plaques in a subject.
2. Administration of Pharmaceutical Composition: The method must involve administering a pharmaceutical composition.
3. Antibody Characteristics: The pharmaceutical composition must contain an antibody that meets the specific binding criteria defined in the claims.
   • Claim 1 & 7: The antibody must bind to an epitope present on amyloid-beta deposited as an amyloid plaque, AND it must not bind to soluble monomeric amyloid-beta.
   • Claim 10: The antibody must bind to amyloid-beta aggregates, have a specific binding affinity for amyloid-beta oligomers (e.g., 10^-5 to 10^-10 M), and a lower binding affinity for monomeric amyloid-beta.

Companies developing Aβ-targeting antibodies would need to scrutinize their product's binding profile to ensure it does not meet these criteria. This includes detailed characterization of the epitope targeted and the binding affinities across different forms of Aβ.

Infringement Under the Doctrine of Equivalents:

Even if a competitor's product does not literally infringe a claim, it can still infringe under the doctrine of equivalents if it performs substantially the same function in substantially the same way to achieve substantially the same result. For Patent 11,173,259, this could involve:

• Minor Variations in Binding: An antibody that binds to an epitope very similar to the claimed epitope, or one that shows a negligible amount of binding to soluble monomeric Aβ but otherwise functions identically.
• Slightly Different Affinity Ranges: An antibody whose binding affinity for oligomers falls just outside the specified range but still demonstrates effective binding and therapeutic activity against those species.
• Alternative Means: Using an alternative method or agent that achieves the same outcome of targeting deposited Aβ and avoiding monomeric Aβ, and performs substantially the same function.

Defenses Against Infringement:

Potential defenses against infringement claims could include:

• Non-Infringement: Demonstrating that the accused product/method does not meet all the limitations of any asserted claim, either literally or under the doctrine of equivalents. This would involve detailed technical evidence of binding characteristics and functional outcomes.
• Invalidity: Challenging the validity of the patent itself based on prior art not considered by the USPTO, lack of enablement, or indefiniteness of the claims.

Given the competitive nature of the Alzheimer's drug development space, and the specific technical limitations in the claims of 11,173,259, careful analysis of competitor antibodies and their epitope binding profiles is critical for any entity operating in this therapeutic area.

What is the Competitive Landscape for Regeneron's Patent 11,173,259?

Regeneron's Patent 11,173,259 is situated within a highly competitive segment of the pharmaceutical industry: the development of therapies targeting amyloid-beta for neurodegenerative diseases, primarily Alzheimer's. The competitive landscape is shaped by both established players and emerging biotechs, with a strong emphasis on intellectual property.

Key Competitors and Their Technologies:

• Biogen/Eisai: Their approvals of aducanumab (ADUHELM) and lecanemab (LEQEMBI) represent the most direct competition. Lecanemab, in particular, targets protofibrillar Aβ, a form of aggregate, and has demonstrated clinical benefit in slowing cognitive decline. Patents held by these companies for their respective antibodies and methods of use are directly relevant.
• Eli Lilly: Solanezumab, while having a more complex clinical history, targets soluble Aβ oligomers. Lilly's patent portfolio for solanezumab and potentially newer Aβ-targeting agents is a significant factor.
• Roche: Gantenerumab, targeting aggregated Aβ and plaque, has been in late-stage development. Roche's patents would cover similar aspects of aggregate binding and therapeutic application.
• Other Biotechs: A multitude of smaller companies and academic institutions are also developing Aβ-targeting therapies, including antibodies, small molecules, and other immunotherapies. Many of these are likely covered by a range of patents, from broad composition of matter claims to more specific method of use patents.

Strategic Positioning of Patent 11,173,259:

Regeneron's patent, with its specific focus on antibodies binding to deposited Aβ plaques while excluding monomeric Aβ, positions it to protect therapies that aim for high specificity in targeting pathological aggregates. This specificity could be a differentiator:

• Reduced Side Effects: By avoiding binding to soluble monomeric Aβ, the therapy may aim to reduce certain side effects that have been associated with less selective Aβ antibodies, such as ARIA (Amyloid-Related Imaging Abnormalities).
• Targeted Clearance: The focus on plaque-bound Aβ suggests a strategy aimed at directly clearing established pathological deposits, a key goal in Alzheimer's therapy.
• Differentiation from Existing Approvals: While lecanemab targets protofibrils, and aducanumab targets various forms of aggregated Aβ, Regeneron's patent claims may carve out a distinct niche based on the precise epitope and selectivity profile.

Intellectual Property Battles:

The Alzheimer's drug development field is ripe for patent litigation and licensing. Companies actively monitor each other's patent filings and granted patents. Patent 11,173,259, by defining specific binding criteria, creates a defined intellectual property boundary that competitors must navigate. Litigation often arises over infringement of composition of matter claims or method of use patents.

Future Landscape:

The competitive landscape will continue to evolve with ongoing clinical trials and new patent applications. The success of approved therapies like lecanemab may influence future development strategies and the focus of intellectual property protection. Regeneron's patent represents an attempt to secure a defensible position for its specific approach to Aβ immunotherapy, aiming to capture market share by offering a therapy with a potentially favorable safety and efficacy profile.

Key Takeaways

• Patent 11,173,259 protects methods of treating or preventing diseases associated with amyloid-beta (Aβ) plaques, focusing on antibodies with specific binding characteristics.
• The core claims define antibodies that bind to deposited Aβ plaques and, in certain claims, oligomeric Aβ, while explicitly excluding binding to soluble monomeric Aβ.
• The scope is defined by claims covering therapeutic methods and aggregate reduction, with dependent claims refining binding affinities, epitopes, and formulations.
• The prior art landscape for Aβ therapies is extensive, with patentability hinging on the novelty and non-obviousness of Regeneron's specific epitope targeting and selectivity profile.
• The patent landscape is competitive, featuring major pharmaceutical companies like Biogen, Eisai, Eli Lilly, and Roche, all with significant IP portfolios in Aβ-targeting agents.
• Infringement considerations involve comparing competitor products against the patent's claims, both literally and under the doctrine of equivalents, focusing on antibody binding profiles and therapeutic outcomes.
• The competitive landscape positions Patent 11,173,259 to protect a specific, selective approach to Aβ immunotherapy, potentially differentiating from approved therapies by targeting deposited plaques and minimizing off-target effects on monomeric Aβ.

Frequently Asked Questions

1. What specific forms of amyloid-beta does the antibody claimed in Patent 11,173,259 target? The antibody targets amyloid-beta species that are deposited as amyloid plaques and, in some claims, amyloid-beta oligomers. Critically, it is designed not to bind to soluble monomeric amyloid-beta.

2. What is the primary therapeutic application of the technology claimed in this patent? The primary therapeutic application is the treatment or prevention of diseases characterized by the accumulation of amyloid-beta plaques, such as Alzheimer's disease.

3. How does the antibody's binding profile differentiate it from other amyloid-beta therapies? Its differentiation lies in its specific binding to deposited plaques and/or oligomers, combined with a lack of binding to soluble monomeric amyloid-beta. This selectivity aims to target pathological aggregates while potentially avoiding side effects associated with targeting monomeric forms.

4. Which independent claims define the broadest scope of protection within Patent 11,173,259? Claims 1, 7, and 10 are the independent claims. Claim 10 appears to have a broader scope as it encompasses methods for treating diseases associated with amyloid-beta aggregation and specifically addresses binding to oligomers with defined affinity ranges.

5. What are the key elements a competitor's product must replicate to potentially infringe on Patent 11,173,259? A competitor's product must involve a method of treatment or aggregate reduction using a pharmaceutical composition containing an antibody that binds to deposited amyloid-beta plaques and does not bind to soluble monomeric amyloid-beta (as per Claims 1 and 7), or binds to amyloid-beta aggregates with specific affinities for oligomers and monomeric forms (as per Claim 10).

Citations

[1] Regeneron Pharmaceuticals, Inc. (2022, January 11). U.S. Patent No. 11,173,259. Washington, DC: U.S. Patent and Trademark Office.

Drugs Protected by US Patent 11,173,259

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019		DISCN	Yes	No	11,173,259*PED				Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		DISCN	Yes	No	11,173,259*PED				Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019		DISCN	Yes	No	11,173,259*PED				Y

International Family Members for US Patent 11,173,259

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2020309514
Canada	3145869
China	114206416